Intravaginal device and method for delivering a medicament

• US 5,002,540 A
• Filed: 05/22/1989
• Issued: 03/26/1991
• Est. Priority Date: 05/22/1989
• Status: Expired due to Fees

• Current Assignee: Biomedical Device Consultants Incorporated
• Original Assignee: Warren Kirschbaum
• Inventors: Brodman, Michael L., Weinberg, Steven L., Kirschbaum, Warren
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rose, Sharon
• Application Number:
  US07/355,407
• Time in Patent Office: 673 Days
• Field of Search: 128/830, 128/832, 128/833, 128/834, 604/890.1, 604/891.1, 604/48, 604/49, 604/54, 604/55, 604/285, 604/286, 424/430-433, 424/436, 424/438, 424/457
• US Class Current: 604/285
• CPC Class Codes: A61F 6/06 for use by females A61F6/20 takes precedence
• 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: A61M 2210/1475 Vagina
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

A device for inserting into the vagina of a patient for delivery of a medicament in the vagina. The walls of the tubular member comprising the device are comprised of water-swellable materials having a higher porosity at one end than the other, the relatively low porosity end being positioned distally in the vagina to the relatively high porosity end. The medicament is contained within a reservoir in the tubular member and delivered to the vagina through the pores in the walls of the tubular member at different rates depending upon the porosity. Also provided is a method of delivering a medicament to the vagina of a patient.

Claims

1. An intravaginal device for delivery of a medicament comprising:

an elongate, tubular member comprised of a water-swellable, porous material, the length and diameter of said tubular member being selected so as to ensure engagement of the walls of the vagina and retention therein upon swelling of said tubular member when said tubular member is inserted into the vagina of a patient;

means for closing one end of said tubular member to form a reservoir within said tubular member for receipt of a medicament to be delivered within the vagina of a patient; and

the porosity of the water-swellable, porous material comprising the walls of said tubular member being selectively varied along the length thereof in accordance with whether the medicament within said tubular member is to be delivered to the vagina from the reservoir, retained within the reservoir, or delivered to the vagina from the reservoir and then absorbed by said tubular member.

2. The device of claim 1 wherein the walls of one end of said tubular member are relatively porous for delivering the medicament to the vagina and the other end is relatively non-porous for preventing delivery of the medicament from the reservoir, the relatively non-porous end of said tubular member functioning to retain the medicament within the vagina when positioned in the lower vagina and the other end is positioned in the upper vagina.

3. The device of claim 2 wherein the porosity of the walls of the relatively porous end of said tubular member ranges from about 60 to about 85% and the porosity of the walls of the relatively non-porous end of said tubular member ranges from about 0 to about 60%.

4. The device of claim 2 additionally comprising an absorbent extension of the non-porous end of said tubular member.

5. The device of claim 1 wherein the porosity of the walls of said tubular member is varied continuously from one relatively porous end for positioning in the upper vagina to the other relatively non-porous end for positioning in the lower vagina whereby the medicament contained within the reservoir is dispensed from the porous end of said tubular member and retained within the vagina by the non-porous end of said tubular member.

6. The device of claim 5 additionally comprising an absorbent extension of the non-porous end of said tubular member.

7. A method of dispensing a medicament in the vagina of a patient from a device placed in the vagina comprising:

filling a reservoir formed by the walls of a generally elongated, tubular member with a medicament to be delivered to a patient from within the vagina of the patient;

inserting the tubular member into the vagina; and

dispensing the medicament from the reservoir through the walls thereof at different rates along the length of the tubular member, the rate at which the medicament is dispensed being a function of the porosity of the material comprising walls of the medicament is dispensed being a function of the porosity of the material comprising walls of the tubular member, which porosity is varied along the length of the tubular member.

8. The method of claim 7 wherein the medicament is dispensed through the walls at the end of the tubular member positioned in the upper vagina at a rate which is higher then the rate at which the medicament is dispensed through the walls at the end of the tubular member which is positioned in the lower vagina.

9. The method of claim 8 additionally comprising absorbing the medicament in the lower vagina.

10. An intravaginal device for delivery of a medicament comprising:

an elongate tubular member comprised of a waterswellable porous material, the length and diameter of said tubular member being selected so as to insure engagement of the walls of the vagina and retention therein upon swelling of said tubular member when said tubular member is inserted into the vagina of a patient;

means for closing one end of said tubular member to form a reservoir within said tubular member for receipt of a medicament to be delivered within the vagina of a patient; and

the porosity of the water-swellable, porous material comprising the walls of said tubular member being varied along the length thereof, the walls of said tubular member being relative porous for delivering the medicament to the vagina at one end and relatively non-porous for preventing delivery of medicament from the reservoir to the vagina at the other end, the relatively non-porous end of said tubular member functioning to retain the medicament within the vagina when positioned in the lower vagina and the other end is positioned in the upper vagina.

11. The device of claim 10 wherein the porosity of the walls of the relatively porous end of said tubular member ranges from about 60 to about 85% and the porosity of the walls of the relatively non-porous end of said tubular member ranges from about 0 to about 60%

12. The device of claim 11 additionally comprising an absorbent extension of the non-porous end of said tubular member.

13. The device of claim 10 wherein the porosity of the walls of said tubular member is varied continuously from the relatively porous end to the relatively non-porous end.

14. The device of claim 13 additionally comprising an absorbent extension of the non-porous end of said tubular member for drawing the medicament dispensed through the walls of said tubular member from the relatively porous end past the non-porous end by absorbing the medicament in the lower vagina in which said absorbent extension is positioned.