Intravaginal ring device

Abstract

To reduce or eliminate temporal ring distortion occurring in an intravaginal ring device made of a copolymeric silicone matrix.SOLUTION: Provided is an intravaginal ring device including a flat and circular or elliptical ring made of a non-segmented, non-coated thermoplastic elastomer excluding copolymeric silicone, the ring containing one or more non-hormonal sperm-immobilizing agents. The ring surrounds a curved, non-absorbable polymer barrier attached to the ring, and the ring covers a uterine cervix when inserted into a subject.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure is in the field of women's health. More specifically, the disclosure relates to an intravaginal ring (IVR) device for use with non-hormonal contraception. The IVR device consists of a non-segmented or segmented ring made of an uncoated thermoplastic polymer surrounding a curved, non-absorbable barrier, which minimizes distortion to the ring structure due to absorption of vaginal fluids or humidity generated during storage of the device prior to use, compared to intravaginal devices made of a copolymer silicone matrix. [Background technology]

[0002] Applicant has discovered that intravaginal ring devices made with a copolymer silicone matrix can distort due to humidity or after a period of use on a subject, resulting in an IVR device that may not fit the subject properly and may result in an intravaginal device that does not function as well as a device that does not distort. The present disclosure relates to new intravaginal ring devices having ring components and / or ring shapes that reduce or eliminate ring distortion over time that occurs in intravaginal ring devices made with a copolymer silicone matrix, allowing for a better fit and more comfort for the subject using the device. Summary of the Invention

[0003] In one aspect of the present disclosure, disclosed herein is an intravaginal ring device having a flat, round or oval ring made of a non-segmented or segmented uncoated thermoplastic elastomer, excluding copolymer silicone. The ring may contain one or more non-hormonal sperm inhibitors, and the ring surrounds a curved, non-absorbable polymer barrier attached to the ring. When inserted into a subject, the ring covers the cervix.

[0004] In some embodiments, the flat, round, or oval intravaginal ring is made of a segmented uncoated thermoplastic elastomer.

[0005] In some embodiments, the number of segmented ring sections is two.

[0006] In some embodiments, the flat, round, or oval intravaginal ring is made of a non-segmented, uncoated thermoplastic elastomer.

[0007] In some embodiments, the uncoated thermoplastic elastomer of the flat, round, or oval intravaginal ring is selected from one or more of styrene-butadiene block copolymers, ethylene-vinyl acetate copolymers, poly(methyl methacrylate), poly(butyl methacrylate), poly(vinyl chloride), nylon, soft nylon, poly(ethylene terephthalate) (PET), poly(ethylene), poly(acrylonitrile), polychlorotrifluoroethylene (PCTFE), poly(ethylene-vinyl ester), poly(ethylene-vinyl acetate), poly(vinyl chloride-diethyl fumarate), poly(acrylic and methacrylic esters), poly(amide), poly(vinyl chloride), PTFE (polytetrafluoroethylene), poly(urethane), polypropylene, or other poly(olefins).

[0008] In some embodiments, the uncoated thermoplastic elastomer for the flat, round, or oval intravaginal ring is selected from one or more of ethylene vinyl acetate copolymer (EVA), polyurethane, or polyethylene terephthalate (PET).

[0009] In some embodiments, the uncoated thermoplastic elastomer for the flat, round, or oval intravaginal ring is EVA.

[0010] In some embodiments, the flat, round, or oval intravaginal ring has a polymeric barrier mesh composed of one or more polyolefins, nylon, and / or silk. In some embodiments, the polyolefin of the polymeric barrier mesh is polypropylene or polyethylene. In some embodiments, the polymeric barrier mesh is a monofilament or multifilament polymer. In some embodiments, the polymeric barrier mesh has pores ranging in size from about 100 to about 150 μm.

[0011] As used herein, the term "about" is used to mean approximately, roughly, in the vicinity of, or in the region of. When the term "about" is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term "about" is used herein to modify numerical values above and below the stated value by a variance of 20 percent above or below (higher or lower).

[0012] In some embodiments, the flat, round, or oval intravaginal ring device has a removal tab that aids in removing the ring after insertion. In some embodiments, the removal tab has a diameter that is about 10 mm in length.

[0013] In some embodiments, the flat, round, or oval intravaginal ring comprises one or more sperm-restoring metals and / or metal salts, hi some embodiments, the salts are selected from one or more of ferrous sulfate, ferrous gluconate, iron amino acid chelate, copper sulfate, copper gluconate, copper amino acid chelate, or copper oxide.

[0014] In some embodiments, the flat, round, or oval intravaginal ring comprises ascorbic acid.

[0015] In another aspect of the present disclosure, the flat, circular, or oval ring device is resistant to distortion of shape due to absorption of vaginal fluids and / or liquids contained in the packaging used to store the device prior to use.

[0016] In some embodiments, a flat, round, or oval ring intravaginal device absorbs less water or simulated vaginal fluid compared to an intravaginal ring made of a copolymer silicone matrix, where both rings contain equivalent amounts and compositions of non-hormonal sperm inhibitors and / or ascorbic acid.

[0017] In some embodiments, simulated vaginal fluid absorption by a flat circular ring intravaginal device is about 95% less, 90% less, 85% less, 80% less, 70% less, 60% less, 50% less, 40% less, 30%, 20% less, 10%, less, 5% less, 4% less, 3% less, 2% less, or 1% less than an intravaginal ring where both rings are made of a copolymer silicone matrix containing an equivalent amount and composition of non-hormonal sperm inhibitor.

[0018] In some embodiments, the simulated vaginal fluid absorption of a flat circular ring intravaginal device is about 1% to 95% less, or any range of less than about 1% to 95%, compared to an intravaginal ring made of a copolymerized silicone matrix containing an equivalent amount and composition of a non-hormonal sperm inhibitor, both rings.

[0019] In some embodiments of the present disclosure, disclosed herein is an intravaginal ring device that is a saddle-shaped oval ring made of a non-segmented or segmented uncoated thermoplastic elastomer, excluding copolymer silicone. The saddle-shaped intravaginal ring contains one or more non-hormonal sperm inhibitors, and the saddle-shaped oval ring surrounds a curved, non-absorbable polymer barrier attached to the ring. When inserted into a subject, the saddle-shaped oval ring covers the cervix.

[0020] In some embodiments, the thermoplastic elastomer of the saddle-shaped oval ring intravaginal device is selected from one or more of the group consisting of styrene-butadiene block copolymers, ethylene-vinyl acetate copolymers, poly(methyl methacrylate), poly(butyl methacrylate), poly(vinyl chloride), nylon, soft nylon, poly(ethylene terephthalate) (PET), poly(ethylene), poly(acrylonitrile), polychlorotrifluoroethylene (PCTFE), poly(ethylene-vinyl ester), poly(ethylene-vinyl acetate), poly(vinyl chloride-diethyl fumarate), poly(esters of acrylic and methacrylic acid), poly(amide), poly(vinyl chloride), PTFE (polytetrafluoroethylene) poly(urethane), polypropylene or other poly(olefins).

[0021] In some embodiments, the uncoated thermoplastic elastomer for the saddle-shaped oval ring intravaginal device is selected from one or more of ethylene vinyl acetate copolymer, polyurethane, or PET.

[0022] In some embodiments, the saddle-shaped oval ring intravaginal device has a polymeric barrier mesh composed of one or more polyolefins, nylon, and / or silk. In some embodiments, the polyolefin is polypropylene or polyethylene. In some embodiments, the polymeric barrier mesh is a monofilament or multifilament polymer. In some embodiments, the barrier has pores. In some embodiments, the barrier has pores in the size range of about 100-150 μm.

[0023] In some embodiments, the saddle-shaped oval ring intravaginal device comprises one or more sperm-restoring metals and / or metal salts, hi some embodiments, the salts are selected from one or more of ferrous sulfate, ferrous gluconate, iron amino acid chelate, copper sulfate, copper gluconate, copper amino acid chelate, and copper oxide.

[0024] In some embodiments, the saddle-shaped oval ring intravaginal device comprises ascorbic acid.

[0025] In some embodiments, the saddle-shaped oval ring intravaginal device absorbs less simulated vaginal fluid or water compared to an intravaginal ring made of a copolymer silicone matrix containing a non-hormonal sperm inhibitor and, if present, ascorbic acid in comparable amounts and compositions, both rings.

[0026] In some embodiments, the amount of simulated vaginal fluid absorption of a saddle-shaped oval ring intravaginal device is about 95% less, 90% less, 85% less, 80% less, 70% less, 60% less, 50% less, 40% less, 30%, 20% less, 10%, less, 5% less, 4% less, or 5% less than an intravaginal ring made of a copolymer silicone matrix, where both rings contain an equivalent amount and composition of non-hormonal sperm inhibitor. 3% less, 2% less, or 1% less.

[0027] In some embodiments, the water absorption of the saddle-shaped oval ring intravaginal device is about 1% to 95%, or any range between about 1% to 95%, compared to an intravaginal ring where both rings are made of a copolymer silicone matrix containing a comparable amount and composition of non-hormonal sperm inhibitor. [Brief explanation of the drawings]

[0028] The figures depict exemplary modes of aspects and embodiments of the present disclosure, however, the scope of the invention is not limited to the specific embodiments disclosed in these figures, and are for illustrative purposes only, as alternative embodiments may be utilized with similar results. [Figure 1] FIG. 1 illustrates a perspective view of an intravaginal ring device of the present disclosure with a curved polymeric barrier and a flat circular ring. [Figure 2] FIG. 2 is a side view of the intravaginal device of FIG. 1, also showing the rounded or curved cross section of the ring. [Figure 3] FIG. 1 illustrates a perspective view of an intravaginal ring device of the present disclosure with a saddle-shaped ring and a curved polymer barrier. [Figure 4] FIG. 4 is a side view of the intravaginal ring device of FIG. 3, also showing the rounded or curved cross section of the saddle-shaped ring. [Figure 5] FIG. 1 is a perspective view of an intravaginal ring device of the present disclosure with a segmented ring, a curved polymer barrier, and a removal tap. [Figure 6] FIG. 6 is a side view of the intravaginal device of FIG. 5, also showing the rounded or curved cross section of the ring. DETAILED DESCRIPTION OF THE INVENTION

[0029] Disclosed herein is an intravaginal ring (IVR) device. In some embodiments, the intravaginal ring device comprises a flat, round, or oval ring made of a non-segmented or segmented, uncoated thermoplastic elastomer, excluding copolymer silicone. The ring surrounds a curved, non-absorbable polymer barrier attached to the ring, and the ring covers the cervix.

[0030] In another embodiment, the IVR device disclosed herein is a saddle-shaped oval ring made of a segmented or segmented uncoated thermoplastic elastomer, surrounding a curved non-absorbable polymer barrier attached to the ring, which covers the cervix when inserted into a subject.

[0031] As used herein, a thermoplastic elastomer is a copolymer or blend of polymers that has thermoplastic and elastomeric properties and excludes silicone polymers.

[0032] Thermoplastic polymers suitable for the IVR devices disclosed herein include polymers and copolymers that can be softened by heating and hardened by cooling through a temperature range characteristic of the polymer, its crystalline melt or glass transition temperature, and that can be molded in the softened state into a system by molding or extrusion. Thermoplastic polymers suitable for this purpose are permeable to non-hormonal sperm inhibitors, ascorbic acid, antibacterial agents, antifungal agents, and absorb small amounts of vaginal fluids when inserted into a subject.

[0033] Examples of thermoplastic polymers that can be used to manufacture the disclosed IVR devices include, but are not limited to, ethylene vinyl acetate copolymers, poly(methyl methacrylate), poly(butyl methacrylate), poly(vinyl chloride), nylon, soft nylon, poly(ethylene terephthalate) (PET), poly(ethylene), PCTFE (polychlorotrifluoroethylene), poly(ethylene-vinyl ester), poly(ethylene-vinyl acetate), poly(vinyl chloride-diethyl fumarate), poly(esters of acrylic and methacrylic acid), poly(amides), poly(vinyl chloride), poly(urethane), polypropylene, and other poly(olefins). These polymers and their physical properties are known in the art, and they can be synthesized according to procedures disclosed in Encyclopedia of Polymer Science and Technology, Vol. 15, pp. 508-530, 1971, published by Interscience Publishers, Inc., New York; Polymer, Vol. 17, pp. 938-956, 1976; Technical Bulletin SCR-159, 1965, Shell Corp., New York, and the references cited therein.

[0034] In some embodiments, the ring of the disclosed IVR device comprises one or more sperm-resting metals and / or metal salts, which may be selected from one or more of ferrous sulfate, ferrous gluconate, iron amino acid chelate, copper sulfate, copper gluconate, copper amino acid chelate, and copper oxide.

[0035] In some embodiments, the rings of the disclosed IVR devices comprise ascorbic acid.

[0036] In some embodiments, the IVR device comprises an antibacterial and / or antifungal agent.

[0037] In some embodiments, the IVR device does not absorb as much vaginal fluid from a subject using the device as compared to an intravaginal ring device made from a copolymer silicone matrix.

[0038] The ability of the disclosed IVR devices to absorb less vaginal fluid or water compared to vaginal rings made of polymeric silicone can be tested in vitro using a liquid such as water or simulated vaginal fluid. Example 4 provides a method for testing the absorption of simulated vaginal fluid by an IVR device.

[0039] In some embodiments, the IVR devices disclosed herein exhibit less distortion than intravaginal ring devices made from a copolymer silicone matrix when used in a subject for a period of about 14 days to about 3 months, or when stored in moisture-sensitive packaging prior to use. Thus, the disclosed rings maintain their shape longer than intravaginal ring devices made from a copolymer silicone matrix, resulting in better fit, performance, and comfort in subjects using the disclosed devices.

[0040] In some embodiments, the device can be used for at least 14 days.

[0041] In some embodiments, the intravaginal ring devices disclosed herein are non-absorbable in the subject.

[0042] In some embodiments, the polymeric barrier of the intravaginal devices disclosed herein is a mesh made of one or more polyolefins, nylon, and / or silk. In some embodiments, the polyolefin is polypropylene or polyethylene. In some embodiments, the polymeric barrier is a monofilament or multifilament polymer. In some embodiments, the polymeric barrier has pores in the size range of about 100-150 μm.

[0043] The pore size can be measured using a microscope.

[0044] In order to facilitate a more complete understanding of the present invention, the following examples are provided. The following examples set forth exemplary modes of making and practicing the invention. However, the scope of the present invention is not limited to the specific embodiments disclosed in these examples, which are for illustrative purposes only, as alternative methods may be utilized to achieve similar results. Example Example 1: Flat Ring

[0045] The barrier mesh of the ring device shown in Figure 1 is fabricated by extruding poly(propylene), nylon, or poly(ethylene), multifilament or monofilament, and using a 3D knitting machine and warp knitting pattern to create a spherical cap shape. The spherical cap shape has an outer diameter of approximately 50 mm (millimeters) and a height of approximately 15 mm.

[0046] Alternatively, we knitted multifilaments or monofilaments of sericin-free silk fibroin using a 3D knitting machine with a warp knitting pattern to create a spherical crown-shaped shape in which part of the sphere is cut off with a saddle rather than a flat surface (Figure 3). The spherical crown shape has an outer diameter of approximately 50 mm (millimeters) and a height of approximately 15 mm.

[0047] The intravaginal contraceptive ring device shown in Figure 1 is prepared using poly(ethyl-co-vinyl acetate) (EVA), approximately 500 milligrams of ferrous gluconate, and approximately 400 mg of ascorbic acid dissolved in approximately 10 mL of a nonpolar solvent such as dichloromethane in a scintillation vial. Approximately 4,000 mg of EVA is then added to the solution and a polymer mixture is prepared by mixing the EVA / drug composition using a rotary shaker. The resulting mixture is then solvent-cast in dry ice using ethanol as the solvent. The solvent is allowed to evaporate overnight, and the dried EVA / drug mixture is then ground into a powder. The EVA / drug powder is placed in an injection molding unit. The injector is heated to approximately 80°C. The barrier mesh is held in a stainless steel mold using an insert molding fixture, and the molten EVA / drug composition is then extruded into the stainless steel mold to create a finished device with an outer diameter of approximately 55 mm and a cross-sectional area of approximately 4 mm.

[0048] Alternatively, the intravaginal contraceptive ring device shown in Figure 1 is prepared using a process similar to that described above, using polyurethane or polyethylene terephthalate as the ring material and copper gluconate and ascorbic acid as sperm inhibitors. Example 2: Saddle Ring

[0049] The barrier mesh for the ring device shown in Figure 3 is made by extruding poly(propylene), nylon, or poly(ethylene), multi- or monofilament, and using a 3D knitting machine and warp knitting pattern to create a spherical cap-type shape in which part of the sphere is cut off by a saddle instead of a flat surface (Figure 3). The spherical crown shape has an outer diameter of approximately 50 mm (millimeters) and a height of approximately 15 mm.

[0050] Alternatively, we knitted multifilaments or monofilaments of sericin-free silk fibroin using a 3D knitting machine with a warp knitting pattern to create a spherical crown-shaped shape in which part of the sphere is cut off with a saddle rather than a flat surface (Figure 3). The spherical crown shape has an outer diameter of approximately 50 mm (millimeters) and a height of approximately 15 mm. Example 3: Flat ring with removal tab

[0051] The barrier mesh for the ring device is created using the process in Example 1 above.

[0052] The intravaginal contraceptive ring device shown in Figure 5 is prepared using poly(ethyl-co-vinyl acetate) (EVA). Approximately 250 milligrams of ferrous gluconate is dissolved in approximately 5 mL of a nonpolar solvent, such as dichloromethane, in a scintillation vial. Approximately 2000 mg of EVA is then added to the solution and a polymer mixture is prepared by mixing the EVA / drug composition using a rotary shaker.

[0053] EVA / ascorbic acid semicircles are prepared using the process described above. Two semicircles are then welded together to form a complete circle with an outer diameter of approximately 55 mm and a semicircular cross section.

[0054] The EVA is then placed in an injection molding unit. The mold is circular, approximately 55 mm in outer diameter, with a removal tab protruding from one side and a semicircular cross-sectional diameter of approximately 4 mm. The injector is heated to approximately 80°C, and the molten EVA / ferrous gluconate is then extruded into a stainless steel mold. The two ring halves are then welded together with a central barrier mesh to create the finished device.

[0055] Alternatively, the intravaginal contraceptive ring device shown in Figure 5 is prepared using a process similar to that described above, using polyurethane or polyethylene terephthalate as the ring material and copper gluconate and ascorbic acid as sperm inhibitors. Example 4 - Measurement of absorption of synthetic vaginal fluid

[0056] The IVR device of the present disclosure is weighed on an analytical balance. It is then submerged in approximately 100 mL of simulated vaginal fluid (SVF) at 37°C for 14-35 days. To create simulated vaginal fluid, see, for example, Rastogi R et al. (2016), "Engineering and Characterization of Simplified Vaginal and Seminal Fluid Simulants," Contraception, 2016, 93(4):337-346. The ring is then removed from the simulated vaginal fluid, patted dry with a Kimwipe, and reweighed. The ring is then placed in a vacuum oven to remove any absorbed moisture. The ring is then stored in the vacuum oven and dried to a constant weight. Its final dry weight is recorded.

[0057] The same process is performed with the comparator ring. Water absorption is quantified by subtracting the weight of the wet ring from the weight of the dry ring to determine the weight of water absorbed per ring. The weight of water absorbed by the comparator ring is divided by the weight of water absorbed by the comparator ring to quantify the percentage of water absorption subtracted.

Claims

1. 1. An intravaginal ring device comprising a flat, circular or oval ring made of a segmented, uncoated thermoplastic elastomer, excluding copolymer silicone, said ring containing one or more non-hormonal sperm inhibitors, said ring surrounding a curved, non-absorbable polymer barrier attached to said ring, said ring covering the cervix when inserted into a subject.

2. 10. The intravaginal ring device of claim 1, wherein the uncoated thermoplastic elastomer is selected from one or more of styrene-butadiene block copolymers, ethylene-vinyl acetate copolymers, poly(methyl methacrylate), poly(butyl methacrylate), poly(vinyl chloride), nylon, plasticized soft nylon, poly(ethylene terephthalate) (PET), poly(ethylene), poly(acrylonitrile), polychlorotrifluoroethylene (PCTFE), poly(ethylene-vinyl ester), poly(ethylene-vinyl acetate), poly(vinyl chloride-diethyl fumarate), poly(acrylic and methacrylic esters), poly(amide), poly(vinyl chloride), PTFE (polytetrafluoroethylene) poly(urethane), polypropylene or other poly(olefins).

3. 3. The intravaginal device of claim 2, wherein the uncoated thermoplastic elastomer is selected from ethylene vinyl acetate copolymer, polyurethane, or PET.

4. 4. The intravaginal ring device of claim 3, wherein the uncoated thermoplastic elastomer is an ethylene vinyl acetate copolymer.

5. The intravaginal ring device of any one of claims 1 to 4, wherein the polymeric barrier is a mesh made of one or more of polyolefin, nylon, and / or silk.

6. 6. The intravaginal ring device of claim 5, wherein the polyolefin is polypropylene or polyethylene.

7. The intravaginal ring device of any one of claims 1 to 6, wherein the mesh or barrier is a monofilament or multifilament polymer.

8. The intravaginal ring device of any one of claims 1 to 7, wherein the ring comprises one or more sperm-static metals and / or metal salts.

9. 9. The intravaginal ring device of claim 8, wherein the ring comprises a spermatogenic metal and / or salt selected from one or more of ferrous sulfate, ferrous gluconate, iron amino acid chelate, copper sulfate, copper gluconate, copper amino acid chelate, and copper oxide.

10. 10. The intravaginal ring device of claim 9, wherein the ring further comprises ascorbic acid.

11. 11. The intravaginal ring device of claim 10, further comprising a removal tab.

12. 12. The intravaginal ring device of any one of claims 1 to 11, wherein the intravaginal ring exhibits less distortion after storage or insertion into a subject for at least 14 days when compared to an intravaginal ring device where both rings are made of a copolymer silicone matrix containing an equivalent amount and composition of non-hormonal sperm inhibitor and / or ascorbic acid, if present.

13. An intravaginal ring device comprising a saddle-shaped oval ring made of a segmented, uncoated thermoplastic elastomer, excluding copolymer silicone, said ring containing one or more non-hormonal sperm inhibitors, said ring surrounding a curved, non-absorbable polymer barrier attached to said ring, said ring covering the cervix.

14. 14. The intravaginal ring device of claim 13, wherein the thermoplastic elastomer is selected from one or more of styrene-butadiene block copolymers, ethylene-vinyl acetate copolymers, poly(methyl methacrylate), poly(butyl methacrylate), poly(vinyl chloride), nylon, soft nylon, poly(ethylene terephthalate) (PET), poly(ethylene), poly(acrylonitrile), PCTFE, poly(ethylene-vinyl ester), poly(ethylene-vinyl acetate), poly(vinyl chloride-diethyl fumarate), poly(acrylic and methacrylic esters), poly(amide), poly(vinyl chloride), PTFE (polytetrafluoroethylene) poly(urethane), polypropylene or other poly(olefins).

15. 15. The intravaginal device of claim 14, wherein the thermoplastic elastomer is selected from ethylene vinyl acetate copolymer, polyurethane, or PET.

16. 16. The intravaginal ring device of claim 15, wherein the uncoated thermoplastic elastomer is an ethylene vinyl acetate copolymer.

17. The intravaginal ring device of any one of claims 13 to 16, wherein the barrier is a mesh made of one or more of polyolefin, nylon, and / or silk.

18. 18. The intravaginal ring device of claim 17, wherein the polyolefin is polypropylene or polyethylene.

19. The intravaginal ring device of any one of claims 13 to 18, wherein the mesh and / or barrier is a monofilament or multifilament polymer.

20. The intravaginal ring device of any one of claims 13 to 19, wherein the ring comprises one or more sperm-static metals and / or metal salts.

21. 21. The intravaginal ring device of claim 20, wherein the spermatogenic metal and / or metal salt is selected from one or more of ferrous sulfate, ferrous gluconate, iron amino acid chelate, copper sulfate, copper gluconate, copper amino acid chelate, copper oxide.

22. 22. The intravaginal ring device of any one of claims 13 to 21, wherein the intravaginal ring exhibits less distortion after storage or insertion into a subject for at least 14 days when compared to an intravaginal ring device where both rings are made of a copolymer silicone matrix containing an equivalent amount and composition of non-hormonal sperm inhibitor and / or ascorbic acid, if present.

23. An intravaginal ring device comprising a flat, circular or oval ring made of a segmented uncoated thermoplastic elastomer, excluding copolymer silicone, with a removal tab, said ring containing one or more non-hormonal sperm inhibitors, said ring surrounding a curved non-absorbable polymer barrier attached to said ring, said ring covering the cervix when inserted into a subject.

24. 24. The intravaginal ring device of claim 23, wherein the uncoated thermoplastic elastomer is chosen from one or more of styrene-butadiene block copolymers, ethylene-vinyl acetate copolymers, poly(methyl methacrylate), poly(butyl methacrylate), poly(vinyl chloride), nylon, soft nylon, poly(ethylene terephthalate) (PET), poly(ethylene), poly(acrylonitrile), PCTFE, poly(ethylene-vinyl ester), poly(ethylene-vinyl acetate), poly(vinyl chloride-diethyl fumarate), poly(acrylic and methacrylic esters), poly(amide), poly(vinyl chloride), PTFE (polytetrafluoroethylene) poly(urethane), or polypropylene or other poly(olefins).

25. 25. The intravaginal ring device of claim 24, wherein the thermoplastic elastomer is selected from ethylene vinyl acetate copolymer, polyurethane, or PET.

26. 26. The intravaginal ring device of claim 25, wherein the thermoplastic elastomer is an ethylene vinyl acetate copolymer.

27. The intravaginal ring device of any one of claims 23 to 26, wherein the barrier is a mesh made of one or more of polyolefin, nylon, and / or silk.

28. 28. The intravaginal ring device of claim 27, wherein the polyolefin is polypropylene or polyethylene.

29. The intravaginal ring device of any one of claims 23 to 28, wherein the barrier or mesh is a monofilament or multifilament polymer.

30. The intravaginal ring device of any one of claims 23 to 29, wherein the intravaginal ring device comprises one or more sperm-static metals and / or metal salts.

31. 31. The intravaginal ring device of any one of claims 23 to 30, wherein the spermatogenic metals and / or salts are selected from one or more of ferrous sulfate, ferrous gluconate, iron amino acid chelate, copper sulfate, copper gluconate, copper amino acid chelate, copper oxide.

32. 32. The intravaginal ring device of claim 31, wherein one segment of the ring comprises a sperm-inhibiting metal and / or metal salt and another segment further comprises ascorbic acid.

33. 33. The intravaginal device of any one of claims 23-32, wherein the intravaginal ring experiences less distortion after storage or insertion into a subject for at least one week when compared to an intravaginal ring device having at least two segments, both rings made from a copolymer silicone matrix containing an equivalent amount and composition of a non-hormonal sperm inhibitor and ascorbic acid.

34. 33. The intravaginal ring device of any one of claims 23-32, wherein the intravaginal ring experiences less distortion after storage in a package containing a subject or after insertion into a subject for at least 14 days when compared to an intravaginal ring device where both rings are made of a copolymer silicone matrix containing an equivalent amount and composition of non-hormonal sperm inhibitor and / or ascorbic acid, if present.

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