Applicator for Self-Expanding Intravaginal Urinary Incontinence Devices

Abstract

An applicator for a self-expanding intravaginal device has a barrel and a plunger that can substantially contain the self-expanding intravaginal device without significant insertion barrel distortion while maintaining comfortable applicator insertion. The barrel has an insertion end, an opposed gripper end, and a central portion therebetween, and it is arranged and configured to substantially contain the self-expanding intravaginal device. The plunger is in telescoping relation with the barrel, and it is arranged and configured to expel the self-expanding intravaginal device out of the insertion end of the barrel when the plunger is pushed into the gripper end of the barrel. A plurality of flexible petals substantially closes the insertion end of the barrel, and the central portion of the barrel has a load to 3 mm deflection of at least about 15 Newtons. Other aspects of the invention include a self-expanding intravaginal urinary incontinence system, and methods of making the applicator.

1 . An applicator for a self-expanding intravaginal device comprising:
 a. a barrel having an insertion end, an opposed gripper end, and a central portion therebetween; arranged and configured to substantially contain the self-expanding intravaginal device;   b. a plunger in telescoping relation with the barrel arranged and configured to expel the self-expanding intravaginal device out of the insertion end of the barrel when the plunger is pushed into the gripper end of the barrel   
       wherein a plurality of flexible petals substantially closes the insertion end of the barrel, and wherein the central portion of the barrel has a load to 3 mm deflection of at least about 15 Newtons. 
     
     
         2 . The applicator of  claim 1 , wherein the plurality of flexible petals comprise a flexible polymeric material selected from the group consisting of low density polyethylene, linear low density polyethylene, thermoplastic elastomer, and combinations thereof. 
     
     
         3 . The applicator of  claim 1 , wherein the central portion of the barrel comprises a rigid polymeric material selected from the group consisting of acrylonitrile-butadiene-styrene, high density polyethylene, linear low density polyethylene, polypropylene, polyamide, polyoxymethylene, polystyrene, and combinations thereof. 
     
     
         4 . The applicator of  claim 1 , wherein the plurality of flexible petals comprise a first, flexible material and the central portion of the barrel comprise a second, rigid material. 
     
     
         5 . The applicator of  claim 4 , wherein the insertion end of the parrel comprising the plurality of flexible petals is mechanically fastened to the central portion of the barrel. 
     
     
         6 . The applicator of  claim 4 , wherein the central portion of the barrel is molded onto the insertion end of the barrel comprising the plurality of flexible petals. 
     
     
         7 . A self-expanding intravaginal urinary incontinence system comprising:
 a. a self-expanding intravaginal urinary incontinence device; and   b. an applicator substantially containing the self-expanding intravaginal urinary incontinence device, the applicator comprising:
 i. a barrel having an insertion end, an opposed gripper end, and a central portion therebetween; wherein a plurality of flexible petals substantially closes the insertion end of the barrel; and wherein the central portion of the barrel has a load to 3 mm deflection of at least about 15 Newtons; and 
 ii. a plunger in telescoping relation with the barrel arranged and configured to expel the self-expanding intravaginal urinary incontinence device out of the insertion end of the barrel when the plunger is pushed into the gripper end of the barrel. 
   
     
     
         8 . A method of making an insertion barrel for an applicator for a self-expanding intravaginal device comprising the steps of:
 a. forming a first mold cavity configuration corresponding to a first section comprising the insertion end of the insertion barrel;   b. injecting a first, flexible polymeric material into the first mold cavity configuration;   c. forming a second mold cavity configuration to permit overmolding a second, relatively rigid polymeric material onto the first section;   d. injecting the second, relatively rigid polymeric material into the second mold cavity configuration to form a second section of the insertion barrel extending from the first section, wherein the second section comprises a central portion and gripper portion of the insertion barrel; and   e. ejecting the insertion barrel from the second mold cavity configuration.   
     
     
         9 . The method of  claim 8 , wherein the flexible polymeric material is selected from the group consisting of low density polyethylene, linear low density polyethylene, thermoplastic elastomer, and combinations thereof. 
     
     
         10 . The method of  claim 8 , wherein the relatively rigid polymeric material is selected from the group consisting of acrylonitrile-butadiene-styrene, high density polyethylene, linear low density polyethylene, polypropylene, polyamide, polyoxymethylene, polystyrene, and combinations thereof. 
     
     
         11 . The applicator of  claim 8 , wherein the flexible polymeric material has a lower flexural modulus than the relatively rigid polymeric material. 
     
     
         12 . A method of making an insertion barrel for an applicator for a self-expanding intravaginal device comprising the steps of:
 a. forming a first mold cavity configuration corresponding to a first section comprising a central portion and gripper portion of the insertion barrel;   b. injecting a first, relatively rigid polymeric material into the first mold cavity configuration;   c. forming a second mold cavity configuration to permit overmolding a second, flexible polymeric material onto the first section;   d. injecting the second, flexible polymeric material into the second mold cavity configuration to form a second section of the insertion barrel extending from the first section, wherein the second section comprises an insertion end of the insertion barrel; and   e. ejecting the insertion barrel from the second mold cavity configuration.   
     
     
         13 . The method of  claim 12 , wherein the flexible polymeric material is selected from the group consisting of low density polyethylene, linear low density polyethylene, thermoplastic elastomer, and combinations thereof. 
     
     
         14 . The method of  claim 12 , wherein the relatively rigid polymeric material is selected from the group consisting of acrylonitrile-butadiene-styrene, high density polyethylene, linear low density polyethylene, polypropylene, polyamide, polyoxymethylene, polystyrene, and combinations thereof. 
     
     
         15 . The applicator of  claim 12 , wherein the flexible polymeric material has a lower flexural modulus than the relatively rigid polymeric material. 
     
     
         16 . A method of making an insertion barrel for an applicator for a self-expanding intravaginal device comprising the steps of:
 a. injecting a first, flexible polymeric material into a first mold cavity to form a first section comprising the insertion end of the insertion barrel;   b. ejecting the first section of the insertion barrel from the first mold;   c. injecting a second, relatively rigid polymeric material into a second mold cavity to form a second section comprising a central portion and gripper portion of the insertion barrel;   d. ejecting the second section of the insertion barrel from the second mold; and   e. attaching the second section to the first section to form the insertion barrel.   
     
     
         17 . The method of  claim 16 , wherein the flexible polymeric material is selected from the group consisting of low density polyethylene, linear low density polyethylene, thermoplastic elastomer, and combinations thereof. 
     
     
         18 . The method of  claim 16 , wherein the relatively rigid polymeric material is selected from the group consisting of acrylonitrile-butadiene-styrene, high density polyethylene, linear low density polyethylene, polypropylene, polyamide, polyoxymethylene, polystyrene, and combinations thereof. 
     
     
         19 . The applicator of  claim 16 , wherein the flexible polymeric material has a lower flexural modulus than the relatively rigid polymeric material.