Diagnostic 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 compressible device comprising a pad that 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 pad, wherein the pad compressible device is configured to be retained between labia of a subject, and the diagnostic agent comprises an antibody that detects a target, or a chemical reagent in which a reaction occurs in the presence of a pathogen of interest, and the device deforms to conform to external genital and/or perineal anatomy when retained interlabially. 
     
     
         2 . The device of  claim 1 , wherein the pad is a highly absorbent non-swellable material. 
     
     
         3 . The device of  claim 1 , wherein the diagnostic agent detects blood, a protein or a nucleic acid. 
     
     
         4 . The device of  claim 1 , wherein the device 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 an antibody. 
     
     
         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 8 , wherein the antibody detects human papillomavirus (HPV) or herpes simplex virus (HSV). 
     
     
         11 . The device of  claim 1 , wherein the diagnostic agent comprises an agent that detects the presence or absence of a cell type in a vaginal discharge. 
     
     
         12 . The device of  claim 1 , wherein the diagnostic agent comprises an agent that detects the presence of blood. 
     
     
         13 . The device of  claim 1 , wherein the diagnostic agent comprises an agent that detects a microorganism. 
     
     
         14 . The device of  claim 1 , wherein the diagnostically effective amount of the diagnostic 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 for diagnosis of a medical condition;   positioning a pad between labia of a subject in an interlabial space of the subject wherein the pad comprises a soft, absorbent material that deforms to conform to external genital and perineal anatomy and carries a diagnostically effective amount of a diagnostic agent, or the diagnostic agent has already been applied to the labia or administered intra-vaginally prior to placing the pad in the interlabial space, wherein the diagnostic agent comprises an antibody or a chemical reagent in which a reaction occurs in the presence of a pathogen of interest;   retaining the pad in the interlabial space with the soft absorbent material in sustained contact with the labial skin and vaginal orifice to absorb a bodily fluid into the pad; and   detecting whether the reaction occurred in the pad to diagnose the medical condition.   
     
     
         20 . The method of  claim 19 , wherein the diagnostic agent detects blood, a protein or a nucleic acid. 
     
     
         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 the 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 diagnostic agent comprises an agent the detects the presence of blood. 
     
     
         28 . The method of  claim 19 , wherein the diagnostic agent comprises an agent that detects a microorganism. 
     
     
         29 . The method of claim  39 , wherein the diagnostic agent changes color in the presence of the pathogen of interest, and the method further comprises detecting whether a color change has occurred in the pad. 
     
     
         30 . The method of  claim 19 , further comprising applying the diagnostic agent to the labia or intra-vaginally prior to placing the pad in the interlabial space. 
     
     
         31 . The method of  claim 19 , wherein the diagnostic agent is present on the surface of the pad. 
     
     
         32 . The device of  claim 1 , wherein the diagnostic agent is present on the surface of the device.