WO2009080784A1 - Inductive control of electrical nerve stimulation system for the treatment of pelvic disorders - Google Patents

Inductive control of electrical nerve stimulation system for the treatment of pelvic disorders Download PDF

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Publication number
WO2009080784A1
WO2009080784A1 PCT/EP2008/068095 EP2008068095W WO2009080784A1 WO 2009080784 A1 WO2009080784 A1 WO 2009080784A1 EP 2008068095 W EP2008068095 W EP 2008068095W WO 2009080784 A1 WO2009080784 A1 WO 2009080784A1
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WO
WIPO (PCT)
Prior art keywords
pulse generator
stimulation
implantable
triggering mechanism
electrode
Prior art date
Application number
PCT/EP2008/068095
Other languages
French (fr)
Inventor
Morten Fjorback
Nico J. M. Rijkhoff
Thomas Borup
Michael Eriksen
Original Assignee
Neurodan A/S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Neurodan A/S filed Critical Neurodan A/S
Priority to EP08865654A priority Critical patent/EP2231269A1/en
Publication of WO2009080784A1 publication Critical patent/WO2009080784A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/3706—Pacemaker parameters
    • A61N1/3708—Pacemaker parameters for power depletion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37258—Alerting the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37264—Changing the program; Upgrading firmware

Definitions

  • the present invention is generally concerned with the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents, such as dorsal penile/clitoral nerves.
  • pudendal nerve afferents Electrical stimulation of pudendal nerve afferents is known to be effective in the treatment of a variety of pelvic disorders, such as urge urinary incontinence.
  • the symptoms of increased daytime frequency, nocturia and urge urinary incontinence are often related to detrusor overactivity (DO), which is characterized by involuntary bladder contractions at low bladder volumes.
  • DO detrusor overactivity
  • Upper urinary tract damage caused by sustained high intravesical pressures and repeated bladder infections is another concern that causes morbidity, hospitalization or even death in patients with DO.
  • Bladder dysfunction is usually one of the most challenging long-term management issues in neurological patients because of the limited treatment options to help relieve symptoms.
  • MS multiple sclerosis
  • SCI spinal cord injury
  • CVA stroke
  • One way of electrically stimulating nerves is to convey electrical pulses to the nerves via an electrode implanted at or near the nerve. Pulses are normally generated by implanted or external pulse generators, from which the electrical pulses are transmitted via an implanted or a percutaneous lead.
  • the implanted parts are powered from external devices by inductive power transmission, which normally requires a power-emitting antenna to be positioned close to an implanted receiver during the entire stimulation period.
  • continuous stimulation systems this implies that the power-emitting antenna has to be permanently worn by the patient and fixed to the patient's skin.
  • Other known systems relying on VHF/UHF radio transmission require a receiver which continuously listens for incoming signals.
  • One drawback of such systems is that the receiver must be continusouly powered, e.g. by an implanted battery, thereby necessitating frequent battery exchange or recharge, or requiring the implantation of relatively large batteries. Summary of the invention
  • the present invention provides a system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents of a living being, including:
  • an implantable electrode configured to be placed on, at, in, around or near a portion of a pudendal nerve or its branches;
  • an implantable pulse generator having a pulse-generating circuitry and optionally a first battery for powering the pulse generator to provide electrical pulses to the electrode in order to achieve said electrical stimulation of the pudendal nerve or its branches, the implantable pulse generator being configured to receive wirelessly transmitted control signals and to provide said electrical pulses in response to said control signals;
  • a user-operable triggering mechanism configured to transmit an inductive wireless control signal to the implantable pulse generator in order to trigger a sequence of said electrical pulses.
  • the invention provides a method for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents in a living being, said method including the steps of:
  • a pulse generator for providing electrical pulses to the electrode in order to achieve said electrical stimulation of the pudendal nerve or its branches, the implantable pulse generator being configured to receive wirelessly transmitted control signals and to provide said electrical pulses in response to said control signals;
  • a wireless control signal to the implanted pulse generator from a position outside the living being's body in order to trigger a sequence of said electrical pulses, the control signal comprising an inductive signal.
  • the invention further provides a user-operable triggering mechanism for a system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents, the triggering mechanism being configured to transmit a wireless control signal to an implantable pulse generator in order to trigger a sequence of electrical pulses, the control signal comprising an inductive signal.
  • an inductive triggering signal is sufficient for the activation of the system of the present invention.
  • the power for the pulses is provided by the implantable battery.
  • the triggering mechanism needs only be placed in the vicinity of the pulse generator during the period of triggering the pulse generator.
  • the triggering period is comparatively very short compared to the stimulation period. In essence, triggering merely requires an activation signal which is transmittable in less than 1 second, whereas the stimulation period typically lasts for a predetermined period of approximately 1-2 minutes, unless stimulation is performed continuously, i.e. during periods of several hours.
  • the pudendal nerve branches such as the genital nerves (penis nerve in men and clitoris nerve in women) may be stimulated by the system and method of the present invention.
  • the invention is particuarily useful for the treatment of urge urinary incontinence, but may also be applied in the treatment of faecal incontinence. Treatment of stress incontinence is also contemplated. Further, the invention may be useful for bladder voiding by stimulation of the perineal nerve afferents.
  • electrodes are said to be placed or placeable at, on, in, near or around nerves. It should be understood that any reference to the placement of electrodes is not limited to any specific of these locations. Hence, an electrode, which for example is said to be placed or placeable ⁇ at' a nerve may be placed or placeable not only ⁇ at', but also on, in, near or around that nerve, unless the present text specifically requires a certain location of the electrode. In general, the reference to any placement ⁇ on', ⁇ in', 'near' or 'around' nerves includes any placement ⁇ at', ⁇ on', ⁇ in', 'near' or 'around'.
  • pudendal nerve afferents includes the sensory part of the sacral nerves, dorsal penile/clitoral nerves (genital nerves), as well as any parts or branches thereof.
  • the system of the present invention is preferably event-triggered.
  • stimulation may be initiated by a patient, once the patient feels a compelling desire to pass urine or faeces.
  • the method of the present invention preferably provides direct sensory nerve stimulation to evoke a detrusor inhibitory reflex together with reflex mediated contraction of pelvic floor muscles that aids to preserve continence.
  • stimulation only affects pudendal nerve afferents, i.e. stimulation is selectively targeted towards nerve afferents that reflexively affect the bladder. This is fundamentally different from systems, which provide continuous neuromodulation to modulate the spinal reflex arches, without allowing the patient to initiate stimulation.
  • the present invention provides a system that allows for patient-initiated stimulation.
  • the patient will typically initiate stimulation once he or she feels a desire to empty the bladder or bowel, whereby the stimulation suppresses the urgefor a period of time of e.g. 10 minutes, allowing the patient sufficient time to reach a toilet.
  • inductive wireless signal are defined as signals transmitted at a frequency below 315 kHz.
  • Radio frequency wireless signals are defined as signals transmitted at a frequency above 400 MHz.
  • inductive signals are to be understood as signals provided at a frequency below 315 kHz, such as in the ULP-AMI band of 9 - 315 kHz according to the TR 101 981 or EN 302 195 standards.
  • Radio frequency signals are to be understood as signals provided at a frequency above 400 MHz, such as in the range of the ULP-AMI band of 401-406 MHz, or in the MICS band of 402-405 MHz, both according to the TR 102 343 standard, or according to the EN 301 839 standard (402-405 MHz).
  • wireless inductive signals should be provided at a frequency of below 315 kHz or below 300 kHz, preferably around 125 kHz. Inductive charging avoids battery replacement by surgical intervention.
  • the system of the present invention may comprise an external programming device for transmitting data to the pulse generator when implanted, the external programming device and the pulse generator being configured to transmit and receive said data via wireless radio communication.
  • radio frequency signals have a wider range than inductive signals, and for certain purposes it may hence be beneficial with respect to user and programmer convenience that programming and other data transmission to the pulse generator is carried out by means of radio frequency signals.
  • the user operable triggering mechanism may be activatable by the user himself/herself, e.g. by finger action on a push button or on a touch screen, or by voice activation.
  • the user operable triggering mechanism may be activatable by a signal transmitted from a separate device, which in turn in activatable by the user, e.g. by finger action or voice activation.
  • the user-operable triggering mechanism comprises a skin-borne device for transmitting said inductive wireless control signal to the implantable pulse generator, and a user activatable device for transmitting a wireless radio frequency signal to the skin-borne device upon user activation of the user activatable device.
  • the skin-borne device is preferably configured to receive the wireless radio frequency signal transmitted from the user activatable device and to generate the inductive wireless control signal for the implantable pulse generator in response thereto.
  • the skin-borne device may be attached to a body portion of the user in the vicinity of the implantation site of the pulse generator, e.g. at the abdominal wall, whereas the user activatable device may be at a distance therefrom, e.g.
  • the present device confers the benefit that the user does not need to observe the limited range of inductive wireless transmission.
  • a non-implanted (i.e. external) battery may be provided for powering the skin-borne device, e.g. within the skin-borne device itself.
  • An implantable battery may be provided for powering the pulse generator.
  • the pulse generator and possibly other implantable parts may be powered solely by inductive power transmission from an external, non-implanted device, such as the skin-borne device.
  • the systems and methods of the present invention may be configured to provide continuous stimulation under certain circumstances, e.g. when the patient is asleep.
  • the system may be inactivated when the patient is asleep.
  • the at least one implantable electrode may include a cuff electrode, a wire, a helix, a double helix, a spiral electrode, or an intra-neural electrode.
  • the electrode is configured to be placed in the immediate vicinity of a pudendal nerve branch or around a nerve branch.
  • the pulse generator includes a receiver for receiving inductively transmitted signals emitted by the triggering device.
  • the receiver is configured to receive inductive signals only, so that it requires no power supply.
  • the pulse generator may further include an electronic memory for storing stimulation programs and/or stimulation parameters.
  • the electronic memory is preferably provided as a non-power consuming memory, such as EPROM, EEPROM, flash memory or the like known per se.
  • the battery is preferably hermetically sealed within an implanted housing.
  • the battery may be provided in hermetically sealed compartment of a housing of the pulse generator.
  • the triggering mechanism may be user-controlled to allow the user to initiate pulse stimulation.
  • stimulation may be event-triggered, e.g. following a compelling desire to pass urine or faeces.
  • the triggering mechanism is preferably provided as an external (i.e. non-implanted) device, which may include a programmable memory for storing stimulation programs and/or stimulation parameters.
  • the lead is detachably connected to the pulse generator, e.g. through a releasable connector.
  • the lead may be permanently secured to the electrode or detachably coupled thereto.
  • the wireless control signal is transmittable through a body portion of the living being within a distance of at most 2.5 m, such as most 1.5 m, 1 m or at most 50 cm from the pulse generator.
  • the pulse generator may be configured such that it is unable to detect the inductive triggering signal if the triggering mechanism is at a distance of more than 2.5 m away from the pulse generator.
  • the triggering mechanism may be configured such that the emitted inductive signals are sufficiently weak in order for them to be undetectable at a distance of more than 2.5 m from the triggering mechanism.
  • the inductive triggering signal has to travel through atmospheric air, clothing and body tissue.
  • the above reach limitation of approximately 2.5 m is to be understood as a reach through atmospheric air.
  • the battery is rechargeable.
  • the battery may be rechargeable while it is left in place in the patient's body.
  • the battery is inductively rechargeable, e.g. by means of the triggering device and a combined trigger and power receiver of the implanted pulse generator.
  • the battery may be removed by surgical intervention and recharged outside the patient's body.
  • the battery is non-rechargeable. In such cases the battery life time may exceed the expectation of the patient's remaining life time or the expected life time of the implanted parts of the product, or battery replacement may be performed by surgical intervention.
  • the pulse generator may be configured to provide the electrical pulses when it is in an active mode and to enter a dormant mode upon completion of a sequence of the pulses.
  • the user- operable triggering mechanism may be configured to provide the inductive control signal with an amount of energy sufficient to cause the pulse generator to switch from the dormant mode to said active mode.
  • the dormant mode is to be understood as the time period between the event-triggered stimulation puls(es) has/have been sent from the pulse generator and the next wake up signal has been received by the pulse generator. Hence the duration of the dormant mode may vary during the day.
  • the stimulator's stimulation circuits consume very little or no power at all. Only a circuit for wakening up the entire stimulator consumes power.
  • energy for initiating wake-up of the pulse generator may be transmitted from an external device, i.e. by inductive energy transfer. In such embodiments, the power consumption of the wake-up circuit is reduced to a minimum.
  • the term 'dormant mode' is hence not a mode, in which the pulse generator is completely disabled.
  • the pulse generator is in a standby state, in which it is capable of receiving a signal transmitted from an external device for causing the pulse generator to initiate the generation of a train of pulses.
  • the dormant mode occurs several times during the day, i.e. following each and every time a pulse train has been delivered.
  • the dormant mode accordingly occurs in cycles, the duration and frequency of which depend from the duration and frequency of user activation of the generation of pulses.
  • the pulse generator In the dormant mode, the pulse generator as such consumes no power.
  • a voltage is maintained only at a wake-up circuit, which is capable of causing the pulse generator to exit the dormant mode and enter the active mode in response to the control signal.
  • the system according to the present invention hence comprises:
  • a wake-up circuit for providing said control signal to the pulse generator to cause it to exit the dormant mode and enter the active mode
  • the power source is configured such that: - a voltage is maintained at the wake-up circuit in the dormant mode of the pulse generator, and
  • the wake-up circuit may be entirely housed or integrated in the pulse generator, or it may be provided as a separate implantable or external component.
  • the power source may comprise one or more batteries, included e.g. in a housing of the pulse generator.
  • the power source may include an external power source for transmitting power to the wake-up circuit and the pulse generator through wireless inductive transmission or by means of a percutaneous wire.
  • the system comprises an implantable battery for powering the wake-up circuit and a second external or implantable power source for powering the pulse generator, so as to reduce the frequency of battery exchange and/or battery recharge.
  • the wake-up signal transmitted to the implantable pulse generator may include stimulation parameters, such as pulse voltage or current amplitude, pulse shape, pulse duration or frequency. Alternatively, these parameters may be provided immediately following the wake- up signal. In a still further alternative, the parameters may be pre-stored in a memory of the pulse generator. If a plurality of stimulation programs are pre-stored in the pulse generator, the external device may transmit a program selection along with the wake-up signal or immediately following the wake-up signal, allowing the pulse generator to choose the desired stimulation program.
  • stimulation parameters such as pulse voltage or current amplitude, pulse shape, pulse duration or frequency.
  • these parameters may be provided immediately following the wake- up signal.
  • the parameters may be pre-stored in a memory of the pulse generator. If a plurality of stimulation programs are pre-stored in the pulse generator, the external device may transmit a program selection along with the wake-up signal or immediately following the wake-up signal, allowing the pulse generator to choose the desired stimulation program.
  • the triggering mechanism may be configured to include at least one of the following commands in the control signal:
  • - stimulation parameters of said stimulation pulses including at least one of: an amplitude of the electrical pulses; a voltage of the electrical pulses; a pulse width of the electrical pulses; a pulse rate of the electrical pulses.
  • the pre-stored stimulation programs may be configured to initiate the sequence of stimulation pulses by stepwise increasing charges of electrical pulses from an initial level to a final level.
  • the stepwise increase of the pulse charges may be achieved by increasing current amplitude, voltage amplitude, pulse width or a combination thereof, or by stepwise increasing pulse rate.
  • One benefit of the stepwise increase of the pulse charges is that it decreases possible discomfort sensed by the patient at the start of stimulation.
  • the gradual increase of the pulse charges may lead to higher patient comfort, not only during stimulation start-up, but also during the entire stimulation period.
  • a stepwise decrease of pulse charges from the final level back to the initial level (e.g. zero) following stimulation is also possible.
  • the stepwise increase of pulse charges may be provided as a user-selectable option.
  • the user may for example select various stimulation programs, of which some provide stepwise increase of pulse charge, and some provide immediate stimulation at the final level without prior stepwise increase of the pulse charges.
  • the parameters of the stepwise pulse increase may be set according to a user selection. For example, the user may be allowed to choose ramp-up time, frequency, number of pulses to be provided during ramp-up etc.
  • the implantable pulse generator may be configured to control stimulation parameters of the stimulation pulses and to charge balance the pulses.
  • Charge balancing may be achieved by alternating polarity, by shortcircuiting the electrodes after each stimulation pulse, through a capacitor coupled in series with the electrodes, or by software-controlled means.
  • the triggering mechanism may comprise a signal receiver for receiving a wireless signal from the implantable pulse generator.
  • the implantable pulse generator may in such an embodiment be configured to transmit a wireless signal to the triggering mechanism, e.g. in case of one or more predetermined conditions of the implantable components, such as upon detection of a low battery voltage.
  • the pulse generator is configured only to communicate a low battery status. In other embodiments, other information may be transmitted by the implanted pulse generator, such as information about malfunctions in the implanted components.
  • the triggering mechanism may be included in a portable device, for example in a device which is sized and configured to be worn around the wrist of a human being.
  • a wrist watch may be integrated with the triggering mechanism.
  • Other portable devices are possible, e.g. devices which may be worn in a necklace, belt clip, devices integrated in cellular telephones or in other common personal items.
  • the triggering mechanism and the implanted pulse generator may be configured such that the wireless control signal and/or wireless triggering signal is only receivable by the pulse generator when the wrist-worn triggering mechanism is within a predetermined range from the implanted pulse generator, e.g. within a distance of 2.5 m or less.
  • the triggering mechanism may be configured to wirelessly transmit stimulation parameters to the implantable pulse generator.
  • stimulation parameters may include at least one of a current of the electrical pulses, e.g. a current amplitude, a voltage of the electrical pulses, a pulse width of the electrical pulses, and a frequency of the electrical pulses.
  • the triggering mechanism comprises a user interface configured to emit a signal indicative of at least one of:
  • Triggering of the pulse generation may in embodiments of the present invention be performed in response to a signal provided by a sensor for determining the bladder pressure or volume.
  • the triggering mechanism can be dispensed with, but may be provided as back-up device allowing the user to trigger pulse generation.
  • the system is programmed to provide a train of a predetermined number of pulses or to calculate the number of pulses (i.e. the duration of the train of pulses), whereby the train of pulses is determined by the control of the system, unless overruled by a patient- activated emergency stop.
  • it may however be desirable to allow the patient to prolong the stimulation period whereby the system is programmed to generate electrical pulses until the patient stops the pulse generation, i.e. until the patient deactivates stimulation.
  • the system will typically be in its active mode for longer periods of time. Prolonged stimulation periods may in particular be useful for extending the patient's continence time immediately prior to bladder voiding, usually for a period of time of 1-5 minutes prior to voiding.
  • User-activated termination of the train of pulses may also be beneficial in cases the patient reaches a toilet facility before expiration of a predetermined or pre-programmed train of pulses, so as to expedite bladder voiding.
  • the possibility of user- activated termination of the pulse train also constitutes a safety feature, which may reduce the risk of nerve damage due to excessive stimulation and/or reduce the patient's sensation of discomfort.
  • the level of charge of the electrical pulses may be controlled by controlling one or more of:
  • the pulse rate of the electrical stimulation pulses i.e. the length of intervals between the pulses
  • the pulse generator may be configured to stepwise increase the pulse charges from the initial level to the final level during a period of time of about 0.1 seconds to about 40 seconds.
  • the stepwise increase of the pulse charges may be linearly or exponentially increased.
  • the pulse generator is preferably configured to provide the pulses at a pulse rate of about 5 pulses per second to about 50 pulses per second.
  • the initial level provides no current
  • the final level provides charges at a current from about 0.01 mA to about 100 mA, such as from about 0.01 mA to about 10 or 20 mA.
  • the at least one electrode is preferably configured to be placed at, on, in, near or around a genital nerve, such as a dorsal penile/clitoral nerve.
  • the pulses are typically provided at a pulse width of about 50 ⁇ s to about 400 ⁇ s, such as at a pulse width of about 200 ⁇ s.
  • the at least one electrode is preferably implanted or implantable at a left and/or right branch of the dorsal penile nerve, which is a distal portion of the pudendal nerve close to the genitals.
  • the electrode may be implanted at or near the genitals or in Alcock's Canal via the perineum.
  • the pulse generator may be implantable/implanted in a subcutaneous pocket in the pelvic or abdominal region at a tissue depth of approximately 4 cm or less. In other embodiments, the pulse generator may be implantable/implanted to a tissue depth of between 0.3 cm and 0.4 cm or between 0.6 cm and 1.4 cm, or between 1.6 cm and 1.9 cm or between 2.1 and 2.8 cm.
  • the pulse generator is preferably implanted in a subcutaneous pocket in the pelvic or abdominal region, such as in the anterior pelvic or abdominal region.
  • the implant may contain means for fixation, e.g. sutures.
  • An external programming device may be provided in order to transmit the pulse stimulation parameters or pulse generation programs to the implantable pulse generator.
  • the external programming device may be at the disposal of the patient, or it may alternatively be provided at a medical facility, operable by a trained physician only.
  • the external programming device includes suitable software, user interface, memory, power unit, and data processor.
  • the lead connecting the pulse generator to the at least one electrode may be helical in order to provide a flexible and mechanically strong connection.
  • the lead may be coated with a biocompatible material or made entirely from a biocompatible material.
  • the housing of the pulse generator is preferably coated and made from a biocompatible material, such as titanium.
  • the invention provides a surgical kit for preparing a system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents of a living being, including:
  • an implantable electrode configured to be placed on, at or near a portion of a pudendal nerve or its branches;
  • an implantable pulse generator having a pulse-generating circuitry and a battery for providing electrical pulses to the electrode in order to achieve said electrical stimulation of the pudendal nerve or its branches, the implantable pulse generator being configured to receive wirelessly transmitted inductive control signals and to provide said electrical pulses in response to said control signals;
  • the electrode may be connected to the lead, thereby alleviating surgical personnel from the task of connecting the electrode to the lead.
  • a tool for connecting the lead to the pulse generator may be included in the kit.
  • the kit may further include tools for implanting at least one of the electrode, the lead and the pulse generator, e.g. for tunnelling the lead through body tissue.
  • the invention provides a method of providing a surgical kit for preparing a system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents of a living being, the method comprising the steps of:
  • an implantable electrode configured to be placed on, at, in, around or near a portion of a pudendal nerve or its branches; - providing an implantable pulse generator having a pulse-generating circuitry and a battery for providing electrical pulses to the electrode in order to achieve said electrical stimulation of the pudendal nerve or its branches, the implantable pulse generator being configured to receive wirelessly transmitted inductive control signals and to provide said electrical pulses in response to said control signals; - providing an electrical lead for connecting the pulse generator to the electrode; - connecting the electrical lead to the electrode; packing the electrode, the lead and the pulse generator in a sterile condition, the lead and the electrode being packed subsequently to the step of connecting the lead to the electrode.
  • the system may be configured to communicate triggering, control and/or programming signals by means of low frequency radio communcation, by means of intrabody communication, such as by volume conductance using the human body as an electrical conductor, and/or by means of pressure waves, such as acoustic waves.
  • Fig. 1 shows an illustration of the pelvic region of a patient, including an implanted electrode, pulse generator and lead, as well as an external triggering mechanism
  • Fig. 2 shows an illustration of the pulse generator shown in Fig. 1
  • Figs. 3 and 4 are illustrations of a wireless external triggering and programming device
  • Fig. 5 is an anatomic view showing the implanted pulse generator of Figs. 1 and
  • Figs. 6 and 7 are flow charts of various processes of the system of the present invention.
  • Figs. 8 and 9 are graphical representations of biphasic stimulus current outputs from the pulse generator
  • Fig. 10 is an illustration of a sterilized kit including implantable elements as well as surgical tools for their implantation;
  • Fig. 11 illustrates a releasable connection between a pulse generator and the lead connecting the pulse generator to the electrode
  • Fig. 12 shows a further embodiment of a system according to the invention.
  • Fig. 1 generally illustrates the pelvis 100 of a patient 102 and a portion of the spinal cord 104.
  • the pudendal nerves 108 exit the sacral cord and branch into the dorsal penile/clitoral nerves 110.
  • Fig. 1 further illustrates Alcock's Canal 112 and the pubic symphysis 114.
  • a cuff electrode 116 is placed around the left dorsal penile/clitoral nerve 110.
  • the electrode 116 is connected to an implanted pulse generator 118 via an implanted lead 120.
  • the pulse generator 118 comprises a battery (not shown in Fig.
  • the battery may be chargeable by means of inductive wireless power transmission providing electromagnetic signals at a frequency of below 315 kHz.
  • An external, wrist worn device 122 is provided for wirelessly communicating with the pulse generator 118.
  • the wrist worn device 122 represents a triggering mechanism for causing the pulse generator 118 to pass a series of electrical pulses to the electrode.
  • the wrist worn device 112 may be configured as a programming device for setting stimulation parameters or for otherwise programming or configuring the implanted pulse generator 118.
  • the pulse generator 118 may be configured for providing data to the external device 122, such as e.g. a low battery warning of the pulse generator 118.
  • Fig. 2 generally shows the main components of the pulse generator 118.
  • the pulse generator includes a telemetry unit 124 for receiving and/or sending information to/from an external device, such as the wrist worn device 122 shown in Fig. 1. Further, the pulse generator includes a pulse generating circuitry 126, and a battery 128.
  • the battery 128 is preferably hermetically sealed within a housing of the pulse generator 118.
  • the pulse generator contains a connector 130 to attach the implantable lead 120.
  • the wrist worn device 122 may serve as a wireless external triggering or programming device for triggering, programming or configuring the pulse generator.
  • the patient 102 may trigger or program the pulse generator 118 by locating the wrist worn device 122 in the vicinity of the implanted pulse generator 118 and activating a programming action, so as to wirelessly transmit an appropriate triggering signal, programming or configuration data to the pulse generator 118, as shown in Fig. 4.
  • Fig. 5 illustrates a clinical programming system for a system according to the invention.
  • the programming system includes a personal computer 132, which is typically operated by a physician, and a programming box 134.
  • the programming box is connected to an inductive coil 138 via a lead 136.
  • Programming of the implanted pulse generator 118 is performed via wireless, inductive telemetry from the inductive coil through the skin of the patient.
  • Fig. 6 shows a flowchart of an embodiment of a process occurring in the systems described above.
  • the pulse generator is in a dormant mode, in which no voltage is maintained at any of the implanted components and circuits, except at the wake-up circuit of the pulse generator.
  • a trigger signal is provided to initiate a wake-up command for the pulse generator 118 via its wake-up circuit.
  • a voltage is applied to the implanted components and circuits, at which no voltage was maintained in the dormant mode.
  • the wake-up command causes the pulse generator to enter an active mode and to activate a predefined stimulation program.
  • a wireless warning signal is provided to an external device, such as the external triggering device 122 or an external programming device. Subsequently, the pulse generator initiates a stepwise increase of pulse charges from zero up to a final charge level, and pulse stimuli are provided for a predetermined period of time, or until the patient deactivates the pulses. Finally, the pulse generator enters a dormant mode, and voltage is cut off to the implanted components and circuits, expect for the wake-up circuit of the pulse generator, at which a voltage is maintained.
  • Fig. 7 illustrates a similar embodiment of a process occurring in the external parts of the systems described above.
  • the trigger device triggering mechanism 122 or user activateable device 162, see Fig. 12
  • a wake-up command is sent to the wake-up circuit of the pulse generator (directly from triggering mechanism 122 or via the skin-borne device 160, see the below description of Fig. 12), and certain stimulation parameters are possibly also sent to the pulse generator.
  • An external signal receiver for a warning signal is initiated, and if a warning signal indicative of e.g. a low battery status of the pulse generator, is received, a warning indicator is initiated. In the same manner, a warning indicator may be initiated, if there is a low battery warning from the trigger device.
  • Figs. 8 and 9 are graphical representations of biphasic stimulus current outputs from the pulse generator during initial stepwise increase of the pulse charges upon activation of the pulse generator.
  • the current amplitudes A of the pulse are stepwise increased. It should however be understood that the pulse charges may also be increased by extending the pulse width t, shortening the intervals between the pulses T, or stepwise increase the pulse voltages.
  • the chart of Fig. 8 illustrates de-charge of a series capacitor upon short-circuiting of electrodes.
  • alternating polarity is achieved by alternating the current through the electrode by means of hardware or software control embedded in the pulse generator.
  • Fig. 10 illustrates an embodiment of a sterilized surgical kit.
  • the kit includes several sterilized packages.
  • One package contains the pulse generator 118.
  • Another package contains the electrode 116, connected to a connector 152 via the lead 120.
  • Further packages 148 and 150 include surgical tools for implanting the electrode 116, pulse generator 118 and lead 120.
  • the surgical tools may for example include tunneling tools for tunneling the lead and/or electrode through the patient's body during surgical intervention.
  • the connector 152 allows the lead 120 to be releasably connected to the pulse generator 118.
  • the user-operable triggering mechanism comprises a skin- borne device 160 releasbly attached to an abdominal wall of the user in the vicinity of the implanted pulse generator 118 and electrode 116.
  • the user-operable triggering mechanism further comprises a hand-held user activatable device 162 for transmitting radio frequency control signals to the skin-borne device 160, which in turn generates inductive wireless signals to the pulse generator 118.

Abstract

A system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents (108; 110) includes an implantable electrode (116) configured to be placed at a pudendal nerve or its branches (108; 110). An implantable pulse generator (118) having a pulse-generating circuitry and a battery for powering the pulse generator (118) provides electrical pulses to the electrode (116). The implantable pulse generator (118) is configured to receive wirelessly transmitted control signals and to provide the electrical pulses. A user- operable triggering mechanism (122) is configured to transmit an inductive wireless control signal to the implantable pulse generator (118) in order to trigger generation of electrical pulses. A skin-borne device (160) may be provided for transmitting the inductive wireless control signal to the pulse generator (118), and a user activatable device (162) may be provided for transmitting a wireless radio frequency signal to the skin-borne device (160) upon user activation.

Description

INDUCTIVE CONTROL OF ELECTRICAL NERVE STIMULATION SYSTEM FOR THE TREATMENT OF PELVIC DISORDERS
Technical field
The present invention is generally concerned with the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents, such as dorsal penile/clitoral nerves.
Background of the invention
Electrical stimulation of pudendal nerve afferents is known to be effective in the treatment of a variety of pelvic disorders, such as urge urinary incontinence. The symptoms of increased daytime frequency, nocturia and urge urinary incontinence are often related to detrusor overactivity (DO), which is characterized by involuntary bladder contractions at low bladder volumes. The aforementioned symptoms adversely affect patients' quality of life due to social and hygienic difficulties. Upper urinary tract damage caused by sustained high intravesical pressures and repeated bladder infections is another concern that causes morbidity, hospitalization or even death in patients with DO. Bladder dysfunction is usually one of the most challenging long-term management issues in neurological patients because of the limited treatment options to help relieve symptoms. Approximately 1 million patients with symptoms of an overactive bladder (35% urge incontinence) are refractory to conventional treatment options world-wide. Especially neurological patients suffering from e.g. multiple sclerosis (MS), spinal cord injury (SCI), or stroke (CVA) are often difficult to treat by conventional means.
One way of electrically stimulating nerves is to convey electrical pulses to the nerves via an electrode implanted at or near the nerve. Pulses are normally generated by implanted or external pulse generators, from which the electrical pulses are transmitted via an implanted or a percutaneous lead.
In some of the known systems the implanted parts are powered from external devices by inductive power transmission, which normally requires a power-emitting antenna to be positioned close to an implanted receiver during the entire stimulation period. In continuous stimulation systems this implies that the power-emitting antenna has to be permanently worn by the patient and fixed to the patient's skin. Other known systems relying on VHF/UHF radio transmission require a receiver which continuously listens for incoming signals. One drawback of such systems is that the receiver must be continusouly powered, e.g. by an implanted battery, thereby necessitating frequent battery exchange or recharge, or requiring the implantation of relatively large batteries. Summary of the invention
It is an object of embodiments of the present invention to provide a system and a method, which overcomes the drawbacks of the known systems. It is a further object of embodiments of the present invention to provide a system and a method which consumes relatively small amounts of power to thereby extend battery life and prolong battery exchange or recharge intervals.
In a first aspect, the present invention provides a system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents of a living being, including:
- an implantable electrode configured to be placed on, at, in, around or near a portion of a pudendal nerve or its branches;
- an implantable pulse generator having a pulse-generating circuitry and optionally a first battery for powering the pulse generator to provide electrical pulses to the electrode in order to achieve said electrical stimulation of the pudendal nerve or its branches, the implantable pulse generator being configured to receive wirelessly transmitted control signals and to provide said electrical pulses in response to said control signals;
- an electrical lead for connecting the pulse generator to the electrode;
- a user-operable triggering mechanism configured to transmit an inductive wireless control signal to the implantable pulse generator in order to trigger a sequence of said electrical pulses.
In a second aspect, the invention provides a method for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents in a living being, said method including the steps of:
- implanting an electrode on, at, in, around or near a portion of a pudendal nerve or its branches,
- implanting a pulse generator for providing electrical pulses to the electrode in order to achieve said electrical stimulation of the pudendal nerve or its branches, the implantable pulse generator being configured to receive wirelessly transmitted control signals and to provide said electrical pulses in response to said control signals;
- powering the pulse generator by means of an implanted battery or by means of power inductively transmitted through the living being's skin from an external device;
- transmitting a wireless control signal to the implanted pulse generator from a position outside the living being's body in order to trigger a sequence of said electrical pulses, the control signal comprising an inductive signal.
In a third aspect, the invention further provides a user-operable triggering mechanism for a system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents, the triggering mechanism being configured to transmit a wireless control signal to an implantable pulse generator in order to trigger a sequence of electrical pulses, the control signal comprising an inductive signal.
Thanks to the provision of the implantable battery, an inductive triggering signal is sufficient for the activation of the system of the present invention. Once the pulse generator has been triggered, the power for the pulses is provided by the implantable battery. Hence, in embodiments comprising an implantable battery, the triggering mechanism needs only be placed in the vicinity of the pulse generator during the period of triggering the pulse generator. The triggering period is comparatively very short compared to the stimulation period. In essence, triggering merely requires an activation signal which is transmittable in less than 1 second, whereas the stimulation period typically lasts for a predetermined period of approximately 1-2 minutes, unless stimulation is performed continuously, i.e. during periods of several hours.
Moreover, due to the provision of an inductive triggering signal there is no requirement of a continuously listening receiver, and consequently less power is consumed. This in turn extends the life time of the implantable battery or, alterntively, allows for a smaller battery to be implanted.
In particular, the pudendal nerve branches, such as the genital nerves (penis nerve in men and clitoris nerve in women) may be stimulated by the system and method of the present invention. The invention is particuarily useful for the treatment of urge urinary incontinence, but may also be applied in the treatment of faecal incontinence. Treatment of stress incontinence is also contemplated. Further, the invention may be useful for bladder voiding by stimulation of the perineal nerve afferents.
In the present context, electrodes are said to be placed or placeable at, on, in, near or around nerves. It should be understood that any reference to the placement of electrodes is not limited to any specific of these locations. Hence, an electrode, which for example is said to be placed or placeable λat' a nerve may be placed or placeable not only λat', but also on, in, near or around that nerve, unless the present text specifically requires a certain location of the electrode. In general, the reference to any placement λon', λin', 'near' or 'around' nerves includes any placement λat', λon', λin', 'near' or 'around'.
As used herein, the reference to pudendal nerve afferents includes the sensory part of the sacral nerves, dorsal penile/clitoral nerves (genital nerves), as well as any parts or branches thereof.
The system of the present invention is preferably event-triggered. In other words, stimulation may be initiated by a patient, once the patient feels a compelling desire to pass urine or faeces. The method of the present invention preferably provides direct sensory nerve stimulation to evoke a detrusor inhibitory reflex together with reflex mediated contraction of pelvic floor muscles that aids to preserve continence. In respect of applications, in which the electrode is implanted on, at or near a dorsal penile/clitoral nerve, stimulation only affects pudendal nerve afferents, i.e. stimulation is selectively targeted towards nerve afferents that reflexively affect the bladder. This is fundamentally different from systems, which provide continuous neuromodulation to modulate the spinal reflex arches, without allowing the patient to initiate stimulation. In such systems, urge to empty the bladder or bowel is suppressed for a period of time, however once the patient feels urgency, such urgency cannot be suppressed by the stimulation. Hence, no warning is given to the patient, who may therefore not have sufficient time to reach a toilet. The present invention provides a system that allows for patient-initiated stimulation. The patient will typically initiate stimulation once he or she feels a desire to empty the bladder or bowel, whereby the stimulation suppresses the urgefor a period of time of e.g. 10 minutes, allowing the patient sufficient time to reach a toilet.
In the present context, inductive wireless signal are defined as signals transmitted at a frequency below 315 kHz. Radio frequency wireless signals are defined as signals transmitted at a frequency above 400 MHz.
Herein, inductive signals are to be understood as signals provided at a frequency below 315 kHz, such as in the ULP-AMI band of 9 - 315 kHz according to the TR 101 981 or EN 302 195 standards. Radio frequency signals are to be understood as signals provided at a frequency above 400 MHz, such as in the range of the ULP-AMI band of 401-406 MHz, or in the MICS band of 402-405 MHz, both according to the TR 102 343 standard, or according to the EN 301 839 standard (402-405 MHz).
Generally, for the purpose of charging a battery within the implantable pulse generator, wireless inductive signals should be provided at a frequency of below 315 kHz or below 300 kHz, preferably around 125 kHz. Inductive charging avoids battery replacement by surgical intervention.
The system of the present invention may comprise an external programming device for transmitting data to the pulse generator when implanted, the external programming device and the pulse generator being configured to transmit and receive said data via wireless radio communication. Generally, radio frequency signals have a wider range than inductive signals, and for certain purposes it may hence be beneficial with respect to user and programmer convenience that programming and other data transmission to the pulse generator is carried out by means of radio frequency signals. The user operable triggering mechanism may be activatable by the user himself/herself, e.g. by finger action on a push button or on a touch screen, or by voice activation. Alternatively, the user operable triggering mechanism may be activatable by a signal transmitted from a separate device, which in turn in activatable by the user, e.g. by finger action or voice activation.
In one embodiment, the user-operable triggering mechanism comprises a skin-borne device for transmitting said inductive wireless control signal to the implantable pulse generator, and a user activatable device for transmitting a wireless radio frequency signal to the skin-borne device upon user activation of the user activatable device. The skin-borne device is preferably configured to receive the wireless radio frequency signal transmitted from the user activatable device and to generate the inductive wireless control signal for the implantable pulse generator in response thereto. Hence, the skin-borne device may be attached to a body portion of the user in the vicinity of the implantation site of the pulse generator, e.g. at the abdominal wall, whereas the user activatable device may be at a distance therefrom, e.g. around the user's wrist, integrated in a mobile phone, PDA, or provided in a separate handheld device. Hence, in comparison to embodiment, in which the inductive wireless signal is provided directly from a user-held device to the pulse generator, the present device confers the benefit that the user does not need to observe the limited range of inductive wireless transmission.
A non-implanted (i.e. external) battery may be provided for powering the skin-borne device, e.g. within the skin-borne device itself.
An implantable battery may be provided for powering the pulse generator. However, as described herein the pulse generator and possibly other implantable parts may be powered solely by inductive power transmission from an external, non-implanted device, such as the skin-borne device.
Though it is preferable that the patient may initiate stimulation for the above reasons, the systems and methods of the present invention may be configured to provide continuous stimulation under certain circumstances, e.g. when the patient is asleep. Alternatively, if the patient's is physically capable of preserving continence when he or she is asleep, the system may be inactivated when the patient is asleep.
The at least one implantable electrode may include a cuff electrode, a wire, a helix, a double helix, a spiral electrode, or an intra-neural electrode. Preferably, the electrode is configured to be placed in the immediate vicinity of a pudendal nerve branch or around a nerve branch. The pulse generator includes a receiver for receiving inductively transmitted signals emitted by the triggering device. Preferably, the receiver is configured to receive inductive signals only, so that it requires no power supply. The pulse generator may further include an electronic memory for storing stimulation programs and/or stimulation parameters. The electronic memory is preferably provided as a non-power consuming memory, such as EPROM, EEPROM, flash memory or the like known per se.
The battery is preferably hermetically sealed within an implanted housing. For example, the battery may be provided in hermetically sealed compartment of a housing of the pulse generator.
The triggering mechanism may be user-controlled to allow the user to initiate pulse stimulation. Hence, stimulation may be event-triggered, e.g. following a compelling desire to pass urine or faeces. The triggering mechanism is preferably provided as an external (i.e. non-implanted) device, which may include a programmable memory for storing stimulation programs and/or stimulation parameters.
In preferred embodiments, the lead is detachably connected to the pulse generator, e.g. through a releasable connector. The lead may be permanently secured to the electrode or detachably coupled thereto.
In one embodiment, the wireless control signal is transmittable through a body portion of the living being within a distance of at most 2.5 m, such as most 1.5 m, 1 m or at most 50 cm from the pulse generator. Thereby, the risk of false or unintended triggering is reduced, and the risk of interference of the surrounding environment is reduced. The pulse generator may be configured such that it is unable to detect the inductive triggering signal if the triggering mechanism is at a distance of more than 2.5 m away from the pulse generator. Alternatively or additionally, the triggering mechanism may be configured such that the emitted inductive signals are sufficiently weak in order for them to be undetectable at a distance of more than 2.5 m from the triggering mechanism.
As the triggering mechanism is external (i.e. non-implanted) the inductive triggering signal has to travel through atmospheric air, clothing and body tissue. The above reach limitation of approximately 2.5 m is to be understood as a reach through atmospheric air.
In one embodiment the battery is rechargeable. For example, the battery may be rechargeable while it is left in place in the patient's body. In one embodiment the battery is inductively rechargeable, e.g. by means of the triggering device and a combined trigger and power receiver of the implanted pulse generator. Alternatively, the battery may be removed by surgical intervention and recharged outside the patient's body. In other embodiments, the battery is non-rechargeable. In such cases the battery life time may exceed the expectation of the patient's remaining life time or the expected life time of the implanted parts of the product, or battery replacement may be performed by surgical intervention.
The pulse generator may be configured to provide the electrical pulses when it is in an active mode and to enter a dormant mode upon completion of a sequence of the pulses. The user- operable triggering mechanism may be configured to provide the inductive control signal with an amount of energy sufficient to cause the pulse generator to switch from the dormant mode to said active mode. By causing the pulse generator to enter the dormant mode, power consumption may be kept at a minimum level, in particular as the power required for causing the pulse generator to switch from the dormant mode to the active mode is provided by the triggering mechanism.
The dormant mode is to be understood as the time period between the event-triggered stimulation puls(es) has/have been sent from the pulse generator and the next wake up signal has been received by the pulse generator. Hence the duration of the dormant mode may vary during the day. In the dormant mode the stimulator's stimulation circuits consume very little or no power at all. Only a circuit for wakening up the entire stimulator consumes power. In case the system relies on wireless inductive telemetry for transmitting data to the implanted pulse generator, energy for initiating wake-up of the pulse generator may be transmitted from an external device, i.e. by inductive energy transfer. In such embodiments, the power consumption of the wake-up circuit is reduced to a minimum.
In the present context, the term 'dormant mode' is hence not a mode, in which the pulse generator is completely disabled. To the contrary, the pulse generator is in a standby state, in which it is capable of receiving a signal transmitted from an external device for causing the pulse generator to initiate the generation of a train of pulses. Thus, in this invention the dormant mode occurs several times during the day, i.e. following each and every time a pulse train has been delivered. The dormant mode accordingly occurs in cycles, the duration and frequency of which depend from the duration and frequency of user activation of the generation of pulses.
In the dormant mode, the pulse generator as such consumes no power. Preferably, a voltage is maintained only at a wake-up circuit, which is capable of causing the pulse generator to exit the dormant mode and enter the active mode in response to the control signal. In one embodiment, the system according to the present invention hence comprises:
- a wake-up circuit for providing said control signal to the pulse generator to cause it to exit the dormant mode and enter the active mode;
- at least one power source for powering the pulse generator and the wake-up circuit; wherein the power source is configured such that: - a voltage is maintained at the wake-up circuit in the dormant mode of the pulse generator, and
- no voltage is maintained at the pulse generator in the dormant mode.
The wake-up circuit may be entirely housed or integrated in the pulse generator, or it may be provided as a separate implantable or external component. The power source may comprise one or more batteries, included e.g. in a housing of the pulse generator. Alternatively, the power source may include an external power source for transmitting power to the wake-up circuit and the pulse generator through wireless inductive transmission or by means of a percutaneous wire. In one embodiment, the system comprises an implantable battery for powering the wake-up circuit and a second external or implantable power source for powering the pulse generator, so as to reduce the frequency of battery exchange and/or battery recharge.
The wake-up signal transmitted to the implantable pulse generator may include stimulation parameters, such as pulse voltage or current amplitude, pulse shape, pulse duration or frequency. Alternatively, these parameters may be provided immediately following the wake- up signal. In a still further alternative, the parameters may be pre-stored in a memory of the pulse generator. If a plurality of stimulation programs are pre-stored in the pulse generator, the external device may transmit a program selection along with the wake-up signal or immediately following the wake-up signal, allowing the pulse generator to choose the desired stimulation program.
In some embodiments, it may be desirable to maintain a voltage at a circuit of the pulse generator other than the wake-up circuit, even in the dormant mode, in order to achieve fast wake up of the generator or in order to allow the pulse generator to perform certain functions in the dormant mode, e.g. low-battery check, hardware function tests etc.
The triggering mechanism may be configured to include at least one of the following commands in the control signal:
- a wake-up command for the implantable pulse generator;
- a command for the pulse generator to select a particular one of a plurality of stimulation programs pre-stored in a memory of the implantable pulse generator; and
- stimulation parameters of said stimulation pulses, including at least one of: an amplitude of the electrical pulses; a voltage of the electrical pulses; a pulse width of the electrical pulses; a pulse rate of the electrical pulses.
The pre-stored stimulation programs may be configured to initiate the sequence of stimulation pulses by stepwise increasing charges of electrical pulses from an initial level to a final level. The stepwise increase of the pulse charges may be achieved by increasing current amplitude, voltage amplitude, pulse width or a combination thereof, or by stepwise increasing pulse rate. One benefit of the stepwise increase of the pulse charges is that it decreases possible discomfort sensed by the patient at the start of stimulation. The gradual increase of the pulse charges may lead to higher patient comfort, not only during stimulation start-up, but also during the entire stimulation period.
A stepwise decrease of pulse charges from the final level back to the initial level (e.g. zero) following stimulation is also possible.
The stepwise increase of pulse charges (ramp up) may be provided as a user-selectable option. Hence, the user may for example select various stimulation programs, of which some provide stepwise increase of pulse charge, and some provide immediate stimulation at the final level without prior stepwise increase of the pulse charges. Likewise, the parameters of the stepwise pulse increase may be set according to a user selection. For example, the user may be allowed to choose ramp-up time, frequency, number of pulses to be provided during ramp-up etc.
In order to avoid tissue damage, the implantable pulse generator may be configured to control stimulation parameters of the stimulation pulses and to charge balance the pulses. Charge balancing may be achieved by alternating polarity, by shortcircuiting the electrodes after each stimulation pulse, through a capacitor coupled in series with the electrodes, or by software-controlled means.
In order to allow the implanted pulse generator to communicate to an external device, the triggering mechanism may comprise a signal receiver for receiving a wireless signal from the implantable pulse generator. The implantable pulse generator may in such an embodiment be configured to transmit a wireless signal to the triggering mechanism, e.g. in case of one or more predetermined conditions of the implantable components, such as upon detection of a low battery voltage. In one embodiment, the pulse generator is configured only to communicate a low battery status. In other embodiments, other information may be transmitted by the implanted pulse generator, such as information about malfunctions in the implanted components.
The triggering mechanism may be included in a portable device, for example in a device which is sized and configured to be worn around the wrist of a human being. For example, a wrist watch may be integrated with the triggering mechanism. Other portable devices are possible, e.g. devices which may be worn in a necklace, belt clip, devices integrated in cellular telephones or in other common personal items. The triggering mechanism and the implanted pulse generator may be configured such that the wireless control signal and/or wireless triggering signal is only receivable by the pulse generator when the wrist-worn triggering mechanism is within a predetermined range from the implanted pulse generator, e.g. within a distance of 2.5 m or less.
The triggering mechanism may be configured to wirelessly transmit stimulation parameters to the implantable pulse generator. Such stimulation parameters may include at least one of a current of the electrical pulses, e.g. a current amplitude, a voltage of the electrical pulses, a pulse width of the electrical pulses, and a frequency of the electrical pulses.
For patient convenience, the triggering mechanism comprises a user interface configured to emit a signal indicative of at least one of:
- a position of the user and/or of a public toilet facility and/or a distance to the nearest public toilet facility; - time elapsed since last bladder voiding and/or since last stimulation pulse train;
- time, alarm and/or date;
- log data related to past stimulation pulse trains;
- log data related to past voiding, such as volume of voided urine.
Triggering of the pulse generation may in embodiments of the present invention be performed in response to a signal provided by a sensor for determining the bladder pressure or volume. In such embodiments, the triggering mechanism can be dispensed with, but may be provided as back-up device allowing the user to trigger pulse generation.
In some setups the system is programmed to provide a train of a predetermined number of pulses or to calculate the number of pulses (i.e. the duration of the train of pulses), whereby the train of pulses is determined by the control of the system, unless overruled by a patient- activated emergency stop. In other setups, it may however be desirable to allow the patient to prolong the stimulation period, whereby the system is programmed to generate electrical pulses until the patient stops the pulse generation, i.e. until the patient deactivates stimulation. In such embodiment, the system will typically be in its active mode for longer periods of time. Prolonged stimulation periods may in particular be useful for extending the patient's continence time immediately prior to bladder voiding, usually for a period of time of 1-5 minutes prior to voiding. User-activated termination of the train of pulses may also be beneficial in cases the patient reaches a toilet facility before expiration of a predetermined or pre-programmed train of pulses, so as to expedite bladder voiding. The possibility of user- activated termination of the pulse train also constitutes a safety feature, which may reduce the risk of nerve damage due to excessive stimulation and/or reduce the patient's sensation of discomfort. The level of charge of the electrical pulses may be controlled by controlling one or more of:
- the amplitude of current of the electrical stimulation pulses;
- the amplitude of voltage of the electrical stimulation pulses;
- the pulse rate of the electrical stimulation pulses, i.e. the length of intervals between the pulses;
- the pulse width of the electrical stimulation pulses;
- the shape of the electrical stimulation pulses, however square pulses are preferred.
The pulse generator may be configured to stepwise increase the pulse charges from the initial level to the final level during a period of time of about 0.1 seconds to about 40 seconds. The stepwise increase of the pulse charges may be linearly or exponentially increased.
The pulse generator is preferably configured to provide the pulses at a pulse rate of about 5 pulses per second to about 50 pulses per second. In preferred embodiments, the initial level provides no current, whereas the final level provides charges at a current from about 0.01 mA to about 100 mA, such as from about 0.01 mA to about 10 or 20 mA. The at least one electrode is preferably configured to be placed at, on, in, near or around a genital nerve, such as a dorsal penile/clitoral nerve.
The pulses are typically provided at a pulse width of about 50 μs to about 400 μs, such as at a pulse width of about 200 μs.
In the present invention, the at least one electrode is preferably implanted or implantable at a left and/or right branch of the dorsal penile nerve, which is a distal portion of the pudendal nerve close to the genitals. The electrode may be implanted at or near the genitals or in Alcock's Canal via the perineum.
The pulse generator may be implantable/implanted in a subcutaneous pocket in the pelvic or abdominal region at a tissue depth of approximately 4 cm or less. In other embodiments, the pulse generator may be implantable/implanted to a tissue depth of between 0.3 cm and 0.4 cm or between 0.6 cm and 1.4 cm, or between 1.6 cm and 1.9 cm or between 2.1 and 2.8 cm. The pulse generator is preferably implanted in a subcutaneous pocket in the pelvic or abdominal region, such as in the anterior pelvic or abdominal region. The implant may contain means for fixation, e.g. sutures.
An external programming device may be provided in order to transmit the pulse stimulation parameters or pulse generation programs to the implantable pulse generator. The external programming device may be at the disposal of the patient, or it may alternatively be provided at a medical facility, operable by a trained physician only. Preferably, the external programming device includes suitable software, user interface, memory, power unit, and data processor.
The lead connecting the pulse generator to the at least one electrode may be helical in order to provide a flexible and mechanically strong connection. The lead may be coated with a biocompatible material or made entirely from a biocompatible material.
The housing of the pulse generator is preferably coated and made from a biocompatible material, such as titanium.
In a fourth aspect, the invention provides a surgical kit for preparing a system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents of a living being, including:
- an implantable electrode configured to be placed on, at or near a portion of a pudendal nerve or its branches;
- an implantable pulse generator having a pulse-generating circuitry and a battery for providing electrical pulses to the electrode in order to achieve said electrical stimulation of the pudendal nerve or its branches, the implantable pulse generator being configured to receive wirelessly transmitted inductive control signals and to provide said electrical pulses in response to said control signals;
- an electrical lead for connecting the pulse generator to the electrode; wherein the electrode, pulse generator and lead are packed in a sterile condition.
The electrode may be connected to the lead, thereby alleviating surgical personnel from the task of connecting the electrode to the lead. A tool for connecting the lead to the pulse generator may be included in the kit. The kit may further include tools for implanting at least one of the electrode, the lead and the pulse generator, e.g. for tunnelling the lead through body tissue.
In a fifth aspect, the invention provides a method of providing a surgical kit for preparing a system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents of a living being, the method comprising the steps of:
- providing an implantable electrode configured to be placed on, at, in, around or near a portion of a pudendal nerve or its branches; - providing an implantable pulse generator having a pulse-generating circuitry and a battery for providing electrical pulses to the electrode in order to achieve said electrical stimulation of the pudendal nerve or its branches, the implantable pulse generator being configured to receive wirelessly transmitted inductive control signals and to provide said electrical pulses in response to said control signals; - providing an electrical lead for connecting the pulse generator to the electrode; - connecting the electrical lead to the electrode; packing the electrode, the lead and the pulse generator in a sterile condition, the lead and the electrode being packed subsequently to the step of connecting the lead to the electrode.
Generally, as an alternative to inductive signals, the system may be configured to communicate triggering, control and/or programming signals by means of low frequency radio communcation, by means of intrabody communication, such as by volume conductance using the human body as an electrical conductor, and/or by means of pressure waves, such as acoustic waves.
Description of the drawings
Embodiments of the invention will be described with reference to the accompanying drawings, in which: Fig. 1 shows an illustration of the pelvic region of a patient, including an implanted electrode, pulse generator and lead, as well as an external triggering mechanism; Fig. 2 shows an illustration of the pulse generator shown in Fig. 1; Figs. 3 and 4 are illustrations of a wireless external triggering and programming device; Fig. 5 is an anatomic view showing the implanted pulse generator of Figs. 1 and
2 in association with a clinical programming system;
Figs. 6 and 7 are flow charts of various processes of the system of the present invention;
Figs. 8 and 9 are graphical representations of biphasic stimulus current outputs from the pulse generator;
Fig. 10 is an illustration of a sterilized kit including implantable elements as well as surgical tools for their implantation;
Fig. 11 illustrates a releasable connection between a pulse generator and the lead connecting the pulse generator to the electrode; Fig. 12 shows a further embodiment of a system according to the invention.
Fig. 1 generally illustrates the pelvis 100 of a patient 102 and a portion of the spinal cord 104. The pudendal nerves 108 exit the sacral cord and branch into the dorsal penile/clitoral nerves 110. Fig. 1 further illustrates Alcock's Canal 112 and the pubic symphysis 114. In the illustration of Fig. 1, a cuff electrode 116 is placed around the left dorsal penile/clitoral nerve 110. The electrode 116 is connected to an implanted pulse generator 118 via an implanted lead 120. The pulse generator 118 comprises a battery (not shown in Fig. 1) and is configured to convey pulses of electrical current through the electrode 116 via the lead 120, so as to provide electrical stimulation to the dorsal penile/clitoral nerve 110. The battery may be chargeable by means of inductive wireless power transmission providing electromagnetic signals at a frequency of below 315 kHz.
An external, wrist worn device 122 is provided for wirelessly communicating with the pulse generator 118. The wrist worn device 122 represents a triggering mechanism for causing the pulse generator 118 to pass a series of electrical pulses to the electrode. Additionally, the wrist worn device 112 may be configured as a programming device for setting stimulation parameters or for otherwise programming or configuring the implanted pulse generator 118. The pulse generator 118 may be configured for providing data to the external device 122, such as e.g. a low battery warning of the pulse generator 118.
Fig. 2 generally shows the main components of the pulse generator 118. The pulse generator includes a telemetry unit 124 for receiving and/or sending information to/from an external device, such as the wrist worn device 122 shown in Fig. 1. Further, the pulse generator includes a pulse generating circuitry 126, and a battery 128. The battery 128 is preferably hermetically sealed within a housing of the pulse generator 118. The pulse generator contains a connector 130 to attach the implantable lead 120.
As mentioned above, the wrist worn device 122 may serve as a wireless external triggering or programming device for triggering, programming or configuring the pulse generator. As shown in Figs. 3 and 4, the patient 102 may trigger or program the pulse generator 118 by locating the wrist worn device 122 in the vicinity of the implanted pulse generator 118 and activating a programming action, so as to wirelessly transmit an appropriate triggering signal, programming or configuration data to the pulse generator 118, as shown in Fig. 4.
Fig. 5 illustrates a clinical programming system for a system according to the invention. The programming system includes a personal computer 132, which is typically operated by a physician, and a programming box 134. The programming box is connected to an inductive coil 138 via a lead 136. Programming of the implanted pulse generator 118 is performed via wireless, inductive telemetry from the inductive coil through the skin of the patient.
Fig. 6 shows a flowchart of an embodiment of a process occurring in the systems described above. Initially, the pulse generator is in a dormant mode, in which no voltage is maintained at any of the implanted components and circuits, except at the wake-up circuit of the pulse generator. When the patient activates the trigger device (triggering mechanism) 122 or 140, a trigger signal is provided to initiate a wake-up command for the pulse generator 118 via its wake-up circuit. Further, a voltage is applied to the implanted components and circuits, at which no voltage was maintained in the dormant mode. The wake-up command causes the pulse generator to enter an active mode and to activate a predefined stimulation program. If the pulse generator detects a low battery status, a wireless warning signal is provided to an external device, such as the external triggering device 122 or an external programming device. Subsequently, the pulse generator initiates a stepwise increase of pulse charges from zero up to a final charge level, and pulse stimuli are provided for a predetermined period of time, or until the patient deactivates the pulses. Finally, the pulse generator enters a dormant mode, and voltage is cut off to the implanted components and circuits, expect for the wake-up circuit of the pulse generator, at which a voltage is maintained.
Fig. 7 illustrates a similar embodiment of a process occurring in the external parts of the systems described above. When the patient activates the trigger device (triggering mechanism 122 or user activateable device 162, see Fig. 12), a wake-up command is sent to the wake-up circuit of the pulse generator (directly from triggering mechanism 122 or via the skin-borne device 160, see the below description of Fig. 12), and certain stimulation parameters are possibly also sent to the pulse generator. An external signal receiver for a warning signal is initiated, and if a warning signal indicative of e.g. a low battery status of the pulse generator, is received, a warning indicator is initiated. In the same manner, a warning indicator may be initiated, if there is a low battery warning from the trigger device.
Figs. 8 and 9 are graphical representations of biphasic stimulus current outputs from the pulse generator during initial stepwise increase of the pulse charges upon activation of the pulse generator. In the example shown, the current amplitudes A of the pulse are stepwise increased. It should however be understood that the pulse charges may also be increased by extending the pulse width t, shortening the intervals between the pulses T, or stepwise increase the pulse voltages. The chart of Fig. 8 illustrates de-charge of a series capacitor upon short-circuiting of electrodes. In the example of Fig. 9, alternating polarity is achieved by alternating the current through the electrode by means of hardware or software control embedded in the pulse generator.
Fig. 10 illustrates an embodiment of a sterilized surgical kit. The kit includes several sterilized packages. One package contains the pulse generator 118. Another package contains the electrode 116, connected to a connector 152 via the lead 120. Further packages 148 and 150 include surgical tools for implanting the electrode 116, pulse generator 118 and lead 120. The surgical tools may for example include tunneling tools for tunneling the lead and/or electrode through the patient's body during surgical intervention. As shown in Fig. 11, the connector 152 allows the lead 120 to be releasably connected to the pulse generator 118.
In the embodiment of Fig. 12, the user-operable triggering mechanism comprises a skin- borne device 160 releasbly attached to an abdominal wall of the user in the vicinity of the implanted pulse generator 118 and electrode 116. The user-operable triggering mechanism further comprises a hand-held user activatable device 162 for transmitting radio frequency control signals to the skin-borne device 160, which in turn generates inductive wireless signals to the pulse generator 118.

Claims

1. A system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents of a living being, including: - an implantable electrode configured to be placed on, at, in, around or near a portion of a pudendal nerve or its branches;
- an implantable pulse generator having a pulse-generating circuitry and optionally a first battery for powering the pulse generator to provide electrical pulses to the electrode in order to achieve said electrical stimulation of the pudendal nerve or its branches, the implantable pulse generator being configured to receive wirelessly transmitted control signals and to provide said electrical pulses in response to said control signals;
- an electrical lead for connecting the pulse generator to the electrode;
- a user-operable triggering mechanism configured to transmit an inductive wireless control signal to the implantable pulse generator in order to trigger a sequence of said electrical pulses.
2. A system according to claim 1, wherein the triggering mechanism is configured to transmit said inductive wireless control signal at a frequency below 315 kHz.
3. A system according to claim 1 or 2, further comprising an external programming device for transmitting data to the pulse generator when implanted, the external programming device and the pulse generator being configured to transmit and receive said data via wireless radio communication at a frequency above 400 MHz.
4. A system according to any of claims 1-3, wherein the user-operable triggering mechanism comprises:
- a skin-borne device for transmitting said inductive wireless control signal to the implantable pulse generator, and
- a user activatable device for transmitting a wireless radio frequency signal to the skin-borne device upon user activation of the user activatable device; the skin-borne device being configured to receive the wireless radio frequency signal transmitted from the user activatable device and to generate the inductive wireless control signal for the implantable pulse generator in response thereto.
5. A system according to claim 4, comprising an external second battery for powering the skin-borne device.
6. A system according to any of the preceding claims, wherein the first battery for powering the pulse generator is implantable.
7. A system according to any of the preceding claims, wherein the wireless control signal is transmittable through a body portion of the living being within a distance of at most 50 cm from the pulse generator.
8. A system according to any of the preceding claims, wherein the first and/or the second battery is rechargeable.
9. A system according to any of the preceding claims, wherein the pulse generator is configured to provide said electrical pulses when it is in an active mode, the pulse generator being further configured to enter a dormant mode upon completion of a sequence of said pulses, and wherein the user-operable triggering mechanism is configured to provide said inductive control signal with an amount of energy sufficient to cause the pulse generator to switch from said dormant mode to said active mode.
10. A system according to any of the preceding claims, wherein the triggering mechanism is configured to include at least one of the following commands in the control signal:
- a wake-up command for the implantable pulse generator;
- a command for the pulse generator to select a particular one of a plurality of stimulation programs pre-stored in a memory of the implantable pulse generator; and - stimulation parameters of said stimulation pulses, including at least one of: an amplitude of the electrical pulses; a voltage of the electrical pulses; a pulse width of the electrical pulses; a pulse rate of the electrical pulses.
11. A system according to claim 10, wherein said pre-stored stimulation programs are configured to initiate said sequence of stimulation pulses by stepwise increasing charges of electrical pulses from an initial level to a final level.
12. A system according to any of the preceding claims, wherein the implantable pulse generator is configured to control stimulation parameters of said stimulation pulses and to charge balance the pulses.
13. A system according to any of the preceding claims, wherein the triggering mechanism comprises a signal receiver for receiving a wireless signal from the implantable pulse generator, and wherien the implantable pulse generator is configured to transmit a wireless signal to the triggering mechanism in case of one or more predetermined conditions of the implantable components.
14. A system according to any of the preceding claims, wherein the triggering mechanism comprises a memory for storing stimulation parameters.
15. A system according to any of the preceding claims, wherein the triggering mechanism is included in a device, which is sized and configured to be worn around the wrist of a human being.
16. A system according to any of the preceding claims, wherein the triggering mechanism is configured to wirelessly transmit stimulation parameters to the implantable pulse generator.
17. A system according to any of the preceding claims, further comprising an external programming device configured to transmit pulse stimulation parameters or pulse generation programs to the implantable pulse generator.
18. A user-operable triggering mechanism for a system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents, the triggering mechanism being configured to transmit a wireless control signal to an implantable pulse generator in order to trigger a sequence of electrical pulses, the control signal comprising an inductive signal.
19. A triggering mechanism according to claim 18, wherein the triggering mechanism is included in a device, which is sized and configured to be worn around the wrist of a human being.
20. A method for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents in a living being, said method including the steps of:
- implanting an electrode on, at, in, around or near a portion of a pudendal nerve or its branches,
- implanting a pulse generator for providing electrical pulses to the electrode in order to achieve said electrical stimulation of the pudendal nerve or its branches, the implantable pulse generator being configured to receive wirelessly transmitted contol signals and to provide said electrical pulses in response to said control signals; - powering the pulse generator by means of an implanted battery or by means of power inductively transmitted through the living being's skin from an external device;
- transmitting a wireless control signal to the implanted pulse generator from a position outside the living being's body in order to trigger a sequence of said electrical pulses, the control signal comprising an inductive signal.
21. A method according to claim 20, further comprising the steps of:
- placing a wrist-worn triggering mechanism around the wrist of a human being, the triggering mechanism being configured such that it is capable of transmitting said wireless control signal; and - configuring the triggering mechanism and the implanted pulse generator such that the wireless control signal is only receivable by the pulse generator when the wrist-worn triggering mechanism is within a predetermined range from the implanted pulse generator.
22. A surgical kit for preparing a system for the treatment of urge incontinence by electrical stimulation of pudendal nerve afferents of a living being, including:
- an implantable electrode configured to be placed on, at, in, around or near a portion of a pudendal nerve or its branches;
- an implantable pulse generator having a pulse-generating circuitry and optionally a battery for providing electrical pulses to the electrode in order to achieve said electrical stimulation of the pudendal nerve or its branches, the implantable pulse generator being configured to receive wirelessly transmitted inductive control signals and to provide said electrical pulses in response to said control signals;
- an electrical lead for connecting the pulse generator to the electrode; wherein the electrode, pulse generator and lead are packed in a sterile condition.
23. A surgical kit according to claim 22, wherein the electrode is connected to the lead.
24. A surgical kit according to claim 22 or 23, further comprising a tool for connecting the lead to the pulse generator.
25. A surgical kit according to any of claims 22-24, further comprising tools for implanting at least one of the electrode, the lead and the pulse generator.
PCT/EP2008/068095 2007-12-21 2008-12-19 Inductive control of electrical nerve stimulation system for the treatment of pelvic disorders WO2009080784A1 (en)

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