Method of treating atherosclerotic occlusive disease
Inventors
Schneider, Peter • Giasolli, Robert M.
Assignees
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Publication Number
US-10835395-B2
Publication Date
2020-11-17
Expiration Date
Abstract
A tack device for holding plaque against blood vessel walls in treating atherosclerotic occlusive disease can be formed as a thin, annular band of durable, flexible material. The tack device may also have a plurality of barbs or anchoring points on its outer annular periphery. The annular band can have a length in the axial direction of the blood vessel walls that is about equal to or less than its diameter as installed in the blood vessel. A preferred method is to perform angioplasty with a drug eluting balloon as a first step, and if there is any dissection to the blood vessel caused by the balloon angioplasty, one or more tack devices may be installed to tack down the dissected area of the blood vessel surface.
Core Innovation
The invention describes a method of treating a blood vessel following balloon angioplasty using a plurality of implants advanced to a treatment area while held in a compressed state by an outer cover. After the outer cover is withdrawn, a first implant expands against a wall of the blood vessel and a second implant expands against the wall while being spaced away from the first implant by a distance equal to at least the implant width of the second implant.
The method is configured so that a portion of the treatment area between the first and second implants that has been treated by the balloon angioplasty includes diseased tissue that is not covered by an implant. Each implant comprises cells formed by first, second and third undulating rings, where the first undulating ring is directly connected to the second undulating ring and the second undulating ring is directly connected to the third undulating ring.
The disclosure also includes a stent-free environment using a thin, flexible annular band described as a plaque tack, with barbs or anchoring points that spring-press plaque against the vessel wall after drug-eluting balloon angioplasty, including tacking down localized dissection or irregularities, and optionally includes spaced-apart multiple tacks. The plaque tack forms include a ribbon tack, folding ring tack, flexible ring tack, spiral coil tack, and metallic mesh tack.
Medication can be delivered via the implants or tack, including delivering eluting biologically active agents through barbs, channels, or coated tack surfaces, and the reduced metal footprint of the tack design is stated to lead to less biological reaction and restenosis compared with traditional stents.
Claims Coverage
The independent claim coverage is centered on a single independent method claim family member, with dependent claims adding spacing, coverage, placement, medication delivery, and additional implant conditions.
Post-balloon compressed implant expansion with diseased tissue left uncovered
Advancing a plurality of implants held in a compressed state by an outer cover to a treatment area after balloon angioplasty, withdrawing the outer cover, allowing a first implant to expand against a wall, and expanding a second implant spaced away from the first so that a portion between the implants that has been treated by the balloon angioplasty includes diseased tissue that is not covered by an implant.
Undulating ring cells forming implant structure
Each implant comprises cells formed by first, second and third undulating rings, where the first undulating ring is directly connected to the second undulating ring and the second undulating ring is directly connected to the third undulating ring.
Spaced implant expansion by at least implant width
Expanding a second implant against the wall of the blood vessel at the treatment area with the second implant spaced away from the first implant a distance equal to at least the implant width of the second implant.
Fractional coverage limited to only half of the balloon-treated area
Limiting the treatment approach such that only half of the balloon angioplasty-treated area is covered with implants.
Implant placement where specific holding forces are required
Applying the first and second and additional implants only at locations where specific holding forces are required to stabilize the treatment area or keep plaque pieces out of a blood flow area.
Plaque treatment medication delivery using implants
Delivering plaque treatment medication to a blood vessel using at least one of the first implant or the second implant.
Condition-based additional implant expansion at damage, dissection, or irregularity with spacing
Expanding additional implants at damage, disruption, dissection, or irregularity in the blood vessel caused by the balloon angioplasty, where the implants hold down the affected vessel surface and are spaced from each other by at least the width of an implant.
Overall, the claim set covers a post-balloon angioplasty method using compressed implants expanded after withdrawal of an outer cover, with implant structure defined by connected undulating rings and spacing and coverage features that leave diseased tissue between spaced implants not covered. The dependents further constrain coverage, restrict implant placement to locations requiring specific holding forces, optionally deliver plaque treatment medication using implants, and add conditional expansion of additional implants at damage, dissection, or irregularities while maintaining implant-to-implant spacing.
Stated Advantages
Stated reduction in biological reaction and restenosis compared with traditional stents, attributed to reduced metal footprint.
Leaves diseased tissue treated by balloon angioplasty not covered by an implant, as part of the treatment design.
Tacks down localized dissection or irregularities after drug-eluting balloon angioplasty in a stent-free environment.
Documented Applications
Treating a blood vessel affected by atherosclerotic occlusive disease after balloon angioplasty, including drug-eluting balloon angioplasty, by expanding implants or plaque tack to stabilize and tack down diseased tissue and localized dissection or irregularities.
Delivering plaque treatment medication to a blood vessel using at least one of the implants.
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