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Details for Patent: 3,845,761

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Details for Patent: 3,845,761

Title: INTRAUTERINE CONTRACEPTIVE ANTI-FERTILITY DEVICE FOR THE MANAGEMENT OF REPRODUCTION
Abstract:An intrauterine contraceptive delivery device for administering an anti-fertility agent at a controlled rate for a prolonged period of time is comprised of a shaped body having a cross member and a depending member defining a "T." The body is comprised of a wall surrounding at least one reservoir containing an anti-fertility agent. The reservoir is formed of a liquid carrier permeable to the passage of the agent and in which the agent has limited solubility. The wall surrounding the reservoir is formed in at least a part of a release rate controlling material permeable to the passage of the agent, but the rate of passage of the agent through the wall is lower than the rate of passage through the carrier so that release by the wall is the release rate controlling step for releasing the anti-fertility agent from the "T" shaped intrauterine contraceptive anti-fertility delivery device.
Inventor(s): Zaffaroni; Alejandro (Atherton, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Filing Date:Aug 17, 1972
Application Number:05/281,445
Claims:1. A method of interfering with the reproductive process of a female mammal by continuously administering a contraceptive agent within the uterine cavity of said female over a prolonged period of time by the steps of: (a) inserting into the uterine cavity an intrauterine device comprising a reservoir containing dissolved agent and undissolved replacement agent in a liquid core material permeable to the passage of the agent, the undissolved replacement agent being present in an amount in excess of its solubility in the core and sufficient to maintain the dissolved agent during the prolonged period substantially equal to the amount of dissolved agent originally present in the core, the reservoir confined within an enveloping shape membrane substantially in the shape of a T comprised of a biologically acceptable material insoluble in mammalian body fluid, and formed at least in part of a material permeable by diffusion to passage of said agent at a rate which is lower than the rate of permeability of said agent through said core, (b) releasing said agent from said reservoir into the uterine cavity at a controlled, continuous, contraceptively effective rate by diffusional passage through said shaped membrane, and (c) continuously replacing the dissolved agent released from the reservoir by continuously dissolving said undissolved replacement agent in the core so as to substantially maintain the amount of dissolved drug at its originally present amount.

2. An intrauterine device for the administration of an anti-fertility agent at a controlled and continuous rate over a prolonged period of time to effect contraception, said device comprising: (a) a reservoir comprising both dissolved anti-fertility agent and undissolved replacement anti-fertility agent in a liquid core material permeable to the passage of the agent, with anti-fertility agent having limited solubility in the liquid core, the undissolved replacement anti-fertility agent being present in an amount in excess of its solubility in the core and in amounts sufficient to maintain the dissolved drug in an amount substantially equal to the amount of dissolved drug originally present in the core material during the prolonged period of time, said reservoir surrounded by, (b) a wall of a configuration which is substantially in the shape of a T, the wall made of a material insoluble in body fluid, and formed in at least a part of a release rate controlling material permeable to the passage of the anti-fertility agent, with the permeability of the wall to anti-fertility agent lower than the permeability of the liquid core material to anti-fertility agent, and (c) wherein the device when placed in the uterus continuously releases anti-fertility agent from the reservoir in a contraceptively effective amount by metered passage through the wall, with released anti-fertility agent being continuously replaced in the liquid core by replacement anti-fertility agent to substantially maintain the amount of dissolved anti-fertility agent at its initial present amount in the liquid core.

3. An intrauterine contraceptive device for the administration of an anti-fertility agent at a controlled and continuous rate over a prolonged period of time, said device comprising: (a) a reservoir comprising both dissolved anti-fertility agent and undissolved replacement anti-fertility agent in a liquid core permeable to the passage of the agent, with the anti-fertility agent having limited solubiltiy in the liquid core, the undissolved replacement anti-fertility agent contained in the liquid core in an excess amount to continuously replenish and maintain dissolved anti-fertility agent substantially at its original amount in the liquid core during the prolonged period of time, said reservoir surrounded by (b) a wall of a configuration which is substantially in the shape of a T, the wall made of a material insoluble in body fluid, and formed in at least a part of a release rate controlling material permeable to the passage of the anti-fertility agent, with the permeability of the wall to anti-fertility agent lower than the permeability of the liquid core to anti-fertility agent, and (c) wherein the intrauterine device when placed in the uterus releases dissolved anti-fertility agent from the reservoir in an effective amount for contraception by metered passage through the release rate controlling wall, with released anti-fertility agent continously replaced in the liquid core by replacement anti-fertility agent simultaneously dissolving to substantially maintain the amount of dissolved anti-fertility agent in the liquid core for release at a controlled and continuous rate over a prolonged period of time.

4. An intrauterine contraceptive device for the administration of an anti-fertility agent at a controlled and continuous rate for a prolonged period of time according to claim 3 wherein the release rate controlling material is a substantially homogenous material permeable to anti-fertility agent, the liquid core is a liquid medium containing anti-fertility agent that constantly bathes the inner surface of the release rate controlling material and is permeable to the passage of anti-fertility agent, and the anti-fertility agent is a progestogen.

5. An intrauterine contraceptive device for the administration of an effective amount of an anti-fertility agent at a controlled and continuous rate over a prolonged time according to claim 3 wherein the release rate controlling material is ethylene vinyl acetate copolymer, the liquid core is silicone oil and the anti-fertility agent is progesterone.

6. An intrauterine contraceptive device for the administration of an effective amount of an anti-fertility agent at a controlled and continuous rate over a prolonged period of time according Jo claim 3 wherein the liquid core is a mixture permeable to the passage of anti-fertility agent comprised of an oil, a liquid prepolymer and an anti-fertiltiy agent which is a progestational agent.

7. An intrauterine contraceptive device for administration of an anti-fertility agent at a controlled and continuous rate for a prolonged period of time according to claim 3 wherein the anti-fertility agent is a progestational agent.

8. An intrauterine contraceptive device for the administration of an anti-fertility agent at a controlled and continuous rate over a prolonged period of time according to claim 3 wherein said agent release rate controlling material is permeable to passage of dissolved anti-fertility agent by diffusion.

9. An intrauterine contraceptive device for the administration of an anti-fertility agent at a controlled and continuous rate over a prolonged period of time according to claim 3 wherein said release rate controlling material is a microporous material having its pores filled with a liquid medium permeable to passage of the anti-fertility agent by diffusion.

10. An intrauterine contraceptive device for the administration of an anti-fertility agent at a controlled and continuous rate over a prolonged period of time according to claim 3 wherein the liquid core is permeable to the passage of dissolved anti-fertility agent by diffusion.

11. An intrauterine contraceptive device for the administration of an anti-fertility agent at a controlled and continuous rate over a prolonged period of time according to claim 3 wherein the liquid core is an oil and the anti-fertility agent is a diffusible estrogenic agent.

12. An improved process of contraception wherein an intrauterine contraceptive device for the administration of an anti-fertility agent at a controlled and continuous rate over a prolonged period of time is placed within a fertile uterus, the improvement comprised of using an intrauterine contraceptive device having (a) a reservoir comprising a liquid core, liquid core containing, (b) both diffusible anti-fertility agent dissolved in the liquid core and undissolved replacement anti-fertility agent in the liquid core, the liquid core permeable to the passage of anti-fertility agent with the anti-fertility agent having limited solubility in the liquid core, the undissolved replacement anti-fertility agent contained in an amount sufficient to continuously dissolve to replenish and substantially maintain dissolved anti-fertility agent in the core for continuous availability at substantially the same rate to the wall during the prolonged period of time, the reservoir surrounded by (c) a wall of a configuration substantially in the shape of a T, the wall made of a material insoluble in body fluid, and formed of a release rate controlling material permeable to the passage of a diffusible anti-fertility agent with the permeability of the wall to the anti-fertility agent lower than the permeability of the liquid core to the anti-fertility agent, and (d) wherein during the process of contraception when the intrauterine device is placed in the uterus, the intrauterine device releases dissolved anti-fertility agent from the reservoir in an effective amount for contraception by metered passage through the release rate controlling wall, with released anti-fertility agent continuously replaced in the liquid core by replacement anti-fertility agent simultaneously dissolving to substantially maintain dissolved anti-fertility agent in the liquid core for release at a controlled and continuous rate over a prolonged period of time to produce contraception.

13. A process of contraception according to claim 12 for the controlled and continuous rate of release over a prolonged time wherein the reservoir consists of an oil and the anti-fertility agent is a diffusible estrogenic anti-fertility agent, or a diffusible progestational anti-fertility agent.

14. An intrauterine contraceptive device for administering a member selected from the group of anti-fertility agents consisting of progestational, estrogenic and mixtures thereof at a controlled and constant rate over a prolonged period of time up to three years comprising: (a) a wall substantially in the shape of a T comprising the anti-fertility device and formed of a release rate controlling material permeable to the passage of the anti-fertility agent by diffusion, the material insoluble in body fluid, and capable of substantially maintaining the device's shape throughout the prolonged period of time, said wall surrounding (b) at least one reservoir defined by the wall's inner surface with the reservoir comprising a liquid core, containing up to 10 grams of both dissolved anti-fertility agent and undissolved replacement anti-fertility agent with the liquid core permeable to the passage of the anti-fertility agent and having limited solubility for the anti-fertility agent, the undissolved replacement anti-fertility agent in the liquid core present in an excess amount to continuously replenish and maintain a substantially constant supply of dissolved anti-fertility agent in the liquid core during the prolonged period of time, with the permeability of the wall to the anti-fertility agent lower than the permeability of the core to the agent, (c) and wherein anti-fertility agent administered from the intrauterine device is effected by releasing dissolved anti-fertility agent with such released agent being replaced by undissolved replacement agent to continuously maintain dissolved anti-fertility agent in the liquid core for supplying the anti-fertility agent at substantially the same rate to the wall so that anti-fertility agent is metered at a controlled and substantially constant rate from the reservoir by passage through the wall over the prolonged period of time.
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