Salvia Bioelectronics B.v.

Sirius Medical Systems B.v.

Salvia Bioelectronic B.v.

Hubert Martens

Rutger Nijlunsing

Stijn Willem Boere

Daniel Schobben

Daniël Schobben

Marjolein Schets

Wim Pollet

Bram Schermers

Takeshi Kaneko

Koen Weijand

Pietro Falgari

Stephen Mark Gee

Maartje Van Der Zalm

Mailys Guillard

Conventional devices deliver a degree of electrical charge into biological tissues; to satisfy regulatory and safety concerns, measures are taken to maintain a zero-charge residual at the stimulation site. Disclosed herein is a method of controlling electrical energy provided by a stimulation device to one or stimulation electrodes comprised in the device, the device including: a first stimulation electrode; a pulse energy controller for transferring electrical energy as one or more electrical stimulation pulses to the first stimulation electrode; the pulse energy controller further including two or more stimulation energy supplies for each supplying electrical energy substantially concurrently to the first stimulation electrode as a first pulse; and each supplying electrical energy separately to the first stimulation electrode as a second pulse. A simpler, more accurate and less-expensive control of stimulation may be provided by considering each energy supply as an energy building block, which may be selected as required.

Method of operating an electrical stimulation device with two or more stimulation energy supplies, and a stimulating device

A method includes configuring, by a computing device, stimulation settings for each electrode in an at least one electrode array in physical contact with a patient, the stimulation settings having adjustable parameters comprising frequency, pulse width, and amplitude, obtaining, by the computing device, feedback information from the patient, and automatically adjusting, by the computing device, at least one of the adjustable parameters based on the feedback information from the patient.

System and method for self-programming stimulation settings

Typically, stimulation therapy is provided using one or more implanted stimulation electrodes. Anatomy and treatment protocols can vary greatly—it is therefore advantageous to provide a highly configurable stimulation system. A tissue stimulation system is provided including an implantable end and a stimulation energy source, the implantable end including: an elongated substrate; one or more stimulation electrodes; and one or more proximal return electrodes; the stimulation energy source including: one or more distal return electrodes, disposed distantly from the one or more stimulation electrodes; and a pulse energy controller including a ratio controller, wherein: the proximal return electrodes and the distal return electrodes are configured as an electrical return for the stimulation electrodes; the ratio controller modifying the electrical potential and/or current ratio of the first part to the second part. A substantially transverse electric field may be provided. In addition, a ratio controller may also be provided.

Tissue stimulation device with distal and proximal return electrode

An implantable restraint is provided that includes an opening-configured to receive a tissue anchor; a pair of protrusions between the opening and a distal edge, providing an anchor resistance to a longitudinal force; where the pair of protrusions are further configured to separate by a distance approximately equal to the tissue anchor when the longitudinal force exceeds a first predetermined threshold, such that the pair of protrusions moves past the tissue anchor. By providing one or more openings extending through the substrate, the growth of tissue which naturally occurs after implantation is utilized to assist in securing the implantable restraint at the implantation site. By providing the pair of protrusions configured to provide resistance, a high degree of control of the restraining force and the explantation force is provided.

Implantable restraint and stimulation device configured for explantation

A mismatch in curvature of an electrode lead section may create unexpected and/or unpredictable electrical resistance with underlying tissue. In addition, repeated movement of the relevant areas of the body may even worsen the mismatch. Implants for electrical stimulation require low electrical resistance conductors for stimulation electrodes, return electrodes and interconnections which conventionally use metal for wires and contacts. These conductors reduce the flexibility, and the problem becomes worse as the number of electrodes increases. An implantable stimulation device is provided with an elongated substrate, one or more interconnections, a flexible electrode with two portions, separated by one or more bending interruptions, wherein the first portion and second portion are in direct electrical connection through the one or more interconnections. The electrode portions on opposite sides of the bending points are electrically connected allowing the mechanical bending and the electrical connections to be optimized separately.

Implantable electrical stimulation device with a flexible electrode

Implants must protect against implant contamination and corrosion of electronics. However, when electrical components are fitted to flexible substrates, failure can occur at electrical connections. An implant comprises: a flexible substrate; a first and second electrical component at a first and second position, electrically connected through an interconnect layer; a first and second component cover, separately encapsulating the first and second component to resist the ingress of body fluids into the component positions; wherein the flexible substrate allows a relative change in disposition between the first component cover and the second component cover. One or more electrodes are provided at a third position. By encapsulating each component separately, the position of force/tension is moved away from the component attachment position to a point somewhere between the component positions. By disposing one or more electrode away from the components, the ingress is further restricted.

Implantable medical device with two or more encapsulated components

During both invasive and non-invasive treatments and therapies, health professionals need to accurately locate areas of interest. Inaccuracies may mean that not all the area is treated, or the treatment is incomplete. Electro-magnetic and RFID (Radio-Frequency Identification) markers have been developed, but these are bulky and prone to failure. For example, any inaccuracy may result in an incomplete resection or removal of the lesion, requiring additional treatments. A magnetic field probeis provided for determining an angular dispositionof an implantable magnetic marker, the probe comprising: a first magnetic sensorclose to the distal end, and a second magnetic sensor, closer to a proximal end, configured to determine two or more magnetic field vectors of the marker; the probe being further configured: to define two or more marker detection zones, extending from the distal end; to determine the angular dispositionto the implantable marker; and to determine whether the angular dispositionsubstantially coincides with one of the two or more marker detection zones, thereby determining that the marker falls within the one marker detection zones. By defining two or more marker detection zones, and configuring the probe to determine whether the magnetic marker appears to be within the one marker detection zone, a simplified and intuitive decision algorithm is provided for indicating the disposition of the marker relative to the probe.

Magnetic field probe for determining a disposition of an implantable marker using two or more detection zones

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 firstand secondincision on opposite sides of a target location, and introducing a first introducer sheathunder the skin with a maximum internal transverse cross-section less than the further maximum transverse cross-sectionof an implantable stimulator. Such a method is advantageous if the maximum transverse cross-sectionof the further portion is at least 1.2 times greater than the maximum transverse cross-sectionof the first portion&#x2014;the dimensions of the implantation tools may be reduced. A further method is provided wherein the first portionwith at least two electrodesis introduced in the skin layers between the nerve tissueto be stimulated and above or in the aponeurosis layer 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.

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

During charging of implantable devices via inductive coupling, heat may be produced within the implantable device, so control of the charging may be desirable to reduce or avoid the risk of undesirable tissue heating. Exchanging parameters relevant for charging may prevent undesirable heating, but typically increase the complexity of the devices used. An implantable device is provided, for wirelessly receiving energy pulses, monitoring the energy storage, and transmitting a first sufficient energy signal if the energy storage exceeds a first maximum value. An associated energy transmission device is provided, for wirelessly transmitting a plurality of successive energy pulses transmitted at a first power level, pausing energy transmission immediately after the first sufficient energy signal is received, and subsequently resuming energy pulse transmission at the first power level if no further sufficient energy signal is received.

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Eindhoven, Netherlands

Hubert Martens