Intra-body communication method for implanted and non-implanted biosensor or device

Abstract

To provide an intra-body communication system for monitoring physiological changes in a patient.SOLUTION: An intra-body communication system includes: a first device implanted in a patient's body in which pre-positioned cells are adapted so as to respond to physiological signals from the patient; a second device implanted in the patient's body capable of dispensing drugs; and a receiver for transmitting information to a doctor. The first device and second device are capable of engaging in a two-way communication through transmission of infrared signals. The infrared signals have a frequency in a range of 3×1011 to 4.3×1014 Hz (wavelength of 7×10-7 to 1×10-3 m). The infrared signals move within the body with minimal interference from surrounding tissues, etc., and, detect and decode the infrared signals for monitoring physiological changes in the patient and triggering adjustments in drug delivery from the second device.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to implantable sensors suitable for monitoring physiological changes within the body. [Background technology]

[0002] In general, wireless communication offers advantages over lead-based systems, but also introduces new technical problems, namely electromagnetic interference. RF-based wireless systems are inherently susceptible to environmental EMI (electromagnetic interference) and have significant power requirements that limit implantable technologies.

[0003] Potential problems that a patient may experience due to interruptions in implantable cardiac device communications, whether wireless or lead-based systems, include: inappropriate shock therapy, unintended inhibition of pacing due to oversensing, commanded therapy signaling that may not be received and acted upon, and premature battery depletion due to the need to repeat transmissions or increase transmit power. Potential problems with wireless communication that affect both the patient with the device of interest and unintended patients who are in the same vicinity at the time need to be addressed.

[0004] Recent advances that allow for validation and security of data sent to the target device have minimized concerns in this area. Pacemaker / ICD programmers have been grappling with issues with the systems clinicians use to interrogate pacemakers in their offices. If an attempt is made to interrogate a different device while a previous patient software interface is active, the device will not allow it because it recognizes a different controller ID during communication. A new link is then required. This encoding can be done at a micro level, providing the necessary protection. The main technical challenge involves ensuring accurate data transmission between modules, including implantable cell-based sensors.

[0005] Thus, there is a need for new systems that utilize at least two, and possibly three, different communication mediums within a single implantable biosensor system. While the use of RF and ultrasonic communication within or around the body is well established, the invention of the present application uses optical radiation, specifically using the body and its tissues as a medium to communicate. Summary of the Invention

[0006] There is a need for improved intrabody communication systems and methods for monitoring physiological changes in a patient. The present invention is directed to further solutions that address this need, in addition to having other desirable features.

[0007] According to an exemplary embodiment of the present invention, an intrabody communication system for monitoring physiological changes in a patient is disclosed. The system can include a first device implanted in the patient's body, a second device spaced apart from the first device, and a receiver for detecting and / or decoding signals to monitor physiological changes in the patient. The first device and the second device can be in bidirectional communication via transmission of one or more signals through at least a portion of the patient's body between the first device and the second device.

[0008] According to an aspect of the invention, the first device may have a biological component.

[0009] In accordance with yet another aspect of the invention, the biological component can have a cell layer with cells from the target site pre-positioned on or in the device prior to implantation.

[0010] In accordance with yet another aspect of the invention, the pre-positioned cells can be adapted to respond to physiological signals from the patient.

[0011] According to yet another aspect of the invention, the first device may further include an electronic component.

[0012] According to yet another aspect of the invention, the electronic component may have at least one sensor and at least one electrode in contact with said biological component.

[0013] According to yet another aspect of the invention, the second device is implantable within the patient's body.

[0014] According to yet another aspect of the invention, the second device can be external to the patient's body.

[0015] According to yet another aspect of the present invention, the bidirectional communication includes transmitting and receiving optical signals.

[0016] According to yet another aspect of the invention, the optical signal is selected from the group consisting of infrared light, visible light, and ultraviolet light.

[0017] According to yet another aspect of the invention, the signals may include infrared light, visible light, ultraviolet light, radio waves, microwaves, x-rays, gamma rays, and ultrasound signals or combinations thereof.

[0018] According to yet another aspect of the invention, the signal is about 1×10 -8 ~1×10 -1 It can transmit at wavelength frequencies in the Hz range.

[0019] In accordance with yet another aspect of the present invention, the signal is capable of traveling within the body with minimal interference from surrounding tissues or organs.

[0020] According to yet another aspect of the invention, the signal may measure blood pressure, ECG, heart rate, body temperature, glucose levels, genetic and protein changes, local cellular changes reflective of changes in a systemic disease or health condition, or combinations thereof.

[0021] In accordance with yet another aspect of the invention, the receiver can compare the signal to a reference signal to diagnose disease or abnormality.

[0022] According to yet another aspect of the invention, the receiver can decode the signal to trigger an event.

[0023] According to yet another aspect of the invention, the event may include adjusting a medical treatment for the patient.

[0024] According to an exemplary embodiment of the present invention, a method for monitoring physiological changes in a patient is provided. The method includes the steps of providing an intrabody communication system, transmitting one or more signals between a first device and a second device through at least a portion of the patient's body, and providing a receiver for detecting and / or decoding the signals to monitor the physiological changes in the patient. The intrabody communication system includes a first device implanted in the patient's body, a second device spaced apart from the first device, and a receiver for detecting and / or decoding the signals to monitor the physiological changes in the patient. The first device and the second device can perform bidirectional communication by transmitting one or more signals between the first device and the second device through at least a portion of the patient's body.

[0025] According to an exemplary embodiment of the present invention, a method for diagnosing a patient is provided. The method includes the steps of providing an intrabody communication system, transmitting one or more signals between a first device and a second device through at least a portion of the patient's body, detecting and / or decoding the one or more signals to monitor physiological changes in the patient, and comparing the one or more signals of the patient with a reference signal to diagnose a disease or abnormality. The intrabody communication system includes a first device implanted in the patient's body, a second device spaced apart from the first device, and a receiver for detecting and / or decoding signals to monitor physiological changes in the patient. The first device and the second device can perform bidirectional communication by transmitting one or more signals between the first device and the second device through at least a portion of the patient's body.

[0026] According to an exemplary embodiment of the present invention, a method of treating a patient is provided. The method includes providing an intrabody communication system, transmitting one or more signals between a first device and a second device through at least a portion of the patient's body, detecting and / or decoding the signal(s) to monitor physiological changes in the patient, evaluating and / or analyzing the signal(s), and treating the patient based on the evaluation and / or analysis of the signal(s). The intrabody communication system includes a first device implanted in the patient's body, a second device spaced apart from the first device, and a receiver for detecting and / or decoding the signal(s) to monitor physiological changes in the patient. The first device and the second device can perform bidirectional communication by transmitting one or more signals between the first device and the second device through at least a portion of the patient's body.

[0027] These and other features of the present invention will be more fully understood by reference to the following detailed description taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0028] [Figure 1] FIG. 1 is a diagram of an intra-body communication (IBC) system according to an embodiment of the present invention. [Diagram 2] FIG. 1 is a diagram of an intrabody communication (IBC) system according to an embodiment of the present invention. [Diagram 3] FIG. 1 is a diagram of an intrabody communication (IBC) system according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Exemplary embodiments of the present invention relate to an intrabody communication system suitable for monitoring physiological changes within the body.

[0030] 1-3 show exemplary embodiments of an intrabody communication system suitable for monitoring physiological changes within the body according to the present invention, with like parts designated with like reference numerals throughout the drawings. Although the present invention will be described with reference to the exemplary embodiments shown in the drawings, it should be understood that many alternative forms can embody the present invention. Those skilled in the art will recognize additional ways to modify the parameters of the disclosed embodiment(s), such as the size, shape, or type of elements or materials, without departing from the spirit and scope of the present invention.

[0031] As shown in FIG. 1, an embodiment of the intrabody communication system 100 may include an implantable device for monitoring physiological changes within the body. As used herein, "internal communication" may refer to internal communication within a single mammalian body. However, the sensors and components may be located inside or outside the individual. In one embodiment, the intrabody communication system 100 may comprise a first device 101 for generating a signal and a second device 103 spaced apart from the first device 101 for receiving the signal. In one embodiment, the direction of the signal is reversed. In one embodiment, both the first device 101 and the second device 103 are located within the body. In another embodiment, only one of the components is outside the individual and the other is inside the body. For example, the first device 101 is inside the body and the second device 103 is outside the body. In another embodiment, there may be any number of devices implanted in the body or located outside the body.

[0032] In one embodiment, the first device 101 may include biological and electronic components. In one embodiment, the biological components may include a cell layer having cells from a target site pre-positioned on or in the device prior to implantation. The pre-positioned cells may be adapted to respond to physiological signals from the patient. In one embodiment, the electronic components may include at least one sensor and at least one electrode that contacts the biological components. The first device 101 may be the same or substantially the same as those described in U.S. Pat. Nos. 8,024,020; 8,849,416; 8,938,300 and U.S. Patent Application No. 13 / 212,804, all of which are incorporated herein by reference.

[0033] In one embodiment, the second device 103 may be the same or substantially the same as the first device 101. In another embodiment, the second device 103 may be different from the first device 101. For example, the second device 103 may be a pacemaker, a glucose monitor pump, an insulin pump, a neurostimulator, a defibrillator, or any other medical device that can be implanted in or worn by a person.

[0034] As shown in FIG. 2, the first device 101 and the second device 103 may perform bidirectional communication by transmitting one or more signals 107 between the first device 101 and the second device 103 through at least a portion of the patient's body. In one embodiment, the bidirectional communication includes transmitting and receiving signals. In one embodiment, the signals may be optical or light signals. As used herein, "optical signals" may refer to infrared light, visible light, and ultraviolet light. According to one embodiment of the present invention, the signals may be infrared light. According to one embodiment of the present invention, the signals may be visible light. According to one embodiment of the present invention, the signals may be ultraviolet light. According to one embodiment of the present invention, the signals may include infrared light, visible light, ultraviolet light, electromagnetic radiation, radio waves, microwaves, x-rays, gamma rays, ultrasound signals, or combinations thereof. It is understood that other signals known in the art may also be included.

[0035] In one embodiment, the signal 107, e.g., an optical signal, may travel within the body with minimal interference from surrounding tissues or organs. For example, the signal 107, e.g., an optical signal, may travel through organs such as muscles, lungs and heart, bone, cartilage, or any other tissue within the body while experiencing minimal interference and / or loss of wavelength frequency. In one embodiment, it is expected that the loss of wavelength frequency will be less than 10%, less than 9%, less than 8%, less than 7%, less than 6%, less than 5%, less than 4%, less than 3%, less than 2%, or less than 1%. It should be understood that the amount of loss may vary based on a number of factors. For example, the amount of loss may depend on the type of signal and / or the type of wavelength selected. Additionally, the amount of loss may depend on the amount of absorption, diffusion, and / or scattering. However, one skilled in the art would understand that the amount of loss is minimal and does not affect the practice of the invention of the present application.

[0036] In some embodiments, the signal is encoded using frequency and / or amplitude modulation. In this manner, the signal 107, e.g., an optical signal, can carry data to the receiver 105, such as blood pressure, heart rate, ECG, body temperature, glucose levels, genetic and protein changes, local cellular changes reflecting changes in systemic disease or health, or other body parameters. In one embodiment, the optical signal has a resolution of about 1×10 -8 ~1×10 -1 The wavelength may have a frequency in the range of 100 Hz. Of course, one skilled in the art will appreciate that the wavelength may vary.

[0037] After traveling through the body, the signal 107 can be transmitted to a receiver 105 that detects the signal 107, as shown in Figure 3. Further, the receiver 105 can decode or demodulate the signal 107 to receive data encoded within the signal 107 and compare the signal 107 to a reference signal to diagnose a disease or abnormality. In response to the detected signal 107, the receiver 105 can initiate an action. This action can include adjusting the patient's medical treatment (e.g., drug delivery), activating an alarm, transmitting information to a physician, etc.

[0038] It is therefore envisioned that the disclosed intrabody communication system 100 may be used in numerous applications. In one embodiment, the intrabody communication system 100 may be used in a drug release application. For example, an internal drug dispensing device may be implanted in a patient. A receiver 105 may be coupled to the drug dispensing device. In response to a signal 107, the receiver 105 may instruct the drug dispensing device to release a drug into the body. A sensor may detect the effectiveness of the drug and allow a user to trigger another dose release. Such a system may enable targeted treatment to a patient. This may be particularly useful for patients with chronic diseases, such as diabetes patients or those undergoing cancer treatment.

[0039] In another application, the intrabody communication system 100 may be used in health monitoring. Similar to the application described above, the receiver 105 may detect and decode the signal 107 and store the data on a storage medium, such as a flash card, hard drive, or other device known to those skilled in the art, and / or transmit the data to a base station, such as a computer, smartphone, or cell phone. Depending on the complexity of the system setup, the information may be forwarded directly to a doctor's office or nurse's station, first responders, or other qualified individuals who can evaluate the data and take the best course of treatment.

[0040] In a further application, embodiments of the disclosed intrabody communication system 100 may be used to diagnose medical abnormalities. Currently, medical personnel may only be able to diagnose abnormalities and diseases after evaluating and analyzing data such as blood test, x-ray, computed tomography or magnetic resonance imaging results. Without being limited by theory, it is believed that the abnormality or disease may have a distorted signal 107. In a healthy individual, the signal 107 may transmit differently than an unhealthy individual. Using embodiments of the disclosed system, the difference in the signal 107 or transmission rate may alert medical personnel to a possible injury, disease or abnormality.

[0041] The following examples are provided to further illustrate various exemplary embodiments of the present invention.

[0042] We propose an in-body communication system that utilizes at least two, and optionally three, different communication mediums within a single implantable biosensor system. The system uses optical radiation, specifically using the body and its tissues as the medium to communicate.

[0043] Communication may be based on any wavelength suitable for the anatomical distance and the matter / tissue surrounding the two communication points.

[0044] This approach focuses the light (infrared) in a synchronized manner to minimize potential gaps in information during transmission as one mode can provide the required information at a time. The communication method used in Phase I is one where all sensors, including cell-based implantable biosensors, have a unique address and all sensors are listening for commands. The host controller sends a command with an embedded address to all sensors. The sensor with the correct address responds to the command and sends an acknowledgement. All other sensors ignore the command and wait for another command to be sent.

[0045] There is minimal information in the literature regarding the use of non-RF based methods for communication between modules implanted within the body. Phase I will explore various options for wireless communication including infrared, ultrasonic, and RF. Key considerations for Phase I include ease of use in prototype development, cost, minimal power requirements, and the need to use the data for advanced development of RF, light based, and / or acoustic communications, especially for use in proof-of-concept prototypes.

[0046] Infrared: While all wireless serial communication methods have their pros and cons, infrared communication (IRC) offers many advantages for this application. IRC hardware potentially has a minimal number of components. These include an emitter, a detector, an amplifier, and a pulse code modulator / demodulator (PCMD). These components are small and may require few supporting components.

[0047] Technology exists to detect and transmit light within the infrared spectrum. All objects with a temperature greater than absolute zero (-273.16°C) emit electromagnetic energy. The spectrum in which the energy is emitted is directly related to the temperature of the object. The human body emits electromagnetic radiation at a wavelength of 9.3uM. The infrared range is defined as electromagnetic energy with wavelengths between 0.7uM and 1000uM. Since the body itself emits infrared light, problems arise for infrared devices to separate true signal vs. noise. The same light changes as it passes through human tissue, especially as the light is transmitted and reflected between various cell layers and organs. Changes in this medium, such as light going from air to liquid, change some of the characteristics of a particular signal, such as wavelength and speed, but do not change the frequency of the waveform. This fact allows for relatively protected signaling using infrared within the human body.

[0048] Key challenges are diode power and sensor capability, both of which are directly related to the distance and medium the infrared signal must travel. For example, an infrared signal that needs to be carried from one part of the heart to another will likely be impeded by the myocardium itself, the blood / tissue interface within the ventricle, and the surrounding tissue through which it must penetrate. However, infrared light can be used reflectively within the body, offering advantages. The ability of light to reflect off tissue surfaces must be considered, and this fact must be used to design a system that combines both transmissive and reflective properties within the medium (body tissue). In this case, a module placed in the epicardial right ventricle may communicate with a module implanted in the left ventricle by transmitting a signal and allowing it to be reflected and absorbed by the surrounding tissue. A sensor at a designated receiving site can decode the information. Specific designs are available that reflect light to a target area, which can be used to build site-specific transmitting and receiving modules.

[0049] Advantages offered by the body as the primary medium in the proposed technology include the human's very stable narrow temperature range, limited distances, and relatively consistent anatomical structure between individuals that allows for modeling of various tissue:tissue interfaces. Environmental noise must be considered as well. Because the body can absorb most wavelengths of infrared and electromagnetic radiation, potential interference exerted on an implanted infrared system must be considered when the patient is exposed to various environments including fluorescent lighting, bright summer sun, etc.

[0050] Design Challenges: IRC can communicate over several meters in free air. Inside the body, infrared light is highly scattered and attenuated. Communication distance inside the body is approximately 10 inches. Body tissue attenuates some wavelengths of infrared light more weakly than others. The most effective wavelength of the infrared source will be determined by experiment. Powerful and efficient infrared sources are available. Infrared sources are generally unidirectional. The infrared source light, even if attenuated, is scattered and refracted by body tissue. This effectively makes the light source omnidirectional. Detectors will be required to be sensitive to pick up the infrared source light. Body tissue provides a natural ambient light filter, reducing noise. In addition, infrared systems often operate on subcarriers of 95 kHz, 250 kHz, 300 kHz, 2.3 MHz and 2.8 MHz. Fluorescent lights (especially those with T-12 ballasts) generate infrared noise that interferes with communication. Infrared receivers tend to use broader spectrum diodes with passband filters that are more vulnerable to infrared interference.

[0051] In Vitro Testing of Wireless Communications The ability to communicate wirelessly is a key aspect of the proposed technology. Primary communication methods being considered include RF, infrared, and tissue-based conduction. Each method has weaknesses, so it is possible that an integrated communication method may be used. Phase I will consider the use of any form of optical or similar, including IR and RF communication for short range, while continuing work on the breadboard prototype system's software, sensing and output circuitry.

[0052] To address the specific challenges associated with the use of light for communication between devices implanted in the human body, we designed a chamber to provide a suitable early stage bench test environment for wireless communication methods for implanted systems. The system is built and used to investigate various wireless communication methods proposed for the system.

[0053] Two chambers are constructed: 1) cylindrical and 2) cubic.

[0054] The primary material framework consists of a non-conductive plastic frame with an outer shell made of interchangeable walls. The system provides a water-tight seal to be filled with solutions of various viscosities and light-changing properties. In addition, there are mechanisms for inserting various optical wavelength filters along the exterior of the chamber, as well as along the interior of the various sub-compartments. Each compartment can be individualized, and the distance between the walls (i.e. interfaces) is adjustable within the chamber. The dimensions of the functional chamber were determined using CT scan images to reproduce the average distances between the major thoracic structures, such as from the sling to the thorax (the parameter that can vary the most depending on the patient's body mass index), the pleural cavity, the mediastinum and the maximum / minimum distances of inspiration and expiration. The goal is not to create an exact replica of the human chest, but to have a clinically relevant test chamber to test various communication modes.

[0055] Electromagnetic interference as well as optical signal generation will be constructed as insert boards throughout the chamber. Different light wavelengths, including those produced by fluorescent and ambient lighting, will be reproduced and evaluated for their impact on effective and reliable communication between intelligent modules.

[0056] The communication sensors and emitters can be placed in the chamber at various positions corresponding to anatomically relevant distances and angles, and the intervening space consists of subcompartments with combinations of solutions and optical filters to mimic interfacial changes between tissue layers in the body. In addition to non-biological materials being used, it also supports the ability to use real organs and tissues (i.e., hearts and lungs derived from slaughterhouse pigs). There are methods to pump solutions (pulsatile and non-pulsatile flows) throughout the various chambers or biological tissues during experiments designed to test the differences in light transmission that might be seen in the chest while the lungs are expanding and the heart is beating. The contribution of low frequency breathing and slightly higher frequency heartbeat motion to noise generation during communication can be studied. Because temperature affects light transmission and tissue absorption properties, the fluids and chambers are maintained at 37°C ± 10°C to define temperature extremes, where the greatest variability exists at the skin:subcutaneous tissue interface and the smallest temperature variations exist in core organs such as the heart. It can be predicted that the dimensions, distances and relationships of thoracic structures will change as the heart fills with blood and the lungs fill with air. The effects of this periodic oscillation of distances in a three-dimensional environment will be explored during Phase I and studied in detail during Phase 2.

[0057] During Phase I, the chamber will provide the data necessary to validate wireless communication, its limitations, and design considerations for an implantable version of the prototype. A number of infrared source parameters will be considered. Parameters investigated include:

[0058] I. Wavelength: Infrared sources are available at 830 nm, 850 nm, 880 nm and 940 nm. Experiments are designed to determine which wavelength has optimal tissue absorption and refraction. Statistically designed experiments identify the significance of this parameter. Student's T-tests are used to compare responses at different wavelengths.

[0059] 2. Optical Power and Energy Density: Infrared sources are available with a variety of maximum powers and energy densities. Experiments will be designed to determine the energy density and total output power required to overcome tissue absorption and provide reliable communication in vivo.

[0060] Silicon photodetectors are available in many sizes (active area) and packages. We start by using the Pin:S-IOCL from UDT Sensors, Inc., which is sold in "chip" form. Since it is not installed in a package, it has the largest percentage of active area relative to its dimensions.

[0061] Numerous modifications and alternative embodiments of the present invention will be apparent to those skilled in the art in view of the above description. This description is therefore to be construed as merely illustrative, and is for the purpose of teaching those skilled in the art the best mode of carrying out the invention. Details of construction may be varied substantially without departing from the spirit of the invention, and the exclusive use of all modifications that come within the scope of the appended claims is reserved. Within this specification, the embodiments have been described in a manner that permits a clear and concise specification to be written, but it is intended and will be understood that the embodiments may be variously combined or separated without departing from the invention. It is intended that the present invention be limited only to the extent required by the appended claims and applicable law.

[0062] The following claims are to be understood as covering all the general and specific features of the invention described herein, and also as covering all statements of the scope of the invention that may be said to fall therebetween as a matter of language.

Claims

1. 1. An intrabody communication system for monitoring physiological changes in a patient, comprising: the intrabody communication system includes a first device, a second device, and a receiver; the first device is implanted within a patient's body and includes an electronic component and a biological component including a cell layer having cells pre-positioned on or in the first device from a target site prior to implantation, the pre-positioned cells adapted to respond to physiological signals from the patient; the second device is positioned remotely from the first device and is implantable within the patient and capable of dispensing a drug; The first device and the second device may be in bidirectional communication via transmission of one or more infrared signals between the first device and the second device through at least a portion of the patient's body, the one or more infrared signals having a frequency of 3×10 １１ ~4.3×10 １４ Hz (wavelength is 7 x 10 －７ ~1×10 －３ m), wherein the communication distance of the two-way communication via the infrared signals within the patient's body is about 10 inches (about 25.4 centimeters), and the transmission of the one or more infrared signals has less than 10% loss in wavelength frequency, and the one or more infrared signals travel within the body with minimal interference from surrounding tissue(s) or organ(s); The receiver detects and / or decodes the one or more infrared signals to monitor physiological changes in the patient and to trigger adjustments in drug delivery from the second device, and transmits information to a physician, and through bidirectional communication of the infrared signals, the intrabody communication system transmits and receives data including blood pressure, ECG, heart rate, body temperature, genetic changes, protein changes, local cellular changes reflecting changes in systemic disease or health, or combinations thereof. Intrabody communication system.

2. The system of claim 1 , wherein the electronic component includes at least one sensor and at least one electrode in contact with the biological component.

3. The system of claim 1 , wherein the two-way communication includes transmitting and receiving infrared signals.

4. The system of claim 1 , wherein the receiver compares the one or more infrared signals to a reference signal to diagnose a disease or abnormality.

5. The system of claim 1 , wherein the receiver decodes the one or more infrared signals to trigger an event.

6. The system of claim 5 , wherein the event comprises adjusting a medical treatment for the patient.

7. 1. A method for monitoring a physiological change in a patient, comprising: providing an intrabody communication system, the intrabody communication system including a first device, a second device and a receiver; the first device is implanted within a patient's body and includes an electronic component and a biological component including a cell layer having cells pre-positioned on or in the first device from a target site prior to implantation, the pre-positioned cells adapted to respond to physiological signals from the patient; the second device is positioned remotely from the first device and is implantable within the patient and capable of dispensing a drug; The first device and the second device can communicate bidirectionally by transmitting infrared signals between the first device and the second device through at least a portion of the patient's body, the infrared signals having a frequency of 3×10 １１ ~4.3×10 １４ Hz (wavelength is 7 x 10 －７ ~1×10 －３ m), wherein the communication distance of the two-way communication via the infrared signals within the patient's body is about 10 inches (about 25.4 centimeters), and the transmission of one or more infrared signals has less than 10% loss in wavelength frequency, and the infrared signals travel within the body with minimal interference from surrounding tissue(s) or organ(s); the receiver detects and / or decodes the signal to monitor physiological changes in the patient; Providing a step of: transmitting the infrared signal between the first device and the second device through at least a portion of the patient's body, wherein the bidirectional communication of the infrared signal allows the intrabody communication system to transmit and receive data including blood pressure, ECG, heart rate, body temperature, genetic changes, protein changes, local cellular changes reflecting changes in a systemic disease or health condition, or combinations thereof; providing the receiver for detecting and / or decoding the infrared signal and transmitting information to a physician for monitoring physiological changes in the patient and for triggering adjustments in drug delivery from the second device; The method includes:

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