Device and means to ameliorate discomfort and pain during visual inspections of inner body parts and similar procedures

Abstract

A device and means to decrease the pain associated with colonoscopy and similar procedures to examine the oesophagus, the stomach, etc. The device uses electrical currents of both positive and negative polarity, or alternating current. The improvement described can be incorporated into existing bodies of existing devices. Application on colonoscopy screenings and intestine polyp collection and other types of biopsies.

Claims

1. An electrical stimulating device composed of: a minimum of one type 1 electrode supported by a first supporting device formed as a flexible penetrating device that is inserted in an animal, with a skin surrounding said animal, whereas said type 1 electrodes are adapted to apply an electric stimulating current to said animal, wherein said type 1 electrode that is supported by said first supporting device formed as said flexible penetrating device that is capable of being inserted into at least part of a volume inside said animal or inside an organ of said animal, is adapted to inject said electric stimulating current in its surroundings, wherein said first supporting device formed as said flexible penetrating device is adapted to be inserted into at least part of said volume inside said animal or inside said organ of said animal, where said first supporting device has a distal extremity, a proximal extremity and a lateral surface, wherein said first supporting device formed as said flexible penetrating device is a pain-inflicting device, which device causes pain on said animal, said pain-inflicting device supporting a minimum of one element belonging to at least one of the five sets: 1. a fiber optic cable used to inspect said organs inside said animal, where said fiber optic cable is inserted from a natural orifice on said animal, 2. said fiber optic cable used to inspect said organs inside said animal, where said fiber optic cable is inserted from an incision or hole on said animal, said incision or hole made by a medical professional, 3. one or more wires adapted to convey electrical signals to the outside of said first supporting device, said one or more wires connected to a pixelized detector fixed at said first supporting device, 4. one or more tubes adapted to convey either air, or carbon dioxide, or other gas, or water, or other liquid, from said proximal extremity of said first supporting device to said distal extremity of said first supporting device, 5. a one or more surgical instruments adapted to extracting tissues from said organ of said animal.

2. Said electrical stimulating device of claim 1 where said pixelized detector is located at said distal extremity of said flexible supporting device.

3. Said electrical stimulating device of claim 1 where said pixelized detector is located at said lateral surfaces of said flexible supporting device.

4. Said electrical stimulating device of claim 1 further provided with at least one type 2 electrode, which are attached to either said first supporting device or to a second supporting device, whereas said first supporting device or said second supporting device that holds in place said type 2 electrode is either a volumetric structure, or a surface structure or a linear structure, wherein the surface structure may be planar or non-planar.

5. Said electrical stimulating device of claim 4 wherein said second supporting device contains said type 1 electrodes which are of a second polarity that is opposite to the first polarity of said type 1 electrodes located at said first supporting device, formed as said flexible penetrating device, or are of said second polarity that is of same polarity as said first polarity of said type 1 electrodes located at said first supporting device formed as said flexible penetrating device.

6. Said electrical stimulating device of claim 4 wherein said second supporting device is provided with a velcro or buttons or zippers or glue to be attached to precise locations inside said animal or outside said animal.

7. Said electrical stimulating device of claim 4 wherein said second supporting device is shaped as a modified fabric capable of conform to said skin of said animal.

8. Said electrical stimulating device of claim 4 wherein said second supporting device comprises part of a flexible cylindrical-type shape adapted to be worn at an abdomen or at a chest by said animal, or part of said cylindrical-type shape.

9. Said electrical stimulating device of claim 4 wherein said second supporting device is adapted to be anchored near or around said organ of said animal.

10. Said electrical stimulator device of claim 4 wherein said second supporting device is shaped as a curved surface that is adapted to be worn on a chest or on a back or around a breast of said animal.

11. Said electrical stimulator device of claim 4 wherein said second supporting device supports subterranean type 3 electrodes.

12. Said minimum of one type 1 electrode supported by said first supporting device formed as said flexible penetrating device that is inserted in the animal of claim 1 wherein said flexible penetrating device contains either a fiber optic bundle or an electric wire or wires, adapted to probe said volume on said inside of said animal and allow for a view of said inside of said animal.

13. Said minimum of one type 1 electrode supported by said first supporting device formed as said flexible penetrating device that is inserted in said animal of claim 1 wherein said flexible penetrating device is a tool adapted at penetrating from the rectum of said animal along either part or the total length of the intestine of said animal.

14. Said method of the electrical stimulating device of claim 1, with one or more type 1 electrode supported by a first supporting device formed as a flexible penetrating device that is inserted in an animal, the method comprising: providing said first supporting device formed as said flexible penetrating device to physically support said electrical stimulation device of claim 1, providing said one or more type 1 electrode supported by said first supporting device, formed as said flexible penetrating device that is inserted in said animal, providing said one or more type 1 electrode with necessary wires and electrical connections that are supported by said first supporting device, formed as said flexible penetrating device that is capable of being inserted into at least part of a volume inside said animal or inside an organ of said animal, that is adapted to inject an electric current in its surroundings, providing said at least one first supporting device formed as said flexible penetrating device with a shape that is adapted to be inserted into at least part of said volume inside said animal or inside said organ of said animal, choosing said at least one first supporting device formed as said flexible penetrating device that is a pain-inflicting device, which pain-inflicting device causes pain on said animal, said pain-inflicting device being at least one device that belongs to at least one of the 6 sets: 1. a set composed of at least one flexible device capable of penetrating in an organ or in a flesh or in a muscle or in a part of said animal, 2. a set composed of at least one tissue extractor Ex adapted to extract tissue samples from said volume inside said animal for later biopsy, 3. a set composed of at least one needle used to suture an orifice made on said animal by said tissue extractor, 4. a set composed of at least one flexible device carrying at least an optical fiber bundle adapted to transmiting a pixelized image of the interior of said animal, or said organ inside said animal, 5. a set composed of at least one said flexible device carrying one or a plurality of electrical wires adapted to carrying an electrical signal from a pixelized image of the interior of said animal, or said organ inside said animal, 6. a set composed of at least one flexible tubing adapted to extracting by suction material from said volume of said animal.

15. Said method of said electrical device of claim 14, wherein said electrodes are one or more from a group composed of: (1) said one or more type 1 electric charge injecting electrode, (2) said one or more type 2 field shaping electrode, (3) said one or more type 3 field shaping electrode, wherein said one or more type 2 or said one or more type 3 field shaping electrodes of said electrical stimulation device are configured to apply a force on either a propagating electric charge injected in said animal by said electrical stimulation device, or said propagating electric charge naturally produced by said animal.

16. Said method of claim 14 further comprising at least one said electrode of one or more of the groups: (1) at least one said type 1 stimulating electrodes, (2) at least one said type 2 field-shaping electrodes, and (3) at least one said type 3 field-shaping electrodes, whereas said at least one electrode belonging to one of the elements (1) or (2) or (3) of said group is located at a second supporting device located at a position different than the position of said first supporting flexible penetrating device.

17. Said method of claim 14 wherein, said first supporting flexible penetrating device is capable of causing discomfort or pain on said animal where said first supporting flexible penetrating device formed as said flexible penetrating device is applied.

18. Said method of said electrical device of claim 14, wherein said at least one type 2 or type 3 field shaping electrodes of said electric stimulating device are configured to apply a force on either said propagating electric charges injected in said animal by said electric stimulation system, or on electric charges naturally produced by said animal.

19. Said method of claim 14 further comprising additional at least one said type 2 or type 3 field-shaping electrodes coupled to said skin of said animal .

20. A method of applying an electrical stimulation to tissues of an animal which consists of a first device and a second device, wherein, said first device is a flexible penetrating device adapted at being inserted in said animal, or in a cavity of said animal, or in a tissue of said animal, or in a part of said animal, said second device is a flexible sheet-like structure adapted to conform to a full external surface of said animal or to part of said external surface of said animal, or to a full internal surface of said animal, or to part of said internal surface of said animal, where said first device is capable of causing pain on said animal, where said first device is adapted of supporting at least one type 1 electrode or at least one type 2 electrode or at least one type 3 electrode, where said second device is adapted of supporting at least one said type 1 electrode or at least one said type 2 electrode or at least one said type 3 electrode.

Description

DRAWINGS

[0060] FIG. 1A - A malleable sheet-like supporting structure (Pat) with one single electrode.

[0061] FIG. 1B - A malleable sheet-like supporting structure (Pat) with several electrodes.

[0062] FIG. 1C - A malleable sheet-like supporting structure (Pat) with both active and field shaping electrodes.

[0063] FIG. 2 - A Dirichlet shirt with electrodes.

[0064] FIG. 3 - a DBS type of electrical stimulator.

[0065] FIG. 4 - Passive electrodes, supercapacitor-type, distributed on a membrane surrounding the pericardio. Such a membrane was developed, fabricated and actually used on a rabbit's heart ex-vivo (see references below). In this case the membrane around the pericardium was populated with data collecting sensors, as pressure sensors, electrical reading electrodes, pH sensors, etc., and they took the heart out of the unfortunate rabbit, then kept it beating with a heart pacemaker and a heart-lung machine. Our device would have passive electrodes on the membrane instead, so it is a simple modification of an existing technology.

[0066] FIG. 5A - Electric fields below the skin on a TENS device.

[0067] FIG. 5B - Electric fields below the skin on a TENS device.

[0068] FIG. 6 - A heart with its parts.

[0069] FIG. 7A - Part of a contraction sequence of an atrium, or upper part of the heart.

[0070] FIG. 7B - Part of a contraction sequence of an atrium, or upper part of the heart.

[0071] FIG. 7C - Part of a contraction sequence of an atrium, or upper part of the heart.

[0072] FIG. 7D - Part of a contraction sequence of an atrium, or upper part of the heart.

[0073] FIG. 8A - Part of a contraction sequence of a ventricle, or lower part of the heart.

[0074] FIG. 8B - Part of a contraction sequence of a ventricle, or lower part of the heart.

[0075] FIG. 8C - Part of a contraction sequence of a ventricle, or lower part of the heart.

[0076] FIG. 8D - Part of a contraction sequence of a ventricle, or lower part of the heart.

[0077] FIG. 9 - Gravitational field of the earth with a mountain causing a deviation on the otherwise gravitational field toward the geometrical center of the planet.

[0078] FIG. 10A - Electric field of a combination of electric charges.

[0079] FIG. 10B - Electric field of a combination of electric charges.

[0080] FIG. 10C - Electric field of a combination of electric charges.

[0081] FIG. 10D - Electric field of a combination of electric charges.

[0082] FIG. 10E - Electric field of a combination of electric charges.

[0083] FIG. 11 - A heart electric stimulator with electrodes.

[0084] FIG. 12A - Possible types of electrodes.

[0085] FIG. 12B - Possible types of electrodes.

[0086] FIG. 13 - Subterranean type of electrode 140_t3.

[0087] FIG. 14 - A pain inflicting device composed of an extractor Ex with an extended hypodermic needle Nd at its distal extremity and several retracted needles at the sides (not seen). The electrodes of all types, 140_t1, 140_t2 and 140_t3 are not shown.

[0088] FIG. 15 - One of the types of extractor Ex. An extractor with this distal extremity has a typical diameter of 2 mm (gauge 12) to 3 mm (gauge 7), or 10 times thicker than a typical hypodermic needle. Other than the larger diameter, this common type of extractor Ex is similar to a standard hypodermic needle used for muscular injections in medical facilities. There are many other, different, shapes of the distal extremity of Ex, and the cell extraction occurs at the distal extremity (as in this type) or at the sides, at other models or types of extractors.

[0089] FIG. 16 - A typical hypodermic needle Nd. A hypodermic needle Nd may have diameters from 200 micrometers to 400 micrometers, or 10 times thinner than the extractor Ex.

[0090] FIG. 17 - Anesthetic injector and several electrodes surrounding the injector.

[0091] FIG. 18 - A flexible penetrating device of our invention, also referred to as first supporting structure, as it is seen when fully inserted into the intestine of a standing human.

DRAWINGS - LIST OF REFERENCE NUMERALS

[0092] AN = Anus [0093] BAT1 = Battery and controlling electronics box, usually implanted in the patient's chest. [0094] DE = Distal extremity [0095] ICE = Image collecting element [0096] ITC = Image transfer cable [0097] MP1 = Microprocessor 1. One of the possible units capable of executing a programmable sequence of instructions, as the venerable 8085, or the 8086 (which was the brain of the first IBM-PC), 80286, 80386, 80487, pentium, DSP, microcontrollers, etc. Some of these may include memory, DAC, ADC, and interface devices. [0098] PE = Proximal extremity [0099] TU = Tube(s) [0100] 100 = body of picafina of our invention. [0101] 110 = electrical energy storage unit (e.g., a battery) + microprocessor (MP1) + parallel-to-serial converter. [0102] 122 = Serial address (may also include return ground, or may use the same return/ground as power 124). [0103] 123 = reset line / control bits. [0104] 124 = power conveying means. [0105] 130 = ST1 = electrical stimulating probe, in the main embodiment is screwed in the inner part of the heart, brain, or other organs. [0106] 131 = anchoring arms to prevent the heart stimulator type (piquita) from moving back once it is forced into the endocardio/miocardio. [0107] 132 = main body of piquita heart pacemaker. 140_t1 = type 1 or active electrodes (standard electrodes, capable of injecting current in its neighborhood). [0108] 140_t2 = type 2 or field shaping electrodes (electrically insulated electrodes, capable of influencing the electric field lines, but not capable to inject current). Typically type 2, field shaping electrodes are covered by a silicon dioxide layer, but any other insulator is possible, the type of insulator being not important for our invention. [0109] 140_t3 = electrodes below the surface of the supporting structure, called here underground electrodes. [0110] 210 = memory with local address for each electrode 140. [0111] 220 = SW = switch to turn electrodes on/off. [0112] 230 = comparator to determine if switch 220 should be turned on or off. [0113] 240 = digital comparator/decoder. [0114] 250 = enable bit for 260. [0115] 260 = comparator/decoder for stimulator addresses. [0116] 307 = tricuspid valve, between the right atrium and ventricle. [0117] 309 = pulmonary valve, exit from the right ventricle. [0118] 310atr = atrium. [0119] 310ventr = ventricle. [0120] 410 = hermetically sealed box containing the energy storage unit (battery), the microprocessor MP1, the serial-to-parallel converter and all the necessary electronics for the device to operate, as is used in prior art. [0121] 510 = serial-to-parallel converter. [0122] 520 = parallel lines for addresses (may also be used for control and data). [0123] 830 = address decoders (AddDec)

Alphabetical Labels

[0124] A = digital, binary address lines. [0125] AVN = Atrial-ventricular node. [0126] B = power line (voltage or current source). [0127] bl = blood level. [0128] Ex = Extractor, cancer cell extractor, sample cell extractor, pain inflicting device [0129] HB = His Bundle. [0130] HN = hypodermic needle [0131] In = Injector, anesthetics injector [0132] LBB = Left bundle branch. [0133] LA = Left atrium. [0134] LV = Left ventricle. [0135] Lm = lumen [0136] m = mountain (exaggerated height for display) [0137] Nd = hypodermic needle. [0138] PF = Purkinje fibers. [0139] RA = right atrium. [0140] RBB = Right bundle brunch. [0141] RV = Right ventricle. [0142] SNA = sino-atrial node. [0143] SW = also220 and 810.

DETAILED DESCRIPTION

Overview

[0144] The main embodiment of our invention is one of the dental tools ordinarily used by the dentists to inflict pain on their clients, as the Jacquette Scaler U15/30, the Sickle Scaler H6/H7, the Probe #9, the Explorer #23, the Explorer # 23/17A, the Tartar Remover Scaler, the Root Canal Spreaders 2S-D11, the Margin Trimmer (Distal and Mesial), the Gracey Periodontal Curettes, the Periodontal Probe, the Heidman Spatula and many others. These may or may not be used together with a variation of a TENS supporting electrodes, preferably a multiplicity of electrodes attached to a flexible surface which may, for example, be temporarily fixed to the outer skin or the patient, most likely at the cheek. Note that it is possible to apply our invention without the TENS supporting electrodes. Other dental tools are also good means to apply our invention, as any of the drills used by the dentist to remove dental tissue attacked by the cavity-causing bacteria, or the tools used to extract the nerve during the dreaded procedure known as root canal treatment. All of these share a common trait of being made of metals or some other electric conductive materials and able to carry electric current to their tips, which current is then injected onto the patient exactly at the point where the pain is being inflicted on the patient by the very tool that is injecting the pain-suppressing electric current.

[0145] The main embodiment of the grand-mother of our invention is seen at FIGS. 1A, 1B and 1C. These figures show several variations of a malleable sheet-like supporting structure Pat with one or more electrodes that may be or either type (active electrodes of field shaping electrodes, 140_t1 and 140_t2, respectively) or both types. For example, the main embodiment may have a malleable sheet-like supporting structure Pat with one active electrode 140_t1 (see figure FIG. 1A), or a malleable sheet-like supporting structure Pat with one field shaping electrode 140_t2, or a malleable sheet-like supporting structure Pat with one of each type 140_t1 and 140_t2, or any other combination (FIGS. 1B and 1C). The malleable sheet-like supporting structure Pat can be made of any material that is reasonably malleable, similar to a bed sheet, as cotton, wool, silk, small metal wires, nylon, thin metal foil, rubber or rubberized materials, plastics, etc. or any other that is capable of adapting its own shape to a curved surface, on which the malleable sheet-like supporting structure Pat is applied. The malleable sheet-like supporting structure Pat may have some type of attaching device to cause it to be in fixed position with the object on which it is applied, for example a glue, a zipper, velcro, a set of screws, stitches, rubber bands and gaskets, or any other device capable of keeping the malleable sheet-like supporting structure Pat in place, or moving within a certain limit that depends on the case. The electrodes may be any material, as metal, metalized foil, or any electrically conducting material. The electrodes may be a simple material or they may be constructed with the technology used to manufacture supercapacitors, which produces a large number of interconnected holes into the bulk of the material, which is capable of increasing the surface of the electrode by a factor of 1,000 and much more, which in turn increases the electrode’s capacitance and with it increases the charge delivering ability of the electrode (important for active electrodes 140_t1) and also the field strength created by the electrode (important for the field shaping electrodes 140_t2).

[0146] Examples of the main embodiment are variations or extensions, or improvements on the existing TENS devices, which then may have a general external appearance of the old, traditional TENS patch but have the new field shaping electrodes 140_t2 or 140_t3, or membranes to cover the heart, as described by LizhiXu, Igor R. Efimov et al. “3D multifunctional intergumentary membranes for spatiotemporal cardiac measurements and stimulation across the entire epicardium” Nature Comm Vol 5 Pg 3329 (March 2014 ), Colleen Clancy and Yang Xiang “Wrapped around the heart” Nature Vol 507 pg 43 (6 Mar. 2014), Pierre Martin “Une membrane artificielle pour surveiller le coeur” La Recherche (1 Mai 2014). The invention is not limited to these two applications or to these two shapes or these two sizes, but is applicable to any other situation which uses electrical stimulation.

[0147] FIG. 2 shows one of the applications of the main embodiment of our invention, which we call Dirichlet's shirt, and which is for heart pacemaking applications. Here one see passive electrodes distributed on a wearable shirt-like support. Such external passive electrodes offer the advantage of using external batteries, simplifying the problem of electrical energy for the electrodes. The fractional surface coverage could be of the order of 75%, which is the approximate solid angle coverage offered by the shirt's front + back + sides. Appropriate modifications that adapt what is described in the main embodiment for other organs, as the brain, nerves in general, the stomach, etc. are obvious for persons that work in the field of electrical stimulation and have knowledge of electrostatic and electromagnetic theories. For example, for brain use, the Dirichlet’s shirt would be a kind of a hat, a Dirichlet’s hat, which may have also extensions behind the head, as used for extra sun protection, and extensions over the ears, as used in cold winters for extra protection against the cold, and perhaps other new surfaces surrounding the head as possible to use, all with view of providing as large a surface as possible around the desired area of influence. For stomach, intestines, etc, it would be a kind of a belt, the Dirichlet’s belt, similar to the wide belt used by workers that need to lift loads all the time, as warehouse workers, household movers, etc. usually 20 cm wide. The Dirichlet’s belt could be wider than the belts used by workers to protect against hernias, both in front and back, due to their intended function.

[0148] FIG. 3 shows a variation of our invention with some connecting wires or electrical connectors. The Dirichlet shirt of our invention has wires 124 as seen if FIG. 3 extending from the controlling electronics, microprocessor and battery to each electrode 140 (of either type, t1 or t2). Wires 124 may be either standard wires or may also be printed circuit wires, as in printed circuit boards. The technology of printed circuits is a well advanced technology with many methods to print the wires, and the wire manufacturing is not part of this invention, as any of the existing technologies are acceptable to implement the invention.

[0149] The main embodiment uses 10 wires from the battery pack/control unit 110 to the Dirichlet shirt, which are connected to the 10 available electrodes 140 by the 10 wires 124 - one wire for each electrode 140. This particular choice of 10 wires and 10 electrodes should not be taken as a limitation on the invention, because more wires and electrodes, or less wires and electrodes are possible still within the scope of the invention, as obvious to people familiar with the art of electronics. It is also possible to connect the ground (or return) wire to any number of electrodes (or pads), both type 1 and type 2. It is also possible to use the wires as address bits, in which case 10 wires would be able to select for 2**10 = 1024 different electrodes. Wires are one of the many technologies to make electrical connections between the electronic parts, which are well known to the persons with knowledge of electronics.

[0150] As seen in FIG. 2, the main embodiment consists of a modified ordinary shirt, for example, a T-shirt or a V-neck type, preferably either tight on the body or conforming to the body, on which there exists a multiplicity of field shaping electrodes (also known as type 2 electrodes), preferably with the necessary battery and electronics together as a unit, but the battery and electronics may be separate from the shirt too, without changing the nature of the invention. The Dirichlet’s shirt may be, for example, a modified T-shirt, preferably fit on the wearer (that is, tight without squeezing the wearer), with a multiplicity of pockets as shown in FIG. 2 which are so designed as to hold specially designed electrodes both of the field shaping and active type, and one or more extra similar pockets capable of holding an electric cell or battery and the associated controlling electronics, which may be in the same box. The pockets for the electrodes are so designed that they allow the field shaping electrodes to work for their objective, which means that typically the electrodes, when inserted in their pockets, should have a flat surface facing the body of the person wearing the Dirichlet’s shirt. The electrodes, which may be of the field shaping electrode type only but may also be of both the field shaping variety and the active or current injecting type in the main embodiment, and the field shaping electrode may be made with the supercapacitor technology, with a porous very large surface area, or may be simple flat surfaces. The Dirichlet shirt may have electrodes on all its surface and the electrodes are preferably facing the skin of the wearer, that is, the electrodes are preferably at the inner surface of the Dirichlet shirt, preferably in direct contact with the skin. Our Dirichlet’s shirt is adaptable to be weared as an ordinary even fashionable shirt as any polka dot shirt that becomes fashionable for women from time to time.

[0151] FIG. 4 shows an improvement over the Dirichlet’s shirt. FIG. 4 is a membrane covering the heart with electrodes on its surface. FIG. 4 shows type 2 (field shaping electrodes) only, but it usually would have both type 1 and type 2 electrodes. The hardware shown in FIG. 4 has been developed recently and has been published in Nature, in La Recherche, and other publications. It was developed to make measurements on the heart, fitted with all sorts of sensors, but not with the field shaping electrode of our invention. See references LizhiXu (2014), Clancy (2014) and Martin (2014). The reader is encouraged to go see the pictures of these membranes. Our invention described here is not new in the membrane, it is new on the use of the passive electrodes on these membranes.

[0152] To physically achieve the above description, the controlling mechanism, in this case a microcontroller residing in the battery/control unit 110 (FIG. 3), is loaded with a program (or software), which is capable of executing automatic repetitive tasks following a programmed sequence the details of which are adjusted by a medical professional or by the patient himself, which determines a particular combination of active and field shaping electrodes to use, also able to determine which electrodes of each type to use, also able to send this information by wires to the stimulating unit 130. The correct sequence can be determined, for example, by the examination of an EKG (Electro Cardiogram) while varying the active electrodes of each type, their voltages and relative time sequence, if the electrical stimulation is acting on the heart, or the correct sequence can be determined by observing the muscle contraction sequence if the stimulation is a TENS stimulation used by a chiropractor or by a physical therapist to treat some muscle or some tendon problem, etc., depending on the case. The microprocessor, located in box 110, select which wires 124 to be connected to electric power and the voltage level as well, which may be different at each wire 124. Each were 124 connects to one of the electrodes 140_t1 or 140_t2. Each electrode type can be turned on or off (connected or disconnected from the electrical power) under the control of microprocessor.

[0153] The random placement, shape and size of the electrodes is a distinct feature of our invention, as it contributes for the creation of a spatial asymmetry of the electrodes, which in turn causes an asymmetry in the spatial distribution of both the electric field E and of the injected current i, either its magnitude or its direction. Careful selection of which electrodes to turn on, and at which electric potentials (voltages) can create the most desirable electric field shape E (x) on the volume of the heart. A careful selection of which electrodes is able to produce a better resulting stimulation which is suited to the asymmetric heart muscle 3-dimensional shape and causes a more complete squeezing sequence and better ejection fraction (the fraction of blood sent out of the heart). It is to be noted that if any symmetry is required, our invention is backwards compatible, being able to reproduce heart pacemakers stimulating surfaces as a particular case of an arbitrary shaped surface. Note that if a symmetry of current magnitude and direction is desired, it can still be achieved within a reasonable accuracy, by the appropriate selection of a number of electrodes which, as a set, defines the desired symmetry. Naturally the degree of symmetry possible to be achieved depends on the number of electrodes available: more asymmetry with more electrodes (that is, more complex electric fields with more electrodes).

Operation of Invention

Background Information on Operation of the Invention

[0154] The operation of our invention is based on the effect of electric fields on electric charges, and on the Newtonian theories relating forces, masses and acceleration, all of which is part of most introductory physics courses. To understand the operation of our invention we will use two examples: the case of TENS and the case of the heart, but the same principles apply to other applications.

[0155] FIGS. 5A and 5B show the skin of a person, with the flesh below the skin line, out of the body above the skin line. For simplicity the TENS is not completely shown, but only one active electrode 140_t1 and four field-shaping electrodes 140_t2, as indicated. Also, to avoid cluttering the drawing only two of the field shaping electrodes are marked, the electrodes on the right of the figure, the other two field shaping electrodes at the left being without indicative letters but only known to be field shaping electrodes of the type 140_t2 for being drawn as open rectangles. FIG. 5A shows the forces for a charge q on the field shaping electrodes 140_t2, while 5B shows the forces for a charge 2q (twice as large) on the field shaping electrodes 140_t2. It worth to point out here that the larger charge on the electrodes are a consequence of a larger electric potential (or larger voltage as the Americans say it), and we use the language of the charges here because it is closer to the physical principles and also direct consequences of Coulomb’s law that are known as a function of the electric charges and not as a function of the electric potentials. The forces on a charge at the same location below the skin are shown: four forces (at an oblique angle) due to each of the four field shaping electrodes 140_t2 and the resultant force (or total force, or combined force) that in this case happens to be on the vertical direction down, a result that can be seen without calculations if one considers the symmetry of the problem. As it is seen on the figures, the force on the case of larger electric charges is larger, and consequently the speed of the charges injected by the central active electrode 140_t1 is larger and the charges will also penetrate deeper into the tissue of the patient on the second, lower case than on the first, upper case. So, FIGS. 5A and 5B show the effect of the field shaping electrodes 140_t2: they control the location of the electric currents injected in the body by the active electrodes 140_t1, which are the only electrodes used by the existing devices.

[0156] The second example we use to show the operation of our invention is the heart. The reader must keep in mind what causes the heart to contract, and therefore to pump the blood, and the sequential nature of this contraction as well, which is the propagation of the ions through the heart muscles. In fact this is also true for the motion of my fingers as I type these very words that the reader is reading right now: similarly to the heart contraction, my fingers move due to the arrival of electric charges (ions) that are transmitted by the nerves, according to a sequence that started at my crazy brain - it is all the same thing, the heart and my fingers. FIG. 6 displays a human heart with the main parts indicated in it. Left and right are designations from the point of view of the person in which the heart is, which is the opposite of the viewer, facing the person. The right and left sections are responsible for two independent closed cycle blood flow: the right side of the heart pumps blood to the lungs then back, so it is called the pulmonary circulation, while the left side of the heart pumps blood to the whole body.

[0157] The heart muscle contraction occurs as a consequence of and following the propagating electric pulse that moves in 3-D (three dimensions) through the heart muscle from an initiating point (the sino-atrial node), which is located at the top of the right atrium - the 3-D electric pulse propagation through the heart muscle is important for the operation of our invention, as it will be seen in the sequel. This propagating electric pulse is known by the medical people as a depolarization wave, and the medical people associate a depolarization event to a muscle contraction event. This sequential contraction, characteristic of all peristaltic pumps, is similar to the process of squeezing toothpaste out of the tube: it is a progressive squeezing sequence which progress from the back (or entrance) to the to the forward (or exit) port. This progressive contraction is in contradistinction with a simultaneous contraction from all sides, as happen when an air balloon pops or when a person squeezes a tennis ball to exercise the muscles at the arm - the few people that do exercise! The collapsing popping air balloon is under the influence of a mostly isotropic force created by the air pressure, which is virtually the same on all the surface of the balloon, which causes that it collapse isotropically, as a sphere of progressing smaller radius. For the toothpaste case, virtually most minimally intelligent person squeezes the tube starting from the back and progressing forward as more squeezing is needed. Granted that there are people that extract the toothpaste squeezing the tube from the middle, but it is universally acknowledged to be inefficient to do so, even by the very people that do it; they make a huge mess and drive other family members crazy trying to fix it all the time. The most perfect simultaneous contraction from all sides is the plutonium bomb, a situation in which great care is taken so that the inward pressure wave causes a perfectly symmetric contraction of the plutonium core. If the core contraction is not perfectly symmetric, the core squeezes out through the point of smaller pressure and the bomb does not explode, a result that would be much preferable but regrettably is not the result acceptable by the bombers. The heart squeezes as a properly used toothpaste tube, not as a collapsing air balloon that collapses upon itself from all directions at the same time, not as an exercising squeezing tennis ball, and not, which is the utmost example of a body squeezing down perfectly symmetrically from all directions, a plutonium bomb. Yet, the heart is not as good as it should be at squeezing from entrance to exit, and our invention improves the heart, directing it to go into a properly sequential squeezing. Pondering at the imperfect heart squeezing sequence it may be said that the American intelligent creator was not that intelligent after all!

[0158] One of the reasons for the lack of appreciation of this sequential contraction is that it is not perfect, as if it occurred within a well-engineered pump. Moreover, the heart is more or less hanging inside the upper torso, suspended by the blood vessels and somewhat resting on the diaphragm, as opposed to a proper peristaltic pump, fixed in relation to the machine in which it works. As a consequence of this, the heart twists and moves on all directions as it pumps, masking its sequential motion. Then, each half squeezes in ½ second, too short a time for a human being to perceive in detail. Finally, it is the opinion of the inventor that the MDs are not interested in the reasons of things, which unfortunately causes them to miss the solution to the problems their patients face.

[0159] This sequential contraction is valid for all four heart chambers: the right atrium, which has its entrance at the top and exit at the bottom, contains the initiating electrical cells at its top (the sino-atrial node), from which the electrical pulse propagates in its muscle walls from top to bottom, which is, accordingly, the sequential squeezing, as per FIGS. 7A, 7B, 7C and 7D (the figure exaggerates and distorts the situation for display purposes and because the inventor is unskilled in drawing too). The ventricle, on the other hand, has both entrance and exit ports at its top, which poses a difficult problem to solve, needing as it does, to contract from bottom to top, to force the blood to exit at the top, while the electric pulse is coming from the top! This was solved by the intelligent designer with a mechanism to arrest the electric pulse at the bottom of the atrium (else the ventricle would contract from top to bottom, where there is no exit point for the blood!), and another specialized set of cells, the atrium-ventricular node, which, upon receiving the weak electric signal that is coming down from the sino-atrial node, re-start another electric pulse, but with a few milliseconds delay, which is in turn delivered for propagation through a set of specialized fast propagating cells lining the wall between the two ventricles: the His short bundle, followed by the right and left bundles, and finally the Purkinje fibers that spread the electrical pulse throughout the bottom and sides of both ventricles. This second electric pulse, delayed from the initial pulse from the sino-atrial node, is then injected at the bottom of the ventricles, from where it propagates upwards, causing an upwards sequential contraction (in the opposite direction as the initial atrium contraction!), as required by an exit point at its top. This process of upwards contraction of the ventricle, the lower chamber, is displayed in FIGS. 8A, 8B, 8C and 8D. It works, though any respectable engineer would have made a different design, with a ventricular exit at the bottom, not at the top, therefore eliminating the His bundle, the left and right bundle and the Purkinjie fibers, which is a source of many hearts malfunctions. As any respectable engineer knows, unnecessary parts should be avoided if possible, and the bundles and the Purkinjie fibers can be made unnecessary with a better design of the heart. Looking at the heart poor desigh at least one can take solace in that this is not the worse design error of the human body - one just has to look at the brain. The left heart pumping in essentially the same, varying only in minor details, there is no need to repeat.

[0160] This said, the reader should keep in mind two important points here which is the detail on which the whole invention hinges, and which we urge the reader to pay attention and ponder on. First, that not only is the heart contraction caused by an electric pulse but also that this electrical pulse, because it relies on the propagation of heavy positive ions in a viscous medium, it propagates relatively slowly through its muscles and special fibers. The propagation of this electrical pulse is very slow as far as electric events happens, the whole process taking just below one second to complete (at a normal heart beating rate of 70 beats per minute). This means that the times involved are of the order of tens and even hundreds of milliseconds. This slow propagation time is important for our invention to work, as it will become evident in the sequel. The much faster propagation of electric charges in wires and transistors (1 million times faster), allows that a human-engineered circuit can take over the natural process and improve on it - a very interesting project indeed, just think of it!

[0161] In this main embodiment, the variation and improvement over our previous cited patents is that there are two types of electrodes (conductive and insulated electrodes, also called active and field shaping electrodes, also called type 1 and type 2 electrodes), which may also be of several shapes and sizes and possibly randomly located on the surface of the device, while still attempting to cover most of the surface with electrodes. The possible random arrangement of the electrodes functions to break the space symmetry, therefore allowing better control of the injected current, or injected electric stimulating current which may need to be asymmetric - most likely will need to be asymmetric, following the heart shape, which is asymmetric. It is to be recalled here that no asymmetric electric field lines can be achieved using a symmetric electrode array, and further, that the resulting electric field shape necessarily have the same symmetry than the symmetry of the surface shape that produces it.

[0162] The shape and size differences is not necessary for the main embodiment, which would also work with electrodes (and non-conductive field shaping surfaces) of the same shape and/or size. The invention is the same for simpler electrode arrays which may be simpler and less expensive to produce, such a choice being a matter of production / cost compromise, still under the scope of the main embodiment. For example, it is possible to control the vector injected electric current (magnitude and direction) with circular electrodes (of either type, conductive or current injecting and insulated or field shaping electrodes) that are of different sizes and randomly distributed on the surface of the Dirichlet shirt. It is also possible to control the vector injected electric current with circular electrodes (of either type), that are of the same size and randomly distributed on the surface of the Dirichlet shirt, in this more restrictive case, same shape and size but randomly distributed on the supporting surface. Or it is also possible to control the injected electric current vector with circular electrodes that are of the same shape and size and orderly distributed on the surface of the Dirichlet shirt, this being the most symmetric electrode arrangement of all. The difference between these options is simply the degree of possible variations and fine control on the vector current, and the choice between each option is based on a cost / benefit analysis, all being still within the scope of our invention. It may also be the case that the shape, size and location of the electrodes be dictated by fashion if the electrodes are visible, which depends on the technology used.

[0163] A moment of thought will show the reader that the good operation of the heart depends on the correct propagation of the electric current through the heart muscle. This latter depends on the electrical characteristics of the diverse muscles (cells) which comprise the heart, including rapidly electric propagating cells (His fibers, left and right bundles, the Purkinjie cells and more), endocardio and miocardio cells, all of which suffer individual variations from person to person, due to their genetic make-up, to which other variations accumulate during the person's lifetime, due to his exercise and eating habits, etc, to which unlucky events as small localized infarctions and heart breaking events add scar tissues with different conductivity than health cells, which then causes loss of contraction capability, all adding to a conceptually simple problem, yet of complex analytical solution due to the large numbers of factors involved. This, in turn, is the problem which our invention address: how to better adjust the 3-D electric current propagation through the heart, in order to cause the best heart squeezing sequence possible for a particular individual, given his possibilities as determined by the physical conditions of his heart.

[0164] Another way to say the same thing, is to notice that unlike a standard electrical network, on which the paths are discrete and fixed (along the wires), the electrical path for the current that produces the muscle contraction is continuous over the whole 3-D structure of the heart muscle, and some leak out of it too, part of which is measured as EKG signals on the chest. Because the former, a standard electrical network is composed of discrete, enumerable paths, the information is given as the denumerable branches and nodes, while in the latter case (the heart) the information is a continuous current vector field.

[0165] Besides selecting which electrodes are turned on or off (connected or disconnected from the electrical power), the controlling microprocessor MP1 can also select one of a plurality of electric potentials (called voltages in U.S.) to be connected to the field shaping electrodes. These voltages may vary as one out of a fixed set of available values, or may vary as a continuous of possible values within a minimum and maximum limits, depending on the design, both possibilities being covered by the invention. Varying the voltage at the field shaping electrodes, the device can adjust the electric field in the heart muscle, and therefore it can adjust the force applied on the propagating ions and ultimately the path of the electric current that is injected by the active electrodes. This offers an advantage over prior art, because out invention can better direct the electric current to the particular desirable target volume and avoid entering into undesirable volumes. Also, varying the voltage at the active electrodes, the device can adjust the current that is injected into the heart.

The Electric Field Lines

[0166] The solution to the problem of controlling the path, in direction and speed, of the moving electric ions as they propagate through the heart muscle is found with a theoretical analysis of electric current propagation within an electric field. As a side remark, this is similar to the motion of an object by gravity within the gravitational field of the planet, which is vertical towards the center of the planet -assuming a perfectly spherically symmetrical Earth. All objects, unless prevented from falling by some means, do fall down in the direction of the center of the Earth, on a straight vertical line, that is, along the gravitational field lines. The earth gravitational field is set of lines radially pointing to its center, as most of the fields in FIG. 9. But FIG. 9 also displays two gravitational field lines next to an exaggerated large mountain, which, due to its large mass tilts the gravitational field lines sideways towards the mountain. An actual large mountain does, surprisingly enough, minutely deflects the gravitational field from its “normal” direction towards the center of the earth, and in amounts that are detectable with modern equipment (see an exaggerated off-radial displacement near the mountain at FIG. 9). This, of course, happens because the mountain attracts sideways. Localized masses always deflect the otherwise vertically down gravitational field away to another direction, an effect that is used by geologists to infer what is underground. Localized oil fields under a particular spot on the surface, cause that the gravitational field at that particular spot is weaker than it would be if, instead of oil there were rock where the oil is, an effect that the geologists use to locate oil underground. The geologists use it all the time, but unfortunately the medical people have not done the same yet - time to do it now guys! Exactly the same happens with the ions as they propagate through the heart muscle, causing a cell-by-cell contraction as they move, and also, as much as the mountain does attract a mass sideways, so does an electric field created by an externally positioned set of electric charges does change the path of the electric ions.

[0167] In the following the vector F is the force acting on an electrically charged particle of charge q and mass m, the vector E is the electric field at the position of same particle, and the vector a is the acceleration of the same particle. The following is then known from elementary physics 101, if not physics 99. Also we are adding the “(vector)” to the letters that are vectors because it is not possible to use the standard boldface convention in this publication. [0168] F(vector) = q × E(vector), and [0169] F(vector) = m × a(vector)

[0170] It follows that the force F, and consequently the acceleration a, are linearly correlated and proportional in magnitude, or, in other words, the acceleration is the force multiplied by a constant: 1 /m, or the electric field E multiplied by a constant scalar q/m. From the acceleration being linearly proportional to the force F, which is, in turn, linearly proportional to the electric field E, it follows that the motion of an electrically charged particle starting from rest is a function of only the electric field lines and some scalar constants (q and m). The electric field can take more complex configurations than the gravitational field, because there are two types of electric charges (usually called positive and negative), while the gravitational field is due to only one type of gravitational charge (called mass, they all attract each other). FIGS. 10A, 10B, 10C, 10D and 10E display five types of simple electric field configurations: FIGS. 10A and 10B display two cases of field lines that are simpler to calculate, of two electric charges, in fact the configuration normally seen in introductory physics books. The field lines are the lines along which an electric charge moves if left unconstrained to move. In other words, the field lines control the flow path of the injected current. From this it follows that to shape the electric field lines is the same as to lay down the “roads” where the current will travel whenever charges are set free in the region. This notion of shaping the field lines to determine the current path is seldom used only because in most electric circuits the current (charge) is forced to follow the wires, the coils, the transistors, etc., with no place for an externally imposed electric field to have any effect. FIG. 10C shows a more complicated case with three charges. The reader is invited to observe the large change of the configuration of the field lines caused by the addition of this third charge, in particular the disappearance of the symmetry that is obvious in FIGS. 10A and 10B. FIGS. 10D and 10E display the effect of varying the value of the third charge. Again the reader is invited to ponder on the consequences of varying the values of the charges. Notice that both FIGS. 10D and 10E are asymmetric, yet the shape of the field lines is vastly different between them!

[0171] The electric field lines are distinctively unequal, very different shapes. Not displayed is also their strengths, which is also distinct, left out to simplify the figure. FIGS. 10 (A, B, C, D and E) illustrate the point of our invention: a method and a means to conform the electric field lines to the desired 3-D shape required for a most desirable electric ions path which determines the heart squeezing sequence. In fact, using the piquita of our invention, it is possible to even create a 3-D electric field which causes a better heart squeezing sequence than the sequence that happens in a normal, healthy heart, because a normal, typical, healthy heart does not actually follow the best possible sequence.

[0172] Taken together, controlling the direction and the magnitude of the current, our invention is capable of controlling the position and the magnitude of the squeezing sequence.

Introduction to the Mathematical Treatment of the Problem of the Best Electric Current Distribution Over the Heart Muscle

[0173] The uniqueness theorem of Poisson’s equation is a well known result in electrostatic. It has a few variations depending on the type of boundary conditions, but making a long story short, it states that if one has complete control of either the electric charges at all points on a closed surface, or else, if one has complete control of the electric potential at all points on a closed surface, then one has complete control on the electric field inside that closed surface. (see Reitz, Milford and Christy (1980), Jackson, (1975) or most any other introductory text in electromagnetic theory). This physical statement is related to the Dirichlet’s principle DIRICHLET (n/d) In our case the stimulating device does NOT have total control, because it would be impossible to set voltages at unconstrained values (the electric energy source / battery is rather limited on its maximum output), nor do we have access and control over some surface that completely encloses the heart (or the brain, etc.), which means that not all desired vector fields are possible. Yet, adjusting the available electric potentials (voltages) over the available surface on the device in the vicinity of the desired volume it is possible to have a certain degree of control of the current vector field over the heart volume, and consequently to have more control on the path and speed of the injected electric electric charges and better results for the patient. This is even more correct when the piquita stimulator is, as is becoming more common nowadays, a three independent stimulators, one at the top right atrium, one at the bottom of each ventricle. Our invention does not create a total control on the field lines, our invention cannot create all arbitrary field shapes, but our invention can shape the field to a better conformation than old art which offered no control of it. In fact, to the best of the knowledge of the inventors, nobody before have ever tried to control the electric field shape on the heart muscle to control the current through it. Our invention cannot solve all heart problems, particularly broken hearts cannot be solved by our invention, but our invention is a step on the right direction and our invention increases the degree of control available to improve the heart functioning.

[0174] This mathematical theory indicates that our invention works better with either a larger area supporting electrodes (which approaches a totally containing surface) and also with just a few small electrodes spread apart, as in the two- and three-electrodes of current heart pacemaking, anchored as they are, at the top of the right atrium and bottom of each ventricle.

[0175] Therefore our invention is the use of a controlled charge distribution (or voltage, which is the same, because one determines the other) over as large an area as feasible, with the objective of adjusting the electric field lines over the heart muscle so that the injected current causes a downwards moving current from the top of the atrium to the boundary between the atrium and the ventricle, then either another current through the His bundle, right and left bundles and Purkinje fibers, or else simply another starting electric current originating on another implant at the bottom of the ventricle, possible if the cardiologist decides to use a two-electrodes pacemaking system. Moreover, the surface electrodes can be of either type 1 (active) or type 2 (field shaping). The first type of electrode can be either starting or finishing points for electric current paths, while the second type of electrodes is able to bend the field lines but not able to inject charges, because it is electrically insulated (though it can act via capacitive effect, as well known to the persons versed in the field of electrical engineering). Finally, given that the times involved are very long for electronics, a typical heart period being almost a full second and its P, Q, R, S and T waves lasting from a few to 10 s milliseconds, while microsecond is easy in electronics, it is perfectly feasible to activate electrodes or either type (active or field shaping types) then turn them off sometime before the slowly moving electric current arrives at the electrode, therefore forestalling the establishing of a terminal point for a current. This can be dynamically adjusted to keep the current moving along a desired path, while never absorbing it. This selective adjusting of the ending points of an electric field line is effective in creating strong field lines with the use of electric charges near the initiation point of the current, which in turn is made to disappear as the current nears intermediate positioned electric charges, which may be substituted by other charges further along the desired path, all working as a carrot moving ahead of a running rabbit. Of course that the reverse action can be also created, of a same sign charge being introduced behind the moving current, in which case this same charge charge could be seen as akin to a whip at the back of the moving current, a horse-type incentive added to a rabbit-type one.

[0176] Two and three electrodes heart pacemakers are becoming common nowadays, and more electrodes may be used if a good reason for them is discovered, as our invention does. Even three anchored heart piquitas in three different places already open new possibilities for shaping the electric field; more than three offer even more possibilities.

Description and Operation of Alternative Embodiments

[0177] Another possible variation for the Dirichlet’s shirt is a long sleeve Dirichlet’s shirt with electrodes at one or both sleeves, for cases of pain control, similar to TENS (Transcutaneous Electrical Neural Stimulation). For home use, if and when there were no concerns about the visual impression, it could be just the sleeve too.

[0178] Another possible variation for the Dirichlet’s shirt is a wrist band adapted to electrically stimulate the nerves and muscles under it. Such a device may be useful as an adjunct to treatment of the carpal tunnel syndrome.

[0179] Another possible variation of the Dirichlet’s shirt is for dental offices. In this case the Dirichlet’s shirt would be a malleable sheet-style surface that conforms to either the full face of the patient or to part of the face of the patient, with electrodes both of the active type 140_t1 and of the field shaping type 140_t2 and/or 140_t3. The active electrodes would preferably be of the positive polarity, and the negative polarity would be connected to the needle that is ready to inject anesthetics or to the drill that is about to drill the tooth, or to the tool that is going to be used to extract a nerve, etc. With this configuration a current would flow from the metallic part that is about to cause pain (the needle, the drill, the nerve extracting tool, etc.) to the positive active electrode on the outer surface of the, through the nerve just ahead of the needle, the drill, the nerve extracting tool, etc. This electrical current would, as it is known, dampen the pain transmission at the nerve that is about to receive injury, because it is just ahead of the injuring element (the needle, the drill, the nerve extracting tool, etc.). The invention still uses field shaping electrodes for this variation, which would direct the current from the injuring element to the positive polarity active electrodes. Of course that the polarity could be reversed: positive polarity at the injuring element, and negative polarity at the active electrode. In general, all the three electrodes, type 1, type 2, and type 3 electrodes may be either positive or negative polarity, including some of each type of positive polarity and others of the same type of the complementary, negative polarity.

[0180] Another variation of the first embodiment is a soft flat surface, similar to an ordinary bed sheet, which is adapted to be folded around the heart, just over the pericardium, that is, just around the heart, which is fitted with a plurality of electrodes, some or all of which are of the field shaping type. We call this variation the Dirichlet’s pericardium cover. This variation of the main embodiment includes a battery and controlling electronics that is implanted somewhere in the patient's chest and connected to the electrodes by wires or other appropriate conducting means, similarly to any other implanted electrical stimulator. This variation is more efficient than the main embodiment in that the field shaping electrodes are closer to the intended volume where the electric field is to be maintained, but suffers from the need of surgery to implant it, also surgery to periodically replace the battery requiring another surgery, though simpler than the electrode sheet implant, because the battery would normally be located just under the patient's skin. The Dirichlets’s pericardium cover is more effective than the Dirichlet’s shirt because it is just near the heart, but the required surgery causes one to think twice (or even three or four times) before using it, in spite of it being more effective. On the other hand, in cases where the heart has to be exposed anyway, for other reasons, a Dirichlet’s pericardium cover may be appropriate. Such a Dirichlet’s pericardium cover has been developed and used in the heart of an unfortunate rabbit that was murdered for the experiment in 2014, or, as they say it, was humanly put to sleep (see LizhiXu, Igor R. Efimov et al. “3D multifunctional intergumentary membranes for spatiotemporal cardiac measurements and stimulation across the entire epicardium” Nature Comm Vol 5 Pg 3329 (March 2014 ), Colleen Clancy and Yang Xiang “Wrapped around the heart” Nature Vol 507 pg 43 (6 Mar. 2014), and Pierre Martin “Une membrane artificielle pour surveiller le coeur” La Recherche (1 Mai 2014) ). LizhiXu and others did not use field shaping electrodes; to our knowledge the use of the 140_t2 electrodes was first described by the inventor and his collaborator Chong I1 Lee (see U.S. Pat. No. 8,954,145, 10 Feb. 2015).

[0181] Another embodiment of our invention is application to DBS (Deep Brain Stimulation). In this application the objective is to disrupt the anomalous neurons firings that cause the tremor characteristic of Parkinson's disease, or of what is known as essential tremor. One of the possible solutions is to place an electrode on a chosen target area in the brain then superimpose a current of frequency around 200 Hz on it. FIG. 11 shows a brain-type stimulator we call picafina, similar in structure to prior art stimulators with 4 rings at their distal extremity ( Butson and McIntyre (2006) ) but with the equivalent electrode described for the heart piquita: field shaping and active electrodes. The objective for the Deep Brain Stimulator (DBS) is to adjust the electric field in the vicinity of the brain electric stimulator, which we call picafina or picafina-style stimulator, to the shape of the particular target volume, which could be the sub-thalamic nucleus (STN), the globus pallidus internus (GPi) or any other. Much effort has been put on the solution of this problem, the solution of which has evaded the practitioners of the art for decades - see, for example, Butson and McIntyre (2006). It can be seen at Butson and McIntyre (2006) that the best solution proposed is still a symmetric field. Such a symmetric field fail to offer a maximum electrical stimulation in any case, particularly when the electric stimulator happens to have been implanted off-center. As discussed by Butson and McIntyre (2006), this is, in fact, a most common occurrence, due to the small size of the target volumes and their location deep in the base of the brain (for DBS), which is also not directly observed by the surgeon, which inserts the electric stimulator through a one-cm diameter hole drilled at the top of the skull, from where she tries to guide the stimulator tip to the desired target. Our invention allows for more control of the electric field around the stimulator, which in turn, allows for better clinical results. More modern stimulators, e.g. the ones introduced by Sapiens Neuro (www.SapiensNeuro.com) a company that has been swallowed by Medtronic for a low price, and are capable of creating an asymmetric electric charge distribution in the target area, but fail to decouple the control of the electric field from the injection of the electric charges, therefore failing to maximize the results.

[0182] The electrodes for DBS can be of different size, of different shapes and also randomly distributed on the surface of the supporting structure or picafina, or they can be of uniform size and shape, perhaps to decrease manufacturing cost, for example, or to simplify the internal wiring, or any other reason. Given the small size of the electrodes, random shape of them is of smaller effect than their numbers, while the use of the two types of electrodes, active or type 1 electrodes and field shaping or type 2 electrodes are of major importance, given that the latter only change the electric field shape around the stimulator device. We are also introducing a type 3 electrode, which is a field shaping electrode as well, but is under the surface of the supporting structure, as opposed to be at the surface of the supporting structure.

[0183] The reader will notice that the DBS application is a natural adaptation of all that is described for the heart pacemaker, yet the DBS needs no time control of a sequential muscular contraction, so it is simpler to program and to use than the heart piquita. A multiplicity of electrodes, of variable shapes and sizes, each associated with a unique wire, which is used to select which electrode is turned on, which electrode is turned off, both for type 1 (active) and type 2 (field shaping). Likewise for the heart pacemaker, the DBS incarnation uses two types of electrodes: a first type, or active type, capable of injecting a current, and a second type, or field shaping type, which is insulated, not capable of injecting any current (though always there is a small leak current due to insulator imperfections), but which is much useful for creating the vector field around the electrode, which, in turn, determine the 3-D path for the injected current.

[0184] For DBS applications the invention has the advantage over existing devices that the field shaping electrodes are capable of keeping the electric charges injected by the active electrodes inside a much smaller volume than can be achieved today. This is very important because the Lara theory of Parkinson’s Disease predicts that the origin of the tremor characteristic of the disease is in a region much smaller than currently accepted. It is the opinion of the inventor that electrically stimulating a large volume as is done by existing electric stimulators is likely to both cause side effects (a known fact) but also likely to eventually develop self sustaining Ramon y Cajal loops. These loops are known as Hebbian loops because D. O. Hebbs is erroneously considered the proposer of the loops as the elementary units of brain activity, the site of memory and other processes. Donald Hebb wrote a beautiful and convincing prose, but he was not the first to come up with the loops. The new loops created by the injected stimulation current, in turn, may cause tremors of their own unless stopped by the use of higher voltages, which explains the known fact that often the voltages have to be increased with time for the same patient, which is considered an unavoidable type of resistance development but that the Lara theory explains as the creation of new Ramon y Cajal loops that could be avoided if the stimulated volume were smaller.

[0185] Another possible application for the invention is for appetite control. In this application there are two possibilities: electrical stimulation on the stomach, and brain stimulation at the locations which are known to control the appetite. In the former case the added electrical stimulation may be turned on before a meal, and the electrodes are selected to affect the neurons that send information to the brain regarding the current amount of food in the stomach, which in turn modulate the appetite. If the stimulation is capable to fool the brain, the individual will feel a decreased urge for food, eat less, and lose weight on the long run. This has been used in humans already. The second case, brain stimulation to control the appetite has been only used in animals so far, and with success. For stomach stimulation the shape of the stimulator should be a flat shape to conform to the curvature of the stomach and its enervations, a variation of what we call planarium. For direct brain control it may be similar to the DBS.

[0186] Another possible application is for cortical brain stimulation, in which case the stimulator has a flat shape to adjust to the cortical application. We call planarium this sheet-like deformable or flexible stimulator.

[0187] Another possible application is for pain control, an improvement of a known device known as TENS (Transcutaneous Electrical Neural Stimulation). In this application the objective is to control superficial pain, as skin pain, and it has used for deeper pain too, as muscle pain. The area (here it is really an area, the surface area of the skin in question, not what the neurologists call area, which is a volume) in question is in this case surrounded by electrodes attached to the skin, from which there is a current flow. Old art used large electrodes, which did not allow for a control of the current path. In this case our invention discloses a large number of small electrodes which are on the surface of the applied patch. Likewise the heart pacemaker, these small electrodes are numbered and individually activated by their dedicated wires which is under control of the controlling electronics, are of three types (type 1, or active, and type 2 or type 3, which are field shaping), and can likewise be turned on at any of a plurality of voltages/currents or off (zero voltage/current). With a wise selection of the active electrodes, it is possible for the medical practitioner to ameliorate the pain felt by the patient in a more effective way than currently used TENS devices. FIGS. 5A and 5B show how to control the depth of penetration of the stimulating current using the field shaping electrodes 140_t2.

[0188] The individual electrodes, which in the main embodiment may be randomly spread on the supporting structure (picafina), and are of various shapes and sizes, can be all of the same shape and/or same size, and/or can be arranged on an orderly arrangement too. In such a case the advantage of maximal symmetry breaking is not achieved, but some partial symmetry breaking is still obtained with the selection of particular electrodes as the points from which to initiate the stimulation, and the selection of other particular (insulated) electrodes from which to originate the field shaping lines. Cost and other factors could determine a simpler regular electrode arrangement. More orderly arrangements of the electrodes than the arrangement disclosed in the main embodiment, which provides maximal advantage, are still in the scope of the invention.

[0189] Persons acquainted with the art of symmetry will recognize that for very small electrodes with small spacing between each, there is little gain if compared with larger electrodes of variable shape and sizes, as particular sets of smaller electrodes can approximately create the shape of a larger electrode of any arbitrary shape. Cost and programming time may dictate one type of another of electrode, and their size and placement, while these variations are still covered in the scope of the invention.

[0190] The relative distribution of the electrodes of type 1 and type 2 (current injecting electrodes and electric field shaping electrodes, or magnitude and direction determining electrodes) is random in the main embodiment of this invention, but it is possible to alternate electrodes from type 1 to type 2, then type 1 again, etc., when the electrodes are of the same size and orderly distributed on the surface of the stimulating piquita, picafina and their variations devices.

[0191] One interesting regular pattern for the electrodes is the hexagonal pattern, which is shown in FIG. 12A, and other variations of it, as the octagonal pattern, shown in FIG. 12B. These are some two possibilities of the many, with the surrounding electrodes of the active type and the center (hexagonally shaped, octagonal shaped, etc), and the electrode of the field shaping type surrounding as needed. Other combinations are possible. It is, of course, possible to use only hexagons, because they completely fill a 2-D space. In this case type 1 and type 2 electrodes would alternate, or they could also be random. This particular electrode distribution is symmetrical, which is a departure from the main embodiment, but, given that the electrodes are small, most asymmetric shapes can be approximated. Variations of FIGS. 12A and 12B are reversing black with white electrodes (that is, reversing active and field shaping-type), or making them random, each electrode, regardless of their position, center hexagon or one of the surrounding six parallelepid, being assigned randomly to be active or field shaping. In later use, it is a computer program that determines, from mathematical calculations, which of the electrodes are on and off, in order to create the desired field shape.

[0192] Persons familiar with the art understand that the hexagonal pattern displayed at figure FIG. 12 is just one of the many possibilities. Triangular arrays square arrays, rectangular arrays, and others are possible, these being examples of arrays that completely fill the space. But the individual units do not have to even completely fill the available space, because maximal asymmetry (maximal lack of symmetry, or maximal symmetry breaking) is achieved with random distribution of electrodes.

[0193] FIG. 13 shows another interesting configuration, in which the field shaping electrodes, otherwise indicated as 140_t2, are there indicated as 140_t3, differing from the 140_t2 field shaping electrodes in that 140_t3 electrodes are buried underneath the other electrodes, both active and field shaping ones. When 140_t3 are buried, all the surface electrodes may be active, which increase the surface available from which to inject current - as there is no need to put field shaping electrodes on the surface. At the same time, the available surface for the field shaping electrodes is also larger when they (the field shaping electrodes) are buried. The subterranean or buried configuration increases the available surface for both active and field shaping type of electrodes, causing an improvement on the device over previously described field shaping electrodes.

[0194] Note that FIG. 13 displays a cut view on the yz-plane (coronal), of a picafina with axis along the y-axis. Typically there are 4-8 electrodes at a particular y-coordinate comprising an angle slightly < 90 dgs (4 electrodes) or slightly < 45 dgs (8 electrodes). In this figure 140_t1 are the active electrodes, which are the ordinary electrodes at the surface, and 140_t3 are the new subterranean passive electrodes underneath the active electrodes. 140_t3 are the new electrodes, which are electrically insulated from their surroundings, therefore incapable of injecting electric charges in their surroundings, this being why they can be under the surface, which is not the case for the normal, or active electrodes 140_t1. 140_t3 are preferably made with supercapacitor technology to maximize the electric charge on them, therefore maximizing the electric field projected in the space surrounding the picafina, which is subjected to electrical stimulation by the active electrodes 140_t1 at the surface. Passive electrodes may be at the surface of the devices, next to the active electrodes, or they may be under the active electrodes, in the configuration known as subterranean passive electrodes 140_t3, which is the one depicted here.

[0195] Another possible alternative embodiment is any device of a class of devices used for cell sample extractor or sample collectors. These devices are used for multiple purposes, their main use being, in general, to extract tissue samples from inside a living organism, say, an animal. An example is the extraction of cells at a location which is suspected to be cancerous, though this is not the only application, but an example of an application, other application being possible as well, and intended to be covered by this patent application. The reader is here reminded that a cancer cannot be confirmed by any method other than visual analysis of the cells; the site can be deemed extremely highly suspicious, perhaps 99% certainty, but the final word can only be spoken by a pathologist looking at the cells under a microscope. It follows that the medical practitioners have a need for devices that are capable of extracting cells from the inside of the body of animals for the final characterization of the potential problem, and accordingly, several of these devices are in use. Our invention, which is another alternative embodiment of the grand-mother invention, and of the mother invention in particular, offers an improvement on such devices, as described below.

[0196] The improvement offered by our fascinating invention is an added layer for pain control caused by the sample extracting device. Indeed, the reader is certainly aware that medicine taken by injection into the muscle is a pain inflicting procedure. Most likely the reader just had recently such an experience with the COVID-19 vaccine, and we are sure the reader did not like it - nobody does; we took it, we did not like it... :( Now, while the needle for a hypodermic syringe may be 200 micrometers in diameter, causing small to zero pain, the device for cell extractor cannot have such a small diameter, but are actually much, much bigger :( , perhaps 3 mm diameter, which is a 7 gauge needle used for extracting samples for breast cancer determination, a sample extractor on the larger size for breast samples, but a sampler that is used for breast cell extraction in many cases. So, dear reader, you were uncomfortable to even look at that 200 micrometers needle when the nurse approached you to apply the COVID-19 vaccine on you, so now just thing about a needle 15 times bigger, 15 times larger diameter, a needle thicker than the lead of an old style wood-type pencil, not a 0.7 mm mechanical pencil, no, these would still be easy, but the lead of an old-style wooden pencil, that big thing! Go look at the lead of one old-style wooden pencil and imagine a needle that may be even a little bigger... Mamma mia, no good, no good. This is what the poor patient has to face! Here is where our invention enters - to save him/her :), to alleviate, at least a little, the pain caused by the pain-causing instrument, A.K.A. (also known as) needle Nd for sample extractor Ex (see figure FIG. 14).

[0197] FIG. 14 is an idealized sample extractor of our invention. It omits the opening for the intake of cells, which is a necessary part of any extractor device, because there are too many different types of openings, at the distal extremity of the extractor Ex (top on FIG. 14), at the sides of the extractor Ex, both places, etc. FIG. 14 omits this detail for being immaterial to our invention, just displaying a semi-hemispherical distal end at the extractor Ex, which is intended to mean any of the existing variations of openings.

[0198] FIG. 15 is a common type of extractor Ex, which is the same general shape as a standard needle for hypodermic injections: a long cylindrical body, ending, at the distal extremity, on a slanted, elliptical cut on the cylinder, as seen in this figure. The ratio width-to-length is much exaggerated in this FIG. 15, the ration width-to-length being much smaller in any device, both for hypodermic needles and for extractors as well. It is exaggerated here for display purposes only, not intending to be realistic in proportions. There is a lumen (Lm) inside the cylindrical body, through which the liquid to be injected flows (say, the COVID vaccine, or the anesthetics), or through which the cells extracted from the possibly cancerous mass are stored when a negative pressure is applied at the distal extremity of the device, sucking in the cells in the immediate neighborhood of the distal extremity of the extractor. Not all extractors are of this shape shown at FIG. 15, just many of them are of this shape, many variations existing and in use. Our invention works for any of the variations of shape and distal extremity of the cylindrical device used as an extractor, so we will use a simplified display, as per FIG. 14, in which the details of the distal extremity are not shown and are instead displayed as a hemispherical ending - a general extractor distal extremity intended to mean any of the actual shapes in use. The reader should keep in mind that the simplified distal extremity shown in FIG. 14 is only for show, any of the actual distal extremity variations being possible to exist with our invention.

[0199] FIG. 16 displays a standard hypodermic needle HN. It is attached, at the proximal extremity of the needle, which is the lower part on the figure, to a syringe, which is the container for the fluid intended to be injected in the poor guy/gal through the hypodermic needle HN. As the reader can see, the hypodermic needle is pretty much the same as the commonly used type of extractor Ex displayed at FIG. 15. Hypodermic needle HN has diameter of the order of 200 micrometers to 400 micrometers, which diameter can be felt by thinking of a hair, which has diameters ranging from 40-100 micrometers, or a typical mechanical pencil lead, with diameter 0.7 mm = 700 micrometers.

[0200] The second supporting structure may be made from a flexible or malleable supporting structure Pat, as seem om FIGS. 1A. 1B and 1C,or it may be made from a solid, non-deformable material. In some situations it may be advantageous to cover the whole chest and abdomen with electrodes to create a most desirable electric field inside the body, to guide the electric current injected by the type 1 electrodes in the best way, as seen at FIG. 2. The electrodes themselves, 140_t1, 140_t2 and 140_t3 may be made on many different shapes, some of which are seen at FIGS. 12A and 12B.

[0201] FIG. 13 is a cut-away of a rigid supporting structure showing active, type 1 electrodes at the surface of the supporting structure and passive, type 3, field shaping electrodes underneath the surface, or underground electrodes, useful to save space on the surface of the device.

[0202] We start the physical description of our invention with FIGS. 14 and 15. The reader is here reminded that the hemispherical top at the distal extremity of the extractor Ex is a general shape intended to mean some sort of opening, which may be at the location of the hemispherical ending, as seen in FIG. 15, or at a different location, as at the sides of the extractor Ex (not shown, but known to people that work on the field, or known to persons familiar with the art, as the lawyers say in their convoluted, old language), or both. Starting from the proximal extremity of the extractor, near the syringe, at the bottom of FIG. 14, our invention is a cylindrical extractor Ex, with a lumen Lm (see FIG. 15). The needle is connected at its proximal extremity, which is the lower extremity in the figure, to a syringe (not shown), which is capable of applying a negative pressure into the lumen Lm. The cylindrical extractor Ex of our invention is open at the distal extremity, which is at the top of FIGS. 14 and 15, or at the sides of the extractor Ex, or both, from which opening the cells, possibly cancerous cells, are sucked into the lumen Lm when a negative pressure is applied to the lumen Lm. The opening is not shown in FIG. 14, but one of the incarnations of the extractor Ex is shown in FIG. 15. At the distal extremity of the extractor Ex our invention may have a needle Nd (see FIG. 14). Needle Nd may be retractable or may be fixed extending out from extractor Ex. On the sides of the cylindrical body of extractor Ex there are possibly other needles Nd which are retractable and capable of being extended out from the body of extractor Ex. Other variations of our invention use a simple opening on the side wall of extractor Ex, which could be seen as a needle which is flush with the side walls of the extractor Ex. The needle at the distal extremity of the extractor Ex may also be permanently inside the extractor Ex. Finally, the needle at the distal extremity of the extractor Ex may not be located at a line which is along the direction of the axis of the extractor Ex. If the extractor happens to have a shape similar or equal to the shape seen at FIG. 15, which is a common shape for the extractors, then needle Nd would probably be located at one of the ends of the larger diameters of the ellipse at the distal extremity of Ex, at the extremity of the device. This and other variations are implied by the simplification of using a hemispherical distal extremity for extractor Ex.

[0203] Moving up on FIG. 14 from the proximal extremity of extractor Ex, the side external walls of extractor Ex may have either openings from which injectors In terminate, and from which injectors either anesthetics may be injected in the surrounding body to further dampen the pain, or needles Nd may be extended out for the same objective of injecting anesthetics, of anesthetics may be simple expelled from the injectors just out of the extractor Ex. Injectors In are inside extractor Ex, displayed as dotted lines In. Needles Nd may be extended out from extractor Ex, or the injectors may be simply openings from which anesthetics are expelled into the body of the poor patient.

[0204] Inside the extractor Ex appropriate tubes capable of carrying the liquid anesthetics exist, shown as the vertical dotted line in FIG. 14, not marked by any name. These tubes receive the anesthetics at the proximal extremity of the extractor Ex and convey the anesthetics to either the needles Nd or to the openings at the surface of extractor Ex.

[0205] Inside the extractor Ex there are wires connected to an electrical power source, as a battery or the electrical mains, at its proximal extremity, which is the lower part of the figure. These wires (not shown) are capable of carrying the necessary electrical current for the electrodes 140_t1, 140_t2 and 140_t3 (not shown in FIG. 14). There may be perhaps a transformer and other electronic circuitry to control the current flow (not shown), external to the extractor Ex.

[0206] Needle Nd (FIG. 14) may be used to inject more anesthetics into the body of the patient, and/or may be used as a supporting structure for electrodes 140_t1, 140_t2 or 140_t3. These electrodes are used to inject electric charges into the body (140_t1), and to guide the electric charges or ions already in the body to a desirable path (140_t2 and 140_t3), near the place where pain is being caused, these electric charges having the objective of dampen the pain, as well known to be the result of electric currents from TENS devices widely used in the medical field.

[0207] FIG. 17 displays a portion of extractor Ex with an opening In, from where anesthetics can be injected around the extractor Ex or from where a needle Nd may be ejected to inject anesthetics further away from the body of Ex. It also shows a number of electrodes of type 1 and type 2 (140_t1 and 140_t2), which are capable of injecting electric charges in the neighborhood of extractor Ex (140_tl) and capable of directing the existing electric charges on any desirable path (140_t2). Controlling the electric potential at 140_t1 and 140_t2 the medical professional is able to vary the amount of current injected into the poor patient (with 140_t1) and also to control the path and speed of the electric currents (with 140_t2). The electrodes 140_t1, 140_t2, and 140_t3 may be positioned at the surface (or below the surface in the case of 140_t3) of extractor Ex and also at the surface (or below the surface) of the needle(s) Nd.

[0208] Our invention uses a well known method of electrical current to fool the afferent neurons, which are the neurons that bring up the brain the information from the sensor detecting parts of our bodies. Some of these sensing neurons bring the sensation of pain, and, as is for a long time well-known, all these neurons work with electrical currents - just look at the Galvani experiments briefly described at the beginning of this patent application, or better, go to a good book for more details than the brief words I laid down up in this document.

[0209] We call the extractor Ex and needle(s) Nd as first supporting devices or rigid penetrating devices. These are devices to either inject anesthetics into the body or to extract tissues for later examination, perhaps for the confirmation or not of cancer or any other medical condition. These first supporting devices, or rigid penetrating devices, are also capable of supporting electrodes of all three types (1, 2 and 3).

[0210] This variation of the earlier invention intended for dental applications is also compatible with a second supporting device that is capable of keeping in place a number of electrodes capable of both injecting electric current into the body of the poor patient (140_t1) and/or to create an electric field E, that is capable of controlling the speed and direction of motion of these injected charges or any other electric ion already inside the body. In the case of application for a breast cancer inspection, this second supporting device may have the shape of a conical device that conforms to the shape of a female breast. But it is intended that applications to the breast is only an example, the same method and device being capable of being used on other organs, in which case the shape of the second supporting device may differ from a conical structure.

[0211] Still another variation of the invention, is a variation of the last incarnation of it, of the mother patent to this one, patent application number 17/501,291, filed on 2021-10-14, titled “Device and means to ameliorate discomfort and pain during breast cancer biopsies and similar procedures”, currently allowed, same inventors as this one. This daughter patent application describes a method and a means to decrease the pain and discomfort associated with the colonoscopy, instead of cancer biopsies, as the mother application does. The mother invention / patent application describes a rigid penetrating device, used for either injecting anesthetics or for extracting samples for later examination, as for pathology examination to determine the existence of cancerous tissues. This daughter invention / patent application describes a flexible penetrating device, used for inspections of the inside of the body of animals and other things, either via a natural orifice, as the anus, or via an opening made by a surgeon, as for laparoscopy. The mother patent application, describes a rigid penetrating device, this daughter patent application describes a flexible penetrating device. The penetrating device does not have to be rigid, as limited by the mother application, there existing flexible devices which are capable of being inserted inside a body cavity but for other purposes, different than the purposes of the rigid penetrating devices described in the mother application 17/501,291. Another possible use is to make inspections inside any mostly closed volume, as a gas tank, or a building piping system, etc. We will here use an application for medical use, and even more focused, an application for colonoscopy, it being understood that the same principles used for the particular embodiment described (colonoscopy) are used for the also medical purpose of examining the oesophagus, or the stomach, or the bladder, or any other organ via a natural orifice. Other obvious variations are, for example, the use of a fiber optic device with most of the characteristics of the colonoscope, but which is inserted in the animal via an incision, or hole, made on the animal by a medical person, e.g., an orifice on the abdomen to inspect some or all the organs in the abdomen, including for making surgeries with a small incision. There are also applications on non animated objects, non-medical applications, as to inspect mostly closed volumes, as an automobile gas tank, or a long building piping system and similar devices.

[0212] FIG. 18 is a schematic view of the device of our invention. FIG. 18 displays the device of our invention as it looks if inserted into a colon via the anus, for a colonoscopy. At the right the anus orifice (AN) is indicated, next to the proximal extremity (PE), which is the extremity of the device that is proximal to the medical person, then there is a generic reference to any of many possible tubing (TU), which, for the colonoscope, can be any or all or more of the following: a tube to bring water into the intestine, a tube to bring some other liquid into the intestine, a tube to bring either air, or nitrogen, or CO2, or any other gas into the intestine, or a tube to extract something from the intestine, or a tool to cut out a polyp, etc. There is also a generic reference ITC (Image Transfer Cable), which can be either a number of optical fibers, perhaps 10,000 or 100,000 of them, perhaps arranged on a pattern known as a coherent fiber bundle, which takes the image from the end, or distal extremity, to the outside, or proximal extremity, pixel-by-pixel, or pixelized image, or it can be a smaller number of electrical wires, which are connected to a CCD or similar pixelized detector, capable of capturing an image at the distal extremity of the colonoscope, then coveying an electric signal to form the image to the outside of the intestine, the particular method being irrelevant for the invention, all being well known in the field, all being used by different devices. Then there is indicated the distal extremity of the colonoscope (DE) and the image capture element (ICE), this latter being either the ending of the 10,000 or 100,000, etc. optical fibers, or being a CCD element, either way is possible and compatible with our amazing invention. The image capture element ICE may be also located on the side walls, or lateral surfaces, of the flexible penetrating device, and there may exist more than one image capture element on the side walls, or lateral surfaces of the flexible penetrating device. The images of the interior of the animal, that is, the images of the intestines for the case of colonoscopy used for the main embodiment, are different, depending on they being taken looking forward at the distal extremity of the flexible penetrating device, or being taken looking to the sides of the flexible penetrating device, from different points on the flexible penetrating device.

[0213] The colonoscope, which is the application for the main embodiment of our invention, is a flexible tube adapted to be inserted into the large intestine, from the anus, up the last third of the large intestine, which is medically known as the descending colon, then around horizontally along what is medically known as the transverse colon, which is roughly horizontal when the animal is a human being that is standing, then down vertically, along what is medically known as the ascending colon, to the end of the large intestine, where the narrower, small intestine ends, and drops the mostly/partly digested matter into the large intestine. Currently used colonoscopes are designed to visually examine only the large intestine, or the end of the food processing system: up, then horizontally, then down. There are two technologies to bring to the outside of the animal an image of the inside of the large intestine: (1) a particular type of fiber optic cable bundle, generally known in the trade as coherent bundle, and (2) a CCD or similar type of electronic image forming element, similar to the ones inside any digital camera, the image captured by it being taken out as an electronic signal via a copper wire, though, in principle, the electronic signal could be transformed into a digital optical signal then be taken out via an optical fiber. We are not going to describe these two technologies, because it is outside of the invention, and our invention works with both technologies, and finally, their descriptions are readily available and well known. We are not going to specify which is the technology used for the particular incarnation we will use, because our invention works for both types of technologies to bring the image out, so it does not matter for this invention. Besides the means to take the image out from the distal extremity of the colonoscope, the colonoscopy has also a few surgical instruments adapted to cut and take out what is known as polyps, a pipe to through water inside, if needed, and perhaps a few more things, which do not matter for our invention. The whole tube is more-or-less flexible, at least enough to bend at the curves made by the large intestine, so that the colonoscope can advance past the intestine bends.

[0214] Colonoscopies are considered to be painful enough that the subject, say, a human, is under general anesthesia for most procedures, a procedure defined by the Mayo Clinic as “... [it] means being put in a sleep-like state during surgery so that you don't feel any pain.”

[0215] (https://www•mayodinic•org/tests-procedures/anesthesia/about/pac-20384568, assessed 2022-09-19)

[0216] A small number of patients elect to receive only enough anesthetics to be mostly pain-free, but still awake, feeling something that is, depending on the patient, described as a smal-to-high discomfort, to a bearable pain. One of the inventors (SLPM) have done this many times. A still smaller number of patients elect to receive no anesthetics at all. One of the inventors (SLPM) have elected this as well, but as SLPM gets older and older, it becomes more difficult to do it with no anesthetics at all. Only the last third part of the procedure, when the colonoscope turns down, at the end of the horizontal section, going down along the part medically known as the ascending colon, there is a deep pain; from there on it becomes hard, really hard to bear it. With a little anesthetics, it is possible to stay awake while having only a discomfort, not pain. Patients undergoing colonoscopies would be wiser to elect to stay awake, both because there are deaths due to the deep anesthetics, few deaths but they do occur, and, above all, because it is extremely interesting to observe one’s own colon - I love it!

[0217] This patent application is a method and a means to decrease the pain and discomfort associated with the colonoscopy, which is performed with a flexible, long tube, or flexible penetrating device - and, it is implied, to other similar medical procedures, as examination of the oesophagus, stomach, etc., which use a flexible penetrating long tube as well. Similarly to the mother application, which describes a hard penetrating device used for several objectives, among them to obtain samples for pathology for cancer confirmation, this similar device also describes the use of the three types of electrodes, called type 1, type 2 and type 3 electrodes, referred on the drawings as 140_t1, 140_t2 and 140_t3. Type 1 electrodes are the old type electrodes, adapted to inject electric charges into the body of the animal for a variety of purposes, among them, to alleviate the sensation of pain, as it is done in TENS, while type 2 and type 3 electrodes are insulated electrodes which have the function of projecting an electric field on the surroundings of the electrodes, which electric field then apply a force on the electric charges injected by the type 1 (or active) electrodes, coaxing them electric charges to follow a desired path or trajectory, which, in the case here, is the direction towards the afferent neurons, with the objective of blocking them afferent neurons from sending the pain information to the brain. The injected electric charges become propagating charges inside the muscle, or flesh, etc. of the animal, the direction of which may be controlled by the electric potential created by the type 2 and type 3 electrodes, as explained elsewhere in this document.

[0218] The reader is here requested to read again the section “the electric field lines” above, to better understand the effect and use of the field shaping electrodes 140_t2 and 140_t3. These field shaping electrodes enter in our invention to force the electric charges (or ions) to follow a desired, chosen path, which is the path towards the afferent neurons, with the objective of fooling them and either preventing, or at least in ameliorating the feeling of pain. The field shaping electrodes 140_t2 and 140_t3 have an effect on the injected charges, to force them towards the information transfering neurons, blocking the transfer of information of pain to the brain. It is, as said above, a variation of what the geologists use to determine the presence of an oil field underground. In this latter case the oil field causing a smaller gravitational field on the ground above an oil field, because the mass density of the oil underground is smaller than the mass density of typical rocks, causing a smaller gravitational field, which the geologists measure, notice, and say: “ah, the gravitational field is smaller here; there ought to be oil under, let us dig right here!”. Contrary to the geologists, we do not simply measure the gravitational field (electrical field in our case), but go further and create the field to suit our objectives. The geologist’s analogy is cited here not for being exactly the same - it is not - but simply to point out to the reader that the situation is an old one, which is used all over the place. Go up there and read it again.

[0219] In the case of the case of the mother patent (and grand-mother patent as well), the pain is caused by a poking device, which is the large “needle” used to extract the tissues for pathology (for the mother patent) and the much smaller needle to inject anesthetics onto the mouth prior to a dental procedure (grand-mother application). In the case of this patent, the pain-inflicting agent or device is the tube inserted into the intestine. For the case here, for the colonoscopy, the objective is more difficult to achieve, because the afferent neurons are far from the colonoscope itself, there being no pain-sensing neurons in the inner lining of the intestine. In the case of this patent application, the type 2 and type 3 electrodes are more important then for the case of the mother and grand-mother patents, because the injected electric charges need to be forced farther from the pain-inflicting device than it is the case for the mother and grand-mother application, that is, for the case of the breast sampling device extracting samples for pathology, and for the case of the pain caused by the needle injecting anesthetics for dental work, both cases having the afferent neurons much closer to the electric current source than is the case for colonoscopy.

Conclusion, Ramifications, and Scope of Invention

[0220] Another way to see the control of the paths of the current in the heart, or the extent of electrical stimulation in brain DBS, etc., is to look at the active electrodes determining the magnitude (and also the direction in a limited way too, because the active electrodes also contribute to the electric field vector) and the field shaping electrodes determining the direction and speed only of the current injected by the former, active electrodes. In this view one considers the stimulating current as a vector which follows the electric field lines.

[0221] Other options are possible for the marker 140-tm that indicates the angular position of the piquita as implanted. For example, all the electrodes may have enough X-ray opacity to show in the fluoroscopic images taken during the heart pacemaker implantation. Or one or more or the anchoring arms 131 may be smaller (or larger), or each anchoring arm may be of a different length and/or diameter, to allow their identification.

[0222] The main embodiment for heart stimulation uses a simple version of stimulation, which is fixed and continuous, of the type of the old heart pacemakers. It is possible to have stimulation on demand too, as many current pacemakers have, which is based, for example, on activating the stimulation only when the natural pacemaker becomes insufficient, or stops, or becomes erratic. This is called stimulation on demand, easily incorporated in our invention that already contains a microprocessor capable of implementing such decisions. Such extensions are part of the current art of heart pacemakers and may or may not be incorporated in our invention. Our invention is independent of stimulation on demand.

[0223] Other variations and modifications are possible for neural electrical stimulation at the head (brain), as for DBS, etc., where it is advantageous to have field shaping electrodes near the holes drilled to insert the implant (burr hole for DBS, etc.), on one or both sides of the skull and on one or both sides of the dura matter. Field shaping electrodes should also exist on the connecting wires that lead to the electrodes (if any) or on the surface of the picafina (the approximately 1.5 mm diameter cylindrical stiff support that is inserted in the brain from the burr hole at the top of the skull for DBS, etc.) field shaping electrodes may also be placed underneath the active electrodes, and these field shaping electrodes underneath the active electrodes are called from now on subterranean field shaping electrodes. The subterranean field shaping electrodes are electrically insulated from the active electrodes. Such subterranean field shaping electrodes being independently connected to the electrical energy source, they can be at a higher or lower electrical potential than the active electrodes on top of them, besides holding a much larger electric charge for the same value of applied electric potential, if made with supercapacitor technology.

[0224] Another variation that can be made is to consider that the influence of the field shaping electrodes 140-t2 on the electric field is proportional to the electric charge accumulated on them. This electric charge accumulated on the electrodes 140-t2, in turn, can be increased if the field shaping electrodes are constructed to increase the electric charge accumulated on them. The accumulated electric charge on the field shaping electrodes 140-t2 can be vastly increased by constructing them as capacitors, and, more precisely, with the technology used for the super-capacitors. This is easy to do with existing technology used for printed circuits and micro-fabrication, and is actually a well developed branch of electronics today, where capacitors of several Farads have been manufactured.

[0225] For the non-technical reader, the large capacitance can be a consequence of several factors, one of which is a larger surface area of the electrode. The surface, and not the volume, is the figure of merit here, because freely moving electric charges on a conducting body always stay at the surface of the body - in order to maximize the distance between them: just make a drawing and think where the electric charges will go once set free in the body (they are doing their best to stay away from each other), then keep in mind that your discovery, if you did not knew it already is mathematically described and predicted by Gauss’ law that says that the electric field inside the volume of an electric conductor is always zero. This is a known fact in the trade, part of the first courses in the electricity part of physics. This is so because the accumulated charges, being as they are by necessity of the same sign, are necessarily repelling each other, so they prevent more charge from coming in their vicinity. Consequently, the surface area is larger, then a larger amount of charge can fit in, so to say. Supercaps are conducting bodies with extremely large porosity, which increases the total surface area. An example for the non-initiated is a 2-D variation: a labirynth, of the type seen in puzzles, where one must find a path from a entrance starting point to a finish exit, has a much longer wall length than a simple hallway leading from the entrance to the exit! Well, the surface area of a 3-D body is the same situation of the labyrinth, just in 3-D, where, as the dimension increased from 2 to 3, what is the wall length in 2-D becomes a surface area in the 3-D case. Ultimately the porous surface of the supercap can store more electric charges than a box-like electrode, and then, because the electric field is dependent of the total accumulated charge (and not on the electric potential, a.k.a. Voltage in U.S.), the electric field created by the supercap is stronger, in magnitude, than the equivalent electric field created by a box-like field shaping electrode for the same electric potential (voltage as it is known in U.S.). The battery can set the electric potential (say 2 V), and for the same electric potential there is more charge on the supercap electrode (porous construction) then in the box-like electrode.

[0226] More variations can be conceived if one considers that if the general method of the field shaping electrodes is to have electric charges at widely separated positions, and preferably close to the point of interest, then each one have a large different contribution from the others, because each of which contribute for the electric field in the heart muscle (miocardium) from different directions. While the active electrodes are turned off after the stimulating pulse is injected, the same is not true for the field shaping electrodes, which continue on. It follows that the wires that connect the battery/controlling electronics to the field shaping electrodes anchored in the heart wall stay on, which in turn means that they hold distributed electric charges (this can be seen as a capacitance). Since the wire capacitance is small, the actual charge distributed along their length is small, as given by the equation that describes the relationship between the applied electric potential (voltage), the capacitance and the charge:

$\text{Q}\text{=}\text{C}\cdot \text{V,}$

so, for a fixed V, a small capacitance means a small charge. Then, because the electric field is directly proportional to the charge Q, it follows that the influence of the wire is small, given that the charge on them is small. A supercapacitor, on the other hand, increasing C also increases Q and therefore the effect on the electric field, this being the reason for the several supercapacitors placed at several locations along the wires leading to the stimulators.

[0227] Each of these supercapacitors should be controlled individually by the controlling electronics, perhaps by a dedicated wire, perhaps by using a digital addressing system to select them. With these supercapacitors, larger charges can be stored at their positions and consequently a larger influence can be caused on the value (magnitude and direction) of the electric field E at the heart walls (miocardium).

[0228] These wires or cables are the wires normally used for the implant. They ran from the subclavian vein (where they are inserted) down the blood vessel system to at least the upper part of the right atrium (C1), or to this and also, with a separate wire C2, to the right ventricle, as in CRT (Cardiac Resynchronization Therapy), or to these and to the left ventrivle (not shown) also in cardiac resynchronization therapy. The position of these wires is relatively fixed, in the sense that the cardiologist have virtually no control on their positions. More wires can be introduced, either from other veins, or using surgery. Using surgery, perhaps laparoscopy (less invasive surgery via small holes) more wires and field-creating supercaps can be placed near the heart at other locations than the wires coming from the subclavian vein.

[0229] In any of these cases, it may be more advantageous to use another, separate and larger supercapacitor SC_energy (not shown), capable of storing enough charge for one or a few days of operation, that is, enough charge for one or a few days of field shaping electrode functioning. SC_energy could then be recharged at night using a pair of coils, one acting as an emitting antenna outside the chest, the other acting as a receiving antenna inside the body, which would then be rectified and manipulated by electronics as needed to keep SC_energy charged for the next day or days.

[0230] One skilled in the relevant art, however, will readily recognize that the invention can be practiced without one or more of the specific details, or with other methods, etc. In other instances, well known structures or operations are not shown in detail to avoid obscuring the features of the invention. For example, the details of the wiring can be realized in several different ways, as coiled wires, as printed circuit wires, etc., many or most of which are compatible with the invention, and therefore the details of these, and other details are not included in this patent disclosure. The invention also requires electronic circuits to adjust the electric potentials to the desired values (or to adjust the “voltage” as it is said in USA), which electronic circuits are not included in this patent application because these are well known in the art of electronics. These electric potential (“voltages”) adjustments can be made with potentiometers and the like, using hardware, or they can be done at a distance using radio waves or other waves, for example using blue-tooth technology (no pun intended) etc., all well known variations that are not disclosed for being well known in the art.

References

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