IP Library › Granted Patent US 12,636,172
Granted Patent B2
US 12,636,172 · App. 19/091,504 · Granted May 26, 2026

Scaffolds having a radiopaque marker and methods for attaching a marker to a scaffold

Inventors: Rommel Lumauig (San Jose, CA); Joel Harrington (Redwood City, CA); Chad Abunassar (San Francisco, CA); David D. Hart (Temecula, CA); Cornel I. Ciurea (Murrieta, CA); Mark A Ritchie (Fallbrook, CA); Jay A. King (Temecula, CA); Jill McCoy (Sunnyvale, CA)
Assignee: ABBOTT CARDIOVASCULAR SYSTEMS INC.
A61F2/915A61F2/844A61F2/86A61F2/89B21J15/02B21J15/14A61F2002/3008A61F2002/91575A61F2210/0014A61F2220/0033A61F2230/0026A61F2230/0069A61F2240/001A61F2250/0098B21J15/04Y10T29/49943Y10T29/49956Y10T29/49993
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Quick Facts
Patent No.
US 12,636,172
App. No.
19/091,504
Granted
May 26, 2026
Kind
B2
Abstract

A scaffold includes a radiopaque marker connected to a strut. The marker is retained within the strut by a head at one or both ends. The marker is attached to the strut by a process that includes forming a rivet from a radiopaque bead and attaching the rivet to the marker including deforming the rivet to enhance resistance to dislodgement during crimping or balloon expansion. The strut has a thickness of about 100 microns.

Claims (30)

1 . A method for making a medical device, comprising:

providing a polymer scaffold having a link with a hole formed in the link, wherein the hole has an upper hole opening, an opposing lower hole opening, and an annular concave wall portion between the upper hole opening and the lower hole opening; and

forcing a spherical marker into one of the hole openings to place the marker flush within the hole such that the forcible insertion of the marker into the hole causes a middle segment of the marker and the concave wall portion to conform to each other for resisting dislodgement of the marker from the hole, wherein an upper and lower exposed surfaces of the marker are flush with luminal and abluminal surfaces of the link, and wherein the polymer scaffold includes a polymer that is heated to a temperature of 0-20 degrees Celsius above the glass transition temperature of the polymer during or after forcing the marker into one of the hole openings, such that the heating improves retention force for maintaining the marker in the hole.

2 . The method of claim 1 , wherein the link has a thickness of between 80 and 120 microns.

3 . The method of claim 1 , wherein the polymer is a polylactide.

4 . The method of claim 1 , wherein a ratio of a width to a thickness of the link is between 1.2 and 2.0.

5 . The method of claim 1 , wherein the marker is made from platinum, iridium, tantalum, palladium, tungsten, niobium, zirconium, iron, zinc, magnesium, manganese, or alloys thereof.

6 . The method of claim 1 , additionally comprising placing the marker on the hole by operation of a tool having a vacuum tip configured for grabbing the marker and releasing the marker by modifying a gas pressure at the tip.

7 . The method of claim 1 , wherein the hole is formed by a laser.

8 . The method of claim 7 , wherein the annular concave wall is formed by the laser.

9 . A polymer stent formed by the method of claim 1 , wherein the stent additionally includes a drug eluting polymer coating such that the coating at least partially covers the marker.

10 . The method of claim 1 , wherein the polymer is heated after forcing the spherical marker into one of the hole openings.

11 . A method for making a medical device, comprising:

providing a polymer scaffold including a strut having a hole formed in the strut, wherein the strut has a thickness less than 150 microns measured between a first side of the strut and a second side of the strut, and the strut comprises poly(L-lactide);

placing a marker on the hole;

pressing the marker into the hole to secure the marker within the hole such that the pressing of the marker into the hole causes the marker and the hole to conform to each other for resisting dislodgement of the marker from the hole; and

heating the scaffold to a temperature of up to 20 degrees Celsius above the glass transition temperature of the poly(L-lactide) during and/or after pressing the marker into the hole, such that the heating improves retention force for maintaining the marker in the hole.

12 . The method of claim 11 , wherein the heating of the scaffold is conducted for 10 to 20 minutes after pressing the marker into the hole and within 24 hours of crimping the scaffold on a balloon of a delivery catheter such that the heating reduces the ability of the marker to dislodge from the hole during the crimping of the scaffold to the balloon of the catheter.

13 . The method of claim 11 , wherein the heating of the scaffold is conducted after pressing the marker into the hole such that the heating reforms the hole and increases securement of the marker in the hole.

14 . The method of claim 11 , wherein the marker comprises a roughened surface for increasing the coefficient of friction between the marker and the hole.

15 . The method of claim 11 , wherein

the marker in spherical, and

the hole, prior to pressing the marker into the hole, has an upper and a lower rim sections in between which the hole has a concave shaped section, such that the upper and lower rim sections in conjunction with the concave shaped section provide a mechanical interlock for the spherical marker.

16 . The method of claim 15 , wherein the distance between the upper and the lower rim sections that defines a depth of the concave shaped section is up to 80% of the thickness of the strut.

17 . The method of claim 11 , wherein pressing the marker into the hole causes at least a luminal side or an abluminal side of the marker to be recessed within the hole.

18 . The method of claim 11 , additionally comprising applying a sealing biodegradable polymer to secure the marker in the hole, wherein

the applying the sealing biodegradable polymer comprises dissolving the sealing biodegradable polymer is a solvent to form a mixture and applying the mixture to the marker; or

the applying the sealing biodegradable polymer comprises applying the sealing biodegradable polymer in a molten state to the marker.

19 . The method of claim 18 , wherein the sealing biodegradable polymer is disposed in gaps between the marker and the hole.

20 . The method of claim 11 , wherein pressing the marker into the hole comprises placing the scaffold over a mandrel and pressing the marker into the hole with a tool and the volume or size of the marker is greater than the volume or size of the hole.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 26, 2025
From: LUMAUIG, ROMMEL; HARRINGTON, JOEL; ABUNASSAR, CHAD; HART, DAVID D.; CIUREA, CORNEL I.; RITCHIE, MARK A.; KING, JAY A.; MCCOY, JILL
To: ABBOTT CARDIOVASCULAR SYSTEMS INC.
Reel/Frame 070641/0289 →
Continuity (5)
Continuation 17954253 · Sep 27, 2022
Continuation 16789217 · Feb 12, 2020
Continuation 15615751 · Jun 6, 2017
Continuation 14738710 · Jun 12, 2015
Related Publication 20250221836A1 · Jul 10, 2025
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