Manufacturing process for polymeric stents

• US 9,198,782 B2
• Filed: 04/14/2014
• Issued: 12/01/2015
• Est. Priority Date: 05/30/2006
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Kleine, Klaus, Gale, David C., Huang, Bin, Abbate, Anthony J., Limon, Timothy A.
• Primary Examiner(s): Koehler, Christopher M
• Application Number:
  US14/252,689
• Publication Number:
  US 20140225311A1
• Time in Patent Office: 596 Days
• Field of Search: 295/08, 295/57, 295/58, 295/05, 295/15, 295/16, 294/46, 294/52, 623/1.15, 623/1.16, 219/121.6, 219/121.67, 219/121.69, 219/121.71, 219/121.72, 219/121.85
• US Class Current: 1/1
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 26/384 of specially shaped holes
• CPC Class Codes: B23K 26/402 involving non-metallic material, e.g. isolators
• CPC Class Codes: B29C 2793/0009 Cutting out
• CPC Class Codes: B29C 48/0022 combined with cutting
• CPC Class Codes: B29C 48/022 characterised by the choice of material
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 55/00 Shaping by stretching, e.g. drawing through a die; Apparatus therefor B29C61/08 takes precedence
• CPC Class Codes: B29C 55/24 radial
• CPC Class Codes: B29C 65/02 by heating, with or without pressure
• CPC Class Codes: B29C 66/534 Joining single elements to open ends of tubular or hollow articles or to the ends of bars
• CPC Class Codes: B29C 71/0063 for changing crystallisation
• CPC Class Codes: B29K 2995/0039 Amorphous
• CPC Class Codes: B29K 2995/006 : Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible
• CPC Class Codes: B29L 2031/7534 : Cardiovascular protheses
• CPC Class Codes: Y10T 29/49874 : Prestressing rod, filament or strand
• CPC Class Codes: Y10T 29/49908 : Joining by deforming
• CPC Class Codes: Y10T 29/49913 : by constricting outer annulus
• CPC Class Codes: Y10T 29/49925 : Inward deformation of aperture or hollow body wall
• CPC Class Codes: Y10T 29/49927 : Hollow body is axially joined cup or tube
• CPC Class Codes: Y10T 29/49995 : Shaping one-piece blank by removing material

Abstract

Methods and systems of fabricating a polymeric stent are disclosed herein. Methods are disclosed that include forming a polymeric tube comprising a polymer using melt processing, radially deforming the formed tube, and forming a stent from the deformed tube. The diameter of the formed tube is less than a target diameter and the tube is radially deformed so that it comprises the target diameter. Forming the stent includes laser machining a stent pattern in the deformed tube at the target diameter with an ultra-short pulse laser.

Claims

1. A method of fabricating a stent comprising:

forming a polymeric tube comprising a polymer using melt processing, wherein a diameter of the formed tube is less than a target diameter;

radially deforming the formed tube so that the deformed tube comprises the target diameter; and

forming a stent from the deformed tube, wherein forming the stent includes laser machining a stent pattern in the deformed tube at the target diameter with an ultra-short pulse laser.

2. The method of claim 1, wherein the melt processing comprises injection molding.

3. The method of claim 1, further comprising crimping the stent on a support element, wherein the stent is at the target diameter prior to crimping.

4. The method of claim 1, wherein the tube is radially deformed with an expansion ratio from 2 to 6.

5. The method of claim 1, wherein the polymer comprises poly(L-lactide).

6. The method of claim 1, further comprising crimping the stent on a support element, wherein a temperature of the stent during crimping is above an ambient temperature.

7. The method of claim 1, wherein the formed tube is at a temperature above the glass transition temperature (Tg) of the polymer during the radial deforming.

8. A method of manufacturing a stent comprising:

forming a stent with a target diameter from a polymeric tube comprising a polymer, wherein prior to forming the stent, the tube was radially deformed to the target diameter,

wherein the deformed tube has induced molecular orientation in the circumferential direction from the radial deformation,

wherein forming the stent includes laser machining a stent pattern in the deformed tube at the target diameter; and

crimping the stent on a support element, wherein the support element comprises a catheter and/or balloon.

9. The method of claim 8, wherein the polymer comprises poly(L-lactide).

10. The method of claim 8, wherein a temperature of the stent during crimping is above an ambient temperature.

11. A method comprising:

radially deforming a polymeric tube comprising a polymer about a cylindrical axis of the tube to a target diameter to form a deformed tube; and

crimping a stent having the target diameter on a support element, the stent being fabricated from the deformed tube at the target diameter by cutting a stent pattern in the deformed tube, wherein the support element comprises a catheter and/or balloon.

12. The method of claim 11, wherein a temperature of the stent during crimping is above an ambient temperature.

13. The method of claim 11, wherein the polymer comprises poly(L-lactide).