Methods of making intra-vaginal devices and/or intra-vaginal devices

• US 4,449,980 A
• Filed: 06/03/1981
• Issued: 05/22/1984
• Est. Priority Date: 06/09/1980
• Status: Expired due to Fees

• Current Assignee: AHI Operations Limited
• Original Assignee: AHI Operations Limited
• Inventors: Millar, Thomas D., Miller, David M.
• Primary Examiner(s): Padgett, Benjamin R.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/269,974
• Time in Patent Office: 1,084 Days
• Field of Search: 128/130, 128/127-132, 424/19-22, 604/890-897
• US Class Current: 424/430
• CPC Class Codes: A61D 7/00 Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals for reproduction or fertilisation A61D19/00 ; devices for implanting pellets, radon seeds or the like A61M37/0069
• 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

Abstract

An intra-vaginal device for supplying minerals, hormones or medicoments to an animal is formed as an injection moulded polymeric body having a skin in which adjacent at least part of the surface thereof at least one active ingredient is incorporated. The body is preferably separately moulded before the skin is applied and the skin is preferably of a two part silicone rubber or a polymer such as ethylene vinyl acetate or a polymer substance and the active ingredient is selected from one or more of progesterone oestrogen testosterone, mineral trace elements such as selenium cobalt copper and boron and anthelmintics.

Claims

1. An intravaginal device for the sustained release of a physiologically active substance into the vagina of a mammal when inserted therein, including a resilient physiologically-inactive supporting skeleton and a polymeric coating having a physiologically-active ingredient incorporated therein moulded over said skeleton to form a physiologically-active skin thereupon, said physiologically active ingredient and said skin affording a sustained release of said physiologically-active ingredient during contact with the body fluids of said mammal, and said skeleton including means for increasing the surface area of the physiologically-active skin exposed to said body fluids comprising at least three broad lobes radiating in a plane from a central body portion, each of which lobes is perforated with a network of holes over which the skin is moulded to provide an undulated skin surface over said skeleton and increase the skin surface area exposed to body fluids.

2. An intra-vaginal device as claimed in claim 1 wherein said sleleton includes at least three intercontrolled lobes foldable to lie close to each other for insertion or removal.

3. An intra-vaginal device as claimed in claim 2, wherein said lobes are intercontrolled by a withdrawing ligament associated with the free end of each of the lobes.

4. An intra-vaginal device as claimed in claim 1 wherein said device is formed as a two part member by first forming the skeleton and then forming said skin on said skeleton, said skin having said active ingredient incorporated therein during moulding of the skin onto the skeleton.

5. An intra-vaginal device as claimed in claim 1 wherein said skin is formed integrally with the skeleton.

6. An intra-vaginal device as claimed in claim 5 wherein said skin is formed from ethylene vinyl acetate.

7. An intra-vaginal device as claimed in claim 1 wherein said skeleton is moulded of a suitable non-toxic and flexible material comprising polypropylene or polyethylene.

8. An intra-vaginal device as claimed in claim 1 wherein said skin is formed from a high-speed curing silicone rubber.

9. An intra-vaginal device as claimed in claim 8 wherein said high speed curing silicone rubber is a two component silicone rubber.

10. An intra-vaginal device as claimed in claim 9 wherein said active ingredient is premixed with one of the silicone rubber components before mixing of the two components in a moulding machine just prior to injection.

11. An intra-vaginal device as claimed in claim 9 wherein said active ingredient is dosed automatically as the silicone rubber components are fed into moulding parts of a moulding machine.

12. An intra-vaginal device as claimed in claim 1, wherein said active ingredient is selected from one or more of progesterone, oestrogen, testosterone;

or mineral trace elements comprising selenium cobalt copper, and boron;

or anthelmintics.

13. An intra-vaginal device as claimed in claim 1 having at least three lobes, and further including means for withdrawing the device from the vagina comprising a filament attached to the free end of one of the lobes so that the remaining lobes flex and fold over within the vagina and trail behind as the filament is pulled and the device withdrawn.

14. An intra-vaginal device as claimed in claim 1, wherein the mammal is a sheep or cow.

15. The intravaginal device of claim 1, wherein the skin is moulded over the skeleton by injecting a two-component liquid silicone rubber containing a physiologically-active ingredient over the skeleton in a mould, and curing the rubber at an elevated temperature.