Radial and trans-endocardial delivery catheter
Inventors
Hsueh, Wai • Palmer, Olin Jay • Comiso, Scott • Ross, James B. • Vien, Ken • Argentieri, Julio • Altman, Peter
Assignees
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Publication Number
US-12311127-B2
Publication Date
2025-05-27
Expiration Date
Abstract
A needle-injection catheter includes a catheter body having a distal end, a proximal end, a stiff proximal portion, a flexible distal portion, and a delivery lumen extending therethrough. In a first embodiment, a straight injection needle extends coaxially from a distal tip of the flexible portion of the catheter body, and a plurality of penetration limiting elements positioned circumferentially about a base of the straight injection needle and configured to fold radially inwardly against a shaft of the needle when constrained in a tubular lumen and to extend radially outwardly when unconstrained. In a second embodiment, a helical needle extends from the distal tip of the flexible portion of the catheter body. The helical needle has at least one helical delivery lumen connected to receive an injectable substance from the delivery lumen of the catheter body.
Core Innovation
The disclosure describes a radial-access needle-injection catheter system for trans-endocardial delivery using a straight coaxial injection needle having passive, circumferentially arranged penetration-limiting elements. The penetration-limiting elements include penetration-limiting petals that fold radially inward in a constrained state and self-deploy radially outward. The self-deploying petals are configured to reduce endocardial perforation risk during needle injection.
As an alternative, the disclosure describes a helical needle configured for delivering an injectable substance through one or more helical delivery lumens. A helical delivery lumen receives injectate from a catheter delivery lumen, and the helical delivery structure is configured to inject particulate/cellular aggregates and inhibit flow-back within a helical tissue tract.
The catheter system includes a catheter body with a stiff proximal portion and a flexible distal portion, with optional contrast lumens and compatibility with navigation. Example structures include distal penetration protection structures with penetration-limiting petals and a helical needle implementation using a large-bore helical delivery approach for cellular aggregates and particulate material.
Claims Coverage
The document provides three independent claims directed to three inventive features.
Forming a helical needle with wrapped hypotube facets and tail
Wrapping a distal portion of a hypotube onto a mandrel into a helical configuration about a central axis; cutting a primary facet and at least one secondary facet at the distal end of the helical distal portion; and forming a tail portion proximal to the helical distal portion.
Helical needle with offset helical center axis and multi-faceted distal tip
A helical needle comprising a hypotube with a tail portion having an axis of symmetry; a helical portion in which a center axis of the helical portion is offset from the axis of symmetry; and a distal end of the helical portion comprising a primary facet and at least one secondary facet.
Catheter with helical hypotube having a multi-faceted tip
A catheter for infusing fluids to a heart comprising a hollow hypotube having a helical portion and a tail portion, wherein a tip of the helical portion of the hypotube has two or more facets.
Across the independent claims, the inventive concept is directed to forming and implementing a helical hypotube or needle with a multi-faceted distal tip, optionally with an offset center axis relative to a tail symmetry axis, and using that helical-tip hypotube in a catheter for infusing fluids to the heart.
Stated Advantages
The self-deploying penetration-limiting petals are configured to reduce endocardial perforation risk during needle injection.
The helical delivery structure is configured to inject particulate/cellular aggregates and inhibit flow-back within a helical tissue tract.
Documented Applications
A radial-access needle-injection catheter system for trans-endocardial delivery of an injectable substance to a heart of a patient.
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