System and method for increasing a cross-sectional area of a body lumen
Inventors
Hsu, Thomas • Hsu, Senzan • Hsu, Ellen
Assignees
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Publication Number
US-11547546-B2
Publication Date
2023-01-10
Expiration Date
Abstract
Devices and methods are disclosed for managing and/or treating body tissues obstructing a hollow body lumen, such as the prostatic lobe tissues obstructing the urethra. A scaffolding may be provided with opposing tissue-engaging portions and at least one expansion member configured to transition between a compressed configuration having a reduced distance between the tissue-engaging portions and a deployed configuration having an increased distance between the tissue-engaging portions.
Core Innovation
The invention provides a device for increasing a cross-sectional area of a body lumen by transitioning a scaffolding between a compressed configuration and a deployed configuration. In the compressed configuration the distance between opposing first and second tissue-engaging portions is reduced, while in the deployed configuration the distance is increased. The transition is carried out with at least one expansion member having a thickness that acts to move the tissue-engaging portions farther apart.
The scaffolding includes opposing first and second tissue-engaging portions that have an increased surface area relative to the thickness of the expansion member. The first tissue-engaging portion is secured to a shaft at a first end of the shaft, where the shaft is slidably secured within a housing and positioned coaxially within the housing. A driving element secured to a second end of the shaft biases the shaft outward from the housing, supporting the compressed-to-deployed transition.
The described architectures include telescoping arrangements in which expansion moves tissue laterally and maintains patency, including a bidirectional telescoping spring-driven system and configurations using paired uni-directional telescoping members coupled by a biased pivot to allow deflection. The device concepts further include tether-assisted deflection for easier placement/removal. Optional features include coatings and agent reservoirs, including anti-encrustation agent and delivery concepts using an endoscope-compatible introducer with a holder that releasably secures the scaffold in a compressed profile and then detaches via a sliding pushing element and an optionally rotatable holder controlled by lines.
Claims Coverage
The document contains one independent claim directed to a device for increasing a body lumen cross-sectional area, with inventive coverage centered on a scaffolding transition between compressed and deployed configurations driven by a coaxially housed, shaft-based biasing arrangement, and on opposing tissue-engaging portions having increased surface area relative to expansion-member thickness. The coverage further specifies additional inventive features through dependent claims addressing particular scaffold/tissue-engaging geometries, telescoping expansion mechanisms, pivot-coupled uni-directional members, and agent reservoir features.
Scaffold transitioning between compressed and deployed configurations
A scaffolding configured to transition between a compressed configuration having a reduced distance between first and second tissue-engaging portions and a deployed configuration having an increased distance between the first and second tissue-engaging portions.
Opposing tissue-engaging portions with increased surface area relative to expansion-member thickness
The first and second opposing tissue-engaging portions having an increased surface area relative to the thickness of the expansion member.
Coaxial shaft slidably secured within a housing with driving element biasing outward
The first tissue-engaging portion being secured to a shaft at a first end of the shaft slidably secured within a housing, the shaft positioned coaxially within the housing, and having a driving element secured to a second end of the shaft for biasing the shaft outwards from the housing.
Lateral plate tissue-engaging portions
Each of the first and second tissue-engaging portions comprises a lateral plate.
Telescoping expansion member
The at least one expansion member is a telescoping expansion member.
Bi-directional telescoping with opposing-end attachment
The at least one expansion member is a bi-directional expansion member and the tissue-engaging portions are secured to opposing ends of the bi-directional expansion member.
Biased pivot coupling permitting deflection of uni-directional members
The pair of uni-directional expansion members are coupled by a pivot biased to align the uni-directional expansion members longitudinally while allowing deflection with respect to each other.
Agent disposed within a reservoir formed in the scaffolding
The device further comprises an agent disposed within at least one reservoir formed in the scaffolding.
Overall, the claim set emphasizes increasing body lumen cross-sectional area by transitioning a scaffold between compressed and deployed configurations, driven by a coaxially arranged shaft biased outward from a housing, with opposing tissue-engaging portions sized to have increased surface area relative to expansion-member thickness. Dependent features further narrow the structure to lateral plates, specify telescoping and bi-directional arrangements, add biased-pivot coupling to permit deflection of uni-directional members, and add an agent reservoir feature.
Stated Advantages
Increases a body lumen’s cross-sectional area by transitioning the scaffolding between compressed and deployed configurations.
Maintains patency by pushing tissue laterally via expansion during deployment.
Documented Applications
Application emphasized for benign prostatic hyperplasia (BPH) involving the prostatic urethra, where deployed scaffolds displace obstructing prostatic lobe tissue.
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