Composition for intravascular delivery of therapeutic composition
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Publication Number
US-11318204-B2
Publication Date
2022-05-03
Expiration Date
Abstract
The present invention relates to a pharmaceutical composition for intravascular delivery of a therapeutic agent, such as paclitaxel, rapamycin, or an analog thereof. The composition includes the therapeutic agent and a biocompatible solvent, such as glycofurol. The composition can aid tissue penetration by the therapeutic agent. A catheter assembly that protects the pharmaceutical composition from the surroundings can be used for its intravascular delivery.
Core Innovation
The invention relates to an intravascular pharmaceutical composition delivered via an intra-arterial catheter, where a reservoir consists of a pharmaceutical composition solution of paclitaxel in an amount in the range of 5 to 40 wt-% and glycofurol in an amount in the range of 60 to 95 wt-%, with paclitaxel and glycofurol totaling 100% of the components of the pharmaceutical composition solution. The reservoir delivers the pharmaceutical composition solution to an exposed interior surface of an artery using a balloon so that paclitaxel appears as a solid on the exterior of the artery after delivery.
The problem addressed is arterial disease characterized by blocked intraluminal channel(s), and the composition and delivery arrangement are configured to treat such arterial disease by delivering paclitaxel to the exposed interior surface of the artery and achieving solid appearance of paclitaxel on the exterior after delivery. The disclosed formulation emphasizes paclitaxel dissolved in glycofurol and released to an arterial surface using a balloon delivery mechanism.
The catheter delivery mechanism is described with an inner expandable and collapsible structure and an outer expandable and collapsible structure defining a cavity between them that serves as the reservoir, and with the outer expandable and collapsible structure having openings in the dilated state that allow the composition solution to move from the reservoir to the interior surface of an artery. An alternative embodiment is described where the reservoir is a lumen in a catheter shaft in fluid communication with the balloon, and the composition solution is released from the balloon upon expansion.
Claims Coverage
The independent claim and related claims cover five inventive features. They address the paclitaxel/glycofurol composition, balloon delivery to an exposed interior artery surface with solid paclitaxel appearance on the exterior, and balloon structural features defining and releasing the reservoir.
Paclitaxel-in-glycofurol pharmaceutical composition solution reservoir
An intra-arterial catheter comprising a reservoir consisting of a pharmaceutical composition solution of paclitaxel in an amount in the range of 5 to 40 wt-% and glycofurol in an amount in the range of 60 to 95 wt-% wherein paclitaxel and glycofurol total 100% of components of the pharmaceutical composition solution.
Balloon delivery to expose interior artery surface with solid paclitaxel exterior appearance
The reservoir delivers the pharmaceutical composition solution to an exposed interior surface of an artery using a balloon in order for the paclitaxel to appear as a solid on the exterior of the artery after delivery to the interior surface of the artery to treat arterial disease characterized by blocked intraluminal channel(s).
Double-wall inner/outer expandable and collapsible balloon structures defining a cavity reservoir
The balloon of the catheter comprises an inner expandable and collapsible structure and an outer expandable and collapsible structure, the inner and outer expandable and collapsible structures configured to expand between a contracted state and a dilated state, the inner and outer expandable and collapsible structures defining a cavity therebetween which is the reservoir for the composition.
State-dependent openings in dilated balloon allow reservoir-to-interior surface movement
The outer expandable and collapsible structure comprises openings in the dilated state that allow the composition solution to move from the reservoir to the interior surface of an artery.
Alternative balloon lumen reservoir in catheter shaft in fluid communication with balloon
The catheter comprises a catheter shaft, and the reservoir is a lumen in the catheter shaft and in fluid communication with the balloon, and the composition solution is released from the balloon upon expansion of the balloon.
Overall claim coverage centers on a paclitaxel/glycofurol pharmaceutical composition solution limited to these two components, balloon-based intra-arterial delivery to an exposed interior artery surface configured so paclitaxel appears as a solid on the exterior after delivery, and balloon structural features that define a reservoir cavity and provide dilated-state openings for release, with a lumen-in-shaft alternative release pathway.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Intravascular (intra-arterial) treatment of arterial disease characterized by blocked intraluminal channel(s) using a balloon catheter delivering a paclitaxel-in-glycofurol pharmaceutical composition solution such that paclitaxel appears as a solid on the exterior of the artery after delivery.
Ex vivo porcine artery testing showing paclitaxel deposition/penetration and comparative delivery fractions for different paclitaxel/glycofurol formulations, including crystal observation versus apparently absorbed material.
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