Biomaterial implants which resist calcification

Claim 2

A biomaterial implant into which is incorporated a sustained release polymer containing at least one anticalcium agent.

Claim 3

The device of claim 1, wherein said polymer is capable of delivering at least 0.5 μg of said anticalcium agent per 24 hours for a period of at least 5 days.

Claim 4

The device of claim 1, wherein said anticalcium agent is capable of binding to hydroxyapatite crystals.

Claim 5

The device of claim 3, wherein said anticalcium agent comprises a pharmaceutically acceptable diphosphonate.

Claim 6

The device of claim 4, wherein said diphosphonate comprises ethanehydroxydiphosphonate (EHDP).

Claim 7

The device of claim 4, wherein said diphosphonate comprises aminopropanediphosphonate (APDP).

Claim 8

The device of claim 1, wherein said anticalcium agent is capable of reacting with calcium ions.

Claim 9

The device of claim 7, wherein said anticalcium agent comprises a pharmaceutically acceptable calcium channel blocker.

Claim 10

The device of claim 8, wherein said calcium channel blocker comprises nifedipine.

Claim 11

The device of claim 8, wherein said calcium channel blocker comprises verapamil.

Claim 12

The device of claim 7, wherein said anticalcium agent comprises a pharmaceutically acceptable calcium chelating agent.

Claim 13

The device of claim 11, wherein said calcium chelating agent comprises EDTA.

Claim 14

The device of claim 11, wherein said calcium chelating agent comprises a pharmaceutically acceptable phosphocitrate analogue.

Claim 15

The device of claim 13, wherein said phosphocitrate analogue comprises 2-aminotricarballylate.

Claim 16

The device of claim 7, wherein said anticalcium agent comprises a pharmaceutically acceptable ionic antagonist.

Claim 17

The device of claim 15, wherein said ionic antagonist comprises lanthanum trichloride.

Claim 18

The device of claim 7, wherein said anticalcium agent comprises a pharmaceutically acceptable calcium ligand former.

Claim 19

The device of claim 17, wherein said calcium ligand former comprises a thiophene derivative.

Claim 20

The device of claim 1, wherein said anticalcium agent is capable of reacting with the free aldehyde groups of a glutaraldehyde-stabilized biomaterial implant.

Claim 21

The device of claim 19, wherein said anticalcium agent comprises pharmaceutically acceptable amino-containing compounds.

Claim 22

The device of claim 20, wherein said amino-containing compound comprises aminopropanediphosphonate (APDP).

Claim 23

The device of claim 20, wherein said amino-containing compound comprises 2-aminotricarballylate.

Claim 24

The device of claim 1, wherein said polymer is a biocompatible polymer which is insoluble in biological fluids.

Claim 25

The device of claim 23, wherein said polymer is chosen from a group of natural and synthetic polymers consisting of acyl substituted cellulose acetates and alkyl derivatives thereof; partially and completely hydrolyzed alkylene-vinyl acetate copolymers; unplasticized polyvinyl chloride; crosslinked homo- and copolymers of polyvinyl acetate; crosslinked polyesters of acrylic and methacrylate; polyvinyl alkyl ethers; polyvinyl fluoride; silicone; polycarbonate; polyurethane; polyamide; polysulphones; styrene acrylonitrile copolymers; crosslinked poly(ethylene oxide); poly(alkylenes); poly(vinyl imidazole); poly(esters); poly(ethylene terephthalate); and chlorosulphonated polyolefins; polyvinylalcohol; and poly-2-hydroxy-ethylmethacrylate.

Claim 26

The device of claim 24, wherein said polymer comprises ethylene-vinyl acetate copolymer.

Claim 27

The device of claim 1, wherein said biomaterial implant is a bioprosthetic cardiac valve.

Claim 28

The device of claim 1, wherein said biomaterial implant is a synthetic vascular graft.

Claim 29

The device of claim 1, wherein said biomaterial implant is an autologous saphenous bypass graft.

Claim 30

The device of claim 1, wherein said biomaterial implant is a detachable cardiac balloon.

Claim 31

The device of claim 1, wherein said biomaterial implant is a ventricular assist device containing an elastomeric bladder.

Claim 32

The device of claim 1, wherein said biomaterial implant is a hip prosthesis.

Claim 33

The device of claim 1, wherein said biomaterial implant is a silastic breast implant.

Claim 34

The device of claim 1, wherein said biomaterial implant is a tendon prosthesis.