Applicator for Self-Expanding Intravaginal Urinary Incontinence Devices
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.