Delivery system for implanting a medical device

Inventors

DEVICH, NICHOLAS • Austin, Eric • Taff, Brian M.

Assignees

Biotronik SE and Co KG

Abstract

A delivery system for implanting a medical device comprises a delivery catheter having an inner lumen, a mandrel received in the inner lumen of the delivery catheter and movable with respect to the delivery catheter, and an adapter piece connected to the mandrel, wherein the adapter piece, by moving the mandrel with respect to the delivery catheter, is displaceable between a first position in which the adapter piece is received within the inner lumen of the delivery catheter and a second position in which the adapter piece is arranged outside of the inner lumen of the delivery catheter. A tethering member comprises a positive-locking member adjoining a tether portion, wherein the positive-locking member in a connection state is received on the adapter piece, but is releasable from the adapter piece by displacing the adapter piece from the first position towards the second position.

Core Innovation

The disclosed invention provides a catheter-based delivery system for implanting a medical device, including a leadless pacemaker device for providing a pacing of the heart's activity. The system includes a delivery catheter having an inner lumen, a mandrel received in the inner lumen of the delivery catheter and movable with respect to the delivery catheter, and an adapter piece connected to the mandrel. The adapter piece is displaceable between a first position in which the adapter piece is received within the inner lumen of the delivery catheter and a second position in which the adapter piece is arranged outside of the inner lumen of the delivery catheter.

A tethering member comprises a tether portion with a first end connected to the adapter piece and a second end spaced from the first end, and a positive-locking member adjoining the tether portion at a distance from the first end. In a connection state, the positive-locking member is received on the adapter piece and is locked with respect to the adapter piece while the adapter piece is in the first position. The positive-locking member is releasable from the adapter piece by displacing the adapter piece from the first position towards the second position, and when in the connection state the tether portion forms a loop such that a fixed connection of the leadless pacemaker to the delivery system is established.

The document further addresses controlled release of the positive-locking member while maintaining connection for evaluation and safety. It includes an initial partial release phase that permits tug testing and electrical testing while the pacemaker remains tether-connected. A security device on the mandrel is described that blocks unintentional mandrel actuation until an actuation member is triggered, and adapter-piece retention structures are provided for safe passage of the positive-locking member during release. The tether can be radiopaque for visualization.

Claims Coverage

The partial content includes two independent claims. Both claims center on a delivery system/method where a movable mandrel and displaceable adapter piece lock and then release a tethering member via a positive-locking member, while forming a tether loop to establish and then disconnect a fixed connection of a leadless pacemaker to the delivery system. The inventive features are reinforced by specific structural aspects in dependent claims, including geometry for positive-locking and adapter-member retention, and a rounded/convex connection-member face.

Across the independent claims, the core claim coverage is the combination of a delivery catheter with an inner-lumen mandrel and a displaceable adapter piece, a tethering member with a positive-locking member that is locked in a first adapter position and releases during transition to a second adapter position, and tether-loop formation for a fixed connection of a leadless pacemaker to the delivery system followed by disconnection.

Stated Advantages

Documented Applications