Controlled disintegrating implantable medical devices
Implantable medical devices for treating bodily disorders local and distally to a region of implantation are disclosed. The devices include a body structure including an active agent, erodable particles acting as a carrier of the active agent, and an erodable binder. The binder releasably binds the particles together such that after implantation the binder erodes to release the particles.
1. An implantable medical device consisting of:
a body structure consisting of erodable particles and an erodable binder releasably binding the particles together such that after implantation the binder erodes to release the particles, wherein the particles have a slower erosion rate than the binder, and wherein the particles are dispersed in the binder,
wherein the particles consist of a bioerodable polymer and an active agent, wherein the bioerodable polymer acts as a carrier of the active agent,
wherein the binder consists of a bioabsorbable polymer,
wherein the bioerodable polymer comprises a polymer selected from the group consisting of poly(ethylene oxide), poly(acrylamide), acrylic polymers and copolymers other than polyacrylates, poly(vinyl alcohol), tyrosine based polycarbonates, cellulose acetate, and polyethylene glycol; and
optionally a coating over the body structure consisting of a coating polymer and a drug,
wherein the device is a stent adapted to be implanted in a bodily lumen.
2. The device of claim 1 , wherein erosion is due to dissolution, chemical breakdown, and/or enzymatic degradation of the binder and/or particles.
3. The device of claim 1 , wherein rheological forces facilitate release of the particles from the binder.
4. The device of claim 1 , wherein at least some of the released particles are adapted to be transported to a selected bodily region distal from a local region of implantation and to treat the distal region with the active agent.
5. The device of claim 4 , wherein the local region comprises a vascular region comprising a lesion and the distal region comprises vasculature distal from the lesion and/or a per-adventitial region.
6. The device of claim 1 , wherein the particles do not undergo substantial erosion prior to being released from the binder.
7. The device of claim 1 , wherein the active agent is encapsulated, embedded, or dispersed within the bioerodable polymer.
8. The device of claim 1 , wherein at least an amount of the active agent is configured to be released from the bioerodable polymer prior to the particles being released from the binder so at to locally administer the active agent at or near a region where the device is implanted.
9. The device of claim 1 , wherein the active agent is coated on the bioerodable polymer.
10. The device of claim 1 , wherein the size of the particles is on a nano-scale or micro-scale.
11. The device of claim 1 , wherein the particles comprise an outer shell and an inner compartment comprising the active agent.
12. The device of claim 1 , wherein the active agent is released subsequent to the release of the particles from the binder.
13. The device of claim 1 , wherein the particles are released upon the degradation of the binder of the body structure, the body structure being a scaffolding that is the primary source of structural support.
14. A stent consisting of:
a scaffold consisting of particles and an erodable binder releasably binding the particles together such that after implantation the binder erodes to release the particles, wherein the particles have a slower erosion rate than the binder, wherein the particles are dispersed in the binder, and wherein the particles consist of an active agent and an amphiphilic block copolymer and the binder consists of a hydrophilic polymer, wherein the amphiphilic block copolymer acts as a carrier of the active agent; and
optionally a coating over the scaffold consisting of a coating polymer and a drug.
15. The stent of claim 14 , wherein the amphiphilic block copolymer is selected from the group consisting of poly(ethylene glycol)-poly(lactic acid), poly(ethylene glycol)-poly(caprolactone), and poly(vinylpyrrolidone)-poly(lactic acid).
16. The stent of claim 15 , wherein the hydrophilic polymer is selected from the group consisting of poly(ethylene glycol), poly(vinylpyrrolidone), and poly(vinyl acetate).
17. A stent consisting of:
a scaffold consisting of particles and an erodable binder releasably binding the particles together such that after implantation the binder erodes to release the particles, wherein the particles have a slower erosion rate than the binder, wherein the particles are dispersed in the binder, and wherein the particles consist of an active agent and micelles consisting of amphipathic molecules having both hydrophobic and hydrophilic groups, wherein the binder consists of a bioabsorbable polymer, wherein the micelles act as a carrier of the active agent, wherein the amphipathic molecules are arranged in a cluster having a spherical, cylindrical, or discoidal shape; and
optionally a coating over the scaffold consisting of a coating polymer and a drug.
18. The stent of claim 17 , wherein the micelles are stabilized by crosslinking of the amphipathic molecules that form the micelles.
19. A stent consisting of:
a scaffold consisting of particles and an erodable binder releasably binding the particles together such that after implantation the binder erodes to release the particles, wherein the particles have a slower erosion rate than the binder, wherein the particles consist of an active agent and vesicles consisting of block copolymers or lipids, wherein the vesicles act as a carrier for the active agent; and
optionally a coating over the scaffold consisting of a coating polymer and a drug.
20. The stent of claim 19 , wherein the vesicle comprises a shell formed by at least one lipid bilayer and an enclosed compartment.
21. The stent of claim 20 , wherein the vesicle is stabilized by crosslinking of the lipid bilayer shell.
22. The stent of claim 19 , wherein the active agent is loaded in an enclosed compartment of the vesicle.