Geometrically complex intravaginal rings, systems and methods of making the same

Patent metadata

Field	Value
Publication number	US-12409134-B2
Application number	US-202217572196-A
Country	US
Kind code	B2
Filing date	Jan 10, 2022
Priority date	Mar 23, 2016
Publication date	Sep 9, 2025
Grant date	Sep 9, 2025

Abstract

Geometrically complex intravaginal rings, systems and methods of making the same are provided herein. Disclosed herein are geometrically complex intravaginal rings with tunable and enhanced drug release, which in some embodiments can be fabricated by 3D printing technologies. The disclosed IVRs include a ring structure comprising a plurality of unit cells or macroscopic and/or microscopic architecture, which can be tuned to control the loading capacity of an active compound within the IVR, the diffusion of an active compound from the IVR, the surface area of the IVR, and/or the mechanical properties of the IVR. The disclosed geometrically complex IVRs can provide superior control over drug loading and drug release compared to conventional IVRs fabricated by injection molding or hot-melt extrusion.

First claim

What is claimed is:

1. A method of fabricating a 3D printed intravaginal ring (IVR), comprising:
providing a template for the IVR, the template comprising:
a three dimensional ring structure comprising a body forming an inner diameter and an outer diameter;
a plurality of unit cells, each of the unit cells comprising a macroscopic architecture and/or microscopic architecture, wherein each of the unit cells forms a geometric shape, wherein the plurality of unit cells together form the body of the ring structure, wherein the IVR comprises one or more types of unit cells, wherein each type of unit cell varies in size, shape, configuration, surface area and/or three dimensional geometry; and
a void volume that is regularly or irregularly distributed continuously or in discrete volumes amongst the plurality of unit cells, wherein the void volume is greater than or equal to about 10;

providing a material from which the IVR is to be fabricated;
providing a 3D printing system; and
producing the IVR from the material using the 3D printing system based on the template.

2. The method of claim 1 , further comprising providing an active compound, wherein the active compound is incorporated into the IVR during or after 3D printing.

3. The method of claim 1 , further comprising providing an active compound, wherein the active compound is captured inside one or more nanoparticles incorporated into the IVR.

4. The method of claim 1 , further comprising providing an active compound, wherein the active compound is incorporated into the IVR after 3D printing by coating, absorption, infusion, or adsorption of the active compound onto the IVR.

5. The method of claim 1 , further comprising providing a gel compound, wherein the gel compound is incorporated into the IVR after 3D printing by filling the void volume of the IVR.

6. The method of claim 2 , wherein the active compound comprises a therapeutic compound selected from a group consisting of an antiviral, antiretroviral, microbicide, contraceptive, antibiotic, biologics, hormone, pre-exposure prophylaxis, small molecule drug, macromolecule drug, biopharmaceutical, chemotherapeutic, other pharmaceutical compound, and combinations thereof.

7. The method of claim 2 , wherein the plurality of unit cells are configured to control a loading capacity of the active compound within or on the IVR, a diffusion of the active compound from the IVR, a surface area of the IVR, and/or mechanical properties of the IVR.

8. The method of claim 1 , wherein the 3D printing system comprises a Continuous Liquid Interface Production (CLIP) system.

9. The method of claim 1 , wherein a shape, size, and/or surface area within the IVR is produced by the 3D printing.

10. The method of claim 1 , wherein physical and mechanical properties of the IVR are controlled by light intensity, print time, or print orientation during or after the 3D printing, the material used during the 3D printing, and/or a degree of cross-linking during or after the 3D printing.

11. The method of claim 1 , further comprising providing a computer readable medium having stored thereon executable instructions that when executed by a processor of a computer control the computer to perform the method.

12. The method of claim 11 , wherein the computer readable medium having stored thereon the executable instructions that when executed by the processor of the computer control the computer to generate a virtual three dimensional template of the IVR.

13. The method of claim 11 , wherein the computer readable medium having stored thereon the executable instructions that when executed by the processor of the computer control the computer to control the 3D printing system in communication with the computer, whereby the 3D printing system prints the IVR.

14. The method of claim 1 , wherein the IVR template can comprise a standard tessellation language (STL) file, the IVR template comprises an IVR with the inner diameter of about 45 mm to about 65 mm and cross-sectional diameter of about 5 mm to about 15 mm and the IVR template comprises a unit cell or cells selected and arrayed within the IVR template to generate a geometrically complex part.

15. The method of claim 14 , wherein the IVR template comprise the STL file, the IVR template comprises an IVR with a patient-specific inner diameter and cross-sectional diameter, a patient is selected from human, non-human primate, mouse or other mammal and the IVR template comprises a unit cell selected and arrayed within the template to generate a geometrically complex part.

16. The method of claim 1 , wherein the IVR template can be iteratively used to generate scaffold IVRs comprised of different unit cells.

17. The method of claim 1 , wherein the plurality of unit cells can range from about 0.1 mm to about 15 mm in three dimensions of X, Y and Z.

18. The method of claim 1 , wherein the macroscopic architecture and/or microscopic architecture of the unit cells is configured to control a loading capacity of the active compound within or on the IVR, a diffusion rate of the active compound from the IVR, a surface area of the IVR, a fractional volume of the IVR, and/or a mechanical property of the IVR.

Assignees

• Univ North Carolina Chapel Hill

Inventors

• Benhabbour Soumya Rahima
• Janusziewicz Rima
• Mecham Sue J

Classifications

• B29L2031/753

  Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008) · CPC title

• B29K2995/0093

  hydrophobic · CPC title

• B29K2283/00

  Use of polymers having silicon, with or without sulfur, nitrogen, oxygen or carbon only, in the main chain, as reinforcement · CPC title

• B29K2105/0035

  Medical or pharmaceutical agents · CPC title

• A61M2207/00

  Methods of manufacture, assembly or production · CPC title