Applicator for catamenial device having improved gripper end

Abstract

The present invention relates to applicators for inserting objects into body cavities, and to methods for making the same. The applicators are particularly useful for inserting catamenial and prophylactic devices into a vaginal canal. The applicators comprise a tubular insertion member and a retrofitted gripping member. The gripping member has an outer diameter greater than that of the insertion member. An interface is created due to this size differential, which provides a visual or tactile cue of applicator insertion depth, and thereafter object positioning within the body cavity. The gripping member comprises at least one raised area on its outwardly disposed surface, providing resistance to movement of the user's manual digit in response to longitudinal forces on the insertion member. Longitudinal forces are created during both the insertion step of use, as well as the expulsion step delivering the contained object from the insertion member into the body cavity.

What is claimed is:  
     
         1 . An applicator for inserting an object into a body cavity, comprising: 
 a) a tubular insertion member having an insertion end, an oppositely disposed trailing end and a trailing end outer diameter; and    b) a gripping member affixed to the tubular insertion member trailing end having an outer diameter greater than the coincident trailing end outer diameter, a length to inner diameter ratio of at least about  0 . 5 , a raised area, and a trailing edge disposed distal the insertion end of the tubular insertion member, as assembled.    
     
     
         2 . The applicator of  claim 1  wherein the raised area is capable of providing resistance to movement of a user's manual digit in response to longitudinal forces on the tubular insertion member.  
     
     
         3 . The applicator of  claim 1  wherein the gripping member has a minimum outer diameter that is greater than the coincident trailing end outer diameter.  
     
     
         4 . The applicator of  claim 1  wherein the gripping member has two raised areas separated longitudinally by an intermediate area having a diameter less than that of each of the raised areas.  
     
     
         5 . The applicator of  claim 4  wherein the intermediate area has a length of at least about  9  mm.  
     
     
         6 . The applicator of  claim 4  wherein the gripping member comprises curvilinear transitions between the intermediate area and the two raised areas.  
     
     
         7 . The applicator of  claim 4  wherein the gripping member comprises a flange at the trailing edge.  
     
     
         8 . The applicator of  claim 1  wherein the gripping member comprises a protuberance extending from an inner surface arranged and configured to press into an inner surface of the tubular insertion member.  
     
     
         9 . The applicator of  claim 8  wherein the tubular insertion member comprises a cavity proximate the trailing end that is arranged and configured to receive the protuberance.  
     
     
         10 . The applicator of  claim 8  wherein the trailing edge of the gripping member has a stop extending inwardly therefrom.  
     
     
         11 . The applicator of  claim 10  wherein the inner diameter of the gripping member terminating at the stop is less than the coincident trailing end outer diameter.  
     
     
         12 . The applicator of  claim 10  wherein the gripping member has a plurality of protuberances and stops.  
     
     
         13 . The applicator of  claim 1  wherein the tubular insertion member comprises paperboard.  
     
     
         14 . The applicator of  claim 1  wherein the gripping member comprises polymeric material.  
     
     
         15 . The applicator of  claim 14  wherein the gripping member comprises foam.  
     
     
         16 . The applicator of  claim 14  wherein the polymeric material is selected from the group consisting of polyethylene, polypropylene, polystyrene, polyvinyl alcohol, polylactic acid, poly(3-hydroxybutyric acid), and combinations thereof.  
     
     
         17 . The applicator of  claim 1  further comprising a tubular expulsion member slideable within the trailing end of the tubular insertion member.  
     
     
         18 . An applicator for inserting an object into a body cavity, comprising: 
 a) a tubular insertion member having a trailing end and a trailing end outer diameter; and    b) gripping member affixed to the tubular insertion member trailing end having an outer diameter greater than the coincident trailing end outer diameter, a length of at least about  5  millimeters, a raised area, and a trailing edge disposed distal the insertion end of the tubular insertion member, as assembled.    
     
     
         19 . The applicator of  claim 18  wherein the raised area is capable of providing resistance to movement of a user's manual digit in response to longitudinal forces on the tubular insertion member.  
     
     
         20 . The applicator of  claim 18  wherein the gripping member has a minimum outer diameter that is greater than the coincident trailing end outer diameter.  
     
     
         21 . The applicator of  claim 18  wherein the length of the gripping member is at least about 10 mm.  
     
     
         22 . The applicator of  claim 18  wherein the gripping member has two raised areas separated longitudinally by an intermediate area having a diameter less than that of each of the raised areas.  
     
     
         23 . The applicator of  claim 22  wherein the intermediate area has a length of at least about 9 mm.  
     
     
         24 . The applicator of  claim 22  wherein the gripping member comprises curvilinear transitions between the intermediate area and the two raised areas.  
     
     
         25 . The applicator of  claim 18  wherein the gripping member comprises a flange at the trailing edge.  
     
     
         26 . The applicator of  claim 18  wherein the gripping member comprises a protuberance extending from an inner surface arranged and configured to press into an inner surface of the tubular insertion member.  
     
     
         27 . An applicator for inserting an object into a body cavity, comprising: 
 a) a tubular insertion member having a trailing end; and    b) a gripping member having at least one flexible arm extending from an inner surface thereof; 
 wherein the tubular insertion member trailing end is fitted between the gripping member inner surface and the at least one flexible arm.  
   
     
     
         28 . The applicator of  claim 27  further comprising a tubular expulsion member slideable fitted within the tubular insertion member trailing end, wherein the expulsion member is arranged and configured to urge the at least one flexible arm against the tubular insertion member.  
     
     
         29 . The applicator of  claim 27  wherein the gripping member has an outwardly disposed raised area.  
     
     
         30 . The applicator of  claim 29  wherein the gripping member has two raised areas separated longitudinally by an intermediate area having a diameter less than that of each of the raised areas.  
     
     
         31 . An applicator for inserting an object into a body cavity, comprising: 
 a) a tubular insertion member having a trailing end and an aperture proximate the trailing end extending from an outer surface to an inner surface thereof; and    b) a gripping member comprising an annular ring, a flexible arm substantially perpendicular to and extending from an inner peripheral edge of the annular ring, the flexible arm having a distally located protuberance; 
 wherein the flexible arm is fitted within the tubular insertion member trailing end, and the protuberance is extends through the aperture.  
   
     
     
         32 . A method for making an applicator, comprising the steps of: 
 a) providing a tubular insertion member having a trailing end and a trailing end outer diameter;    b) affixing a gripping member to the trailing end, the gripping member having an outer diameter greater than the coincident tubular insertion member outer diameter, a length to diameter ratio of at least 0.5, and a raised area.    
     
     
         33 . The method of  claim 32  wherein the tubular insertion member comprises paperboard.  
     
     
         34 . The method of  claim 32  wherein the step of affixing the gripping member comprises advancing the gripping member toward and rotating the gripping member with respect to the tubular insertion member.  
     
     
         35 . The method of  claim 34  wherein the step of rotating the gripping member results in a rotational displacement of about 10 to about 45 degrees.  
     
     
         36 . The method of  claim 34  wherein the gripping member has at least one protuberance having an arc length and extending from an inner surface, and the step of affixing the gripping member comprises rotating the gripping member an amount greater than the arc length of the at least one protuberance.  
     
     
         37 . A method for making an applicator, comprising the steps of: 
 a) providing a tubular insertion member having a trailing end, and a tubular expulsion member slideable within the trailing end;    b) providing a gripping member capable of fitting over a portion of the tubular insertion member trailing end;    c) coaxially aligning the tubular insertion member and the gripper member;    d) clamping the insertion end with a first clamping mechanism and the gripping member with a second clamping mechanism;    e) engaging the gripping member with a displacement tool telescopically positioned over the internal stabilizing tool;    f) retracting the second clamping mechanism, while advancing the displacement tool toward the tubular insertion member to move the gripping member onto the trailing end;    g) retracting the displacement tool; and    h) retracting the first clamping mechanism.    
     
     
         38 . The method of  claim 37  further comprising the step of passing an internal stabilizing tool through the gripping member and into the tubular expulsion member prior to engaging the gripping member with the displacement tool.  
     
     
         39 . The method of  claim 37  further comprising a step of rotating the displacement tool to rotate the gripping member with respect to the trailing end of the tubular insertion member, after the gripping member is moved onto the trailing end.  
     
     
         40 . The method of  claim 39  wherein the gripping member has a trailing edge having at least one stop extending inwardly therefrom, and the displacement tool has at least one prong capable engaging with the at least one stop, wherein rotating the displacement tool rotates the gripping member.  
     
     
         41 . The method of  claim 39  wherein the step of rotating the gripping member results in a rotational displacement of about 10 to about 45 degrees.