The present invention relates to an implantable medical device. More specifically, the invention relates to an implantable pulse generator (IPG) for a medical device, the IPG having the ability to sense the presence of an external magnetic field, such as a magnetic field associated with magnetic resonance imaging, and to take appropriate actions to protect the patient and the IPG.
Implantable stimulation devices are devices that generate and deliver electrical stimuli to body nerves and tissues for the therapy of various biological disorders, such as pacemakers to treat cardiac arrhythmia, defibrillators to treat cardiac fibrillation, cochlear stimulators to treat deafness, retinal stimulators to treat blindness, muscle stimulators to produce coordinated limb movement, spinal cord stimulators to treat chronic pain, cortical and deep brain stimulators to treat motor and psychological disorders, and other neural stimulators to treat urinary incontinence, sleep apnea, shoulder subluxation, etc.
The implantable stimulation device may further comprise a handheld Remote Control (RC) (not shown) to remotely instruct the neurostimulator to generate electrical stimulation pulses in accordance with selected stimulation parameters. The RC is used to send data to and receive data from the IPG 10. For example, the RC can send programming data to the IPG 10 to dictate the therapy the IPG 10 will provide to the patient. Also, the RC can act as a receiver of data from the IPG 10, such as various data reporting on the IPG's status. Wireless data transfer between the IPG 10 and the RC can take place via magnetic inductive coupling. To implement such functionality, both the IPG 10 and the RC typically have electrical coils that can act as the transmitter or the receiver, thus allowing for two-way communication between the two devices, as is well known in the art.
IPGs are routinely implanted in patients who are in need of Magnetic Resonance Imaging (MRI). Thus, when designing implantable neurostimulation systems, consideration must be given to the possibility that the patient in which neurostimulator is implanted may be subjected to electro-magnetic forces generated by MRI scanners, which may potentially cause damage to the neurostimulator as well as discomfort to the patient. In particular, in MRI, spatial encoding relies on successively applying magnetic field gradients. The magnetic field strength is a function of position and time with the application of gradient fields throughout the imaging process. Gradient fields typically switch gradient coils (or magnets) ON and OFF thousands of times in the acquisition of a single image in the present of a large static magnetic field. Present-day MM scanners can have maximum gradient strengths of 100 mT/m and much faster switching times (slew rates) of 150 mT/m/ms, which is comparable to stimulation therapy frequencies. Typical MRI scanners create gradient fields in the range of 100 Hz to 30 KHz, and radio frequency (RF) fields of 64 MHz for a 1.5 Tesla scanner and 128 MHz for a 3 Tesla scanner.
The strength of the gradient magnetic field may be high enough to induce voltages (5-10 Volts depending on the orientation of the lead inside the body with respect to the MRI scanner) on to the stimulation lead(s) 18, which in turn, are seen by the IPG electronics. If these induced voltages are higher than the voltage supply rails of the IPG electronics, there could exist paths within the IPG that could induce current through the electrodes on the stimulation lead(s), which in turn, could cause unwanted stimulation to the patient due to the similar frequency band, between the MM-generated gradient field and intended stimulation energy frequencies for therapy, as well as potentially damaging the electronics within the IPG. The gradient (magnetic) field may induce electrical energy within the wires of the stimulation lead(s), which may be conveyed into the circuitry of the IPG and then out to the electrodes of the stimulation leads.
Accordingly, the IPG may feature an MM-safe mode that protects the IPG 10 and the patient from damage or injury due to magnetic field-induced electrical energy when the patient undergoes an MRI. For example, in MRI-safe mode, the IPG may cease providing stimulation to the patient. Additionally, (or alternatively) the IPG may increase the voltage within the IPG to prevent unwanted induced current through the IPG. The IPG may modify or suspend other operations, such as passive charge recovery, an operation whereby charge is passively conveyed to AC ground by closing switches associated with the active electrodes. Within an MRI, the closed switches may potentially provide a path for magnetically induced currents into and out of the IPG. The recovery switches are therefore left open during MRI-safe mode.
The IPG can be set to MM-safe mode using the RC. Additionally, some IPGs can be set to MM mode by placing a magnet against the patient's skin over the IPG. Some IPGs include internal magnetic sensors, typically Hall effect magnetic sensors, that are capable of sensing an external magnetic field, such as an MM field. Hall effect magnetic sensor have a limitation in that they are unidirectional. In other words, a Hall effect magnetic sensor is only effective when it is situated in a particular orientation with respect to the magnetic field. Therefore, a series of three orthogonally oriented Hall effect sensors must be used to reliably sense the presence of an external magnetic field. Such a sensor design is undesirably large.
Communication among internal components within the IPG 10 may be via one or more digital busses 300 and analog busses 301. The microcontroller (μC, 302) functions as the master controller for all of the other blocks. The telemetry block 303 couples to a telemetry coil 304 and includes transceiver circuitry for communicating with an external controller. The charging block 306 couples to a charging coil 307 and includes charging circuitry for rectifying power received from an external charger and for charging the power source (battery, 308) in a controlled fashion.
The microcontroller 302 is coupled to monitoring circuitry 313, which monitors the status of various nodes or other points throughout the IPG 10. For example, the monitoring circuitry can monitor power supply voltages, current values, temperature and impedances of the electrodes E1-En. As discussed in more detail below, the monitoring circuitry can monitor voltages across components of the stimulation output circuitry 309.
The stimulation output circuitry 309 includes circuitry for generating electrical stimulation energy in accordance with a defined pulsed waveform having a specified pulse amplitude, pulse rate, pulse width, pulse shape, and burst rate under control of control logic 310. The stimulation output circuitry 309 is coupled to the electrodes E1-En and includes drivers for the electrodes, with a digital-to-analog converter (DAC) 311 being responsive to the stimulation program to supply the specified electrode currents. The electrodes E1-En are coupled to capacitors C1-Cn, which prevent injection of DC current into the patient's tissue. Clock circuitry 312 and V+ generation circuitry 314 will be discussed in more detail below. For now, merely note that V+ generation circuitry provides a high voltage, V+ (referred to as compliance voltage, typically on the order of about 15 V) by boosting the voltage provided by the power source 308 (referred to as Vbat, typically about 3 V). For reasons explained below, DAC 311 requires a high voltage source V+ to operate properly.
If V+ is set to a constant value, the voltage drops across the PDAC and NDAC (i.e., VP and VN, respectively) will necessarily decrease because Vc1 and Vc2 increase. The changing voltage drops of the PDAC and NDAC can cause problems because those elements contain output transistors that operate at optimal voltages. The optimal voltage for the PDAC VP (opt) is typically about 1.5V and the optimal voltage for the NDAC VN (opt) is typically about 1.2V. (The difference between the values of VP (opt) and VN (opt) is because the PDAC uses p-channel transistors and the NDAC uses n-channel transistors). When the PDAC and/or NDAC operate below the optimal voltage, they are not able to provide the desired current. Operating above the optimal voltage wastes power and generates unnecessary heat. It is therefore desirable to operate the PDAC and the NDAC at or just slightly above the optimal voltages. The compliance voltage V+ often needs to be adjusted to a proper value for allowing the PDAC and NDAC to operate at their optimal values.
V+ monitor and adjust logic circuitry 404 (which may comprise part of the IPG's microcontroller 302 or the IPG's monitoring circuitry 313, or may be a standalone circuit block) adjusts V+ so that the DACs operate at optimum voltages. Details about how the V+ monitor and adjust logic circuitry 404 works are well described in the prior art, and are not described here in detail. See, for example, U.S. Pat. No. 8,175,719, issued May 8, 2012; U.S. Pat. No. 9,174,051, issued Nov. 3, 2015; and U.S. Pat. No. 9,314,632, issued Apr. 19, 2016, the entire contents of each being incorporated herein by reference. Briefly, the V+ monitor and adjust logic circuitry 404 includes voltage sensing circuitry that senses the voltages VP and VN at the PDAC and NDAC. If VP and/or VN falls below an optimum operating value, the V+ monitor and adjust logic circuitry executes an algorithm to determine an amount to increase V+ and outputs an appropriate “boost” signal to the pulse width modulator 405.
The boost signal instructs the pulse width modulator 405 how to adjust the pulse width of a clock signal, CLK, thereby determining how VG is modulated. How the pulse width modulator 405 modulates VG determines the percentage of time the transistor 406 is turned on, referred to as the transistor's duty cycle. The V+ monitor and adjust logic circuitry increases the duty cycle of the transistor 406 to increase V+ and decreases the duty cycle to decrease V+. The reason for this is explained in more detail below.
The inventors have discovered that a boost converter circuit, such as the one illustrated in
As explained above, when the transistor 406 is on, current flows through the inductor 407 to ground. When the transistor 406 is off current in the inductor 407 discharges through the diode 408 to the charging capacitor 402.
The middle line IL represents the current across the inductor 407. During the charge phase the inductor current rises linearly to a peak current IPK, according to Eq. 1:
where L is the inductance of the inductor 407. The peak current IPK can be calculated by Eq. 2:
where T is time of a single charge phase.
Assume that the transistor is turning on and off such that period for a single on-off cycle is P and that the percentage of time that the transistor is on during a single cycle is D (the duty cycle). Then T=DP. Since the frequency f is 1/P, the formula for the peak current IPK can be rewritten in terms of frequency and duty cycle as shown in Eq. 3:
As the current flows through the inductor 407, energy is stored in the inductor's magnetic field. That energy is described by Eq. 4:
E=½LIPK2 Eq. 4
When the transistor 406 is turned off at the beginning of the discharge phase, the current through the inductor 407 rapidly drops, producing a back e.m.f. in the inductor 407. The energy stored in the inductor 407 is discharged through the diode 408 and the voltage VL at node 620 swings high to a peak voltage VL, Peak. Current flows through the diode 408 to the capacitor 409 during the discharge phase if VL is greater than V+. As shown in the energy equation, the amount of energy transferred increases as the square of the peak current IPK. Moreover, IPK increases as a function of the duty cycle D. Thus, increasing the duty cycle D increases the current discharged through the diode 408, thereby increasing the compliance voltage V+.
Recall from the discussion of
In the absence of an external magnetic field, the inductance of the inductor 407 remains constant. However, when it is subject to a strong magnetic field, the magnet 503 at the core of the inductor “saturates,” meaning that it becomes less able to support magnetic field generated by charges moving within the wire coil of the inductor. As a result, the inductance of the inductor 407 decreases in the presence of an external magnetic field. The inductance drops by about two orders of magnitude in a 1.5 tesla external magnetic field, such that the inductor 407 behaves essentially like an air-core inductor. Curve 650 of
From equations Eq. 1-Eq. 3, it is apparent that when the inductance L of the inductor 407 decreases due to saturation, dI/dt and IPK increase. Consequently, the magnitude of the spike in voltage VL,Peak at node 620 also increases. The dashed lines in
The increase in the magnitude of VL, Peak as a consequence of the inductor core becoming saturated can be used to detect when the IPG is in a magnetic field. Moreover, when VL increases V+ also increases. Referring to
Each of the variables of Eq. 5 are very precisely known in the IPG—Vbat and Iout are monitored using monitoring circuitry 313 (
However, when the IPG is within an external magnetic field that is strong enough to begin saturating the core of the inductor 407, the measured V+ will not agree with the value calculated according to Eq. 5 using the known values for the variables. Instead, the measured V+ will exceed the expected value because the inductance L will be less than expected.
According to some embodiments, the IPG periodically measures V+. For example, the IPG may use the monitoring circuitry 313 to measure V+ every second or multiple times per second, such as three times per second. If the monitoring circuitry senses a sudden increase in V+, then the IPG can be instructed to activate its MRI-safe mode. According to some embodiments, the monitoring circuitry may compare the increase in V+ to threshold value (3 V, for example) and set the IPG to MM-safe mode only if the increase exceeds that threshold value.
As mentioned above, entering MRI-safe mode may cause the IPG to take one or more actions, such as: (1) ceasing to provide stimulation to the patient, (2) increasing the compliance voltage V+ to prevent unwanted induced current through the IPG, (3) confirming that the battery is fully charged, (4) suspending passive charge recovery.
If the calculated inductance is less than the nominal inductance (i.e., the inductance rating of the inductor used in the circuit), then it is assumed that the inductor is at least partially saturated due to the presence of an external magnetic field. According to some embodiments, the IPG can calculate the strength of the external magnetic field based on a function relating the inductance to magnetic field strength. Such a function would have to have been calculated empirically beforehand and programmed into the IPG.
The IPG can take steps to enter MM-safe mode if the calculated magnetic field exceeds a threshold value. In alternative embodiments wherein the IPG is not programmed to calculate the strength of the magnetic field, the IPG can take steps to enter an MM-safe mode based on the calculated decrease in inductance. Moreover, the IPG can take steps to enter an MM-safe mode based on an increase in V+, as mentioned above.
According to a further embodiment, the IPG is already in an MM-safe mode and executes an algorithm to adjust the duty cycle of the pulse width modulator 405 (
If neither the Dmax or V+max conditions are met, then the IPG incrementally increases the duty cycle and re-executes the measurement and determinations at the new increased duty cycle. If either V+max or Dmax are met, then the IPG ceases incrementing D. The IPG then can calculate the inductance L using Eq. 5. According to some embodiments, the IPG can calculate the magnetic field strength H, from empirically derived data as described above.
It should be noted here that the circuit described herein and used for induction-based determination of an external magnetic field is a boost circuit that is commonly used to provide a compliance voltage in an IPG. Extending the boost circuit for magnetic field detection offers advantages in space saving and design considerations, especially compared to using Hall effect transistors. However, it should be appreciated that a circuit, similar to the one illustrated in
Although particular embodiments of the present invention have been shown and described, it should be understood that the above discussion is not intended to limit the present invention to these embodiments. It will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the present invention. Thus, the present invention is intended to cover equivalents that may fall within the spirit and scope of the present invention as defined by the claims.
This is a non-provisional application based on U.S. Provisional Patent Application Ser. No. 62/393,008, filed Sep. 10, 2016, which is incorporated by reference in its entirety, and to which priority is claimed.
Number | Name | Date | Kind |
---|---|---|---|
5280239 | Klimovitsky | Jan 1994 | A |
5287059 | Ando | Feb 1994 | A |
6181969 | Gord | Jan 2001 | B1 |
6516227 | Meadows et al. | Feb 2003 | B1 |
6553263 | Meadows et al. | Apr 2003 | B1 |
7127298 | He et al. | Oct 2006 | B1 |
7177698 | Klosterman et al. | Feb 2007 | B2 |
7444181 | Shi et al. | Oct 2008 | B2 |
7539538 | Parramon et al. | May 2009 | B2 |
7623916 | Julian | Nov 2009 | B2 |
7801600 | Carbunaru et al. | Sep 2010 | B1 |
7801602 | McClure et al. | Sep 2010 | B2 |
7872884 | Parramon et al. | Jan 2011 | B2 |
7881803 | Parramon et al. | Feb 2011 | B2 |
7890182 | Parramon et al. | Feb 2011 | B2 |
8606362 | He et al. | Dec 2013 | B2 |
8620436 | Parramon et al. | Dec 2013 | B2 |
8649858 | Griffith et al. | Feb 2014 | B2 |
8768453 | Parramon et al. | Jul 2014 | B2 |
9002465 | Ranu | Apr 2015 | B2 |
9008790 | Griffith et al. | Apr 2015 | B2 |
9037241 | Lamont et al. | May 2015 | B2 |
9061140 | Shi et al. | Jun 2015 | B2 |
9174051 | Marnfeldt | Nov 2015 | B2 |
9220901 | Gururaj | Dec 2015 | B2 |
9233254 | Nimmagadda | Jan 2016 | B2 |
9259574 | Aghassian et al. | Feb 2016 | B2 |
9308373 | Lee | Apr 2016 | B2 |
9314632 | Marnfeldt et al. | Apr 2016 | B2 |
9327135 | Vansickle et al. | May 2016 | B2 |
9352162 | Lamont et al. | May 2016 | B2 |
9397639 | Feldman et al. | Jul 2016 | B2 |
20060173493 | Armstrong et al. | Aug 2006 | A1 |
20070191914 | Stessman | Aug 2007 | A1 |
20080071168 | Gauglitz | Mar 2008 | A1 |
20090182389 | Stessman | Jul 2009 | A1 |
20100268309 | Parramon et al. | Oct 2010 | A1 |
20110160565 | Stubbs | Jun 2011 | A1 |
20110160806 | Lyden | Jun 2011 | A1 |
20110306860 | Halperin | Dec 2011 | A1 |
20120046707 | Gauglitz | Feb 2012 | A1 |
20120053652 | Dianaty | Mar 2012 | A1 |
20120095529 | Parramon et al. | Apr 2012 | A1 |
20120215271 | Min | Aug 2012 | A1 |
20120277817 | Ellingson et al. | Nov 2012 | A1 |
20130184794 | Feldman et al. | Jul 2013 | A1 |
20130245723 | Gururaj | Sep 2013 | A1 |
20130289638 | Newman | Oct 2013 | A1 |
20130325085 | Carbunaru et al. | Dec 2013 | A1 |
20140194729 | Gauglitz | Jul 2014 | A1 |
20150134029 | Ozawa | May 2015 | A1 |
20150144183 | Yang et al. | May 2015 | A1 |
20150157861 | Aghassian | Jun 2015 | A1 |
20160051825 | Ter-Petrosyan et al. | Feb 2016 | A1 |
20170173328 | Ostroff | Jun 2017 | A1 |
Entry |
---|
International Search Report and Written Opinion regarding corresponding PCT application No. PCT/US2017/050311, dated Nov. 7, 2017. |
Number | Date | Country | |
---|---|---|---|
20180071522 A1 | Mar 2018 | US |
Number | Date | Country | |
---|---|---|---|
62393008 | Sep 2016 | US |