Purified pentagalloyl glucose and devices for delivery
Inventors
Assignees
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Publication Number
US-11331102-B2
Publication Date
2022-05-17
Expiration Date
Abstract
Disclosed herein is a method of producing high purity pentagalloyl glucose (PGG), analogues or derivatives thereof, at least 99.9% pure, by washing with dimethyl ether. PGG may be provided in a kit, including a hydrolyzer for dissolving the PGG and a saline solution. Also disclosed herein is a device for delivery of a therapeutic solution to a blood vessel. The device may be a catheter having an upstream balloon and a downstream balloon. The upstream balloon may be expanded to anchor the catheter and occlude antegrade blood flow. The downstream balloon may be expanded to occlude retrograde blood flow, creating a sealed volume within the blood vessel. The downstream balloon may have pores configured to deliver a therapeutic inflation solution into the sealed volume or a portion thereof. The downstream balloon may be expanded by the expansion of a balloon disposed inside the downstream balloon.
Core Innovation
The invention describes purification of 1,2,3,4,6-pentagalloyl glucose (PGG) to very high purity (≥99.9%) by washing with solvents such as dimethyl ether to remove toxic impurities, including gallic acid and methyl gallate. The invention further relates to delivering an aneurysm-reducing composition using a catheter device having an upstream balloon and a downstream balloon, wherein the downstream balloon includes a plurality of pores that configure the interior volume of the downstream balloon in fluid communication with the intravascular environment.
A combination of a contrast agent for visualization and a composition is administered to the aneurysm via the plurality of pores in the downstream balloon, the composition comprising an excipient and an effective amount of 1,2,3,4,6-pentagalloyl glucose (PGG). The balloons are positioned upstream and aligned with the aneurysm to anchor the catheter and to provide counter pressure at the aneurysm, and expanding the downstream balloon displaces blood from the volume of the aneurysm so that the outer surface of the downstream balloon sufficiently conforms to the shape of the aneurysm.
Claims Coverage
The disclosed independent claim set centers on using a catheter with an upstream and a pore-bearing downstream balloon, and administering a visualization contrast agent together with a composition containing an effective amount of 1,2,3,4,6-pentagalloyl glucose (PGG) via the pores to reduce or inhibit aneurysm growth. The main inventive features are captured in one independent claim provided in the partial content.
Pore-bearing downstream balloon providing fluid communication
The downstream balloon includes a plurality of pores configured to place the interior volume of the downstream balloon in fluid communication with the intravascular environment.
Upstream-downstream balloon positioning to anchor and align with aneurysm
The catheter device is positioned such that the upstream balloon is upstream of the aneurysm and the downstream balloon is sufficiently aligned with the aneurysm, and the upstream balloon is expanded to anchor the catheter device.
Downstream balloon expansion to displace blood and provide counter pressure
Expanding the downstream balloon is configured to displace blood from the volume of the aneurysm so that the outer surface of the downstream balloon sufficiently conforms to the shape of the aneurysm, and to provide counter pressure at the aneurysm.
Administering contrast agent and PGG composition through the pores
A combination of a contrast agent for visualization and a composition is administered to the aneurysm via the plurality of pores in the downstream balloon, the composition comprising an excipient and an effective amount of 1,2,3,4,6-pentagalloyl glucose (PGG).
Overall, the claim coverage ties aneurysm growth reduction or inhibition to a downstream balloon with pores enabling intravascular fluid communication, positioning and expansion of upstream and downstream balloons for anchoring, conformance, blood displacement, and counter pressure, and delivery of a contrast agent plus an excipient and PGG composition through the pores.
Stated Advantages
Reduces or inhibits growth of an aneurysm in a subject having the aneurysm.
Documented Applications
Reducing or inhibiting aneurysm growth using a catheter device with upstream and downstream balloons and administering an excipient and 1,2,3,4,6-pentagalloyl glucose (PGG) composition via pores, with a contrast agent for visualization.
Application to an abdominal aortic aneurysm (AAA).
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