Administration of therapeutic or diagnostic agents using interlabial pad

Abstract

A diagnostic agent is delivered intravaginally or to the interlabial space by positioning an interlabial device, such as an absorbent pad, between the labia. The pad is retained between the labia to deliver an active agent, or allow a reaction with a diagnostic agent. Alternatively, the pad is applied after the diagnostic agent is administered, to help reduce discomfort to the subject, or loss of the diagnostic agent. The active agent may be carried by the pad itself, or in an intravaginal extension of the pad, or separately in a suppository or other dosage form. In particular examples, the pad has a smaller minor portion superimposed on a larger major portion, and the smaller minor portion is inserted as a leading edge between the labia of the subject to facilitate interlabial insertion. In another example, the pad is placed interlabially after insertion of an agent.

1 . An interlabial delivery device comprising a pad, wherein the pad is configured to be retained between labia of a subject, and the pad carries a diagnostically effective amount of a diagnostic agent for diagnosing a medical condition that is detectable in a bodily fluid absorbed by the interlabial device.  
     
     
         2 . The device of  claim 1 , wherein the pad is a highly absorbent non-swellable material.  
     
     
         3 . The device of  claim 1 , wherein the pad is non-adhesive.  
     
     
         4 . The device of  claim 1 , wherein the pad is impregnated throughout with the diagnostically effective amount of the diagnostic agent.  
     
     
         5 . The device of  claim 1 , wherein the pad has a uniform cross-section along its entire length or is tapered along its length.  
     
     
         6 . The device of  claim 1 , wherein the pad has a minor portion superimposed on a major portion, the minor portion having a cross-sectional area smaller than a cross-sectional area of the major portion and wherein the minor portion is tapered to facilitate insertion between the labia and retention in the interlabial space.  
     
     
         7 . The device of  claim 6 , wherein the minor and major portions of the pad have an elliptical cross-section with a major axis, wherein the major axis of the minor portion is less than the major axis of the major portion.  
     
     
         8 . The device of  claim 1 , wherein the diagnostic agent comprises a qualitative, semi-quantitative or quantitative test agent for a test to be performed on a discharge collected by the pad.  
     
     
         9 . The device of  claim 1 , wherein the pad comprises an intravaginal portion and an extravaginal portion, and only the intravaginal portion carries the diagnostic agent.  
     
     
         10 . The device of  claim 1 , wherein the diagnostic agent is an antibody.  
     
     
         11 . The device of  claim 1 , wherein the diagnostic agent comprises an agent that detects the presence or absence of a cell type, protein, or nucleic acid in a vaginal discharge.  
     
     
         12 . The device of  claim 1 , wherein the diagnostic agent comprises an agent that detects the presence of blood or a microorganism.  
     
     
         13 . The device of  claim 1 , wherein the diagnostic agent comprises an agent that detects a pathogen.  
     
     
         14 . The device of  claim 1 , wherein the diagnostically effective amount of agent is carried in a cavity within the pad.  
     
     
         15 . The device of  claim 14 , wherein the cavity is in an exterior surface of the pad.  
     
     
         16 . The device of  claim 14 , wherein the cavity communicates with a surface of the pad.  
     
     
         17 . The device of  claim 14 , wherein the pad is elongated, and the cavity extends longitudinally along the pad.  
     
     
         18 . The device of  claim 1 , wherein the pad has a tapered leading edge.  
     
     
         19 . A method of diagnosing a medical condition in a subject, comprising: 
 selecting a subject in need of diagnosis of a medical condition;    positioning a pad configured to be retained between labia of a subject in an interlabial space of a subject in need of diagnosis of a medical condition, wherein the pad carries a diagnostically effective amount of a diagnostic agent, or the agent has already been applied to the labia or administered intra-vaginally prior to placing the pad in the interlabial space.    
     
     
         20 . The method of  claim 19 , wherein the pad is non-adhesive.  
     
     
         21 . The method of  claim 19 , wherein the pad is impregnated throughout with the diagnostically effective amount of the diagnostic agent.  
     
     
         22 . The method of  claim 19 , wherein the pad is placed substantially completely external to a vaginal orifice.  
     
     
         23 . The method of  claim 19 , wherein the pad has a tapered leading edge, and the method further comprises inserting the pad into an interlabial space to push the labia apart as the leading edge of the pad is inserted between the labia.  
     
     
         24 . The method of  claim 23 , wherein the tapered leading edge is positioned against the vaginal orifice, and a remainder of the pad has a width which is wider than a normal anatomic interlabial space, such that the remainder of the pad is frictionally engaged and retained by opposing labia.  
     
     
         25 . The method of  claim 19 , wherein the method comprises locally delivering the diagnostic agent to the peri-labial area.  
     
     
         26 . The method of  claim 19 , wherein the medical condition is a disease detectable in a bodily fluid absorbed by the pad.  
     
     
         27 . The method of  claim 19 , wherein the diagnostically effective amount of the agent is carried in a cavity of the pad.  
     
     
         28 . The method of  claim 27 , wherein the cavity is in an exterior surface of the pad.  
     
     
         29 . The method of  claim 27 , wherein the cavity communicates with a surface of the pad.  
     
     
         30 . The method of  claim 27 , wherein the pad is elongated, and the cavity extends longitudinally along the pad.  
     
     
         31 . The method of  claim 19 , wherein the pad is devoid of corners and flat surfaces intermediate its ends.  
     
     
         32 . The method of  claim 19 , wherein and the pad has a minor portion superimposed on a major portion, the minor portion having a cross-sectional area smaller than a cross-sectional area of the major portion, wherein both the minor and the major portion are curvilinear in cross-section, and wherein the minor portion facilitates insertion between the subject's labia and retention in the interlabial space.  
     
     
         33 . The method of  claim 19 , wherein the pad is elongated and has a uniform cross-section along its entire length, or is tapered along its length.  
     
     
         34 . The method of  claim 19 , wherein the pad is elongated, and when placed in the interlabial space, extends external to the vaginal orifice.  
     
     
         35 . The method of  claim 32 , wherein the minor and major portions of the pad have a length greater than their width, and the shape of the pad substantially conforms to the interlabial space in which the pad is retained.