Angioplasty balloon having selectively deployable cutting or scoring element and related methods
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Publication Number
US-9808276-B2
Publication Date
2017-11-07
Expiration Date
Abstract
Balloon angioplasty catheters having cutting or scoring members that are moveable in at least one direction between a stowed position (away from the angioplasty balloon) and an operative position (on the angioplasty balloon). A balloon catheter of the present invention alternately useable to perform balloon dilation of a body lumen with and without concurrent cutting or scoring.
Core Innovation
The invention relates to a balloon catheter device having an inflatable balloon and at least one cutting or scoring element that is axially moveable relative to the catheter shaft along a longitudinal axis. The cutting or scoring element is alternately deployable between a first position wherein it does not cause the balloon to perform a cutting or scoring function and a second position wherein it does cause the balloon to perform a cutting or scoring function. This arrangement allows the balloon to be used for standard balloon dilation without concurrent cutting/scoring or for concurrent cutting/scoring without exchanging catheters.
In one aspect, the cutting or scoring element comprises a single elongate member that forms loops or convolutions when in the first position, and forms loops or convolutions around the balloon when in the second position and the balloon is in an inflated configuration. Multiple embodiments are described in which a retractable or advanceable member exposes a scoring element for concurrent scoring during balloon inflation, including a retractable Nitinol helically coiled wire scoring element within a secondary lumen. An outer advanceable/retractable sheath can cover the cutting/scoring element during advancement and expose it for concurrent scoring upon balloon inflation.
Additional disclosed configurations include a layered catheter configuration using proximal and distal positioning balloons and a control wire to deploy a helix over a deflated balloon, and a biased helical element pulled by a proximal pull member into convolutions around the balloon. The document further describes options for a releasable distal attachment and trauma-reducing withdrawal, as well as optional energized (RF/thermal) cutting/scoring. The document also notes potential drug-coated variants for restenosis reduction, including drug-coated cutting/scoring element variants.
Claims Coverage
The independent claims coverage centers on a balloon catheter device with an inflatable balloon and an axially moveable cutting or scoring element that changes between a first non-cutting/non-scoring position and a second cutting/scoring position, where a single elongate member forms loops or convolutions around the balloon in the second position. Across dependent claim refinements within this partial set, the inventive features include specific structural implementations and staged treatment logic linked to moving the cutting or scoring element between positions.
Axially moveable cutting or scoring element between non-scoring and scoring positions
A balloon catheter device comprising an elongate catheter shaft, an inflatable balloon positioned on the catheter shaft, and at least one cutting or scoring element that is axially moveable relative to the catheter shaft along a longitudinal axis between a first position that does not cause cutting or scoring and a second position that does cause cutting or scoring.
Single elongate member forming loops or convolutions around the inflated balloon in the scoring position
The at least one cutting or scoring element comprises a single elongate member that forms loops or convolutions when in the first position and forms loops or convolutions around the balloon when in the second position and the balloon is in an inflated configuration.
Staged dilation by moving the cutting or scoring element between positions tied to first and second diameters
A method using the balloon catheter device to perform staged dilation of a stenotic region by advancing the catheter, moving the cutting/scoring member between first and second positions, inflating to a first diameter for an initial stage, deflating, and then inflating to a second diameter for a second stage where obstructive matter was previously cut or scored.
Within the provided claim set, the core inventive concept is an axially moveable cutting/scoring element that can be positioned to be non-functional in a first state and to form loops or convolutions around an inflated balloon in a second state, with staged dilation logic tied to movement between positions and first/second diameters.
Stated Advantages
Enables selective use of cutting/scoring concurrently with balloon inflation without exchanging catheters.
Supports standard balloon dilation without concurrent cutting/scoring by placing the cutting or scoring element in a first position that does not cause cutting or scoring.
Provides trauma reduction during withdrawal via trauma-reducing withdrawal options.
May reduce restenosis through drug-coated cutting/scoring variants.
Documented Applications
Treatment of atherosclerotic plaque/stenotic regions of a body lumen using a balloon catheter device that can cut or score and perform balloon dilation.
Lesion pre-treatment using the cutting or scoring function during balloon inflation in the operative position.
Renal denervation is mentioned as an energy-based example.
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