Implantable electrical leads and associated delivery systems
Inventors
Sanghera, Rick • Rollins, Matthew • Beck, John • BORN, William • Sage, Shahn • Marcovecchio, Alan
Assignees
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Publication Number
US-11998735-B2
Publication Date
2024-06-04
Expiration Date
Abstract
Systems, methods, and devices to facilitate insertion of certain leads with electrode(s) into patients are described. Leads can be implanted to work in conjunction with a cardiac pacemaker or cardiac defibrillator. A lead for cardiac therapy may be inserted into an intercostal space associated with the cardiac notch of a patient. Devices for delivery may include, for example, a delivery system coupled with an electrical lead and having a handle, a component advancer and insertion tips. The handle is configured to be actuated by an operator and the component advancer is configured to advance an electrical lead into the patient. The insertion tips can be configured to close around the electrical lead within the component advancer, to push through biological tissue, and to open to enable the lead to advance into the patient. The electrical lead can also be maintained in a particular orientation during the advancement into the patient.
Core Innovation
The invention provides an implantable lead delivery system including an operator-actuated handle coupled to a component advancer that removably engages a portion of a component and advances the component into a patient by applying force to the portion in response to actuation of the handle. The system includes a unitary insertion tip configured to hold a distal tip of the component when the component is placed within the component advancer.
The unitary insertion tip includes a planar surface parallel to a longitudinal axis along the entire length of the unitary insertion tip, and a distal orifice extending through the distal end of the planar surface. A ramped portion at a distal tip includes a curved surface opposite only the distal orifice and is configured to facilitate advancement of the component into the patient in a particular direction, through the distal orifice.
Additional disclosed structural features maintain lead/component orientation to avoid rotation and include coupling features such as notch and channel-like engagement to preserve orientation during advancement. The disclosed embodiments further include delivery system structures that translate handle actuation into lead advancement using mechanisms such as rack-and-pinion, clamp, or pusher-tube configurations, and may include locks that prevent inadvertent spreading or deployment of insertion tips.
Claims Coverage
The independent claims identified for the provided set are those for a delivery system with a handle-actuated component advancer and a unitary insertion tip having a planar surface, a distal orifice, and a ramped distal tip to facilitate advancement in a particular direction. Across the provided dependent claim refinements, the inventive coverage adds features related to lateral insertion direction, distal orifice protection, mechanical advantage/disadvantage, pusher-tube actuation, and coupling features to maintain component orientation and avoid rotation.
Handle-actuated component advancer with force to removably engaged portion
A delivery system includes a handle configured to be actuated by an operator and a component advancer configured to advance a component into a patient by removably engaging a portion of the component; the component advancer is coupled to the handle and configured to advance the component into the patient by applying a force to the portion of the component in response to actuation of the handle by the operator.
Unitary insertion tip with planar surface parallel to longitudinal axis and distal orifice
The delivery system includes a unitary insertion tip configured to hold a distal tip of the component when the component is placed within the component advancer, where the unitary insertion tip includes a planar surface parallel to a longitudinal axis of the unitary insertion tip along the entire length of the unitary insertion tip and a distal orifice extending through a distal end of the planar surface.
Ramped distal portion facilitating advancement through distal orifice in particular direction
The unitary insertion tip includes a ramped portion at a distal tip of the unitary insertion tip, where the ramped portion includes a curved surface opposite only the distal orifice and is configured to facilitate advancement of the component into the patient in a particular direction, through the distal orifice.
Lateral particular direction for advancement
The system is configured such that the particular direction is a lateral direction relative to a position of the insertion tip.
Movable cover for distal orifice protection during advancement
The system includes a unitary insertion tip with a movable cover that protects biological tissue by blocking biological tissue from entering a distal orifice during tissue penetration and moves to enable advancement of the component into a patient.
Mechanical advantage or mechanical disadvantage leveraging handle actuation
The system is configured so that components providing a mechanical advantage or mechanical disadvantage apply to advancement such that actuation of the operator’s handle makes advancing the component into a patient easier or more difficult.
Pusher tube coupled to handle for advancing component
The system includes a component advancer with a pusher tube connected to the handle so that actuating the handle moves the pusher tube to push a component to advance it into the patient.
Coupling features to maintain component orientation and prevent rotation
The system includes a pusher tube with coupling features that engage a component portion and hold the component in a specified orientation to prevent rotation within the device.
The claim coverage centers on a handle-actuated component advancer that applies force to a removably engaged component portion to advance a component into a patient, combined with a unitary insertion tip defined by a planar surface parallel to its longitudinal axis, a distal orifice, and a ramped distal portion configured to facilitate advancement through the orifice in a particular direction. Dependent refinements further specify lateral advancement, movable cover protection for the distal orifice, mechanical advantage/disadvantage mechanics, pusher-tube actuation, and coupling features that maintain component orientation to avoid rotation.
Stated Advantages
Facilitates advancement of the component into the patient in a particular direction through the distal orifice.
Helps protect biological tissue from entering the distal orifice during tissue penetration using a movable cover.
Avoids rotation by holding the component in a specified orientation using coupling features.
Makes advancing the component easier or more difficult via components providing mechanical advantage or mechanical disadvantage.
Documented Applications
Delivery of implantable electrical leads for therapeutic energy delivery and sensing, as part of a cardiac pacing/defibrillation context including a cardiac notch, intercostal space, mediastinum, and pericardium.
Placement of a lead into the mediastinum with reference to avoiding pericardium invasion, using insertion near the cardiac notch and related delivery system structures.
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