# US 10,898,620 B2 · Composite stent having multi-axial flexibility and method of manufacture thereof

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- Number: US 10,898,620 B2
- Document ID: US10898620B2
- Status: Granted
- Kind: B2
- Application number: 15/624,235
- Filed: 2017-06-15
- Published: 2017-10-05
- Granted: 2021-01-26
- Earliest claimed: 2008-06-20
- Assignees: Razmodics LLC
- Applicants: Razmodics LLC
- Inventors: Kamal Ramzipoor; Richard J. Saunders
- Web page: https://patentgrep.com/patent/US10898620B2

## CPC

- A61L 31/148: {Materials at least partially resorbable by the body}
- A61F 2/07: Stent-grafts
- 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)
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61L 31/04: Macromolecular materials
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- B29C 41/003: {characterised by the choice of material}
- B29C 41/14: Dipping a core {(B29C41/10 takes precedence)}
- A61F 2/24: Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body}
- A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive}
- A61F 2002/30535: {Special structural features of bone or joint prostheses not otherwise provided for}
- A61F 2002/828: {Means for connecting a plurality of stents allowing flexibility of the whole structure}
- A61F 2002/91558: {connected peak to peak}
- A61F 2210/0004: bioabsorbable
- A61F 2210/0019: operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
- A61F 2240/004: Using a positive or negative model, e.g. moulds
- B29K 2105/0035: {Medical or pharmaceutical agents}
- B29K 2995/0056: Biocompatible, e.g. biopolymers or bioelastomers
- B29L 2031/7532: {Artificial members, protheses}
- 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)
- 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)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

A bioabsorbable composite stent structure, comprising bioabsorbable polymeric ring structures which retain a molecular weight and mechanical strength of a starting substrate and one or more interconnecting struts which extend between and couple adjacent ring structures. The ring structures can have a formed first diameter and being radially compressible to a smaller second diameter and re-expandable to the first diameter. The ring structures can comprise a base polymeric layer. The interconnecting struts can be formed from a polymer blend or co-polymer of poly-L-lactide (PLLA) and an elastomeric polymer. The interconnecting struts each can have a width that is less than a circumference of one of the ring structures. The adjacent ring structures can be axially and rotationally movable relative to one another via the interconnecting struts. The interconnecting struts can also be bioabsorbable.

## Claims

### Claim 1

A bioabsorbable composite stent structure, comprising:
bioabsorbable polymeric ring structures which retain a molecular weight and mechanical strength of a starting substrate, the ring structures having a formed first diameter and being radially compressible to a smaller second diameter and re-expandable to the first diameter, wherein the ring structures are separated from one another and comprise a base polymeric layer;
one or more interconnecting struts which extend between and couple adjacent ring structures, wherein the interconnecting struts each has a width which is less than a circumference of one of the ring structures,
wherein the interconnecting struts are formed from a polymer blend or co-polymer of poly-L-lactide (PLLA) and an elastomeric polymer,
wherein the adjacent ring structures are axially and rotationally movable relative to one another via the interconnecting struts, and
wherein the one or more interconnecting struts are bioabsorbable.

### Claim 2 (depends on 1)

The stent structure of claim 1, wherein the elastomeric polymer is polycaprolactone (PCL).

### Claim 3 (depends on 2)

The stent structure of claim 2, wherein the PCL is 1% to 10% of the polymer blend or co-polymer.

### Claim 4 (depends on 2)

The stent structure of claim 2, wherein the PCL is 1% to 50% of the polymer blend or co-polymer.

### Claim 5 (depends on 1)

The stent structure of claim 1, wherein the polymer blend or co-polymer has a glass transition temperature between 50° C. and 65° C.

### Claim 6 (depends on 1)

The stent structure of claim 1, wherein the ring structures are spaced closer to one another along a first portion than along a second portion of the stent structure.

### Claim 7 (depends on 1)

The stent structure of claim 1, wherein a terminal ring structure is relatively more flexible than a remainder of the ring structures.

### Claim 8 (depends on 1)

The stent structure of claim 1, wherein the base polymeric layer is a bioabsorbable polymeric substrate formed via a dip-coating process.

### Claim 9

A bioabsorbable composite stent structure, comprising:
bioabsorbable polymeric ring structures which retain a molecular weight and mechanical strength of a starting substrate, the ring structures having a formed first diameter and being radially compressible to a smaller second diameter and re-expandable to the first diameter, wherein the ring structures are separated from one another and comprise a base polymeric layer;
a plurality of interconnecting struts which extend between and couple adjacent ring structures, wherein the interconnecting struts each has a width which is less than a circumference of one of the ring structures,
wherein the interconnecting struts are formed from a polymer blend or co-polymer of poly-L-lactide (PLLA) and an elastomeric polymer,
wherein the plurality of interconnecting struts are positioned along a length of the stent structure in a circumferentially alternating manner between immediately adjacent ring structures,
wherein the ring structures are spaced closer to one another along a first portion than along a second portion of the stent structure, and
wherein the one or more interconnecting struts are bioabsorbable.

### Claim 10 (depends on 9)

The stent structure of claim 9, wherein the elastomeric polymer is polycaprolactone (PCL).

### Claim 11 (depends on 10)

The stent structure of claim 10, wherein the PCL is 1% to 10% of the polymer blend or co-polymer.

### Claim 12 (depends on 10)

The stent structure of claim 10, wherein the PCL is 1% to 50% of the polymer blend or co-polymer.

### Claim 13 (depends on 9)

The stent structure of claim 9, wherein the polymer blend or co-polymer has a glass transition temperature between 50° C. and 65° C.

### Claim 14 (depends on 9)

The stent structure of claim 9, wherein the base polymeric layer is a bioabsorbable polymeric substrate formed via a dip-coating process.

### Claim 15

A bioabsorbable composite stent structure, comprising:
bioabsorbable polymeric ring structures which retain a molecular weight and mechanical strength of a starting substrate, the ring structures having a formed first diameter and being radially compressible to a smaller second diameter and re-expandable to the first diameter, wherein the ring structures are separated from one another and comprise a base polymeric layer;
one or more interconnecting struts which extend between and couple adjacent ring structures, wherein the interconnecting struts each has a width which is less than a circumference of one of the ring structures,
wherein the interconnecting struts are formed from a polymer blend or co-polymer of poly-L-lactide (PLLA) and an elastomeric polymer,
wherein the one or more interconnecting struts is more elastic than the ring structures,
wherein a terminal ring structure is relatively more flexible than a remainder of the ring structures, and
wherein the one or more interconnecting struts are bioabsorbable.

### Claim 16 (depends on 15)

The stent structure of claim 15, wherein the elastomeric polymer is polycaprolactone (PCL).

### Claim 17 (depends on 16)

The stent structure of claim 16, wherein the PCL is 1% to 10% of the polymer blend or co-polymer.

### Claim 18 (depends on 16)

The stent structure of claim 16, wherein the PCL is 1% to 50% of the polymer blend or co-polymer.

### Claim 19 (depends on 15)

The stent structure of claim 15, wherein the polymer blend or co-polymer has a glass transition temperature between 50° C. and 65° C.

### Claim 20 (depends on 15)

The stent structure of claim 15, wherein the base polymeric layer is a bioabsorbable polymeric substrate formed via a dip-coating process.
