MULTILAYERED BALLOON
A multilayered inflatable medical appliance is disclosed. The appliance may comprise multiple adjacent layers disposed to increase total burst strength, puncture resistance or other properties. One or more layers may be comprised of a rotational spun fiber coating. Further, in some embodiments, additional top coatings may be included. Multilayered constructs may be configured with higher burst strengths and/or puncture resistance as compared to single layer constructs.
1 . A balloon catheter, comprising:
an inflatable balloon portion including a wall portion comprising a first layer and a second layer, the second layer being formed separately from the first layer; and
a catheter portion comprising a lumen in fluid communication with the inflatable balloon portion and configured to deliver inflation fluid from an inflation device to the inflatable balloon portion.
2 . The balloon catheter of claim 1 , wherein the first layer and the second layer are unconstrained relative to each other over part of the wall portion, such that the first layer can slide with respect to the second layer.
3 . The balloon catheter of claim 1 , wherein the first layer and the second layer are formed of a thermoplastic polymer material.
4 . The balloon catheter of claim 3 , wherein the first layer and the second layer are formed of the same material.
5 . The balloon catheter of claim 3 , wherein the second layer is formed of a different material than the first layer, such that a modulus of elasticity of the second layer is no more than 20% different than a modulus of elasticity of the first layer.
6 . The balloon catheter of claim 1 , wherein the first layer comprises a first balloon and the second layer comprises a second balloon disposed within the first balloon.
7 . The balloon catheter of claim 1 , further comprising a fiber layer disposed on an outer surface of the first layer.
8 . The balloon catheter of claim 7 , wherein the fiber layer comprises serially deposited nano-fibers or micro-fibers.
9 . The balloon catheter of claim 8 , wherein the serially deposited fibers comprise rotational spun fibers that comprise a material selected from at least one of the following: polyamide, aromatic polyimide, polyethylene and polypropylene.
10 . The balloon catheter of claim 9 , wherein the rotational spun nano-fibers or micro-fibers comprise a polyamide.
11 . The balloon catheter of claim 10 , wherein the polyamide is nylon 6 or nylon 6-6.
12 . The balloon catheter of claim 7 , further comprising a polyurethane coat or an Elvamide coat over the fiber layer.
13 . The balloon catheter of claim 1 , further comprising a Kapton layer disposed on an outer surface of the first layer.
14 . The balloon catheter of claim 1 , further comprising a radiopaque material disposed on the inflatable balloon portion.
15 . The balloon catheter of claim 14 , wherein the radiopaque material is selected from at least one of: a rotational spun bismuth ring, a ribbon, or a thin film.
16 . The balloon catheter of claim 14 , wherein the radiopaque material comprises a polymer fiber coated bismuth subcarbonate.
17 . The balloon catheter of claim 8 , wherein the serially deposited fibers comprise fibers that have been stretched in a first direction.
18 . A method for manufacturing a balloon catheter, comprising:
forming a first thermoplastic polymer balloon layer;
forming a second thermoplastic polymer balloon layer that is disposed inside the first thermoplastic polymer balloon layer, such that the first and second thermoplastic polymer balloon layers comprise an inflatable balloon portion; and
coupling a catheter comprising a lumen to the inflatable balloon portion such that the lumen is in fluid communication with the inflatable balloon portion.
19 . The method of claim 18 , wherein forming the second thermoplastic polymer balloon layer comprises:
inflating the first thermoplastic polymer balloon layer;
forming the second thermoplastic polymer balloon layer separate from the first thermoplastic polymer balloon layer;
collapsing the second thermoplastic polymer balloon layer;
inserting the second thermoplastic polymer balloon layer into the first thermoplastic polymer balloon layer; and
inflating the second thermoplastic polymer balloon layer.
20 . The method of claim 18 , wherein forming the second thermoplastic polymer balloon layer comprises forming the second thermoplastic polymer balloon layer within the first thermoplastic polymer balloon layer.
21 . The method of claim 18 , further comprising applying negative gauge pressure to remove air from the inflatable balloon portion.
22 . A method for manufacturing a balloon catheter, comprising:
forming a first thermoplastic polymer balloon layer;
serially depositing a nano-fiber or micro-fiber layer onto the first thermoplastic polymer balloon layer; and
coupling a catheter comprising a lumen to the inflatable balloon portion such that the lumen is in fluid communication with the inflatable balloon portion.
23 . The method of claim 22 , further comprising forming a second thermoplastic polymer balloon layer inside the first thermoplastic polymer balloon layer.
24 . The method of claim 22 , wherein serially depositing a nano-fiber or micro-fiber layer comprises rotational spinning polymeric fibers.
25 . The method of claim 24 , wherein the rotational spun nano-fibers or micro-fibers comprise a material selected from at least one of the following: polyamide, aromatic polyimide, polyethylene and polypropylene.
26 . The method of claim 25 , wherein the rotational spun nano-fibers or micro-fibers comprise a polyamide.
27 . The method of claim 26 , further comprising dissolving the polyamide into an organic or inorganic solvent to create a solution.
28 . The method of claim 27 , wherein the solvent is selected from hexafluoro propanol or formic acid.
29 . The method of claim 28 , wherein the solution comprises 5% to 30% polyamide by weight.
30 . The method of claim 24 , wherein the first thermoplastic polymer balloon layer is rotated about an axis orthogonal to an axis of rotation of a rotational spinning apparatus.