Radial and trans-endocardial delivery catheter

Inventors

Hsueh, Wai • Palmer, Olin Jay • Comiso, Scott • Ross, James B. • Vien, Ken • Argentieri, Julio • Altman, Peter

Assignees

Biocardia Inc

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

A needle injection catheter system is provided for delivering cellular aggregations to a patient's heart, including a catheter body with a distal end, a proximal end, and a delivery lumen. A helical needle extends from the distal end of the catheter body and includes at least one helical delivery lumen connected to receive the injectable amount of cellular aggregations from the delivery lumen. The helical delivery lumen has a bore size sufficiently large to deliver the injectable amount of cellular aggregations into heart tissue.

The helical needle is anchored in an endocardial wall of a heart chamber so that a port on the needle lies near an interior end of a helical tissue tract formed by the needle. Cellular aggregations are injected through the helical lumen into the endocardial wall, and the helical tissue tract has a helical shape that inhibits flow back of the cellular aggregates even after the needle is withdrawn from the endocardial wall.

The catheter system architecture includes delivery-lumen and helical-lumen configurations sized for cellular aggregation delivery, with optional multiple lumens and helical delivery lumens connected to catheter body lumens. The catheter construction can include a stiff proximal portion and a highly flexible and elastic distal portion, with the stiff proximal portion comprising a braided polymeric tube and the highly flexible and elastic distal portion comprising a helical metal coil.

Claims Coverage

The document provides two independent claims focused on a helical needle injection catheter system and a corresponding method for delivering cellular aggregations. The core inventive features are the helical needle with helical delivery lumen sized for cellular aggregates, endocardial anchoring of the helical needle to form a helical tissue tract, and injection with flow-back inhibition by the helical tissue tract.

Independent claim 1 covers catheter-body delivery of cellular aggregations to a helical needle whose helical delivery lumen bore size is sufficiently large for delivering aggregates into heart tissue. Independent claim 13 covers a method that anchors the helical needle in the endocardial wall to position the port near an interior end of a helical tissue tract, injects aggregates through the helical lumen, and relies on the helical tissue tract shape to inhibit flow back after withdrawal.

Stated Advantages

Documented Applications