Medical balloon
Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a catheter. The catheter may include a catheter shaft and a balloon. The balloon may comprise a cone portion, a waist portion, and a body portion. A fiber braid may be disposed along the balloon. An inner surface of the waist portion may be thermally bonded to an outer surface of the catheter shaft and an inner surface of the fiber braid may be adhesively bonded to an outer surface of the waist portion.
1. A catheter comprising a catheter shaft, a balloon comprising a cone portion, a waist portion, and a body portion, and a fiber braid disposed along at least a portion of the balloon, the fiber braid comprising a molecularly oriented ultra high molecular weight polyethylene;
wherein the catheter is formed by disposing the fiber braid over the balloon such that the fiber braid extends over the waist portion, then withdrawing the fiber braid to expose the waist portion, inserting the catheter shaft into the waist portion and applying heat to thermally bond an inner surface of the waist portion to an outer surface of the catheter shaft; and
after the waist portion of the balloon is thermally bonded to the catheter shaft, applying a non-heat curing thermoset adhesive to only the waist portion of the balloon that has been exposed, then moving the fiber braid back over the waist portion to adhesively bond an inner surface of the fiber braid to an outer surface of only the waist portion; and
wherein the thermal bond between the inner surface of the waist portion and an outer surface of the catheter shaft and the adhesive bond between the waist portion and the inner surface of the fiber braid are maintained when the balloon is inflated to pressures of about 20 atm to about 50 atm.
2. The catheter of claim 1 , wherein the balloon is formed of a poly(ether-block-amide).
3. The catheter of claim 1 , wherein the balloon includes an inner layer formed of a poly(ether-block-amide) and an outer layer formed of a polyamide.
4. The catheter of claim 1 , wherein the catheter shaft includes a polyamide.
5. The catheter of claim 1 , wherein the thermoset adhesive includes a moisture cure material, a UV cure material, or a combination thereof.
6. The catheter of claim 1 , wherein the catheter shaft is a dual lumen catheter shaft.
7. The catheter of claim 1 , wherein applying heat to thermally bond the inner surface of the waist portion to the outer surface of the catheter shaft while the fiber braid is withdrawn to expose the waist portion, and then moving the fiber braid back over the waist portion to adhesively bond the inner surface of the fiber braid to the outer surface of only the waist portion preserves the molecular orientation of the molecularly oriented ultra high molecular weight polyethylene of the fiber braid.
8. The catheter of claim 1 , further comprising disposing a first thermoplastic polyurethane coating between the fiber braid and an outer surface of the balloon.
9. The catheter of claim 8 , further comprising disposing a second thermoplastic polyurethane coating along an outer surface of the fiber braid.
10. A catheter comprising a polymeric catheter shaft, a balloon including a thermoplastic elastomer and having a cone portion, a waist portion, and a body portion, and a fiber braid disposed along the balloon, the fiber braid including molecularly oriented high molecular weight polymer;
wherein the catheter is formed by disposing the fiber braid over the balloon such that the fiber braid extends over the waist portion, then withdrawing the fiber braid to expose the waist portion, inserting the polymeric catheter shaft into the waist portion and bonding an inner surface of the waist portion to an outer surface of the polymeric catheter shaft using a first method; and
after the waist portion of the balloon is bonded to the polymeric catheter shaft, bonding an inner surface of the fiber braid to an outer surface of only the waist portion by a second method that is different than the first method, the second method comprising applying a thermoset adhesive including a moisture cure material, a UV cure material, or a combination thereof, to only the waist portion of the balloon that has been exposed, then moving the fiber braid back over the waist portion to adhesively bond the inner surface of the fiber braid to the outer surface of only the waist portion of the balloon, wherein the second method preserves the molecular orientation of the molecularly oriented high molecular weight polymer of the fiber braid;
wherein the thermal bond between the inner surface of the waist portion and an outer surface of the polymeric catheter shaft and the adhesive bond between the waist portion and the inner surface of the fiber braid are maintained when the balloon is inflated to pressures of about 20 atm to about 50 atm.
11. The catheter of claim 10 , wherein the first method includes thermally bonding the outer surface of the polymeric catheter shaft to the inner surface of the waist portion.
12. The catheter of claim 11 , wherein the thermal bond between the outer surface of the polymeric catheter shaft and the inner surface of the waist portion forms an interface comprising the thermoplastic elastomer of the balloon and a polymeric material of the polymeric catheter shaft.
13. The catheter of claim 11 , wherein the thermoplastic elastomer of the balloon and a polymer of the polymeric catheter shaft have a common monomer.