Injectable subcutaneous string heart device

Inventors

Strommer, Gera M. • Fischel, Robert S. • Broder, Avi

Assignees

Newpace Ltd

Abstract

A method for subcutaneously implanting a heart device in a patient using an implantation device involves making a first incision in the vicinity of the sternum of the patient and a second incision in the lumbar region of the patient posterior to the vertebral column of the patient. The implantation device is inserted through the first incision to the second incision, and a guidewire is placed through the implantation device via the second incision to the first incision. An end of the guidewire is coupled to the heart device, and the guidewire is pulled through the implantation device until the guidewire is placed within the patient. The guidewire then is detached from the heart device, and the implantation device is removed. The first and second incisions are sutured such that the heart device is left positioned completely subcutaneously around the heart and outside of the ribcage of the patient.

Core Innovation

The invention relates to an injectable subcutaneous heart device for arrhythmia therapy, including a spine/string-shaped device with flexibility in at least three directions. The heart device comprises a plurality of similarly shaped linked structures having a spine-like shape and a substantially symmetric circular cross-section, integrated to include power source, electronics, capacitor(s), electrodes, and sensors within a single hollow flexible device. Biocompatible hermetic electrically insulating coatings are used for electrical insulation and electromagnetic interference immunity.

The device is configured to be positioned subcutaneously around the heart and outside a ribcage, enabling heart therapy functions such as defibrillation/ICD functions and optional pacing functions without intracardiac leads or a bulky can, as described in the provided content. Electrode/sensor configurations are described, including double-helix or linear-pair electrode arrangements, together with sensors for monitoring and/or control. Rechargeable power is described using wireless energy transfer, and wireless RF transceiver functions for monitoring/programming are described.

A minimally invasive implantation and removal concept is described for positioning the spine/string-shaped heart device completely subcutaneously around the heart outside the ribcage. The provided content describes use of an implantation device including a hollow elongated cylindrical shape and a guidewire to pull the heart device into patient tissue in a manner that positions the device regardless of a roll position. The positioning rationale described includes depolarization vector through ventricles, and comfort/aesthetics related to subcutaneous placement.

Claims Coverage

The only independent claim provided covers a subcutaneous implantation method that includes a specific implantation device geometry and a guidewire-guided coupling and pulling sequence to position a spine-like, multi-linked, flexible heart device completely subcutaneously around the heart and outside the ribcage, with a larger portion positioned in an abdominal region regardless of roll position. The claim also requires a particular two-incision access scheme and final suturing of both incisions.

The independent claim focuses on a guidewire-guided pull-through implantation method for a spine-like, multi-linked flexible heart device with a symmetric circular cross-section, using a smaller hollow elongated cylindrical implantation device with a gap and a two-incision sternum-to-lumbar pathway to achieve complete subcutaneous placement around the heart outside the ribcage regardless of roll position, with a larger portion in an abdominal region.

Stated Advantages

Documented Applications