CA2357412A1 - Subcutaneously implantable power supply - Google Patents

Abstract

A subcutaneous photovoltaic power supply device is disclosed that is adapted to supply electrical power sufficient to maintain a near 100% float-charge in a battery of a medical device implanted beneath living tissue. The device includes at least one subcutaneously implanted photovoltaic cell adapted to produce a predetermined power output sufficient to, when the tissue is exposed to light, recharge the battery of the medical device. In alternative embodiments, the photo cell(s) are configured to bypass the battery(s) and directly power the implanted device.

Description

Subcutaneously Implantable Power Supply BACKGROUND OF THE INVENTION
This invention relates to photovoltaic cells commonly known as solar cells, designed to be inserted under living tissue, optimized to prevent the ingress of bodily fluids, designed for high spectral response.
There are several electronic devices presently implanted in humans and animals that require a power source, typically Lithium-Ion rechargeable batteries. There are some devices using SVO (not rechargeable) batteries, however they can be switched to rechargeable types, once this practical recharging method is implanted. This method of keeping a battery float-charged near 100% opens up the possibility of using other battery types. Ni-Cads, might be considered, since they can be recharged up 1,000 deep-cycle discharges, which will not be the case with solar trickle-charging (float-charging). The "memory effect" is not important in constant trickle-charge applications. These implantable devices include:
cardiac pacemakers;
cardiac defibrillators; pain suppressors; drug infusion pumps, augmentation heart pumps, retinal eye implant devices, limb implant devices, bodily fluid valves, a partial list. Also, implantable hearing aid devices, with other transmitter-receiver devices in the planning stage.
One interesting new bodily implanted transmitter-receivers) is directed to a method of bridging the gap over severed or damaged nerves in living organisms.
Researchers at Reading University in England have implanted a glass tube beneath the skin of a subject. The tube contains a device that transmits signals outside the body: possibly a forerunner of nerve-gap transmission of signals. These devices presently employ a battery within the implanted device, charged by an internal-external induction coil. Although external-internal induction coils work as a method of recharging implanted batteries, they are far from ideal because of the impracticality of taping an external coil on the skin and being worn in this manner for long periods of time, necessary to trickle-charge the battery(s). Thus, due to practicality, the induction coil method dictates a rapid recharging process, which shortens battery life.
Very slow trickle charging at a rate not to exceed the average discharge rate of the implanted device is essential for maximum battery life-which is the primary objective of this invention. This charging method opens up the possibility of using less exotic Ni-Cd batteries and other types. Ni-Cds can be recharged up to a thousand times from a 90%
discharge, which will not be the case of implanted batteries.
In excess of two hundred thousand electronic devices are implanted annually.
When newer implantable hearing aids and other devices receive FDA or CE Mark (European) approval, the market for implanted battery powered devices will dramatically increase.
Regarding cardiac pacemakers, the average age upon implantation is seventy-three years. Batteries in these devices last from three to thirteen years, with an average life of seven.
Thus, when the typical wearer reaches eighty, the entire device usually requires replacement, since the battery is typically sealed inside a titanium case, requiring the entire unit to be replaced at considerable cost and with significant risk of death. At eighty the wearer's health has frequently deteriorated to the point where they have difficulty tolerating the trauma of replacement surgery. This surgery causes death in about 12% percent of replacement procedures. For teenagers requiring implantable devices, they could experience replacement surgery up to fifteen times during their lives, considering the endurance of battery technology.
The batteries powering heart defibrillators generally deplete more rapidly than pacemakers because they must maintain a constant charge in the unit's capacitor(s). When a firing sequence begins, the defibrillator must impart a series of strong electrical charges to shock the heart repeatedly, about once per second, until a stabilized pattern of beats is established. This firing sequence may have to be repeated, requiring a fast recharging cycle of the unit's one or two capacitors. The sudden current demand on a defibrillator tends to be greater than that of pacemakers, although the life of defibrillators batteries depends upon how many "cardiac events" the wearer experiences. Defibrillator batteries frequently last only three years due to the voltage requirement of the capacitors: upwards of 400 to 800 volts, at low amperage.
Regarding those electrically driven devices such as insulin infusion pumps now being implanted under the skin in the wearer's abdomen have a shunt leading into the pancreas, with another exiting the side of the abdomen where it plugs into an external bag of insulin. This bag is worn on a separate belt positioned above a patient's clothing belt so the shunt tube will not be pinched off. This internal pump also includes a sensing device which measures the sugar level in the blood and commands the pump to switch on and off, injecting one or two drops of insulin into the pancreas per-actuation. Trickle-feeding insulin prevents large fluctuations in the insulin level of the blood, presently the case when syringes are used.
For this application, as well as mechanical heart pumps, and limb actuation devices, or other large power consuming devices, a larger triangular multi-layer solar array, shown in the drawings, (multi-layers of transn~ent cells positioned atop each other) can be located over the upper Sternum will be required due to the power demand of heart pumps, presently requiring external battery packs. Also, implanting larger thin, flexible arrays under the dermis on the wearer's back will be an option, since this is the largest relatively flat surface area of the human body, and least articulated. The total solar surface area of mufti-layers of triangular or rectangular cells will exceed two square feet when implanted over the sternum, and up to eight square feet of surface area for these mufti-layered cells implanted under the dermis of the wearer's back. Picture a six-layer transparent solar array approx. .030" total thickness, remaining flexible partly due to the resin type, and body heat keeping it pliable. This much surface area might be needed for maintaining the charge level in mechanical heart back-up batteries, or implanted batteries for mechanical arms, etc. Also, these implanted cells can (via nearly flat induction coils) may also generate power while implanted i si the body, then transmit the current o i the body into a device-motor positioned in a mechanical limb, strapped to the wearer's body.

It should also be noted that a flat induction coil can be located on the back (inward) side of implanted solar arrays, since such arrays are electromagnetically penetrable and can transmit power into a bodily device for which the cells are positioned directly over such device, with or without the solar array being physically attached to the implanted device. ('The cells penetrability is possible because the grids or fingers on the top or bottom layer of cells ideally occupies as little as 5% to 7% of their surface area.) A second induction coil can be positioned on the surface or directly underneath the device cover, if the cover is non-metallic, so electro-magnetic waves can "j ump" from the solar positioned flat coil if it is aligned over top of the second device-coil. Axial alignment of these two induction coils, plus being close together is necessary for the maximum transfer of electrical energy, with the least transfer loss. Having the solar array's induction coil larger than the implanted device induction coil will permit more axial misalignment and spatial separation of the coils. When the two complementary coils are different in size, a voltage shift up or down must be taken into account to determine which coil should be bigger or have more turns of wire on it. Also, having more turns of the secondary coil will pernlit a jump in the voltage as it passes between the two coils, if needed.
Regarding the solar array shown in the drawings implanted under the dermis of a wearer's forehead, that array is designed to (among other uses) provide power for new retinal eye implants that are presently in the experimental stage, having already been successfully tested. Note a small, flat or near-flat, induction coil shown in two downward extensions of that array, designed to be less than one inch from a similar flat coil on a supporting structure that surrounds the retinal eye implant. Picture an implant roughly the size of a contact lens facing in the opposite direction, attached to the back of the eye, over the retina, so its concave side is facing outward. Around the periphery of that platform is the second or receiving induction coil which energizes photo-cells occupying the middle 90% of this implant device. Note that one coil is positioned to be directly above each eye, residing behind each of the wearer's eyebrows, thus being positioned as close to the retinal-implant coil. These downward positioned coils can wrap around and under the top of the eye socket, bringing the coils within 1/2" inch of the eye implant coil, though at right angles or extending behind the eye. Since the power generated from all solar cells is d.c., a small, flat crystal oscillator, oscillating at perhaps 60 cycles per second or a lower speed will convert the power from the cells into a.c., so current will "jump" from one coil to the other. Of course, the retinal eye implant coil will also have an ultra small inverter on its back side, converting the power back into d.c., if that is deemed desirable to electronically excite (amplify) the light photo-receptors attached to the back of the retina. Such cells might be powered from pulsating d.c. if the pulse rate is fast enough so that electron extinction rate of the electrical field is not realized between d.c. pulses, reducing the number of inverter parts, even though they will be micro-miniature in size.
Formerly blind implantees may enjoy superior night vision to normally sighted individuals, by stimulating these photo-receptors to respond to very weak incoming light.
The triangular solar cell implant over the Sternum, or elsewhere in the body, will not only be multi-layered, but each successively back layer of cells will be slightly larger in dimensions with edges that terminate at a 45° angle relative to the skin surface, so light may also enter each of the respective layers from their edges and refract across the surface of each layer of cells, forming a "light trap": since light will be entering each layer, from all the sides simultaneously.
Continuing on the subject of retinal eye implants and a dual method of providing power to reach the photoreceptors, a second method of transfernng light to the mufti-layered induction coil calls for the primary induction coil to be implanted in both of the wearer's eye glass rims. This second method has the advantage of being in perfect axial alignment with the retinally implanted coil, with the disadvantage of being farther from the implanted coil.
However, the external coil, which is fed current both from a battery and from solar cells

2 S imbedded in the eyeglasses side frames designed for maxim width to give them more surface area. These glasses frames can also have a small battery holder on the side frames or an electrical plug, permitting a battery earned in the wearer's pocket or attached to the wearer's belt that supplies power to the eye glasses frame-coil, thus providing a dual source of power to the retinal implant: solar cells for daytime powering; external battery for night-time powering. Since use of human eyes is primarily a daytime event, forehead implanted solar cells can easily provide daytime electrical excitation of eye implanted cells, since little electrical energy is needed for eye implant cells. These cells will initially be few in number, perhaps 72, then will be expanded to perhaps 300, giving the implantee high-resolution vision. A useful comparison is that of computer printers. Originally as dot-matrix types, the resolution was around 72 dpi. When the resolution with ink jets was increased to 300 dpi, text with the naked eye, appeared to have sharp edges.
My tests have demonstrated that a strong Electromotive Force (EMF) is present at a distance of four (4") inches using two one-inch by one-fourth inch thick ring magnets. One was positioned inside a small plastic cup set afloat in water. A second identical magnet was positioned on the surface oriented in its repelling position. The cup-borne magnet was repelled rapidly ahead of the second magnet which was being pushed toward the cup-magnet 1 S by me. This demonstrated that the effective EMF field exceeded four inches. When one considers the extremely small amount of electrical energy needed to amplify the weak current at the rod & cone photo-receptor site, it becomes apparent that a numerous turn induction coil embedded in plastic eye glass lens will duplicate this magnetic field, and can increase the micro-volts at the implant site, if the secondary coil has more turns of a .005" coated copper wire than the primary coil. It should also be considered that ferrous oxide material can be embedded in the resin before the plastic lens frames are injection molded, increasing the EMF
field at the primary coil site, based on this researcher's extensive molding experience.
Mechanical hearts require more electrical power than any other implanted device, because their drive motors must open and close valves or spin centrifugal impellers at high speeds, providing the propulsive force to push blood through the body against the body's natural resistance, resulting from blood being progressively forced through narrowing capillaries. The difficulty of this task is increased when the wearer is standing or moving.
F, While standing, blood must be pumped up to the brain, a level higher than the mechanical heart, and must be pumped to the feet and its return path up the veins to the lungs, where it is re-oxygenated. The power supplied for such devices requires, ideally, one rechargeable battery inside the mechanical heart, and a much larger battery pack worn externally.
These outside batteries typically comprise a series of thin units wired in a string and sewn into a belt-like construction with wires exiting the body and attaching to them, or better, by having a small flat inverter-induction coil attached to the inside wall of the battery pack-belt.
This outside induction coil must be axially positioned over a second induction coil-inverter implanted underneath the skin-opposite the belt. This permits current to jump across the two coils, after it is first converted from d.c. to a.c. power, penetrating the dermis, and entering the body as a.c. current, where it is converted back to d.c.. for transmittal by wires to the mechanical heart. In my design, the internal battery, (ideally inside the mechanical heart), provides temporary power for the device when the wearer removes the external belt while showering, swimming or to replace one belt pack with another. Thus, it is clear that a back-up power source consisting of an internal battery is a wise design approach. The external battery pack-belt, if used alone, also presents a problem when the wearer is asleep.
Tossing and turning may cause the external and internal coils to become sufficiently misaligned so as to cut off the flow of current to the mechanical heart. The apparent solution is for the wearer to slip on a tight fitting sleeved vest with straps on both sleeves, tied to raised bedside railings, to prevent dangerous movement.
Cardiac pacemakers presently account for the most widespread use of internal batteries, typically single cell L-I types, although newer batteries are being introduced. The L-I
battery generates a nominal 2.8 volts from a single cell when fresh, and is allowed to drop about (0.2) two-tenths of one volt before replacement is indicated. However, depending on the construction of the cathode and anode plates, the L-I battery can generate up to 3.7 volts from a single cell, according to one battery reference source.

More efficient electrical circuit designs have been made through the years, however, added telemetry functions for implantable devices have tended to offset these gains. With external telemetry, the surgeon can change the rate (time-duration-width) and the intensity (voltage) of the beats in a non-invasive manner. Regardless of the improvements in electronically implantable batteries and devices, the wearer and ethical medical people will want as few replacement surgeries as possible.
What has been needed but heretofore unavailable, is an improved method for powering implantable medical devices of all kinds. Additionally, an improved device for recharging such subcutaneous devices is needed that will improve internal battery longevity.
SUMMARY OF THE INVENTION
The present invention is directed to a device that improves the longevity of internal batteries contained within and used in connection with implantable medical devices. Implanted solar cells can be used via internal-external induction coils to recharge an external batteries used in mechanical arm implants, etc. The instant invention is also directed to a device that is capable of powering a wide variety of implantable devices without the need for cumbersome external battery packs or stationary power sources. With use of the improved device of the present invention, implantable device patients will now have the ability to move about freely in the day and night without concern for maintaining predetermined positions of internal-external induction coils and external battery packs or other types of power sources which are subject to being accidentally torn off.
In general, this new charging technology is directed to subcutaneously implantable solar cells having a wide array of configurations. Each of the many types of variations are configured to supply a predetermined amount of power that corresponds to the operating power and battery recharge requirements of the desired implantable device.
Many variations and modifications have been tested to ascertain the desired configurations for different externally warn and implanted solar cell devices.
Regarding my new charging technology, initial tests were performed in the following manner: a volt-ammeter was attached to small amorphous silicon cells that were placed under a larger sheet of plexiglass. Atop this plexiglass were placed successive layers of skin from the breasts of birds. With each additional layer of skin, the drop in current generated by the cells was recorded. The shortcoming of this first test was the fact that the skin from birds is without pigmentation, due to feather coverings, explaining why multiple layers were used, whereas human dermis has varying degrees of pigmentation. Next, I placed a small cutout section of a man's tee shirt, and recorded the current drop (very small). Then I added a 12 ounce single layer white dress shin over the above and found that I could still generate about 86% of the current with these three barners, compared to what was generated before coverings were placed over the cells. Further tests have demonstrated that a "One Sun"
sky condition:
sun at its zenith without sky obscuration (clouds or dust), the output of the cells, in terms of their voltage should be two or three times the fully charged voltage of the implanted battery, due to light loss from penetration of skin and thin white clothing. Plus, the device must be operative in cloudy conditions, although only two minutes per month exposure to bright light is needed. After the clothing and light barriers are taken into account, the voltage under bright light will still exceed that of a fresh battery by a small margin. This ideal charging voltage for battery longevity should not exceed the fully charged rated voltage for the battery under the brightest lighting conditions. The charging voltage will not exceed the full-charge rating, by virtue of a resistor or other power limiting components, which is a practical approach, considering that d.c. voltage comes from the voltaics and can be reduced by a small wattage resistor, approximating the diameter of pencil lead.
The documented results of the most recent implanted solar cell tests are included in the following text.

A test was conducted using this investigator as the subject in the following manner: I
placed a single solar cell (single-crystal type) measuring 2 cm X 4 cm inside a clear plastic case of slightly larger dimensions, with positive and negative wires extending outside the case, and outside of my mouth, placed between gum and cheek. They where attached to a sensitive volt-ammeter, with the cell facing the sun under a One-Sun sky condition at 11:00 a.m. on April 12, 1999 at Merntt Island, Florida, at 26° degrees North Latitude.
April 12, 1999 Merritt Island, Florida 26~ North Latitude. A One Sun Sky iceaam s w ere:

0.6 volt @ 182 mA ( 182,000 Outside m cheek uA) 0 .4 volt @ 6 mA (6,000 uA) Inside m 3/8" inch thick ri ht cheek The test was performed with the cell outside my mouth, then repeated one minute later with this encased cell positioned ' si a my mouth-between gum and cheek. This time the readings were: 0.4 volt @ 6 mA, as shown above. This test was most relevant, since the thickness of my cheek is about 3/8"inch, measured by calipers-much thicker than the typical thickness of body dermis where cells will be implanted. Also, this single cell was approximately one-half the size of the 1 "X 2" implanted cells to power small current demand implantable devices. Fatty tissue will be separated from the outer dermis, so the cells will typically be surgically implanted to a depth of only 1/8" inch. (Fatty tissue provides far less light barrier than lean tissue.) Subcutaneous cranial locations will permit the use of short, flat ribbon-type wire leads.
However, the test is valid for cells) placed anywhere beneath the skin, not covered by clothing. The cells can also be positioned anywhere around the side of the skull and permit the patient to wear a hat without undue blockage of light. Or, the cells can be placed so as to cover part or most of the top of the skull, or the forehead, if more power output is needed in the cranial area (unlikely).
Light penetrates scalp hair with good success, unless it is thick and black.
In such cases, the cells can be implanted subcutaneously under the lower side of the cranium, (below and behind the ear or upper part of the wearer's neck above a shirt collar), where hair can be kept to a minimum length without being cosmetically objectionable, or under the forehead. By using transparent silicon cells, they will not be visible under the skin-not cosmetically objectionable. The scalp will also be the logical location for cells used to power brain stimulation or brain pain suppression devices, some such devices are already on the market by Medtronic and others. Thus, the amount of current generated with this behind-the-cheek test of 6 milliamps (6,000 micro-amps) is far in excess the amount needed to keep the typical pacemaker battery with a current consumption rate of only 20 micro-amps, fully charged. The cheek positioned small cell produced approximately 300 times more power than is needed. I
estimate these cells will ~ require an average of two minutes of sun or bright indoor light exposure per month~ither will be suitable.
Going back to pacemaker defibrillator implantation of cells in the upper chest area, tests have shown that sufficient light will penetrate the wearer's outer shirt and under-garment and still produce useful amounts of current, with the exception of when the person is wearing a heavy suit coat or overcoat. One test with cells placed beneath undergarments, and under a summer-weight tan suit coat produced .85 Volt, from three series-wired 1/3 inch square cells, capable of 1.9 no-load volts. If a pacemaker battery depletes at an average rate of only 0.2 tenths of a volt in six years, that means its battery drops only 1 / 10,950th of one volt per day.
Therefore, the photovoltaic cells need only be exposed to moderate intensity light, indoor or outdoor type, occasionally.
Another series of tests were conducted where moderate indoor lighting for the original series of tests consisted of a 100 W tungsten filament reading lamp with the cells positioned precisely 24" inches from the bulb, without light blockage from the shade.
Thus, a situation will never exist where the cells need to be constantly exposed to light. A
wearer will be exposed to hundreds of times that much light duration every month. Even the most restricted shut-in wearer will get far more exposure than is needed to keep the battery(s) charged. This Indoor ~ using a single solar cell (2cm X 4cm) extruded-crystal type, positioned 24"
inches from a new 100 watt lamp bulb produced the following readings:
Indoor Test: Single Cell 24" inches from 100 W tungsten filament light bulb Outside Cheek: .24 volt. > Inside Cheek: .OS volt. (single cell) Outside Cheek: 1,770 uA > Inside Cheek: 46 uA (twice typical amount needed) This equals 46 uA (micro amps), about twice the current demand of the typical pacemaker. With cells, in most cases, one-third the size of a business card, describing a 1 "
inch X 2"inch oval, laminated between possibly polyester or Mylar~ layers) for electrical insulation or another suitable electrical barners, the power output will be four times the above readings. Even in cases where the pacemaker is implanted deeper into the chest (for cosmetic reasons, so a bulge will not be visible), the cells can still be implanted just under the skin, to a depth of only 1/8" inch, about one-third the depth of the cells in my inside cheek test.
A duplication of the above Merntt Island, Florida test, conducted at Columbus, Ohio (40° North Latitude) two days later also under a near One Sun sky produced the following results:
Ma 2, 1999 at Columbus, OH (40 N Lat.) under a light-smog sky.

0.50 V @ 156 mA ( 156,000 uA) Outside cheek 0.25 V C? 1.8 mA (1,800 uA) Inside cheek Regarding the placement of photovoltaic cells under dark-skinned people, the cells can be larger, which will not present a problem. The size recommend for Caucasian pacemaker-defibrillator wearers will be approximately 1"X 2". Doubling that for dark skinned people, means cells 2" X 4", still comfortably small in size, considering their flexibility and the ample space available around the upper Sternum. This larger size will not be uncomfortable.
Moreover, multiple 1" X 2" photovoltaic cells may be used and electrically connected in series or parallel as may be required by the particular application. And, those people having darker skin pigment levels can hold a small flashlight over the implanted cells for about two minutes monthly, to accomplish similar results.
Columbus. Ohio test repeated 12:IN) Nnnn Mav 11_ 1999 ldll° N l.at1 ha~~ nra c.~h 0.51 V C 176 ( 176,000 uA) Outside cheek mA

0.26 V C 1.7 (1,800 uA) Inside cheek mA

S
Using the same single cell as in the above test, this test was repeated standing in the driveway near a tan painted house, performed at twelve noon in the presence of a witness: Mr.
David E. Dolle, 578 Lynwood Lane, Lancaster, OH 43130, retired engineer.
Columbus test repeated at Lancaster, at Ohio 12:00 Noon May 12, 1999 (39.8°N) 5k (:ondition: (:fear of Clouds, with visible haze.

0.53 V @ 175 mA ( 175,000 uA) Outside cheek 0.30 V C~ 1.5 mA (1,500 uA) Inside cheek Numerous other tests were conducted over the many years this project was under development, not included here. Regarding the manufacture of the final design of these photovoltaics, Iowa Thin Film Technology and other companies could capable of manufacturing these cells, with the multiple laminations) done in-house.
In other variations of the present invention, the photovoltaic cells may be integrally formed into the plastic cases of the implantable medical device that is implanted subcutaneously. In this configuration, the present invention eliminates the need for additional subcutaneous wiring. Moreover, with minimized wiring configurations, less power loss is experienced as power is transmitted across shorter wire leads, although this loss is minimal.
In one possible modification, the photovoltaic cells may be contained within a clear or transparent plastic case that surrounds the medical device to be implanted.

If the cells are not placed on or within the clear plastic case, they can be in their own laminated encasement located near or distal to the device, and plugged into the device they supply via a short or long transparent ribbon wire, leaving no visible evidence on the surface of the body. Anyone familiar with solar cells will have noticed that the back substrate layer of those cells is typically dark brown, violet or green. They are manufactured this way based on the assumption they will be exposed to direct outdoor sunlight while in a fixed position relative to the sun. The dark coloring serves to absorb rather than reflect light. Light reflection will not be a problem because of the tissue above implanted cells not permitting reflectivity.
The removal of this unnecessary coloring has cosmetic value, since the above mentioned coloring would make the cells visible under the skin, especially of fair-skinned people. These cells can be nearly transparent, except for their pick-up grids or "fingers"
affixed to the outward facing side, which are normally very thin so not to block the silicon:
typically about 5°Io of a cell surface. When cells are placed under the skin, the dermis with blood flowing through the capillaries directly above the cells will shift the color of incoming light to that 1 S Kelvin range where silicon cells are most responsive: 1500K to 1$OOK-orange-cherry-red.
Cells recharging a mechanical heart battery, and an insulin pump battery, must be larger than those for pacemakers or defibrillators, with much more surface area. For those devices, a larger thin array, (.012" inch thick and flexible), may be placed under the skin, over the Sternum as mentioned earlier-the obvious location for implanting a large array that may be up to six inches across its top side and extending downward up to seven inches for (adult size). For this configuration, child and adult sizes will be necessary. This is the logical placement for recharging a heart pump battery for two reasons: when the pump is implanted, the sternum is sawed vertically down its center, leaving the ribs on both sides attached, then pulled apart for access into the thoracic cavity. After the pump's emplacement, the Sternum is closed and stapled or wired together. Before this closure, a two-lead thin ribbon wire will be inserted around the bottom of the Sternum halves and plugged into a hermetically sealed miniature flat socket, plugging in a second heart battery inside the heart pump, and into the solar array, requiring no additional surgery. The second reason is when the wearer is attired in a suit coat, the edge of the two lapels form two sides of a triangular area, wherein there is the least clothing blockage of light striking the cells. In the case of a male wearer, if the person wears a bow tie instead of the conventional pendulum type, it will not block light access to the cells, leaving only a white undershirt and preferably white outer dress shirt providing minimal light blockage. It should be kept in mind that a mechanical heart and an insulin pump will be the most current-demanding devices implanted in the body, requiring this small consideration, partly because the heart pump must run constantly, unlike pacemakers and defibrillators, except for their monitoring circuitry.
Cells for bodily implantation can involve a combination of series and parallel wired circuits, possibly wired in what are called "strings," capable of producing an outside-the-body voltage at least 100% greater than that produced when implanted, since the voltage generated under the skin must equal or exceed the fully-charged battery. If a single wiring strategy is preferred, parallel wiring will best insure that adequate current is generated, with a voltage-doublet circuit employed outside the cells to boost voltage at the expense of current output. Pacemakers typically use a single cell 2.8 V Lithium-Ion battery when fresh, and with voltage doublets, routinely increase the voltage to five volts going through the wire into the wearer's heart. (One of the first pacemakers by Greatbatch included a doublet.) Also, the covering of the implanted cells can be tinted so as to shift the incoming light to that color, which produces the best spectral response for a particular type of cell.
Although blood passing through the capillaries directly over the implanted cells will benefit silicon cells, without any case tinting of their lamination covers required. Other constructions of solar cells, such as those made from Gallium-Arsenide are more responsive to light in a wider portion of the light spectrum, although their Arsenide toxicity must be considered. Thus, shifting the color of incoming light will be a straight-forward matter by using tinted plastics, all of which provide good electrical insulation. TefzelTM (registered trade mark of The DuPont Company) is one encapsulating material presently used on outdoor cells, and can possibly be a half-mil thick lamination on both sides of those cells, possibly laminated to Mylar~ (a small molecule resin with high gas-barrier properties. Mylar balloons are now commonly seen, because Mylar has high barner properties to gas and liquids.) so bodily fluids can not short circuit the cells. A forward-biasing diode, preferably placed in the plug-in socket, will prevent any back flow of current when the cells are in low light. TefzelTM or other plastics can also be molded into compound shapes, if needed, so it acts as a magnification lens, mufti or single-faceted type under the skin. Tinting cells, of course, involves a trade-off, since it reduces the amount of light energy that can pass through.
Preferred solar cell types are those which are most responsive in low-light conditions, including those with sintered or crenellated surfaces, which give the cells more surface area for a given linear dimension. Cells made of gallium arsenide, with their band gap of 1.4 eV
(electron volts) will be appealing, although their cost and toxicity is a contra-indication to their use. However, the small amount of cell area required is an argument in favor of their use.
Gallium-Arsenides have much higher range of solar absorption than silicon, with conversion 1 S efficiencies around 26%. Gallium-Arsenide . As used in multiple cell-spectral separation will be desirable, if the outer laminations) provide an absolute barner. In any case, the search for new photovoltaic cell materials is ongoing, with silicon an excellent choice for the present because of its transparent and non-toxic nature.
Regarding light skinned wearers who may get excessive sun exposure to the cells (improbable) an ON-OFF convex shaped button can be provided on the solar array or on the device case (facing outward), permitting the wearer to switch off the electrical output from the cells by feeling for the button through the skin and pressing it. The wearer will be able to feel the location of the implanted cells, and the location of this button, perhaps placed at the 2 5 junction point where the ribbon lead wire attaches to the cells, or better, on the plug that attaches the cells) into a device case. Thus, the wearer can switch off the cells, if that proves desirable, though a simple resistor can be in the circuit to reduce the maximum voltage output on a continuous basis, keeping in mind that the true challenge is to prevent excessive battery charging.
Rechargeable Lithium-Ion batteries have a shelf life of up to twenty years.
When used in an electronic application, without the benefit of a practical trickle-charging means, their life span averages about I/3 of that. However, their life can be safely doubled, up to twelve or fifteen years in the body by recharging. This is very important both from the standpoint of cost savings to the individual and insurer, and in the reduction of repeat traumas from surgeries. This investigator presently knows of two pacemaker wearers in their mid-eighties whose batteries are below the replacement voltage levels. However, their health is so fragile surgery is contraindicated, leaving them to expire as a result of gradual battery failure. Thus, it is abundantly clear that this invention, using specially designed photovoltaics constructed in several configurations for the particular body device they charge, will save thousands of lives per year. And they will reduce litigation resulting from premature battery failures.
This investigator knew a man whose pacemaker battery failed prematurely.
BRIEF DESCRIPTION OF THE DRAWINGS
Features of this invention will be more readily understood upon examination of the enclosed drawings:
FIG.1 Shows an "exploded view" of a conventional cardiac pacemaker wherein the top or outward facing half, or the entire case, has been injection molded of a clear resin.
FIG. 2 Shows an implanted electronic device wherein the photovoltaic cells are outside the device case.
FIG. 3 Shows a larger implanted triangular array or stack of photovoltaic cells positioned under the dermis, over the wearer's sternum, for maximum light exposure when attired in a suit, and includes an induction coil which can be used to transmit power into a device implanted directly underneath or used to transmit power into the coil, externally, via current inverters FIG. 4 Shows photovoltaic cells inserted under the dermis along the side of the cranium at the top of the wearer's neck for minimum hair blockage.
FIG. 5 Shows an array of cells placed under skin over the wearer's forehead, a portion of the cranium where hair blockage is not a factor. Shown are two induction coils extending downward from the solar array positioned under the wearer's eyebrows so the coils will be as near as possible to a smaller coil on a retinal eye implant.
FIG. 6 Shows a person's left arm with a tubular glass or resin capsule containing transceivers used to transmit nerve impulses across the gap when the nerve is severed.
FIG. 7 Shows an exploded view of a transceiver, including a tubular solar cell(s)which will receive light through the skin, when placed on the outward side of an appendage.
FIG. 8 Shows a double scale oval voltaic for pacemakers & defibrillators with eight cell divisions and a typical two strand ribbon wire leading from the cells.
FIG. 9 Shows a cross-sectional view of a flattened, two-strand ribbon wire encased in a resinous material, typical of the flat type of wire, necessary to get a good liquid seal at the point where the ribbon wire edges pass through the lamination encasement of the cells.
FIG. 10 Shows a frontal and a side exploded view of a mufti-layered, transparent solar array, providing approximately two square feet of solar surface area.
FIG.11 Shows the 45° desired angle of the mufti-layers of stacked transparent solar cells.
FIG 12. Shows six layers of solar cells with the desired 45° angle mentioned above.
FIG 13. Shows a side view of the wearer's eye glasses, illustrating the potential area 2 S that is available for implanted solar cells in clear plastic, but does not show a second layer facing inward, toward the wearer's head.

FIG 14. Shows a frontal view of wearer with these special eye glasses, the space between the inner and outer lines of the frame holding the lenses in place containing a multi-layered induction coil.
FIG 15. Shows a side view of the lens frame embedded coil transmitting electrical energy to the secondary coil, embedded in the plastic implant support structure, feeding power to the photo light receptors.
FIG 16. Shows a close-up view of the retinal eye implant with the induction coil at the periphery, with numerous photo-receptor cells in the central area.
DESCRIPTION OF PREFERRED EMBODIMENTS
FIG 1. Shows a typical cardiac pacemaker modified so the top 10 is made of a clear resin of the high-impact type, permitting a high percentage of light transmission, while having a high resistance against impact damage. Resins are presently available which can withstand the impact of a rifle bullet fired at a distance of two feet. Note in this design the leads housing 20 is molded as an integral part of the outward case half, though it can be molded as a separate part. (Pacemakers have one or two leads extending from the case, leading to the heart, depending on the type required: single or dual chamber models.) Incorporation of the leads housing into one or the other half of the case reduces the number of case parts, and the possibility of case leaking of bodily fluids into the device, which is presently one cause of device failures. Reference numeral 30 represents a generic depiction of a photovoltaic array, which can be made from silicon or gallium arsenide or other combinations of materials. This array would have the appropriate cell divisions so that in a "One Sun"
condition it can generate a voltage that doubles or triples the full-charge voltage of the battery. Thus, in moderate lighting conditions, it will still generate a voltage equaling that of the battery(s). In edge view 40 is a thin piece of metal beneath the photovoltaic cells. This serves to prevent unwanted bombardment of the implant device by electro-magnetic waves (RF) typically encountered when the wearer is going through an x-ray device or any type of metal detectors, encountered at airports or at any location where electronic security precautions are taken. It will also provide a barner when the wearer is standing near a leaking microwave oven door.
Not shown is an electronic circuit that will permit the cells to provide direct power to the pacemaker's Central Processing Unit should the battery(s) experience failure.
Also not shown are forward-biasing diodes that prevent the back-flow of current when the cells are not being exposed to light. This is necessary to prevent the cells from draining the battery(s), which is standard circuitry for all photovoltaic cells, when used to charge batteries. In the event of battery failure, the wearer would hold a flashlight against their skin directly above the implanted device, especially if the occurrence happens at night, so the photovoltaics will continue to operate while the wearer calls for an ambulance or drives to a hospital. Reference numeral 50 represents the device battery, which typically occupies 40% to 60%
of the inside area of the case. The RAM and ROM chips and the device's Central Processing Unit are not identified in this drawing, though all pacemakers are fairly simple, dedicated computers, commonly referred to as pulse generators, typically with thirty to fifty component parts.
1 S Reference numeral 60 shows the bottom of the device case.
FIG. 2 Depicts a pacemaker or other implanted device wherein the photovoltaic cells are not inside the case 90, but are laminated between sheets of resin 70, and plug into the electronic device's case via a flat ribbon wire 75 with moisture-sealed plug-in connectors in a typical pacemaker lead wire housing 80. This arrangement will be necessary for mechanical hearts, possibly defibrillators, and insulin pumps: devices where greater cellular surface area is required. Encapsulation by cartilaginous body tissue tends to occur as a natural function when any foreign object is introduced, which tends to hold the device in the position it occupied when implanted. Reference numeral 110 shows a pacemaker lead wire running into a heart. Reference numeral 100 depicts a human heart. Reference numeral 120 shows the 2 5 sternum bone and its spatial relationship to the implanted photovoltaics.
FIG. 3 shows a triangular array of photovoltaic cells designed for maximum exposure to light by a person wearing a suit coat with a bow-tie 140. These cells were designed mainly zo for an implanted mechanical heart, but can also be used to recharge batteries in a defibrillator or an insulin pump, typically implanted along the side of a wearer, near the pancreas. It should be self evident that a smaller version can be made for juvenile wearers.
Reference numeral 130 shows two holes where stitches can temporarily attach the photovoltaic array to the wearer's under dermis to hold the device in place until it is encapsulated by body tissue. Reference numeral 131 shows a two-lead wire running to the array. Reference numeral 132 shows the inner coil of fine wires, this space permitting a large number of turns of wire, should a voltage increase be desired, at the expense of current. Ref. 133 shows the outer resin lamination seal.
At the bottom of this array is shown a ribbon wire leading to a hermetically sealed electrical socket 150, which can contain the forward-biasing diode. This wire can run under the bottom of the sternum or between the ribs to an implanted mechanical heart. Or it can run to a defibrillator or drug infusion pump by passing just under the dermis. These photovoltaics will be made from the already available ultra thin cells which are typically seven thousandths of an inch thick (.007") and be very flexible, partly due to body heat keeping the cells warm. It 1 S should be noted that these flexible cells can be laminated between one-half mill thick laminating sheets with a curved bias so they will not tend to stick up at their corners, rounded to prevent their becoming a source of irritation. Having the wearer attire themselves with a bow tie in place of the conventional pendulum tie is a small concession to practicality for this application. Or this feature might be needed when the motor for an insulin pump or a mechanical heart should begin to malfunction or the valves in its heart start sticking so that the motor must labor harder, producing a power drain on the batteries beyond normal parameters.
FIG. 4 Shows one of the new surgically implanted hearing devices which are awaiting Food and Drug Administration approval in the U.S., and from similar sanctioning bodies in other countries. Reference numeral 160 shows an implanted amplifier, partly recessed in the cranium. Reference numeral 170 shows the power wire running from the amplifier to the separate array of photocells. Reference numeral 180 shows a small array. More devices show promise of being on the market in the next five years. A promising device by St. Croix Medical Corporation uses transducers implanted through the mastoid bones where vibrations are picked up from bones in the middle ear and fed into an amplifier, partly recessed in the side of the skull for cosmetic reasons. In this device, like pacemakers, these photovoltaic cells may be implantable inside the amplifier. If that is not considered feasible, due to space limitations, the cells can be a stand-alone separate group of cells plugging into the side of the device's amplifier. In this application, an ideal situation will exist for the cells to be laminated into the shape of a gradual curve that duplicates the curvature of the cranium. And with the dark substrate or superstrate of the cells omitted, these very thin cells will not be visible through the skin. With a black haired and or black skinned person, this stand-alone lamination can be positioned lower on he side of the skull or the neck, where hair is short or non-existent.
FIG. 5 In this location, an ideal situation exists for the cells to be laminated or molded into the shape of a gradual curve reference numeral 190, duplicating the curvature of the forehead. This will permit the wearer to wear a hat, without light blockage.
Also shown is a hole on one side of the array, opposite where the ribbon wire attaches, if applicable. This is used to aid the surgeon in inserting the array under the skin from one side of the forehead, to avoid leaving a visible surgical scar on the forehead.
FIG. 6 Shows a left human arm with a tubular glass or resin transceiver implanted under the skin, preferably on the outside of the arm, positioned forward of lateral to avoid side impact. This encasement will contain a transceiver, though it can be placed in most locations of the human or animal body. The shown example is circular for structural strength, but can be an oval of nearly symmetrical shape of a near-flat oval.
FIG. 7 is an exploded view showing the upper 210 and the lower case half 200.
Reference numeral 220 represents the transceiver without the individual components identified. Reference numeral 230 shows the battery and/or the antenna for the implanted device. Note that with the solar cells comprising this tubular array 240 running circumferentially, it is assured that part of the surface of all cells in the array are exposed to zZ

approximately the same amount of light. This is important if the cells are wired in a series circuitry that they run circumferentially around a tubular configuration, so all the cells get exposure to light. It is useful to note that the contact grid wires can be far enough apart so that radio waves can pass between the grids, especially if the positive and negative grid wires are aligned atop of each other.
FIG. 8 shows a photovoltaic array 250 that is laminated between layers) of light-transparent resinous material of a larger size, this example comprised of eight cells 260 which might be used to power a device with larger power requirements. Also shown is the special flat ribbon wire 270 leading to the device the cells empower.
FIG. 9 shows an ultra flat ribbon wire 280 with two plated ribbon wires 290.
This very important feature consisting of gradually tapered sides being necessary to get a liquid seal between the wire and the laminated solar cell laminating sheets of resinous film, necessary to prevent the ingress of bodily fluids.
FIG. 10 shows a triangular array 300 positioned over the sternum.
FIG.11 shows the layers at the ideal 45° angle 310.
FIG.12 shows a six layered array 320, which can be comprised of an indeterminate number of layers, depending on the accumulating stiffness of the multiple layers and the progressive amount of light barner as the number of layers increases.
FIG.13 Shows a side view of eye glass frames providing the maximum amount of surface area for embedding solar cells on both sides of the side frames. Not shown is a battery holder in the frames, and/or a plug-in socket for a separate battery connector, said battery being carried in a shirt pocket of on the wearer's belt.
FIG. 14 Shows a frontal view 410 of wearer with circular rimmed eye glasses, though they can be more stylish, having oval or modified rectangular frames.
2 S FIG. 15 Shows a cut-away view of the eyeglass frames 500 with an embedded primary induction coil, which is transmitting electromotive force (EMF) into the secondary coil 520 shown in side view, located on the periphery of the retinal implant, providing the amplification of light picked up by the numerous photo-receptors.
FIG. 16 Shows a frontal view of the retinal implant 6~, similar in size to an ordinary contact lens, turned so its concave side faces outward, its convex side in electrical contact against the retina/optical nerve. The secondary coil is represented by the ring surrounding the photo-receptors 610, with the central area 620 showing numerous light gathering photo-receptors.
2~

Claims (30)

I CLAIM:

1. At least one photovoltaic solar cell implanted subcutaneously under living tissue and electrically connected to an implanted electronic device, at least one cell positioned with a fluid barrier material and configured to energize an implanted device.

2. The at least one cell according to Claim 1, wherein the cell is responsive to light radiation and is encased within an electronic device case transparent to such light radiation.

3. The at least one cell in accordance with Claim 1, wherein the cell is responsive to light radiation and is positioned proximate to an electronic device case, the cell being laminated with a substantially electrically insulating cover material selected to be translucent to the light, and wherein the cell is in electronic communication with a device contained in the case.

4. The at least one cell in accordance with Claim 3, wherein the cell is responsive to a predetermined frequency range of light radiation and is configured to be implantable and wherein the laminated-electrically isolating cover material is tinted to be translucent only to the predetermined frequency range of light radiation.

5. The at least one cell according to Claim 3 wherein the electrically isolating and laminating material is made of a polyester.

6. The at least one cell according to Claim 3 wherein the electrically isolating and laminating material is formed from at least two layers wherein the layers are selected from the group including polyester and mylar.

7. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell is formed with an area sufficient to produce electrical current that at least meets the current demand of the electronic device, and wherein the at least one cell is in electrical communication with at least one voltage doubler.

8. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell is laminated with a substantially electrically isolating cover material that is tinted to be translucent to a frequency range of light energy to which the at least one cell is most responsive.

9. At least one photovoltaic solar cell according to Claim , wherein the at least one cell is formed with a substantially triangular shape that conforms to the region of upper-body clothing wherein a dressed wearer has the least light blockage from the clothing.

10. At least one photovoltaic solar cell according to Claim 1, wherein the at least one triangular cell includes transmittal wires running from the cell(s) to a remote location from the cells.

11. At least one photovoltaic solar cell according to Claim2, wherein the at least one cell includes an induction coil and an a.c. to d.c. converter incorporated into the cell(s) so the cell can also receive current from an outside of body source.

12. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell is constructed to have a tubular shape adapted to at least partially encase the implanted device.

13. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell is constructed to have an oval shape.

14. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell is in a shape conformal to its location in the body.

15. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell is formed with holes adapted to receive surgical stitches whereby the at least one cell is maintained in a fixed location until surrounding tissue encapsulates the cells.

16. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell wherein the device case is substantially transparent and is formed to have a convex, thickened topside that is selected to have a higher impact resistance and which is also formed to function as a focusing lens for incoming light.

17. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell wired to another cell in a parallel circuit whereby circuit current resistance is minimized.

18. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell is adapted to, when the tissue is exposed to light, generates current in excess of that needed by the electronic device.

19. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell includes a resistor to prevent a charging voltage exceeding the full-charge rated voltage of the battery(s).

20. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell is adapted to connect to the device case at a junction that includes additional electrical leads whereby the number of exit points in the case are minimized.

21. At least one photovoltaic solar cell according to Claim 17, wherein the device case junction is fitted with at least one annular ring adapted to seal against the intrusion of bodily fluids.

22. At least one photovoltaic solar cell according to Claim 17, wherein a forward biasing diode is incorporated in the device permitting a one-way flow of current from the cells to the device.

23. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell is in electrical communication with a reactance switching circuit included within the electronic device that is operative to switch the current generated by the at least one cell between a battery recharge circuit and a device powering circuit.

24. At least one photovoltaic solar cell according to Claim 1, wherein the at least one cell is in electrical communication with a switch that can be operated by pressing on the tissue proximate to the switch.

25. A subcutaneous photovoltaic power supply device for supplying electrical power to recharge a battery of a medical device implanted beneath living tissue, comprising: at least one subcutaneously implanted photovoltaic cell adapted to produce a predetermined power output sufficient to, when the tissue is exposed to light, recharge the battery of a medical device.

26. A subcutaneous photovoltaic power supply device for supplying electrical power to energize a medical device implanted beneath living tissue, comprising: at least one subcutaneously implanted photovoltaic cell adapted to produce a continuous, predetermined power output sufficient to, when the tissue is exposed to light, energize the medical device.

27. At least one solar cell according to Claim 1, wherein an a.c. back to d.c.
inverter attached to an induction coil which is an integral part of implanted solar cell(s) on their underside designed to receive current from an external induction coil with the current feeding into the pick-up wires imbedded in the implanted solar cell(s).

28. At least one solar cell according to Claim 1, wherein the cell(s) is placed underneath dermis over the wearer's forehead so as to transmit current into a second induction coil placed on the periphery of a concave base attached to the back of the eye directly to light sensitive cells transmitting visual images into the wearer's brain.

29. At least one solar cell according to Claim 1, wherein an aggregation of cells are positioned along the wearer's temple so as to transmit electrical energy into an eye implanted receiving coil.

30. At least one solar cell according to Claim 1, wherein an induction coil is added to the inward facing side of sub-cutaneously implanted solar cell(s) that transmit electrical energy to a second induction coil located directly underneath the solar cell mounted coil inside an optically transparent device so current is transmitted to the second coil without physical connection of the two coils.