Claims for Patent: 4,393,871

Summary for Patent: 4,393,871

Title:	Vaginal device
Abstract:	A vaginal device adapted for insertion and placement in the human vaginal cavity and subsequent removal therefrom for the administration of spermicide or a variety of medications such as anti-infectives, anti-inflammatories, estrogens, progestogens, and the like. When used as a contraceptive, the vaginal device covers/blocks the cervix, soaks up and traps sperm, and slowly releases a spermicide.
Inventor(s):	Vorhauer; Bruce W. (Irvine, CA), Dobbie, Jr.; Thomas A. (Newport Beach, CA)
Assignee:	VLI Corporation (Costa Mesa, CA)
Application Number:	06/249,228
Patent Claims:	1. A vaginal device adapted for insertion and placement in the human vaginal cavity and subsequent removal therefrom, comprising: a spermicide-foaming agent in a dry weight percentage of from about 10% to about 50%, and a water-catalyzed foamed urethane polymer from which the spermicide is slowly released from the sponge during use. 2. The vaginal device of claim 1 including a drug for local delivery to the vaginal area, which drug is slowly released from the device during use. 3. The vaginal device of claim 1 including a non-toxic acid for lowering the pH of the device to between 4.0 and 5.0. 4. The vaginal device of claim 1 wherein the dry weight percentage of spermicide-foaming agent is at least 30%. 5. The vaginal device of claim 1 wherein the spermicide-foaming agent is nonylphenoxy polyethoxyethanol. 6. The vaginal device of claim 1 wherein the urethane polymer is water catalyzed from an isocyanate-capped hydrophilic polyoxyethylene polyol. 7. The vaginal device of claim 1 being in the shape of a flattened ball, one side of the device having a recess contoured to fit over the os of the cervix. 8. The vaginal device of claim 1 wherein the dry weight percentage of the spermicide-foaming agent is at least 30%. 9. A vaginal device adapted for insertion and placement in the human female vaginal cavity and subsequent removal therefrom, for the local administration of a drug, comprising: a drug for local delivery to the vaginal area, a foaming agent in a dry weight percentage of form about 10% to about 50%, and a water-catalyzed foamed urethane polymer from which the drug is slowly released from the sponge during use. 10. The vaginal device of claim 9 wherein the drug is selected from the group consisting of anti-infectives, anti-inflammatories, estrogenic steroids, progestational agents, and prostaglandins. 11. The vaginal device of claim 9 being in the shape of a flattened ball, one side of the device having a recess contoured to fit over the os of the cervix. 12. A method for forming a vaginal device adapted for insertion and placement in the human vaginal cavity and subsequent removal therefrom; and mixing from about 10% to 50% by dry weight of a foaming agent with a water-catalyzed, foam-forming urethane prepolymer and a dry agent for local delivery to the vaginal area; and permitting the mixture of prepolymer, compound, and foaming agent to foam and form a stable, flexible, sponge-like structure from which the drug is slowly released from the sponge-like structure while in the vagina over a period of time. 13. The vaginal device of claim 12 being in the shape of a flattened ball, one side of the device having a recess contoured to fit over the os of the cervix. 14. The method of claim 12 wherein the foaming agent is a spermicide. 15. The method of claim 12 wherein the drug is selected from the group consisting of anti-infectives, anti-inflammatories, estrogenic steroids, progestational agents, and prostaglandins. 16. The method of claim 12 wherein the urethane prepolymer is an isocyanate-capped hydrophilic polyoxyethylene polyol. 17. A method for forming a vaginal device adapted for insertion and placement in the human vaginal cavity and subsequent removal therefrom, the device for the local administration of a spermicide, comprising: mixing from about 10% to about 50% by dry weight of a spermicide-foaming agent with a water catalyzed, foam-forming urethane prepolymer; and permitting the mixture of prepolymer and spermicide-foaming agent to foam and form a stable, flexible, sponge-like structure from which the spermicide-foaming agent is slowly released from the sponge structure while in the vagina over a period of time. 18. The method of claim 17 wherein the prepolymer is an isocyanate-capped hydrophilic polyoxyethylene polyol. 19. The method of claim 17 wherein the spermicide-foaming agent is nonylphenoxypoly ethoxyethanol. 20. The method of claim 17 wherein the dry weight percentage of spermicide-foaming agent is at least 30%. 21. The method of claim 17 wherein a drug intended for local delivery to the vaginal area is mixed with the spermicide-foaming agent and the prepolymer. 22. The method of claim 17 wherein a non-toxic acid is mixed with the spermicide-foaming agent and the prepolymer in quantity sufficient to lower the pH of the device to between about 4.0 and 5.5. 23. The method of claim 17 wherein the vaginal device is generally in the shape of a flattened ball, one side of the device having a recess contoured to fit over the os of the cervix. 24. A method of delivering an effective amount of a drug to the vaginal area comprising inserting into the human female vagina the device of claim 2.