Method for implanting a stimulator with a foil-like electrode portion

Inventors

Schobben, Daniel • Martens, Hubert • Schets, Marjolein • Pollet, Wim

Assignees

Salvia Bioelectronics BV

Abstract

In general, implantation of neurostimulation systems or device includes subcutaneous or percutaneous placement of at least the electrodes. Preferred are minimally invasive implantation procedures, systems and devices that can reliably operate for extended periods, and systems and devices providing a high degree of comfort for the subject. The implantation specialist may need to address adequate placement of the electrodes with respect to the nerve tissue to be stimulated, and to choose between one or more convenient locations for the elements of the system or device.Methods are provided comprising forming a first 1250 and second 1260 incision on opposite sides of a target location, and introducing a first introducer sheath 3050a under the skin with a maximum internal transverse cross-section less than the further maximum transverse cross-section 710 of an implantable stimulator. Such a method is advantageous if the maximum transverse cross-section 710 of the further portion is at least 1.2 times greater than the maximum transverse cross-section 730 of the first portion—the dimensions of the implantation tools may be reduced.A further method is provided wherein the first portion 630 with at least two electrodes 200, 400 is introduced in the skin layers between the nerve tissue 2003 to be stimulated and above or in the aponeurosis layer 2009. By being implanted deeper and/or more accurately, comfort and/or reliability for the subject may be improved. In addition, the chance that the stimulator is implanted under the nerve tissue is greatly increased.

Core Innovation

The invention relates to a kit of parts for implanting an implantable stimulator. The stimulator comprises a longitudinally-extended substrate having a conformable first portion and a further portion, with at least two electrodes comprised in the conformable first portion. The first portion has a first maximum transverse cross-section, while the further portion has a further maximum transverse cross-section that is at least 1.2 times greater than the first maximum transverse cross-section.

The kit further comprises an introducer system structured to match the transverse cross-sections of the stimulator components. A first introducer sheath has a maximum internal transverse cross-section less than the further maximum transverse cross-section of the substrate. A guide wire has a maximum transverse cross-section less than the minimum internal transverse cross-section of the introducer sheath. A guidewire introducer needle has a minimum internal transverse cross-section greater than the maximum transverse cross-section of the guide wire.

The disclosed implanting concept includes placing the foil-like conformable first electrode portion in skin layers between nerve tissue and the inner aponeurosis, or directly adjacent to the aponeurosis, using matched introducer tools. The further/proximal portion is positioned in pockets at controlled depth for comfort and stability, while tool-size matching logic is used to enable deep, accurate electrode placement and to reduce tool size/invasiveness.

The disclosure also links the larger electrode surface area enabled by the thin foil substrate to reduced impedance and power, while aiming to reduce incorrect under-nerve placement and unwanted muscle stimulation.

Claims Coverage

The partial content provides one independent claim defining a kit of parts for implanting an implantable stimulator. The independent claim includes four inventive features defined by quantitative transverse cross-section relationships among the stimulator substrate, introducer sheath, guide wire, and guidewire introducer needle.

Across the independent claim, the inventive coverage centers on quantitative transverse cross-section compatibility between the stimulator substrate, including the conformable first portion and larger further portion, and the introducer sheath, guide wire, and guidewire introducer needle.

Stated Advantages

Documented Applications