Cross-linked radiopaque bioresorbable polymers and devices made therefrom
AssigneeREVA Medical, Inc.
InventorsRobert K. Schultz, Lioubov Kabalnova, Donald K. Brandom, Jessica Earley, Ernest G. Baluca, Durgadas Bolikal
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Abstract
The present application provides polymer materials having the desired properties for implantation into a human or animal body, in particular, biocompatibility, biodegradability, radiopacity and mechanical properties. Methods of making such polymer materials, compositions or devices comprising such polymer materials, and uses of such polymer materials, compositions and devices are also disclosed.
Claims30
A polymer material, comprising one or more of polymers, homogeneous polymers, copolymers, block co-polymers, and/or blends or mixtures thereof;
- wherein the biocompatible polymer material is optionally inherently radiopaque, and/or bioresorbable;
- wherein the polymer material comprises at least one polymer component which, as initially prepared, has a latently cross-linkable state, such that it comprises functional groups which are configured to react upon being subjected to at least one cross-linking initiation treatment to crosslink the polymer;
- wherein the polymer material comprises at least one polymer component which, as initially prepared, has a rubbery or partially rubber state at a temperature less than 37° C.;
- wherein the polymer material, prior to being subjected to the at least one cross-linking initiation treatment, has properties allowing it to be formed into a selected structural shape without initiating cross-linking;
- and
- wherein the polymer material, after subjected to at least one cross-linking initiation treatment, has a cross-linked state, such that it has a sufficient number and/or density of cross-links between polymer chains within the material so as to enhance the material properties to create a strong, tough, resilient material, such that a selected shape composed of the cross-linked polymer material has crush-recoverable properties allowing substantial return to the selected shape following mechanical deformation.
A medical device comprising at least one structural portion;
- wherein the structural portion has been previously formed from a latently cross-linkable polymer material to have a pre-formed shape, the latently cross-linkable polymer material including one or more polymers or copolymers which are inherently radiopaque, biocompatible, and/or bioresorbable;
- wherein, subsequent to the formation of the pre-formed shape of the structural portion, the latently cross-linkable polymer material of the structural portion has been subjected to at least one cross-linking initiation treatment so as to form a sufficient number and/or density of cross-links between polymer chains within the material so as to enhance the material properties to create a strong, tough, resilient, and/or crush-recoverable material having the pre-formed shape;
- and
- wherein optionally the cross-linked pre-form shape is further fabricated to making the medical device.
A method of making a medical device having a structure comprising an inherently radiopaque, biocompatible, and/or bioresorbable polymeric material, the structure having at least one of the properties of toughness, resiliency, impact-resistance and/or crush recoverability upon deformation, the method comprising, in any functional order, the steps of:
- (a) preparing a latently cross-linkable polymer material which comprises polymer or copolymer which is inherently radiopaque, biocompatible and/or bioresorbable, and which is capable of subsequently forming cross-links between polymer chains upon being subjected to at least one cross-linking initiation treatment;
- (b) forming at least one pre-formed structural shape portion, the pre-formed structural shape portion including the latently cross-linkable polymer material;
- (c) after forming step (b), subjecting the pre-formed structural shape portion to at least one cross-linking initiation treatment so as to forming cross-links between polymer chains, resulting in the formation of a cross-linked structural shape portion having at least one of the properties of toughness, resiliency, impact-resistance and/or crush recoverability upon deformation;
- (d) after treatment step (c), optionally carrying out forming, treating and/or conditioning steps to modify the cross-linked structural shape portion;
- (e) making the medical device so as to comprise the cross-linked structural shape portion.
Dependencies are inferred from the claim text.