Vaginal discharge collection device and intravaginal drug delivery system

• US 5,295,984 A
• Filed: 06/26/1992
• Issued: 03/22/1994
• Est. Priority Date: 12/07/1989
• Status: Expired due to Term

• Current Assignee: Evofem Inc. (Evofem Biosciences, Inc.)
• Original Assignee: Ultrafem, Inc.
• Inventors: Rose, Bruce F., Potter, Richard C., Contente, Audrey
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Gualtieri, Gina M.
• Application Number:
  US07/904,367
• Time in Patent Office: 634 Days
• Field of Search: 604/317, 604/327, 604/328, 604/358, 604/330, 604/331, 128/834, 128/837, 128/838, 128/884, 128/841, 128/887, 128/760, 128/769, 128/767
• US Class Current: 604/317
• CPC Class Codes: A61B 2010/0074 Vaginal or cervical secretions
• CPC Class Codes: A61F 5/4553 placed in the vagina, e.g. for catamenial use pessaries A61F6/08; absorbent cups A61F13/2045
• 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

A vaginal discharge collection device is formed of an elastomeric rim and a flexible film reservoir. The rim may have a generally rectangular cross section and forms a collection space for collecting vaginal discharge. The reservoir may be collapsible so as to be substantially enclosed within the rim when the device is being used. Advantageously, the rim and the reservoir are arranged such that compressing diametrically opposed portions of the rim toward each other causes a leading portion of the rim to dip downwardly to facilitate insertion of the device. The device is ergonomically constructed so as to be convenient to use, comfortable to wear internally, and reliable. A system for reliably, comfortably and conveniently introducing agents, including drugs and other substances, into the vaginal canal is also disclosed.

Claims

1. A method of using a plurality of menstrual discharge collectors during a period of menstruation, said method comprising the steps of:

(a) providing a first menstrual discharge collector including body means for providing a collection space for the collection of menstrual discharge and having an opening for the passage of said menstrual discharge into said space, and rim means for providing resilient outward holding force sufficient for holding said collector in position within a woman'"'"'s vaginal canal during use, said body means having a top, said rim means having a leading portion and a trailing portion, said rim means being affixed to said body means proximate said top of said body means;

(b) positioning said discharge collector in said position such that said leading portion of said rim means is located at a rearward location behind the woman'"'"'s cervix, such that said trailing portion of said rim means is located at a forward location behind the woman'"'"'s pubic bone, and such that the woman'"'"'s cervix is located between said leading and trailing portions of said rim means;

(c) holding said collector in said position, with a substantially looser fit than would be needed to inhibit the passage of sperm around said rim means, by applying said resilient outward holding force against the walls of the woman'"'"'s vaginal canal;

(d) while holding said collector in said position, collecting a first volume of said menstrual discharge in said collection space without absorbing said discharge by allowing said discharge to flow through said opening and into said space;

(e) subsequently, disposing of said vaginal discharge collector together with said first volume of said menstrual discharge;

(f) providing a second menstrual discharge collector including body means for providing a collection space for the collection of said menstrual discharge and having an opening for the passage of said menstrual discharge into said collection space of said collector, and rim means for providing a second resilient outward holding force sufficient for holding said second collector in said position within the woman'"'"'s vaginal canal during use, said body means of said second collector having a top, said rim means of said second collector having a leading portion and a trailing portion, said rim means of said second collector being affixed to said body means of said second collector proximate said top of said body means of said second collector;

(g) positioning said second discharge collector in said position such that said leading portion of said rim means of said second collector is located at the rearward location behind the woman'"'"'s cervix, such that said trailing portion of said rim means of said second collector is located at the forward location behind the woman'"'"'s pubic bond, and such that the woman'"'"'s cervix is located between said leading and trailing portions of said rim means of said second collector;

(h) holding said second collector in said position, with a substantially looser fit than would be needed to inhibit the passage of sperm around said rim means of said second collector, by applying said second resilient outward holding force against the walls of the woman'"'"'s vaginal canal;

(i) while holding said second collector in said position, collecting a second volume of said menstrual discharge in said collection space of said second collector without absorbing said discharge by allowing said discharge to flow through said opening of said second collector and into said collection space of said second collector; and

(j) subsequently, disposing of said second discharge collector together with said second volume of said menstrual discharge; and

wherein said steps of positioning and disposing of said first discharge collector and said steps of positioning and disposing of said second discharge collector all occur during said period of menstruation.

2. The method of claim 1, further comprising the step of releasing a substance from said first and second discharge collectors.

3. The method of claim 2, wherein said substance is a medicine.

4. The method of claim 1, wherein said body means of said first discharge collector includes a reservoir space extending from said collection space of said first discharge collector.

5. The method of claim 4, wherein said body means of said first collector includes a generally cup-shaped main wall portion and a bubble-like protrusion, with said generally cup-shaped main wall portion including said top of said body means of said first collector, and with said bubble-like protrusion being integrally connected to said generally cup-shaped main wall portion along a generally annular inwardly directed edge, and wherein said generally cup-shaped main wall portion forms said collection space of said first collector, and wherein said bubble-like protrusion forms said reservoir space of said first collector, and wherein said bubble-like protrusion is substantially smaller than said generally cup-shaped main wall portion, and wherein said second collector is substantially identical to said first collector.

6. The method of claim 1, wherein said first collector includes closure means for at least partially covering said opening of said first collector for inhibiting said discharge from exiting said collection space of said first collector.

7. The method of claim 6, further comprising the step of releasing a substance from said first and second discharge collectors.

8. The method of claim 7, wherein said substance is a medicine.

9. The method of claim 6, further comprising the step of rolling said body means of said first collector on said rim means of said first collector from a rolled-down position to a rolled-up position, wherein said collection space of said first collector is smaller when said body means of said first collector is in said rolled-up position, and wherein said step of rolling said body means of said first collector on said rim means of said first collector is performed prior to said step of holding said first collector in said position.

10. The method of claim 1, wherein said rim means of said first collector has a generally rectangular cross section.

11. The method of claim 10, wherein said body means of said first collector includes a flexible film reservoir, said reservoir being attached to said rim means.

14. The method of claim 1, wherein said rim means of said first collector comprises thermoplastic material, and wherein the stiffness of said rim means of said first collector decreases subsequent to said step of positioning said first collector.

12. A method of using a vaginal discharge collector, comprising the steps of:

(a) providing a vaginal discharge collector including body means for providing a collection space for the collection of discharge and having an opening for the passage of said discharge into said space, and rim means for providing resilient outward holding force sufficient for holding said collector in position within a woman'"'"'s vaginal canal during use, said body means having a top, said rim means being affixed to said body means proximate said top of said body means;

(b) holding said collector in said position by applying said resilient outward holding force;

(c) while holding said collector in said position, collecting said discharge in said collection space by allowing said discharge to flow through said opening and into said space; and

(d) rolling said body means on said rim means from a rolled-down position to a rolled-up position, wherein said collection space is smaller when said body means is in said rolled-up position, and wherein said step of rolling said body means on said rim means is performed prior to said step of holding said collector in said position.

13. A method of using a vaginal discharge collector, comprising the steps of:

(a) providing a vaginal discharge collector including body means for providing a collection space for the collection of discharge and having an opening for the passage of said discharge into said space, and rim means for providing resilient outward holding force sufficient for holding said collector in position within a woman'"'"'s vaginal canal during use, said body means having a top, said rim means being affixed to said body means proximate said top of said body means, said body means including a reservoir space extending from said collection space;

(b) holding said collector in said position by applying said resilient outward holding force;

(c) while holding said collector in said position, collecting said discharge in said collection space by allowing said discharge to flow through said opening and into said space; and

(d) rolling said body means on said rim means from a rolled-down position to a rolled-up position without substantially changing the size of said reservoir space, and wherein said step of rolling said body means on said rim means is performed prior to said step of holding said collector in said position.