WO2023022917A1 - Network of optogenetic devices - Google Patents

Network of optogenetic devices Download PDF

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Publication number
WO2023022917A1
WO2023022917A1 PCT/US2022/040049 US2022040049W WO2023022917A1 WO 2023022917 A1 WO2023022917 A1 WO 2023022917A1 US 2022040049 W US2022040049 W US 2022040049W WO 2023022917 A1 WO2023022917 A1 WO 2023022917A1
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WIPO (PCT)
Prior art keywords
implant
optogenetic
array
illuminators
node
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PCT/US2022/040049
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French (fr)
Inventor
JR. James Richard DODD
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Dodd Jr James Richard
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Publication of WO2023022917A1 publication Critical patent/WO2023022917A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/062Photodynamic therapy, i.e. excitation of an agent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/0622Optical stimulation for exciting neural tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0601Apparatus for use inside the body
    • A61N5/0603Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0605Ear
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05BELECTRIC HEATING; ELECTRIC LIGHT SOURCES NOT OTHERWISE PROVIDED FOR; CIRCUIT ARRANGEMENTS FOR ELECTRIC LIGHT SOURCES, IN GENERAL
    • H05B47/00Circuit arrangements for operating light sources in general, i.e. where the type of light source is not relevant
    • H05B47/10Controlling the light source
    • H05B47/105Controlling the light source in response to determined parameters
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05BELECTRIC HEATING; ELECTRIC LIGHT SOURCES NOT OTHERWISE PROVIDED FOR; CIRCUIT ARRANGEMENTS FOR ELECTRIC LIGHT SOURCES, IN GENERAL
    • H05B47/00Circuit arrangements for operating light sources in general, i.e. where the type of light source is not relevant
    • H05B47/10Controlling the light source
    • H05B47/175Controlling the light source by remote control
    • H05B47/19Controlling the light source by remote control via wireless transmission

Definitions

  • the present invention relates to optogenetic devices. More particularly, the invention relates to a network of optogenetic devices which may be used in a variety of applications including but not limited to cochlear implants, spinal cord implants, ocular implants, and brain implants.
  • implantable neural stimulators For decades, doctors and scientists have had access to implantable neural stimulators to help treat a variety of conditions. These devices, which include deep brain stimulators, spinal cord stimulators, cochlear implants, and others, use electrodes to send electrical current to a patient’s nearby neurons. Because neurons react to electrical activity, the implant can be used to cause a patient’s neurons to fire in a beneficial way.
  • cochlear implant a device intended to treat profound hearing loss.
  • cochlear implants are electronic devices — they include an electrode array implanted into the cochlea; Electrical current from the electrode array stimulates neurons in the cochlea, causing the wearer to perceive auditory information.
  • the cochlear implant system also includes a microphone to detect sound information near the wearer and a processing system that transforms this sound information into the electrical impulses to be sent to the electrode array and, from there, to the wearer’s neurons.
  • the human cochlea contains some 30,000 spiral ganglion neurons, arranged in order of the sound frequencies they respond to.
  • Example 1 An optogenetic implant, comprising: an array of optical stimulation nodes connected together in a network; wherein each optical stimulation node of the array of optical stimulation nodes includes a plurality of illuminators and a smart backplane, the smart backplane including at least one CMOS chip, the at least one CMOS chip supplying a pattern of electrical current to selected ones of the plurality of illuminators at predetermined timing, intensity and duration.
  • Example 2 The optogenetic implant of Example 1, wherein the plurality of illuminators comprise microLEDs or VCSELs.
  • Example 3 The optogenetic implant of Example 1, wherein the plurality of illuminators include illuminators which emit light of a single color.
  • Example 4 The optogenetic implant of Example 1, wherein some illuminators of the plurality of illuminators emit light of a first color, while other illuminators of the plurality of illuminators emit light of a second color, where the second color is different from the first color.
  • Example 5 The optogenetic implant of Example 1, wherein the array of illuminators is bonded to a flexible substrate.
  • Example 6 The optogenetic implant of Example 1, further comprising an array of focusing lenslets attached to at least one optical stimulation node with one focusing lenslet of the array of focusing lenslets provided on one or more of the plurality of illuminators.
  • Example ? The optogenetic implant of Example 1, wherein the array of nodes are connected together in one of a linear, a ring, and a mesh network.
  • Example 8 The optogenetic implant of Example 1, wherein the optical stimulation node includes logic to minimize the communication bandwidth between smart backplane and the array of nodes.
  • Example 9 The optogenetic implant of Example 1, wherein at least one optical stimulation node of the array of optical stimulation nodes is assigned an address or identifier for communications purposes.
  • Example 10 The optogenetic implant of Example 1, further comprising a power control sub-system communicating instructions to the smart backplane.
  • Example 11 The optogenetic implant of Example 1, wherein the smart backplane includes one or more of an input/output driver logic, serializer/de-serializers, timing circuits, and local memory.
  • Example 12 The optogenetic implant of Example 1, further comprising a power, computer and control subsystem operably connected to and communicating with the smart backplane of each one of the at least one optical stimulation node.
  • Example 13 The optogenetic implant of Example 1, further comprising at least one special node connected to the array of optical stimulation nodes, wherein the special node includes at least one sensor selected from the group temperature sensor, pH sensor, light sensor, one or more electrodes that sense neural activity, and a positional detector/accelerometer or other motion detector.
  • the special node includes at least one sensor selected from the group temperature sensor, pH sensor, light sensor, one or more electrodes that sense neural activity, and a positional detector/accelerometer or other motion detector.
  • Example 14 The optogenetic implant of Example 12, wherein the special node receives power from the smart backplane of a selected optical stimulation node of the array of optical stimulation nodes.
  • FIG. 1 is an exemplary block diagram of a system according to the present invention.
  • FIG. 2 is an exploded view of a smart optical stimulator 112;
  • FIG. 3 is an exemplary linear network of smart optical stimulators 112 and an optional non-illuminator node;
  • FIG. 4 is an exemplary mesh network of smart optical stimulators 112 and an optional non-illuminator node;
  • FIG. 5 is an exemplary ring network of smart optical stimulators 112 and an optional non-illuminator node
  • FIGs. 6A-6C depict example stimulation patterns using rectangular illuminator array 114.
  • the present invention is a very high-precision optical stimulator which can be implanted or partially implanted in the human body. It uses arrays of very small light emitting elements (such as microLEDs). These arrays are connected together in a network and provide optogenetic stimulation which is both programmable and precisely controllable.
  • the present invention allows differing shapes and sizes of cellular-resolution implants to be built from a small set of re-usable “building block” components, reducing both cost and development time, and enabling a broader range of implant shapes and sizes than might otherwise be possible.
  • the LED arrays are bonded electrically and mechanically to the CMOS driver chips such that each individual LED gets electrical current from the CMOS driver chip, not directly from a wiring matrix.
  • the CMOS driver chips are, in turn, connected with wiring to one another to form a network. Because the wiring in the present invention is connected to CMOS driver chips, each of which can control numerous LEDs, the wiring does not limit the number of LEDs which can be practically used.
  • LED arrays form a network with one another.
  • increasing the number of LEDs can be accomplished by adding an additional LED stimulator array to the existing network. This is analogous to the way that adding a new computer to an Ethernet network is simply a matter of plugging the new computer into the existing network. The previously existing network need not be redesigned or rewired.
  • the present invention also allows for much smaller LEDs (sometimes called “microLEDs”) than are achieved in prior art, because of the use of precision bonding between the LED array chip and a supporting CMOS chip.
  • the present invention can support microLEDs which are a few microns in diameter or even smaller. This enables the present invention to achieve cellular-resolution stimulation, since many relevant cells (notably neurons) are often a few microns in size.
  • the stimulated tissue is often very sensitive to increased heat as well as mechanical impingement which may be associated with an implanted device.
  • This invention allows multiple chips, which are typically inflexible and generate heat, to be connected together with flexible wiring, which generates almost no heat.
  • the present invention enables precise stimulation over a variety of tissue shapes and sizes while enabling lower heat generation and greater mechanical flexibility than alternative approaches.
  • the invention is not limited to cochlear implants or brain stimulation devices but for the purpose of explaining the invention, various examples of using the device in conjunction with a cochlear implant will be explained.
  • FIG. 1 is a block diagram of a system 100 according to the present invention.
  • System 100 includes a power, compute, and control subsystem 120 (PCCS), which may be implantable in a human body or may be placed or worn outside the body, as well as an implantable lead 300.
  • the lead 300 includes at least one smart optical stimulator array, described below.
  • the PCCS 120 includes a power subsystem 102 which may include a battery or the like and may be inductively charged.
  • the system includes a controller or processor 104 which receives power from power subsystem 102.
  • a Bluetooth antenna 106 or like wireless communications package receives power from the power supply 102 and communicates with the processor 104.
  • a memory 108 which may be a random access memory (RAM) and/or other volatile or non-volatile memory or the like is provided to hold information such as programming code, data, or libraries related to stimulation patterns or the like, which will be explained in further detail below.
  • the processor 104 is operably connected to the memory 108 and instructs the memory 108 to store and/or retrieve information.
  • a communications interface 109 manages any communications between the PCCS 120 and any nodes 112, 112S on the network 110. Such communications traffic, along with power required by any nodes, is carried along wiring 119. Network communications between nodes 112, 112S may use conventional wired or wireless communications protocols or may use optical communications protocols as desired.
  • the hardware of PCCS 120 may be contained in a single physical housing or may be distributed between multiple housings which are connected with wires or wirelessly.
  • System 100 includes at least one network 110 comprising a plurality of nodes 112, 112S.
  • a node may be a smart optical stimulator 112 or a device 112S providing a function other than optogenetic stimulation.
  • Each node 112 is electrically connected to the power, processing, and control unit 120 and receives instructions as to which pixels should be activated at what time and at what power level.
  • the network 110 in Figure 1 may optionally include one or more special nodes 112S which may or may not be smart optical stimulators 112 and which may or may not include any LEDS and a focusing layer.
  • Special nodes 112S may include a variety of sensors and/or may include a reservoir containing a medicament or the like such as light-sensitive proteins which may be dispensed from the reservoir into specific types of cells in order to monitor and/or control their activity precisely using light signals.
  • Sensors might include (i) electrodes that sense neural activity; (ii) sensors which sense other biological attributes such as temperature, pH, or other; (iii) positional detector/accelerometer or other motion detector; and (iv) light sensing elements such as photodetectors or camera sensors.
  • Special nodes 112S are connected to nodes 112 and/or the PCCS 120 over wiring 119 and use this wiring to receive both electrical power and to send and/or receive any relevant communications messages.
  • the PCCS 120 also decodes and executes instructions received from an external device such as a smartphone 200.
  • the PCCS 120 instructs each node 112 when to initiate/terminate optical stimulation provided by microLEDs 114M (shown in FIG. 2).
  • the node 112S transmits sensor data to the PCCS 120 which may act upon the sensor data by for example adjusting the stimulation pattern if the data falls outside of established minimum or maximum values.
  • the PCCS 120 may simply store the sensor data in memory for subsequent transmission to the external device 200.
  • the system 100 is biocompatible and power efficient, providing both long battery life and low temperature increases from waste heat.
  • FIG 2. This shows the smart optical simulator 112 in more detail.
  • Figure 2 shows an exploded view of the three component chips 118, 114, and 116 for simplicity.
  • the smart backplane 116 and Illuminator array 114 may be bonded together electrically and mechanically; the optional focus elements array 118 may be bonded or otherwise mechanically associated with the joined chips 114 and 116.
  • Each smart optical stimulator node 112 includes a compound semiconductor chip such as but not limited to Gallium Nitride (GaN) which includes a plurality of optical illuminators 114M such as microLEDs, Vertical -cavity surface-emitting laser (VCSEL) or the like.
  • GaN Gallium Nitride
  • VCSEL Vertical -cavity surface-emitting laser
  • LED or microLED as used throughout this application should be understood to include VCSEL.
  • the terms LED, microLED, and optical illuminator may be used interchangeably.
  • the terms LED array, microLED array, and optical illuminator array refer to the chip including a plurality of illuminators and may all be used interchangeably.
  • microLEDs in the microLED array may be arranged in rows and columns, analogous to the pixels of a conventional digital display, the term “pixel” may also be used to refer to a microLED, and the term “pixel array” may be used to refer to a microLED array.
  • the individual microLEDs 114M themselves may be only a few microns in size, or even smaller.
  • the microLED array may include only LEDs of a single color (e.g., a monochrome microLED array) or may include several different types of LEDs, each type emitting a different color (e.g., a multi-color microLED array).
  • Optogenetic stimulation as used in this invention as well as in prior art, requires the use of a light-sensitive protein called an opsin.
  • opsin a light-sensitive protein
  • researchers have access to many different opsins, most of which respond to human-visible light. Some opsins, however, respond to infrared light, which is not human visible.
  • the word “color” in this disclosure may refer to human-visible wavelengths as well as non-visible radiation (such as infrared or ultraviolet light) which is close to the human visible spectrum.
  • LEDs do not emit only a single wavelength of light; they have an emission spectrum which contains a number of wavelengths, typically described by a full width at half maximum (FWHM) of several tens of nanometers.
  • FWHM full width at half maximum
  • the purpose of the microLED array 114 is to turn electrical current at a given pixel location into light. That current is supplied by the smart backplane 116.
  • the smart backplane is fabricated in silicon complementary metal-oxide-semiconductor (CMOS) or other transistor logic fabrication process which is bonded pixel by pixel to the aforementioned optical illuminator chip.
  • CMOS complementary metal-oxide-semiconductor
  • the smart backplane 116 is used to selectively activate or deactivate selected ones of the plurality of LEDs by supplying electrical current to the appropriate LEDs, based on instructions provided by the PCCS 120.
  • the smart backplane 116 may also include logic to perform or improve connectivity between nodes or between nodes and the PCCS 120.
  • the smart backplane 116 may include input/output driver logic, serializer/de- serializers, timing circuits, local memory, and the like.
  • An optional but recommended feature is a focusing layer 118 which may consist of a plurality of focusing lenslets 118L.
  • the focusing layer is bonded to or mechanically associated with the optical illuminator array 114 such that light from the microLED array is collected and focused on the desired target tissue. It may also include features such as optical baffles or isolators to further reduce crosstalk between nearby optical stimulator microLEDs.
  • Lenslets may be physically shaped or may use differential index of refraction, e.g., like a gradient index (GRIN) lens. They may be mechanically associated with an optical illuminator by being built into a transparent biocompatible sheathing made from silicone or like material.
  • GRIN gradient index
  • Each node in the network is connected to at least one other node 112 or 112S or to the PCCS with wiring 119 for power and, optionally, communication.
  • the communication may be wireless rather than wired.
  • the communication may be optical rather than electrical, using optical fiber connected to dedicated communication LEDs and photodetectors on the microLED array 114.
  • Each smart optical stimulator node 112 or special node 112S has an address or identifier which is unique for a given system 100.
  • the PCCS 120 uses the identifier when providing stimulation instructions such that each node responds only to the instructions provided to it.
  • the three-node network 110 shown in Figure 1. It includes two smart optical stimulator nodes 112 and one special node 112S.
  • each node has an address or identifier, let’s say “01” for the leftmost smart optical stimulator node 112, “02” for the special node 112S, and “03” for the rightmost smart optical stimulator node 112.
  • the PCCS 120 sends information messages along wiring 119 to instruct each of the optical stimulator nodes 112 how to activate their respective microLEDs.
  • the desired activation patterns for the leftmost smart optical stimulator will often be different than the desired activation patterns for the rightmost optical stimulator nodes.
  • the PCCS 120 will “address” its intended stimulation pattern with the appropriate identifier — in this case “01” for leftmost and “03” for rightmost optical stimulator node.
  • Messages may also be sent from nodes 112 and/or 112S to the PCCS or to other nodes.
  • a sensing node 112S may report the values it is sensing by transmitting this information over wiring 119 to the PCCS 120 or other nodes; smart optical stimulator nodes may report status information such as failure information in the same way.
  • Messages intended for a given node may be broadcast to all, with each node only taking action on those messages addressed to it specifically, or messages may be sent to a select node or nodes, with those nodes repeating messages intended for different nodes to some or all nodes to which it is connected. Any of a number of networking protocols may be used to prevent messaging loops, unreachable nodes, data collisions, or other problems common to computer networking.
  • system 100 can use software to initiate, stop, or change the behavior of the implanted stimulators and special nodes. This means the system 100 can evolve and/or can be optimized to better serve its wearer/user.
  • the PCCS 120 hardware and software may connect to other devices and software applications, such as an application (an app) running on an external device 200 such as a smartphone or the like.
  • the connection to other systems may be done wirelessly over Bluetooth, Wi-Fi, or other communications protocol.
  • the user may be provided with an option to select between different sensitivity modes, each of which is associated with different power consumption, thereby allowing the user to select for a more sensitive response and greater energy consumption (shorter battery life) or less sensitive response and reduced energy consumption (longer battery life).
  • a more sensitive response may be elicited, at the expense of increased energy consumption, by increasing the duration, frequency, and/or intensity of power supplied to the optical illuminator 114M, or possibly by increasing the number of optical illuminators 114M used.
  • less sensitive, energy-conserving mode may be elicited by decreasing the duration and/or intensity of power supplied to the illuminators 114M, or by decreasing the number of illuminators 114M being used.
  • Device 200 may be used to upload a new stimulation pattern to device 100.
  • Device 200 may further include software, e.g., an App, which may be used to electronically shift or otherwise alter the stimulation pattern until the location providing the greatest response is identified.
  • system 100 may include a semi-automatic tuning app on external device 200.
  • the app may tweak the activation pattern of individual illuminators 114M, prompt the user for feedback as to whether the adjustment made an improvement, made things worse, or did not make any difference.
  • the adjustments made by the semi-automatic tuning app may, in some examples, be specific to a given one node 112, may be applied globally to all nodes 112, or may be specific to a subset of optical illuminators 114M on a given node 112.
  • the process of tuning the stimulation pattern using the semi-automatic tuning app may be gamified - turned into a game - to make the otherwise tedious task more enjoyable.
  • stimulation pattern refers to the timing in which one or more optical illuminators 114M are selectively activated and deactivated by the smart backplane 116. It also includes details such as the duration, frequency, intensity of the illumination provided by the optical illuminator array 114. Since each smart illuminator 112 is analogous to a tiny display, and each LED 114M is analogous to a single pixel on that display, think of a given stimulation pattern as a specific “picture”, shown for a given amount of time, possibly flashing at a certain frequency, and at a given brightness level. [0066] In some examples, the tuning app is semi-automatic and relies on the user's response to prompts regarding the activation pattern.
  • the tuning app may receive feedback from sensors on any individual nodes 112S.
  • the feedback may be used in an autotune mode in which the stimulation pattern is adjusted based on feedback from the sensors.
  • the auto-tune may be used as a first pass or coarse tuning, whereas the semi-automatic tuning may be used to fine tune the stimulation pattern.
  • the device disclosed herein has orders of magnitude more stimulating elements than a typical electronic stimulator.
  • a conventional electrical Deep Brain Stimulator may have four discrete electrodes whereas an optogenetic implant according to the present invention may have 40,000 or even 400,000 optical stimulators in the same volume, distributed over one or more smart illuminators 112.
  • Each of these optical stimulators is individually addressable.
  • a key challenge with brain stimulating devices or cochlear implants is accurate placement of the implant during surgery such that the stimulation is applied to the desired region of interest.
  • the efficacy of the implant in terms of its ability to stimulate a response from tissue within a region of interest depends on placing the implant such that its stimulators are located as closely as possible to the region of interest it is intended to stimulate.
  • the implant should be capable of selectively and independently stimulating individual neurons without inadvertently stimulating neighboring neurons.
  • neurons in the human cochlea are arranged tonotopically, i.e., they are ordered according to the sound frequencies they respond to.
  • An ideal cochlear implant would detect the sound frequencies in the environment around the implant wearer, and then stimulate only those neurons which correspond to those frequencies.
  • This invention enables precise stimulation over a variety of tissue shapes and sizes and can be adjusted, in software, for optimal stimulation in cases where surgical placement is non-ideal or in cases where the target tissue grows, shrinks, or moves relative to the implant. This is possible because the invention allows orders of magnitude more stimulating microLEDs than prior art. Because we have so many stimulators, we can use software to virtually “shift” the stimulation pattern to a desired location even after implantation.
  • FIGs. 6A-6C depict an example rectangular illuminator array 114 relative to a section of tissue it is intended to stimulate.
  • Fig. 6A shows the desired pattern of illumination relative to the target tissue.
  • the black squares represent the select microLEDs 114M in the rectangular microLED array 114 which should light up to provide the desired stimulation.
  • FIG. 6B the stimulator array has been implanted slightly incorrectly such that the desired pattern does not fall in the right place relative to the tissue to be stimulated.
  • the same approach can be used to shift stimulation patterns over the life of the device. If the optogenetic implant shifts or moves or the tissue to be stimulated changes in size, the software may be used to adjust stimulation patterns accordingly without the need for surgical intervention.
  • the user may be provided access to software running on an external device 200 such as a smartphone or the like to help the user optimize his/her experience.
  • an external device 200 such as a smartphone or the like
  • a smartphone app running on the device 200 communicates with the cochlear implant, and provides the user with the ability to adjust (tune) the stimulation pattern of the implant.
  • Software on device 200 may be used to optimize the performance of system 100 either directly, for instance by asking the user to adjust software sliders or knobs until desired performance is reached; or indirectly, for instance through gamification where the user plays a game designed to determine how well the user is receiving desired stimulation signals from the device.
  • an optogenetic cochlear implant user might be asked to perform tasks requiring sounds, with different sounds corresponding to different stimulation settings. The results of the task performance could be used to adjust stimulation settings.
  • the software would also automatically tweak the device’s stimulation pattern as time passes and the user’s relationship to the device evolves. For instance, we may find that the gene expression required for optogenetic stimulation “fades” over time and so the stimulation patterns need to be made brighter (e.g., adjust intensity), be made longer (e.g., adjust duration), repeat more frequently (adjust frequency), or the area being stimulated may be adjusted or shifted to compensate. In some examples, the adjustment may be coded into software and might extend the useful life of the device or the time between gene therapy “refresh”.
  • the software may transmit data describing the change to a central data repository.
  • This will facilitate aggregated data from numerous users over time which may be used to optimize the experience for many users. For instance, we may learn that users of a particular patient population tend to change their stimulation patterns in a certain way over time. Future members of that patient population could have their software automatically change to provide the best possible experience without the need to intervene. This could be done either using analytical techniques (e.g., regression analysis) or using some artificial intelligence technique such as feeding large amounts of patient data through a (computational) neural network.
  • This invention of a network of smart stimulator arrays has several key advantages over prior art. It allows the construction of many shapes and sizes of therapeutic implants using a common set of “Lego brick” nodes, thus providing devices better fit to individual patient needs at lower cost. Creating a device 100 with a network of multiple nodes 112 and 112S, rather than individually implanting n-individual devices, means more efficient use of compute and power resources plus easier coordination between illuminator arrays.
  • FIGs. 3-5 show implants of different topological configurations.
  • FIG. 3 shows is a small network of four smart stimulator arrays 112 connected by a linear network and a single special node 112S. Mechanical flexibility in the power and communication wiring allows the implant to be flexible as well. [0079] Alternatively, an implant could have a branched or mesh topology with nodes 112 or 112S “branching off’ of other stimulators, as shown in FIG. 4.
  • the communications along the network could be a bus (e.g., the power, compute and a control subsystem “talks” to all arrays simultaneously and uses an addressing scheme so that each array sends and receives the appropriate messages.) It could be a “peer-to-peer” relay scheme where arrays communicate with one another, or it could be a ring system where communications messages are passed node-by-node along the ring.
  • a bus e.g., the power, compute and a control subsystem “talks” to all arrays simultaneously and uses an addressing scheme so that each array sends and receives the appropriate messages.
  • It could be a “peer-to-peer” relay scheme where arrays communicate with one another, or it could be a ring system where communications messages are passed node-by-node along the ring.

Abstract

Disclosed is an optogenetic implant, including: an array of nodes connected together in a network, each node of the array of nodes being at least one of an optical stimulation node and a special node; wherein the special node includes at least one sensor selected from the group temperature sensor, pH sensor, light sensor, one or more electrodes that sense neural activity, and a positional detector/accelerometer or other motion detector; wherein each one of the at least one optical stimulation node includes a plurality of illuminators and a smart backplane, the smart backplane including at least one CMOS chip, the at least one CMOS supplying a pattern of electrical current to selected ones of the plurality of illuminators at predetermined timing, intensity and duration.

Description

NETWORK OF OPTOGENETIC DEVICES
[0001] Field of the Invention
[0002] The present invention relates to optogenetic devices. More particularly, the invention relates to a network of optogenetic devices which may be used in a variety of applications including but not limited to cochlear implants, spinal cord implants, ocular implants, and brain implants.
[0003] Background of the Invention
[0004] For decades, doctors and scientists have had access to implantable neural stimulators to help treat a variety of conditions. These devices, which include deep brain stimulators, spinal cord stimulators, cochlear implants, and others, use electrodes to send electrical current to a patient’s nearby neurons. Because neurons react to electrical activity, the implant can be used to cause a patient’s neurons to fire in a beneficial way.
[0005] For the purposes of this backgrounder, we’ll use the cochlear implant as an example of a neural stimulation device. But the concepts and limitations of electrical neural stimulation, described below, can also apply to neural stimulator implants built for other applications as well.
[0006] Consider the cochlear implant: a device intended to treat profound hearing loss. Today’s cochlear implants are electronic devices — they include an electrode array implanted into the cochlea; Electrical current from the electrode array stimulates neurons in the cochlea, causing the wearer to perceive auditory information. The cochlear implant system also includes a microphone to detect sound information near the wearer and a processing system that transforms this sound information into the electrical impulses to be sent to the electrode array and, from there, to the wearer’s neurons. [0007] The human cochlea contains some 30,000 spiral ganglion neurons, arranged in order of the sound frequencies they respond to. Because evolution has given us so many neurons, many people without hearing loss are capable of very fine-grained frequency discrimination — researchers have found that humans can perceive differences between musical “notes” whose frequencies differ by less than 1%. In an ideal world, a cochlear implant would be capable of stimulating the neurons in the cochlea with similar precision. Such precision would, in theory, help the wearer to understand speech in challenging environments and to appreciate music.
[0008] Unfortunately, today’s cochlear implants are not capable of such precision in neural stimulation. This is because electrical current spreads easily within the body such that electrical current intended to stimulate a small number of spiral ganglion neurons will accidentally stimulate large numbers of nearby neurons as well. Thus, today’s cochlear implants tend to provide roughly 12 to 24 electrodes despite the presence of tens of thousands of neurons.
[0009] What is needed is a device capable of stimulating neurons with significantly higher precision than is possible with the current generation of neural stimulation devices.
[0010] Summary of the Invention
[0011] Example 1 : An optogenetic implant, comprising: an array of optical stimulation nodes connected together in a network; wherein each optical stimulation node of the array of optical stimulation nodes includes a plurality of illuminators and a smart backplane, the smart backplane including at least one CMOS chip, the at least one CMOS chip supplying a pattern of electrical current to selected ones of the plurality of illuminators at predetermined timing, intensity and duration. [0012] Example 2: The optogenetic implant of Example 1, wherein the plurality of illuminators comprise microLEDs or VCSELs.
[0013] Example 3 : The optogenetic implant of Example 1, wherein the plurality of illuminators include illuminators which emit light of a single color.
[0014] Example 4: The optogenetic implant of Example 1, wherein some illuminators of the plurality of illuminators emit light of a first color, while other illuminators of the plurality of illuminators emit light of a second color, where the second color is different from the first color.
[0015] Example 5: The optogenetic implant of Example 1, wherein the array of illuminators is bonded to a flexible substrate.
[0016] Example 6: The optogenetic implant of Example 1, further comprising an array of focusing lenslets attached to at least one optical stimulation node with one focusing lenslet of the array of focusing lenslets provided on one or more of the plurality of illuminators.
[0017] Example ?: The optogenetic implant of Example 1, wherein the array of nodes are connected together in one of a linear, a ring, and a mesh network.
[0018] Example 8: The optogenetic implant of Example 1, wherein the optical stimulation node includes logic to minimize the communication bandwidth between smart backplane and the array of nodes.
[0019] Example 9: The optogenetic implant of Example 1, wherein at least one optical stimulation node of the array of optical stimulation nodes is assigned an address or identifier for communications purposes.
[0020] Example 10: The optogenetic implant of Example 1, further comprising a power control sub-system communicating instructions to the smart backplane. [0021] Example 11 : The optogenetic implant of Example 1, wherein the smart backplane includes one or more of an input/output driver logic, serializer/de-serializers, timing circuits, and local memory.
[0022] Example 12: The optogenetic implant of Example 1, further comprising a power, computer and control subsystem operably connected to and communicating with the smart backplane of each one of the at least one optical stimulation node.
[0023] Example 13: The optogenetic implant of Example 1, further comprising at least one special node connected to the array of optical stimulation nodes, wherein the special node includes at least one sensor selected from the group temperature sensor, pH sensor, light sensor, one or more electrodes that sense neural activity, and a positional detector/accelerometer or other motion detector.
[0024] Example 14: The optogenetic implant of Example 12, wherein the special node receives power from the smart backplane of a selected optical stimulation node of the array of optical stimulation nodes.
[0025] Brief Description of Drawings
[0026] The invention can be better understood by referring to the following figures. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. In the figures, like reference numerals designate corresponding parts throughout the different views.
[0027] FIG. 1 is an exemplary block diagram of a system according to the present invention;
[0028] FIG. 2 is an exploded view of a smart optical stimulator 112; [0029] FIG. 3 is an exemplary linear network of smart optical stimulators 112 and an optional non-illuminator node;
[0030] FIG. 4 is an exemplary mesh network of smart optical stimulators 112 and an optional non-illuminator node;
[0031] FIG. 5 is an exemplary ring network of smart optical stimulators 112 and an optional non-illuminator node; and
[0032] FIGs. 6A-6C depict example stimulation patterns using rectangular illuminator array 114.
[0033] Detailed Description
[0034] The present invention is a very high-precision optical stimulator which can be implanted or partially implanted in the human body. It uses arrays of very small light emitting elements (such as microLEDs). These arrays are connected together in a network and provide optogenetic stimulation which is both programmable and precisely controllable.
[0035] In addition, the present invention allows differing shapes and sizes of cellular-resolution implants to be built from a small set of re-usable “building block” components, reducing both cost and development time, and enabling a broader range of implant shapes and sizes than might otherwise be possible.
[0036] With the advent of optogenetics, researchers have begun exploring the use of light, rather than electricity, for neural stimulation. Light spreads in the body less than electricity does and can be focused into small spot sizes. Thus, light holds promise for higher precision neural stimulation than does electricity.
[0037] With respect to the cochlear implant example mentioned above, existing work toward optogenetic cochlear implants aims for improvements of 5-1 Ox greater resolution than electrical approaches. The present invention, by contrast, provides for lOOOx greater resolution, enabling stimulation of individual neurons or even sections of individual neurons. Thus, a cochlear implant using the present invention could have the same auditory frequency resolution enjoyed by people without profound hearing loss.
[0038] This invention departs from designs of prior art in several ways.
[0039] First, consider prior art of a 144-LED cochlear implant design: htps://www.froitiersin.org/aticjes/10.3389/ftu ns 2018.00659/frdl This approach uses a method of attaching 144 individual LEDs to a wiring matrix to allow the per-LED control required by a neural stimulator. Such an approach is limited by the complexity of the wiring as the number of LEDs scale. The present invention avoids wiring complexity even at tens or hundreds of thousands of LEDs by attaching arrays of LEDs to CMOS driver chips, referred to herein as a “smart backplane”. In the present invention, the LED arrays are bonded electrically and mechanically to the CMOS driver chips such that each individual LED gets electrical current from the CMOS driver chip, not directly from a wiring matrix. The CMOS driver chips are, in turn, connected with wiring to one another to form a network. Because the wiring in the present invention is connected to CMOS driver chips, each of which can control numerous LEDs, the wiring does not limit the number of LEDs which can be practically used.
[0040] Second, with the same 144-LED example as well as other optical cochlear implant designs such as htps://pubmed .ncbi .nlm.nib.gov/32718992/, increasing the number of LEDs in the implant (to provide, for instance, greater resolution in a new product; or to develop a different sized implant) requires a redesign of the wiring apparatus. In the present invention, LED arrays form a network with one another. Thus, increasing the number of LEDs can be accomplished by adding an additional LED stimulator array to the existing network. This is analogous to the way that adding a new computer to an Ethernet network is simply a matter of plugging the new computer into the existing network. The previously existing network need not be redesigned or rewired.
[0041] The present invention also allows for much smaller LEDs (sometimes called “microLEDs”) than are achieved in prior art, because of the use of precision bonding between the LED array chip and a supporting CMOS chip. The present invention can support microLEDs which are a few microns in diameter or even smaller. This enables the present invention to achieve cellular-resolution stimulation, since many relevant cells (notably neurons) are often a few microns in size.
[0042] Finally, the stimulated tissue is often very sensitive to increased heat as well as mechanical impingement which may be associated with an implanted device. This invention allows multiple chips, which are typically inflexible and generate heat, to be connected together with flexible wiring, which generates almost no heat. Thus, the present invention enables precise stimulation over a variety of tissue shapes and sizes while enabling lower heat generation and greater mechanical flexibility than alternative approaches.
[0043] The invention is not limited to cochlear implants or brain stimulation devices but for the purpose of explaining the invention, various examples of using the device in conjunction with a cochlear implant will be explained.
[0044] As used throughout the disclosure the terms “implant” and “device” may be used interchangeably. Also, the term “stimulate” may be used to mean “causing a neuron to fire” or “suppressing neural activity”. FIG. 1 is a block diagram of a system 100 according to the present invention. System 100 includes a power, compute, and control subsystem 120 (PCCS), which may be implantable in a human body or may be placed or worn outside the body, as well as an implantable lead 300. The lead 300 includes at least one smart optical stimulator array, described below.
[0045] The PCCS 120 includes a power subsystem 102 which may include a battery or the like and may be inductively charged. The system includes a controller or processor 104 which receives power from power subsystem 102. A Bluetooth antenna 106 or like wireless communications package receives power from the power supply 102 and communicates with the processor 104. A memory 108 which may be a random access memory (RAM) and/or other volatile or non-volatile memory or the like is provided to hold information such as programming code, data, or libraries related to stimulation patterns or the like, which will be explained in further detail below. The processor 104 is operably connected to the memory 108 and instructs the memory 108 to store and/or retrieve information. A communications interface 109 manages any communications between the PCCS 120 and any nodes 112, 112S on the network 110. Such communications traffic, along with power required by any nodes, is carried along wiring 119. Network communications between nodes 112, 112S may use conventional wired or wireless communications protocols or may use optical communications protocols as desired. The hardware of PCCS 120 may be contained in a single physical housing or may be distributed between multiple housings which are connected with wires or wirelessly.
[0046] System 100 includes at least one network 110 comprising a plurality of nodes 112, 112S. A node may be a smart optical stimulator 112 or a device 112S providing a function other than optogenetic stimulation. Think of each optical stimulator node 112 as a tiny display, individually addressable by the PCCS 120, and containing numerous pixels. Each node 112 is electrically connected to the power, processing, and control unit 120 and receives instructions as to which pixels should be activated at what time and at what power level. [0047] In some examples, the network 110 in Figure 1 may optionally include one or more special nodes 112S which may or may not be smart optical stimulators 112 and which may or may not include any LEDS and a focusing layer. Special nodes 112S may include a variety of sensors and/or may include a reservoir containing a medicament or the like such as light-sensitive proteins which may be dispensed from the reservoir into specific types of cells in order to monitor and/or control their activity precisely using light signals. Sensors might include (i) electrodes that sense neural activity; (ii) sensors which sense other biological attributes such as temperature, pH, or other; (iii) positional detector/accelerometer or other motion detector; and (iv) light sensing elements such as photodetectors or camera sensors. Special nodes 112S are connected to nodes 112 and/or the PCCS 120 over wiring 119 and use this wiring to receive both electrical power and to send and/or receive any relevant communications messages.
[0048] The PCCS 120 also decodes and executes instructions received from an external device such as a smartphone 200. The PCCS 120 instructs each node 112 when to initiate/terminate optical stimulation provided by microLEDs 114M (shown in FIG. 2). In an example where a special node 112S includes one or more sensors, the node 112S transmits sensor data to the PCCS 120 which may act upon the sensor data by for example adjusting the stimulation pattern if the data falls outside of established minimum or maximum values. Alternatively, the PCCS 120 may simply store the sensor data in memory for subsequent transmission to the external device 200.
[0049] The system 100 is biocompatible and power efficient, providing both long battery life and low temperature increases from waste heat.
[0050] FIG 2. This shows the smart optical simulator 112 in more detail. Figure 2 shows an exploded view of the three component chips 118, 114, and 116 for simplicity. Please note that, in operation, the smart backplane 116 and Illuminator array 114 may be bonded together electrically and mechanically; the optional focus elements array 118 may be bonded or otherwise mechanically associated with the joined chips 114 and 116.
[0051] Each smart optical stimulator node 112 includes a compound semiconductor chip such as but not limited to Gallium Nitride (GaN) which includes a plurality of optical illuminators 114M such as microLEDs, Vertical -cavity surface-emitting laser (VCSEL) or the like. As a matter of convenience, the term LED or microLED as used throughout this application should be understood to include VCSEL. Moreover, the terms LED, microLED, and optical illuminator may be used interchangeably. The terms LED array, microLED array, and optical illuminator array refer to the chip including a plurality of illuminators and may all be used interchangeably. Because the microLEDs in the microLED array may be arranged in rows and columns, analogous to the pixels of a conventional digital display, the term “pixel” may also be used to refer to a microLED, and the term “pixel array” may be used to refer to a microLED array.
[0052] To provide cellular resolution stimulation, the individual microLEDs 114M themselves may be only a few microns in size, or even smaller. The microLED array may include only LEDs of a single color (e.g., a monochrome microLED array) or may include several different types of LEDs, each type emitting a different color (e.g., a multi-color microLED array). Optogenetic stimulation, as used in this invention as well as in prior art, requires the use of a light-sensitive protein called an opsin. Researchers have access to many different opsins, most of which respond to human-visible light. Some opsins, however, respond to infrared light, which is not human visible. For the sake of simplicity, the word “color” in this disclosure may refer to human-visible wavelengths as well as non-visible radiation (such as infrared or ultraviolet light) which is close to the human visible spectrum. LEDs, of course, do not emit only a single wavelength of light; they have an emission spectrum which contains a number of wavelengths, typically described by a full width at half maximum (FWHM) of several tens of nanometers. When referring to wavelength spectra, we also use “color” in the conventional manner: a “single-color LED” should not be assumed to emit at a single wavelength, but rather to have an emissions spectrum such that the majority of optical power is contained in a reasonably small range of wavelengths.
[0053] The purpose of the microLED array 114 is to turn electrical current at a given pixel location into light. That current is supplied by the smart backplane 116. The smart backplane is fabricated in silicon complementary metal-oxide-semiconductor (CMOS) or other transistor logic fabrication process which is bonded pixel by pixel to the aforementioned optical illuminator chip. The smart backplane 116 is used to selectively activate or deactivate selected ones of the plurality of LEDs by supplying electrical current to the appropriate LEDs, based on instructions provided by the PCCS 120. The smart backplane 116 may also include logic to perform or improve connectivity between nodes or between nodes and the PCCS 120. For instance, the smart backplane 116 may include input/output driver logic, serializer/de- serializers, timing circuits, local memory, and the like.
[0054] An optional but recommended feature is a focusing layer 118 which may consist of a plurality of focusing lenslets 118L. The focusing layer is bonded to or mechanically associated with the optical illuminator array 114 such that light from the microLED array is collected and focused on the desired target tissue. It may also include features such as optical baffles or isolators to further reduce crosstalk between nearby optical stimulator microLEDs. Lenslets may be physically shaped or may use differential index of refraction, e.g., like a gradient index (GRIN) lens. They may be mechanically associated with an optical illuminator by being built into a transparent biocompatible sheathing made from silicone or like material.
[0055] Each node in the network, whether smart optical stimulator node 112 or special node 112S, is connected to at least one other node 112 or 112S or to the PCCS with wiring 119 for power and, optionally, communication. In some examples of this invention, the communication may be wireless rather than wired. In others, the communication may be optical rather than electrical, using optical fiber connected to dedicated communication LEDs and photodetectors on the microLED array 114.
[0056] Each smart optical stimulator node 112 or special node 112S has an address or identifier which is unique for a given system 100. The PCCS 120 uses the identifier when providing stimulation instructions such that each node responds only to the instructions provided to it.
[0057] Consider, for example the three-node network 110 shown in Figure 1. It includes two smart optical stimulator nodes 112 and one special node 112S. In this invention, each node has an address or identifier, let’s say “01” for the leftmost smart optical stimulator node 112, “02” for the special node 112S, and “03” for the rightmost smart optical stimulator node 112. During operation, the PCCS 120 sends information messages along wiring 119 to instruct each of the optical stimulator nodes 112 how to activate their respective microLEDs. The desired activation patterns for the leftmost smart optical stimulator will often be different than the desired activation patterns for the rightmost optical stimulator nodes. Thus, the PCCS 120 will “address” its intended stimulation pattern with the appropriate identifier — in this case “01” for leftmost and “03” for rightmost optical stimulator node.
[0058] Messages may also be sent from nodes 112 and/or 112S to the PCCS or to other nodes. For instance, a sensing node 112S may report the values it is sensing by transmitting this information over wiring 119 to the PCCS 120 or other nodes; smart optical stimulator nodes may report status information such as failure information in the same way.
[0059] Messages intended for a given node may be broadcast to all, with each node only taking action on those messages addressed to it specifically, or messages may be sent to a select node or nodes, with those nodes repeating messages intended for different nodes to some or all nodes to which it is connected. Any of a number of networking protocols may be used to prevent messaging loops, unreachable nodes, data collisions, or other problems common to computer networking.
[0060] Because the PCCS 120 has processing and memory plus a means of communicating with any node 112 or 112S, system 100 can use software to initiate, stop, or change the behavior of the implanted stimulators and special nodes. This means the system 100 can evolve and/or can be optimized to better serve its wearer/user.
[0061] As mentioned above, the PCCS 120 hardware and software may connect to other devices and software applications, such as an application (an app) running on an external device 200 such as a smartphone or the like. The connection to other systems may be done wirelessly over Bluetooth, Wi-Fi, or other communications protocol.
[0062] For instance, the user may be provided with an option to select between different sensitivity modes, each of which is associated with different power consumption, thereby allowing the user to select for a more sensitive response and greater energy consumption (shorter battery life) or less sensitive response and reduced energy consumption (longer battery life). In some examples, a more sensitive response may be elicited, at the expense of increased energy consumption, by increasing the duration, frequency, and/or intensity of power supplied to the optical illuminator 114M, or possibly by increasing the number of optical illuminators 114M used. Conversely, less sensitive, energy-conserving mode may be elicited by decreasing the duration and/or intensity of power supplied to the illuminators 114M, or by decreasing the number of illuminators 114M being used.
[0063] Device 200 may be used to upload a new stimulation pattern to device 100. Device 200 may further include software, e.g., an App, which may be used to electronically shift or otherwise alter the stimulation pattern until the location providing the greatest response is identified.
[0064] In some examples, system 100 may include a semi-automatic tuning app on external device 200. The app may tweak the activation pattern of individual illuminators 114M, prompt the user for feedback as to whether the adjustment made an improvement, made things worse, or did not make any difference. The adjustments made by the semi-automatic tuning app may, in some examples, be specific to a given one node 112, may be applied globally to all nodes 112, or may be specific to a subset of optical illuminators 114M on a given node 112. The process of tuning the stimulation pattern using the semi-automatic tuning app may be gamified - turned into a game - to make the otherwise tedious task more enjoyable.
[0065] The term “stimulation pattern” refers to the timing in which one or more optical illuminators 114M are selectively activated and deactivated by the smart backplane 116. It also includes details such as the duration, frequency, intensity of the illumination provided by the optical illuminator array 114. Since each smart illuminator 112 is analogous to a tiny display, and each LED 114M is analogous to a single pixel on that display, think of a given stimulation pattern as a specific “picture”, shown for a given amount of time, possibly flashing at a certain frequency, and at a given brightness level. [0066] In some examples, the tuning app is semi-automatic and relies on the user's response to prompts regarding the activation pattern. In other examples, the tuning app may receive feedback from sensors on any individual nodes 112S. The feedback may be used in an autotune mode in which the stimulation pattern is adjusted based on feedback from the sensors. The auto-tune may be used as a first pass or coarse tuning, whereas the semi-automatic tuning may be used to fine tune the stimulation pattern.
[0067] According to one aspect of the invention, the device disclosed herein has orders of magnitude more stimulating elements than a typical electronic stimulator. For instance, a conventional electrical Deep Brain Stimulator may have four discrete electrodes whereas an optogenetic implant according to the present invention may have 40,000 or even 400,000 optical stimulators in the same volume, distributed over one or more smart illuminators 112. Each of these optical stimulators is individually addressable. In some examples, in fact the most typical examples, it is possible to simultaneously activate two or more optical illuminators 114M. Power consumption and in particular the amount of charge available on the onboard battery may limit the number of optical stimulators activated at any given time.
[0068] A key challenge with brain stimulating devices or cochlear implants is accurate placement of the implant during surgery such that the stimulation is applied to the desired region of interest. The efficacy of the implant in terms of its ability to stimulate a response from tissue within a region of interest depends on placing the implant such that its stimulators are located as closely as possible to the region of interest it is intended to stimulate. Ideally, the implant should be capable of selectively and independently stimulating individual neurons without inadvertently stimulating neighboring neurons. For example, neurons in the human cochlea are arranged tonotopically, i.e., they are ordered according to the sound frequencies they respond to. An ideal cochlear implant would detect the sound frequencies in the environment around the implant wearer, and then stimulate only those neurons which correspond to those frequencies. Such a scheme would give the wearer the most realistic aural interpretation of the outside world. This invention enables precise stimulation over a variety of tissue shapes and sizes and can be adjusted, in software, for optimal stimulation in cases where surgical placement is non-ideal or in cases where the target tissue grows, shrinks, or moves relative to the implant. This is possible because the invention allows orders of magnitude more stimulating microLEDs than prior art. Because we have so many stimulators, we can use software to virtually “shift” the stimulation pattern to a desired location even after implantation.
[0069] To illustrate, consider FIGs. 6A-6C, which depict an example rectangular illuminator array 114 relative to a section of tissue it is intended to stimulate. Fig. 6A shows the desired pattern of illumination relative to the target tissue. The black squares represent the select microLEDs 114M in the rectangular microLED array 114 which should light up to provide the desired stimulation. In FIG. 6B, the stimulator array has been implanted slightly incorrectly such that the desired pattern does not fall in the right place relative to the tissue to be stimulated.
[0070] In a prior art device, the interventionist would need to physically reposition the implanted device to achieve proper orientation. Whereas in a device 100 according to the present invention we simply, in software, “shift” the intended stimulation patterns by m rows and/or n columns of pixels, thus realigning intended stimulation patterns with intended target, taking into consideration actual rather than intended device placement. This is represented in FIG.
6C. [0071] In a device according to the present invention, the same approach can be used to shift stimulation patterns over the life of the device. If the optogenetic implant shifts or moves or the tissue to be stimulated changes in size, the software may be used to adjust stimulation patterns accordingly without the need for surgical intervention.
[0072] We envision that in some cases, the user may be provided access to software running on an external device 200 such as a smartphone or the like to help the user optimize his/her experience. In the example of cochlear implant, a smartphone app running on the device 200 communicates with the cochlear implant, and provides the user with the ability to adjust (tune) the stimulation pattern of the implant.
[0073] Software on device 200 may be used to optimize the performance of system 100 either directly, for instance by asking the user to adjust software sliders or knobs until desired performance is reached; or indirectly, for instance through gamification where the user plays a game designed to determine how well the user is receiving desired stimulation signals from the device. In one example, an optogenetic cochlear implant user might be asked to perform tasks requiring sounds, with different sounds corresponding to different stimulation settings. The results of the task performance could be used to adjust stimulation settings.
[0074] The software would also automatically tweak the device’s stimulation pattern as time passes and the user’s relationship to the device evolves. For instance, we may find that the gene expression required for optogenetic stimulation “fades” over time and so the stimulation patterns need to be made brighter (e.g., adjust intensity), be made longer (e.g., adjust duration), repeat more frequently (adjust frequency), or the area being stimulated may be adjusted or shifted to compensate. In some examples, the adjustment may be coded into software and might extend the useful life of the device or the time between gene therapy “refresh”. [0075] Each time the user (manually) or the system (automatically) adjusts the stimulation pattern which includes but is not limited to adjusting the intensity, the frequency, the duration, and/or the location of the pattern, the software may transmit data describing the change to a central data repository. This will facilitate aggregated data from numerous users over time which may be used to optimize the experience for many users. For instance, we may learn that users of a particular patient population tend to change their stimulation patterns in a certain way over time. Future members of that patient population could have their software automatically change to provide the best possible experience without the need to intervene. This could be done either using analytical techniques (e.g., regression analysis) or using some artificial intelligence technique such as feeding large amounts of patient data through a (computational) neural network.
[0076] This invention of a network of smart stimulator arrays has several key advantages over prior art. It allows the construction of many shapes and sizes of therapeutic implants using a common set of “Lego brick” nodes, thus providing devices better fit to individual patient needs at lower cost. Creating a device 100 with a network of multiple nodes 112 and 112S, rather than individually implanting n-individual devices, means more efficient use of compute and power resources plus easier coordination between illuminator arrays.
[0077] Many implant configurations may be built with this approach. By way of example, FIGs. 3-5 show implants of different topological configurations.
[0078] FIG. 3 shows is a small network of four smart stimulator arrays 112 connected by a linear network and a single special node 112S. Mechanical flexibility in the power and communication wiring allows the implant to be flexible as well. [0079] Alternatively, an implant could have a branched or mesh topology with nodes 112 or 112S “branching off’ of other stimulators, as shown in FIG. 4.
[0080] Building a mesh network of illuminator arrays rather than a single large illuminator allows significant manufacturing flexibility, more customizability at lower cost, and overall lower product cost (because manufacturing yield for smaller devices will be higher than for larger devices and thus cost per area of a small device is lower than for a larger device.)
[0081 ] One could also envision a ring topology to provide redundant paths to the power and control subsystem, FIG. 5.
[0082] All of these topologies could be built from the same set of building block nodes 112, 112S, and PCCS 120.
[0083] Logically the communications along the network could be a bus (e.g., the power, compute and a control subsystem “talks” to all arrays simultaneously and uses an addressing scheme so that each array sends and receives the appropriate messages.) It could be a “peer-to-peer” relay scheme where arrays communicate with one another, or it could be a ring system where communications messages are passed node-by-node along the ring.
[0084] The above disclosure generally describes the present invention so that one of ordinary skill in the art can implement the system and method of the present invention. Changes in form and substitution of equivalents are contemplated as circumstances may suggest or render expedient. Other generic configurations will be apparent to one skilled in the art. All journal articles and other documents such as patents or patent applications referred to herein are hereby incorporated by reference.
[0085] Although the preceding description of the invention is in the context of the embodiments and examples described herein, the embodiments are not intended to be a limitation on the scope and application of the invention. As readily recognized by those skilled in the art, the disclosed invention encompasses the disclosed idea and embodiments along with other embodiments providing alterations and modifications to any part of the system and methodology including variations on communications, data transfer and interface subsystems and equipment, choice and design of data management software and subsystems, choice and design of data security methods and subsystems, choice and design of data acquisition subsystems and equipment, choice and design of machine learning and inference methods, choice and design of signal and information processing methods and computational models, and the like without departing from the form, scope and spirit of the invention and teaching disclosed herein.

Claims

Claims:
1. An optogenetic implant, comprising: an array of optical stimulation nodes connected together in a network; wherein each optical stimulation node of the array of optical stimulation nodes includes a plurality of illuminators and a smart backplane, the smart backplane including at least one CMOS chip, the at least one CMOS chip supplying a pattern of electrical current to selected ones of the plurality of illuminators at predetermined timing, intensity and duration.
2. The optogenetic implant of claim 1, wherein the plurality of illuminators comprise microLEDs or VCSELs.
3. The optogenetic implant of claim 1, wherein the plurality of illuminators include illuminators which emit light of a single color.
4. The optogenetic implant of claim 1, wherein some illuminators of the plurality of illuminators emit light of a first color, while other illuminators of the plurality of illuminators emit light of a second color, where the second color is different from the first color.
5. The optogenetic implant of claim 1 , wherein the array of illuminators is bonded to a flexible substrate.
6. The optogenetic implant of claim 1, further comprising an array of focusing lenslets attached to at least one optical stimulation node with one focusing lenslet of the array of focusing lenslets provided on one or more of the plurality of illuminators.
7. The optogenetic implant of claim 1, wherein the array of nodes are connected together in one of a linear, a ring, and a mesh network.
8. The optogenetic implant of claim 1, wherein the optical stimulation node includes logic to minimize the communication bandwidth between smart backplane and the array of nodes.
9. The optogen etic implant of claim 1, wherein at least one optical stimulation node of the array of optical stimulation nodes is assigned an address or identifier for communications purposes.
10. The optogenetic implant of claim 1, further comprising a power control sub-system communicating instructions to the smart backplane.
11 . The optogenetic implant of claim 1, wherein the smart backplane includes one or more of an input/output driver logic, serializer/de-serializers, timing circuits, and local memory.
12. The optogenetic implant of claim 1, further comprising a power, computer and control subsystem operably connected to and communicating with the smart backplane of each one of the at least one optical stimulation node.
13. The optogenetic implant of claim 1, further comprising at least one special node connected to the array of optical stimulation nodes, wherein the special node includes at least one sensor selected from the group temperature sensor, pH sensor, light sensor, one or more electrodes that sense neural activity, and a positional detector/accelerometer or other motion detector.
14. The optogenetic implant of claim 12, wherein the special node receives power from the smart backplane of a selected optical stimulation node of the array of optical stimulation nodes.
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