Drug-eluting medical implants
Inventors
Palasis, Maria • You, Changcheng • Concagh, Danny • Core, Lee • Ho, Kicherl • Sharma, Upma • Zugates, Gregory T.
Assignees
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Publication Number
US-10568994-B2
Publication Date
2020-02-25
Expiration Date
Abstract
Disclosed are self-expanding medical implants for placement within a lumen of a patient. The implants comprise a woven or non-woven structure having a substantially tubular configuration, and are designed to be low-profile such that they are deliverable with a small diameter catheter. The implants have a high recoverability and desired mechanical properties.
Core Innovation
The invention relates to self-expanding drug-eluting medical implants with a tubular structure comprising biostable struts and configured for deployment via a delivery catheter. The drug delivery architecture includes a first conformal coating comprising a first polymeric material at least partially coating the struts, and a second conformal coating at least partially coating the first conformal coating. The second conformal coating includes pacilitaxel as a sole therapeutic agent.
The tubular structure is characterized by a surface area of from 11.4 to 53.8 mm2 per mm length, and the pacilitaxel amount is within a range of about 0.002 to about 0.175 micrograms per square millimeter of the surface area. In the described embodiments, the therapeutic agent is conformally coated and can be embedded or provided as discrete drug areas on strands. The coatings can be implemented as a biodegradable support coating together with a drug coating, with an optional topcoat diffusion barrier.
The disclosed implants emphasize improved mechanical strength and elastic recovery, including radial strength and chronic outward force, while maintaining drug-elution performance. Preclinical findings described include in-vitro and in-vivo pacilitaxel elution profiles and deployment outcomes, including sheep artery deployment safety and patency at 1 month, with no drug-related deaths or adverse events described. Dose-dependent tissue responses are also described in the provided content.
Claims Coverage
The independent claims cover biostable tubular implants with two-layer conformal polymer coatings carrying pacilitaxel as a sole therapeutic agent, with dosing constrained by pacilitaxel amount normalized to implant surface area and the tubular structure constrained by surface area per unit length. Across the two independent claims, the inventive features are centered on the two conformal coating layers, pacilitaxel as the sole/single therapeutic agent in the second coating, and the specified surface-area metrics for the tubular structure and pacilitaxel loading/amount.
Biostable tubular structure with struts
A tubular structure comprising struts, wherein said tubular structure is biostable, and wherein said tubular structure is characterized by a surface area of from 11.4 to 53.8 mm2/mm length of the tubular structure.
First conformal polymeric coating on struts
A first conformal coating comprising a first polymeric material at least partially coating said struts.
Second conformal coating with pacilitaxel as the sole/single therapeutic agent
A second conformal coating at least partially coating said first conformal coating, said second conformal coating comprising pacilitaxel as a sole therapeutic agent (and/or comprising a second polymeric material and an amount of pacilitaxel as a single therapeutic agent).
Pacilitaxel amount constrained by surface-area normalization
The amount of pacilitaxel is within the range of about 0.002 to about 0.175 micrograms per square millimeter of said surface area.
Taken together, the independent claims require a biostable strut-based tubular implant with a first conformal polymer coating and a second conformal polymer coating that contains pacilitaxel as the sole/single therapeutic agent, while constraining both the implant surface-area-per-length metric and the pacilitaxel amount normalized to surface area.
Stated Advantages
Improved mechanical strength and elastic recovery, including radial strength and chronic outward force.
Provides pacilitaxel elution profiles with described in-vitro and in-vivo outcomes.
Deployment safety and patency outcomes are reported at 1 month, including no drug-related deaths or adverse events described.
Dose-dependent tissue responses are described.
Documented Applications
Self-expanding deployment of the drug-eluting tubular implants in an artery model, including sheep peripheral artery deployment and patency at 1 month.
In-vitro pacilitaxel elution profile assessment is documented.
In-vivo pacilitaxel elution profile assessment is documented.
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