Implantable medical balloon and method of making

A self-sealing medical balloon of unitary construction, implantable in a human body, comprising:

• a cylindrical valve body having a predetermined diameter and an upper side and a lower side;
• an inlet defined by said valve body lower side;
• a cylindrical valve stem extending upwardly from said valve body, said valve stem having a diameter smaller than said valve body diameter;
• a balloon wall extending upwardly from said valve body, said balloon wall having an inner diameter, while in a deflated state, which is larger than said valve stem diameter such that an annular space exists between said balloon wall and said valve stem while said balloon is deflated, said annular space provided to relieve stress from a union of said balloon wall and said valve body when said balloon is inflated;
• a piercing extending from said inlet, through said valve body and through said valve stem, into an inner chamber defined by said balloon, said piercing constructed and arranged to remain closed unless a substantially rigid member is pushed through said piercing, such as to inflate said balloon, whereby said piercing recloses after said member is withdrawn, thereby preventing a fluid from escaping from said inner chamber.

A method of forming a medical balloon, implantable into a human body, comprising:

• providing a valve portion having a body, an elongate cylindrical sidewall extending from said body, and an end portion extending from said sidewall, said end portion defining an opening, said valve portion constructed of a first material;
• dipping said end portion into a pool of a second material in molten form such that said opening enters first, thereby forming a meniscus over said opening when said valve portion is removed from said pool;
• removing said end portion from said pool;
• allowing said meniscus to harden such that said meniscus becomes integral with said end portion;
• dipping said valve portion into said pool to form a layer of material over said sidewall;
• removing said valve portion from said pool;
• allowing said layer to harden;
• repeating the steps of dipping a second predetermined length, removing, and allowing said layer to harden, until a desired thickness of material has formed over said sidewall.

A valve of unitary construction, useable to prevent fluid from escaping from an implantable balloon operably attached to the valve, the valve comprising:

• a substantially cylindrical body defining an inlet, concentric with said body, opening in a direction opposite the balloon;
• a valve stem, integral with said body, having a substantially cylindrical side and rounded tip opposite said body and leading to an interior of the balloon;
• a piercing, defined by said valve body and said valve stem, extending from said inlet toward said balloon and leading to the interior of the balloon, said piercing having a bend which curves toward said stem side;
• a cylindrical sidewall, integral with said body, extending in a direction toward said balloon, radially displaced from said stem side, thereby creating an annular space between said stem and said sidewall, said sidewall having an external surface attachable to said balloon.

A valve constructed and arranged to be useable to form a balloon when said valve is subjected to a dip-coating process, said valve comprising:

• a body;
• a cylindrical sidewall extending from said body, said sidewall having a lower portion and an upper portion;
• an end portion extending from said sidewall upper portion and defining an opening of a predetermined size;
• whereby said predetermined opening is sized to allow a liquid, useable in said dip-coating process, to form a meniscus over said opening when said end portion is dipped in a quantity of said liquid and removed therefrom.

A method of creating a channel through a valve useable in an implantable medical balloon, thereby creating an improved self-sealing characteristic of the valve when subjected to back pressure, the valve having a stem extending from the valve into an interior chamber of the balloon, the method comprising:

• pushing a sharp, needle-like implement into said valve, opposite said stem, approximately along a longitudinal axis of said valve, until a sharpened end of said implement enters said stem;
• bending said stem;
• pushing said implement further until said implement exits a side of said stem, displaced from said axis, and enters said chamber;
• removing said implement and releasing said stem, thereby allowing said stem to return to an original shape, and leaving a curved channel in said stem, due to said bending.

A method of forming a medical balloon, implantable into a human body, comprising:

• providing a pool of silicone dispersion;
• providing a valve portion having a body, an elongate cylindrical sidewall extending from said body, an inlet defined by said body opposite said sidewall, a skirt extending from said body opposite said sidewall, a valve member extending from said body inside and concentric with said sidewall, and an end portion extending from said sidewall, said end portion defining an opening;
• attaching said valve portion skirt to a handling member;
• dipping said end portion into said pool, thereby forming a meniscus over said opening when said valve portion is removed from said pool;
• removing said end portion from said pool;
• allowing said meniscus to harden such that said meniscus becomes integral with said end portion;
• repeating said steps of dipping said end portion, removing said end portion from said pool, and allowing said meniscus to harden, until a meniscus plug of a desired thickness has formed over said opening;
• partially vulcanizing said end portion;
• dipping said valve portion into said pool to form a layer of silicone over said sidewall;
• removing said valve portion from said pool;
• allowing said layer to harden;
• repeating the steps of dipping said valve portion, removing, and allowing said layer to harden, until a desired thickness of material has formed over said sidewall;
• fully vulcanizing said balloon;
• performing a piercing operation;
• removing said balloon from said handling member;
• performing an inflation test;
• drying said balloon.