Reduced Energy Interleaved Multi-Contact Neuromodulation Therapy

Abstract

To provide a device and a method for controlling electrical stimulation pulses that enable a patient's burden to be reduced, therapy coverage to be extended, therapy effectiveness to be improved and, in particular, device sizes to be reduced.SOLUTION: A medical device 1 for generating electrical stimulation of a patient P includes: a pulse generator 2 configured to generate current pulses CP for electrical stimulation of the patient P; and at least one electrode lead 3 configured to be connected to the pulse generator 2. The electrode lead has a plurality of electrode contacts E1, ..., E8 for delivering the current pulses to tissue S of the patient P. The pulse generator is configured to generate the current pulses with a rate in the range from 1 Hz to 100 kHz, and the individual current pulse has a pulse width in the range from 10 μs to 10 ms.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to medical devices and methods for controlling electrical stimulation pulses using leads with multiple electrodes. [Background technology]

[0002] In the field of neuromodulation, spinal cord stimulation (SCS) has been applied as a means of analgesia in patients suffering from neuropathic pain. SCS has traditionally been considered to require that paresthesia perceptions be superimposed on the patient's painful area to allow pain relief. Recent studies have shown that high-frequency paresthesia stimulation is an alternative mechanism of pain relief that is effective in patients without the need for intraoperative electrode mapping selection.

[0003] In particular, electrical stimulation requires charge balance to terminate electrochemical reactions that may cause harmful conditions for both tissue and electrodes. High frequency (HF) stimulation is constrained in timing requiring an active balancing phase instead of the passive balancing phase utilized in traditional 40-60 Hz SCS. At 10,000 Hz (10 kHz), the timing (i.e., interpulse interval) between stimulation and balancing phase is very short, which causes the balancing phase amplitude to affect the effect desired to be caused by the stimulation phase. This implies higher energy is required, resulting in more frequent device charging to support continuous stimulation, and larger implantable device size to fit larger batteries.

[0004] Furthermore, high energy requirements are currently mitigated by stimulation over a single bipolar electrode pair or similarly few electrodes, which can lead to under-treatment efficacy as the patient's pain area expands over time, resulting in further visits to reprogram to attempt to cover a larger pain area.

[0005] Associated with these drawbacks are increased burden on the patient for charging and mobility, increased opportunity for uncomfortable implantable device pocket placement or device erosion through the skin due to large size, reduced service time resulting in patients requiring more revision surgeries for device exchange, and an overall decrease in the effectiveness and patient satisfaction with the implant.

[0006] US Patent Application Publication No. 2017 / 001014 describes an electrode-based stimulation delivery method in which a charge-balanced pulse is distributed across two or more electrodes.

[0007] Additionally, 10 kHz incongruence therapy and so-called burst therapy (incongruence in most patients) using stimulation duty cycling are known in the art.

[0008] 10 kHz therapy using duty cycling can reduce charge usage for a given stimulation amplitude due to the repetitive incorporation of time periods when stimulation is off between time periods when stimulation is on. However, a problem with this approach is that it can also reduce the overall pain relief for the patient as a result of an overall reduction in therapeutic dose.

[0009] Furthermore, burst therapy, although requiring less energy than 10 kHz therapy, suffers from lower pain relief performance as evidenced by reported responder rates, resulting in reduced levels of pain relief in patients with low back and leg pain.

[0010] Furthermore, it has been found that multiple electrode "current steering" can be inefficient for simultaneously driving stimulation pulses on multiple electrodes to reach the dorsal horn region of the spinal cord as a therapeutic target. Moreover, driving multiple split current sources typically requires complex electronics, which may be ideal for paresthesia therapeutic steering, but this complexity is undesirable for high frequency stimulation purposes. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] US Patent Application Publication No. 2017 / 001014 Summary of the Invention [Problem to be solved by the invention]

[0012] Based on the above, it is therefore an object of the present invention to provide a device and method for controlling electrical stimulation pulses, which allows the burden on the patient to be reduced, the treatment coverage to be extended, the treatment efficacy to be improved, and in particular the size of the device to be reduced. [Means for solving the problem]

[0013] According to claim 1, there is provided a medical device for generating electrical stimulation (in particular spinal cord stimulation) of a patient, comprising: a pulse generator configured to generate current pulses for electrical stimulation of a patient; at least one electrode lead configured to be connected to a pulse generator and having a plurality of electrode contacts for delivering said current pulses to tissue of a patient; Equipped with A medical device is disclosed in which the pulse generator is configured to generate the current pulses at a rate in the range of 1 Hz to 100 kHz, with each current pulse comprising a pulse width in the range of 10 μs to 10 ms.

[0014] According to one embodiment, each individual electrode contact is capable of generating current pulses at the above rates.

[0015] Moreover, according to one embodiment, the rate is in the range of 50Hz to 1470Hz and the pulse width is in the range of 30μs to 1000μs.

[0016] Furthermore, according to one embodiment, each current pulse comprises an amplitude in the range of 0.01 mA to 20 mA, preferably in the range of 0.1 mA to 10 mA.

[0017] Moreover, according to one embodiment, the pulse generator is configured to deliver a current pulse between two electrode contacts of the plurality of electrode contacts, deliver a subsequent current pulse between two further electrode contacts of the plurality of electrode contacts, and thereafter deliver or allow a charge balancing current between the two electrode contacts.

[0018] In particular, in one embodiment, the pulse generator is configured to deliver the current pulses using at least four electrode contacts.

[0019] According to a further embodiment, said rate is 1470 Hz and the pulse width is 90 μs, in particular the pulse generator is configured to deliver the current pulses using at least four electrode contacts.

[0020] Moreover, according to one embodiment, the rate is 625 Hz and the pulse width is 200 μs, and in particular, the pulse generator is configured to deliver the current pulses using at least four electrode contacts.

[0021] Moreover, in one embodiment, the rate is 1470 Hz and the pulse width is 60 μs, and in particular, the pulse generator is configured to deliver the current pulses using at least four electrode contacts.

[0022] In particular, in one embodiment, the rate is 1470 Hz and the pulse width is 120 μs, and in particular, the pulse generator is configured to deliver the current pulses using at least four electrode contacts.

[0023] Furthermore, according to one embodiment, the pulse generator is configured to sequentially deliver current pulses through different electrode contacts, and for each current pulse, at least two charge-balanced current pulses are delivered subsequently through respective electrode contacts to reach a charge-balanced state, and in particular, each charge-balanced current pulse is delivered simultaneously with a stimulation current pulse delivered through one of the different electrode contacts.

[0024] Moreover, according to one embodiment, the rate is 300 Hz and the pulse width is 300 μs, and in particular, the pulse generator is configured to deliver the current pulses using at least three electrode contacts.

[0025] Moreover, according to one embodiment, the rate is 556 Hz and the pulse width is 300 μs, and in particular, the pulse generator is configured to deliver the current pulses using at least three electrode contacts.

[0026] In particular, according to one embodiment, said rate is 556 Hz and the pulse width is 90 μs, and in particular the pulse generator is configured to deliver the current pulses using at least three electrode contacts.

[0027] In particular, in one embodiment, the rate is 300 Hz and the pulse width is 90 μs, and in particular, the pulse generator is configured to deliver the current pulses using at least three electrode contacts.

[0028] In particular, in one embodiment, the rate is 50 Hz and the pulse width is 300 μs, and in particular, the pulse generator is configured to deliver the current pulses using at least three electrode contacts.

[0029] Moreover, according to one embodiment, each current pulse is a cathodic current pulse and / or each charge balancing current pulse is an anodic current pulse.

[0030] Moreover, according to one embodiment, the pulse generator is configured to deliver said current pulses to the patient's central nervous system such that no paresthesia is induced in the patient.

[0031] Alternatively, according to one embodiment, the pulse generator is configured to deliver said current pulses to the patient's central nervous system such that paresthesia is induced in the patient.

[0032] Moreover, according to one embodiment, at least one electrode lead is implanted along the patient's spinal cord and configured to deliver said current pulses to a longitudinal region of the spinal cord greater than one vertebral body of the patient, in other words, the active electrode contact is adjacent to an area of ​​tissue greater than one vertebral body.

[0033] Furthermore, according to one embodiment adjacent and / or simultaneously active electrode contacts of an electrode lead are separated by a distance in the range of 7mm to 14mm. According to one embodiment adjacent and / or simultaneously active electrode contacts of an electrode lead are separated by a distance in the range of 6mm to 6.5mm measured from the center of an electrode contact to the center of an adjacent electrode contact.

[0034] Moreover, according to one embodiment, the medical device is configured to alternately deliver current pulses during on periods and suspend delivery of current pulses during off periods, wherein the length of time during which the current pulses are actually delivered by the pulse generator during the on periods includes a length corresponding to 10%-100%, particularly 25%-100%, particularly 30%-100%, particularly 10%-60% of the length of the on periods, this percentage value also being referred to as a duty cycling value.

[0035] A further aspect of the present invention is a method for controlling electrical stimulation pulses using a medical device according to any one of the preceding claims, comprising the steps of: sequentially delivering current pulses through the electrode contacts, where for each current pulse, at least one charge-balancing current pulse is subsequently delivered through the respective electrode contact to reach a charge-balancing state; The current pulses are delivered at a rate in the range of 1 Hz to 100 kHz, and each current pulse comprises a pulse width in the range of 10 μs to 10 ms.

[0036] Furthermore, according to yet another aspect of the present invention there is provided a medical device for generating electrical stimulation (particularly in the form of spinal cord stimulation) in a patient, comprising: a pulse generator configured to generate current pulses for electrical stimulation of a patient; at least one electrode lead configured to be connected to a pulse generator and comprising a plurality of electrode contacts for delivering said current to tissue of a patient (in particular, said tissue comprises a spinal cord, according to one embodiment), the pulse generator configured to repeatedly deliver current pulses between at least two electrodes (of said plurality of electrode contacts) forming a first group of electrode contacts, the pulse generator further configured to deliver a charge-balanced current pulse after each current pulse such that each current pulse is separated from a subsequent charge-balanced current pulse by an inter-pulse interval, each current pulse comprising an amplitude having the same absolute value as a subsequent charge-balanced current pulse but of opposite polarity, and the pulse generator configured to deliver a current pulse between each current pulse and the subsequent charge-balanced current pulse, the current pulse being delivered between at least two further electrode contacts (of said plurality of electrode contacts) forming a second group of electrode contacts; A medical device is disclosed comprising:

[0037] According to one embodiment, each individual electrode contact is capable of generating a current pulse at said rate, preferably said rate being applied in relation to a cathodal stimulation pulse.

[0038] According to one embodiment of the medical device, the pulse generator is further configured to deliver a charge-balanced current pulse between the electrodes of the second group after each current pulse delivered between the electrodes of the second group, each current pulse delivered between the electrodes of the second group including an amplitude having the same absolute value but opposite sign as a subsequent charge-balanced current pulse delivered between the electrodes of the second group.

[0039] Further, according to one embodiment of the medical device, each current pulse is a cathodic current pulse delivered by electrical contacts forming a cathode (i.e., corresponds to a cathodic phase) and / or each charge-balancing current pulse is an anodic charge-balancing current pulse delivered by electrical contacts forming an anode (i.e., corresponds to an anodic phase).

[0040] Furthermore, according to one embodiment of the medical device, the two groups of electrode contacts are arranged consecutively to one another in the longitudinal extension direction of the electrode lead, and the pulse generator is configured to deliver said current pulses as cathodic current pulses in a sequential manner (i.e. as a so-called sequential cathodic train) such that each electrode contact of the two groups of electrode contacts delivers a cathodic current pulse following the cathodic current pulse of the preceding electrode contact and prior to the anodic charge balancing current pulse of the preceding electrode contact.

[0041] According to one embodiment, the pulse generator is configured to deliver cathodal current pulses in a sequential manner that includes temporal and / or spatial variation, i.e., variation in the timing of the pulses and / or the selection of electrode contacts (or stimulation locations) for delivering the pulses.

[0042] In particular, the group of electrode contacts includes a first electrode contact, a second electrode contact, a third electrode contact, and a fourth electrode contact (of the plurality of electrode contacts) that are arranged consecutively with one another in the longitudinal extension direction of the electrode lead, the first group of electrode contacts including the first electrode contact and the third electrode contact and the second group of electrode contacts including the second electrode contact and the fourth electrode contact, such that the two groups overlap (i.e., the second electrode contact of the second group is arranged between the first and third electrode contacts of the first group, and the third electrode contact of the first group is arranged between the second and fourth electrode contacts of the second group).

[0043] Moreover, according to one embodiment, the medical device is an implantable medical device, in particular the pulse generator is an implantable pulse generator, and in particular the electrode lead is an implantable electrode lead.

[0044] According to a further embodiment of the medical device according to the invention, the pulse generator of the medical device is adapted to generate current pulses for spinal cord stimulation, i.e. the medical device is a spinal cord stimulator.

[0045] According to a further embodiment of the medical device, the plurality of electrode contacts disposed along the electrode lead total eight electrode contacts, each of which may be a cylindrical electrode contact extending longitudinally of the lead or an annular electrode contact extending circumferentially of the electrode lead, each adjacent electrode contact being separated by an electrically insulating material that forms a portion of an outer surface of the electrode lead.

[0046] In particular, according to a preferred embodiment of the device according to the invention, the pulse generator is adapted to generate the current pulses without inducing paresthesia in the patient receiving the current pulses.

[0047] Furthermore, according to one embodiment of the medical device, the pulse generator is configured to deliver current pulses having a frequency within the range of 200 Hz to 100 kHz.

[0048] Furthermore, according to one embodiment, only one electrode contact of the plurality of electrode contacts of the electrode lead is arranged on the electrode lead between two electrode contacts of a first group and / or only one electrode contact of the plurality of electrode contacts is arranged on the electrode lead between two electrode contacts of a second group.

[0049] Furthermore, the above-described interleaved electrical stimulation with two groups of electrode contacts can also be achieved with more than two pairs of electrodes or more than two groups of electrodes.

[0050] A further aspect of the invention is a method for controlling electrical stimulation pulses, in particular using a medical device according to the invention (in particular a spinal cord stimulator), the method comprising: a) delivering a current pulse between at least two electrode contacts forming a first group of electrode contacts; b) delivering a charge-balancing current pulse between the first group of electrodes to perform charge balancing, the charge-balancing current pulse having an amplitude of the same absolute value as the amplitude of the preceding current pulse but of opposite sign; c) delivering a further current pulse between at least two electrode contacts forming a second group of electrode contacts after said current pulse and before the charge-balancing current pulse; The present invention relates to a method comprising the steps of:

[0051] According to one embodiment, the method comprises a further step d), according to which after said further current pulse and after the charge balancing pulse of the first group of electrode contacts a further charge balancing current pulse is delivered between electrodes of said second group, the further charge balancing current pulse having an amplitude of the same absolute value as the amplitude of the further current pulse but of opposite polarity in order to perform charge balancing.

[0052] According to a further embodiment of the method, steps a) to d) of the method are repeated starting with step a).

[0053] Furthermore, according to one embodiment of the method, the current pulses (i.e. each current pulse and each further current pulse) are delivered in a spatially and temporally sequential manner as cathodic current pulses (i.e. as a so-called sequential cathodic train) such that each electrode contact of the two groups of electrode contacts delivers a cathodic current pulse (as a cathode) following the cathodic current pulse of the preceding electrode contact and prior to the anodic charge balancing current pulse of the preceding electrode contact.

[0054] In other words, the stimulation preferably results in a sequential cathodic train, with adjacent electrode contacts delivering a cathodic stimulation subsequent to the cathodic stimulation of a preceding adjacent cathode and before the preceding cathode delivers its anodic charge balancing phase.

[0055] Furthermore, according to one embodiment of the method, the groups of electrode contacts overlap along the longitudinal extension of the electrode lead that comprises the electrode contacts (see also above, for example).

[0056] According to a further embodiment of the method according to the invention the current pulses are delivered with a frequency in the range of 200 Hz to 100 kHz.

[0057] Furthermore, according to one embodiment of the method, the current pulses are preferably adapted to perform spinal cord stimulation (SCS).

[0058] According to a further embodiment of the method according to the invention, the electrical stimulation / current pulses are applied without inducing paresthesia (particularly in the case of SCS).

[0059] According to a further embodiment of the method according to the invention, electrical stimulation by current pulses is applied to induce electric field changes in the spinal cord with a frequency in the range of 200 Hz to 100 kHz.

[0060] According to a further embodiment of the method, only one further electrode contact is arranged on the electrode lead between two electrode contacts of the first group, more particularly, only one further electrode contact is arranged on the electrode lead between two electrode contacts of the second group.

[0061] Of course, also with regard to the method according to the invention, the above-mentioned interleaved stimulation can be realised with more than two pairs of electrode contacts or more than two groups of electrode contacts (see also above).

[0062] A further aspect of the invention relates to the use of the method according to the invention for configuring or operating a spinal cord stimulator.

[0063] In the following, exemplary embodiments and further features of the invention will be explained in more detail with reference to the drawings. [Brief description of the drawings]

[0064] [Figure 1] FIG. 1 shows an example of a medical device according to the present invention in the form of a spinal cord stimulation device having electrode leads that can be implanted in the epidural space of a patient. [Diagram 2] FIG. 1 is a schematic diagram of one embodiment of a medical device according to the present invention, in which the pulse generator is configured for dual bipolar spinal cord stimulation. [Diagram 3] FIG. 1 is a schematic diagram of one embodiment of a medical device according to the present invention, in which the pulse generator is configured for dual bipolar spinal cord stimulation. [Figure 4] FIG. 2 is a schematic illustration of the principle of duty cycling that can be used by a medical device according to the present invention. [Figure 5A] FIG. 1 illustrates an electrode lead of one embodiment of a medical device according to the present invention in the form of an 8-contact SCS lead having four active electrode contacts designated E1-E4, where the dark grey contacts are the active cathodes of a given electrode group and the light grey contacts are the active anodes of a given electrode group, showing a first phase, first group G1, with the cathode being superior (inter-pulse phases where no stimulation is delivered are not shown). [Figure 5B] FIG. 1 shows an electrode lead of one embodiment of a medical device according to the present invention in the form of an 8-contact SCS lead having four active electrode contacts designated E1-E4, where the dark grey contacts are the active cathodes of a given electrode group and the light grey contacts are the active anodes of a given electrode group, illustrating a second phase, second group G2, with the cathode being superior (inter-pulse phases where no stimulation is delivered are not shown). [Figure 5C] FIG. 1 illustrates an electrode lead of one embodiment of a medical device according to the present invention in the form of an 8-contact SCS lead having four active electrode contacts designated E1-E4, where the dark grey contacts are the active cathodes of a given electrode group and the light grey contacts are the active anodes of a given electrode group, showing the third phase, first group G1, with the cathode inferior (inter-pulse phases where no stimulation is delivered are not shown). [Figure 5D]FIG. 1 shows an electrode lead of one embodiment of a medical device according to the present invention in the form of an 8-contact SCS lead having four active electrode contacts designated E1-E4, where the dark grey contacts are the active cathodes of a given electrode group and the light grey contacts are the active anodes of a given electrode group, illustrating the final phase, second group G2, with the cathode inferior (inter-pulse phases where no stimulation is delivered are not shown). [Figure 6] FIG. 1 is a diagram of a conventional high frequency stimulation waveform between two electrode contacts, where AP denotes the anodic phase, CP denotes the cathodic phase, W denotes the pulse width, and II denotes the interpulse interval. [Figure 7] FIG. 1 is a diagram of a subthreshold sensory stimulation waveform between two groups (G1 and G2) of two electrode contacts (E1, E3 in G1 and E2, E4 in G2) according to one embodiment of the present invention, where AP indicates the anodic phase, CP indicates the cathodic phase, W indicates the pulse width, and II indicates the interpulse interval. [Figure 8A] FIG. 1 shows the electrode configurations being tested in a diagram illustrating spinal recruitment efficiency seen in study BENEFIT-01. [Figure 8B] FIG. 11 shows normalized paresthesia threshold amplitudes per configuration in a diagram illustrating spinal recruitment efficiency seen in study BENEFIT-01. [Figure 8C] FIG. 1 shows impedance by configuration in a diagram illustrating spinal recruitment efficiency seen in Study BENEFIT-01. [Figure 8D] FIG. 11 shows the average power required to reach paresthesia threshold via spinal recruitment per configuration from a diagram illustrating spinal recruitment efficiency found in study BENEFIT-01. [Figure 9] Transverse cross-section of the spine model used for SCS simulations (A) and the contours of the recruitment areas of 1, 10, 100 and 200 DC fibers in the most superficial layer (B). [Figure 10A] FIG. 1 shows the stimulation amplitudes required to activate DC fibers at the superficialest layer (most dorsal) depths of 1, 10, 100 and 200 μm with various electrode configurations. [Figure 10B] FIG. 1 shows the power required to activate DC fibers at the superficialest layer (most dorsal) depth of 1, 10, 100 and 200 μm with various electrode configurations. [Figure 11] FIG. 13 shows one example of a novel stimulation waveform between three electrodes, with cathode priority. [Figure 12] FIG. 13 shows another example of a novel stimulation waveform between four electrodes, with cathode priority. [Figure 13] FIG. 13 shows another example of a novel stimulation waveform between four electrodes, with anode priority. [Figure 14] FIG. 13 shows another example of a novel stimulation waveform between three electrodes, with cathode priority. [Figure 15] FIG. 13 shows another example of a novel stimulation waveform between three electrodes, with cathode priority. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0065] Conventional paresthesia-based spinal cord stimulation (SCS) therapy utilizes spinal axon recruitment to induce a tingling sensation that overlaps the infringing area, thus reducing the perception and experience of pain. The effect begins within minutes, and the paresthesia perception is usually tolerated by the patient because the perception of pain is continually reduced. Using the patient remote control device, the patient can adjust the stimulation amplitude to a higher level to enhance pain relief during periods of increased pain, and can reduce the amplitude and perception of paresthesia during periods of quiet, periods of reduced pain, or periods when different body locations are stimulated that affect the lead position relative to the spinal cord. Due to the fact that paresthesia is an unnatural perception, patients generally prefer to use the control device to minimize it.

[0066] The mechanism by which paresthesia-based stimulation works is as follows: Electric fields generated by SCS electrode leads across the spinal column induce action potentials in the large axially oriented spinal axons associated with the transmission of sensory information to the brain. These action potentials propagate to the brain, inducing paresthesia perceptions, and travel retrogradely to the dorsal horn network of spinal gray matter. This retrograde propagation of action potentials reaches and stimulates inhibitory interneurons, whose excitation promotes the inhibition of pain relay neurons.

[0067] High frequency SCS therapy utilizes stimulation frequencies between 1 kHz and 100 kHz to achieve a neuromodulatory effect without recruiting the spinal fibers associated with paresthesia. Studies have shown that this treatment modality reduces wind-up hypersensitivity of spinal dorsal horn interneurons, which are responsible for relaying pain sensation from the peripheral nervous system to the central nervous system. Pain relief associated with this stimulation may require several hours to a day to take effect.

[0068] Figure 6 shows a diagram to illustrate a conventional high frequency stimulation waveform between two electrodes E1, E2. Stimulation begins with a cathodic phase of width W, includes an interpulse interval II, ends with an anodic (charge balancing) phase of width W, and repeats. The return electrode E2 passes the same but opposite current. Additional electrodes may share the current with different amounts but the same timing and waveform.

[0069] Although the mechanism by which this treatment method works is still under debate, the prevailing theory is that high-frequency SCS stimulation has little effect on the spinal axons that drive the paresthesia in low-frequency SCS therapy, and instead, this stimulation directly induces a subtle potentiation change on lamina I neurons in the dorsal horn of the spinal cord. The potentiation change triggers a series of intracellular signaling responses that induce a direct inhibition of sensitization and the inhibition of activity of neuropathic pain relay neurons in the dorsal horn.

[0070] This technique is similar in frequency to radiofrequency transcutaneous spinal electroanalgesia (TSE), which has been available for several decades. Whether the underlying mechanisms and sites of pain relief are the same between radiofrequency TSE and radiofrequency SCS remains to be determined.

[0071] During a recent clinical study (see Figs. 8A-8D), several common combinations of stimulation contacts were tested to determine their paresthesia threshold current with a fixed set of stimulation waveform parameters. The impedance between the contacts was also measured to allow calculation of the paresthesia threshold power for each electrode contact combination. This part of the study found that electrode contact combinations with bipolar pairs and multiple cathodes (EC603, EC605, EC608) consisting of adjacent electrode contacts are relatively inefficient stimulation techniques when compared to spaced dipoles or tripoles (EC606, EC607). These findings apply to the invention disclosed herein, particularly by utilizing spacing between electrode contacts in addition to interleaved delayed charge balance.

[0072] In particular, the present invention therefore provides an SCS stimulation approach that is designed to reduce energy demands while providing comparable or improved pain relief and greater therapeutic coverage of painful skin areas compared to existing methods.

[0073] In particular, the present invention can be used with implantable spinal cord stimulators that include percutaneous electrodes or paddle leads that are implanted in the epidural space within the patient's spinal canal. Using such leads, the present invention allows the patient to receive SCS, among other things, by applying a time delay prior to charge equilibration, thereby allowing the effect of a single pulse on neuronal membrane potentials to be maximally successful before charge equilibration (polarity reversal) of the stimulating electrode contacts. At the same time, the disclosed stimulation maximizes the therapeutic effect of the stimulation pulse by delivering pulses of the same polarity on adjacent electrode contacts during this delay time. Notably, this approach distinguishes it from conventional neuromodulation stimulation, where each stimulation pulse and its charge equilibration phase occurs prior to stimulation on another set of electrodes.

[0074] FIG. 1 together with FIG. 2 shows an example of a medical device 1 for generating electrical stimulation of a patient P, comprising a pulse generator 2 configured to generate current pulses for electrical stimulation of a patient P, and at least one electrode lead 3 configured to be connected to the pulse generator 2 and comprising a plurality of electrode contacts E1, ..., E8 for delivering said current pulses to tissue S of the patient P, the pulse generator 2 being configured to generate said current pulses at a rate in the range of 1 Hz to 100 kHz, each current pulse comprising a pulse width in the range of 10 μs to 10 ms.

[0075] In particular, as shown in FIG. 2, the pulse generator 2 of the medical device 1 is configured to deliver a current pulse CP between two electrode contacts E1, E3 of the plurality of electrode contacts, deliver a subsequent current pulse CP between two further electrode contacts E2, E4 of the plurality of electrode contacts, and then deliver a charge-balancing current pulse AP between the two electrode contacts E1, E3 to reach a charge-balancing state.

[0076] Thus, the medical device 1 according to the present invention realizes a spatial and temporal pattern for power-efficient stimulation. The basic concept of this pattern is illustrated in Fig. 2. In particular, cathodic current pulses CP are delivered in a sequential pattern from all active electrode contacts E1, ..., E4 during each stimulation period (T=1 / frequency). This makes it possible to provide therapeutic (cathodic) current pulse delivery in every stimulation cycle via all active electrode contacts E1, ..., E4 (here four electrode contacts). This increases the spatial range of therapeutic modulation.

[0077] Furthermore, to provide efficient therapeutic stimulation, the electrode contacts E1, ..., E4 are preferably spaced from one another by approximately 14 mm, measured from the center of one electrode contact to the center of an adjacent electrode contact. This spacing of the electrode contacts has been found to allow for deeper tissue modulation within the spinal cord at lower current amplitudes compared to the current state of the art.

[0078] Furthermore, the so-called dual bipolar stimulation shown in FIG. 2 includes delayed balancing of the therapeutic current pulses CP on each electrode contact E1, . . . , E4.

[0079] Although necessary to safely avoid electrochemical reactions in the tissue, each anodic charge-balancing phase AP may reduce the therapeutic modulating effect of the preceding cathodic phase CP. By delaying the anodic charge-balancing phase AP, the possibility of affecting the therapeutic effect is reduced.

[0080] Operating at twice the frequency and therefore requiring approximately the same energy (in standard "high density" treatment (see FIG. 6), the therapeutic effect is largely limited to the area between the active electrode contacts E1, E2. Secondly, the close proximity of the active electrode contacts E1, E2 reduces the penetration depth of the therapeutic modulation into the spinal cord. Finally, the cathodic modulation phase CP is rapidly counterbalanced by the subsequent balancing phase AP, which may reduce the therapeutic effect.

[0081] Dual bipolar spinal cord stimulation according to FIG. 2 has been shown to be particularly effective, for example, using four active electrode contacts E1, ..., E4 with the following rates and pulse widths of the current pulses CP: Rate = 1470Hz and pulse width = 90μs, Rate = 625Hz and pulse width = 200μs, Rate = 1470Hz and pulse width = 60μs, or Rate = 1470Hz and pulse width = 120μs.

[0082] For these rates and pulse widths, the current pulse CP and the charge balancing current pulse AP preferably have amplitudes in the range of 0.1 mA to 10 mA.

[0083] As further shown in FIG. 4 , in one embodiment, the medical device 1 according to the present invention is configured to alternately deliver a current pulse CP during an on period (on time) and suspend the delivery of the current pulse CP during an off period (off time), wherein the length of time during which the current pulse is actually delivered by the pulse generator during the on period (on time) comprises a length corresponding to 10% to 100%, in particular 30% to 100%, of the length of the on period.

[0084] In other words, "duty cycling" means that the pulse generator 2 of the medical device 1 can be programmed so that the therapy is on for some phase, the "on time," and the therapy is off for some phase, the "off time." The duty cycling value defines how long (in %) the therapy is on within the "on time."

[0085] In the illustrated embodiment of Figures 1 and 2, the number of electrode contacts E1, E2, E3, E4 is limited to four electrode contacts, but the number of active electrode contacts is preferably in the range of 4 to 32.

[0086] According to an alternative embodiment shown in Figures 1 and 3, the pulse generator 2 is configured to deliver successive current pulses CP via associated electrode contacts E1, E3, E5, and for each current pulse CP, at least two charge-balanced current pulses AP are subsequently delivered via the respective electrode contacts E1, E3, E5 to reach a charge-balanced state, where each charge-balanced current pulse AP is preferably delivered simultaneously with one of the current pulses CP.

[0087] The configuration shown in Figure 3, also denoted as rotating cathodal spinal cord stimulation, also achieves a power-efficient spatial and temporal simulation pattern of stimulation, where cathodal current pulses CP are delivered sequentially from all active electrode contacts E1, E3, E5 during each stimulation period (T=1 / frequency).

[0088] This allows for providing therapeutic (cathode) current pulse delivery in every stimulation cycle through all active electrode contacts (in this example, three electrode contacts E1, E2, E3 spanning the length of five electrode contacts). This increases the spatial range of therapeutic modulation. Furthermore, stimulation in the rotating cathode configuration preferably uses an optimal spacing of about 14 mm between adjacent active electrode contacts E1, E3, E5. Furthermore, prior studies have shown that this spacing of electrode contacts allows for deeper modulation of tissue within the spinal cord at lower current amplitudes compared to the current state of the art.

[0089] Furthermore, the delayed balancing of the therapeutic current pulse CP on each electrode contact E1, E3, E4 is necessary to safely avoid electrochemical reactions in the tissue, which may reduce the therapeutic modulation effect of the preceding cathodic phase. By delaying the anodic charge balancing phase AP, the possibility of affecting the therapeutic effect is reduced, and the anodic current is distributed over multiple electrodes (i.e., two electrodes in Figure 3). This increases the area of ​​therapeutic modulation and also reduces the impedance of the electrode configuration (hence reducing the power requirements).

[0090] The configuration shown in Figure 3 allows for a larger number of electrode contacts (larger area of ​​therapeutic effect) to be covered and has been shown to provide superior pain relief using long pulse widths (e.g., 300 μs) and low rates (e.g., 300 Hz) of the current pulses CP (see study BENEFIT-02). Longer pulse widths typically produce therapeutic effects at lower current amplitudes. This, in combination with a low stimulation frequency, greatly reduces power requirements.

[0091] In particular, the following parameter values ​​showed very good results using, for example, three active electrode contacts (E1, E3, E5): Rate = 300Hz and pulse width = 300μs, Rate = 556Hz and pulse width = 300μs, Rate = 556Hz and pulse width = 90μs, Rate = 300Hz and pulse width = 90μs, or Rate = 50Hz and pulse width = 300μs.

[0092] In particular, the above parameters are preferably used with a number of active electrode contacts in the range of 3 to 32, in particular 3 to 6. The cycling is preferably performed in the range of 25% to 100% of the on-time (see FIG. 4) and the current pulses preferably comprise an amplitude in the range of 0.01 mA to 20 mA. In particular, one of the active electrode contacts may be the housing of the medical device 1 or a group of other electrode contacts combined together. EXAMPLES

[0093] In particular, to evaluate pain relief using the medical device 1 / method according to the present invention, the following measurements were performed:

[0094] "Example 1" Rotating cathode Here, the subject was implanted with two percutaneous 8-contact SCS leads 3. The lead tip of the first lead was placed at the upper T9 level and the lead tip of the second lead was placed at the lower T9 level. Contact coverage was between upper T9 and mid T11. The subject was experiencing low back and leg pain and the stimulation electrodes selected were E4, E6, and E8 (lowest contact) on the second lead. The subject was given a 3-phase polyphasic treatment using 1.1 mA amplitude, continuous at 300 Hz and 300 μs. The subject baseline pain was 9 / 10 and treatment pain was reduced to 1 / 10. According to one embodiment, continuous means that the pulse sequence is always on and no duty cycling is used.

[0095] "Example 2" Double dipole The subject was implanted with two percutaneous 8-contact SCS leads 3. The tip of the first lead was placed at the upper T9 level and the tip of the second lead was placed at the mid-T9 level. Contact coverage was between upper T9 and upper T11. The subject was experiencing low back and leg pain and the stimulation electrodes selected were E1 (the uppermost contact), E2, E3, and E4 on the first lead. The subject was given a 4-phase multiphasic treatment at 1492 Hz, 4.8 mA continuous for 90 μs. The subject's baseline pain was 7 / 10 and treatment procedural pain was 2 / 10.

[0096] "Example 3" Rotating cathode The subject was implanted with two percutaneous 8-contact SCS leads 3. The tip of the first lead was placed at the lower T7 level and the tip of the second lead was placed at the mid-T8 level. Contact coverage was between lower T7 and lower T10. The subject was experiencing low back and leg pain and the stimulation electrodes selected were E4, E6, and E8 (lowest contact) on the first lead. The subject was given a 3-phase multiphasic treatment at 0.7 mA, continuous at 556 Hz, 300 μs. The subject's baseline pain was 7 / 10 and treatment pain was 2 / 10. The leg pain of this subject described improved with the multiphasic treatment, which could not be achieved with standard 10 kHz, 30 μs stimulation.

[0097] "Example 4" Double dipole The subject was implanted with two percutaneous 8-contact SCS leads 3. The tip of the first lead was placed at the superior T9 level and the tip of the second lead was placed at the superior T10 level. Contact coverage was between superior T9 and superior T12. The subject was experiencing low back and leg pain, and the stimulating electrode contacts selected were E1 (the uppermost contact), E2, E3, and E4 on the second lead. The subject was given a 4-phase multiphasic treatment at 625 Hz, 200 μs continuous, 0.24 mA. The subject's baseline pain was 9 / 10 and treatment procedural pain was 3 / 10.

[0098] Furthermore, Fig. 1 together with Figs. 5A-5D and 7 shows an embodiment of a medical device 1 according to yet another aspect of the present invention, comprising a pulse generator 2 configured to generate current pulses for electrical stimulation of a patient, and an electrode lead 3 with a plurality of electrode contacts E1...E8 configured to be connected to the pulse generator 2 for delivering said current pulses to tissue, here the spinal cord S, of a patient P, the pulse generator 2 being configured to repeatedly deliver current pulses CP between two electrodes E1, E3 of said plurality of electrode contacts forming a first group G1 of electrode contacts, the pulse generator 2 being configured to repeatedly deliver current pulses CP between two electrodes E1, E3 forming a first group G1 of electrode contacts, the pulse generator 2 being configured to repeatedly deliver current pulses CP between the two electrodes E1, E3 of said plurality of electrode contacts forming a first group G1 of electrode contacts, the pulse generator 2 being configured to repeatedly deliver current pulses CP between the two electrodes E1, E3 ... the pulse generator 2 is further configured to deliver a charge-balanced current pulse AP after each current pulse CP between the electrodes of said first group such that the pulse CP is separated from the subsequent charge-balanced current pulse AP by an inter-pulse interval II, each current pulse CP comprising an amplitude A having the same absolute value A but opposite sign as the subsequent charge-balanced current pulse AP, and the pulse generator 2 comprises electrode leads configured to deliver a current pulse CP between two further electrodes E2, E4 forming a second group G2 of electrode contacts between each current pulse CP and the subsequent charge-balanced current pulse AP delivered between the electrodes of the first group G1.

[0099] In particular, the pulse generator 2 is further configured to deliver a charge-balanced current pulse AP between the electrodes E2, E4 of the second group G2 after each current pulse CP is delivered between the electrodes E2, E4 of the second group G2, each current pulse CP delivered between the electrodes E2, E4 of the second group G2 comprising an amplitude B having the same absolute value but opposite polarity as a subsequent charge-balanced current pulse AP delivered between the electrodes E2, E4 of the second group.

[0100] In this embodiment, in accordance with Figures 5A to 5D, four active electrode contacts E1 to E4 are used, in particular separated by 7 mm (center to center), with the corresponding gap between every two adjacent electrodes being filled by an electrically insulating portion 30 forming part of the outer surface 3a of the lead 3.

[0101] In particular, as shown in Figures 5A to 5D, the groups G1, G2 of the electrode contacts E1...E4 include a first electrode contact E1, a second electrode contact E2, a third electrode contact E3, and a fourth electrode contact E4 that are arranged consecutively to one another in the longitudinal extension direction x of the electrode lead wire 3, the first group G1 of electrode contacts includes the first electrode contact E1 and the third electrode contact E3, and the second group G2 of electrode contacts includes the second electrode contact E2 and the fourth electrode contact E4, so that the two groups G1, G2 overlap, i.e., the second electrode contact E2 of the second group G2 is arranged between the first electrode contact E1 and the third electrode contact E3 of the first group G1, and the third electrode contact E3 of the first group G1 is arranged between the second electrode contact E2 and the fourth electrode contact E4 of the second group G2.

[0102] As further shown in Figures 5A-5D and 7, these electrode contact groups G1, G2 can be used to deliver stimulation from the pulse generator 2 as follows: Here, the two groups G1, G2 form two independent stimulation channels, the first channel providing stimulation through electrode contacts E1 and E3 and the second channel providing stimulation through electrode contacts E2 and E4. Each channel G1, G2 provides a bipolar, constant current stimulation with a symmetric charge-balanced waveform. For each electrode contact, a cathodic stimulation phase (current pulse) CP is balanced by an anodic phase (charge-balanced current pulse) AP delayed by half a cycle, which also serves as a cathodic stimulation on the paired electrode contact. In particular, the two channels or groups G1, G2 provide stimulation at the same frequency but with a cycle delay of 0.25 of the cycle period. This results in cathodic stimulation being provided every 0.25 cycles at anatomically distinct locations, thus providing efficient therapeutic coverage.

[0103] In particular, as shown in FIG. 7, the pulse generator 2 is configured to deliver the cathodic current pulses CP in a sequential manner, i.e. as a sequential cathode train T, such that each electrode contact E1...E4 of the two groups G1, G2 delivers a cathodic current pulse CP following the cathodic current pulse CP of the preceding electrode contact and before the anodic charge balancing current pulse AP of the preceding electrode contact.

[0104] Preferably, the respective active electrode contact spacing CS as shown in Figures 5A-5D (e.g., G1), defined as 2-20 mm, e.g., 2-3 mm, 7 mm, 14 mm, etc., is selected large enough to provide effective electric field penetration in and along the spinal cord throughout the treatment coverage while minimizing spatial summation of neuronal membrane potential changes between contacts, the interpulse interval is selected large enough to reduce neurorefractory effects, and the interleaved stimulation is set with symmetric charge-balanced phases. The stimulation is subthreshold, i.e., the stimulation amplitude is set below the perceptual threshold and therefore does not produce a sensation that the patient can feel.

[0105] Further, an embodiment of the method according to the invention is shown in Fig. 7. According to it, stimulation (in particular SCS) starts with a cathodic phase CP, includes an interpulse interval II, ends with an anodic (charge-balancing) phase AP, and repeats. The return electrode carries the same but opposite current. Stimulation of each group G1 or G2 is performed during the charge-balancing phase of the preceding group G2 or G1.

[0106] In detail, the method comprises at least delivering a current pulse CP of amplitude -A between at least two electrodes E1, E3 of a first group G1; delivering a current pulse CP of amplitude -B between at least two electrodes E2, E4 comprised in a second group G2, before the charge balancing AP of the first group G1; Includes.

[0107] In addition, in particular, the following steps are performed: A charge-balancing current pulse AP of amplitude A is then delivered to the first group G1. A charge-balancing current pulse AP of amplitude B is then delivered to the second group G2. The current pulses are repeated cyclically.

[0108] As previously discussed, the electrical stimulation preferably results in a sequential cathodic train T as shown in FIG. 7, where adjacent electrode contacts E1, E2, E3, E4 deliver a cathodic stimulation CP following the cathodic stimulation of a preceding adjacent cathode and before the preceding cathode delivers its anodic charge balancing phase AP.

[0109] The stimulation parameters tested in the aforementioned clinical study BENEFIT-01 were previously evaluated in a modeling study. The modeling study compared the activation thresholds of dorsal column (DC) axons for the six electrode configurations tested (see FIG. 5(A)), namely EC602, EC603, EC605, EC606, EC607, and EC608. DC fiber activation is widely accepted in the literature as the primary mechanism of low-frequency SCS-induced pain relief [1], [2]. Although the mechanisms involved in high-frequency (HF) SCS and stimulation patterns according to the present invention may differ from LF SCS, the DC fiber response remains a comparative indicator of the neural effects induced by the stimulation.

[0110] All simulations were performed using a mathematical axonal model coupled to a 3D model of the spinal cord, in which a single implanted lead is positioned against the dura at the dorsal-ventral midline of the spinal cord (see FIG. 9). Activation thresholds were calculated for a grid of neurons covering the spinal column, i.e., the spinal fibers. The amplitude and power required to activate the first 1, 10, 100 and 200 neurons in the superficial spinal region (i.e., the fibers closest to the electrode) are plotted in FIG. 10A and FIG. 10B, respectively.

[0111] The results support clinical findings that adjacent bipolar counter electrodes and multiple cathodes (EC603, EC605, EC608) are relatively inefficient configurations compared to spaced single cathode configurations. These findings extend from recruiting a single fiber to 200 most superficial DC neurons, indicating that these relative performances persist regardless of whether the stimulation target is located on the superficial regions of the spinal cord or deeper internally. Thus, applying spaced bipolar electrode configurations to embodiments of the present invention helps reduce SCS energy demands while maintaining comparable or improved performance.

[0112] According to the present invention a "spaced apart" electrode configuration is to be understood as at least two spatially separated electrodes. The distance between the electrodes can be, for example, 2-3 mm, 7 mm, 14 mm (measured between the centers of the electrodes).

[0113] The present invention can be used to provide novel SCS therapeutic stimulation that delivers pain relieving neuromodulation at high frequencies and with lower energy requirements and greater coverage compared to the current state of the art.

[0114] This stimulation pattern according to the present invention gives a wider coverage of spinal segment levels (along the spinal axis) with cathodal stimulation, which is known to drive neuronal depolarization. Due to the topographical distribution of fibers in the spinal cord, stimulating a larger longitudinal portion of the spinal cord implies that the activity of neural elements directly or indirectly connected to more dermatomes is modulated by the stimulation. Moreover, due to the delayed onset time associated with subliminal sensory SCS and possibly the mismatch of neural targets between subliminal sensory SCS treatment and paresthesia-based SCS treatment, lead placement is usually not mapped for low-frequency SCS-induced paresthesia, but rather arbitrarily placed at the T9-T10 spinal junction. By covering a wider portion of spinal levels, this novel SCS therapy is less sensitive to variations in the anesthesia sweet spot.

[0115] In particular, due to the longer period between each pulse of one given electrode contact, the range of possible pulse widths W is larger than in high frequency stimulation mode. This novel stimulation pattern allows for more adaptive treatment to inter- and intra-patient variability by programming different pulse widths W, thus increasing the SCS responder rate in the short term, but also in the long term by adapting the stimulation settings to the newly developed pain area.

[0116] FIG. 11 shows a diagram of one embodiment of a stimulation waveform according to the present invention between three (N=3) treatment electrodes, with cathode being prioritized. The exemplary system / device comprises three electrodes (electrode 1, electrode 2, and electrode 3), each of which undergoes a repeating pattern of a sequence consisting of a cathodic phase (treatment phase, also denoted herein as treatment electrical pulse) having a current amplitude I and two charge-balanced anodic phases (charge-balanced phase, also denoted herein as charge-balanced electrical pulse) passing 1 / 2 of the current amplitude I reversed from the treatment phase. The treatment phase and the charge-balanced phase are separated by one interphase interval. While electrode 1 passes through a treatment phase with amplitude I, electrodes 2 and 3 each pass through one charge-balanced phase with amplitude I / 2. While electrode 2 passes through a treatment phase with amplitude I, electrodes 1 and 3 each pass through one charge-balanced phase with amplitude I / 2. While electrode 3 goes through a treatment phase having amplitude I, electrodes 2 and 1 each go through one charge balance phase having amplitude I / 2. After electrode 3 goes through one treatment phase, the cycle begins again with electrode 1 until it is terminated. In this way, charge neutrality at any given electrode is maintained and at any given time in the waveform, the sum of the currents exiting the cathodes is equal to the sum of the currents entering the anodes.

[0117] FIG. 12 shows a diagram of another embodiment of a stimulation waveform according to the present invention between four (N=4) treatment electrodes, with cathode being prioritized. The exemplary system comprises four electrodes (electrode 1, electrode 2, electrode 3, and electrode 4), each of which undergoes a repeating pattern of a sequence consisting of a cathodic phase (treatment phase, also denoted herein as treatment electrical pulse) having a current amplitude I and three charge-balanced anodic phases (charge-balanced phase, also denoted herein as charge-balanced electrical pulse) passing 1 / 3 of the reversed current amplitude I of the treatment phase. The treatment phase and the charge-balanced phase are separated by one interphase interval. While electrode 1 passes through a treatment phase with amplitude I, each of electrodes 2, 3, and 4 passes through one charge-balanced phase with amplitude I / 3. While electrode 2 passes through a treatment phase with amplitude I, each of electrodes 1, 3, and 4 passes through one charge-balanced phase with amplitude I / 3. While electrode 3 goes through a treatment phase with amplitude I, electrodes 1, 2 and 4 each go through one charge balance phase with amplitude I / 3. While electrode 4 goes through a treatment phase with amplitude I, electrodes 1, 2 and 3 each go through one charge balance phase with amplitude I / 3. After electrode 4 goes through one treatment phase, the cycle begins again with electrode 1 until it is terminated. In this way, charge neutrality at any given electrode is maintained and at any given time in the waveform, the sum of the currents exiting the cathodes is equal to the sum of the currents entering the anodes.

[0118] FIG. 13 shows a diagram of another embodiment of a stimulation waveform according to the present invention between four (N=4) treatment electrodes, with anodes being prioritized. The exemplary system / device comprises four electrodes (electrode 1, electrode 2, electrode 3, and electrode 4), each of the three electrodes undergoes a repeating pattern of a sequence consisting of an anodic phase (treatment phase, also denoted herein as treatment electrical pulse) having a current amplitude I and two charge-balanced cathodic phases (charge-balanced phase, also denoted herein as charge-balanced electrical pulse) passing 1 / 3 of the reversed current amplitude I of the treatment phase. The treatment phase and the charge-balanced phase are separated by one interphase interval. While electrode 1 passes through a treatment phase with amplitude I, each of electrodes 2, 3, and 4 passes through one charge-balanced phase with amplitude I / 3. While electrode 2 passes through a treatment phase with amplitude I, each of electrodes 1, 3, and 4 passes through one charge-balanced phase with amplitude I / 3. While electrode 3 goes through a treatment phase with amplitude I, electrodes 1, 2 and 4 each go through one charge balance phase with amplitude I / 3. While electrode 4 goes through a treatment phase with amplitude I, electrodes 1, 2 and 3 each go through one charge balance phase with amplitude I / 3. After electrode 4 goes through one treatment phase, the cycle begins again with electrode 1 until it is terminated. In this way, charge neutrality at any given electrode is maintained and at any given time in the waveform, the sum of the currents entering the anodes is equal to the sum of the currents exiting the cathodes.

[0119] Alternatively, the anode and cathode preferences may be mixed or combined in different sequences, and alternatively the amplitude of the charge balance phase may have different values ​​for each phase.

[0120] FIG. 14 shows a diagram of another example of a novel stimulation waveform between three electrodes, where the cathode is prioritized. Stimulation begins with a cathode phase and ends with a series of anodic (charge-balancing) phases that include interphase intervals and are aligned with the cathode phases of different electrodes. In this example, each return electrode (electrodes 2 and 3 when electrode 1 stimulates) carries an opposite current at half the amplitude as the currently active cathode electrode, and the second anodic phase is delivered with passive balance that may last longer than the cathode phase of the opposing electrode. In this way, charge neutrality at any given electrode is maintained, and at any given time in the waveform, the sum of the currents leaving the cathodes is equal to the sum of the currents entering the anodes.

[0121] FIG. 15 shows a diagram of another example of a novel stimulation waveform between three electrodes, in which the cathode is prioritized. The stimulation begins with a cathode phase and ends with a series of anodic (charge-balanced) phases that include interphase intervals and are aligned with the cathode phase of a different electrode. In this example, the return currents do not share equal current, but the sum of their currents is equal and opposite in amplitude to the current of the currently active cathode electrode. In this way, charge neutrality at any given electrode is maintained, and at any given time in the waveform, the sum of the currents leaving the cathodes is equal to the sum of the currents entering the anodes.

[0122] Those skilled in the art will appreciate that many modifications and variations of the described examples and embodiments are possible in light of the above teachings. The disclosed examples and embodiments have been presented for purposes of illustration only. It is therefore intended to cover all such modifications and alternative embodiments as may fall within the true scope of the invention.

Claims

1. A medical device (1) for generating electrical stimulation of a patient (P), comprising: a pulse generator (2) configured to generate a plurality of current pulses (CP) for electrical stimulation of the patient (P); at least one electrode lead (3) configured to be connected to said pulse generator (2) and comprising a plurality of electrode contacts (E1...E8) for delivering said current pulses (CP) to tissue (S) of said patient (P); Equipped with the plurality of electrode contacts includes at least two interleaved groups, one contact of a first group being disposed between two contacts of a second group; The pulse generator (2) is configured to generate the current pulses (CP) at a rate in the range of 1 Hz to 100 kHz, each of the current pulses (CP) having a pulse width in the range of 10 μs to 10 ms; The medical device (1), wherein the pulse generator is configured to generate a stimulation pulse between the plurality of electrode contacts of the first group, followed by a stimulation pulse between the plurality of electrode contacts of the second group, followed by a charge balancing pulse between the plurality of electrode contacts of the first group, followed by a charge balancing pulse between the plurality of electrode contacts of the second group.

2. 2. The medical device of claim 1, wherein the rate is in the range of 50 Hz to 1470 Hz and the pulse width is in the range of 30 μs to 1000 μs.

3. The medical device of claim 1 or 2, wherein each of the current pulses comprises an amplitude in the range of 0.01 mA to 20 mA.

4. 3. The medical device of claim 1, wherein when the plurality of electrode contacts is at least four electrode contacts, the pulse generator is configured to deliver a current pulse CP between two electrode contacts (E1, E3) of the plurality of electrode contacts, deliver a subsequent current pulse (CP) between two further electrode contacts (E2, E4) of the plurality of electrode contacts, and then deliver a charge-balanced current pulse (AP) between the two electrode contacts (E1, E3).

5. 5. The medical device of claim 1, wherein the rate is 1470 Hz and the pulse width is 90 μs.

6. 5. The medical device of claim 1, wherein the rate is 625 Hz and the pulse width is 200 μs.

7. 4. The medical device according to claim 1, wherein the pulse generator (2) is configured to deliver the current pulses (CP) sequentially through the different electrode contacts (El, E3, E5), and for each of the current pulses (CP), at least two charge-balanced current pulses (AP) are delivered simultaneously with a stimulation current pulse delivered through one of the different electrode contacts (El, E3, E5).

8. 8. The medical device of claim 7, wherein the rate is 300 Hz and the pulse width is 300 μs.

9. 8. The medical device of claim 7, wherein the rate is 556 Hz and the pulse width is 300 μs.

10. The medical device according to any one of claims 1 to 9, wherein the pulse generator (2) adjusts predetermined power thresholds for combinations of multiple current contacts so as not to induce paresthesia in the patient (P) and delivers the current pulse (CP) to the central nervous system of the patient (P).

11. The medical device according to any one of claims 1 to 9, wherein the pulse generator (2) adjusts predetermined power thresholds for a combination of multiple current contacts so as to induce paresthesia in the patient (P) and delivers the current pulse (CP) to the central nervous system of the patient (P).

12. 12. The medical device of claim 1, wherein the at least one electrode lead (3) is configured to be implanted along the spinal cord of a patient (P) and to deliver the current pulse (CP) to a longitudinal region of the spinal cord that is larger than one vertebral body of the patient.

13. A medical device according to any one of claims 1 to 12, wherein adjacent electrode contacts (E1, E2) and / or simultaneously active electrode contacts (E1, E3, E5) of the plurality of electrode contacts (E1, E2, E3, E4, E5) are separated by a distance in the range of 7 mm to 14 mm.

14. 14. The medical device of claim 1, wherein the medical device (1) is configured to alternately deliver current pulses (CP) during on periods and suspend delivery of current pulses (CP) during off periods, the length of time during which a current pulse is delivered by the pulse generator (2) during each on period comprising a length corresponding to between 10% and 100% of the length of each on period.

15. The medical device of claim 1 or 2, wherein each of the current pulses comprises an amplitude in the range of 0.1 mA to 10 mA.

16. The medical device of claim 7 , wherein each of the charge-balanced current pulses (AP) is delivered simultaneously with one of the current pulses (CP).

17. 15. The medical device of claim 1, wherein the medical device (1) is configured to alternately deliver current pulses (CP) during on periods and suspend delivery of current pulses (CP) during off periods, the length of time during which a current pulse is delivered by the pulse generator (2) during each on period comprising a length corresponding to between 25% and 100% of the length of each on period.

18. 15. The medical device of claim 1, wherein the medical device (1) is configured to alternately deliver current pulses (CP) during on periods and suspend delivery of current pulses (CP) during off periods, the length of time during which a current pulse is delivered by the pulse generator (2) during each on period comprising a length corresponding to between 30% and 100% of the length of each on period.

19. 15. The medical device of claim 1, wherein the medical device (1) is configured to alternately deliver current pulses (CP) during on periods and suspend delivery of current pulses (CP) during off periods, the length of time during which a current pulse is delivered by the pulse generator (2) during each on period comprising a length corresponding to between 10% and 60% of the length of each on period.

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