Method and system for monitoring internal body disorders by detecting and analyzing tissue frequencies - Patents.com

Abstract

The method for determining and treating a patient's diseased tissue induces an energy signal generation from the diseased tissue. An energy sensor structure obtains an energy signal from the patient's tissue. The obtained energy signal is compared in a processor circuit with a known energy signal of the same tissue under normal function of the tissue. If the comparing step determines that the obtained energy signal is different from the known energy signal, the tissue is identified as diseased tissue. The diseased tissue is localized in the patient via the energy signal. A physical disability caused by the localized diseased tissue is diagnosed by an AI module. The physical disability is then treated.

Description

[Technical field]

[0001] This application is a PCT application claiming priority to US17 / 667,695, filed February 9, 2022, which is a continuation-in-part of U.S. patent application Ser. No. 17 / 338,876, filed June 4, 2021.

[0002] The present invention relates to a system and method for monitoring internal disorders by detecting and analyzing tissue frequencies, thus providing information for the treatment of the physical disorders. [Background technology]

[0003] Many physical illnesses only manifest in their most severe form when symptoms appear. For example, many internal disorders, such as endometriosis, intestinal obstructions, possible tumors, etc., require the use of endoscopic or laparoscopic techniques to locate and diagnose the disorder so that it can be subsequently treated, for example, by surgery. These techniques are invasive and expensive, requiring the patient to be treated in a hospital setting or other medical facility.

[0004] Early disease detection has traditionally been associated with the ability to often cure, or at least limit the progression to more serious complications requiring invasive treatment. Being able to diagnose more subtle forms of the disease is a clear advantage.

[0005] Therefore, there is a need to provide a novel method and home-based system for non-invasively identifying and determining the specific location and progression of an internal disorder by monitoring specific frequencies resulting from the disordered tissue, analyzing the frequency data, and transmitting the analyzed data for use in treating the physical disorder. Summary of the Invention

[0006] The object of the present invention is to meet the above mentioned need. According to the principles of the present embodiment, this object is obtained by a method for determining and treating a diseased tissue of a patient, which induces (induces) an energy signal generation from the diseased tissue. An energy detection sensor structure obtains an energy signal from the patient's tissue. The obtained energy signal is compared in a processor circuit with a known energy signal of the same tissue under normal functioning of the tissue. If the comparing step determines that the obtained energy signal is different from the known energy signal, the tissue is identified as diseased tissue. The diseased tissue is localized in the patient via the energy signal. A physical disorder caused by the localized diseased tissue is diagnosed by an artificial intelligence (AI) module. The physical disorder is then treated.

[0007] Other objects, features and characteristics of the present invention, as well as its method of operation and function of related elements of construction, combination of parts, and economy of manufacture, will become more apparent from a consideration of the following detailed description and the appended claims, all of which form a part hereof, when taken in conjunction with the accompanying drawings.

[0008] The present invention will be better understood from the following detailed description of preferred embodiments thereof, illustrated in conjunction with the accompanying drawings, in which like reference numerals refer to like parts, and in which: [Brief description of the drawings]

[0009] [Figure 1] 1 is a block diagram of a diseased tissue monitoring system provided in accordance with a first embodiment of the present invention; [Diagram 2] FIG. 2 is a block diagram of a diseased tissue monitoring system provided in accordance with a second embodiment of the present invention. [Diagram 3] FIG. 1 illustrates an embodiment of the system in which electrodes are attached to the abdomen of a patient. [Figure 4] FIG. 2 is a plan view of an electrode grid for use in the system of FIG. 1. [Diagram 5]2 is a plan view of an electrode slide structure having an electrode movable in a slot for use in the system of FIG. 1. [Figure 6] FIG. 2 is a flow diagram of steps of a method of an embodiment. [Figure 7] FIG. 1 is a plan view of a medical skin patch incorporating an integrated circuit containing the components of the system. [Figure 8] FIG. 1 is a perspective view of another embodiment of a system provided in accordance with the principles of the present invention shown inserted into the stomach with electrodes and treatment delivery structure engaging damaged tissue in the stomach. [Figure 9] FIG. 9 is an enlarged side view of the distal end of an embodiment of the system of FIG. 8. [Figure 10] FIG. 4 is a flow diagram of steps of another method of an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Referring to FIG. 1, there is shown an embodiment of a disordered tissue monitoring system, generally designated 10, for monitoring and diagnosing disorders within the body. The system 10 includes an energy detection sensor structure in the form of an electrode structure preferably including at least two (preferably three) electrodes 12, each of which is preferably a silver-silver chloride electrode connected via an electrode connector 13 to an instrumentation amplifier 14 that provides a first gain stage for the electrode electrical signal 16. A filter structure 18 provides high-pass and low-pass filtering of the signal 16. The filter structure 18 may include analog (hardware) or digital (software) high-pass and low-pass filters, or a combination of analog and digital filters. The amplifier 14 and filter structure 18 may be combined into a signal conditioner.

[0011] The electrical signal 16 is also passed to a 16-bit A / D converter 20. The digitized electrode electrical signal 16', including the frequency signal and the intensity of the frequency signal, is then passed to a transmitter 22, which wirelessly transfers the data (e.g., signal 16') to an external portable handheld device 24 (such as a conventional smart phone, tablet, laptop, etc.) or to a network 30. Once transmitted to the portable device 24, the data is received by a receiver 28 of the portable device 24. In an embodiment, the electrodes 12 are provided on the outside of a portable unit 25, which may be considered a substrate or housing. A power source 26, such as a battery, powers the unit 25.

[0012] The portable device 24 may be considered as a processing device that may also communicate in a wireless manner with a network 30 via a transmitter 32 of the portable device 24. The network 30 may include at least one of a telecommunications network, such as a computer network (e.g., a LAN or WAN), the Internet, a cloud-based server, and a telephone network.

[0013] The portable device 24 may include an application (APP) 40 executed by a microprocessor circuit 42 that may analyze the raw data (e.g., signal 16 including at least the frequency and strength of the frequency data) received from the transmitter 22 and provide treatment data including the identification, severity, location and progression of the patient's physical impairment based on the raw data. The treatment data may be stored on the network 30, shared or obtained via the network 30, or stored in a memory circuit 35 of the portable device 24. The portable device 24 may also receive data from the network 30 via the receiver 28.

[0014] The transmitter 22 may take the form of a transceiver to receive data from the portable device 24. For example, the portable device 24 may transmit a calibration signal 37 to the transceiver 22 that can be received by the amplifier 14 for calibration purposes to determine whether the system 10 is performing within specifications.

[0015] Referring to FIG. 2, there is shown a second embodiment of a monitoring system for diagnosing internal disorders, generally designated 10'. The system 10' includes an energy detection sensor structure in the form of a single sensor structure 11 (which may include at least two or more miniaturized electrodes) disposed within a portable unit 25' and connected to a microprocessor circuit 44. The microprocessor circuit 44 is provided within the unit 25' and configured and arranged to convert an analog electrical signal 16 into a digitized electrical signal 16' including a frequency signal and an intensity of the frequency signal. In this embodiment, the microprocessor circuit 44 includes an amplifier circuit 46 configured and arranged to amplify the analog electrical signal 16, a filter circuit 48 configured and arranged to filter the amplified analog electrical signal, and an A / D conversion circuit 50 configured and arranged to convert the amplified and filtered analog electrical signal into a digitized electrical signal 16'. The filter structure 48 preferably includes digital high-pass and low-pass filters because digital filters can be made much more accurately than analog filters and do not suffer from the same analog component tolerances that lead to less than ideal performance when equipment is changed and over time. Analog components can be manually selected so that only ideal components are used, but this can add significant cost and increase the final price to the physician, and these components are still subject to environmental stresses and damage over time that can impair accuracy. The microprocessor circuit 44 includes an artificial intelligence (AI) module 49 configured to execute at least one algorithm for 42 that can analyze the raw data (e.g., signal 16' including at least the frequency and intensity of the frequency data) and provide treatment data including identification, severity, location and / or propagation (growth, spread) of the patient's physical disorder based on the raw data.The localization and propagation data can be obtained using the AI ​​module 49 by utilizing conventional triangulation and / or trilateration techniques based on frequency and intensity data obtained by an energy directing sensor structure (e.g., at least two electrodes), as described further below. Alternatively, the AI ​​module 49 can be part of the APP 40 in the device 24.

[0016] The AI ​​module 49 is preferably configured to provide a diagnosis of a suspected disability due to a diseased tissue. An initial (first level) software analysis is performed by the AI ​​module 49 using a 100% sensitivity marker equation. If the patient tests negative for having a disability (e.g., endometriosis as described below) using the 100% sensitivity marker equation, the patient is no longer considered to have a disability. If the patient passes the first level of analysis, the programming in the AI ​​module 49 moves to the next memory level (second level) to check different equations to ensure there are no false negatives. If no false negatives are determined, the patient is considered to have a disability (e.g., endometriosis).

[0017] The AI ​​module includes a third level, which is a more sophisticated level in which the software is given the ability to find answers not determined by the algorithms of the first and second levels. The memory circuit 51 includes an additional database of information (e.g., patient's age, symptoms) that the software can access. Such information may include any information that plays a role in the diagnosis or at least in the predictability of the disability. Information that is considered to be of a high statistical level of predictability should be examined in this third level program. Thus, in this third level of analysis, the AI ​​module is configured to search for information in the memory circuit 51 to result in the largest number of variables (information) that result in the highest probability level of a positive diagnosis of the disability.

[0018] It should be noted that there are other ways to predict the presence of a suspicious condition. One of these ways is the use of a patient questionnaire. The AI ​​module 49 can be configured to have a fourth level of analysis (self-aware AI). The programming in the AI ​​module 49 may be configured to be able to ask additional questions that help to confirm the diagnosis. For example, the AI ​​module 49 may query the patient (e.g., via the APP 40) using a broad but subjective questionnaire. Thus, the programming in the AI ​​module 49 may decide to include the probability of known questionnaire answers to achieve maximum predictability of the physical condition. The system can be a wearable device (see FIG. 7) that interfaces with a server in the network 30, so that data from around the world can be collected daily from millions of patients. The AI ​​module 49 can access and analyze data from around the world, and the programming in the AI ​​module 49 is configured to be able to "think outside the box" on the most important parameters and develop its own internal algorithms to evolve its own hierarchy to maximize the diagnosis.

[0019] A transmitter 22 is provided in the unit 25' and is constructed and arranged to transmit the treatment data described above in a wireless manner to the portable device 24 and / or to the network 30. A power supply 26 is provided for powering the device 10'.

[0020] The gain in the preferred embodiment of the system 10, 10' is fixed and is set according to the maximum normally expected peak-to-peak signal 16. The 16-bit A / D converter 20, 50 provides sufficient resolution to adequately process lower level signals, such as those that may be recorded from a person with a significant amount of adipose tissue between the electrodes 12 when placed in direct contact with the skin surface, stomach or other adipose tissue. Of course, the gain may be made controllable via analog control at additional cost, or via digital control.

[0021] The use of wireless transmitter 22 for data communication with portable device 24 and / or network or computer 30 eliminates the need for cumbersome cables and complicated interfaces, each of which clearly presents the possibility of intermittent or total failure that can degrade system performance. Resulting treatment data may be transmitted wirelessly to network 30 or portable device 24, for example, via cellular signals, Bluetooth, or WIFI. Memory circuits 35 or 51 each provide sufficient on-board memory to store an entire test's worth of data for later transmission to network 30.

[0022] The applicant has found that when an internal disorder is present in the body, the nerves of the tissue causing the disorder emit a specific energy (e.g., frequency), defining a "fingerprint" of the specific tissue disorder compared to normal such tissue. The normal functioning of tissues and processes in the human body is related to organs. Specialized tissues and cells that act as regulators are responsible for what is known as internal control or homeostasis. The detection of normal tissue frequencies that represent normal homeostasis is useful in determining the difference between health and disease. Disease occurs when it causes a disturbance of the normal controller or homeostasis that can be seen as an alteration in energy or energy patterns, which represents the underlying disease and symptoms. Thus, the disordered tissue can be a non-normal or diseased tissue.

[0023] For example, endometriosis is a condition where tissue breaks out of the uterus, causing nervous system problems and pain. The applicant has found that when sensing endometriosis, the endometriotic tissue is not directly sensed. However, the effect of endometriotic tissue on the energy of the body can be sensed. Endometriotic tissue secretes neurotransmitters that increase the frequency of small intestine contractions. The uterus in normal conditions gives off energy in the frequency range of 1 cpm to 3 cpm, except during menstruation, where the frequency range is 4 cpm to 8 cpm. It has been determined that the energy effect of the broken out (disordered or non-normal) tissue is detectable in the frequency range of 12 cpm to 60 cpm (cycles per minute), more specifically in the frequency range of 12 cpm to 22 cpm near the proximal duodenum and in the frequency range of 30 cpm to 60 cpm near the distal duodenum.

[0024] As another example, the normal state of the intestine radiates energy in the frequency range of 3 cpm to 15 cpm, depending on the location in the intestine. It has been determined that intestinal spasms or blockages due to scar tissue (diseased or non-normal tissue) can be detected in the frequency range of 180 cpm to 200 cpm near the distal ileum, and in the frequency range of 50 cpm to 70 cpm near the small intestine. In a further example, urethral obstruction can be detected. The normal frequency for urethral tissue that passes urine is 7 cpm. Applicant has found that frequencies of at least 18 cpm and above are indicative of damaged or non-normal urethral tissue.

[0025] Thus, the filter structures 18, 48 of the systems 10 and 10', respectively, may be configured to detect frequency ranges known to define the "fingerprint" of any physical impairment.

[0026] To detect endometriosis, the filter structure 18, 48 is selected such that the high pass and low pass filters allow detection of frequencies in the range of 12 cpm to 60 cpm. To detect bowel obstruction, the filter structure 18, 48 is selected such that the high pass and low pass filters allow detection of frequencies in the range of 180 cpm to 200 cpm or in the range of 50 cpm to 70 cpm depending on the location of the detection target. To detect urethral obstruction, the filter structure 18, 48 is selected such that the high pass and low pass filters allow detection of frequencies in the range of 15 cpm to 25 cpm. These filters are typically both second order, although higher order digital filters may be implemented. An optional second digital filter may be implemented in software (computer readable medium) to achieve the desired band pass filtering of the signal 16' prior to software analysis with high pass and / or low pass functions. This approach also provides great flexibility in the system to change the specific frequency ranges in the digital filters to focus on specific physical disorders.

[0027] Because the system 10, 10' can be utilized to locate any internal tissue disorder that produces an energy "fingerprint," it is preferable that the electrodes 12 or sensor structures 11 are 1) capable of sensing a large area of ​​a body part, 2) movable relative to each other and to the patient tissue they contact or are adjacent to, or 3) fixed on a grid that is movable relative to the patient tissue they contact or are adjacent to.

[0028] Referring to FIG. 3, the system 10, 10' is shown utilizing an energy detection sensor structure in the form of a plurality of electrodes 12 (preferably at least three) attached in contact with or in close proximity to the body surface of the patient P. Each electrode 12 has a sensing area S that defines an overall sensing area (cross-hatched at A). The sensing areas S overlap in the double cross-hatched area O, whereby the AI ​​module 49 of the microprocessor circuit 42 or 44 can determine the severity, location and / or propagation (movement or change) of the damaged tissue in three dimensions from at least two, preferably at least three electrodes 12, utilizing triangulation and / or trilateration of the electrode signals when the strongest frequency signal (signal strength) is obtained. When the electrodes 12 are external to the unit 25, the electrical connection 41 of each electrode 12 can be connected to the electrode connector 13 (FIG. 1) of the unit 25. The electrodes 12 are preferably disposable. Although multiple overlapping detection fields are disclosed, it will be appreciated that instead of multiple electrodes, a single sensor structure or electrode having a wide detection field may be provided and disposed on or adjacent to the body surface, and further, such a single wide field sensor or electrode may be implanted under the skin.

[0029] In another embodiment, referring to FIG. 4, the energy detection sensor structure takes the form of an electrode array structure generally designated 52, which includes a plurality of electrodes 12′ (preferably at least three electrodes 12′) provided in an array or grid fixed on a flexible substrate 54. A single connector 56 may connect with the electrode connector 13 (FIG. 1) of the unit 25. The electrode array structure 52 can be disposed on the patient's body and moved to various positions, so that when the AI ​​module 49 of the microprocessor circuit 42 or 44 obtains the strongest frequency signal (signal strength), it can determine the severity, location and propagation (movement or change) of the damaged tissue in three dimensions from at least two, preferably at least three electrodes 12′, utilizing triangulation and / or trilateration of the electrode signals. Alternatively, the electrode array structure 52 may be disposed in a vest worn by the patient such that the electrodes 12' are adjacent to the patient's skin, with the vest being movable, so that the AI ​​module 49 of the microprocessor circuit 42 or 44 can determine the severity, location and propagation (movement) of the damaged tissue in three dimensions from at least two, and preferably at least three, electrodes 12' using triangulation and / or trilateration of the electrode signals when it gets the strongest frequency signal (signal strength). The electrode array structure 52 is preferably disposable.

[0030] Alternatively, instead of fixing the electrodes on a flexible substrate, and referring to Figure 5, there is shown an electrode slide structure, generally designated 58, which includes a flexible substrate 60 having a plurality of spaced apart horizontal slots 62 and a plurality of spaced apart vertical slots 64 therein. A plurality of electrodes 12'' (preferably at least three electrodes 12'') are provided, each having a base 66 frictionally engaged with the slots 62, 64 so as to be movable both horizontally and vertically relative to the substrate 60. Electrical connections 68 of the electrodes 12'' may be connected to the electrode connector 13 (Figure 1) of the unit 25. Thus, the electrode slide structure 58 can be disposed on the patient's body and moved to various positions on the body, and the electrodes 12'' can be slid or moved to various positions on the substrate 60, so that when the AI ​​module 49 of the microprocessor circuit 42 or 44 gets the strongest frequency signal (signal strength), it can use triangulation and / or trilateration of the electrode signals to determine the severity, location and propagation (movement or change) of the lesion tissue in three dimensions from at least two, preferably at least three, electrodes 12''. For example, referring to FIG. 3, if the lesion tissue is partially in more than one of the electrode sensing areas S, using trilateration, the location T of the lesion tissue is at the intersection of the perimeters of the three electrode areas S. If the three perimeters (circles) do not intersect at a point, a location area will be obtained. Triangulation can be used when the lesion tissue falls within the sensing area S of only one of the electrodes.

[0031] Alternatively, the electrode slide structure 58 may be disposed in a vest worn by the patient such that the electrodes 12'' are adjacent to the patient's skin, with the vest movable to various positions on the body and the electrodes 12'' slid or moved to various positions on the substrate 60, so that the AI ​​module 49 of the microprocessor circuit 42 or 44 can determine the severity, location and propagation (movement or change) of the damaged tissue in three dimensions from at least two, and preferably at least three, electrodes 12'' using triangulation and / or trilateration of the electrode signals when the strongest frequency signal (signal strength) is obtained. The electrode slide structure 58 is preferably disposable.

[0032] The energy detection sensor structure 11, 12, 12', 12'' can detect the frequency, frequency intensity, and direction of origin of the frequency signal of the affected tissue or other tissues affected by the affected tissue. By using triangulation and / or trilateration as described above, treatment data including severity, specific location and propagation of the affected tissue can be identified. The specific location does not have to be a pinpoint location. Thus, treatment data regarding the affected tissue can be obtained if the frequency of the monitored tissue is within the "fingerprint" range caused by the specific affected tissue. Also, other characteristics such as the specific location and propagation of the affected tissue can be determined by the system 10, 10', so that treatment can be performed without further invasive endoscopic or laparoscopic localization procedures. For example, an intestinal obstruction can be detected based on the specific disturbance frequency of the intestinal tissue or other tissues affected by the affected intestinal tissue compared to normal frequencies as described above. If the intensity (strength) of the frequency signal (e.g. caused by muscle contact) remains constant over a defined area, this indicates a static location of the obstruction. However, if the intensity of the frequency signal is detected to increase and then decrease over a distance, the propagation (change and severity or extent) of the obstruction (disturbed tissue) is determined. For example, the physical obstruction of endometriosis may change during a woman's menstrual cycle, as may the associated spasms of the enteric nervous system, or the intestinal obstruction may change location or affect different parts of the digestive system. If the intestinal obstruction is fixed or stationary, the propagation is zero. The time it takes for the frequency signal to travel from one location along the disturbed tissue to a second location, and the distance between the two locations, can be obtained by the AI ​​module 49 and used to determine the propagation of the disturbed tissue and / or the location of the obstruction or obstruction. Thus, the system 10, 10'' can determine the focus of the disturbed tissue and the extent of the disturbed tissue, e.g., upstream, downstream, or at a location different from the focus.

[0033] It should be noted that the unit 25, 25' (e.g., energy detection sensor structure such as at least two electrodes, amplifier, filter structure, A / D converter, microprocessor circuit, and transmitter) may be miniaturized down to a single integrated circuit with a small power source so as to be portable, flexible, wearable, and disposable. Thus, a housing is not required, or the flexible substrate of the integrated circuit may be considered as the housing. To enhance wearability, the unit 25, 25', whether miniaturized or not, is preferably flexible and sweat-resistant or water-resistant. For example, referring to FIG. 7, if the overall wearing position on the body is known, the integrated circuit 25, 25' may be configured in a medical skin patch 78 or worn adhered to the skin of the user in place of an adhesive bandage pad. The skin patch 78 may have a portion 80 covering the integrated circuit and may include a wearing portion 82 whose underside is adhered to the skin. Alternatively, the integrated circuit may be attached to the body using a self-adhesive bandage (e.g. wrapped around the abdomen) or incorporated into a belt, allowing it to be moved and reattached to different parts of the body as needed. Thus, when worn by the patient, the unit 25, 25' can acquire data over a period of time and transmit the data over the network 30.

[0034] Once the treatment data is obtained by the system 10, 10', the system 10, 10' can notify the user to start the treatment. The treatment may be performed by directly modulating the disordered tissue with energy, such as, for example, electromagnetic frequency (EMF) or electrical stimulation or shock treatment from a treatment delivery structure (treatment implementation structure) 53 included in the unit 25' (FIG. 2). The treatment delivery structure 53 may be of the type disclosed in US Patent Application Publication No. 20170332961A1, the contents of which are incorporated herein by reference. The treatment delivery structure 53 is separate from the unit 25' and external to the unit 25' (e.g., drugs or hormones), may be implanted or placed in the patient's body, and may communicate wirelessly with the network 30 or the portable device 24. Drugs or hormones may be delivered directly to the disordered tissue or to tissue in the vicinity of the disordered tissue to treat the physical disorder associated with the disordered tissue. Thus, the treatment of the disordered tissue may be performed directly or indirectly on the disordered tissue. The microprocessor circuit 42 or 44 may signal the treatment delivery structure 53 to deliver (perform) a treatment. Alternatively, the treatment may be surgical removal of the damaged tissue. If a drug or hormone treatment is utilized, the treatment delivery structure 53 placed on the patient or implanted in the patient may deliver drugs or hormones to the damaged tissue or nearby tissue as needed to calm the damaged tissue, preferably with authorization from a physician and controlled by the APP on the portable device 24. For example, if the system 10, 10' detects an abnormality in motility of the gastrointestinal tract, the treatment delivery structure 53 may deliver a treatment (drug, EMF, etc.) to speed up, slow down, or stop the motility. Alternatively, if the unit 25' is in the form of an integrated circuit on a medical skin patch 78, the treatment delivery structure 53 may be the patch itself, whereby the drug or hormone may be delivered transdermally through the patch, or the patch 78 may wirelessly communicate instructions to another skin patch (not shown) that delivers the treatment. The unit 25' may have input buttons for initiating the controls.

[0035] The treatment data obtained or received by the handheld device 24 or computer 30 may include color coded data. For example, different frequencies may be assigned different colors, such as frequencies indicative of abnormal tissue being color coded red and other normal frequencies being color coded blue. The intensity of the frequency signals may also be displayed along with the data.

[0036] Thus, by utilizing the algorithm outlined above, and referring to FIG. 6, a method of monitoring diseased tissue in a patient includes, in step 70, identifying a frequency range associated with a particular diseased tissue of the patient that is outside the frequency range of the associated normal tissue (e.g., based on the "fingerprint" described above). In step 72, an energy detection sensor structure 11, 12, 12', 12'' is disposed on or in close proximity to the body tissue of the patient. In step 74, energy signal generation is induced, such as by utilizing a water loading test (hydration test) or any number of other methods that cause stimulation of the diseased tissue, so that the diseased tissue emits an "abnormal" frequency or energy signal that can be detected. The water loading test is conventional and involves the patient ingesting (consuming) an amount of water that will fit in the stomach. In step 76, frequency data and the intensity of the frequency of the diseased tissue (abnormal tissue) are obtained by the energy detection sensor structure. In step 78, the frequency data is analyzed by the microprocessor 42, 44 to determine whether it is within a specified frequency range associated with a particular affected tissue of the patient, and if so, the AI ​​module 49 of the microprocessor 42, 44 determines the specific location of the affected tissue in the patient's body by trilateration. In step 79, the frequency data and the location data are optionally transmitted to another device. As explained above, the transmission of data is preferably in a wireless manner, but it is within the contemplation of the embodiment that the transmission may include transferring data in a wired manner. The AI ​​module 49 is configured to determine a diagnosis of a physical condition caused by the affected tissue, as explained above. Once it is known that the patient has a physical disorder caused by the affected tissue, a treatment can be performed, for example, by modulating the affected tissue with EMF, performing surgery, or delivering drugs or hormones to the patient. Thus, a personalized treatment can be performed that depends on the generated signal.Therefore, the same system 10, 10' capable of detecting abnormal signals in damaged tissue can prescribe a treatment or procedure via another separate device (not shown) or via the same system 10' (see FIG. 2, via treatment delivery structure 53).

[0037] Following a therapeutic procedure, the system 10, 10' can be utilized again immediately thereafter, after a delay period, or after an extended period of time to determine whether there is a change in the sensed frequency at the location(s) where the damaged tissue was previously identified.

[0038] Although embodiments for endometriosis and intestinal obstruction have been disclosed, the system 10, 10' can be configured to locate any internal disorder by ensuring detection of the appropriate frequency range, so long as the disorder emanates an energy "fingerprint" as described above. For example, and without limitation, by identifying a disease state when the energy obtained from a suspected diseased organ / tissue differs from the known energy of the organ / tissue in a normal functioning state, the following organs / tissues having associated disease states can be identified by the system 10, 10' and methods herein: Ureter, normal condition = 1cpm~4cpm Disease conditions: obstruction, stones, cancer Bladder, normal condition = 2cpm~4cpm Disease Conditions: Cystitis due to infectious, autoimmune or other causes bladder spasms Invasive diseases such as cancer and autoimmune diseases Kidney stones and other obstructions Fallopian tubes: normal = 1cpm-4cpm, but during ovulation 8cpm-12cpm Frequency is related to the menstrual cycle and may allow prediction of ovulation and the optimal time for fertility Disease status: Blockage, tubal pregnancy Uterus: Normal = 1cpm-3cpm, except during menstruation, where it is 4cpm-8cpm Disease status: Adenomyosis, tumors Motility disorders that affect fertility Biliary system, normal condition = 1cpm~2cpm Disease status: Stones, strictures, tumors, obstructions Abnormal frequency within the range of 12cpm to 18cpm Large and small intestine, normal = 3cpm-15cpm, depending on location in the intestine Disease status: Inflammatory bowel disease and obstruction or altered contractility Drug therapy is used to control these disorders, but it is often not possible to determine efficacy. Sensing a return to normal homeostatic frequencies can be used to indicate a return to normal while avoiding invasive testing. Stomach, normal condition = 3cpm Disease condition: Ulcer Aorta and other large blood vessels Disease status: aneurysm Obstruction

[0039] The systems 10, 10' are configured for external use on a subject. However, devices such as catheter structures as disclosed in U.S. Patent No. 8,753,340, the contents of which are incorporated herein by reference, may be modified to use the electrodes to sense the effects of diseased tissue inside the body and / or deliver treatment to diseased tissue inside. Thus, referring to FIG. 8, another embodiment of the system 10''' in the form of a catheter structure is shown inserted through an endoscope 84 or the like to access tissue in a human organ 86, such as the stomach, uterus, intestine, or other internal organ or human system as described above. The system 10''' includes an elongated tubular structure 88 having a distal end 90 and a proximal end 92. Thus, the system 10''' with the tubular structure 88 may be inserted into any body orifice to access and treat diseased tissue. An energy detection sensor structure, preferably three electrodes 12''', is associated with the distal end 90 of the tubular structure 88 such that it can be moved from a position preferably substantially retracted relative to the distal end 90 of the tubular structure 88 to an operating position extending directly from the distal end 90. A signal wire 94 is associated with each electrode 12''' for obtaining a signal from the electrode, as will be described more fully below. The wires 94 extend within the tubular structure 88 to its proximal end 92.

[0040] Apart from the electrodes 12''', a treatment delivery structure 96 is also provided in the tubular structure 88. When inserted into the human organ 86, the electrodes 12''' and the treatment delivery structure 96 are in an insertion position. More specifically, the electrodes 12''' and the treatment delivery structure 96 are retracted and positioned near the distal end 90, preferably within the tubular structure 88. The electrodes 12''' and the treatment delivery structure 96 are delivered via the tubular structure 88 which is threaded through the biopsy channel of a standard endoscope 84. In the illustrated embodiment, three electrodes 12''' are provided, one for a positive signal, one for a negative signal, and one for ground.

[0041] In one embodiment, an actuation structure 98, 100 is provided to move the electrodes 12''' and treatment delivery structure 96 between retracted and extended positions. In an embodiment, the actuation structure can be, for example, one or more wires 98 operably associated with the electrodes 12''' that are manually movable separately or together at the proximal end of the tubular structure 88. For example, FIG. 8 shows a single plunger 100 coupled to the wires 98. Movement of the plungers 100 extends and retracts the electrodes 12''', preferably together. Alternatively, referring to FIG. 9, instead of retracting and repositioning the electrodes 12''' to seek out lesion tissue such as an ulcer 102, the system 10''' can include multiple lumens 104 within the tubular structure 88. Each lumen 104 can include a different electrode 12''', allowing each electrode 12''' to be separately oriented in a different direction to expand diagnostic tracking locations and enable multiple treatment and sensing sites. In the embodiment of FIG. 9, the electrodes may be retractable for ease of insertion / removal of the system 10'' into / from a damaged tissue site.

[0042] Returning to FIG. 8, the system 10''' includes the processor circuit 44, memory circuit 51 and transmitter 22 of FIG. 2. Thus, the processor circuit 44 includes a filter 48 with appropriate signal filtering for sensing frequencies associated with the lesion tissue of interest. The microprocessor circuit 44 includes an artificial intelligence (AI) module 49 (FIG. 2) configured to execute at least one algorithm that can analyze the raw data (e.g., signals such as frequency and intensity of frequency data) and provide treatment data including identification, severity, location and / or propagation of the patient's physical lesion based on the raw data, as described above. For treatment by electrically stimulating the tissue, an energy source 106, preferably an electrical energy source, is provided and the treatment delivery structure 96 includes electrodes 108 (FIG. 9) for engaging the lesion tissue 102 and providing electrical stimulation to the lesion tissue 102. Instead of providing electrical stimulation, the treatment delivery structure 96 may be configured to provide drugs, hormones, synthetic substances, cells, tissue / bioengineered tissue and / or chemicals to the lesion tissue 102.

[0043] For treatment by electrically stimulating the tissue, an energy source 106, preferably an electrical energy source, is provided and the treatment delivery structure 96 includes electrodes 108 (FIG. 9) for engaging the disordered tissue 102 and providing electrical stimulation to the disordered tissue 102. Instead of providing electrical stimulation, the treatment delivery structure 96 may be configured to provide drugs, hormones, synthetic substances, cells, tissue / bioengineered tissue and / or chemicals to the disordered tissue 102.

[0044] Although electrodes are disclosed for sensing energy in normal tissue and changes in energy due to diseased tissue, other energy sensing devices may be utilized, for example, energy sensor structures capable of detecting electromagnetic energy changes in tissue.

[0045] Referring to FIG. 10, a method for determining and treating a patient's diseased tissue is disclosed. In step 110, energy signal generation is induced from the diseased tissue (e.g., via water loading). In step 112, an energy detection sensor structure (e.g., 11, 12, 12', 12'') is utilized to obtain an energy signal from the patient's tissue. In step 114, the obtained energy signal is compared in the processor circuit 44 with a known energy signal of the same tissue under normal function of the tissue. In step 116, if the comparing step determines that the obtained energy signal is different from the known energy signal, the tissue is identified as diseased tissue. In step 118, the diseased tissue is located in the patient via the energy signal (e.g., via triangulation / trilateration as described above). In step 120, a physical disorder caused by the located diseased tissue is diagnosed (via AI module 49). Thereafter, in step 122, the physical disorder is treated.

[0046] The operations and algorithms described herein may be implemented as executable code within a microprocessor circuit 42, 44 as described, or may be stored in a stand-alone computer or a machine-readable non-transitory tangible storage medium and completed based on execution of the code by a processor circuit implemented using one or more integrated circuits. Exemplary implementations of the disclosed circuits include hardware logic implemented by mask programming of a logic array such as a programmable logic array (PLA), a field programmable gate array (FPGA), or an integrated circuit such as an application specific integrated circuit (ASIC). Any of these circuits may be implemented using software-based executable resources executed by a corresponding internal processor circuit such as a microprocessor circuit and implemented using one or more integrated circuits, where execution of executable code stored in an internal memory circuit causes the integrated circuit(s) implementing the processor circuit to store application state variables in the processor memory and create executable application resources (e.g., application instances) that perform the operations of the circuit described herein. Thus, use of the term "circuitry" herein refers to both hardware-based circuitry implemented using one or more integrated circuits and including logic for performing the operations described, or software-based circuitry including a processor circuit (implemented using one or more integrated circuits) that includes reserved portions of the processor memory for storage of application state data and application variables that are modified by execution of executable code by the processor circuit. The memory circuits 35, 51 may be implemented using, for example, non-volatile memory such as programmable read-only memory (PROM) or EPROM, and / or volatile memory such as DRAM.

[0047] The foregoing preferred embodiment has been shown and described for the purposes of explaining the structural and functional principles of the invention and explaining the manner in which the preferred embodiments may be utilized, and is susceptible to modification without departing from such principles, therefore, the invention includes all modifications encompassed within the spirit of the following claims.

Claims

1. 1. A method for determining damaged tissue in a patient, comprising: inducing energy signal generation from the damaged tissue; obtaining an energy signal from tissue of the patient utilizing an energy detection sensor structure; comparing, in the processor circuit, the obtained energy signal with a known energy signal of the same tissue under normal function of said tissue; identifying the tissue as a disordered tissue if the comparing step determines that the obtained energy signal is different from the known energy signal; and diagnosing, via said processor circuit, a physical disability caused by said affected tissue; A method comprising:

2. The method of claim 1, further comprising the step of treating the physical disorder, wherein the treating step comprises treating the disordered tissue or tissue affected by the disordered tissue using surgery, EMF, electrical stimulation treatment, drugs, hormones, synthetic substances, cells, tissues, bioengineered tissues or chemicals.

3. The energy detection sensor structure and the processor circuit are part of a single wearable unit, the single unit further including a transmitter, and the method further comprises: sending instructions via the transmitter to a separate device, the separate device performing the disposing step; The method of claim 2 further comprising:

4. 3. The method of claim 2, wherein the energy detection sensor structure and the processor circuit are part of a single wearable unit, the single unit further comprising a treatment delivery structure constructed and arranged to perform the treating step.

5. The method of claim 1 , wherein the energy detection sensor structure is utilized external to the patient's body.

6. 3. The method of claim 2, wherein the energy detection sensor structure is movably housed within a tubular structure, the method further comprising inserting the tubular structure through a body opening and moving the energy sensor structure to extend from a distal end of the tubular structure to an operating position for obtaining the energy signal from the tissue of a patient.

7. 2. The method of claim 1, wherein the damaged tissue is associated with endometriosis, the known energy signal is a frequency signal less than 8 cpm, and the derived energy signal is a frequency signal in the range of 12 cpm to 60 cpm.

8. 2. The method of claim 1, wherein the impaired tissue is tissue causing intestinal spasms or obstructions, the known energy signal is a frequency signal in a range of 3 cpm to 15 cpm, and the derived energy signal is a frequency signal in a range of 50 cpm to 70 cpm or 180 cpm to 200 cpm.

9. The method of claim 1 , wherein the utilized energy detection sensor structure includes a plurality of electrodes.

10. 10. The method of claim 1, wherein the inducing step comprises having the patient ingest a water load.

11. 10. The method of claim 1, wherein the diagnosing step includes utilizing the processor circuitry configured to determine whether the patient is negative for having the physical disorder and to determine a false negative.

12. 12. The method of claim 11, further comprising a memory circuit that stores data regarding specific patient information, wherein the processor circuit is further configured to search the memory circuit and utilize the patient information to determine a probability level of a positive diagnosis of the physical disorder.

13. 10. The method of claim 1, wherein the diagnosing step includes utilizing the processor circuitry connected to a network, the processor circuitry configured to access and analyze data collected from other patients via the network for use in making the diagnosis.

14. A method for determining damaged tissue in a patient, comprising: inducing energy signal generation from the damaged tissue; obtaining the intestinal contraction frequency using an energy detection sensor structure; and identifying the affected tissue as endometriotic tissue if the resulting intestinal contraction frequency is within the range of 12 cpm to 60 cpm; A method comprising:

15. The method described in claim 14, wherein the step of inducing the generation of an energy signal includes having the patient ingest a water load.

16. The method described in claim 14, wherein the energy detection sensor structure includes a plurality of electrodes.

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