Controlled steering functionality for implant-delivery tool
Inventors
Sheps, Tal • Hammer, Tal • Aviv, Ehud • Reich, Tal • Herman, Yaron • GROSS, AMIR
Assignees
Valtech Cardio Ltd • Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-11857415-B2
Publication Date
2024-01-02
Expiration Date
2032-11-08
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Abstract
A first catheter has a first lumen therealong, a first-catheter proximal portion, and a steerable first-catheter distal portion that is transluminally advanceable to the heart. A second catheter has second lumen therealong, a second-catheter proximal portion, and a steerable second-catheter distal portion. The second catheter extends through the first lumen, such that the second-catheter proximal portion extends proximally out from the first-catheter proximal portion, the second-catheter distal portion extends distally out from the first-catheter distal portion, and within at least the first-catheter proximal portion, the first lumen and the second lumen are coaxial on a longitudinal axis. A first handle is coupled to the first-catheter proximal portion, and extends obliquely away from the first-catheter proximal portion at a nonzero angle with respect to the longitudinal axis. A second handle is coupled to the second-catheter proximal portion, and is disposed proximally from the first handle. Other embodiments are also described.
Core Innovation
The invention relates to a multi-component steerable catheter system designed for accessing the heart of a patient, specifically for delivering and implanting an annuloplasty ring structure to a cardiac valve. The system comprises a first steerable catheter with a coaxial lumen and a second steerable catheter that is transluminally advanceable through the first lumen. The first catheter has a proximal handle angled obliquely relative to the longitudinal axis, and the second catheter has a proximal handle positioned proximally to the first. These catheters feature steering mechanisms with pull wires enabling the control of their distal steerable ends in orthogonal planes.
The problem addressed is maintaining precise spatial orientation and control over flexible, steerable catheter components during transluminal access to the heart. Particularly, the challenge is to allow independent steering of the inner catheter's distal portion without substantially distorting the spatial orientation of the outer catheter's distal portion, and vice versa. Existing steerable catheters often struggle with controlled relative rotation and bending, which can impede precise implant delivery and deployment at the annulus of cardiac valves.
The invention solves this problem by introducing a coupling mechanism between the first and second catheters comprising a first coupling (a slit) on the first catheter and a second coupling (a depressible pin or engager) on the second catheter. This mechanism enables the second catheter to be introduced within the first catheter lumen in any rotational orientation and then rotationally locked by aligning and engaging the pin with the slit. This locking restricts rotation of the second catheter relative to the first, allowing steering of the respective distal catheter portions in orthogonal planes without interfering with each other’s spatial orientation, facilitating precise implant delivery and anchoring.
Claims Coverage
The patent presents two independent claims describing apparatuses and systems involving pairs of steerable catheters with specific coupling and handle configurations facilitating controlled steering and implant delivery.
Pair of coaxially arranged steerable catheters with angled and longitudinal handles
A first catheter with a proximal handle obliquely angled relative to its longitudinal axis and a second coaxial catheter extending through the first lumen with a proximal handle positioned proximally from the first handle.
Couplings enabling rotational locking between catheters
The first and second catheters comprise respective first and second couplings—such as a slit and a depressible engager—that allow the second catheter to be introduced in any rotational orientation and then coupled to lock rotation within the first lumen.
Independent steering mechanisms in orthogonal planes
Each catheter has steering knobs coupled via pull wires to steer their steerable distal portions independently in respective planes—typically generally orthogonal—thus allowing precise control during implant delivery.
Stand and extracorporeal locking system
The assembly may include a stand with a track allowing the handles to slidably couple and a rotational locking mechanism preventing handle rotations relative to each other, facilitating controlled catheter positioning.
Implant delivery features with anchor drivers and annuloplasty structure
The apparatus includes an annuloplasty structure with a flexible contracting member and multiple tissue anchors; and an anchor driver configured to advance and screw the anchors through the second catheter into cardiac tissue.
The claims cover a steerable dual-catheter system with specialized handle and coupling configurations enabling controlled, independent steering and rotational locking, facilitating transluminal implant delivery and anchoring to cardiac tissue with precision.
Stated Advantages
Minimizes distortion of spatial orientation of one catheter while steering the other, enabling independent and controlled steering in orthogonal planes.
Allows introduction of the inner catheter into the outer catheter lumen in any rotational orientation, enabling ease of use and flexibility during procedures.
Reduces interference between catheters during manipulation, enhancing precision in reaching and deploying implants at targeted cardiac valve annuli.
Supports axial sliding of the inner catheter within the outer catheter even when coupled, providing variable exposed distal portion length for versatile operation.
Provides extracorporeal indicators and locking mechanisms giving real-time feedback and secure locking states to the user during deployment.
Documented Applications
Delivering and anchoring an annuloplasty ring structure to repair a mitral or tricuspid cardiac valve by advancing through the vasculature, crossing the interatrial septum, and positioning an implant in a desired orientation at the valve annulus.
Transluminal or transthoracic access to the heart for cardiac valve repair using steerable catheters to deliver implants and tissue anchors.
Implanting adjustable annuloplasty rings to tighten dilated valve annuli using related deployment and adjustment mechanisms delivered through the catheter system.
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