# US 8,540,765 B2 · Medical implant

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- Number: US 8,540,765 B2
- Document ID: US8540765B2
- Status: Granted
- Kind: B2
- Application number: 13/370,025
- Filed: 2012-02-09
- Published: 2012-06-07
- Granted: 2013-09-24
- Earliest claimed: 2009-05-20
- Assignees: 480 Biomedical, Inc.
- Applicants: Maria Palasis; Chang Cheng You; Daniel Concagh; Lee Core; Kicherl Ho; Upma Sharma; Greg Zugates
- Inventors: Maria Palasis; Chang Cheng You; Daniel Concagh; Lee Core; Kicherl Ho; Upma Sharma; Greg Zugates
- Web page: https://patentgrep.com/patent/US8540765B2

## CPC

- A61L 31/10: Macromolecular materials
- A61F 2/07: Stent-grafts
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61F 2210/0004: bioabsorbable
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2230/0054: V-shaped
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61F 2250/0036: differing in thickness
- A61F 2250/0048: differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
- A61L 2300/606: Coatings
- A61L 2420/02: Methods for coating medical devices
- 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)

## Abstract

Disclosed is a self-expanding medical implant for placement within a lumen of a patient. The implant comprises a woven or non-woven structure having a substantially tubular configuration, and is designed to be low-profile such that it is deliverable with a small diameter catheter. The implant has a high recoverability and desired mechanical properties.

## Claims

### Claim 1

An implantable medical device, comprising:
a self-expanding tubular structure comprising at least one strand comprising a first polymer characterized by a modulus of elasticity greater than about 1 GPa; and
a second polymer at least partially and conformally coating said strand, said second polymer being an elastomeric thermoset polymer characterized by a percent elongation to break that is greater than about 150 percent at 37° C.;
wherein the second polymer increases the mass of said self-expanding tubular structure by at least about 20 percent.

### Claim 2 (depends on 1)

The implantable medical device of claim 1, wherein said first polymer is biodegradable.

### Claim 3 (depends on 2)

The implantable medical device of claim 2, wherein said first polymer comprises poly(lactic acid co-glycolic acid).

### Claim 4 (depends on 3)

The implantable medical device of claim 3, wherein said poly(lactic acid co-glycolic acid) comprises at least about 75 weight percent of lactic acid.

### Claim 5 (depends on 4)

The implantable medical device of claim 4, wherein said poly(lactic acid co-glycolic acid) comprises about 85 weight percent of lactic acid.

### Claim 6 (depends on 4)

The implantable medical device of claim 4, wherein said second polymer is poly(lactic acid-co-caprolactone) comprising about 50 to 70 weight percent lactic acid, wherein said polymer is cross-linked.

### Claim 7 (depends on 6)

The implantable medical device of claim 6, wherein said poly(lactic acid-cocaprolactone) is crosslinked with hexamethylene diisocyanate.

### Claim 8 (depends on 6)

The implantable medical device of claim 6, wherein the number average molecular weight (Mn) of said second polymer is greater than about 24,000 Da and less than about 100,000 Da.

### Claim 9 (depends on 3)

The implantable medical device of claim 3, wherein said poly(lactic acid co-glycolic acid) comprises up to about 20 weight percent of lactic acid.

### Claim 10 (depends on 1)

The implantable medical device of claim 1, wherein said first polymer is characterized by a modulus of elasticity greater than about 6 GPa.

### Claim 11 (depends on 1)

The implantable medical device of claim 1, wherein said second polymer is biodegradable.

### Claim 12 (depends on 11)

The implantable medical device of claim 11, wherein said second polymer is a random copolymer that is crosslinked.

### Claim 13 (depends on 11)

The implantable medical device of claim 11, wherein said second polymer is selected from the group consisting of poly(lactic acid-co-caprolactone), poly(glycolide-co-caprolactone, poly trimethylene carbonate, and poly(lactic acid-co-dioxanone) and wherein said second polymer is cross-linked.

### Claim 14 (depends on 1)

The implantable medical device of claim 1, wherein said second polymer is characterized by an elastic segment having a glass transition temperature less than about 5, degree. C.

### Claim 15 (depends on 1)

The implantable medical device of claim 1 wherein said self-expanding tubular structure is a braided structure.

### Claim 16 (depends on 15)

The implantable medical device of claim 15, wherein said braided structure comprises between 16 and 48 strands.

### Claim 17 (depends on 16)

The implantable medical device of claim 16, wherein said strands form an average braid angle of between about 90 degrees and about 135 degrees.

### Claim 18 (depends on 17)

The implantable medical device of claim 17, wherein said strands form an average braid angle of between about 110 degrees and about 135 degrees.

### Claim 19 (depends on 1)

The implantable medical device of claim 1, further comprising a therapeutic agent within at least one of said first polymer material and said second polymer material.

### Claim 20 (depends on 1)

The implantable medical device of claim 1, wherein the second polymer increases the mass of said self-expanding tubular structure by at least about 30 percent.

### Claim 21 (depends on 1)

The implantable medical device of claim 1, further comprising a third polymer at least partially coating said second polymer.

### Claim 22 (depends on 21)

The implantable medical device of claim 21, further comprising a therapeutic agent within said third polymer.

### Claim 23 (depends on 1)

The implantable medical device of claim 1, wherein said second polymer comprises a first segment having a Tg less than about 5.degree. C. and a second segment that is harder than the first segment.

### Claim 24 (depends on 1)

The implantable medical device of claim 1, wherein said self expanding tubular structure has a first end and a second end.

### Claim 25

An implantable medical device, comprising:
a self-expanding tubular structure comprising:
at least one biodegradable strand comprising poly(lactic acid-co-glycolic acid) comprising at least 75 weight percent of lactic acid; and
poly(lactic acid-co-caprolactine) at least partially coating said strand;
wherein said poly9lactic acid-co-caprolactone) is cross-linked and has a number average molecular weight (Mn) greater than 30,000 Da;
wherein said poly(lactic acid co-caprolactone) increases the mass of said self-expanding tubular structure by at least 24 percent;
wherein said self-expanding tubular structure is a braided structure comprising between 16 and 48 strands forming an average braid angle of between 110 degrees and 135 degrees.
