US-12623069-B2 - Self-sufficient neural tissue stimulator

US12623069B2US 12623069 B2US12623069 B2US 12623069B2US-12623069-B2

Abstract

The invention discloses a neural tissue stimulator, characterized in that the neural tissue stimulator comprises a multiple of microneedles and a chip comprising at least one comparator with adaptive level, sequence control circuit, at least one capacitor stack built by n capacitors and 2n switches, at least one buffer capacitor outside the at least one capacitor stack, at least two additional switches outside the at least one capacitor stack, a CMOS-Logic, wherein further, the neural tissue stimulator comprises an interposer layer comprising holes for the multiple of microneedles and a lid. The neural tissue stimulator is characterized in, that the chip is located on one surface of the interposer layer and that the lid and the interposer layer form a capsule for the chip. Further, the neural tissue stimulator is adapted to be electrically self-sufficient.

Inventors

Jarek BUDNY
Judith PIORKOWSKI
Gerd TEEPE

Assignees

CELTRO GMBH

Dates

Publication Date: 20260512
Application Date: 20220429
Priority Date: 20210430

Claims (15)

1 . A neural tissue stimulator, comprising a multiple of microneedles forming an array of microneedles; a chip comprising at least one comparator with adaptive level, a sequence control circuit, at least one capacitor stack built by n capacitors and 2n switches, at least one buffer capacitor outside the at least one capacitor stack, at least two additional switches outside the at least one capacitor stack and a CMOS-Logic, wherein n∈N; wherein the n capacitors are adapted to be sequentially charged by at least one microneedle of the array of microneedles, which functions as DC input source, one after the other and wherein the 2n switches of the capacitor stack couple the n capacitors selectively to at least one microneedle of the array of microneedles and wherein the buffer capacitor outside the at least one capacitor stack is dedicated to be charged from the n capacitors of the capacitor stack at once; an interposer layer comprising holes for the multiple of microneedles; a lid; at least one startup circuit device; wherein the chip, is located on one surface of the interposer layer; wherein the lid and the interposer layer form a capsule for the chip; wherein each microneedle has a distal end which protrudes from the chip; wherein the neural tissue stimulator is adapted to be electrically self-sufficient due to harvesting of electrical energy from neural cells; and the distal ends of at least two microneedles of the array of microneedles have a different electrical insolation.
2 . A neural tissue stimulator according to claim 1 , wherein the neural tissue stimulator further comprises at least one further capacitor.
3 . A neural tissue stimulator according to claim 1 , wherein the neural tissue stimulator comprises between 5 and 1 000 000 microneedles.
4 . A neural tissue stimulator according to claim 1 , wherein the distal end of at least one microneedle of the array of microneedles is at least partially covered by an electrically insulating material.
5 . A neural tissue stimulator according to claim 1 , wherein the neural tissue stimulator has an I-shape, T-shape, H-shape, circular or O-shape.
6 . A neural tissue stimulator according to claim 1 , wherein the neural tissue stimulator further comprises an external programmer unit.
7 . A neural tissue stimulator according to claim 1 , wherein every microneedle is adapted to be operable independent of the other microneedles.
8 . A neural tissue stimulator according to claim 1 , wherein the diameters of the distal ends of the multiple of microneedles are between 0.001 mm and 0.1 mm.
9 . A neural tissue stimulator according to claim 1 , wherein the microneedles comprise a material of the group comprising Platin/Iridium (PtIr), gold, and fine metals.
10 . A neural tissue stimulator according to claim 1 , wherein each microneedle is adapted to be able to harvest cellular energy, to electrically stimulate live tissue and to sense intrinsic cellular electrical activity.
11 . Method for stimulating neural tissue utilizing a neural tissue stimulator according to claim 1 , wherein the microneedles of the array of microneedles are inserted into neural tissue; at least one reference level for cellular electrical activity is set; at least one microneedle of the array of microneedles is set to emit an electrical pulse; at least one microneedle of the array of microneedles is set to sense the amplitude of the cellular electrical activity and to harvest energy; the amplitude of the cellular electrical activity is sensed and energy is harvested at least by one microneedle; and an electrical pulse is applied to the neural tissue by at least one microneedle of the array of microneedles; wherein the electrical pulse is generated utilizing the harvested energy.
12 . Method according to claim 11 , wherein a cellular cycle time is set and the cellular cycle time starts if the amplitude of the cellular electrical activity sensed by at least one microneedle of the array of microneedles reaches the reference level of the corresponding microneedle of the array of microneedles or after a pulse is emitted into the neural tissue by at least one microneedle of the array of microneedles and that an electrical pulse is applied to the neural tissue by at least one microneedle of the array of microneedles if no cellular electrical activity with an amplitude above the reference level is sensed anymore during the cellular cycle time after the amplitude of the sensed cellular electrical activity has been fallen below the reference level.
13 . Method according to claim 11 , wherein an electrical pulse is applied to the neural tissue by the microneedle having the lowest energy demand.
14 . Method according to claim 11 , wherein the electrical pulse is a monophasic pulse or a bipolar pulse.
15 . Method according to claim 11 , wherein the harvested energy is collected into the at least one buffer capacitor or a buffer capacitor-array.

Description

CROSS REFERENCE TO RELATED APPLICATIONS The present application is a U.S. National Phase of International Application No. PCT/EP2022/061445 entitled “SELF-SUFFICIENT NEURAL TISSUE STIMULATOR,” and filed on Apr. 29, 2022. International Application No. PCT/EP2022/061445 claims priority to European Patent Application No. 21171554.5 filed on Apr. 30, 2021. The entire contents of each of the above-listed applications are hereby incorporated by reference for all purposes. TECHNICAL FIELD The invention discloses a neural tissue stimulator, characterized in that the neural tissue stimulator comprises a multiple of microneedles and a chip comprising at least one comparator with adaptive level, sequence control circuit, at least one capacitor stack built by n capacitors and 2n switches, at least one buffer capacitor outside the at least one capacitor stack, at least two additional switches outside the at least one capacitor stack, a CMOS-Logic, wherein further, the neural tissue stimulator comprises an interposer layer comprising holes for the multiple of microneedles and a lid. The neural tissue stimulator is characterized in, that the chip is located on one surface of the interposer layer and that the lid and the interposer layer form a capsule for the chip. Further, each microneedle of the array of microneedles has a distal end which protrudes from the chip, wherein the distal ends of at least two microneedles of the array of microneedles have a different electrical insoaimlation. Further, the neural tissue stimulator is adapted to be electrically self-sufficient. BACKGROUND AND SUMMARY Neural tissue stimulation has evolved to (i) treat chronic pain; (ii) treat neurological disorders, e.g., Parkinson's Disease and epilepsy; (iii) treat paraplegia; (iv) treat systemic diseases, e.g. arterial hypertension, sleep apnea, heart failure; and (v) connect external electronic devices to biological neural networks for data transfer and exchange. Neural tissue stimulation (neuromodulation) has been introduced more than 30 years ago and has undergone a significant technological evolution. This was driven by (i) progress in understanding of electrical impulse propagation physiology over neural tissue such as brain, spinal cord and peripheral nerve tissue; (ii) progress in semiconductor, lead and battery technology; and (iii) progress in surgical access technologies. Today's neural tissue stimulators typically have a diameter size of several centimeters and are placed outside the brain or the spinal cord. Long leads connect from the stimulator to the stimulation target site, where they are fixated and electrically connected to neural tissue. Limited numbers of electrodes provide connection to the stimulated target site. Leads consist of electrical wires coated with bio-compatible material. Unfortunately, over time these leads are ingrown by connective tissue. Furthermore, until today all neural tissue stimulators are powered by a built-in chemical battery and therefore need repetitive device replacements over a patient's lifetime. This requires surgery with associated risks. Another option is to recharge the battery. These systems suffer from the fact that additional technical devices outside the patient's body must be used to charge the neural tissue stimulator, which still makes it necessary to check the neural tissue stimulator's performance status and perform a battery charging procedure either by a technician or by the patient if necessary. A procedure which is usually unfavorable for the patient. Besides limitations in power supply, the designs of the semiconductor-to-tissue interfaces are limiting factors for clinical usage of existing neural tissue stimulation technologies. Limited numbers of electrode numbers lack anatomical specificity of stimulated target sites with limitations to achieve desired clinical stimulation effects. Intradural stimulation sites with extradural lead-to-battery connection require permanent lead access over the dura barrier into the intradural cavity, with the associated risks of cerebral fluid leakage and infection entrance. Extradural electrode placement and stimulation sites exponentially decrease stimulation specificity and increase electrical energy drainage. These factors have led to a plateau of clinical usability of current neurostimulator technologies. Therefore, it is the purpose of the invention to overcome the above-mentioned disadvantages of the state of the art and to provide a neural tissue stimulator which is electrically self-sufficient and therefore (i) can be implanted to be fully contained in the intradural cavity, and (ii) does not need a recharge procedure for a battery or even a whole replacement by a new one due to an empty battery. Therefore, the present invention provides a neural tissue stimulator, characterized in that the device comprises a multiple of microneedles forming an array of microneedles;a chip comprising at least one comparator with adaptive level, a seq