Electrical stimulation of neural activity in the neural innervation of the spleen provides a useful way to treat acute medical conditions. The disclosed systems and methods stimulate the neural activity of a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, such that the electrical signal produces an improvement in a physiological parameter indicative of treatment of an acute medical condition.
Systems for applying electrical stimulation to a nerve and determining a change in measured impedance or sensed electrical fields that is indicative of an electrical event, are disclosed herein. The system comprises an implantable housing comprising a signal generator, an implantable neural interface, an impedance measuring circuit or an electrical field sensing circuit, and processing circuitry. Methods for determining the presence of an electrical event in a system for applying electrical stimulation to a nerve, are also disclosed herein. The method comprises periodically sensing an impedance in an electrical pathway and determining an electrical event in the electrical pathway by identifying a change in the sensed impedance.
A system (1) for electrically stimulating a nerve (3), the system comprising: a first stimulator (5) and a second stimulator (7) for electrically stimulating the nerve, the first stimulator and the second stimulator spaced apart from one another by a first distance; and a controller (9) arranged to: a) set a time interval as a function of the first distance and the speed of propagation of an action potential in the nerve; b) activate the first stimulator for a first stimulation period, thus inducing electrical activity in the nerve; and c) activate the second stimulator for a second stimulation period after the time interval has elapsed after the end of the first time period.
Stents for intravascular neural stimulation are disclosed herein that at least partially contact a vessel wall. The stent comprises a scaffold extending in a longitudinal direction and having an outer perimeter that at least partially contacts the wall. A pulse generator can generate electrical signals for delivery to a nerve for intravascular neural stimulation. The scaffold has mounted thereon a first set of one or more electrodes electrically coupled to the pulse generator. The stent further comprises a second set of one or more electrodes electrically coupled to the pulse generator. The second set of electrodes is unconnected to the scaffold, i.e. not directly mounted on the scaffold. Methods of implanting a stent into a vessel using a deployment catheter are disclosed herein. The stent to be implanted comprises a pulse generator, a scaffold, and a distal set of one or more electrodes electrically coupled to the pulse generator. The distal set of electrodes is unconnected to the scaffold, i.e. not directly mounted on the scaffold. The method comprises positioning a distal end of the deployment catheter at the intravascular location, advancing the stent within the deployment catheter, further advancing the stent to expose the one or more electrodes of the distal set of one or more electrodes outside of, preferably beyond the deployment catheter, providing an electrical stimulation via the exposed electrodes, and withdrawing the stent within the deployment catheter.
The present invention provides devices and methods that can prevent or ameliorate bronchoconstriction by stimulating neural activity, in contrast to those techniques based on denervation, ablation or blocking of neural activity. Methods and devices according to the invention may act responsively or on demand, can preserve neuronal structure and function and will be associated with minimal collateral side-effects. In particular, the invention provides devices and methods in which signals are delivered to the vagus nerve in order to stimulate neural activity in the vagal nerve.
A method of inserting and affixing an implant by making an incision in an abdominal wall is disclosed. A subcutaneous pocket is formed between a first layer of the abdominal wall and a second layer of the abdominal wall, such that the pocket is at least 2 centimeters from the costal margin. An implant is placed into the subcutaneous pocked and affixed within the subcutaneous pocket in the abdominal wall.
A61N 1/375 - Constructional arrangements, e.g. casings
A61B 17/04 - Surgical instruments, devices or methods for closing wounds or holding wounds closedAccessories for use therewith for suturing woundsHolders or packages for needles or suture materials
A61B 17/10 - Surgical instruments, devices or methods for closing wounds or holding wounds closedAccessories for use therewith for applying or removing wound clampsWound clamp magazines
Electrical stimulation of neural activity in the neural innervation of the spleen that is associated with neurovascular bundles provides a useful way to treat acute medical conditions, such as trauma, hemorrhaging and shock.
Electrical stimulation of neural activity in the neural innervation of the spleen provides a useful way to treat acute medical conditions. The disclosed systems and methods stimulate the neural activity of a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, such that the electrical signal produces an improvement in a physiological parameter indicative of treatment of an acute medical condition.
Stimulation of neural activity in a nerve supplying the spleen, wherein the nerve is adjacent to the splenic artery at a position where the splenic artery is not in direct contact with the pancreas, can modulate pro- and anti-inflammatory molecules levels, thereby reducing inflammation and providing ways of treating disorders, such as disorders associated with inflammation. The invention provides improved ways of reducing inflammation with minimized off-target effects, in particular surgical trauma.
The present invention provides an implantable neuromodulation system for delivering an electrical signal to a nerve to stimulate, inhibit or block conduction of action potentials in the nerve. The system comprises a neural interface device comprising first and second electrodes; a signal generator and a first closed-loop controller configured to generate a control signal based a property of the signal based on a measured voltage across the first and second electrodes, and cause the signal generator to adjust the electrical signal to modify the property of the signal.
An implantation system and methods of inserting an implant are disclosed. The method includes the step of making an incision in an abdominal wall with an instrument positioned within an abdominal cavity. The method further includes the steps of forming a pocket between a first surface of the abdominal wall and a second surface of the abdominal wall, such that the incision defines an opening into the pocket, inserting an implant through the opening and into the pocket, and closing the opening such that the implant is captured within the pocket.
CENTRE NATIONALE DE LA RECHERCHE SCIENTIFIQUE (France)
Inventor
Blancou, Philippe
Glaichenhaus, Nicolas
Sridhar, Arun
Abstract
Devices and methods for the stimulation of neural signalling of an apical splenic nerve, the device having a transducer for placement on or around the apical splenic nerve, and a signal generator to generate a signal that stimulates or inhibits the neural activity of the apical splenic nerve to produce a physiological response. The transducer has at least one electrode, and the signal generator is a voltage or current source. The stimulation electrical signal has a frequency of between 1 Hz and 50 Hz.
An extravascular neural interface is disclosed containing electrodes for neurostimulation of the vessel. The devices are housed in flexible substrates, each substrate having a spinal portion for routing leads/conductors into the device for connection to the electrodes. Extending from opposite sides of the spinal portion is a self-sizing inner flap that supports and positions the electrodes to be inward facing, i.e., extravascular designs, and one more rigid outer flap. The electrodes may be flexible multifilar coil electrodes.
Systems for applying electrical stimulation to a nerve and determining a change in measured impedance or sensed electrical fields that is indicative of an electrical event, are disclosed herein. The system comprises an implantable housing comprising a signal generator, an implantable neural interface, an impedance measuring circuit or an electrical field sensing circuit, and processing circuitry. Methods for determining the presence of an electrical event in a system for applying electrical stimulation to a nerve, are also disclosed herein. The method comprises periodically sensing an impedance in an electrical pathway and determining an electrical event in the electrical pathway by identifying a change in the sensed impedance.
The present disclosure provides an apparatus for stimulating neural activity in a pudendal nerve of a subject, the apparatus comprising of: at least one primary electrode configured to apply a first electrical signal to said nerve; and a controller coupled to said primary electrode (s) and controlling the first electrical signal to be applied thereby, wherein said controller is configured to cause said at least one primary electrode to apply said first electrical signal that stimulates neural activity in the pudendal nerve to improve bladder function, and wherein the first electrical signal is applied in a burst pattern.
Stimulation of the spleen and/or neural activity of one or more nerves supplying the spleen, such as a nerve associated with the splenic arterial neurovascular bundle, can decrease C- Reactive Protein (CRP) levels and post-operative surgical complications. The system for stimulating the spleen and/or neural activity of one or more nerves supplying the spleen for reducing post-operative surgical complications can include at least one transducer in signaling contact with the spleen and/or the one or more nerves; and at least one controller electrically coupled to the at least one transducer. The at least one controller can be configured to control the operation of the at least one transducer to apply a stimulating signal to the spleen and/or the one or more nerves. The stimulating signal may produce a change in a physiological parameter indicative of a target engagement of the nerves resulting in a reduction in C-reactive protein (CRP) plasma levels and/or Interleukin-6 (IL-6) plasma levels after surgery and reducing post- operative surgical complications and/or days in hospital.
A belt-like garment is disclosed herein that addresses the need in the wireless recharging field for a holder that maintains the proximity of the recharger to the implanted device, is less bulky and better conforming to the wearer, is easy to don and doff, and prevents shifting throughout the recharging session.
Centre Nationale de La Recherche Scientifique (France)
Université Côte d'Azur (France)
Inventor
Sridhar, Arun
Blancou, Philippe
Glaichenhaus, Nicolas
Abstract
Modulation of neural signaling of a pancreas-related sympathetic nerve is capable of improving glycaemic control by inhibiting T cell activation or migration to the pancreas, and hence providing a way of treating or preventing type 1 diabetes.
Provided herein is a solution to the problem of stimulation of a target pudendal nerve such that the stimulation applied by the electrode at that position selectively modulates the external urtheral sphincter (EUS), or selectively modulates the external anal sphincter (EAS).
An extravascular of intravascular neural interface is disclosed containing electrodes for neurostimulation of the vessel. The devices are housed in flexible substrates formed from a multilumen tubing housing conductors for electrodes positioned in a distal serpentine shaped end of the device. The distal serpentine shaped end includes rows or strips of electrodes or coil electrodes.
This disclosure provides an apparatus or system for the modulation of neural activity in the cervical sympathetic chain (CSC) or superior cervical ganglion (SCG) or SCG post-ganglionic branch(es) and for the treatment of sleep apnoea, as well as methods for their use.
Modulation of neural activity of a ganglion, by applying a signal to a sympathetic nerve adjacent to the ganglion, results in preferential reduction of sympathetic signals to an effector, thereby providing ways of treating and preventing conditions associated with exacerbated sympatho-excitation.
An implantable neural interface system comprising: at least one electrode; a spine providing a passage for electrical conductors connectable to a pulse generator and the at least one electrode; at least one arm extending from the spine, wherein the electrode is positioned on the arm; and a strain relief feature configured to reduce strain in relative movement of portions of neural interface system to accommodate a curvature in an axis of a target on or in which the neural interface is provided.
A stent for intravascular stimulation comprises a scaffold comprising first and second scaffold structures, each scaffold structure comprising at least one substantially annular portion. The stent further comprises one or more anodal electrodes formed from or electrically coupled to at least a substantially annular portion of the first scaffold structure and one or more cathodal electrodes electrically formed from or coupled to at least a substantially annular portion of the second scaffold structure. The stent further comprises an anodal lead electrically coupled to the first scaffold structure to form a conductive path from the one or more anodal electrodes to a generator and a cathodal lead electrically coupled to the second scaffold structure to form a conductive path from the one or more cathodal electrodes to the generator. The stent further comprises a sleeve of insulating material, wherein the scaffold structures are attached to or formed on the sleeve of insulating material and are separated from each other by a distance such that the first and second scaffold structures are electrically insulated from each other.
In embodiments a neural interface comprising at least one C-ring portion can be used to apply a pressure in a range of 0 mmHg to 30 mmHg to a target tissue arranged within the C-ring portion and comprising at least one electrode arranged on the at least one C-ring portion.
A deployment tab for deploying a neural interface device, the deployment tab comprising a first portion configured, in use, to be positioned proximal to the neural interface device; and a connector, for releasably coupling the first portion to the neural interface device, the connector being anchored to the first portion.
Stents for intravascular neural stimulation are disclosed herein that at least partially contact a vessel wall. The stent comprises a scaffold extending in a longitudinal direction and having an outer perimeter that at least partially contacts the wall. A pulse generator can generate electrical signals for delivery to a nerve for intravascular neural stimulation. The scaffold has mounted thereon a first set of one or more electrodes electrically coupled to the pulse generator. The stent further comprises a second set of one or more electrodes electrically coupled to the pulse generator. The second set of electrodes is unconnected to the scaffold, i.e. not directly mounted on the scaffold. Methods of implanting a stent into a vessel using a deployment catheter are disclosed herein. The stent to be implanted comprises a pulse generator, a scaffold, and a distal set of one or more electrodes electrically coupled to the pulse generator. The distal set of electrodes is unconnected to the scaffold, i.e. not directly mounted on the scaffold. The method comprises positioning a distal end of the deployment catheter at the intravascular location, advancing the stent within the deployment catheter, further advancing the stent to expose the one or more electrodes of the distal set of one or more electrodes outside of, preferably beyond the deployment catheter, providing an electrical stimulation via the exposed electrodes, and withdrawing the stent within the deployment catheter.
Stimulation of neural activity in a nerve supplying the spleen, wherein the nerve is adjacent to the splenic artery at a position where the splenic artery is not in direct contact with the pancreas, can modulate pro- and anti-inflammatory molecules levels, thereby reducing inflammation and providing ways of treating disorders, such as disorders associated with inflammation. The invention provides improved ways of reducing inflammation with minimized off-target effects, in particular surgical trauma.
Electrical stimulation of neural activity in the neural innervation of the spleen that is associated with neurovascular bundles provides a useful way to treat acute medical conditions, such as trauma, hemorrhaging and shock.
Stimulation of neural activity in a nerve supplying the spleen, wherein the nerve is associated with a neurovascular bundle, can modulate pro- and anti-inflammatory molecules levels, thereby reducing inflammation and providing ways of treating inflammatory disorders. The invention provides improved ways of treating inflammatory disorders which minimize off-target effects.
Electrical stimulation of neural activity in the neural innervation of the spleen provides a useful way to treat acute medical conditions. The disclosed systems and methods stimulate the neural activity of a nerve supplying a spleen, wherein the nerve is associated with a neurovascular bundle, such that the electrical signal produces an improvement in a physiological parameter indicative of treatment of an acute medical condition.
A method for use in making an electrode assembly (20) comprises the steps of applying an electrode (24) on a first layer of material (22); laser welding a lead (23) to the electrode; applying an adhesive backfill (26) over the electrode and the lead; and applying a second layer of material (28) over the adhesive backfill and a portion of the first layer to prevent a leakage path between the electrode and the second layer.
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
B29C 45/16 - Making multilayered or multicoloured articles
B29C 45/14 - Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mouldApparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
42.
NEUROSTIMULATION DEVICE FOR BLOCKING BLOOD FLOW BETWEEN ELECTRODES
A neurostimulation device 1 for non-destructively stimulating neural activity in a nerve 3 in proximity to a blood vessel 5. The neurostimulation device 1 comprises a catheter 7 for insertion into the blood vessel 5; a proximal electrode 11 offset from a distal electrode 9 along a length of the catheter 7; and an insulator 13 positioned between the proximal electrode 11 and the distal electrode 9 on the catheter 7. The insulator 13 has a contracted configuration in which the size of the insulator 13 allows the catheter 7 to travel inside the blood vessel 5. The insulator 13 has an expanded configuration in which the insulator 13 blocks blood flowing through the blood vessel between the proximal electrode 11 and the distal electrode 9. The neurostimulation device 1 comprises a stimulator 15 arranged to apply an electrical signal between the proximal electrode 11 and the distal electrode 9 when the insulator 13 is in the expanded configuration, thus inducing electrical activity in a wall portion of the blood vessel between the proximal and distal electrodes 9, 11. There is also an insulation portion between the distal electrode 9 and a distal end of the catheter 7 for offsetting the distal electrode 9 from a wall of the blood vessel 5.
Stimulation of neural activity in a splenic arterial nerve at a position where the splenic artery is not in direct contact with the pancreas, can modulate pro- and anti-inflammatory molecules levels, thereby reducing inflammation and providing ways of treating disorders, such as disorders associated with inflammation. The invention provides improved ways of reducing inflammation with minimized off-target effects, in particular surgical trauma.
A neuromodulation device for measuring an evoked response comprising a first electrode; a second electrode, wherein the first and second electrodes are alternately configured as a stimulation electrode; a sensing electrode for sensing an evoked response to a stimulus pulse; and a controller configured to measure an evoked response at the sensing electrode after a stimulus pulse at a first stimulation electrode configuration and after a stimulus pulse at a second alternate stimulation electrode configuration, and to add said pair of measurements.
An extravascular neural interface includes a device containing electrodes for neurostimulation of a vessel. The devices are housed in flexible substrates forming two flaps, an inner flap having a spinal portion for routing leads/conductors into the device for connection to the electrodes and an outer flap that overlaps the inner flap. The inner flap supports and positions the electrodes to be inward facing, i.e., extravascular designs. The electrodes may be circular or elliptical and include a plurality of wings for securing the electrodes within a flap.
Electrical stimulation of neural activity in the neural innervation of the spleen that is associated with neurovascular bundles provides a useful way to treat acute medical conditions, such as trauma, hemorrhaging, shock, acute respiratory distress syndrome (ARDS), severe respiratory distress syndrome (SARS), and coronavirus disease 19 (COVID-19).
Electrical stimulation of neural activity in the neural innervation of the spleen that is associated with neurovascular bundles provides a useful way to treat acute medical conditions, such as trauma, hemorrhaging, shock, acute respiratory distress syndrome (ARDS), severe respiratory distress syndrome (SARS), and coronavirus disease 19 (COVID-19).
a) extending from the at least one electrically conductive pad. The pad may be formed of a non-abrasive material, such as conductive foam or smooth metal. The substrate may be a probe formed with a number of slots for holding pads and routing wires, a mandrel with openings for holding pads and routing wires, and a flexible circuit with exposed smooth metal surfaces. The test fixture may be suitable for testing cuff-like and paddle-like devices.
A neuromodulation system is described in which electrodes are mounted within a neural interface device configured to include elastic self-pulsatile or IPG-controlled pneumatic/hydraulic collars in a distal end of the system. One or more electrodes are mounted in each collar. Each collar is connected to an implanted pulse generator (IPG) at the proximal end of the neuromodulation system via a lead body that includes pneumatic/hydraulic lines to the collars and electrical wiring to the electrodes. Gas or fluid pressure supplied to each collar can be controlled by one or more precision step motors inside the IPG. Proximal connectors to the lead body have one or more gas or liquid (biocompatible) reservoirs whose pressure is individually or collectively controlled by the one or more precision motors inside the IPG. The IPG can drive one common or multiple independent precision motors lined around each reservoir to drive one or more collars in the neural interface device.
Systems and methods are provided for stimulating one or more nerves with an implantable device. The implantable device may comprise an antenna circuit including a loop antenna and a control circuit including a rectifying diode for rectifying an alternating voltage induced in the antenna circuit by an external electromagnetic field. The implantable device may also include a chargeable storage element for storing energy from the rectified voltage without using a battery. The device may also include an electrode array containing a set of electrodes for emitting an electric field using the stored energy in response to a control signal received from the control circuit. The components of the device may be affixed onto a soft polymer substrate including a linkable peripheral tab on at least two edges of a substantially rectangular body section of the substrate for forming a cuff about the one or more nerves to be stimulated.
H02J 7/02 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries for charging batteries from AC mains by converters
H02J 7/34 - Parallel operation in networks using both storage and other DC sources, e.g. providing buffering
H02J 50/10 - Circuit arrangements or systems for wireless supply or distribution of electric power using inductive coupling
H02J 50/20 - Circuit arrangements or systems for wireless supply or distribution of electric power using microwaves or radio frequency waves
H02J 50/80 - Circuit arrangements or systems for wireless supply or distribution of electric power involving the exchange of data, concerning supply or distribution of electric power, between transmitting devices and receiving devices
52.
METHODS FOR INSERTING AND AFFIXING AN IMPLANT IN AN ABDOMINAL WALL CAVITY BY USING LAPAROSCOPY
Systems and methods for treating an inflammatory condition in a subject are provided. One or more signal-conducting interfaces are placed in signaling contact with one or more splenic nerves of the subject. A connection is formed between a signal-generating source and the one or more signal-conducting interfaces. A stimulation is generated, by the signal-generating source, at the one or more signal-conducting interfaces, where the stimulation activates the ALOX15 pathway to achieve a change in a parameter.
A neural interface system, comprises a lead body including a first electrode; a cuff body having a first section and a second section separated by a gap for providing a path of least electrical resistance, a second electrode positioned within the first section; and a junction between the lead body and the cuff body, wherein the gap extends around an axis of the cuff body and comprises a first area proximal to the junction.
A system (1) for electrically stimulating a nerve (3), the system comprising: a first stimulator (5) and a second stimulator (7) for electrically stimulating the nerve, the first stimulator and the second stimulator spaced apart from one another by a first distance; and a controller (9) arranged to: a) set a time interval as a function of the first distance and the speed of propagation of an action potential in the nerve; b) activate the first stimulator for a first stimulation period, thus inducing electrical activity in the nerve; and c) activate the second stimulator for a second stimulation period after the time interval has elapsed after the end of the first time period. Preferably, the time interval is a sum of the first time period and a buffer time period for allowing the nerve to recover from stimulation.
This disclosure relates to implantable neuromodulation systems and methods, and in particular to systems and methods for sensing blood-based parameter changes triggered by neural stimulation and subsequently optimizing the stimulation parameters based on feedback from the sensed blood-based parameter changes. Embodiments are directed to a method that includes delivering neural stimulation to a nerve or artery/nerve plexus based on a first set of stimulation parameters, monitoring a response to the neural stimulation that includes monitoring responses of the nerve or artery/nerve plexus and blood-based parameters of the artery, modifying the first set of the stimulation parameters based on the blood-based parameters to create a second set of stimulation parameters, and delivering the neural stimulation based on the second set of the stimulation parameters.
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A61N 1/375 - Constructional arrangements, e.g. casings
59.
IMPLANTABLE PULSE GENERATOR WITH SUTURE HOLES, METHODS FOR IMPLANTING THE SAME, AND ENCAPSULATION OF EXTERNAL COMPONENTS IN ACTIVE IMPLANTABLE MEDICAL DEVICES
An implantable pulse generator is provided that includes a power source, a wireless communication component configured to facilitate wireless communication with a non-implanted device and pulse-generating circuitry connected to the power source. The pulse-generating circuitry can be configured to identify, based on wireless communication with the non-implanted device, temporal and amplitude characteristics for electrical pulse stimuli and to trigger electrical output stimuli having the temporal and amplitude characteristics. The implantable pulse generation can further include one or more lead connections—each being shaped to engage a lead and electrically connected to the pulse-generating circuitry to enable the lead to deliver at least part of the electrical output stimuli triggered by the pulse-generating circuitry. The implantable pulse generator can further include one or more suture-engagement components, each including one or more holes each having a diameter that is at least 0.1 mm and less than 5 mm.
The present invention provides an implantable neuromodulation system for delivering an electrical signal to a nerve to stimulate, inhibit or block conduction of action potentials in the nerve. The system comprises a neural interface device comprising first and second electrodes; a signal generator and a first closed-loop controller configured to generate a control signal based a property of the signal based on a measured voltage across the first and second electrodes, and cause the signal generator to adjust the electrical signal to modify the property of the signal.
Centre Nationale de La Recherche Scientifique (France)
Université Côte d'Azur (France)
Inventor
Sridhar, Arun
Blancou, Philippe
Glaichenhaus, Nicolas
Abstract
Modulation of neural signaling of a pancreas-related sympathetic nerve is capable of improving glycaemic control by inhibiting T cell activation or migration to the pancreas, and hence providing a way of treating or preventing type 1 diabetes.
An electrode system for neuromodulation and for recording of signals indicative of nerve activity is provided. The system can include a plurality of electrodes provided on a flexible, non-conductive substrate. The substrate can be rolled into a cuff for encircling a nerve bundle of a patient. The plurality of electrodes on the cuff can be interconnected using flexible conductors provided on the substrate. In one implementation, the electrodes can be interconnected using conductors that have spring-like configuration. Flexibility of the conductors allows the cuff to expand and contract with the nerve without causing excessive stress/strain at the nerve-cuff interface.
A stent for intravascular stimulation comprises a scaffold comprising first and second scaffold structures, each scaffold structure comprising at least one substantially annular portion. The stent further comprises one or more anodal electrodes formed from or electrically coupled to at least a substantially annular portion of the first scaffold structure and one or more cathodal electrodes electrically formed from or coupled to at least a substantially annular portion of the second scaffold structure. The stent further comprises an anodal lead electrically coupled to the first scaffold structure to form a conductive path from the one or more anodal electrodes to a generator and a cathodal lead electrically coupled to the second scaffold structure to form a conductive path from the one or more cathodal electrodes to the generator. The stent further comprises a sleeve of insulating material, wherein the scaffold structures are attached to or formed on the sleeve of insulating material and are separated from each other by a distance such that the first and second scaffold structures are electrically insulated from each other.
An extravascular or intravascular neural interface is disclosed comprising three C-ring portions, with at least two including an electrode, an electrode pair or an electrode array. The portions are formed of a flexible material that is configured to enable the portions to self-size to fit around or against a surface of a target vessel when the neural interface is released at a position along the target vessel. A spinal portion configured to house electrical conductors for the electrodes is connected to one or more portions. The portions may be spaced sufficient apart to permit radial expansion and contraction of a target vessel around or within which the neural interface is placed, to reduce never compression, open trench low-pressure unrestricted blood-flow, and to enhance fluid exchange with the target vessel. The portions may be arranged in a low helix angle forming at least two full turns.
The present disclosure provides an apparatus for stimulating neural activity in a pudendal nerve of a subject, the apparatus comprising of: at least one primary electrode configured to apply a first electrical signal to said nerve; and a controller coupled to said primary electrode (s) and controlling the first electrical signal to be applied thereby, wherein said controller is configured to cause said at least one primary electrode to apply said first electrical signal that stimulates neural activity in the pudendal nerve to improve bladder function, and wherein the first electrical signal is applied in a burst pattern.
Provided herein is a solution to the problem of stimulation of a target pudendal nerve such that the stimulation applied by the electrode at that position selectively modulates the external urtheral sphincter (EUS), or selectively modulates the external anal sphincter (EAS).
An implantable neural interface system comprising: at least one electrode; a spine providing a passage for electrical conductors connectable to a pulse generator and the at least one electrode; at least one arm extending from the spine, wherein the electrode is positioned on the arm; and a strain relief feature configured to reduce strain in relative movement of portions of neural interface system to accommodate a curvature in an axis of a target on or in which the neural interface is provided.
A neural delivery device (1500) for delivery a neural interface device (1504) into an abdominal cavity for implantation within a patient, wherein the neural delivery device is configured to be inserted through a sealed port of an insertion tube, and wherein the neural delivery device comprises an opening at a distal end of the neural delivery device for the neural interface device.
A deployment tab (110) for deploying a neural interface device (106), the deployment tab comprising a first portion configured, in use, to be positioned proximal to the neural interface device; and a connector, for releasably coupling the first portion to the neural interface device, the connector being anchored to the first portion.
In embodiments a neural interface comprising at least one C-ring portion can be used to apply a pressure in a range of 1 mmHg to 30 mmHg to a target tissue arranged within the C-ring portion and comprising at least one electrode arranged on the at least one C-ring portion.
Implantable systems are described that include a stimulation device positionable in vivo and configured to communicatively couple to electrodes configured to stimulate or block body tissue and an auxiliary device positionable in vivo and including one or more coils configured to wirelessly couple, in vivo, to the stimulation device and to wirelessly couple to an ex vivo device. The auxiliary device may include a coil driver and a power source controlled by a processor and memory for storing data instructions for the coil driver and for storing data received from the stimulation device. The auxiliary device may also include a radio transceiver and an antenna. The stimulation device may include a housing, a coil, a power source and an integrated circuit for controlling the electrodes. The stimulation device may be coupled to a cuff via a lead and physically coupled to the auxiliary device.
There is provided a nerve interface device including (1, 3) comprising: at least one cuff portion; and a first pair of electrodes mounted on the at least one cuff portion. The cuff portion has an assembled position in which the cuff portion forms at least part of a passageway for receiving a nerve along a cuff axis passing through the passageway. The electrodes of the first pair are spaced apart from one another in the direction of the cuff axis.
There is provided a nerve activity monitoring method that includes receiving an input signal indicative of activity in a nerve of a subject; receiving physiological data indicative of physiological activity in the subject; establishing a relationship between the physiological data and the input signal; identifying a plurality of periodic portions in the input signal based on the relationship between the physiological data and the input signal; and outputting the periodic portions identified.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G16H 20/30 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
A61B 5/11 - Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
A61B 5/388 - Nerve conduction study, e.g. detecting action potential of peripheral nerves
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A belt-like garment is disclosed herein that addresses the need in the wireless recharging field for a holder that maintains the proximity of the recharger to the implanted device, is less bulky and better conforming to the wearer, is easy to don and doff, and prevents shifting throughout the recharging session.
An implantation system and methods of inserting an implant are disclosed. The method includes the step of making an incision in an abdominal wall with an instrument positioned within an abdominal cavity. The method further includes the steps of forming a pocket between a first surface of the abdominal wall and a second surface of the abdominal wall, such that the incision defines an opening into the pocket, inserting an implant through the opening and into the pocket, and closing the opening such that the implant is captured within the pocket.
There is provided a neural interface device for unidirectional stimulation of a nerve including at least one A-type nerve fiber or at least one at least partially myelinated nerve fiber. The device includes an electrode arrangement for placing on or around the nerve. The electrode arrangement includes a first electrode configured to be positively charged and a second electrode configured to be negatively charged, where the surface area of the second electrode is larger than the surface area of first electrode.
An implant insertion system and methods of use of the implant insertion system are disclosed. The implant insertion system includes an implant and an instrument configured to deliver the implant to a biological structure and assist in deploying the implant to the biological structure. The instrument includes a retention member the secures the implant to the instrument and retains the implant in a first configuration. The retention member is movable to decouple the implant from the instrument. The implant is configured to transition from the first configuration to a second configuration, such that in the second configuration the implant is secured to the biological structure.
Stimulation of neural activity in a nerve supplying the spleen, wherein the nerve is adjacent to the splenic artery at a position where the splenic artery is not in direct contact with the pancreas, can modulate pro- and anti-inflammatory molecules levels, thereby reducing inflammation and providing ways of treating disorders, such as disorders associated with inflammation. The invention provides improved ways of reducing inflammation with minimized off-target effects, in particular surgical trauma.
An extravascular or intravascular neural interface is disclosed containing electrodes for neurostimulation of the vessel. The devices are housed in flexible substrates formed from a multilumen tubing housing conductors for electrodes positioned in a distal serpentine shaped end of the device. The distal serpentine shaped end includes rows or strips of electrodes or coil electrodes.
An extravascular neural interface is disclosed including a device containing electrodes for neurostimulation of a vessel. The devices are housed in flexible substrates forming two flaps, an inner flap having a spinal portion for routing leads/conductors into the device for connection to the electrodes and an outer flap that overlaps the inner flap. The inner flap supports and positions the electrodes to be inward facing, i.e., extravascular designs. The electrodes may be circular or elliptical and include a plurality of wings for securing the electrodes within a flap.
Electrical stimulation of neural activity in the neural innervation of the spleen that is associated with neurovascular bundles provides a useful way to treat acute medical conditions, such as trauma, hemorrhaging and shock.
Modulation of neural activity of a ganglion, by applying a signal to a sympathetic nerve adjacent to the ganglion, results in preferential reduction of sympathetic signals to an effector, thereby providing ways of treating and preventing conditions associated with exacerbated sympatho-excitation.
A neurostimulation device (1) for non-destructively stimulating neural activity in a nerve (3) in proximity to a blood vessel (5). The neurostimulation device (1) comprises a catheter (7) for insertion into the blood vessel (5); a proximal electrode (11) offset from a distal electrode (9) along a length of the catheter (7); and an insulator (13) positioned between the proximal electrode (11) and the distal electrode (9) on the catheter (7). The insulator (13) has a contracted configuration in which the size of the insulator (13) allows the catheter (7) to travel inside the blood vessel (5). The insulator (13) has an expanded configuration in which the insulator (13) blocks blood flowing through the blood vessel between the proximal electrode (11) and the distal electrode (9). The neurostimulation device (1) comprises a stimulator (15) arranged to apply an electrical signal between the proximal electrode (11) and the distal electrode (9) when the insulator (13) is in the expanded configuration, thus inducing electrical activity in a wall portion of the blood vessel (5) between the proximal and distal electrodes (9, 11). There is also an insulation portion between the distal electrode (9) and a distal end of the catheter (7) for offsetting the distal electrode (9) from a wall of the blood vessel (5).
Stimulation of neural activity in a splenic arterial nerve at a position where the splenic artery is not in direct contact with the pancreas, can modulate pro- and anti-inflammatory molecules levels, thereby reducing inflammation and providing ways of treating disorders, such as disorders associated with inflammation. The invention provides improved ways of reducing inflammation with minimized off- target effects, in particular surgical trauma.
A neuromodulation device for measuring an evoked response comprising a first electrode; a second electrode, wherein the first and second electrodes are alternately configured as a stimulation electrode; a sensing electrode for sensing an evoked response to a stimulus pulse; and a controller configured to measure an evoked response at the sensing electrode after a stimulus pulse at a first stimulation electrode configuration and after a stimulus pulse at a second alternate stimulation electrode configuration, and to add said pair of measurements.
Electrical stimulation of neural activity in the neural innervation of the spleen that is associated with neurovascular bundles provides a useful way to treat acute medical conditions, such as trauma, hemorrhaging, shock, acute respiratory distress syndrome (ARDS), severe respiratory distress syndrome (SARS), and coronavirus disease 19 (COVID-19).
Stimulation of neural activity in a nerve supplying the spleen, wherein the nerve is associated with a neurovascular bundle, can re-programme immune cells in the spleen, modulate pro- and anti-inflammatory molecules levels, and induce disease-resolution pathways systemically thereby reducing inflammation and providing ways of treating inflammatory disorders. The invention provides improved ways of treating inflammatory disorders which minimize off-target effects.
Modulation of the neural activity of a nerve adjacent to the left gastro epiploic artery (LGEA) and/or a nerve adjacent to a short gastric artery (SGA) can modulate the neural activity of the sympathetic nerves that impact splenic function. This is useful for reducing inflammation and providing ways of treating inflammatory disorders.
Electrical stimulation of neural activity in the neural innervation of the spleen that is associated with neurovascular bundles provides a useful way to treat acute medical conditions, such as trauma, hemorrhaging, shock, acute respiratory distress syndrome (ARDS), severe respiratory distress syndrome (SARS), and coronavirus disease 19 (COVID-19).
Stimulation of neural activity in a nerve supplying the spleen, wherein the nerve is associated with a neurovascular bundle, can modulate pro- and anti-inflammatory molecules levels, thereby reducing inflammation and providing ways of treating inflammatory disorders. The invention provides improved ways of treating inflammatory disorders which minimize off-target effects.
Modulation of the neural activity of a nerve adjacent to the left gastro epiploic artery (LGEA) and/or a nerve adjacent to a short gastric artery (SGA) can modulate the neural activity of the sympathetic nerves that impact splenic function. This is useful for reducing inflammation and providing ways of treating inflammatory disorders.
A nerve stimulation system including at least one nerve interface device is disclosed. The device includes a cuff portion having an assembled position in which the cuff portion forms at least part of a passageway for receiving a nerve along a longitudinal axis passing through the passageway; and first and second rings of electrodes mounted on the cuff portion, each ring of electrodes including a plurality of electrodes, and wherein each electrode in the first ring has a corresponding longitudinally-aligned electrode in the second ring so as to form a plurality of pairs of electrodes spaced apart from each other along the longitudinal axis. The system includes a stimulation device in communication with the pairs of electrodes to generate different electrical signals for the pairs of electrodes and a control system that causes the different signals to causes different physiological responses.
A method for use in making an electrode assembly (20) comprises the steps of applying an electrode (24) on a first layer of material (22); laser welding a lead (23) to the electrode; applying an adhesive backfill (26) over the electrode and the lead; and applying a second layer of material (28) over the adhesive backfill and a portion of the first layer to prevent a leakage path between the electrode and the second layer.
B29C 45/14 - Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mouldApparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
97.
NON-DESTRUCTIVE TEST FIXTURE FOR SCREENING ELECTRICAL CONTINUITY
A test fixture (20) for testing continuity in at least one electrode of a neuromodulation device. The test fixture may comprise a substrate (22), at least one electrically conductive pad (24a) disposed on the substrate for reducing pressure applied to the at least one electrode when the electrically conductive pad makes contact with an exposed surface of the electrode, and a wire (26a) extending from the at least one electrically conductive pad. The pad may be formed of a non-abrasive material, such as conductive foam or smooth metal. The substrate may be a probe formed with a number of slots for holding pads and routing wires, a mandrel with openings for holding pads and routing wires, and a flexible circuit with exposed smooth metal surfaces. The test fixture may be suitable for testing cuff-like and paddle-like devices.
A neuromodulation system is described in which electrodes are mounted within a neural interface device configured to include elastic self-pulsatile or IPG-controlled pneumatic/hydraulic collars in a distal end of the system. One or more electrodes are mounted in each collar. Each collar is connected to an implanted pulse generator (IPG) at the proximal end of the neuromodulation system via a lead body that includes pneumatic/hydraulic lines to the collars and electrical wiring to the electrodes. Gas or fluid pressure supplied to each collar can be controlled by one or more precision step motors inside the IPG. Proximal connectors to the lead body have one or more gas or liquid (biocompatible) reservoirs whose pressure is individually or collectively controlled by the one or more precision motors inside the IPG. The IPG can drive one common or multiple independent precision motors lined around each reservoir to drive one or more collars in the neural interface device.
Electrical stimulation of neural activity in the neural innervation of the spleen that is associated with neurovascular bundles provides a useful way to treat acute medical conditions, such as trauma, hemorrhaging and shock.
A nerve interface device including at least one cuff portion having an assembled position in which the cuff portion forms at least part of a passageway for receiving a nerve along a longitudinal axis passing through the passageway; and first and second rings of electrodes mounted on the at least one cuff portion, each ring of electrodes including a plurality of electrodes. Each electrode in the first ring has a corresponding longitudinally-aligned electrode in the second ring so as to form a plurality of pairs of electrodes spaced apart from each other along the longitudinal axis. The plurality of pairs of electrodes includes at least a first pair of electrodes, the first pair of electrodes mounted on the at least one cuff portion. The at least one cuff portion includes an asymmetric configuration about a central axis perpendicular to the longitudinal cuff axis.
