Implantable electrical leads and electrodes
Inventors
Sanghera, Rick • Rollins, Matthew • Beck, John • BORN, William • Sage, Shahn • Marcovecchio, Alan
Assignees
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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 relates to an electrical lead for implantation in a patient, including a distal portion with one or more electrodes configured to generate therapeutic energy for biological tissue and a proximal portion configured to engage a controller when implanted. The disclosed delivery and lead structures include an implantable cardiac therapy lead delivery system that uses an insertion mechanism with tips that close around tissue and then open to push through and deploy the lead.
A central feature is a distal end designed to change course when encountering sufficient resistance during travel through biological tissue. The distal end includes a flexible portion comprising one or more cutouts formed in one or more surfaces, where the cutouts increase flexibility to allow the distal end to change course under resistance. The distal end is at least partially paddle-shaped with planar surfaces, where a first cutout is formed in a first planar side and a second cutout is formed in a second planar side opposite the first cutout.
The disclosed geometry supports directional movement and electrode orientation. A proximal shoulder engages an advancer to prevent rotation, and distal flexibility mechanisms include paddle-shaped distal end structures and cutouts or reduced cross-sections that allow the distal end to change course while maintaining the electrodes facing the heart. The document also describes optional electrode and distal tip structures, including multi-electrode arrangements and distal tip features that maintain lead orientation, as well as optional reload and packing structures for delivery.
Claims Coverage
The independent claim set in the partial content is centered on one independent claim directed to an implantable electrical lead with a paddle-shaped, cutout-bearing flexible distal end that changes course under tissue resistance while maintaining electrode positioning. Dependent claims refine flexibility and orientation behavior via material and polymer distinctions and directional biasing.
Therapeutic electrode lead with controller-coupled proximal portion
A distal portion comprising one or more electrodes configured to generate therapeutic energy for biological tissue, and a proximal portion coupled to the distal portion, the proximal portion configured to engage a controller to cause the electrode to generate the therapeutic energy.
Flexible distal end with cutouts to increase flexibility for course change under resistance
The distal portion includes a distal end having a flexible portion comprising one or more cutouts formed in one or more surfaces adapted to increase flexibility so the distal end changes course when encountering sufficient resistance traveling through biological tissue.
Paddle-shaped distal end with electrodes on one planar surface and opposite planar side cutouts
The distal end is at least partially paddle-shaped with a planar surface that includes at least one of the one or more electrodes and another planar surface opposite the planar surface, the one or more cutouts including a first cutout formed in a first planar side and a second cutout formed in a second planar side opposite the first planar side.
Flexible portion material more flexible than other distal portion material
The flexible portion includes a material that flexes more easily than the material in another area of the distal portion.
Cutouts as reduced cross-section areas relative to other distal areas
The one or more cutouts form areas having a reduced cross section compared to other areas of the distal portion.
Flexible portion different polymer than other distal portion areas
The flexible portion includes a different polymer than the other areas of the distal portion.
Directional bias for distal end course change
The flexible portion is configured to bias the distal end to change its course in a particular direction.
Bias maintaining electrodes facing the heart
The bias is configured to maintain the one or more electrodes facing the heart of the patient.
Overall, the claim coverage focuses on the combination of a therapeutic-energy distal electrode portion with a controller-coupled proximal portion, and a paddle-shaped distal end that has cutouts in opposite planar sides to increase flexibility and enable course change under resistance, with dependent refinements specifying reduced cross-section, material and polymer distinctions, and biasing that maintains electrode orientation toward the heart.
Stated Advantages
Allows the distal end to change course when encountering sufficient resistance traveling through biological tissue.
Increases flexibility of the distal end via cutouts formed in surfaces.
Maintains one or more electrodes facing the heart of the patient.
Documented Applications
Implantation of an electrical lead in a patient for generating therapeutic energy for biological tissue using a controller-coupled proximal portion.
Implantable cardiac therapy lead delivery and deployment, including delivery mechanisms for cardiac therapy leads through tissue with lead orientation maintenance.
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