Granted Patent B2

US 11,369,498 · App. 13/014,632 · Granted Jun 28, 2022

Inventors: James B. McClain (Raleigh, NC); Douglas Taylor (Franklinton, NC); David Enscore (Alpharetta, GA)

Assignee: MT Acquisition Holdings LLC

A61F2/958A61F2/0077A61F2002/826A61F2250/003

Abstract

Claims (28)

1. A stent delivery system comprising:

a. an elongate member having an inflation lumen and a guidewire lumen therein;

b. a balloon having an interior that is in fluid communication with the inflation lumen; and

c. a stent comprising a bioabsorbable polymer coating, consisting essentially of a hydrophilic polymer comprising at least one of PLGA, a PLGA copolymer, poly(glycolide) (PGA), poly(l-lactide) (LPLA), poly(dl-lactide) (DLPLA), poly(e-caprolactone) (PCL), poly(dioxolane) (PDO), PGA-TMC, 85/15 p(dl-lactide-co-glycolide) (PLPLG) 75/25 DLPL, 65/35 (DLPLG), 50/50 DLPLG, poly(trimethylcarbonate) (TMC), and poly(1,3-bis-p-(carboxyphenoxy)propane-co-sebacic acid) (p(CPP:SA), with a pharmaceutical agent dispersed within the polymer, the stent mounted on the balloon,

wherein when at least a portion of the stent system that includes the mounted stent is tested using Lubricity Test 1, the lubricity is at most 7 g, wherein the polymer coating is at most 20 micrometers in thickness and provides the lubricity.

2. The stent delivery system of claim 1 , wherein for a stent of about 2.25 mm in diameter to about 4.0 mm in diameter by about 9 mm to about 30 mm in length in an expanded state, a stent system trackability expressed as a mean force over the track length is at most 0.5 Newtons, wherein the polymer coating is at most 20 micrometers in thickness.

3. The stent delivery system of claim 2 , wherein stent system trackability is tested according to at least one of: Tortuosity test 1 and Tortuosity test 2.

4. The stent delivery system of claim 2 ,

in which the balloon comprises a polymer, and

in which the stent mounted on the balloon has a crossing profile of at most 1.12 mm.

5. The stent delivery system of claim 2 , wherein the stent system trackability is achieved with at least one of: at most 5% coating delamination, at most 10% coating delamination, at most 15% coating delamination, at most 20% coating delamination, at most 5% coating cracking, at most 10% coating cracking, at most 15% coating cracking, and at most 20% coating cracking.

6. The stent delivery system of claim 1 , wherein a stent of about 2.25 mm in diameter to about 4.0 mm in diameter by about 9 mm to about 30 mm in length in an expanded state has a stent system pushability ((Fdist/Fprox)×100%) of at most 18%, wherein the polymer coating is at most 20 micrometers in thickness.

7. The stent delivery system of claim 6 , wherein the stent system pushability is measured according to Tortuosity Test 2.

8. The stent delivery system of claim 6 ,

in which the balloon comprises a polymer, and

in which the stent mounted on the balloon has a crossing profile selected from the group consisting of at most 1.06 mm for a 2.25 diameter balloon, at most 1.09 mm for a 2.5 diameter balloon, at most 1.11 mm for a 2.75 diameter balloon, at most 1.12 mm for a 3.0 diameter balloon, at most 1.18 mm for a 3.5 diameter balloon, and at most 1.35 mm for a 4.0 diameter balloon.

9. The stent delivery system of claim 6 , wherein the stent system pushability is achieved with at least one of: at most 5% coating delamination, at most 10% coating delamination, at most 15% coating delamination, at most 20% coating delamination, at most 5% coating cracking, at most 10% coating cracking, at most 15% coating cracking, and at most 20% coating cracking.

10. The stent delivery system of claim 1 , wherein a stent of about 2.25 mm in diameter to about 4.0 mm in diameter by about 9 mm to about 30 mm in length in an expanded state has a stent system crossability measured as mean cross force of less than 0.03 Newtons, wherein the polymer coating is at most 20 micrometers in thickness.

11. The stent delivery system of claim 10 , wherein the stent system crossability is measured according to at least one of: tortuosity test 1 and tortuosity test 2.

12. The stent delivery system of claim 10 ,

in which the balloon comprises a polymer, and

in which the stent mounted on the balloon has a crossing profile selected from the group consisting of at most 1.06 mm for a 2.25 diameter balloon, at most 1.09 mm for a 2.5 diameter balloon, at most 1.11 mm for a 2.75 diameter balloon, at most 1.12 mm for a 3.0 diameter balloon, at most 1.18 mm for a 3.5 diameter balloon, and at most 1.35 mm for a 4.0 diameter balloon.

13. The stent delivery system of claim 10 , wherein the stent system crossability is at most 0.1 Newton expressed as peak cross force.

14. The stent delivery system of claim 10 , wherein the stent system crossability is achieved with at least one of: at most 5% coating delamination, at most 10% coating delamination, at most 15% coating delamination, at most 20% coating delamination, at most 5% coating cracking, at most 10% coating cracking, at most 15% coating cracking, and at most 20% coating cracking.

15. The stent delivery system of claim 1 , wherein when tested using Lubricity Test 1, at least the portion of the stent system that includes the mounted stent has a lubricity of at most about 6 g, or at most about 5 g.

16. The stent delivery system of claim 1 ,

in which the balloon comprises a polymer, and

in which the stent mounted on the balloon has a crossing profile selected from the group consisting of at most 1.06 mm for a 2.25 diameter balloon, at most 1.09 mm for a 2.5 diameter balloon, at most 1.11 mm for a 2.75 diameter balloon, at most 1.12 mm for a 3.0 diameter balloon, at most 1.18 mm for a 3.5 diameter balloon, and at most 1.35 mm for a 4.0 diameter balloon.

Assignments (6)