Abstract:
Formulations and methods are disclosed which provide controlled, sustained release of a biologic therapeutic to a space within the body. More specifically, formulations comprising a plurality of hydrophilic polymer strands, and methods of forming and administering such formulations, are disclosed. In some embodiments, the formulations exhibit a burst release, an initial release, a triphasic release, and release over thirty to ninety days of the biologic therapeutic. In some embodiments, the formulations exhibit reversible precipitation of the biologic therapeutic into precipitates having a diameter of about 50 nm to about 10 μm.
Abstract:
Methods of treating a diseased blood vessel exhibiting stenosis with a bioabsorbable stent are disclosed. The implanted stent supports the section of the vessel at an increased diameter for a period of time to allow the vessel to heal. The stent loses radial strength sufficient to support the section of the vessel in less than 6 months after implantation, loses mechanical integrity, and then erodes away from the section. The biodegradable stent results in changes in properties of plaque with time as the stent degrades. The time-dependent properties include the luminal area of the plaque and plaque geometric morphology parameters.
Abstract:
A polymeric stent can be implanted for treatment of the Eustachian tube. The stent can be designed to have length-dependent radial strength to allow it to stay within the Eustachian tube and to allow normal closing and opening of the Eustachian tube. A balloon can be used to implant the stent, and the balloon can be coated with a therapeutic agent. A coated balloon can also be used to transfer therapeutic agents to the sinus cavity during a balloon sinus dilation procedure.
Abstract:
A stent or scaffold has a tapered end or ends. The scaffold is made using an additive manufacturing technique such as stereolithography (SLA). The scaffold may take the shape of a frustum, or a scaffold having one or both of its ends flared. The scaffold has varying mechanical properties over its length, such as a varying ring stiffness, porosity or elasticity modulus. In one embodiment the strut and link widths change linearly from the distal to proximal ends.
Abstract:
A therapeutic agent delivery system formed of a specific type of poly(ester amide) (PEA), a therapeutic agent, and a water miscible solvent is described herein. A method of delivering the therapeutic agent delivery system by delivering the therapeutic agent delivery system formed of a PEA polymer, a therapeutic agent, and a water miscible solvent to a physiological environment and separating the phase of the therapeutic agent delivery system to form a membrane from the polymer to contain the therapeutic agent within the physiological environment is also described. Additionally disclosed is a kit including a syringe and a therapeutic agent delivery system within the syringe.
Abstract:
A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, wherein the cytostatic therapeutic agent and the at least one excipient have a weight ratio of about 20:1 to about 1:20, and further wherein the coating provides increased efficiency of therapeutic transfer to a body lumen.
Abstract:
A method of crimping a stent is disclosed. The stent includes a minimum crimped diameter such that in the minimum crimped diameter, a pair of stent rings, between which marker support structures reside, do not make contact with the marker support structures. The crimped profile of the stent of the present invention can be as small as the crimped profile of a same stent but without the maker support structures.
Abstract:
A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold, after being deployed by the balloon, provides a crush recovery of about 90% after the diameter of the scaffold has been pinched or crushed by 50%. The scaffold has a pattern including an asymmetric closed cell connecting links connecting the closed cells.
Abstract:
A stent made from a material comprising a polymer is disclosed. The stent has a pre-crimp diameter and a wall thickness such that a ratio of the pre-crimp diameter to the wall thickness is between 30 and 60. The stent has a pattern of interconnected elements. The interconnected elements including a plurality of rings connected by links, wherein each ring includes struts and crowns, and the struts are configured to fold at the crowns when the stent is crimped to the balloon.
Abstract:
A method of accelerated aging of bioresorbable polymer scaffolds including exposing the scaffold to water is disclosed. The scaffold is exposed to water at a controlled temperature for a selected aging time. The functional outputs, such as radial strength, expandability, and % recoil obtained from aged scaffolds predict those of real-time aging of the scaffold. The accelerated aging factor, which is the required shelf life divided by the aging time, is significantly higher for poly(L-lactide) scaffolds tested than thermal aging.