The implantable, electrically operated medical device system comprises an implanted radio frequency (rf) receiving unit (receiver) incorporating a back-up rechargeable power supply and an implanted, electrically operated device, and an external rf transmitting unit (transmitter). rf energy is transmitted by the transmitter and is coupled into the receiver which is used to power the implanted medical device and/or recharge the back-up power supply. The back-up power supply within the receiver has enough capacity to be able to, by itself, power the implanted device coupled to the receiver for at least 24 hours during continual delivery of medical therapy. The receiver is surgically implanted within the patient and the transmitter is worn externally by the patient. The transmitter can be powered by either a rechargeable or non-rechargeable battery. In a first mode of operation, the transmitter will supply power, via rf coupled energy, to operate the receiver and simultaneously recharge the back-up power supply. In a second mode of operation, the receiver can, automatically or upon external command from the transmitter, acquire its supply of power exclusively from the back-up power supply. Yet, in a third mode of operation, the receiver can, automatically or upon command from the transmitter, alternatively acquire its supply of power from either, rf energy coupled into the receiver or the internal back-up power supply.
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0. 29. An rf coupled implantable medical system comprising:
a transmitting unit;
a receiving unit including an implantable, electrically operated, medical device, rf energy receiving means, and a rechargeable power supply;
said transmitting unit including a power source and an rf energy transmitting means;
said receiving unit including control means coupled to said rechargeable power supply and to said implantable medical device for adjusting the charging current flowing into said rechargeable power supply; and,
mode selection means for controlling the supply of power in one of several modes of operation selected from one of: a) simultaneously operate the implanted medical device and recharge the rechargeable power supply from the transmitted rf energy, b) operate the implanted medical device exclusively from the rechargeable power supply, or c) operate the implanted medical device from the transmitted rf energy.
23. An rf coupled implantable medical system comprising:
a transmitting unit;
a receiving unit including an implantable, electrically operated, medical device;
said transmitting unit including rf energy transmitting means, rf signal receiving means and first control means coupled to said rf energy transmitting means and to said rf signal receiving means for controlling the amount of rf energy transmitted to said receiving unit;
said receiving unit including rf energy receiving means, rf signal transmitting means, a rechargeable power supply coupled to said rf energy receiving means and second control means for adjusting the charging current flowing into said rechargeable battery coupled to said rechargeable power supply means, to said rf energy receiving means, to said rf signal transmitting means and to said implanted medical device, and
mode selection means for setting said receiving unit to operate in one of the following modes: (1) “RF only”, (2) “battery only” or (3) “combination of both”.
1. An rf coupled implantable medical system comprising:
a transmitting unit;
a receiving unit including an implantable, electrically operated, medical device, rf energy receiving means, rf signal transmitting means and a rechargeable battery;
said transmitting unit including a power source, rf energy transmitting means, rf signal receiving means and first control means coupled to said rf energy transmitting means and to said rf signal receiving means for controlling the amount of rf energy transmitted to said receiving unit thereby to conserve on the amount of power obtained from said power source; and,
second control means coupled to said rf energy receiving means, to said rechargeable battery, to said rf signal transmitting means and to said implantable medical device, for adjusting the charging current flowing into said rechargeable battery, as a function of (a) the charge level of said rechargeable battery, (b) selected charging rate, and (c) selected power supply for the implantable medical device.
0. 31. An rf coupled implantable medical system comprising:
a transmitting unit;
a receiving unit including an implantable, electrically operated, medical device, rf energy receiving means, and a rechargeable power supply;
said transmitting unit including a power source, rf energy transmitting means, and transmitting control means coupled to said rf energy transmitting means for controlling the amount of rf energy transmitted to said receiving unit thereby to conserve on the amount of power obtained from said power source;
said receiving unit including second control means coupled to said rechargeable power supply and to said implantable medical device for adjusting the charging current flowing into said rechargeable power supply; and,
mode selection means for controlling the supply of power in one of several modes of operation selected from one of: a) simultaneously operate the implanted medical device and recharge the rechargeable power supply from the transmitted rf energy, b) operate the implanted medical device exclusively from the rechargeable power supply, or c) operate the implanted medical device from the transmitted rf energy.
28. An rf coupled implantable medical system comprising:
a transmitting unit;
a receiving unit including an implantable, electrically operated, medical device;
said transmitting unit including rf energy transmitting means, rf signal receiving means and first control means coupled to said rf energy transmitting means and to said rf signal receiving means for controlling the amount of rf energy transmitted to said receiving unit;
said receiving unit including rf energy receiving means, rf signal transmitting means, a rechargeable power supply coupled to said rf energy receiving means and second control means for adjusting the charging current flowing into said rechargeable battery coupled to said rechargeable power supply means, the current to said rf energy receiving means, the current to said rf signal transmitting means and to output signals from an output of said implanted medical device; and,
said receiving unit comprising means for measuring the charge level of said rechargeable battery power supply and, upon sensing a fully charged battery power supply, automatically up-linking a coded signal which commands said transmitting unit to “stop” stop transmitting rf energy; and,
mode selection means for controlling the supply of power in one of several modes of operation selected from one of: a) simultaneously operate the implanted medical device and recharge the rechargeable power supply from the transmitted rf energy, b) operate the implanted medical device exclusively exclusively from the rechargeable power supply, or c) operate the implanted medical device from the transmitted rf energy.
2. The system of
3. The system of
4. The system of
5. The system of
6. The system of
7. The system of
said receiving unit, when set to operate in said “RF coupled energy” mode, is operable to supply regulated electrical energy to said implantable device so long as said transmitting unit is located proximate to said receiving unit and said receiving unit is sensing transmitted rf energy.
8. The system of
9. The system of
10. The system of
11. The system of
12. The system of
13. The system of
14. The system of
19. The system of
20. The system of
21. The system of
22. The system of
(a) when said implanted receiving unit is set to operate in said “RF only” mode, said transmitted rf energy is automatically adjusted to the amount of rf energy required (i) to operate said implanted device and (ii) to maintain said rechargeable battery, which is powering said implanted device, in a fully charged state;
(b) when said implanted receiving unit is set to operate in said “battery only” mode, said transmitted rf energy is automatically adjusted to the amount of rf energy required (i) to operate said implanted device and (ii) to recharge quickly said rechargeable battery which is powering said implanted device; and,
(c) when said implanted receiving unit is set to operate in said “combination of both” mode, said receiving unit is set to switch automatically to either said “RF only” mode upon detecting said transmitted rf energy, or to said “battery only” mode upon detecting a loss of said transmitted rf energy.
24. The system of
25. The system of
26. The system of
27. The system of
0. 30. An rf coupled implantable medical system of claim 29 further comprising memory means coupled to said control means for storing information for controlling an output signal from said implantable medical device.
0. 32. An rf coupled implantable medical system of claim 31 further comprising memory means coupled to said second control means for storing information for controlling an output signal from said implantable medical device.
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1. Field of the Invention
The present invention relates to an implantable medical device including a rechargeable back-up power source and a charging unit for recharging the back-up power source via RF coupling.
2. Description of the Related Art Including Information Disclosed Under 37 CFR §§1.97-1.99
The concept of using an implantable, electrically operated medical device for treating specific diseases or physical disorders is well known. Examples of implantable, electrically operated medical devices are: cardiac pacemakers which restore a sick human heart to a normal rhythm, neural simulators which control nerve or brain response (such as pain or epileptic seizures), infusion pumps for subcutaneously drug delivery (such as insulin pump), and diagnostic devices for monitoring a patient's condition.
With respect to all of these implantable, electrically operated devices, it is necessary to provide power to the device implanted below the skin. Since the medical device is subcutaneously implanted in the patient, the power source must supply electrical energy for a reasonable period of time in order to reduce further surgical trauma to the patient and financial cost to the medical provider.
Implantable, electrically operated medical devices can be classified in three general areas: radio frequency (RF) coupled and partially powered implanted devices, non-rechargeable battery powered totally implanted devices, and devices which combine RF coupling and battery powered systems.
The RF coupled and powered devices do not carry or contain an independent power source. Therefore, the RF coupled device requires an external RF transmitter and a surgically implanted receiver. Such a device is an RF coupled neural stimulator. The RF link transfers stimulation pulses percutaneously through the skin and adjacent tissue layers of the patient from the external RF transmitter to the surgically implanted RF receiver and stimulator device. The transmitter sends, on a real-time basis, stimulation pulses to be applied ultimately to the implanted electrodes plus programming data defining the polarity of each electrode relative to each other to the implanted stimulation device. The implanted receiver obtains these stimulation pulses and programming data, converts pulses as necessary, delivers the energy contained in each transmitted stimulation pulse to the implanted electrodes as defined in the real-time programming data. The stimulation energy for each stimulation pulse is inductively coupled on a real-time basis from the external transmitter to the implanted receiver.
The common disadvantage of the RF coupled and powered stimulator is that the patient must always wear the external transmitter and antenna (even during sleep) in order for the implanted receiver to deliver stimulation pulses to the targeted tissue. Stimulation therapy ceases the moment the transmitter antenna is withdrawn just a few inches away from the implanted receiver. Although the RF coupled stimulator has this disadvantage, the service life of such an RF coupled and powered stimulator is not limited to the life of a battery contained within a fully implantable stimulation unit. Accordingly, the long term cost of the RF coupled and powered simulators is less than the non-rechargeable battery powered simulators because the service life of the former is much longer than that of the latter. RF coupled and powered simulators have been commercially marketed by Medtronic of Minneapolis, Avery Laboratories of New York and Neuromed of Dallas, Tex.
The battery powered stimulator utilizes a primary, non-rechargeable battery to power the implanted stimulator. The battery provides sole and exclusive power to the implanted stimulator continually while the stimulator generates one or more electric stimulation pulses, in a controlled manner, to the targeted tissue. Of course, the stimulation pulses are delivered to the targeted tissue via implanted leads. An external programmer may be used to non-invasively adjust the stimulation parameters, such as amplitude, pulse width or rate, or to control the duration of stimulation therapy each day. Programming may be provided through an RF telemetry link. After programming, the stimulator remembers the parameter values (the values are stored in an electronic memory) as long as the battery voltage remains above a minimum voltage level required by the electronics. Unfortunately, the service life of these battery powered implantable simulators is limited to the battery life. Accordingly, it is necessary to surgically remove and then replace the battery powered implantable simulators upon depletion of the electrochemically active materials in the battery. This disadvantage (i.e. surgical replacement) increases its long term cost to the medical provider relative to the aforementioned RF coupled and powered simulators. The battery powered implantable simulators do not require an external transmitter to deliver the stimulating electrical pulses. Accordingly, the battery powered implantable simulators are less complicated to use and more comfortable to wear than the RF coupled and powered simulators. Battery powered simulators have been marketed by Medtronic of Minneapolis and Exonix of Miami.
A third category of implantable, electrically operated devices include neural simulators which combine the RF coupled/powered systems with the battery powered implantable stimulator technology. These types of simulators enable the patient to obtain therapy without the necessity of having an external RF coupled unit proximate to the implant at all times. However, the stimulator must be surgically replaced after the battery is depleted if use of the external RF transmitter is not desired. This type of stimulator allows RF coupled stimulation at times when wearing the external transmitter is not objectionable, thereby extending battery life. Also, this type of stimulator may allow for continuing RF coupled stimulation after the internal rower source is depleted, although some of these RF coupled and battery powered implantable simulators do not operate if the battery is completely depleted in the implanted stimulator.
Several examples of such previously proposed implantable devices are disclosed in the following U.S. patents:
U.S. Pat. No.
Patentee
4,408,607
Maurer
4,793,353
Borkan
5,279,292
Baumann et al.
5,314,453
Jeutter
U.S. Pat. No. 5,314,453 to Jeutter describes and claims an implant “locator” means to aid in locating an implanted device. The locator means comprises a reed switch affixed to the center of a transmitting coil and a magnet affixed within the implanted device. Transmission of high frequency RF energy is possible only when the reed switch is closed by the magnet within the implanted device, thus insuring some degree of good coupling between the transmitter and receiver. However, this patent describes a full wave rectifier along with rechargeable batteries. Accordingly, it incorporates a rechargeable battery. The present invention differs from the teachings of the Jeutter patent in the following respects:
U.S. Pat. No. 5,279,292 to Joachim Baumann et al. teaches a series resonant circuit in an implantable device. The device disclosed hereinafter uses a parallel resonant circuit which can be tuned at low frequencies, 60 Hz to 500 kHz, such as, for example 8 kHz, which couples well through a titanium enclosure. Further this patent does not teach adjusting charging current as a function of battery temperature or controlling the charging current with the current output from a D/A converter.
U.S. Pat. No. 4,793,353 to William Borkan discloses a non-invasive multiprogramable tissue stimulator which utilizes RF coupling to charge and recharge a capacitor or other rechargeable voltage source. The Borkan circuit differs from the circuit disclosed hereinafter in several respects:
U.S. Pat. No. 4,408,607 to Donald Maurer teaches a capacitive energy source and associated circuitry for powering a medical apparatus. The Maurer circuitry differs from our the circuitry disclosed hereinafter in that:
Moreover, Maurer does not teach the capability to switch automatically between RF coupled (power upon detection of RF energy) and battery power (upon sensing absence of RF energy).
According to the present invention there is provided an implantable, electrically operated medical device comprising an implanted radio frequency (RF) receiver incorporating a rechargeable back-up power source and an external RF transmitter. RF transmissions are coupled into the implanted receiver for powering delivery of medical therapy and simultaneous recharging of the back-up power source within the receiver. The back-up power source has enough capacity to be able to autonomously power the receiver for at least seven days during continual delivery of medical therapy. The receiver is surgically implanted within the patient and the transmitter is worn externally by the patient. The transmitter can be powered by either a rechargeable or non-rechargeable battery.
In a first mode of operation, the supply of power to operate the receiver, recharge the back-up power source and deliver therapy is acquired primarily from the RF energy coupled into the receiver, until the receiver senses a loss of RF power at which point it will automatically switch to the back-up power source in order to continue delivery of medical therapy. In this first mode of operation, the transmitter will transmit lower energy RF waves since the back-up power source is recharged at a slower rate.
In a second mode of operation, the receiver can, automatically or upon external command from the transmitter, acquire its supply of power exclusively from the back-up power source. In the second mode of operation, the transmitter will transmit high energy RF waves in order to recharge the back-up power source at a faster rate and will terminate the RF transmission upon receiving from the receiver a “termination command” which indicates that the back-up power source is fully charged.
Yet, in a third mode of operation the receiver can, automatically or upon command from the transmitter, alternatively acquire its supply of power from either or both, RF energy coupled into the receiver and/or the internal back-up power source. This third mode of operation is useful in patients where it is desirable to power the receiver from RF coupled energy during periods of awakeness, but switch to the back-up power source during sleep for greater comfort. In this third mode of operation, a real time clock within the receiver can be programmed by the transmitter with different start/stop times for RF coupled power than for back-up battery power. In this fashion, the switching is done automatically and the external transmitter unit will alert the patient which is the source of power for the receiver at all times.
The receiver includes a mechanism for alerting the patient when the back-up power source is nearing depletion and needs to be recharged. The mechanism can include: 1) a vibrating device within the receiver; 2) an audible tone generating device within the receiver; or, 3) a specific message shown in the transmitter's display combined with a specific audible tone generated by the transmitter.
The transmitter incorporates a transmitting antenna which generates RF wave-fronts which are coupled into an inductor within the implanted receiver. This RF coupled power, which is alternating current or AC in nature, is rectified, filtered and converted into a high DC voltage within the receiver. Further, a voltage regulator within the receiver converts the high DC voltage into a lower precise DC voltage from which the receiver operates.
It is the objective of the present invention to provide an implantable, electrically operated medical device (receiver) capable of obtaining its source of electrical power from either, an external battery coupled via low level RF transmissions (transmitter), or a back-up rechargeable battery contained within the implanted receiver.
According to one aspect of the present invention, there is provided a method of supplying power, on an exclusive basis, from externally low energy RF coupled power (transmitter), to an implanted receiver during continual delivery of medical therapy.
According to another aspect of the present invention, there is provided circuitry for programming into the receiver the times of day (meaning a continuous 24 hour period) in which the receiver automatically switches it's supply of power from RF coupled energy to the back-up power source, and vice-versa.
According to still another aspect of the present invention, there is provided a method for recording into a non-volatile memory contained within the implanted receiver the stimulation values and other critical data, so that it will not be erased if the back-up power source is depleted and to eliminate the need for the transmitter to generate and regulate, on a real time basis, the delivery of medical therapy.
According to still another aspect of the present invention, there is provided a method of supplying power, on an exclusive basis, during at least a seven day cycle of substantially continual delivery of medical therapy utilizing a rechargeable power source.
According to still another aspect of the present invention, there is provided a method for non-invasively recharging the power source within the receiver, whereby the electrical energy contained in the battery powering the external transmitter is transferred into the rechargeable power source within the receiver utilizing an inductive RF power link between the external transmitter (recharging unit) and the implanted receiver (unit being recharged).
According to still another aspect of the present invention, there is provided a method for regulating the rate of recharging the back-up power source contained within the implanted receiver as a function of temperature of the back-up power source, in order to inhibit the power source from generating harmful gases and to prevent electrolyte loss, thereby enhancing the service life of the back-up power source and increasing the possible number of recharge cycles.
According to still another aspect of the present invention, there is provided a method, interactive between the transmitter and receiver, for regulating the RF energy generated by the external RF transmitter as a function of distance between the transmitting and receiving inductors.
With these methods, the level of RF energy coupled into the receiver antenna is monitored by the receiver which telemeters specific commands to the RF transmitter to adjust the RF energy level being generated. This real-time feedback system allows generation of just the minimum RF power needed at the receiver, thereby extending the service time of the battery powering the RF transmitter.
According to still another aspect of the present invention, there is provided in transmitter for the patient to select between RF powered operation only, back-up power source operation only, or a combination of both. If “RF power” is selected, the implanted receiver will only operate when the transmitter unit is proximate to the implanted receiver, and the transmitter will generate low level RF energy. If “back-up power” is selected, the implanted receiver will draw it's operating power exclusively from the back-up power source, and the transmitter will generate higher level RF energy when used to quickly recharge the back-up power source. If “combination power” is selected, the implanted receiver will draw it's operating power from the transmitter via low level RF coupled energy, but will automatically switch to draw it's operating power from the internal back-up power source when the transmitter is removed or turned off. The patient may select one of these options via a specific menu shown in the transmitter's display.
According to still another aspect of the present invention, there is provided a method for the receiver to automatically terminate the recharge cycle upon sensing a fully charged back-up battery by the transmission of a specific telemetry command to the transmitter, thereby enhancing the service life of the battery powering the RF transmitter.
According to still another aspect of the present invention, there is provided several receiver-initiated commands for alerting the patient when the rechargeable power source is nearing depletion and needs to be recharged. Some alerting signals are generated by the receiver itself and other alerting signals are generated by the transmitter.
According to still another aspect of the present invention, power sources and methods are utilized for non-invasively coupling energy and recharging the implanted battery, in combination with an implantable tissue stimulator.
According to still another aspect of the present invention, there is provided an implantable drug delivery system utilizing these power sources and methods for non-invasively coupling electric energy into the implanted drug delivery system and recharging its battery.
According to still another aspect of the present invention, there is provided an implantable monitor and diagnostic system utilizing these power sources and methods for non-invasively coupling electrical energy into the implanted monitor which is used to collect vital physical data from the patient which can be interrogated by a receiver external to the patient.
According to still another aspect of the present invention, there is provided an implantable cardiac pacemaker utilizing these power sources and methods for non-invasively coupling electrical energy into the implanted pacemaker and recharging its battery.
According to still another aspect of the present invention, there is provided an implantable cardioverter/defibrillator utilizing these power sources and methods for non-invasively coupling electrical energy into the implanted cardioverter/defibrillator and recharging its battery.
According to still another aspect of the present invention, there is provided a method for recharging power via an inductive RF power link between the recharging unit and the implant and through the hermetic titanium encasement of the implant.
According to still another aspect of the present invention, a patient is permitted to vary the delivery schedule and/or quantities of the medical therapy via the external RF transmitter/recharger unit.
According to still another aspect of the present invention, a medical physician, nurse or technician is allowed to program into the implanted medical device, via the external RF transmitter/recharger unit, the delivery schedule, values or quantifies of the medical therapy and to set the limit for these schedules, values or quantities within which the patient may safely adjust them later on.
Referring to the drawings in greater detail, there is illustrated in
Referring again to
From the foregoing description, it will be apparent that the RF coupled, implantable medical system 10 with the rechargeable back-up power supply/source 44 of the present invention has a number of advantages, some of which have been described above and others of which are inherent in the invention. Also it will be understood that modifications can be made to the RF coupled, implantable medical system including the rechargeable back-up power supply/source 44 described above without departing from the teachings of the present invention. Accordingly, the scope of the invention is only to be limited as necessitated by the accompanying claims.
Barreras, Sr., Francisco Jose, Jimenez, Oscar
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