Applicator for the delivery of topical formulations into mucosal cavities

• US 20030088217A1
• Filed: 07/05/2002
• Published: 05/08/2003
• Est. Priority Date: 10/20/2000
• Status: Active Grant

• Current Assignee: Universite Laval
• Original Assignee: Infectio-Recherche Inc.
• Inventors: Bergeron, Michel G., Omar, Rabeea F., Desormeaux, Andre
• Granted Patent: US 7,465,295 B2
• Time in Patent Office: Days
• US Class Current: 604/228
• CPC Class Codes: A61M 2210/1067 Anus
• 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

This invention relates to a vaginal/ano-rectal applicator for the uniform delivery of any topical formulations to treat and/or prevent any infection and/or abnormal conditions of mucosa cavity caused by any pathogen and/or disease. The present applicator comprises a longitudinally extending body that has proximal and distal ends. The proximal end is located close to the external site of a mucosal cavity accessible to a user. The body has external perforations, made as a series of slots or holes, for uniform distribution of any formulation to be delivered to the user'"'"'s mucosal cavity. Upon insertion of the applicator and expulsion of the formulation in the mucosal cavity, the formulation, which is contained in a reservoir, travels through a diffusion channel having a small volume, prior to being expelled through the perforations.

Claims

1. An applicator for delivering a formulation into a user'"'"'s mucosal cavity which comprises:

a body having proximal and distal ends, a longitudinally extending external wall provided with perforations, and a longitudinally extending internal wall configured and sized to be spaced from said external wall to define a diffusion channel therebetween;

said diffusion channel having a proximal inlet end;

a reservoir capable of receiving said formulation;

an expulsion element connected to said reservoir and actuable by the user to expel said formulation from said reservoir to said diffusion channel;

whereby, when actuated, said expulsion element forces the formulation out of said reservoir into said diffusion channel through the proximal inlet end thereof, and the formulation is delivered to the mucosal cavity through said perforations.

2. An applicator as defined in claim 1, further comprising a directing element located at the proximal end of said body for directing any formulation to said proximal inlet end of said diffusion channel.

3. An applicator as defined in claim 2, further comprising a connector element for connecting said expulsion element with the proximal end of said body.

4. An applicator as defined in claim 2, wherein said perforations of said external wall include both longitudinal and distal perforations.

5. An applicator as defined in claim 2, wherein said expulsion element and said reservoir are one single element.

6. An applicator as defined in claim 5, wherein said expulsion element is a flexible element which is actuated by compression.

7. An applicator as defined in claim 5, wherein said expulsion element is a piston actuatable by the user.

8. An applicator as defined in claim 2, wherein said expulsion element comprises a piston actuatable by the user.

9. An applicator as defined in claim 8, wherein said expulsion element also includes a seat located distally from said reservoir within a lumen formed by said internal wall, said seat being operatively connected to a piston located near said reservoir;

whereby, when said piston is pulled by the user, the seat compresses said reservoir which expulses the formulation into the diffusion channel.

10. An applicator as defined in claim 7, wherein said piston has a external wall of a diameter greater than the outer diameter of said internal wall and smaller than the inner diameter of the external wall of said body, and said piston is actuated by the user by slidably engaging the external wall thereof between said internal and external walls of said body.

11. An applicator as defined in claim 2, wherein said directing element comprises a closing element to close an internal lumen formed by said internal wall of said body.

12. An applicator as defined in claim 11, wherein said directing element further comprises an opened element concentric to the closing element, said opened element opening into the proximal inlet end of said diffusion channel, and through which the formulation is forced by actuating the expulsion element.

13. An applicator as defined in claim 11, wherein said directing element is integrally formed with said proximal end of said internal wall of said body.

14. An applicator as defined in claim 8, wherein said directing element is formed by the proximal entry channel and a closing element provided in the proximal end of said body.

15. An applicator as defined in claim 2, which further comprises a low-resistance membrane located between the reservoir and the proximal inlet of said diffusion channel.

16. An applicator as defined in claim 15, further comprising a tapered element to break said membrane, said tapered element being located at the proximal end of said directing element.

17. An applicator as defined in claim 13, wherein said directing element is terminated at the proximal end thereof with a tapered element.

18. An applicator as defined in claim 16, wherein said perforations are formed by at least two slots longitudinally spaced by a substantially equal distance and a distal perforation.

19. An applicator as defined in claim 18, wherein said slots and distal perforations are continuous.

20. An applicator as defined in claim 4, wherein said perforations are formed by a plurality of holes, which are spaced in such a way that the formulation is delivered substantially uniformly to the mucosal cavity.

21. An applicator as defined in claim 3, which further comprises a grasping element located at the outer periphery of said connector element.

22. An applicator as defined in claim 3, which further comprises a grasping element integrally formed with said connector element.

23. An applicator as defined in claim 1, which further comprises a grasping element located at the proximal end of the external wall.

24. An applicator as defined in claim 5, wherein said directing element is terminated at the proximal end thereof with a tapered element.

25. An applicator as defined in claim 24, wherein said reservoir has a proximal end which is configured to fit in complementarily with the tapered element.

26. An applicator as defined in claim 24, wherein said perforations are formed by a plurality of holes, which are spaced in such a way that the formulation is delivered substantially uniformly to the mucosal cavity.

27. An applicator as defined in claim 25, wherein said perforations-are formed by a plurality of holes, which are spaced in such a way that the formulation is delivered substantially uniformly to the mucosal cavity.