Patent Grant
11648410
The present invention relates generally to medical devices, and specifically to apparatus and methods for neurostimulation.
Neurological disorders affect the nerves, muscles or the brain. Many neurological disorders reduce or eliminate voluntary recruitment of muscles, which may result in loss of ability to perform motor tasks or to maintain systems that depend on muscle activity for their function. Other disorders may cause pain to adjacent tissues.
Neurostimulation is a clinical tool used to treat various neurological disorders. This technique involves modulation of the nervous system by electrically activating fibers in the body.
For some applications of the present invention, a system for wireless neurostimulation comprises a circuitry unit, coupled to at least two electrodes. According to one application of the present invention, one electrode is disposed on an outer surface of the circuitry unit, whereas a second electrode is coupled to a nerve cuff. According to another application of the present invention, the at least two electrodes are coupled to the nerve cuff (or to two or more nerve cuffs). Typically, the circuitry unit and nerve cuff are coupled by a lead.
Typically, the circuitry unit comprises circuitry for receiving and processing energy for driving the electrodes, and this energy is received from a site outside of the circuitry unit. For example, the site may be inside, or outside, of the subject's body.
For some applications of the present invention, the circuitry unit is coupled via leads to two nerve cuffs. Typically, each nerve cuff comprises one or more electrodes.
For some applications of the present invention, the circuitry unit is coupled via a lead to an antenna.
For some applications of the present invention, the circuitry unit is coupled via a lead to an array of microelectrodes. For some applications of the present invention, the microelectrodes are disposed on the circuitry unit itself.
There is therefore provided, in accordance with an application of the present invention, apparatus for applying a treatment to at least one tissue of a subject, the apparatus including:
a transmitting unit, configured to transmit a wireless power signal; and
a first implant and a second implant, each of the implants being configured to receive the power signal and to apply the treatment asynchronously to each other, in response to the power signal.
In an application, the first implant includes a plurality of first implants, the first implants being configured to apply the treatment synchronously with respect to each other, in response to the power signal.
In an application, at least one of the implants includes a subcutaneously-implantable implant.
In an application, the implants are configured to receive power from the power signal.
In an application, the first implant does not include a power supply that is able to continuously power the first implant for a period greater than one minute.
In an application, the second implant does not include a power supply that is able to continuously power the second implant for a period greater than one minute.
In an application:
the first implant is configured to receive the power signal, and to apply the treatment after a first duration following receiving the power signal, and
the second implant is configured to receive the power signal, and to apply the treatment after a second duration following receiving the power signal, the second duration being longer than the first duration.
In an application:
the transmitting unit is configured to transmit a plurality of wireless power signals, including at least first and second wireless power signals,
the first implant is configured to receive power from the first power signal, and
the second implant is configured to receive power from the second power signal.
In an application, the transmitting unit is configured to transmit the first and second power signals asynchronously.
In an application, the first implant is configured to apply the treatment in response to the first power signal, and the second implant is configured to apply the treatment in response to the second power signal.
In an application:
the transmitting unit is configured to configure the first and second power signals to have respective first and second characteristics that differ from one another,
the first implant is configured to receive power from the first power signal, in response to an effect of the first characteristic on the first implant, and
the second implant is configured to receive power from the second power signal, in response to an effect of the second characteristic on the second implant.
In an application:
the first and second characteristics include respective first and second frequencies, and
the transmitting unit is configured to configure the first and second power signals to have the respective first and second frequencies.
In an application:
the first and second characteristics include respective first and second codes, and
the transmitting unit is configured to configure the first and second power signals to have the respective first and second codes.
In an application, the transmitting unit is configured to transmit a control signal, and each implant is configured to apply the treatment in response to the control signal.
In an application, the transmitting unit is configured to modulate the control signal onto the power signal.
In an application:
the first implant is configured to receive the control signal, and to apply the treatment after a first duration following receiving the control signal, and
the second implant is configured to receive the control signal, and to apply the treatment after a second duration following receiving the control signal, the second duration being longer than the first duration.
In an application, the transmitting unit is configured to configure the power signal to be at least as long as the second duration.
In an application:
the transmitting unit is configured to transmit a plurality of control signals, including at least first and second control signals,
the first implant is configured to apply the treatment in response to the first control signal, and
the second implant is configured to apply the treatment in response to the second control signal.
In an application, the transmitting unit is configured to transmit the power signal at least during the transmission of both the first and the second control signals.
In an application, the first and second implants are each configured to apply the treatment while receiving the first and second control signals, respectively.
In an application, the apparatus includes a plurality of implants that include at least the first and second implants, and the apparatus is configured such that each implant is implantable at a pre-selected distance from another one of the implants.
In an application, the apparatus further includes a support to which at least two of the implants are couplable, at the pre-selected distance from one another.
In an application, the support includes a stent, configured to be implanted in a tubular structure of the subject.
In an application, the support includes a cuff, configured to be disposed around a tubular structure of the subject.
In an application, the support includes a delivery device, configured to facilitate the implantation at the pre-selected distance.
In an application:
the delivery device has a distal portion and a proximal portion,
the delivery device includes a release member at the proximal portion, and
the at least two of the implants are decouplable from the distal portion of the delivery device, by activation of the release member at the proximal portion.
There is further provided, in accordance with an application of the present invention, apparatus for applying a treatment to a tissue of a subject,
the apparatus including a medical implant,
the implant including a plurality of components,
In an application, the implant does not include a power supply that is able to continuously power the implant for a period greater than one minute.
In an application, the effector element includes an electrode.
In an application, the apparatus further includes a nerve cuff, the nerve cuff including the electrode.
There is further provided, in accordance with an application of the present invention, apparatus for treating a condition of a subject, the apparatus including an implant, the implant:
having a skin-facing side on which at least one effector element is disposed,
having an opposing side on which no effector element is disposed,
being configured to be implanted at an implantation site that is deeper than a surface of skin of the subject, such that the skin-facing side faces superficially, and including a circuitry unit, configured to drive the effector element to apply a treatment that stimulates sensory fibers of the skin of the subject.
In an application, the implant is configured to be implanted subcutaneously.
In an application, the implant is configured to be implanted intradermally.
In an application, the implant does not include a power supply that is able to continuously power the implant for a period greater than one minute.
In an application, the effector element includes a vibrating element, and the circuitry unit is configured to drive the vibrating element to stimulate the sensory fibers, by driving the vibrating element to vibrate.
In an application, the implant is configured not to induce contraction of a muscle of the subject.
In an application, the effector element is disposed farther than 1 mm from any lateral edge of the implant.
In an application, the effector element is disposed farther than 2 mm from any lateral edge of the implant.
In an application, the effector element is disposed farther than 5 mm from any lateral edge of the implant.
In an application, the apparatus further includes a transmitting unit, configured to transmit wireless power, and the implant is configured to receive the wireless power.
In an application, the implant is configured to apply the treatment in response to receiving the wireless power.
In an application, the implant is configured to apply the treatment only when the implant receives the wireless power.
In an application, the implant has a height, from the skin-facing side to the opposing side of the implant, that is smaller than both a longest length and a width of the implant.
In an application, the implant is generally flat.
In an application, the implant is generally shaped to define a prism that has a transverse cross-sectional shape that is generally semicircular.
In an application, the implant is generally shaped to define a prism that has a transverse cross-sectional shape that is generally elliptical.
In an application, the implant is configured not to directly initiate action potentials in a nerve of the subject.
In an application, the implant is configured not to directly initiate the action potentials in the nerve of the subject, by being configured to apply the treatment that stimulates sensory fibers of the skin of the subject from an implantation site that is farther than 1 cm from the nerve of the subject.
In an application, the implant is configured not to directly initiate the action potentials in the nerve of the subject, by being configured to apply the treatment that stimulates sensory fibers of the skin of the subject from an implantation site that is farther than 2 cm from the nerve of the subject.
In an application, the implant is configured not to directly initiate the action potentials in the nerve of the subject, by being configured to apply the treatment that stimulates sensory fibers of the skin of the subject from an implantation site that is farther than 3 cm from the nerve of the subject.
In an application, the effector element includes an electrode, and the circuitry unit is configured to drive the electrode to stimulate the sensory fibers, by driving a current through the electrode.
In an application, the implant is configured not to directly initiate the actions potentials in the nerve of the subject, by the circuitry unit being configured to configure the current not to directly initiate the action potentials in the nerve of the subject.
In an application, the implant is configured not to directly initiate action potentials in the nerve of the subject, by being configured to direct the treatment superficially from the implant.
In an application, the implant is configured to direct the treatment superficially, by the effector element being disposed on the skin-facing superficial side of the implant.
In an application, the implant is configured to direct the treatment superficially, by the implant including an insulating member, disposed on the opposing side of the implant.
In an application, the implant is configured to induce a sensation in the skin of the subject.
In an application, the effector element includes an electrode, and the circuitry unit is configured to drive the electrode to stimulate the sensory fibers, by driving a current through the electrode.
In an application, the implant is configured, when implanted at the implantation site, to drive the current superficially to the implant.
In an application, the implant further includes an accelerometer, configured to detect movement of at least the implant.
In an application, the implant is configured to be implanted in a limb of the subject, and the accelerometer is configured to detect movement of the limb of the subject.
In an application, the implant is configured to be implanted in a limb of the subject that is affected by tremor, and the accelerometer is configured to detect the tremor of the limb of the subject.
In an application, the circuitry unit is configured to configure the treatment at least in part responsively to the detection of the movement.
In an application, the movement has a phase, and the circuitry unit is configured to configure the treatment by applying the treatment in phase with the phase of the movement.
In an application, the circuitry unit is configured to configure the treatment by altering an angle of phase of the treatment with respect to the phase of the movement.
In an application, the treatment includes application of an electrical current, and the circuitry unit is configured to configure the treatment by configuring one or more parameters of the current selected from the group consisting of: an amplitude of the current, a frequency of the current, a pulse-width of the current, and an on-off pattern of the current.
There is further provided, in accordance with an application of the present invention, apparatus for applying a treatment to a tissue of a subject, the apparatus including a medical implant, the implant including:
an injectable circuitry unit;
at least one effector element, coupled to the circuitry unit, and configured to be driven by the circuitry unit to apply the treatment;
at least one anchor, coupled to the circuitry unit, and having a delivery configuration, and an anchoring configuration in which, when the implant is implanted in the tissue of the subject, the anchor inhibits movement of the implant along a longitudinal axis thereof.
In an application, the implant does not include a power supply that is able to continuously power the implant for a period greater than one minute.
In an application, the apparatus further includes a delivery device, shaped to define a lumen, and:
the implant is disposable in, slidable through, and slidable out of the lumen of the delivery device, and is deliverable to the tissue of the subject by sliding the device out of the lumen of the delivery device, and
the anchors are configured:
There is further provided, in accordance with an application of the present invention, apparatus for applying at least one treatment to a subject, the apparatus including:
a first transmitting unit, configured to transmit a first wireless signal;
a second transmitting unit, configured to transmit a second wireless signal;
a first implant, configured to be implanted at a first implantation site of the subject, and to apply the at least one treatment to the subject in response to the first wireless signal; and
a second implant, configured to be implanted at a second implantation site of the subject, to apply the at least one treatment to the subject in response to the second wireless signal, and not to apply the at least one treatment to the subject in response to the first wireless signal.
In an application, each implant does not include a power supply that is able to continuously power the implant for a period greater than one minute.
In an application, the first transmitting unit is configured to configure the first wireless signal to have a first frequency, and the second transmitting unit is configured to configure the second wireless signal to have a second frequency that is different from the first frequency.
In an application:
the first and second wireless signals include first and second wireless power signals,
the first implant is configured to receive power from the first power signal, and
the second implant is configured to receive power from the second power signal, and not to receive power from the first power signal.
In an application, the transmitting units are configured to be coupled to the subject.
In an application, the implants are configured to be implanted such that the implants are disposed, at least part of the time, within 30 cm of each other.
In an application, the first implant is configured to be implanted in a first leg of the subject and the second implant is configured to be implanted in a second leg of the subject.
In an application, the first transmitting unit is configured to be coupled to the first leg of the subject, and the second transmitting unit is configured to be coupled to the second leg of the subject.
There is further provided, in accordance with an application of the present invention, a method for use with a medical implant for implanting at a tissue of a subject, the method including:
percutaneously delivering at least part of at least one temporary electrode to the tissue of the subject;
electrically stimulating the tissue of the subject for between 1 and 120 minutes, using the temporary electrode;
receiving information indicative of a desired change in a sensation experienced by the subject between a time before a start of the electrical stimulation and a time after a start of the electrical stimulation; and
at least in part responsively to the received information, implanting the medical implant at the tissue of the subject.
In an application, electrically stimulating includes electrically stimulating the tissue for between 10 and 30 minutes.
In an application, receiving the information indicative of the desired change in the sensation includes receiving information indicative of a desired change in a pain experienced by the subject.
In an application, receiving the information indicative of the desired change in the sensation includes receiving information indicative of paresthesia induced by the electrical stimulation of the tissue of the subject.
In an application, the method further includes:
receiving a first value indicative of the factor before the electrical stimulation; and
receiving a second value indicative of the factor after the electrical stimulation,
and receiving the information indicative of the change in the factor includes receiving a value indicative of a difference between the first value and the second value.
In an application, receiving the information indicative of the change in the factor, includes receiving information indicative of a change in pain experienced by the subject.
In an application, the tissue of the subject includes a tibial nerve of the subject, and stimulating the tissue of the subject includes stimulating the tibial nerve of the subject.
There is further provided, in accordance with an application of the present invention, a method for applying a treatment to at least one tissue of a subject, the method including:
transmitting a wireless power signal;
receiving the power signal using a first implant and a second implant, each of the implants being implanted at the tissue of the subject; and
in response to receiving the power signal, asynchronously applying the treatment using the first implant and using the second implant.
In an application, transmitting includes extracorporeally transmitting the wireless power signal.
In an application, receiving the power signal includes subcutaneously receiving the power signal using the first and second implants.
In an application, receiving the power signal includes receiving the power signal using the first and second implants, after they have been transluminally implanted.
In an application, asynchronously applying the treatment includes:
receiving the power signal using the first implant, and applying the treatment using the first implant after a first duration following receiving the power signal; and
receiving the power signal using the second implant, and applying the treatment using the second implant after a second duration following receiving the power signal, the second duration being longer than the first duration.
In an application:
transmitting the power signal includes transmitting a plurality of wireless power signals, including at least first and second wireless power signals, and
receiving the power signal includes receiving the first power signal using the first implant, and receiving the second power signal using the second implant.
In an application, transmitting includes transmitting the first and second power signals asynchronously.
In an application, applying the treatment includes:
applying the treatment using the first implant in response to the first power signal and not in response to the second power signal; and
applying the treatment using the second implant in response to the second power signal and not in response to the first power signal.
In an application, applying the treatment includes:
applying the treatment using the first implant while receiving the first power signal;
and applying the treatment using the second implant while receiving the second power signal.
In an application:
transmitting the first and second power signals includes transmitting first and second power signals that have respective first and second characteristics that differ from one another,
receiving power from the first power signal, using the first implant, in response to an effect of the first characteristic on the first implant, and
receiving power from the second power signal, using the second implant, in response to an effect of the second characteristic on the second implant.
In an application:
the first and second characteristics include respective first and second frequencies, and
transmitting includes transmitting first and second power signals that have the respective first and second frequencies.
In an application:
the first and second characteristics include respective first and second codes, and
transmitting includes transmitting first and second power signals that have the respective first and second codes.
In an application, the method further includes:
transmitting a control signal; and
receiving the control signal using the first and second implants,
and asynchronously applying the treatment includes, in response to the control signal, asynchronously applying the treatment using the first implant and using the second implant.
In an application, transmitting the control signal includes modulating the control signal onto the power signal.
In an application, asynchronously applying the treatment includes:
receiving the control signal using the first implant, and applying the treatment using the first implant after a first duration following receiving the control signal; and
receiving the control signal using the second implant, and applying the treatment using the second implant after a second duration following receiving the control signal, the second duration being longer than the first duration.
In an application, transmitting the power signal includes transmitting the power signal for a duration that is at least as long as the second duration.
In an application:
transmitting the control signal includes transmitting a plurality of control signals, including at least first and second control signals, and
asynchronously applying the treatment includes:
In an application, transmitting the power signal includes transmitting the power signal at least during the transmission of both the first and the second control signals.
In an application, applying the treatment using the first implant includes applying the treatment using the first implant while receiving the first control signal, and applying the treatment using the second implant includes applying the treatment using the second implant while receiving the second control signal.
In an application, receiving the power signal includes receiving the power signal using the first and second implants, after each of the implants has been implanted at a pre-selected distance from the other one of the implants.
In an application, the implants are couplable to a support at the pre-selected distance from one another, and receiving the power signal includes receiving the power signal using the first and second implants, after the support has been implanted in a tubular structure of the subject.
In an application, the support includes a stent, and receiving the power signal includes receiving the power signal using the first and second implants, after the stent has been implanted in the tubular structure of the subject.
In an application, the support includes a cuff, and receiving the power signal includes receiving the power signal using the first and second implants, after the cuff has been implanted in the tubular structure of the subject.
In an application, the support includes a delivery device, and receiving the power signal includes receiving the power signal using the first and second implants, after the stent has been implanted using the delivery device.
In an application, receiving the power signal includes receiving the power signal using the first and second implants, after the stent has been decoupled from the delivery device.
There is further provided, in accordance with an application of the present invention, a method for treating a condition of a subject, the method including:
driving a subcutaneously-implanted effector element to apply a treatment that stimulates sensory fibers of skin of the subject; and
using an inhibiting element, inhibiting direct stimulation of a nerve of the subject that is closest to the effector element, during the application of the treatment by the effector element.
In an application, inhibiting the direct stimulation of the nerve includes preventing direct initiation of action potentials in the nerve.
In an application, inhibiting the direct stimulation of the nerve includes preventing direct initiation of action potentials in an ulnar nerve of the subject.
In an application, inhibiting the direct stimulation of the nerve includes preventing direct initiation of action potentials in a median nerve of the subject.
In an application, inhibiting the direct stimulation of the nerve includes preventing direct initiation of action potentials in a nerve of the subject that is disposed deeper than the inhibiting element.
In an application, driving the effector element to apply the treatment includes driving the effector element to vibrate.
In an application, inhibiting further includes inhibiting direct induction of contraction of a muscle of the subject.
In an application, driving the effector element includes driving the effector element using an implanted circuitry unit.
In an application, driving the effector element includes wirelessly driving the effector element.
In an application, inhibiting the direct stimulation of the nerve includes directing the treatment away from the nerve.
In an application, directing the treatment includes directing the treatment superficially.
In an application, driving the effector element includes driving the effector element after an implant that includes the effector element has been subcutaneously implanted in the subject.
In an application, the effector element is disposed only on a skin-facing side of the implant, and inhibiting the direct stimulation of the nerve includes driving the effector element that is disposed on the skin-facing side of the implant.
In an application, inhibiting the direct stimulation of the nerve includes insulating the nerve from the treatment using the inhibiting element.
In an application, insulating includes electrically insulating the nerve from the treatment.
In an application, insulating includes mechanically insulating the nerve from the treatment.
In an application, driving the effector element includes driving the effector element after an implant that (1) has a height from a lower portion to an upper portion of the implant that is smaller than both a longest length and a width of the implant, and (2) includes the effector element, has been subcutaneously implanted in the subject.
In an application, driving the effector element includes driving the effector element after an implant that (1) is generally shaped to define a prism that has a transverse cross-sectional shape that is generally semicircular, and (2) includes the effector element, has been subcutaneously implanted in the subject.
In an application, driving the effector element includes driving the effector element after an implant that (1) is generally shaped to define a prism that has a transverse cross-sectional shape that is generally elliptical, and (2) includes the effector element, has been subcutaneously implanted in the subject.
In an application, driving the effector element includes driving the effector element after an implant that (1) is generally flat, and (2), includes the effector element, has been subcutaneously implanted in the subject.
In an application, inhibiting the direct stimulation of the nerve includes inhibiting the direct stimulation of the nerve by driving the effector element after an implant that includes the effector element has been implanted at an implantation site that is farther than 1 cm from the nerve of the subject.
In an application, inhibiting the direct stimulation of the nerve includes inhibiting the direct stimulation of the nerve by driving the effector element after an implant that includes the effector element has been implanted at an implantation site that is farther than 2 cm from the nerve of the subject.
In an application, inhibiting the direct stimulation of the nerve includes inhibiting the direct stimulation of the nerve by driving the effector element after an implant that includes the effector element has been implanted at an implantation site that is farther than 3 cm from the nerve of the subject.
In an application, the effector element includes an electrode, and driving the effector element to apply the treatment includes driving a current through the electrode.
In an application, inhibiting the direct stimulation of the nerve includes configuring the current not to directly stimulate the nerve of the subject.
In an application, inhibiting the direct stimulation includes directing the current superficially.
In an application, the method further includes detecting movement of a limb of the subject in which the effector element has been implanted, and driving the effector element includes driving the effector element at least in part responsively to the detected movement.
In an application, detecting the movement includes detecting movement of the limb of the subject by detecting movement of an accelerometer that is coupled to the effector element.
In an application, detecting the movement of the limb of the subject includes detecting tremor of the limb of the subject.
In an application, driving the effector element at least in part responsively to the detected movement includes configuring the treatment at least in part responsively to the detected movement.
In an application, the movement of the limb has a frequency, and configuring the treatment includes configuring the treatment to have the frequency of the movement of the limb.
In an application, configuring the treatment includes configuring the treatment to be in phase with a phase of the movement of the limb.
In an application, configuring the treatment includes configuring the treatment to be out of phase with a phase of the movement of the limb.
There is further provided, in accordance with an application of the present invention, an implant, including:
a circuitry unit, configured to receive power wirelessly;
a lead, having a proximal end and a distal end, the proximal end configured to be coupled to the circuitry unit; and
an array of microelectrodes, configured to be coupled to the circuitry unit by the lead, and configured to be coupled to a carotid sinus of a patient.
In an application, the microelectrodes are configured to contact one or more baroreceptors in the carotid sinus.
In an application, the circuitry unit is configured to drive the microelectrodes to deliver a current between 1 and 100 microamps.
In an application, the circuitry unit is configured to separately drive each microelectrode to apply a respective voltage.
There is further provided, in accordance with an application of the present invention, an implant, including:
a circuitry unit, configured to receive power wirelessly; and
an array of microelectrodes, disposed on an outer surface of the circuitry unit.
The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:
Reference is made to
For some applications of the invention, circuitry unit 22 comprises or is coupled to an antenna 30. Antenna 30 is illustrated as a coiled antenna purely as an example, but may take other forms, such as, but not limited to, those described with reference to
Circuitry unit 22 is typically small and tubular (e.g., 1-6 mm in diameter, and 5-50 mm in length), although the scope of the present invention includes other shapes for the circuitry unit (e.g., prismatic shapes, as described hereinbelow). For some applications, at least the circuitry unit itself is “injected” into a desired implantation site, using techniques known for implanting a BION™. For some applications, the entire implant is configured to be injectable. Similarly, except for differences noted herein, the circuitry unit typically comprises stimulation and/or sensing circuitry as is known for a BION™ or other tissue stimulation devices.
Reference is now made to
Reference is now made to
Reference is now made to
Reference is now made to
Reference is now made to
According to some applications of the present invention, microelectrode array 82 may be coupled to a carotid sinus of the patient, and more specifically to baroreceptors in the carotid sinus. According to one application of the present invention, each microelectrode 84 is individually controllable by circuitry unit 22, thereby facilitating a calibration period in which the effect of current from each microelectrode on baroreceptor activity and/or blood pressure may be assessed, and in which a stimulation protocol for each microelectrode may be created. For example, each microelectrode may be individually coupled to circuitry unit 22, or may be coupled to the circuitry unit via a multiplexer.
For some applications of the invention, the techniques described for use with implant 80 and/or microelectrode array 82 may be combined with other implants described herein. For example, each microelectrode of the microelectrode array of implant 90, described with reference to
According to some applications of the present invention, microelectrodes 84 each deliver a current that is less than 1000 microamps, e.g., 10-100 microamps, or 1-10 micro amps.
Reference is now made to
Reference is now made to
For some applications of the invention, and as shown in
For applications of the invention in which circuitry unit 22 is disposed within flexible tubular casing 52 (e.g., as described with reference to
Reference is again made to
Reference is made to
Anchors 112 are configured to inhibit movement of implant 110, following delivery of the implant to the desired implantation site. Implant 110 is typically “injected” into the desired implantation site, e.g., using techniques known for implanting a BION™. Typically, anchors 112 have (1) a delivery configuration, in which the anchors are configured to fit within, and be slidable through, a lumen of a delivery device 114, such as a hollow needle, and (2) an anchoring configuration in which the anchors protrude laterally and/or radially from the body of implant 110 (e.g., from circuitry unit 22), and into tissue at the implantation site. As shown in step (1) of
As shown in step (1) of
As shown in steps (2) and (3) of
Although
It is to be noted that anchors 112 (e.g., anchors 112a and 112b) are shown and described with reference to
It is to be noted that the configuration of the circuitry unit and electrodes of implant 110 shown in
Reference is made to
For some applications of the invention, an extracorporeal device, e.g., a worn extracorporeal device, such as a wristwatch-based device may alternatively or additionally comprise an accelerometer, and transmit wireless power in response to a detected movement, activity level, and/or position.
Reference is made to
Typically, dimension d1 is greater than 0.5 mm and/or less than 3 mm (e.g., about 1.5 mm). Typically dimension d4 is greater than 0.5 mm and/or less than 3 mm (e.g., between 1.5 and 2 mm). Typically, dimensions d2 and d5 are greater than 5 mm and/or less than 30 mm (e.g., between 10 and 30 mm, such as between 10 and 20 mm). Typically, dimensions d3 and d6 are greater than 1 mm and/or less than 5 mm (e.g., between 1.5 and 3 mm).
The shapes of implant 130 and 140 are given as non-limiting examples of flattened configurations; other shapes may also be used. For example, implant 130 and/or 140 may be generally flat (e.g., sheet-like), having electrodes 28 disposed on one side. When the implant is flat, the implant typically comprises a resilient material, and is configured to remain generally flat or slightly curved (e.g., not to curl up). Furthermore, other medical implant and/or circuitry units described herein may also be configured to have a flattened configuration for intradermal and/or subcutaneous implantation.
Typically, electrodes 28 of implant 130 and 140 are disposed generally on one side of the implant. For example, electrodes 28 of implant 130 are typically disposed only on upper portion 132, and electrodes 28 of implant 140 are typically disposed only on upper portion 142. Thereby, implants 130 and 140 typically have a conducting side (i.e., the side on which the electrodes are disposed). This configuration is hypothesized to direct the current that is driven through electrodes 28 by circuitry unit 22, to tissue at the conducting side of the implant (e.g., to tissue adjacent to the upper portion of the implant). That is, implants 130 and 140 are typically directional. Typically, the skin-facing side of the implant defines the conducting side of the implant.
For some applications of the invention, and as shown for implant 130, the implant may comprise an inhibiting element, such as an insulating member 136, (e.g., an insulating layer), configured to inhibit electrical conduction therethrough. Typically, insulating member 136 is disposed on, such as coupled to, the lower portion and/or the opposing side of the implant, so as to inhibit electrical conduction from electrodes 28 into tissue adjacent to the lower portion of the implant, i.e., into tissue at the opposing side of the implant. Thereby, insulating member 136 contributes toward the one-sided configuration of the implant. Although insulating member 136 is shown as a component of implant 130, the insulating member may be used to facilitate the one-sidedness of medical implant 140. Element 136 may also be used in combination with other medical implant described herein. For example, one or more elements 136 may be (1) disposed around at least part of nerve cuff 26, so as to inhibit conduction of current away from a nerve around which the cuff is disposed, or (2) disposed around at least part of a circuitry unit and/or tubular element, so as to provide one-sidedness thereto. Insulating member 136 may comprise any suitable material known in the art, such as insulating silicone.
For some applications of the invention in which the implant comprises an insulating member, electrodes 28 laterally circumscribe the implant, and part of the electrodes is covered by the insulating member. That is, for some applications of the invention, electrodes 28 are not disposed generally on one side of the implant. For example, electrodes 28 of implant 130 may be disposed circumferentially around circuitry unit 22, and part of the electrodes is sandwiched between the circuitry unit and insulating member 136. For some such applications, this configuration facilitates manufacturing of the implant, e.g., by facilitating the application of the electrodes to the surface of the circuitry unit.
Implants 130 and 140 are thereby typically directional, having a conducting skin-facing side and, for some applications, an insulating member at the lower portion of the implant, which provides an insulating opposing side of the implant. Typically, electrodes 28 of implants 130 and 140 are disposed at least 1 mm (e.g., greater than 2 mm, such as greater than 5 mm) from the lateral edges of the implant. That is, the implants typically define respective lateral zones 131 and 141, on the skin-facing side of the implants, the lateral zones having a width of distance d7, in which electrodes 28 are not disposed, distance d7 being greater than 1 mm (e.g., greater than 2 mm, such as greater than 5 mm). For example, the lateral zone may include the insulating member (as shown in
For some applications of the invention, implants 130 and 140 define lateral zones 131 and 141 on the opposing side of the implant, and are configured to be implanted such that the electrodes of the implant face away from the skin. Thereby, for such applications, implants 130 and 140 are configured to inhibit electrical conduction from the electrodes into the skin that is superficial to the implant, e.g., so as to stimulate underlying muscle and or nerves. It is hypothesized that, for such applications, current applied from electrodes 28 advantageously induces less pain in the subject than does current from external skin-mounted electrodes (e.g., Transcutaneous Electrical Nerve Stimulation electrodes), e.g., due to reduced stimulation of sensory nerve fibers.
Typically, implants 130 and 140 further comprise accelerometer 122, described hereinabove with reference to
Reference is again made to
For some applications, the implants described with reference to
For such applications, the implants typically do not comprise a power supply such as a battery. For clarity, throughout this patent application, including the claims, a “power supply” is defined as an element that is configured to continuously power the implant for a period of greater than one minute. For some applications, the implants described with reference to
Alternatively, the implants described with reference to
Reference is made to
Implantation sites 150 (e.g., implantation site 150a and implantation site 150b) are intradermal or subcutaneous. Typically, implant 130 is implanted within subcutaneous tissue of a subject, and is typically delivered by injection (e.g., using techniques known for implanting a BION™, and/or as described with reference to
Circuitry unit 22 is typically configured to drive a current through electrodes 28, and to configure the current to stimulate sensory fibers in the skin of the subject. Typically, the subject thereby feels the current being delivered (i.e., the implant induces a sensation in the skin of the subject). For some applications, the current may induce at least temporary discomfort or even pain in the subject, and, for some applications, this is desirable for successful treatment. For some applications, the current may be configured to have an amplitude that is great as possible without causing pain. For some applications, the current and/or sensations induced by the current may be similar to those of TENS apparatus, as is known in the art. Typically, circuitry unit 22 configures the current to a frequency of greater than 1 and/or less than 150 Hz, but other frequencies may also be used.
It is hypothesized that stimulation of sensory fibers in the skin of the limb of the subject (e.g., as described in the above paragraph) reduces the intensity and/or frequency of tremor in at least that limb. Typically, the stimulation of the sensory fibers in the skin is performed predominantly without directly stimulating underlying tissue such as underlying muscles and/or nerves (i.e., muscles and/or nerves that are disposed deeper than the implant). That is, action potentials are predominantly initiated in sensory fibers in the skin, i.e., upstream of nerves. (In this application, the term “nerve” is intended to be distinct from the term “sensory fiber”.) For example, the implant is typically configured so as to predominantly not (1) directly initiate action potentials in nerves, such as ulnar nerve 156, (2) stimulate sensory fibers in underlying muscle, and/or (3) induce contraction of underlying muscle (e.g., spasm).
For some applications of the invention, the implant is configured to perform this selective stimulation of sensory fibers by the implant being directional, e.g., as described with reference to
For some applications of the invention, the implant is configured to perform the selective stimulation of sensory fibers in the skin, by circuitry unit 22 being configured to configure the current that it drives via electrodes 28, to selectively stimulate the sensory fibers in the skin. For example, circuitry unit 22 may configure the current to have an amplitude that is sufficient to stimulate the sensory fibers in the skin but insufficient to initiate action potentials in sensory fibers in muscle and/or nerves, and/or to induce contraction of muscle. Alternatively or additionally, circuitry unit 22 may configure the current to have another characteristic, such as a frequency, a pulse width, and/or an on-off pattern (i.e., durations for which the wireless power is transmitted and not transmitted) that facilitates such selective stimulation of sensory fibers in the skin.
For some applications, the electrodes of the implant are disposed close to each other (e.g., less than 10 mm from each other, such as less than 2 mm from each other), so as to inhibiting the current that flows between the electrodes, from flowing far from the implant, and thereby inhibiting the current that flows between the electrodes from reaching the nerves disposed deeper than the implanted implant.
For some applications of the invention, the implant is configured to perform the selective stimulation of sensory fibers in the skin by being implanted sufficiently close to the sensory fibers in the skin, and sufficiently far from the underlying muscle and/or nerves. For example, and as shown in
For some applications, and as shown in
As described hereinabove, implant 130 typically comprises accelerometer 122, which is configured to sense movement of the implantation site, and to responsively provide a signal to circuitry unit 22. Accelerometer 122 is typically configured to sense tremor of the limb, and circuitry unit 22 is typically configured to drive the current via electrodes 28 at least in part responsively to the sensed tremor. The circuitry unit may be configured to apply the current in phase or out of phase with the tremor. For example, circuitry unit 22 may be configured to drive the current only during particular phases of the tremor (e.g., during a highest speed portion of the tremor, or, alternatively, only when the limb is at one or both of the endpoints of its tremor-induced travel). That is, the circuitry unit may be configured to modulate the current onto the tremor. Alternatively or additionally, the circuitry unit may be configured to change one or more parameters of the current during particular phases of the tremor.
For some applications of the invention, accelerometer 122 is used to adjust timing (e.g., phasing) and/or other parameters of the current, so as to optimize treatment of the tremor. For example, circuitry unit 22 may automatically adjust the phase(s) of the tremor during which it drives the current (i.e., the “angle of phase” at which it drives the current), until optimal treatment is achieved, e.g., by “sweeping” different angles of phase. Similarly, other current parameters, such as frequency and amplitude, may be optimized automatically by circuitry unit 22.
For some applications of the invention, an extracorporeal device, e.g., a worn extracorporeal device, comprises an accelerometer, and is configured and/or positioned to detect the tremor, and circuitry unit 22 of the implant is configured to drive the current in response to the extracorporeal device detecting the tremor. For example, a wristwatch-based extracorporeal device may be worn on an arm of the subject. The wristwatch-based extracorporeal device comprises an accelerometer and, in response to detecting the tremor in the arm of the subject, transmits wireless power. The implant receives the wireless power and, in response to the wireless power (e.g., powered by the wireless power), drives the current into the arm of the subject (e.g., into the skin thereof). For such applications, the implant typically does not comprise a power supply. For applications in which a worn extracorporeal device comprises an accelerometer, the implant typically does not comprise an accelerometer.
For some applications, circuitry unit 22 is configurable (e.g., manually configurable) using an extracorporeal device, such that an operator may adjust parameters such as phase angle, frequency and amplitude of the current.
For some applications of the invention, tremor in one limb may be treated by an implant implanted in a contralateral limb. For example, tremor in only one limb may be treated by an implant implanted in a contralateral limb, or tremor in a pair of limbs may be treated by an implant implanted in only one of the pair of limbs (i.e., a limb that is contralateral to at least one of the limbs that experiences the tremor).
Reference is made to
Transmitting unit 210 is typically extracorporeal. For example, the transmitting unit may be couplable to a part of the body of the subject, may be wearable by the subject, and/or may be disposed in an item of furniture on which the subject frequently rests, such as a bed or mattress.
Typically, each implant 202 comprises a receiver 206, configured to receive at least one of the wireless signals transmitted by transmitting unit 210, and a circuitry unit 208, which, at least in part responsively to the receiver receiving the wireless signal, drives effector elements 204 to apply the treatment. Typically, effector elements 204 comprise electrodes 205, and circuitry unit 208 drives a current via the electrodes, at least in part responsively to receiver 206 receiving signal 212. That is, the treatment typically comprises the delivery of the current.
Typically, duration 218 of each implant is pre-set (e.g., circuitry unit 208 of each implant is pre-configured thus). For some applications, the duration may be set and/or altered following implantation of implants 202, e.g., so as to optimize the application of the treatment. For example, duration 218 may be altered wirelessly by an operator, such as a physician who is monitoring the efficacy of the treatment. Alternatively or additionally, duration 218 may be automatically altered by system 200, using feedback from sensors that monitor the physiological changes caused by the treatment (not shown).
For the applications of the invention described with reference to
For the applications of the invention described with reference to
Each of the plurality of control signals (e.g., control signals 212a, 212b, 212c, and 212d) typically have an identifying feature that facilitates each implant to respond to a respective signals. That is, control signals 212a-d are typically “coded” (i.e., each signal includes a respective code), and each implant is configured to respond to a signal that includes a specific code. For example, implant 202a (e.g., circuitry unit 208 thereof) may be configured to drive a current through electrodes 205 in response to receiving control signal 212a, but not in response to any of control signals 212b, 212c, or 212d. For some applications, one or more of the implants are each configured to respond to more than one control signal, i.e., such that one signal activates more than one implant.
Reference is still made to
For some applications, power signal 214 is only transmitted at generally the same time as control signal(s) 212. For the applications of the invention described with reference to
For some applications of the invention, power signal 214 is transmitted at times when signals 212 are not transmitted. For example, power signal 214 may be transmitted both at generally the same time as control signal(s) 212, and at at least some times when signals 212 are not transmitted. For the applications of the invention described with reference to
For some applications, control signals 212 are modulated onto power signal 214 (e.g., by amplitude and/or frequency modulation). For example, with reference to
For some applications, signals 212 and 214 comprise different signals. For example, the signals may be RF signals of different frequencies, or control signal 212 may be an RF signal whilst power signal 214 is a magnetic signal. For some applications, power signal 214 is not transmitted by transmitting unit 210. For example, power signal 214 may be provided by a separate power-transmitting unit (not shown). For some applications, implants 202 do comprise a power supply, such as a battery, that is able to continuously power the implants for a period greater than one minute. For such applications, implants 202 are typically wirelessly rechargeable.
Reference is still made to
Reference is made to
Typically, system 220 is configured such that each implant 222 is implanted at a pre-selected distance from at least another implant. Typically, system 220 comprises a support 228 that is configured to facilitate such implantation, e.g., to facilitate simultaneous delivery of all the implants and/or to retain the implants 222 at a pre-selected spacing.
Effector elements 224 typically comprise electrodes 205. Implants 222 are implanted such that electrodes 205 are in electrical contact with structure 226 (e.g., disposed against the structure). For example, support 228 is pressed against the structure. For some applications, electrodes 205 comprise ring electrodes, and implants 222 are coupled to structure 226 such that the ring electrodes are disposed over a portion of the structure. Each implant 222 applies the treatment at the portion of structure 226 to which it is coupled, by driving a current via electrodes 205, into the portion of the structure. For some applications, when structure 226 comprises a nerve, the current is configured to induce at least one action potential in the nerve. For some applications, when structure 226 comprises a hollow tubular structure, such as a blood vessel or intestine, the current is configured to induce constriction in at least the portion of structure 226 to which the electrode is in contact.
For some applications, when structure 226 comprises a hollow tubular structure, effector element 224 comprises an annular constricting element that is couplable to a respective portion of the structure, and circuitry unit 208 of implant 222 is configured to drive the constricting element to constrict, thereby inducing constriction of the portion of the structure.
For some applications of the invention, system 220 is configured such that at least one of the implants applies the treatment asynchronously to at least another one of the implants, using techniques described with reference to
For some applications of the invention, system 220 is configured such that at least one of the implants applies the treatment asynchronously to at least another one of the implants, using techniques described with reference to
When system 220 is configured to induce constriction in portions of a tubular anatomical structure such as a blood vessel or intestine, system 220 is typically configured to induce pumping in the structure. Typically, system 220 is configured this way by being configured such that implants 222 induce constriction (i.e., are activated) consecutively according to the order in which they are disposed on structure 226, thereby inducing an advanced form of peristaltic pumping. For example, consecutive activation of implants 222a, 222b, 222c, and 222d may induce peristalsis in structure 226.
For some applications of the invention, structure 226 comprises a blood vessel of the subject, and system 220 is used to alter blood flow in the blood vessel. For example, structure 226 may comprise the aorta of the subject, and system 220 may be used to enhance downstream bloodflow in the aorta by inducing downstream peristalsis (e.g., to treat peripheral vascular disease) and/or to increase blood flow into the coronary arteries by inducing upstream peristalsis (e.g., during ventricular diastole).
For some applications of the invention, structure 226 is a component of the gastrointestinal tract, such as an intestine or an esophagus, and system 220 may be used to induce peristalsis or tighten a sphincter or valve in the component of the gastrointestinal tract. For example, system 220 may be used to induce peristalsis in an esophagus of the subject or tighten the lower esophageal sphincter, so as to treat gastroesophageal reflux disease. Alternatively or additionally, system 220 may be used to induce peristalsis in a duodenum of the subject, so as to treat obesity.
For some applications of the invention, pumping is induced by stimulating one or more skeletal muscles in a vicinity of a blood vessel, e.g., so as to compress the blood vessel. Typically, such pumping is induced by stimulating two or more skeletal muscles to contract. For some such applications of the invention, system 200 is used, rather than system 220.
Reference is still made to
Reference is made to
Typically, transmitting units 210a and 210b and/or implants 242a and 242b are disposed, at least some of the time, in close proximity to each other (e.g., within 1 m of each other, such as within 30 cm of each other, such as within 10 cm of each other). For example, and as shown in
The use of one or more transmitting units to control a plurality of implants may be subjected to problems, such as interference and/or misdirected signals. That is, a first implant may receive, and respond to, a signal that is intended to be received by a second implant. This is more likely when the transmitting units and implants are in close proximity to each other. For example, implant 242b might respond to signals transmitted by unit 210a, and/or implant 242a might respond to signals transmitted by unit 210b.
Typically, apparatus 240 is configured to use coded signals, e.g., as described hereinabove with reference to
For some applications of the invention, transmitting units 210a and 210b are configured to be in wireless communication with each other. For example, it may be desirable for the transmitting units to coordinate the driving of implant 242b with respect to the driving of implant 242a. For example, transmitting unit 210b may be configured to drive implant 242b only when transmitting unit 210a is not driving implant 242a (i.e., asynchronously). Alternatively, transmitting unit 210b may be configured to drive implant 242b at the same time as transmitting unit 210a drives implant 242a. It is to be noted that these two examples are illustrative, and that the scope of the invention includes any coordination between transmitting units 210a and 210b for driving implants 242a and 242b.
Reference is again made to
Reference is made to
Reference is again made to
For some applications, a combination of electrodes and vibrating units is used in the same implant and/or in different implants. It is noted with reference to
Similarly, one or more of the effector elements described hereinabove may comprise a heating and/or cooling element, a pressure-exerting element, an ultrasound transducer, and/or a laser. Alternatively or additionally, one or more of the implants described hereinabove may comprise one or more sensors, e.g., to provide feedback.
The implantation sites and disorders described hereinabove are examples for illustrating the use of the techniques described herein. The implants described herein may be implanted at a variety of implantation sites, and the techniques described herein may be used to treat a variety of disorders. For example:
stimulation of the tibial nerve (and/or of sensory fibers that lead to the tibial nerve), e.g., to treat neuropathic pain and/or urge incontinence;
stimulation of sensory fibers that lead to the radial and/or ulnar nerves, e.g., to treat tremor (e.g., essential tremor, and tremor associated with Parkinson's disease);
stimulation of the occipital nerve, e.g., to treat migraine;
stimulation of the sphenopalatine ganglion, e.g., to treat cluster headaches;
stimulation of the sacral and/or pudendal nerve, e.g., to treat urge incontinence;
direct stimulation of an implantation site within the brain (e.g., deep brain stimulation), such as the thalamus, e.g., to treat tremor, obsessive-compulsive disorder, and/or depression;
stimulation of the vagus nerve, e.g., to treat epilepsy, depression, inflammation, tinnitus, and/or congestive heart failure (e.g., by incorporating some or all of device 20 into an aortic stent);
stimulation of baroreceptors in a blood vessel wall (e.g., the wall of the carotid sinus and/or aorta, e.g., to treat high blood pressure);
stimulation of the spinal cord, e.g., to treat pain;
stimulation of one or more muscles (such as shoulder muscles), e.g., to treat muscle pain;
stimulation of the medial nerve, e.g., to treat carpal tunnel syndrome;
stimulation of the hypoglossal nerve and/or one or more muscles of the tongue, e.g., to treat obstructive sleep apnea;
stimulation of cardiac tissue, e.g., to pace and/or defibrillate the heart (e.g., the use of the implant as a leadless pacemaker);
stimulation to treat dystonia;
stimulation of the vagus nerve, e.g., to treat epilepsy;
stimulation to treat interstitial cystitis;
stimulation to treat gastroparesis;
stimulation to treat obesity;
stimulation of the anal sphincter, e.g., to treat fecal incontinence;
stimulation to treat bowel disorders;
stimulation of peripheral nerves of the spinal cord, e.g., to treat chronic pain;
stimulation of the dorsal root ganglion for the treatment of chronic pain; and
stimulation of motor nerves and/or muscles to improve mobility.
Implants whose effector element comprises an electrode and/or a vibrating element may also be used to block nerve signals, such as to induce local anesthesia. It is hypothesized that paresthesia may be induced by driving a relatively low-frequency current (e.g., greater than 1 and/or less than 120 Hz, e.g., between 10 and 40 Hz) into the nerve, and that a relatively high-frequency current (e.g., greater than 5 and/or less than 20 kHz, e.g., between 10 and 20 kHz) may be used to induce complete blocking.
Tibial nerve stimulation (e.g., electrical stimulation) may be used to treat pain, such as neuropathic pain, e.g., neuropathic pain in the legs of a subject. Implants, such as those described hereinabove, may be used to provide such stimulation. However, variation between subjects exists, and such treatment does not sufficiently reduce pain in all subjects. In experiments conducted by the inventors, percutaneous electrodes (i.e., temporary electrodes) were used to stimulate the tibial nerve of 8 subjects by percutaneously delivering at least part (e.g., a tip) of the electrodes to a site in a vicinity of the tibial nerve, and applying a current to the tibial nerve. Sessions comprised 15-60 minutes of stimulation. Of these 8 subjects, 6 experienced good pain relief and 2 experienced moderate pain relief. Interestingly, the degree of pain relief for each subject in the first session was similar to that for the successive sessions. That is, a first session of stimulation was indicative of responsiveness to subsequent treatment. It is therefore hypothesized that data from a single session of percutaneous stimulation of the tibial nerve, lasting 1-120 minutes (e.g., 10-30 minutes) of stimulation and successfully inducing paresthesia in the subject's foot, may be used to facilitate a decision of whether to implant one or more stimulatory implants at the tibial nerve of a given subject.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
The present application is a Continuation of U.S. patent application Ser. No. 15/638,924 to Oron et al., filed Jun. 30, 2017, entitled “Wireless Neurostimulators,” now U.S. Pat. No. 10,653,888, which is a Continuation of U.S. patent application Ser. No. 14/374,375 to Gross et al., filed Jul. 24, 2014, entitled “Wireless Neurostimulators”, which published as US 2015/0018728, and which is the US National Phase of International Application PCT/IL2013/050069 to Gross et al., filed Jan. 24, 2013, which published as WO 2013/111137, and which (1) claims priority from (a) U.S. Provisional Application 61/591,024 to Gross, filed Jan. 26, 2012, and (b) U.S. Provisional Application 61/662,073 to Gross et al., filed Jun. 20, 2012, and (2) is related to (a) U.S. application Ser. No. 12/796,102 to Gross, filed Jun. 8, 2010, now U.S. Pat. No. 8,788,045 and (b) U.S. application Ser. No. 13/528,433 to Gross, filed Jun. 20, 2012, now U.S. Pat. No. 8,755,893, all of which are assigned to the assignee of the present application, and all of which are incorporated herein by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20200254266 A1 | Aug 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61662073 | Jun 2012 | US | |
| 61591024 | Jan 2012 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15638924 | Jun 2017 | US |
| Child | 16863153 | US | |
| Parent | 14374375 | US | |
| Child | 15638924 | US |
