Intrauterine device for managing the reproductive process

• US 3,903,880 A
• Filed: 08/17/1972
• Issued: 09/09/1975
• Est. Priority Date: 08/17/1972
• Status: Expired due to Term

• Current Assignee: Anwar Hussain, Takeru Higuchi
• Original Assignee: Anwar Hussain, Takeru Higuchi
• Inventors: Higuchi, Takeru, Hussain, Anwar
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US05/281,446
• Time in Patent Office: 1,118 Days
• Field of Search: 424/19-22 128/260,130,131
• US Class Current: 128/833
• CPC Class Codes: A61F 6/14 intra-uterine type
• CPC Class Codes: A61F 6/142 Wirelike structures, e.g. loops, rings, spirals
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61K 9/0039 Devices retained in the uterus for a prolonged period, e.g. intrauterine devices for contraception
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

Drug-delivery device for releasing a drug at a continuous and controlled rate for a prolonged period of time is comprised of a shaped body of polymeric material containing a pharmaceutically acceptable drug and permeable to passage of the drug by diffusion. The polymeric material is an ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight and a melt index of about 0.1 to 1000 grams per 10 minutes.

Claims

1. IN AN INTRAUTERINE DEVICE FOR CONTROLLING FERTILITY COMPRISING A BODY OF POLYMERIC MATERIAL CONTAINING A PROGESTATIONAL STEROID CAPABLE OF DIFFUSING THROUGH SAID POLYMERIC MATERIAL AT A FERTILITY CONTROLLING RATE, SAID BODY BEING ADAPTED FOR INSERTION AND RETENTION IN THE UTERINE LUMEN, THE IMPROVEMENT WHEREIN SAID INTRAUTERINE POLYMERIC BODY IS COMPRISED OF UTERINE ACCEPTABLE ETHYLENE-VINYL ACETATE COPOLYMER HAVING A VINYL ACETATE CONTENT OF ABOUT 4 TO 80% BY WEIGHT, A MELT INDEZ OF 0.1 TO 1,000 GRAMS PER TEN MINUTES AND PERMABLE TO THE PROGESTATIONAL STEROID WITH THE STEROID DISSOLVING IN AND PASSING THROUGH THE ETHYLENE-VINYL ACATATE COPOLYMER BY DIFFUSION.

2. In an intrauterine device for controlling fertility comprising a body of polymeric material surrounding a reservoir containing from 250 nanograms to 5 grams of an anti-fertility progestational steroid capable of diffusing through said polymeric material at a fertility controlling rate, said body shaped and adapted for insertion and retention in the uterine lumen for a prolonged period of time, the improvement wherein said intrauterine polymeric body is comprised of biologically compatible ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight, a melt index of about 0.1 to 1,000 grams per minute, a density having a range of about 0.920 to 0.980, and a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8, and permeable to the progestational steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion for releasing said progestational anti-fertility steroid in an effective amount to a uterine lumen for controlling fertility.

3. In an intrauterine device for controlling fertility according to claim 2 wherein the anti-fertility steroid is progesterone and the ethylene-vinyl acetate copolymer has a vinyl acetate content of about 4 to 50% by weight and a melt index of 0.5 to 250 grams per ten minutes.

4. A method for controlling fertility which method is comprised of placing in the uterine lumen of a warm blooded female animal an intrauterine device for controlling fertility comprising a body of a polymeric material surrounding a reservoir containing from 250 nanograms to 5 grams of an anti-fertility progestational steroid, and capable of diffusing through said polymeric material in a fertility controlling rate, said body being adapted for insertion and retention in the uterine lumen, the improvement wherein said intrauterine polymeric body is comprised of an ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight, a melt index of about 0.1 to 1,000 grams per minute, a density having a range of about 0.920 to 0.980 an a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8, and permeable to the progestational steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion in a fertility controlling effective amount for controlling fertility in the uterine cavity.

5. A method for controlling fertility which method is comprised of placing an intrauterine device for controlling fertility of claim 4 in the uterine cavity wherein the anti-fertility agent is progesterone.

6. In an intrauterine device for controlling fertility comprising a body of polymeric material adapted for insertion and retention in the uterine lumen for a prolonged period of time, said material containing from 250 nanograms to 5 grams of a fertility controlling progestational steroid capable of diffusing through said polymeric material in an amount effective for controlling fertility, the improvement wherein the intrauterine polymeric material is comprised of essentially shaped retaining ethylene vinylacetate copolymer having a vinylacetate content of 4 to 50% by weight, a melt index of 0.5 to 250 grams per 10 minutes, a density of 0.920 to 0.980, a frequency of acetoxy groups on the polyethylene of 1/150 to 1/8 and permeable to the progestational steroid with the steroid dissolving in and passing through the ethylene vinylacetate copolymer in an effecTive amount for controlling fertility by diffusion.

7. In an intrauterine device for controlling fertility comprising a body of polymeric material containing from 250 nanograms to 5 grams of an anti-fertility estrogenic steroid capable of diffusing through said polymeric material at a fertility controlling rate, said body being shaped and adapted for insertion and retention in the uterine lumen for a prolonged period of time, the improvement wherein said intrauterine polymeric body is comprised of uterine acceptable ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight, a melt index of about 0.1 to 1,000 grams per ten minutes, and a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8, and wherein the ethylene-vinyl acetate copolymer is permeable to the estrogenic steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion for controlled release to a uterine lumen in an effective amount for controlling fertility.

8. In an intrauterine device for controlling fertility comprising a body of polymeric material surrounding a reservoir containing from 250 nanograms to 5 grams of an anti-fertility estrogenic steroid capable of diffusing through said polymeric material in an effective amount for controlling fertility, said body being adapted for insertion and retention in the uterine lumen for a prolonged period of time, the improvement wherein said intrauterine polymeric body is comprised of biologically compatible ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight, a melt index of about 0.1 to 1,000 grams per minute, a density having a range of about 0.920 to 0.980, and a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8 for releasing said anti-fertility steroid, and permeable to the estrogenic steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion for controlled release to a uterine lumen for controlling fertility.

9. A method for controlling fertility which method is comprised of placing in the uterine lumen of a warm blooded female animal an intrauterine device for controlling fertility comprising a body of a polymeric material surrounding a reservoir containing from 250 nanograms to 5 grams of an anti-fertility estrogenic steroid, and capable of diffusing through said polymeric material in a fertility controlling rate, said body being shaped and adapted for insertion and retention in the uterine lumen for a prolonged period of time, the improvement wherein said intrauterine polymeric body is comprised of an ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight, a melt index of about 0.1 to 1,000 grams per minute, a density having a range of about 0.920 to 0.980 and a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8, and permeable to the estrogenic steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion in a fertility controlling effective amount for controlling fertility in a uterine cavity.

10. In an intrauterine device for controlling fertility comprising a body of polymeric material surrounding a reservoir containing from 250 nanograms to 5 grams of a fertility controlling estrogenic steroid and capable of diffusing through said polymeric material in an effective amount for controlling fertility, said body being shaped and adapted for insertion and retention for a prolonged period of time in the uterine lumen, the improvement wherein the intrauterine polymeric body is comprised of essentially shaped retaining pharmaceutically acceptable ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 50% by weight, a melt indeX of 0.5 to 250 grams per ten minutes, a density of 0.920 to 0.980, a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8, and permeable to the estrogenic steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer by diffusion in an effective amount for controlling fertility in a uterine lumen.