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EP-4483943-B1 - APPARATUS WITH ENHANCED STIMULATION WAVEFORMS

EP4483943B1EP 4483943 B1EP4483943 B1EP 4483943B1EP-4483943-B1

Inventors

  • MISHRA, LAKSHMI NARAYAN
  • MAKOUS, JAMES C.
  • HARTLEY, Lee Fason
  • PIVONKA, Daniel M.
  • FLAHERTY, CHRISTOPHER J.

Dates

Publication Date
20260513
Application Date
20170215

Claims (15)

  1. An implantable stimulation device (200) for a patient, comprising: an implantable functional element (260) configured to deliver a stimulation waveform to tissue of the patient; and an implantable controller (250) configured to provide the stimulation waveform to the functional element (260), the stimulation waveform comprising bursts of trains of therapeutic pulses, wherein each burst comprises a burst-on period from a beginning of a first therapeutic pulse of a first train of therapeutic pulses to an end of a last therapeutic pulse of a last train of therapeutic pulses of the burst, wherein there is a burst-off period between an end of a first burst and a beginning of a next burst, and wherein the implantable controller (250) is further configured to provide a charge recovery pulse to the functional element during the burst-off period.
  2. The implantable stimulation device of claim 1, wherein each therapeutic pulse comprises a first phase, and wherein the charge recovery pulse comprises a second, opposite phase.
  3. The implantable stimulation device of claim 2, wherein the first phase comprises a cathodic phase and the second phase comprises an anodic phase.
  4. The implantable stimulation device of any one of claims 1 to 3, wherein the implantable controller is further configured to discharge into the tissue of the patient during the burst-off period.
  5. The implantable stimulation device of claim 4, wherein the charge recovery pulse is provided during a charge recovery slot of the burst-off period, and wherein the functional element discharges during the charge recovery slot of the burst-off period.
  6. The implantable stimulation device of any one of claims 1 to 5, wherein the therapeutic pulses have a frequency of at least 1 kHz.
  7. The implantable stimulation device of any one of claims 1 to 6, wherein the burst-on period is between 8 msec and 12 msec.
  8. The implantable stimulation device of any one of claims 1 to 7, wherein the burst-off period is between 8 msec and 18 msec.
  9. The implantable stimulation device of any one of claims 1 to 8, wherein the stimulation waveform comprises an inter-pulse gap between the therapeutic pulses with a duration between 1 µsec and 100 µsec.
  10. The implantable stimulation device of any one of claims 1 to 9, wherein the therapeutic pulses each comprise a pulse width between 1 µsec and 10 msec.
  11. The implantable stimulation device of any one of claims 1 to 10, wherein the bursts comprise a first burst with a first frequency and a first amplitude and one or more second bursts with one or both of a second, different frequency and a second, different amplitude.
  12. The implantable stimulation device of any one of claims 1 to 11, wherein the implantable controller is further configured to maintain an amplitude of the therapeutic stimulation pulses at a compliance voltage while varying a pulse width of the therapeutic pulses.
  13. The implantable stimulation device of any one of claims 1 to 12, wherein the tissue is of or associated with a spinal cord of the patient.
  14. The implantable stimulation device of any one of claims 1 to 13, wherein the tissue is peripheral nerve tissue.
  15. The implantable stimulation device of any one of claims 1 to 14, wherein the implantable functional element comprises an electrode.

Description

Field of the Invention The present invention relates generally to medical apparatus for a patient, and in particular, apparatus that deliver enhanced stimulation waveforms to effectively treat pain while avoiding undesired effects. BACKGROUND OF THE INVENTION Implantable devices that treat a patient and/or record patient data are known. For example, implants that deliver energy such as electrical energy, or deliver agents such as pharmaceutical agents are commercially available. Implantable electrical stimulators can be used to pace or defibrillate the heart, as well as modulate nerve tissue (e.g. to treat pain). Most implants are relatively large devices with batteries and long conduits, such as implantable leads configured to deliver electrical energy or implantable tubes (i.e. catheters) to deliver an agent. These implants require a fairly invasive implantation procedure, and periodic battery replacement, which requires additional surgery. The large sizes of these devices and their high costs have prevented their use in a variety of applications. Nerve stimulation treatments have shown increasing promise recently, showing potential in the treatment of many chronic diseases including drug-resistant hypertension, motility disorders in the intestinal system, metabolic disorders arising from diabetes and obesity, and both chronic and acute pain conditions among others. Many of these implantable device configurations have not been developed effectively because of the lack of miniaturization and power efficiency, in addition to other limitations. There is a need for apparatus, systems, devices and methods that provide one or more implantable devices and are designed to provide enhanced treatment of pain and other enhanced benefits. WO2014/145222 discloses an external control device, neuromodulation system, and method of providing therapy to a patient. Electrical modulation energy is delivered to a target tissue site of the patient at a programmed amplitude value, thereby providing therapy to the patient without the perception of paresthesia. In US2016/008604, a neuromodulation system comprises a plurality of electrical terminals configured for being respectively coupled to electrodes, modulation output circuitry configured for respectively outputting a plurality of individual electrical pulse trains in a plurality of timing channels to the electrical terminals, wherein each of the timing channels prevents the respective pulse train from having a specific characteristic, and control circuitry configured for controlling the modulation output circuitry in a manner that outputs the pulse trains to a common set of the electrical terminals, thereby creating a combined electrical pulse train at the common set of electrical terminals that has the specific characteristic. US9,174,053 relates to a neuromodulation system comprises a plurality of electrical terminals configured for being respectively coupled to a plurality of electrodes, a user interface configured for receiving input from a user that selects one of a plurality of different shapes of a modulating signal and/or selects one of a plurality of different electrical pulse parameters of an electrical pulse train, neuromodulation output circuitry configured for outputting an electrical pulse train to the plurality of electrical terminals, and pulse train modulation circuitry configured for modulating the electrical pulse train in accordance with the selected shape of the modulating signal and/or selected electrical pulse parameter of the electrical pulse train. In US8,965,521, various implantable device embodiments may comprise a neural stimulator configured to deliver a neurostimulation therapy with stimulation ON times and stimulation OFF times where a dose of the neurostimulation therapy is provided by a number of neurostimulation pulses over a period of time. The neural stimulator may be configured to monitor the dose of the delivered neurostimulation therapy against dosing parameters. The neural stimulator may be configured to declare a fault if the monitored dose does not favorably compare to a desired dose for the neurostimulation therapy, or may be configured to record data for the monitored dose of the delivered neurostimulation therapy, or may be configured to both record data for the monitored dose of the delivered neurostimulation therapy and declare a fault if the monitored dose does not favorably compare to a desired dose for the neurostimulation therapy. SUMMARY According to an aspect of the present inventive concepts, a medical apparatus for a patient comprises an implantable system. The implantable system comprises a first implantable device comprising at least one implantable functional element configured to deliver stimulation energy to tissue of the patient, and an implantable controller configured to provide a stimulation waveform to the at least one implantable functional element, the stimulation waveform comprising one or more stimulation p