Methods of fabricating a transcatheter device having an inflatable balloon

• US 10,722,693 B2
• Filed: 11/16/2017
• Issued: 07/28/2020
• Est. Priority Date: 11/20/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Zhou, Pu, Tian, Bin, Zhu, Yidong M.
• Primary Examiner(s): Cozart, Jermie E
• Application Number:
  US15/815,599
• Publication Number:
  US 20180071500A1
• Time in Patent Office: 985 Days
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/107 having a longitudinal slit in the balloon
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: B21D 39/00 Application of procedures in order to connect objects or parts, e.g. coating with sheet metal otherwise than by plating joining mitred profiles B21D53/745; riveting B21J; uniting components by forging or pressing to form integral members B21K25/00; welding B23K; press-fitting, force-fitting, or shrinking in general B23P11/00, B21D19/00; by adhesives F16B11/00 ; Connections as such F16L, F16B; Tube expanders
• CPC Class Codes: B23K 2103/42 Plastics B23K2103/16 takes precedence
• CPC Class Codes: B23K 2103/50 Inorganic material, e.g. metals, not provided for in B23K2103/02 – B23K2103/26
• CPC Class Codes: B23K 26/0624 using ultrashort pulses, i.e. pulses of 1ns or less
• CPC Class Codes: B23K 26/0626 Energy control of the laser beam B23K26/0622 takes precedence
• CPC Class Codes: B23K 26/361 for deburring or mechanical trimming B23K26/351 takes precedence
• CPC Class Codes: B23K 26/362 Laser etching
• CPC Class Codes: B23K 26/402 involving non-metallic material, e.g. isolators

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.

Claims

1. A method of fabricating a transcatheter device having an inflatable balloon, the method 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 body region and the leg regions;

applying low heat laser pulses to an outer surface of the cone regions to form a laser-formed modification, the pulses being less than 1000 picoseconds in duration to ablate material from the outer surface, the low heat laser pulses being configured so as to leave the polymer network morphology surrounding the laser-formed modification substantially unchanged;

folding the balloon; and

crimping a heart valve around the body region of the folded balloon.

2. The method of claim 1, wherein the pulses are less than 10 picoseconds in duration.

3. The method of claim 2, wherein the pulses are less than 800 femtoseconds in duration.

4. The method of claim 1, wherein the step of applying includes ablating in the direction of a longitudinal axis of the inflatable device.

5. The method of claim 1, wherein the laser-formed modification creates a longitudinal recession.

6. The method of claim 5, wherein the longitudinal recession tapers from a narrow width to a wider width toward the body region.

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

8. The method of claim 1, wherein the pulses have a maximum pulse energy of 40 micro joules.

9. The method of claim 1, wherein the pulses have a maximum pulse energy of 200 micro joules.

10. The method of claim 1, wherein the laser-formed modification extends parallel to the longitudinal axis.

11. The method of claim 1, wherein the laser-formed modification extends around a circumferential perimeter of the cone regions.

12. The method of claim 1, wherein the laser-formed modification extends parallel to the longitudinal axis and around a circumferential perimeter of the cone regions.

13. 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.

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

15. A method of fabricating a transcatheter device having an inflatable balloon, the method 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 body region and the leg regions;

applying low heat laser pulses to the leg regions to form a laser-formed modification, the pulses being less than 1000 picoseconds in duration to ablate material from the leg regions, the low heat laser pulses being configured so as to leave the polymer network morphology surrounding the laser-formed modification substantially unchanged;

folding the balloon; and

crimping a heart valve around the body region of the folded balloon.

16. The method of claim 15, wherein the pulses are less than 10 picoseconds in duration.

17. The method of claim 16, wherein the pulses are less than 800 femtoseconds in duration.

18. The method of claim 15, wherein the laser-formed modification comprises a wedge, a taper, or an increase in surface roughness on an inner surface of the leg region.

19. The method of claim 15, wherein the laser-formed modification creates a diminished wall thickness of the leg region.