# US 9,750,622 B2 · High molecular weight polylactide and polycaprolactone copolymer and blends for bioresorbable vascular scaffolds

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- Number: US 9,750,622 B2
- Document ID: US9750622B2
- Status: Granted
- Kind: B2
- Application number: 14/307,440
- Filed: 2014-06-17
- Published: 2015-12-17
- Granted: 2017-09-05
- Earliest claimed: 2014-06-17
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Abbott Cardiovascular Systems Inc.
- Inventors: Xiao Ma; Mary Beth Kossuth; James P. Oberhauser; Stephen D. Pacetti; Manish Gada
- Web page: https://patentgrep.com/patent/US9750622B2

## CPC

- A61F 2/90: characterised by a net-like or mesh-like structure
- A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61L 31/041: {Mixtures of macromolecular compounds}
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Bioresorbable polymer vascular scaffolds made of combinations of polylactide and polycaprolactone having a high molecular weight polymer, thin struts in a selected range and sufficient radial strength to support a vessel upon deployment. The scaffolds have degradation behavior of molecular weight, radial strength, and mass that are conducive to healing of a vessel including providing patency to a vessel, reduction of radial strength, breaking up, and resorbing to allow return of the vessel to a natural state.

## Claims

### Claim 1

A stent comprising:
a bioresorbable polymer scaffold comprising a polymer combination including a polylactide polymer and polycaprolactone,
wherein the polymer combination is a blend of poly(L-lactide) (PLLA) and 70/30 poly(L-lactide-co-caprolactone) random copolymer, wherein caprolactone units of the copolymer are 1 to 5 wt % of the blend,
wherein the scaffold includes a plurality of interconnected struts,
wherein a thickness of the struts is 80 to 100 microns and a width of the struts is 200 to 250 microns, and
wherein the scaffold has a crimped state and a deployed state and a radial strength of the scaffold when expanded from the crimped state to the deployed state in saline or bodily fluid at 37° C. is at least 650 mm Hg.

### Claim 2 (depends on 1)

The stent of claim 1, wherein a hoop ultimate tensile strength is at least 25% greater than an axial ultimate tensile strength of the scaffold.

### Claim 3 (depends on 1)

The stent of claim 1, wherein a concentration of unreacted lactide monomer in the scaffold is 0.5 to 1 wt %.

### Claim 4 (depends on 1)

The stent of claim 1, wherein a number average molecular weight (Mn) of the polymer combination is less than 60 kDa at 1 year of exposure of the scaffold to saline or bodily fluids at 37° C.

### Claim 5 (depends on 1)

The stent of claim 1, wherein a crystallinity of the scaffold is 25% to 50%.

### Claim 6 (depends on 1)

The stent of claim 1, wherein a change in retardance as measured by polarized light microscopy (PLM) from an inner diameter to 50% of the thickness to the outer diameter of the scaffold is less than 50%.

### Claim 7

A stent comprising:
a bioresorbable polymer scaffold comprising a polymer formulation including a blend of polylactide (PLA) polymer and a PLA and polycaprolactone (PCL) copolymer,
wherein the PLA polymer is poly(L-lactide) (PLLA) and the copolymer is 70/30 poly(L-lactide-co-caprolactone) random copolymer, wherein caprolactone units of the copolymer are 1 to 5 wt % of the blend,
wherein the scaffold includes a plurality of interconnected struts,
wherein a thickness of the struts is 80 to 100 microns and a width of the struts is 200 to 250 microns,
wherein a number average molecular weight (Mn) of the blend is greater than 60 kDa, and
wherein the scaffold has a crimped state and a deployed state and a radial strength of the scaffold when expanded from the crimped state to the deployed state in saline or bodily fluid at 37° C. is at least 650 mm Hg.

### Claim 8 (depends on 1)

The stent of claim 1, wherein a number average molecular weight (Mn) of a polymer of the polymer combination is greater than 110 kDa.