Medical Device – Rafael Carbunaru, Jordi Parramon, Robert Ozawa, Jess Shi, Joey Chen, Md. Mizanur Rahman, Boston Scientific Neuromodulation Corp

Abstract for “Exeficient external charger for implantable medical devices optimized for fast charging and constrained with an implant power dissipation limitation”

“An external charger to charge a battery inside an implantable medical device is disclosed. Charging techniques are also described. The power dissipation of charging circuitry within the implant is modeled using simulation data at different levels of implant power. The charging circuitry is limited in its ability to produce heat to the surrounding tissue. A power dissipation limitation limits the charging circuitry’s output. Duty cycles for a charging field must not exceed this limit. The maximum simulated battery current determines the fastest charging speed. An indicator parameter is also determined and stored in an external charger. The actual value of that parameter is determined during charging. In order to ensure fast charging without exceeding the power dissipation limit, the charging field intensity and/or duty cycles are adjusted.

Background for “Exeficient external charger for implantable medical devices optimized for fast charging and constrained with an implant power dissipation limitation”

“Implantable stimulation device generate and deliver electrical stimuli nerves and tissues to treat various biological disorders. These include pacemakers to treat heart arrhythmia, defibrillators for treating cardiac fibrillation, cochlear stimulaters to treat deafness, retinal and cochlear stimulators that treat blindness, neuromodulators to produce coordinated movement of the limbs, spinal cord stimulators and spinal stimulators, deep and cortical brain stimulators, motor and psychological disorders, cortical nerve stimulators, sleep apnea, sleep apneapneapneapneapneapneapnea, and other neural stimulators, to treat apneapneapneapneapneapneapne, sublaxation, shoulder sublaxation and to treat apneapneapneapneapneapneap to treat to treat to treat to treat to to treat to to to to to to to to to to to to to to to to to to to to to to to to to to treat to to to treat to to treat to to to to treat to to to to to to to to to to to to to to to to to to to to to to to to to to to to Although the present invention is applicable to all of these applications as well as other implantable medical devices systems, the following description will focus on Bion? “microstimulator device system according to the U.S. Patent Application Publication 2010,/0268309.

“Microstimulator devices typically comprise a small generally-cylindrical housing which carries electrodes for producing a desired stimulation current. These devices are placed proximate the target tissue in order to permit stimulation current to reach the target tissue. This allows for therapy for many conditions and disorders. A microstimulator typically includes or carries stimulating electrodes that are intended to contact patient’s tissues. However, the electrodes may also be coupled to the device’s body via a lead. Microstimulators may contain two or more electrodes. Microstimulators are simple to use. The microstimulator’s small size allows for easy implanting at any site that requires patient therapy.

“FIG. “FIG. 1” shows an implantable microstimulator 100. The microstimulator 100 has a power source 145, such as a battery and a programmable storage 146. It also includes electrical circuitry 144 and a coil. These components are contained within a capsule 200, which is typically a narrow, elongated cylindrical. However, it may be any shape depending on the target tissue structure, method of implantation and the size and position of the power source. 145, and/or the number or arrangement of external electrodes. 142. Some embodiments have a volume that is at least three cubic centimeters.

The battery 145 provides power to various components of the microstimulator 100 such as the electrical circuitry (144) and the coil (147). The battery 145 provides power for therapeutic stimulation current that is sourced from or submerged from the electrodes. Power source 145 can be either a primary or rechargeable battery. We will describe further the systems and methods of charging a rechargeable batteries 145.

The coil 147 can receive and/or transmit a magnetic field. This magnetic field is used to communicate or receive power from one or more external devices supporting the microstimulator 100. Examples of such devices will be discussed below. This type of communication and/or power transfer can be transcutaneous, as it is well-known.”

“The programmable storage 146 can be used in at least part to store one or more sets data, including electrical stimulation parameters, that are safe for a specific medical condition and/or patient. The stimulation parameters can control the parameters of stimulation current to target tissue. These parameters include frequency, pulse width and amplitude as well as burst pattern (e.g. burst on and burst off times), duty cycle, burst repeat intervals, ramp on and ramp off times, and so on.

“The illustrated microstimulator 100 has electrodes 142-1, 142-2 on the outside of the capsule. The electrodes 142 can be placed at either the capsule’s exterior (as illustrated) or along its length. You may have more than one electrode arranged along the length the capsule. One electrode 142 could be used as a stimulating electrode and the other as an indifferent (reference node), to complete a stimulation circuit that produces monopolar stimulation. One electrode could be used to produce bipolar stimulation by acting as both a cathode and an anode. Alternately, electrodes 142 can be found at the ends flexible and short leads. These leads allow for electrical stimulation to be directed at targeted tissue(s), within a relatively short distance of the surgical fixation 100 of the device 100.

“The electrical circuitry144 generates the stimulation pulses that are delivered via electrodes 142 to the target nerve. One or more microprocessors, or microcontrollers, may be included in the electrical circuitry 144. These microprocessors are used to decode stimulation parameters stored in memory 146 and generate stimulation pulses. Other circuitry will be included in the electrical circuitry 144, such as the current source circuitry and the transmission-receiver circuitry coupled with coil 147, electrode out capacitors, etc.”

“The exterior surfaces of the microstimulator100 are preferred to be made of biocompatible materials. The capsule 202, for example, may be made from glass, ceramic, metal or any other material that allows the passage of magnetic fields that are used to transmit data or power. To avoid electrolysis or corrosion, the electrodes 142 can be made from a noble or reactive metal or compound such as platinum, tantalum or titanium, titanium nitride or niobium, or any alloys of any of these.

The microstimulator 100 could also have one or more infusion outlets, 201 that allow for the infusion of drugs into target tissue. To deliver drug therapy to target tissues, catheters can be attached to the infusion outlets. The microstimulator 100 can be configured to deliver drug stimulation via infusion outlets 201. A pump 149 may also be included in the microstimulator100. This pump is designed to store and dispense the drugs.

“Turning towards FIG. 2. The microstimulator 100 has been shown as being implanted in a patient 150. Additional components that could be used to support it 100 are also shown. A communication link 156 can be used to program the microstimulator 100 and test it. This link 156, which is usually a two-way connection, allows the microstimulator 100 to report its status and other parameters to the external control 155. Magnetic inductive coupling is used to communicate on link 156. When data is being sent from the external control 155 to microstimulator 100 via magnetic inductive coupling, a coil (158) in the external controller is excited to create a magnetic field which includes the link 156. This magnetic field is detected by the coil 147 of the microstimulator. The same applies to data that is sent from the microstimulator 100 into the external controller. A coil 147 is excited to create a magnetic force that includes the link 156. This magnetic field can be detected at the coils 158 in external controller. The magnetic field is usually modulated with Frequency Shift Keying modulation (FSK) or similar to encode the data.

“An external charger (151) provides power to recharge the battery (FIG. 1). This power transfer is achieved by activating the coil 157 using the external charger151. This creates a magnetic field that includes link 152. The magnetic field 152 is used to energize the coil 147 via the patient’s 150?s tissue. This magnetic field can be rectified, filtered and used to recharge battery 145, as described below. Like link 156 and link 152, link 152 can be bidirectional so that the microstimulator 100 can report status information to the external charger.151 The microstimulator 100’s circuitry 144 can detect if the power source 145 has been fully charged and the coil 147 can notify the external charger 151. This will allow charging to stop. Patients 150 can have charging at convenient times, such as every night.

“FIG. “FIG. The coil 147 receives the charging energy, i.e. the magnetic charge field, via link 152. Combining coil 147 and capacitor 162 creates an AC voltage of Va. The AC voltage can be rectified using rectifier circuitry 164, which may include a well-known 4-diode circuit bridge circuit. However, it is shown in FIG. 3. is a single diode, for simplicity. Capacitor 16 helps to filter the signal at Vb so that Vb is essentially DC voltage with a small ripple. Charging circuitry 170 is the one that intercedes between Vb, the rechargeable battery 140, and Vb. It takes Vb’s DC voltage and produces a controlled charging current, Ibat. It is not difficult to understand charging circuitry 170. The art of power circuitry 160 is well-known to those who are skilled in it.

“The art recognizes that heating can be controlled through the control of the intensity magnetic charge field generated at the external charger.151 To reduce temperature during charging, you can decrease the current flowing through the charging coil 157. It has been recognized by the art that heating can also be controlled by duty cycling the charging fields, i.e. turning on and off the external charger 151. FIG. FIG. The magnetic charging field is active for 50% of the time, which equals DC1. The second duty cycle DC2, which equals 75%, means that the magnetic charging field remains on for much longer (i.e. t2(1)=3t2(2)). Higher duty cycles mean higher temperatures, as one would expect.

Although changing the intensity or duty cycle of the magnetic charge field generated by the external charger 151 may be an effective way to control implant temperature, inventors realized that these approaches don’t adequately address important issues. The first is that prior methods do not consider whether the magnetic charging field intensity, duty, or combination should be altered for temperature control. These techniques do not allow for efficient charging of the implant batteries 145. You can adjust the magnetic field’s intensity and/or duty to achieve the desired temperature control. However, the parameters selected may result in a battery charging power that is too low. This could prolong the charging process. Long-term charging is inefficient because the patient must wait for the battery to fully charge 145 in their implant. Patients don’t want charging to take longer than is necessary, which is understandable.

“Finding the optimal charging conditions (intensity and duty cycle) is difficult with prior art techniques. This disclosure provides a method to overcome this problem and make charging more efficient both from a time perspective and for implant heating.

“An improved external charger is provided for an implantable medical device. A method for charging the battery with such an improved external charger is also disclosed. Simulation data is used to model power dissipation in the charging circuitry of an implant at different levels of implant power. To prevent the charging circuitry from heating up excessively to the surrounding tissue, a power dissipation limit has been set. Duty cycles have been determined for different input intensities in order to limit the power limit. The maximum simulated battery current is used to determine the fastest (or quickest) charging speed. An optimal value for a parameter that indicates this current, such as the voltage across the battery charging circuitry or the voltage across it, is also determined and stored in an external charger. The implant reports the actual value of that parameter to the external charger during charging. This adjusts the intensity or duty cycle of magnetic charging fields consistent with the simulation to ensure charging is as fast and efficient as possible while not exceeding the power dissipation limits. The charging process is optimized to maximize speed and safety while maintaining tissue heating.

“Prior discussing the disclosed technique is made reference to the microstimulator circuitry 160 in FIG. 3. This circuitry was used to explain the technique. However, it is important to understand that the disclosed technique can be used with any power circuitry not shown 160.

“The inventors discovered through simulations that power loss from the various components of the power circuitry 160 was complex and nonlinear in nature. FIGS. FIGS. 5A, 5B and 5C show one such simulation 200. Some portions of simulation 200 are kept in the external charger (151) and used to regulate charging, as will be explained below. Simulation 200 will be explained before we get into the charging process.

Simulation 200 illustrates the effects of changing the intensity (e.g. current) of the external controller’s charging loop 157 (Iprim(rms),) on various components of the power circuitry 160. Each row represents an increasing value of Iprim(rms). The simulation 200 results will change depending on the state of the implant battery 145 at any given time. To provide accurate simulation results, the battery’s capacity may be filled during charging. If the battery 145 is full, simulations 200 can be generated for Vbat=3.1 V3, 3.3 V, 3.7V and 4.1V to provide a range of expected battery capacities. If the parameters of simulation 200 are not affected by Vbat, then additional simulations 200 may not be required for different battery capacities. Mentor Graphics Design Architect is a useful simulation program for creating a simulation 200.

“The simulation 200 assumes that there is a specific coupling factor between the primary and secondary coils 157 and 147 in the implant 100. This coupling factor is modelled taking into consideration factors such as coil alignment, coil inductances, coil inductances, and distances and permittivity between any materials (e.g. tissue, air). To conservatively represent a worst-case alignment between charging coils 157 & 147, the simulation depicted uses a coupling factor of k=0.017. The coupling factor results in a simulated inductive current in the implant charging coil 147 (Isec(rms),) and a current in the tank capacitor 162 (162(rms),) a voltage across coil 147(Vcoil(rms),) a DC voltage generated by the rectifier circuit 164 (Vna), and a battery charging current / battery voltage (Vbat) which is the result of the input of the charging current. This battery voltage takes into consideration the internal resistance of the internal resistance of the 145. Relevant parameters (resistances and capacitances, inductances, coupling factors, etc.) for various components of the power circuitry 160 are also available. To allow the simulation program generate the simulation results, the relevant parameters for the power circuitry 160 (resistances, capacitances and inductances, etc.) must be entered.

“Voil across the charging circuitry 170 is Vnab. This represents the difference between Vna, Vbat. The charging circuitry 170 is set to Ibat so any voltage buildup across the charging circuitry will result in unwanted heat generation. Modeling shows that the rate of heat dissipation by the charging circuitry 170 increases exponentially with increasing battery charging current. FIG. FIG. 6 shows that as the battery charging current Ibat rises, the voltage across the battery protection circuitry Vnab also increases at an increasing rate. The charging circuit 170 draws power equal to the voltage times the current, so the power also increases exponentially. The parameter Vnab, which is the charging power lost as heat, can be summarized as follows: It is controlled and monitored in the disclosed method to allow charging at an optimally efficient level.

“From the various simulation voltages and currents shown in FIG. The simulation 200 can calculate the power dissipated from the various components of the power circuitry 160 using the simulated voltages and currents in FIG. 5B, which powers are essentially the product of voltage across and current through various components. The element number for each component represents the power drawn. For example, P145 denotes the power drawn during charging by battery 145. Pfes is the power drawn by front-end switches in series with charging circuitry 170. These switches are not shown because of their small power dissipation. In FIG. 5, the sum of power dissipated each component of the power circuitry 160 can be seen in the last column. 5B (Ptotal).”

To keep the total power below 32 mW, you can duty cycle the external charger’s power 151. The computed duty cycle can be found in FIG. 5C. 5C.

FIG. 7, for the third, fourth and fifth rows of the simulation 200. This is when Iprim(rmss) equals 600 800 1000 mA. The simulated total power was 27.5mW in the third row. This is lower than the 32 mW limit. Duty cycling is not required for this level Iprim(rms), 600 mA. To allow for an off time (TW), the duty cycle is 90 percent. This allows the implant 100 to back-telemeter data to external charger 151. For example, the telemetry window (TW), which is usually 10 seconds, can be used to indicate that the duty cycle period, typically 100 sec, is approximately 10 times longer. The telemetry window (TW) can be set to a fixed time, but it can also be adjusted to adjust the amount of data that is required to be sent back to the external charger. The TW can be adjusted to transmit data in the required time. The on portion of the duty cycle can also be adjusted to suit the requirements. The implant 100 will experience less temperature ripple if the duty cycle is shorter.

“As you will see, it is beneficial to telemeter data, e.g. Vnab and Vbat, back to the external charger. 151 This allows charging to be iteratively optimized. FIG. FIG. 7 shows that the duty cycle applies to the primary coil of the external charger (Iprim(rms),) which in turn causes the same duty cycles in the battery charging current Ibat. The average battery current, Ibat (avg), can also be calculated using the product of Ibat, the duty cycle, and a time-average indication of how much charging current is being received by the battery despite the duty cycling. We will discuss the significance of Ibat (avg) further below.

“The fourth row of simulation 200 (Iprim(rms),=800 mA) showed that the simulated total power was 38.6MW, which is above the 32mW limit. As a heat control measure, duty cycling is also imposed. This duty cycling is equal to 82.9% (32/38.6) in order to maintain a maximum dissipated energy of 32 mW. The fifth row is also processed to calculate a duty cycle at 61.2%. Iprim(rmss) and Ibat’s effects are shown.

“Remember from FIG. 7. The average battery current, Ibat (avg)(opt), is maximized when Iprim equals 600 mA. The optimal charging current for an implant battery is Ibat(avg(opt)=11.6mA. This is because it has the highest average current, and will therefore charge the battery the fastest. Due to the duty cycling that is used to calculate the Ibat (avg), values, Ibat[avg](opt) has been optimized to allow 32 mW of power dissipation per average. The Ibat(avg),(opt) optimization is therefore optimized for speed and heat dissipation.

“Also illustrated in FIG. “Also shown in FIG. 10 are the transmitter and receiver circuits 304 and 306 connected to the external charger’s coil.157. This circuitry is well-known. The transmitter 304 emits an AC signal that causes the L-C Tank circuit (156/157), to vibrate and generate the magnetic charge field. The microcontroller 300 sends control signals to the transmitter 304. These signals indicate the intensity of the signal (e.g. the magnitude of Iprim) as well as the duty cycle. The data is transmitted from the implant 100 periodically to the receiver 306, e.g. during the telemetry window, TW, or off portions of a duty cycle (see FIG. 7). These data can be transmitted via radio-frequency (RF telemetry) or Load Shift Keying, for example. U.S. Pat. No. No.

“Traditionally, such back-telemetry from an implant to an external charger is used for transmitting the battery capacity 145 during charging (Vbat), which informs external charger 151 when the battery has reached its maximum capacity and can be stopped charging. The disclosed system reports the battery capacity, but also the Vnab value at the implant 100. Vnab can be reported to the external charger151 at any time during charging. For example, once every 100 seconds. Vnab can be reported more often, which allows for charging to be optimized.

“Now that we have an understanding of the structure of the external charger, 151, let’s focus our attention on the actual charging session. The basic steps are shown at FIG. 11. The external charger 151 is first turned on by the patient. It then generates a magnetic charge field using an initial intensity (i.e. an initial Iprim), and an initial duty cycle. Simulation 200 is not able to determine the initial power and duty cycle levels of the external charger. The coupling to the implant 100 in real-life charging sessions cannot be predicted in advance. Different patients might have their implants at different depths or have different alignments between the external chargers and their implant. The initial power and duty cycles values are not critical as they will be modified in accordance to the disclosed charging technique. However, they are logically set at initial values that are guaranteed to not injure patients.

“Periodically, during charging, for instance, maybe every 100 seconds, both the battery voltage (Vbat), and the voltage across charging circuitry (Vnab), are measured at the implant 100 and telemetered from the external charger. This telemetry may include RF or LSK data telemetry that is performed within the telemetry window or off times in the duty cycle. The length of communication between charger and implant may determine how often they communicate. This is similar to the communication time during the Telemetry Window (TW). The implant 100 will experience less temperature ripple if communication is increased more often.

“Once Vnab has been reported, the microcontroller 300 consults the memory 302 in order to determine if Vnab=Vnab (opt) for the reported Vbat. If it is not, the intensity of magnetic charging field will be changed. Referring to FIG. 300, this is an example. 10. If Vnab is close to 0.293V and Vbat=3.1V, then the microcontroller 300 would recognize that intensity is too high and reduce Iprim to try to make Vnab (opt) approach Vnab(opt). Iprim would be increased if Vnab was near 0.181V.

“At the exact same time, the duty cycles of the magnetic charging fields would be modified to match the Vnab being described. To ensure compliance with the power dissipation limit, it is necessary to modify the duty cycle. Referring to FIG. 10, let’s say that Vnab is near 0.293V. 10 assume that Vnab nears 0.293V and that the duty cycle at transmitter 304 is 85%. Referring to memory 302, it is clear that the duty cycle is too high and will generate too much heat. The microcontroller 300 will adjust the duty cycle to 61.2% if the total dissipated energy is not exceeded.

FIG. 11 Once the intensity and duty cycles have been adjusted at the external charger151, the process continues: Vbat, Vnab are reported again after some time and, if needed, the intensity, duty cycle are adjusted again. This iterative adjustment of power from the external charger151 is especially useful in cases where the coupling between external charger151 and implant 100 may change. During charging, the patient might move the external charger relative the implant. These coupling changes can easily be corrected using the disclosed method, which allows for adjustments to be made in situ to ensure that the charging process is as fast and safe as possible.

“To the point of disclosure, it was assumed that Vnab(opt) is the optimal Vnab value. Vnab (opt) could also be used to represent a range acceptable Vnab value. FIG. Five-C displays three Ibat(avg), over eleven mA values (rows four through six), that correspond to Vnab (FIG. 5A) between 0.243 and 0.319V. If any of these charging currents provide satisfactory charging of the implant battery, 145, Vnab(opt), as illustrated in FIG. 12. If Vnab falls within the range, Iprim would not change the intensity of the external charger. To ensure compliance with the heat limit, however, it is possible to adjust the duty cycle to Vnab even though the intensity has not been changed. FIG. 5C illustrates this point. 5C shows that Ibat(avg), although it does not change significantly across the Vnab range (11.6 to 11.0mA), but the duty cycle changes sharply (82.9 to 53.6%). Changing duty cycling within Vnab(opt), depending on the details of the simulation and the conservative nature the heat limit, might not be necessary. However, the definition of Vnab(opt), as a range, will simplify the operation of the technique and require less frequent modification to the magnetic charging field at external charger 151.

“It is important to understand that different parameters (e.g. Vnab(opt); the DC corresponding to a specific Vnab)) can be interpolated/extrapolated from simulation 200 and are not necessarily bound to the actual values appearing in simulation. This interpolation was not demonstrated to make the discussion of this technique more simple.

“Many parameters found herein (e.g. Vnab(opt),) are determined by the simulation 200. This simulation is a convenient way to understand the external charger/implanter system. Not all applications of the technique require a simulation. Based on the designer’s consideration of important factors, it is possible to use empirical data, models, analytical tools or other methods.

“The implant’s power consumption is limited by the disclosed technique. The technique can be restricted to limit heating at a specific area of the implant. The technique can be used to limit heating in large implants and implants with low heat conductivity. The technique could use a parameter, possibly different than Vnab, to indicate heating to the section and limit heating to that specific section to acceptable limits. This modification would limit the power dissipated in heat to the relevant section.

This disclosure uses the term “Vnab” to indicate excess power dissipation. Other parameters can also be taken from the implant to indicate incoming power. These include total power delivered, ripple of coil voltage, ripple rectified voltage, time of rectifying circuit and duty cycle. These parameters can be measured or inferred from the implant in many ways.

“Even though this technique refers to periodic measurement of implant parameters during charging sessions and periodic adjustment magnetic charging field, it is not a ‘periodic?. These actions should not be interpreted as requiring that they are taken at a specific time. Instead, ?periodic? “Periodic” should be understood to mean taking multiple actions at once, even if they are not at regular intervals.

“The inventions described have been made by specific embodiments and/or applications of them, but those skilled in art could make many modifications or variations without departing from their literal and equivalent scope.”

Summary for “Exeficient external charger for implantable medical devices optimized for fast charging and constrained with an implant power dissipation limitation”

“Implantable stimulation device generate and deliver electrical stimuli nerves and tissues to treat various biological disorders. These include pacemakers to treat heart arrhythmia, defibrillators for treating cardiac fibrillation, cochlear stimulaters to treat deafness, retinal and cochlear stimulators that treat blindness, neuromodulators to produce coordinated movement of the limbs, spinal cord stimulators and spinal stimulators, deep and cortical brain stimulators, motor and psychological disorders, cortical nerve stimulators, sleep apnea, sleep apneapneapneapneapneapneapnea, and other neural stimulators, to treat apneapneapneapneapneapneapne, sublaxation, shoulder sublaxation and to treat apneapneapneapneapneapneap to treat to treat to treat to treat to to treat to to to to to to to to to to to to to to to to to to to to to to to to to to treat to to to treat to to treat to to to to treat to to to to to to to to to to to to to to to to to to to to to to to to to to to to Although the present invention is applicable to all of these applications as well as other implantable medical devices systems, the following description will focus on Bion? “microstimulator device system according to the U.S. Patent Application Publication 2010,/0268309.

“Microstimulator devices typically comprise a small generally-cylindrical housing which carries electrodes for producing a desired stimulation current. These devices are placed proximate the target tissue in order to permit stimulation current to reach the target tissue. This allows for therapy for many conditions and disorders. A microstimulator typically includes or carries stimulating electrodes that are intended to contact patient’s tissues. However, the electrodes may also be coupled to the device’s body via a lead. Microstimulators may contain two or more electrodes. Microstimulators are simple to use. The microstimulator’s small size allows for easy implanting at any site that requires patient therapy.

“FIG. “FIG. 1” shows an implantable microstimulator 100. The microstimulator 100 has a power source 145, such as a battery and a programmable storage 146. It also includes electrical circuitry 144 and a coil. These components are contained within a capsule 200, which is typically a narrow, elongated cylindrical. However, it may be any shape depending on the target tissue structure, method of implantation and the size and position of the power source. 145, and/or the number or arrangement of external electrodes. 142. Some embodiments have a volume that is at least three cubic centimeters.

The battery 145 provides power to various components of the microstimulator 100 such as the electrical circuitry (144) and the coil (147). The battery 145 provides power for therapeutic stimulation current that is sourced from or submerged from the electrodes. Power source 145 can be either a primary or rechargeable battery. We will describe further the systems and methods of charging a rechargeable batteries 145.

The coil 147 can receive and/or transmit a magnetic field. This magnetic field is used to communicate or receive power from one or more external devices supporting the microstimulator 100. Examples of such devices will be discussed below. This type of communication and/or power transfer can be transcutaneous, as it is well-known.”

“The programmable storage 146 can be used in at least part to store one or more sets data, including electrical stimulation parameters, that are safe for a specific medical condition and/or patient. The stimulation parameters can control the parameters of stimulation current to target tissue. These parameters include frequency, pulse width and amplitude as well as burst pattern (e.g. burst on and burst off times), duty cycle, burst repeat intervals, ramp on and ramp off times, and so on.

“The illustrated microstimulator 100 has electrodes 142-1, 142-2 on the outside of the capsule. The electrodes 142 can be placed at either the capsule’s exterior (as illustrated) or along its length. You may have more than one electrode arranged along the length the capsule. One electrode 142 could be used as a stimulating electrode and the other as an indifferent (reference node), to complete a stimulation circuit that produces monopolar stimulation. One electrode could be used to produce bipolar stimulation by acting as both a cathode and an anode. Alternately, electrodes 142 can be found at the ends flexible and short leads. These leads allow for electrical stimulation to be directed at targeted tissue(s), within a relatively short distance of the surgical fixation 100 of the device 100.

“The electrical circuitry144 generates the stimulation pulses that are delivered via electrodes 142 to the target nerve. One or more microprocessors, or microcontrollers, may be included in the electrical circuitry 144. These microprocessors are used to decode stimulation parameters stored in memory 146 and generate stimulation pulses. Other circuitry will be included in the electrical circuitry 144, such as the current source circuitry and the transmission-receiver circuitry coupled with coil 147, electrode out capacitors, etc.”

“The exterior surfaces of the microstimulator100 are preferred to be made of biocompatible materials. The capsule 202, for example, may be made from glass, ceramic, metal or any other material that allows the passage of magnetic fields that are used to transmit data or power. To avoid electrolysis or corrosion, the electrodes 142 can be made from a noble or reactive metal or compound such as platinum, tantalum or titanium, titanium nitride or niobium, or any alloys of any of these.

The microstimulator 100 could also have one or more infusion outlets, 201 that allow for the infusion of drugs into target tissue. To deliver drug therapy to target tissues, catheters can be attached to the infusion outlets. The microstimulator 100 can be configured to deliver drug stimulation via infusion outlets 201. A pump 149 may also be included in the microstimulator100. This pump is designed to store and dispense the drugs.

“Turning towards FIG. 2. The microstimulator 100 has been shown as being implanted in a patient 150. Additional components that could be used to support it 100 are also shown. A communication link 156 can be used to program the microstimulator 100 and test it. This link 156, which is usually a two-way connection, allows the microstimulator 100 to report its status and other parameters to the external control 155. Magnetic inductive coupling is used to communicate on link 156. When data is being sent from the external control 155 to microstimulator 100 via magnetic inductive coupling, a coil (158) in the external controller is excited to create a magnetic field which includes the link 156. This magnetic field is detected by the coil 147 of the microstimulator. The same applies to data that is sent from the microstimulator 100 into the external controller. A coil 147 is excited to create a magnetic force that includes the link 156. This magnetic field can be detected at the coils 158 in external controller. The magnetic field is usually modulated with Frequency Shift Keying modulation (FSK) or similar to encode the data.

“An external charger (151) provides power to recharge the battery (FIG. 1). This power transfer is achieved by activating the coil 157 using the external charger151. This creates a magnetic field that includes link 152. The magnetic field 152 is used to energize the coil 147 via the patient’s 150?s tissue. This magnetic field can be rectified, filtered and used to recharge battery 145, as described below. Like link 156 and link 152, link 152 can be bidirectional so that the microstimulator 100 can report status information to the external charger.151 The microstimulator 100’s circuitry 144 can detect if the power source 145 has been fully charged and the coil 147 can notify the external charger 151. This will allow charging to stop. Patients 150 can have charging at convenient times, such as every night.

“FIG. “FIG. The coil 147 receives the charging energy, i.e. the magnetic charge field, via link 152. Combining coil 147 and capacitor 162 creates an AC voltage of Va. The AC voltage can be rectified using rectifier circuitry 164, which may include a well-known 4-diode circuit bridge circuit. However, it is shown in FIG. 3. is a single diode, for simplicity. Capacitor 16 helps to filter the signal at Vb so that Vb is essentially DC voltage with a small ripple. Charging circuitry 170 is the one that intercedes between Vb, the rechargeable battery 140, and Vb. It takes Vb’s DC voltage and produces a controlled charging current, Ibat. It is not difficult to understand charging circuitry 170. The art of power circuitry 160 is well-known to those who are skilled in it.

“The art recognizes that heating can be controlled through the control of the intensity magnetic charge field generated at the external charger.151 To reduce temperature during charging, you can decrease the current flowing through the charging coil 157. It has been recognized by the art that heating can also be controlled by duty cycling the charging fields, i.e. turning on and off the external charger 151. FIG. FIG. The magnetic charging field is active for 50% of the time, which equals DC1. The second duty cycle DC2, which equals 75%, means that the magnetic charging field remains on for much longer (i.e. t2(1)=3t2(2)). Higher duty cycles mean higher temperatures, as one would expect.

Although changing the intensity or duty cycle of the magnetic charge field generated by the external charger 151 may be an effective way to control implant temperature, inventors realized that these approaches don’t adequately address important issues. The first is that prior methods do not consider whether the magnetic charging field intensity, duty, or combination should be altered for temperature control. These techniques do not allow for efficient charging of the implant batteries 145. You can adjust the magnetic field’s intensity and/or duty to achieve the desired temperature control. However, the parameters selected may result in a battery charging power that is too low. This could prolong the charging process. Long-term charging is inefficient because the patient must wait for the battery to fully charge 145 in their implant. Patients don’t want charging to take longer than is necessary, which is understandable.

“Finding the optimal charging conditions (intensity and duty cycle) is difficult with prior art techniques. This disclosure provides a method to overcome this problem and make charging more efficient both from a time perspective and for implant heating.

“An improved external charger is provided for an implantable medical device. A method for charging the battery with such an improved external charger is also disclosed. Simulation data is used to model power dissipation in the charging circuitry of an implant at different levels of implant power. To prevent the charging circuitry from heating up excessively to the surrounding tissue, a power dissipation limit has been set. Duty cycles have been determined for different input intensities in order to limit the power limit. The maximum simulated battery current is used to determine the fastest (or quickest) charging speed. An optimal value for a parameter that indicates this current, such as the voltage across the battery charging circuitry or the voltage across it, is also determined and stored in an external charger. The implant reports the actual value of that parameter to the external charger during charging. This adjusts the intensity or duty cycle of magnetic charging fields consistent with the simulation to ensure charging is as fast and efficient as possible while not exceeding the power dissipation limits. The charging process is optimized to maximize speed and safety while maintaining tissue heating.

“Prior discussing the disclosed technique is made reference to the microstimulator circuitry 160 in FIG. 3. This circuitry was used to explain the technique. However, it is important to understand that the disclosed technique can be used with any power circuitry not shown 160.

“The inventors discovered through simulations that power loss from the various components of the power circuitry 160 was complex and nonlinear in nature. FIGS. FIGS. 5A, 5B and 5C show one such simulation 200. Some portions of simulation 200 are kept in the external charger (151) and used to regulate charging, as will be explained below. Simulation 200 will be explained before we get into the charging process.

Simulation 200 illustrates the effects of changing the intensity (e.g. current) of the external controller’s charging loop 157 (Iprim(rms),) on various components of the power circuitry 160. Each row represents an increasing value of Iprim(rms). The simulation 200 results will change depending on the state of the implant battery 145 at any given time. To provide accurate simulation results, the battery’s capacity may be filled during charging. If the battery 145 is full, simulations 200 can be generated for Vbat=3.1 V3, 3.3 V, 3.7V and 4.1V to provide a range of expected battery capacities. If the parameters of simulation 200 are not affected by Vbat, then additional simulations 200 may not be required for different battery capacities. Mentor Graphics Design Architect is a useful simulation program for creating a simulation 200.

“The simulation 200 assumes that there is a specific coupling factor between the primary and secondary coils 157 and 147 in the implant 100. This coupling factor is modelled taking into consideration factors such as coil alignment, coil inductances, coil inductances, and distances and permittivity between any materials (e.g. tissue, air). To conservatively represent a worst-case alignment between charging coils 157 & 147, the simulation depicted uses a coupling factor of k=0.017. The coupling factor results in a simulated inductive current in the implant charging coil 147 (Isec(rms),) and a current in the tank capacitor 162 (162(rms),) a voltage across coil 147(Vcoil(rms),) a DC voltage generated by the rectifier circuit 164 (Vna), and a battery charging current / battery voltage (Vbat) which is the result of the input of the charging current. This battery voltage takes into consideration the internal resistance of the internal resistance of the 145. Relevant parameters (resistances and capacitances, inductances, coupling factors, etc.) for various components of the power circuitry 160 are also available. To allow the simulation program generate the simulation results, the relevant parameters for the power circuitry 160 (resistances, capacitances and inductances, etc.) must be entered.

“Voil across the charging circuitry 170 is Vnab. This represents the difference between Vna, Vbat. The charging circuitry 170 is set to Ibat so any voltage buildup across the charging circuitry will result in unwanted heat generation. Modeling shows that the rate of heat dissipation by the charging circuitry 170 increases exponentially with increasing battery charging current. FIG. FIG. 6 shows that as the battery charging current Ibat rises, the voltage across the battery protection circuitry Vnab also increases at an increasing rate. The charging circuit 170 draws power equal to the voltage times the current, so the power also increases exponentially. The parameter Vnab, which is the charging power lost as heat, can be summarized as follows: It is controlled and monitored in the disclosed method to allow charging at an optimally efficient level.

“From the various simulation voltages and currents shown in FIG. The simulation 200 can calculate the power dissipated from the various components of the power circuitry 160 using the simulated voltages and currents in FIG. 5B, which powers are essentially the product of voltage across and current through various components. The element number for each component represents the power drawn. For example, P145 denotes the power drawn during charging by battery 145. Pfes is the power drawn by front-end switches in series with charging circuitry 170. These switches are not shown because of their small power dissipation. In FIG. 5, the sum of power dissipated each component of the power circuitry 160 can be seen in the last column. 5B (Ptotal).”

To keep the total power below 32 mW, you can duty cycle the external charger’s power 151. The computed duty cycle can be found in FIG. 5C. 5C.

FIG. 7, for the third, fourth and fifth rows of the simulation 200. This is when Iprim(rmss) equals 600 800 1000 mA. The simulated total power was 27.5mW in the third row. This is lower than the 32 mW limit. Duty cycling is not required for this level Iprim(rms), 600 mA. To allow for an off time (TW), the duty cycle is 90 percent. This allows the implant 100 to back-telemeter data to external charger 151. For example, the telemetry window (TW), which is usually 10 seconds, can be used to indicate that the duty cycle period, typically 100 sec, is approximately 10 times longer. The telemetry window (TW) can be set to a fixed time, but it can also be adjusted to adjust the amount of data that is required to be sent back to the external charger. The TW can be adjusted to transmit data in the required time. The on portion of the duty cycle can also be adjusted to suit the requirements. The implant 100 will experience less temperature ripple if the duty cycle is shorter.

“As you will see, it is beneficial to telemeter data, e.g. Vnab and Vbat, back to the external charger. 151 This allows charging to be iteratively optimized. FIG. FIG. 7 shows that the duty cycle applies to the primary coil of the external charger (Iprim(rms),) which in turn causes the same duty cycles in the battery charging current Ibat. The average battery current, Ibat (avg), can also be calculated using the product of Ibat, the duty cycle, and a time-average indication of how much charging current is being received by the battery despite the duty cycling. We will discuss the significance of Ibat (avg) further below.

“The fourth row of simulation 200 (Iprim(rms),=800 mA) showed that the simulated total power was 38.6MW, which is above the 32mW limit. As a heat control measure, duty cycling is also imposed. This duty cycling is equal to 82.9% (32/38.6) in order to maintain a maximum dissipated energy of 32 mW. The fifth row is also processed to calculate a duty cycle at 61.2%. Iprim(rmss) and Ibat’s effects are shown.

“Remember from FIG. 7. The average battery current, Ibat (avg)(opt), is maximized when Iprim equals 600 mA. The optimal charging current for an implant battery is Ibat(avg(opt)=11.6mA. This is because it has the highest average current, and will therefore charge the battery the fastest. Due to the duty cycling that is used to calculate the Ibat (avg), values, Ibat[avg](opt) has been optimized to allow 32 mW of power dissipation per average. The Ibat(avg),(opt) optimization is therefore optimized for speed and heat dissipation.

“Also illustrated in FIG. “Also shown in FIG. 10 are the transmitter and receiver circuits 304 and 306 connected to the external charger’s coil.157. This circuitry is well-known. The transmitter 304 emits an AC signal that causes the L-C Tank circuit (156/157), to vibrate and generate the magnetic charge field. The microcontroller 300 sends control signals to the transmitter 304. These signals indicate the intensity of the signal (e.g. the magnitude of Iprim) as well as the duty cycle. The data is transmitted from the implant 100 periodically to the receiver 306, e.g. during the telemetry window, TW, or off portions of a duty cycle (see FIG. 7). These data can be transmitted via radio-frequency (RF telemetry) or Load Shift Keying, for example. U.S. Pat. No. No.

“Traditionally, such back-telemetry from an implant to an external charger is used for transmitting the battery capacity 145 during charging (Vbat), which informs external charger 151 when the battery has reached its maximum capacity and can be stopped charging. The disclosed system reports the battery capacity, but also the Vnab value at the implant 100. Vnab can be reported to the external charger151 at any time during charging. For example, once every 100 seconds. Vnab can be reported more often, which allows for charging to be optimized.

“Now that we have an understanding of the structure of the external charger, 151, let’s focus our attention on the actual charging session. The basic steps are shown at FIG. 11. The external charger 151 is first turned on by the patient. It then generates a magnetic charge field using an initial intensity (i.e. an initial Iprim), and an initial duty cycle. Simulation 200 is not able to determine the initial power and duty cycle levels of the external charger. The coupling to the implant 100 in real-life charging sessions cannot be predicted in advance. Different patients might have their implants at different depths or have different alignments between the external chargers and their implant. The initial power and duty cycles values are not critical as they will be modified in accordance to the disclosed charging technique. However, they are logically set at initial values that are guaranteed to not injure patients.

“Periodically, during charging, for instance, maybe every 100 seconds, both the battery voltage (Vbat), and the voltage across charging circuitry (Vnab), are measured at the implant 100 and telemetered from the external charger. This telemetry may include RF or LSK data telemetry that is performed within the telemetry window or off times in the duty cycle. The length of communication between charger and implant may determine how often they communicate. This is similar to the communication time during the Telemetry Window (TW). The implant 100 will experience less temperature ripple if communication is increased more often.

“Once Vnab has been reported, the microcontroller 300 consults the memory 302 in order to determine if Vnab=Vnab (opt) for the reported Vbat. If it is not, the intensity of magnetic charging field will be changed. Referring to FIG. 300, this is an example. 10. If Vnab is close to 0.293V and Vbat=3.1V, then the microcontroller 300 would recognize that intensity is too high and reduce Iprim to try to make Vnab (opt) approach Vnab(opt). Iprim would be increased if Vnab was near 0.181V.

“At the exact same time, the duty cycles of the magnetic charging fields would be modified to match the Vnab being described. To ensure compliance with the power dissipation limit, it is necessary to modify the duty cycle. Referring to FIG. 10, let’s say that Vnab is near 0.293V. 10 assume that Vnab nears 0.293V and that the duty cycle at transmitter 304 is 85%. Referring to memory 302, it is clear that the duty cycle is too high and will generate too much heat. The microcontroller 300 will adjust the duty cycle to 61.2% if the total dissipated energy is not exceeded.

FIG. 11 Once the intensity and duty cycles have been adjusted at the external charger151, the process continues: Vbat, Vnab are reported again after some time and, if needed, the intensity, duty cycle are adjusted again. This iterative adjustment of power from the external charger151 is especially useful in cases where the coupling between external charger151 and implant 100 may change. During charging, the patient might move the external charger relative the implant. These coupling changes can easily be corrected using the disclosed method, which allows for adjustments to be made in situ to ensure that the charging process is as fast and safe as possible.

“To the point of disclosure, it was assumed that Vnab(opt) is the optimal Vnab value. Vnab (opt) could also be used to represent a range acceptable Vnab value. FIG. Five-C displays three Ibat(avg), over eleven mA values (rows four through six), that correspond to Vnab (FIG. 5A) between 0.243 and 0.319V. If any of these charging currents provide satisfactory charging of the implant battery, 145, Vnab(opt), as illustrated in FIG. 12. If Vnab falls within the range, Iprim would not change the intensity of the external charger. To ensure compliance with the heat limit, however, it is possible to adjust the duty cycle to Vnab even though the intensity has not been changed. FIG. 5C illustrates this point. 5C shows that Ibat(avg), although it does not change significantly across the Vnab range (11.6 to 11.0mA), but the duty cycle changes sharply (82.9 to 53.6%). Changing duty cycling within Vnab(opt), depending on the details of the simulation and the conservative nature the heat limit, might not be necessary. However, the definition of Vnab(opt), as a range, will simplify the operation of the technique and require less frequent modification to the magnetic charging field at external charger 151.

“It is important to understand that different parameters (e.g. Vnab(opt); the DC corresponding to a specific Vnab)) can be interpolated/extrapolated from simulation 200 and are not necessarily bound to the actual values appearing in simulation. This interpolation was not demonstrated to make the discussion of this technique more simple.

“Many parameters found herein (e.g. Vnab(opt),) are determined by the simulation 200. This simulation is a convenient way to understand the external charger/implanter system. Not all applications of the technique require a simulation. Based on the designer’s consideration of important factors, it is possible to use empirical data, models, analytical tools or other methods.

“The implant’s power consumption is limited by the disclosed technique. The technique can be restricted to limit heating at a specific area of the implant. The technique can be used to limit heating in large implants and implants with low heat conductivity. The technique could use a parameter, possibly different than Vnab, to indicate heating to the section and limit heating to that specific section to acceptable limits. This modification would limit the power dissipated in heat to the relevant section.

This disclosure uses the term “Vnab” to indicate excess power dissipation. Other parameters can also be taken from the implant to indicate incoming power. These include total power delivered, ripple of coil voltage, ripple rectified voltage, time of rectifying circuit and duty cycle. These parameters can be measured or inferred from the implant in many ways.

“Even though this technique refers to periodic measurement of implant parameters during charging sessions and periodic adjustment magnetic charging field, it is not a ‘periodic?. These actions should not be interpreted as requiring that they are taken at a specific time. Instead, ?periodic? “Periodic” should be understood to mean taking multiple actions at once, even if they are not at regular intervals.

“The inventions described have been made by specific embodiments and/or applications of them, but those skilled in art could make many modifications or variations without departing from their literal and equivalent scope.”

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What is a software medical device?

The FDA can refer to software functions that include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)”, which are software functions that are integral to (embedded in a) a medical device.

Section 201(h),?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, implements, machine, contrivances, implant, in vitro regulator, or other similar or related articles, as well as a component or accessory. . . (b) is intended for diagnosis or treatment of disease or other conditions in humans or animals. (c) Is intended to alter the structure or function of human bodies or animals. To be considered a medical device, and thus subject to FDA regulation, the software must meet at least one of these criteria:

  • It must be used in diagnosing and treating patients.
  • It must not be designed to alter the structure or function of the body.

If your software is designed to be used by healthcare professionals to diagnose, treat, or manage patient information in hospitals, the FDA will likely consider such software to be medical devices that are subject to regulatory review.

Is Your Software a Medical Device?

FDA’s current oversight, which puts more emphasis on the functionality of the software than the platform, will ensure that FDA does not regulate medical devices with functionality that could be dangerous to patient safety. Examples of Device Software and Mobile Medical Apps FDA is focused on

  • Software functions that aid patients with diagnosed mental disorders (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) by providing “Skill of the Day”, a behavioral technique, or audio messages, that the user can access when they are experiencing anxiety.
  • Software functions that offer periodic reminders, motivational guidance, and educational information to patients who are recovering from addiction or smokers trying to quit;
  • Software functions that use GPS location data to alert asthmatics when they are near high-risk locations (substance abusers), or to alert them of potential environmental conditions that could cause symptoms.
  • Software that uses video and games to encourage patients to exercise at home.
  • Software functions that prompt users to choose which herb or drug they wish to take simultaneously. They also provide information about interactions and give a summary of the type of interaction reported.
  • Software functions that take into account patient characteristics, such as gender, age, and risk factors, to offer patient-specific counseling, screening, and prevention recommendations from established and well-respected authorities.
  • Software functions that use a list of common symptoms and signs to give advice about when to see a doctor and what to do next.
  • Software functions that help users to navigate through a questionnaire about symptoms and to make a recommendation on the best type of healthcare facility for them.
  • These mobile apps allow users to make pre-specified nurse calls or emergency calls using broadband or cell phone technology.
  • Apps that allow patients or caregivers to send emergency notifications to first responders via mobile phones
  • Software that tracks medications and provides user-configured reminders to improve medication adherence.
  • Software functions that give patients access to their health information. This includes historical trending and comparisons of vital signs (e.g. body temperature, heart rate or blood pressure).
  • Software functions that display trends in personal healthcare incidents (e.g. hospitalization rates or alert notification rate)
  • Software functions allow users to electronically or manually enter blood pressure data, and to share it via e-mail, track it and trend it, and upload it to an electronic or personal health record.
  • Apps that offer mobile apps for tracking and reminders about oral health or tools to track users suffering from gum disease.
  • Apps that offer mobile guidance and tools for prediabetes patients;
  • Apps that allow users to display images and other messages on their mobile devices, which can be used by substance abusers who want to quit addictive behaviors.
  • Software functions that provide drug interaction and safety information (side effects and drug interactions, active ingredient, active ingredient) in a report based upon demographic data (age and gender), current diagnosis (current medications), and clinical information (current treatment).
  • Software functions that allow the surgeon to determine the best intraocular lens powers for the patient and the axis of implantation. This information is based on the surgeon’s inputs (e.g., expected surgically induced astigmatism and patient’s axial length, preoperative corneal astigmatism etc.).
  • Software, usually mobile apps, converts a mobile platform into a regulated medical device.
  • Software that connects with a mobile platform via a sensor or lead to measure and display electrical signals from the heart (electrocardiograph; ECG).
  • Software that attaches a sensor or other tools to the mobile platform to view, record and analyze eye movements to diagnose balance disorders
  • Software that collects information about potential donors and transmits it to a blood collection facility. This software determines if a donor is eligible to collect blood or other components.
  • Software that connects to an existing device type in order to control its operation, function, or energy source.
  • Software that alters or disables the functions of an infusion pump
  • Software that controls the inflation or deflation of a blood pressure cuff
  • Software that calibrates hearing aids and assesses sound intensity characteristics and electroacoustic frequency of hearing aids.

What does it mean if your software/SaaS is classified as a medical device?

SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.

So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.

Software As Medical Device Patenting Considerations

The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.

Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.

In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.

The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.

When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.

An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.

Patent PC is an intellectual property and business law firm that was built to speed startups. We have internally developed AI tools to assist our patent workflow and to guide us in navigating through government agencies. Our business and patent lawyers are experienced in software, SaaS, and medical device technology. For a flat fee, we offer legal services to startups, businesses, and intellectual property. Our lawyers do not have to track time as there is no hourly billing and no charges for calls or emails. We just focus on getting you the best legal work for your needs.

Our expertise ranges from advising established businesses on regulatory and intellectual property issues to helping startups in their early years. Our lawyers are familiar with helping entrepreneurs and fast-moving companies in need of legal advice regarding company formation, liability, equity issuing, venture financing, IP asset security, infringement resolution, litigation, and equity issuance. For a confidential consultation, contact us at 800-234-3032 or make an appointment here.