System and method for treatment of hemorrhagic stroke

Inventors

Imran, Mir

Assignees

Incube Laboratories LLC

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Publication Number

US-10137280-B2

Patent

Publication Date

2018-11-27

Expiration Date


Abstract

Embodiments of the invention provide apparatus, methods and systems for delivering treatments and for medications to the site of an aneurysm (SOA). One embodiment of a method comprises delivering a neural growth stimulating factor (NGSF) to the site of the aneurysm to grow new nerve cells and/or stimulate the regeneration of damaged nerve cells. The NGSF may be delivered in a carrier such as a gel which can be selected to allow for long term delivery of the NGSF to the SOA. In many embodiments, the NGSF may be delivered to the SOA using a micro-catheter based system which includes a microcatheter that can be advanced in the cerebral vasculature. The microcatheter may also be used to delivery occlusive element to the SOA such as occlusive coils or balloon which promote clotting and reduce bleeding at the SOA and together with the carrier allow for long term release of NGSF.

Core Innovation

The invention provides a catheter-based method for treating a cerebral aneurysm by advancing a microcatheter having a delivery lumen to a site of the aneurysm. A carrier containing a first agent and a second agent is delivered through the delivery lumen to at least partially fill a sac of the aneurysm. The carrier includes first and second gel components, with the first agent comprising an anti-inflammatory agent and the second agent comprising a member of the transforming growth factor-β family.

The method further provides controllably releasing the first and second agents from the carrier to the site of the aneurysm. The first gel component has a first viscosity selected to release the first agent at a first rate of release. The second gel component has a second viscosity different from the first viscosity, selected to release the second agent at a second rate of release slower than the first rate of release.

In addition, a method is provided for treating a cerebral aneurysm having an aneurysmal sac by advancing a microcatheter in which the delivery lumen delivers both a gel carrier and occlusive elements to the aneurysm. The gel and occlusive elements at least partially fill the aneurysmal sac so as to have the gel and the occlusive elements stop or inhibit bleeding at the aneurysm site. The first and second agents are controllably released from the gel into the surrounding brain tissue to promote healing of injured nerve cells and/or generation of new nerve cells in surrounding brain tissue.

Claims Coverage

The independent claims identified in the provided material are two: clm-00001 and clm-00012. Across these independent claims, the inventive subject matter centers on delivering a dual-agent, dual-gel carrier via a microcatheter to an aneurysm sac, with controllable agent release rates defined by different gel viscosities; and, in one independent claim, combining the gel carrier with occlusive elements to stop or inhibit bleeding and promote nerve healing.

Dual-agent gel carrier delivered via microcatheter with controllable release rates

Advancing a microcatheter having a delivery lumen to the site of the aneurysm; delivering a carrier containing a first agent and a second agent to the aneurysm through the delivery lumen so as to at least partially fill a sac of the aneurysm; wherein the first agent comprises an anti-inflammatory agent and the second agent comprises a member of the transforming growth factor-β family; and controllably releasing the first and second agents from the carrier to the site of the aneurysm, wherein the carrier comprises a first gel component including the first agent and a second gel component including the second agent.

Viscosity-selected release using first and second gel components

Wherein the first gel component has a first viscosity selected to release the first agent at a first rate of release, and wherein the second gel component has a second viscosity different from the first viscosity, the second viscosity being selected to release the second agent at a second rate of release slower than the first rate of release.

Gel carrier delivered with occlusive elements to stop or inhibit bleeding

Advancing a microcatheter having an aneurysm site to deliver both a gel carrier and occlusive elements to the aneurysm; delivering through the delivery lumen to the aneurysm site i) the gel carrier and ii) the occlusive elements; at least partially filling the aneurysmal sac with the gel and occlusive elements so as to have the gel and the occlusive elements stop or inhibit bleeding at the aneurysm site; wherein the first agent comprises an anti-inflammatory agent and the second agent comprises a member of the transforming growth factor-β family.

Controllably releasing agents into surrounding brain tissue to promote nerve healing

Controllably releasing the first and second agents from the gel into the surrounding brain tissue so as to promote i) healing of injured nerve cells and/or ii) generation of new nerve cells in the surrounding brain tissue, wherein the first gel component has a first viscosity selected to release the first agent at a first rate of release, and wherein the second gel component has a second viscosity different from the first viscosity, the second viscosity being selected to release the second agent at a second rate of release slower than the first rate of release.

Taken together, the independent claims define microcatheter delivery of a two-agent, two-component gel carrier into an aneurysm sac, with agent-specific release rates determined by different gel viscosities, and (in clm-00012) simultaneous delivery of occlusive elements to stop or inhibit bleeding while releasing the agents into surrounding brain tissue to support healing of injured nerve cells and/or generation of new nerve cells.

Stated Advantages

Stops or inhibits bleeding at the aneurysm site.

Promotes healing of injured nerve cells and/or generation of new nerve cells in surrounding brain tissue.

Documented Applications

Treating a cerebral aneurysm by delivering a carrier and controllably releasing agents to the aneurysm site.

Treating a cerebral aneurysm having an aneurysmal sac by delivering a gel carrier together with occlusive elements to stop or inhibit bleeding and promote nerve healing.

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