Shape-memory polymer foam device for treating aneurysms
Inventors
Ortega, Jason M. • Benett, William J. • Small, Ward • Wilson, Thomas S. • Maitland, Duncan J. • Hartman, Jonathan
Assignees
Lawrence Livermore National Security Inc • Texas A&M University System • Shape Memory Medical Inc
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Publication Number
US-12268393-B2
Publication Date
2025-04-08
Expiration Date
Abstract
A system for treating an aneurysm in a blood vessel or vein, wherein the aneurysm has a dome, an interior, and a neck. The system includes a shape memory polymer foam in the interior of the aneurysm between the dome and the neck. The shape memory polymer foam has pores that include a first multiplicity of pores having a first pore size and a second multiplicity of pores having a second pore size. The second pore size is larger than said first pore size. The first multiplicity of pores are located in the neck of the aneurysm. The second multiplicity of pores are located in the dome of the aneurysm.
Core Innovation
The invention relates to an endovascular system for aneurysm treatment using shape memory polymer (SMP) foam positioned within an aneurysm between a dome and a neck. The SMP foam is delivered into the vasculature and deployed as separate individual pieces along a backbone, with different pore sizes in different foam portions positioned relative to the aneurysm dome and neck.
A first individual separate piece of SMP foam includes a first multiplicity of pores having a first average pore size, and a second individual separate piece of SMP foam includes a second multiplicity of pores having a second average pore size that is larger than the first average pore size. The pore-size gradation is described as continuous or discrete across foam portions, with the smaller pores associated with the neck region and the larger pores associated with the dome region.
The arrangement creates hemodynamic conditions that decelerate blood near the neck and fundus while preserving some flow to vessels lining the aneurysm wall. Optional non-porous SMP coatings and/or baffles, and internal channels, can be included to shape the hemodynamic conditions within the aneurysm and promote thrombus and collagen formation.
The device is described as enabling compact configurations suitable for small intracranial arteries, including cranial aneurysms such as fusiform aneurysms.
Claims Coverage
The claim set includes two independent claims. The inventive coverage centers on deploying two not permanently directly connected SMP foam pieces along a backbone through a patient's vasculature in serial fashion, with different average pore sizes associated with different foam pieces and specified relative deployment order.
Serial deployment of two separate SMP foam pieces with different average pore sizes
First and second individual separate pieces of shape memory polymer (SMP) foam are not permanently directly connected to each other, are distributed along the backbone, and are arranged to deploy from the delivery conduit and into the vasculature in serial fashion, with one piece deploying before the other; the first piece includes a first multiplicity of pores having a first average pore size and the second piece includes a second multiplicity of pores having a second average pore size larger than the first average pore size.
Backbone-delivery system with advancement through a patient's vasculature
A delivery conduit; a backbone; and a means for advancing the backbone through a patient's vasculature, the means for advancing the backbone being coupled to the backbone, wherein the first and second individual separate pieces of SMP foam are distributed along the backbone.
Relative placement of the second foam piece along the backbone
The first individual separate piece of SMP foam is between the means for advancing the backbone and the second individual separate piece of SMP foam, with the serial deployment order arranged so that the second foam piece deploys before the first foam piece.
Non-porous SMP coating on at least one foam piece
A backbone a coating of non-porous SMP on at least one of the first or second individual separate pieces of SMP foam.
Second foam piece position relative to the advancing means with opposite serial deployment order
The second individual separate piece of SMP foam is between the means for advancing the backbone and the first individual separate piece of SMP foam, and the first and second individual separate pieces of SMP foam are arranged to deploy in serial fashion with the first individual separate piece deploying before the second individual separate piece.
Overall, the independent claims cover an apparatus that advances a backbone with two individually separated SMP foam pieces through a patient's vasculature and deploys them serially, where one foam piece has smaller average pore size pores and the other has larger average pore size pores; the claims additionally specify either which foam piece is between the advancing means and the other, together with the deployment order, and in one independent claim, the presence of a non-porous SMP coating.
Stated Advantages
Decelerates blood near the neck and fundus while preserving some flow to vessels lining the aneurysm wall.
Promotes thrombus formation and collagen formation.
Enables compact devices for small intracranial arteries.
Documented Applications
Endovascular aneurysm treatment using SMP foam positioned within an aneurysm between a dome and a neck.
Treatment of cranial aneurysms, including fusiform aneurysms.
Use in small intracranial arteries.
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