Methods of fabricating a heart valve delivery catheter

Patent metadata

Field	Value
Publication number	US-12076513-B2
Application number	US-202318379539-A
Country	US
Kind code	B2
Filing date	Oct 12, 2023
Priority date	Nov 20, 2014
Publication date	Sep 3, 2024
Grant date	Sep 3, 2024

Abstract

Inflatable devices are disclosed including a surface which has a network of polymer chains and is configured to be inflatable into a therapeutically or diagnostically useful shape, and at least one ultrashort laser pulse-formed modification in the surface. The network can, for example, include a network morphology that is substantially unchanged by modification with the ultrashort pulse laser. Ultrashort laser pulses can be laser pulses equal to or less than 1000 picoseconds in duration. Advantageously, the etching process uses a relatively low-heat laser to avoid significant heating of surrounding polymers while modifying the surface (and other structures) of the device. The process is configured so that the polymer chain morphology adjacent the modification is substantially unaffected by the low-heat laser. The resulting inflatable device has customized surface features while still retaining substantially homogenous polymer network morphology. This preserves the elasticity, especially the surface elasticity, of the inflatable device.

First claim

What is claimed is:

1. A method of fabricating a heart valve delivery catheter, comprising:
obtaining a polymer tube defined by a wall along a longitudinal axis having an inner surface and an outer surface, the polymer comprising a network of polymer chains with a homogenous network morphology;
blow molding the polymer tube into a hollow balloon shape having a central body region, a pair of leg regions on opposite ends of the balloon shape that are radially smaller than the central body region and define axial openings therethrough, and a pair of cone regions extending between the central body region and the leg regions;
applying low heat laser pulses to an outer surface of the cone regions to ablate material and form a first laser-formed modification in the outer surface of the cone regions, the low heat laser pulses being configured so as to leave the polymer network morphology surrounding the laser-formed modification substantially unchanged, and wherein the pulses are less than 1000 picoseconds in duration and have a maximum pulse energy of 200 micro-joules;
wherein the blow molded and laser-modified polymer tube forms a balloon,
bonding the leg regions of the balloon to a catheter;
folding the balloon; and
crimping a heart valve around the central body region of the folded balloon.

2. The method of claim 1 , further including forming a second laser-formed modification in the central body region to form recessions that enhance a frictional capacity of the central body region.

3. The method of claim 1 , wherein the step of applying is done prior to the step of blow molding.

4. The method of claim 1 , wherein the low heat laser pulses are applied to create a constant wall thickness in the cone regions.

5. The method of claim 1 , further including forming a second laser-formed modification comprising a wedge, a taper, or an increase in surface roughness on an inner surface of the leg region.

6. The method of claim 1 , further including forming a second laser-formed modification that creates a diminished wall thickness of the leg region.

7. The method of claim 1 , further including forming a second laser-formed modification in the central body region to form a recession that extends parallel to the longitudinal axis and around a circumferential perimeter of the central body region to reduce the wall thickness in a portion thereof.

8. A method of fabricating a heart valve delivery catheter, comprising:
obtaining a polymer tube defined by a wall along a longitudinal axis having an inner surface and an outer surface, the polymer comprising a network of polymer chains with a homogenous network morphology;
blow molding the polymer tube into a hollow balloon shape having a central body region, a pair of leg regions on opposite ends of the balloon shape that are radially smaller than the central body region and define axial openings therethrough, and a pair of cone regions extending between the central body region and the leg regions;
applying low heat laser pulses to an outer surface of the cone regions to ablate material and form a first laser-formed modification in the outer surface of the cone regions, the low heat laser pulses being configured so as to leave the polymer network morphology surrounding the laser-formed modification substantially unchanged, wherein the step of applying is done prior to the step of blow molding;
wherein the blow molded and laser-modified polymer tube forms a balloon,
bonding the leg regions of the balloon to a catheter;
folding the balloon; and
crimping a heart valve around the central body region of the folded balloon.

9. The method of claim 8 , wherein the low heat laser pulses are applied to create a constant wall thickness in the cone regions.

10. The method of claim 8 , further including forming a second laser-formed modification comprising a wedge, a taper, or an increase in surface roughness on an inner surface of the leg region.

11. The method of claim 8 , further including forming a second laser-formed modification that creates a diminished wall thickness of the leg region.

12. The method of claim 8 , further including forming a second laser-formed modification in the central body region to form a recession that extends parallel to the longitudinal axis and around a circumferential perimeter of the central body region to reduce the wall thickness in a portion thereof.

13. A method of fabricating a heart valve delivery catheter, comprising:
obtaining a polymer tube defined by a wall along a longitudinal axis having an inner surface and an outer surface, the polymer comprising a network of polymer chains with a homogenous network morphology;
blow molding the polymer tube into a hollow balloon shape having a central body region, a pair of leg regions on opposite ends of the balloon shape that are radially smaller than the central body region and define axial openings therethrough, and a pair of cone regions extending between the central body region and the leg regions;
applying low heat laser pulses to an outer surface of the cone regions to ablate material and form a first laser-formed modification in the outer surface of the cone regions, the low heat laser pulses being configured so as to leave the polymer network morphology surrounding the laser-formed modification substantially unchanged;
applying low heat laser pulses to further form a second laser-formed modification in the central body region including recessions that enhance a frictional capacity of the central body region;
wherein the blow molded and laser-modified polymer tube forms a balloon,
bonding the leg regions of the balloon to a catheter;
folding the balloon; and
crimping a heart valve around the central body region of the folded balloon.

14. The method of claim 13 , wherein the low heat laser pulses are applied to create a constant wall thickness in the cone regions.

15. The method of claim 13 , further including forming a third laser-formed modification comprising a wedge, a taper, or an increase in surface roughness on an inner surface of the leg region.

16. The method of claim 13 , further including forming a third laser-formed modification that creates a diminished wall thickness of the leg region.

17. The method of claim 13 , wherein the second laser-formed modification in the central body region also forms a recession that extends parallel to the longitudinal axis and around a circumferential perimeter of the central body region to reduce the wall thickness in a portion thereof.

18. The method of claim 13 , wherein the recessions of the second laser-formed modification in the central body region include uniformly or randomly spaced circles, squares, rectangles, or triangles.

19. The method of claim 13 , wherein the recessions of the second laser-formed modification in the central body region extend circumferentially around the perimeter of the device and are spaced along the longitudinal axis.

Assignees

• Edwards Lifesciences Corp

Inventors

• Zhou Pu
• Tian Bin
• Zhu Yidong M

Classifications

• A61M2025/1075

  having a balloon composed of several layers, e.g. by coating or embedding · CPC title

• B23K26/0626

  Energy control of the laser beam (B23K26/0622 takes precedence) · CPC title

• A61M2025/1088

  having special surface characteristics depending on material properties or added substances, e.g. for reducing friction · CPC title

• A61M2025/1079

  having radio-opaque markers in the region of the balloon · CPC title

• A61M2025/107

  having a longitudinal slit in the balloon · CPC title