Implantable devices and methods of use

Abstract

To provide an implantable device for monitoring physiological changes in a patient.SOLUTION: The device can include: a vessel adapted to being implanted in a patient's body; a chamber having a cell layer and capable of being secured to the vessel; a light source for shining light onto the cell layer; and a reader for detecting and / or decoding signals from the cell layer to monitor physiological changes in the patient. The device is capable of engaging in a two-way communication with a second device through transmission of one or more electromagnetic signals through at least a portion of the patient's body.SELECTED DRAWING: Figure 5B

Description

[Technical field]

[0001] The present invention relates to implantable devices 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 of local noise or motion artifacts that introduce or contribute to 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 communication interruptions in any implantable cardiac device, whether wireless or lead-based, include inappropriate shock therapy, unintended inhibition of pacing due to oversensing, commanded therapy cues not being received or acted upon, and rapid battery depletion due to the need for repeated transmissions or increased transmission power. There is a need to address the potential problems of wireless communication that affect unintended patients who are in the same vicinity as the patient with the intended device at the time.

[0004] Recent advances that allow for validation and security of data during transmission to the target device have minimized concerns in this area. Pacemaker / ICD programmers have addressed issues in the systems that clinicians use to interrogate pacemakers in the office. When the past patient software interface is active, if the clinician attempts to interrogate a different device, the device will not allow this as it recognizes a different controller ID during communication. A new link is then required. This encoding can be done at a micro level and provides the necessary safety features. The main technical issue concerns ensuring accurate data transmission between modules, including implantable cell-based sensors.

[0005] Therefore, a need exists for a new system that uses at least two, and possibly three, different mediums for communication in 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 specifically employs optical emissions using the body and its tissues as a medium through which to communicate both within the body and also with the outside world. Summary of the Invention [Problem to be solved by the invention]

[0006] There is a need for improved implantable devices and methods for monitoring physiological changes in a patient. The present invention is directed to further solutions for addressing this need, in addition to having other desirable characteristics. [Means for solving the problem]

[0007] According to an example embodiment of the present invention, an implantable device for monitoring physiological changes in a patient is disclosed, which may include a container adapted to be implanted within a patient's body, a chamber having a cell layer and capable of being secured to the container, a light source for shining light onto the cell layer, and a reader for detecting and / or decoding signals from the cell layer to monitor physiological changes in the patient.

[0008] According to aspects of the present invention, the container may be tubular, rectangular, square, or any other shape, and may be adapted to be implanted in each of the intravascular, extravascular, and perivascular spaces within a patient's body.

[0009] According to yet a further aspect of the invention, the chamber comprises a body adapted to be secured to the container. The chamber may include a biological component. The biological component may include a cell layer having cells pre-positioned on or in the device prior to implantation. The pre-positioned cells may be adapted to respond to a physiological signal from the patient.

[0010] According to yet a further aspect of the present invention, the chamber may further comprise a first membrane and a second membrane on either side of the biological component. The first membrane may be a non-porous membrane on which the cell layer is pre-positioned. The first membrane may be made of glass. The second membrane may be a porous membrane that allows selective passage of fluids and nutrients through the cell layer. The second membrane may be distal to a light source. The light source may illuminate the cell layer to cause certain cells in the cell layer to glow.

[0011] According to yet further aspects of the invention, the device may be capable of wireless communication. The device may be capable of engaging in bidirectional communication by transmission of one or more signals through at least a portion of the patient's body. The bidirectional communication may include transmitting and receiving electromagnetic radiation signals. The signals may be on the order of 1×10 -8~ 1×10 -1 The electromagnetic radiation signals may be transmitted at wavelength frequencies in the range of 100 Hz. The electromagnetic radiation signals may include infrared, visible light, radio waves, microwaves, ultraviolet, x-rays, gamma rays, ultrasound signals, or combinations thereof. The electromagnetic radiation signals may travel further through the body with minimal interference from surrounding tissues or organs. The signals may measure blood pressure, ECG, heart rate, body temperature, blood glucose levels, genetic and protein changes, local cellular changes that reflect changes in systemic disease or health, or combinations thereof. The signals may be transmitted to an external receiver. The receiver may compare the signals to reference signals to diagnose a disease or condition. The receiver may decode the signals to trigger an event. The event may include adjusting the patient's medical treatment.

[0012] According to an example embodiment of the present invention, a chamber for use in monitoring physiological changes in a patient is disclosed, which may include a body adapted to be secured to a container for implantation within a patient's body, an opening in the body, and a biological component disposed within the body and comprising a cell layer having cells pre-deposited on or in the device prior to implantation, said pre-deposited cells adapted to respond to physiological signals from the patient.

[0013] According to aspects of the invention, the body may be tubular, rectangular, square, or any other shape. The body may be made of plastic, stainless steel, polyamide, Teflon, polymer, or other synthetic or biological materials. The body may be made of one piece of material. The body may be made of two pieces of material secured together. The body may have at least one opening.

[0014] According to yet a further aspect of the invention, a biological component may be placed within the opening. The biological component may further include a first membrane and a second membrane on either side of the biological component. The first membrane may be non-porous. The first membrane may be made of glass. The second membrane may be porous to allow selective fluid and nutrient passage through the cell layer. The opening may have a wall on one side to secure the cell layer within the biological component. The wall may have angled sides.

[0015] These and other features of the present invention will be better understood by reference to the following detailed description taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0016] [Figure 1] FIG. 1 is a diagram of an intra-body communication (IBC) system according to an embodiment of the present invention. [Diagram 2] 1 is a photograph of an implantable device according to an embodiment of the present invention. [Figure 3A] FIG. 1 is a perspective view of an implantable device according to an embodiment of the present invention. [Figure 3B] FIG. 1 is a perspective view of an implantable device according to an embodiment of the present invention. [Figure 3C] FIG. 1 is a perspective view of an implantable device according to an embodiment of the present invention. [Figure 4] 1 is a diagram of an implantable device according to an embodiment of the present invention. [Figure 5A] 1 is a diagram of an implantable device according to an embodiment of the present invention. [Figure 5B] 1 is a diagram of an implantable device according to an embodiment of the present invention. [Figure 6A] 1 is a diagram of an implantable device according to an embodiment of the present invention. [Figure 6B] 1 is a diagram of an implantable device according to an embodiment of the present invention. [Figure 6C] 1 is a diagram of an implantable device according to an embodiment of the present invention. [Figure 6D] 1 is a diagram of an implantable device according to an embodiment of the present invention. [Figure 7A] 1 is a diagram of an implantable device according to an embodiment of the present invention. [Figure 7B] 1 is a diagram of an implantable device according to an embodiment of the present invention. [Figure 7C] 1 is a diagram of an implantable device according to an embodiment of the present invention. [Figure 7D] 1 is a diagram of an implantable device according to an embodiment of the present invention. [Figure 8A] 1 is a photograph of an implantable device according to an embodiment of the present invention. [Figure 8B] 1 is a photograph of an implantable device according to an embodiment of the present invention. [Figure 9] FIG. 1 is a diagram of an intra-body communication (IBC) system according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Exemplary embodiments of the present invention relate to implantable devices suitable for monitoring physiological changes within the body.

[0018] 1-9, in which like parts are designated by like reference numerals throughout, illustrate one or more example embodiments of an implantable biosensor suitable for monitoring physiological changes within the body in accordance with the present invention. Although the present invention will be described with reference to one or more example embodiments illustrated in the figures, it should be understood that many alternative forms may embody the invention. Those skilled in the art will recognize additional ways to change the parameters of the disclosed embodiment(s), such as, for example, the size, shape, or type of elements or materials, while remaining within the spirit and scope of the present invention.

[0019] As shown in FIG. 1, an embodiment of an intrabody communication system 100 for use in monitoring physiological changes in a patient may include an implantable device 101, such as a biosensor, for monitoring physiological changes within the body. As used herein, "internal communication" may refer to internal communication within a single mammalian body. However, the sensor and components may be within or outside the individual's body. In one embodiment, the intrabody communication system 100 may include a first device 101 for generating a signal and a second device 103 for receiving the signal, spaced apart from the first device 101. In an embodiment, the first device 101 can monitor the integrated living tissue (biopsy and living cells) and notify if there is a change in electrical activity of the cells, increased contraction or stretching activity, or metabolic activity in response to a physiological signal of interest. In one embodiment, the direction of the signal is reversed. In one embodiment, both the first device 101 and the second device 103 are placed within the body. In other embodiments, only one of the components is outside the individual's body and the other is within the body. For example, the first device 101 is inside the body and the second device 103 is outside the body. In other embodiments, there may be any number of devices implanted inside the body or placed outside the body. The first device 101 may be the same or substantially the same as those described in U.S. Patent Nos. 8,024,020, 8,849,416, 8,938,300, and U.S. Patent Application No. 13 / 212,804, which are incorporated herein by reference.

[0020] In an embodiment, the first device 101 may include a container 110 adapted for implantation into a patient's body. By "patient" or "subject" or "individual" or "animal" or "mammal" is meant any subject for which diagnosis, prognosis, or treatment is desired, particularly a mammalian subject. Mammalian subjects include humans, domestic animals, livestock, and zoo, sport, or pet animals, such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, dairy cows, bears, and the like. The container 110 may be placed anywhere within the body, in direct contact with blood or within other tissues, such as adipose tissue, muscle, or certain organs, including the spine and nervous system. In an embodiment, the container 110 is adapted to be implanted within each of the intravascular, extravascular, and perivascular spaces within the patient's body. Thus, the container 110 may have any suitable shape and size. The container 110 may be oval, tubular, rectangular, square, pentagonal, hexagonal, or any other shape as long as the container 110 is implantable within a patient's body. The edges of the tube may be radiused or chamfered to prevent sharp edges or obstructions from being directed at tissue or surrounding materials when in use and moved. The container 110 may be constructed of any material suitable for forming structures, such as, for example, stainless steel, plastic, polyamide, Teflon, polymer, ceramic, or synthetic materials, or biological materials, such as, but not limited to, cartilage. In one embodiment, the material has sufficient rigidity to maintain its respective posts and can increase the bending stiffness of the probe to which they are applied.

[0021] The first device 101 does not require permanent long lead electrodes to be placed in body tissue or vasculature. By combining cellular biosensors with microcircuitry and eliminating the need for leads, the first device 101 is small and can be placed in areas inaccessible by long-term lead placement techniques. In addition, the device may have wires networking multiple devices together, although the networking may be wireless. The device may be placed intravenously as well as subcutaneously and / or within organs such as the brain, gastrointestinal tract, and central nervous system.

[0022] In an embodiment, the container 110 may include a cavity 112. The cavity 112 may be capable of holding a chamber 120 for use in monitoring physiological changes in a patient. In an embodiment, the cavity 112 may be of any size or shape suitable for holding the chamber 120. The cavity 112 may be tubular, rectangular, square, pentagonal, hexagonal, or any other shape.

[0023] 3, 4, and 5 show various embodiments of the chamber 120. As shown in FIG. 3A, the chamber 120 may include a body 122 that can be secured to the cavity 112 of the container 110. The body 122 of the chamber 120 may be permanently secured to the cavity 112 of the container 110 or may be removable. To fit within the cavity 112 of the container 110, the body 122 of the chamber 120 may be tubular, rectangular, square, pentagonal, hexagonal, or any other shape. The body 122 of the chamber 120 may be composed of any material suitable for forming a structure, such as, for example, stainless steel, plastic, polyamide, Teflon, polymer, ceramic, or other synthetic material, or biological material, such as, but not limited to, cartilage. In an embodiment, the body 122 may be in the range of about 0.40 mm to about 0.80 mm in length. As shown in FIG. 4, the body 122 may be about 0.663 mm in length. In an embodiment, the body 122 may range in width from about 0.10 to about 0.50 mm. As shown in FIG. 4, the body 122 may be about 0.375 mm wide. In an embodiment, the body 122 may range in height from about 0.05 mm to about 0.20 mm. As shown in FIG. 4, the body 122 may be about 0.135 mm high. As used herein, the terms "about" or "approximately" refer to a 10% variation from a specified value (e.g., 0.40, 0.80, etc.) or, in the case of a range of values, a 10% variation from both the lower and upper limits of such range. For example, "about 0.40 mm" refers to a range of about 0.36 mm to about 0.44 mm.

[0024] 3, 5, 6, and 7 show various embodiments of the body 122. As shown in Figures 3B and 3C, the body 122 may be made of two pieces of material that can be secured together. In an embodiment, the body 122 may be made of a main enclosure 124 and a lid 126 that can be secured together using fasteners 128. It should be further understood by one skilled in the art that the body 122 may be made of one continuous piece of material or more than two pieces of material.

[0025] 6A, 6B, 6C, and 6D provide various dimensions of the primary enclosure 124 according to one embodiment of the present invention. In an embodiment, the primary enclosure 124 may be in the range of about 0.40 mm to about 0.80 mm in length. As shown in FIG. 6B, the primary enclosure 124 may be in the range of about 0.66 mm in length. In an embodiment, the primary enclosure 124 may be in the range of about 0.10 mm to about 0.50 mm in width. As shown in FIG. 6B, the primary enclosure 124 may be in the range of about 0.38 mm in width. In an embodiment, the primary enclosure 124 may be in the range of about 0.05 mm to about 0.20 mm in height. As shown in FIG. 6C, the primary enclosure 124 may be in the range of about 0.14 mm in height at the first end 150 and about 0.07 mm in height at the second end 152. The first end 150 may further include a lip 154 ​​for securing the lid 126 .

[0026] 7A, 7B, 7C, and 7D provide various dimensions of the lid 126 according to one embodiment of the present invention. In an embodiment, the lid 126 may range from about 0.40 mm to about 0.80 mm in length. As shown in FIG. 7B, the lid 126 may be about 0.59 mm long. In an embodiment, the lid 126 may range from about 0.10 mm to about 0.59 mm in width. As shown in FIG. 7B, the lid 126 may be about 0.38 mm wide. In an embodiment, the lid 126 may range from about 0.02 mm to about 0.15 mm in height. As shown in FIG. 7C, the lid 126 may be about 0.02 mm high at the first end 156 and about 0.06 mm high at the second end 158. The first end 156 of the lid 126 is designed to fit securely into the lip 154 ​​of the primary enclosure 124.

[0027] As shown in FIG. 3A, the chamber 120 may include at least one opening 130 in the body 122. The opening 130 may be circular, rectangular, square, pentagonal, hexagonal, or any other shape. In one embodiment, the opening 130 is circular. The opening 130 may be any size suitable for the chamber 120. In an embodiment, the diameter of the opening 130 is in the range of about 0.10 mm to about 0.40 mm. As shown in FIG. 6B, the diameter is about 0.17 mm in diameter.

[0028] In an embodiment, the chamber 120 may include a biological component 132 disposed within an opening 130 in the body. In an embodiment, the biological component may include cells 134 pre-positioned on or within the device prior to implantation. The pre-positioned cells 134 may be adapted to respond to physiological signals from the patient. In one embodiment, the cells 134 may be obtained from a target site. In another embodiment, the cells 134 may be obtained from other sites.

[0029] The cells 134 may be plated in one, two, or multiple layers. The cells may also be plated in a three-dimensional (i.e., multiple layers) matrix and are not limited to such layers on a two-dimensional plate. The cells 134 are plated such that the cells 134 generally have a thickness of about 0.5-1 mm or less so that they receive sufficient nutrients, including oxygen exposure.

[0030] The cells 134 are cells of interest (e.g., but not limited to, cardiac, vascular, gastrointestinal, bone, tissue, or cartilage, depending on the application) that have been cultured or otherwise obtained from a patient and grown within the implantable chamber. The internal environment and architecture of the chamber is optimized to support the particular cells of interest and may include, but is not limited to, a natural or synthetic matrix used to scaffold and support the cells 134. Because the cells are cells of interest obtained from the patient, they are able to survive when implanted. The chamber 120 is a biocompatible structure that allows for healthy growth and attachment of the cells. While synthetic and / or naturally occurring materials are preferred, any material that is biocompatible with the target cells and keeps the cellular architecture intact while allowing the cells to grow and survive within the environment may be used.

[0031] The cells 134 are selected based on their ability to detect and respond to physiological signals of interest. For example, if response to circulating chemical mediators such as catecholamines is the desired information, skeletal muscle may be used. These cells therefore eliminate the need for a separate sensor to detect the desired chemical mediator. In this setup, muscles are biopsied from an arm or leg and placed in an environment that allows for the isolation of the cells in an atraumatic manner to minimize damage. The cells are then grown on the device. The site of growth includes direct contact with an array of electrodes or microelectromechanical devices. The electrode array interface may be in a single plane or may be electrodes distributed in a three-dimensional architecture such that the cells are in direct contact with the various electrodes. Once the cells have matured and attached themselves to the electrodes / sensor circuitry / MEMS, the device is ready for implantation into the same human from whom the cells were obtained. Alternatively, the cells may be obtained from other human or non-human sources and produced in a manner that is compatible with the human into whom the cells are to be implanted. This minimizes scar formation and rejection.

[0032] In this scenario, the cells 134 respond to the increase in catecholamines by increasing the frequency of their firing and the strength of contraction measured by shear stress recording sensors, pressure via pressure transducers, and the rate of change of mechanical conformational changes. Changes in shear stress / pressure and / or electrical activity (amplitude and frequency) can be detected. Electrical activity is also recorded if it is a desired signal or cellular response to be used as a marker. The first device 101 may then have its own controller that stores and / or acts on the information by transmitting the detection to an external controller or emitting electrical stimuli that inhibit or stimulate the target organ in which the device is implanted. The data may be transmitted wirelessly, for example using ultrasound, to other networked implantable or external devices that then perform an intervention that may consist of electrical stimuli or may trigger the infusion of a substance by an implantable or external pump.

[0033] In the chamber 120, the cells 134 are placed between a first membrane 136 and a second membrane 138, as shown in FIG. 3C. The first membrane 136 and the second membrane 138 function to keep the cells 134 in one place and prevent them from becoming distorted. In one embodiment, the first membrane 136 is non-porous. The first membrane 136 is adjacent to or abuts the container 110 and provides an interface between the container 110 and the cells 134 it contacts. In one embodiment, the first membrane 136 is made of glass. The second membrane 138 is adjacent to the human body and provides an interface between the human body and the cells 134 it contacts. In contrast to the first membrane 136, the second membrane 138 may be porous to allow selective passage of fluids and nutrients to the cells 134.

[0034] To maintain the positioning of the cells 134 between the first membrane 136 and the second membrane 138, the opening of the chamber 120 may be in the shape of a crater, as shown in Figures 3A and 3B. In one embodiment shown in Figure 3B, the crater shape may include a wall 140 extending from a crater base 142 to a crater apex 144. At the crater base 142 is a second membrane 138 containing a layer of cells 134. The wall 140 acts to anchor the cell layer within the biological material and prevent distortion or migration of the cells. In one embodiment, the crater base 142 has a smaller diameter than the crater apex 144. In another embodiment, the crater base 142 has the same or substantially the same diameter as the crater apex 144. In one embodiment, the wall 140 may have an angled side with respect to the biological material 132. In one embodiment, the side of the wall 140 may have an angle of about 30 degrees to 90 degrees. In one embodiment, the side of the wall 140 may have an angle of about 45 degrees.

[0035] Additionally, an optional coating may be applied to the outer surface of the cells 134 or the first membrane 136 or the second membrane 138. The coating may prevent scar tissue formation or fibrotic growth on the first device 101. Additionally, the coating may include a substance that promotes blood vessel growth around the device to improve or optimize contact with blood / fluid-borne signals. In other embodiments, the coating may be a drug-eluting coating that delivers a drug to the surrounding tissue at a predetermined rate. In embodiments, the coating may be GORE-TEX®, manufactured by Guidant, which is suitable for high voltage applications, but may also be a steroid or a combination of a steroid and GORE-TEX®. The steroid will dilute over time and eventually disappear.

[0036] In an embodiment, the first device 101 may further include electronic components 114. In an embodiment, the electronic components may include a light source (not shown) for shining light through the first membrane 136 onto the cell 134, causing a particular cell 134 to emit light, as shown in FIG. 8A. In FIG. 8A, an excitation signal in the form of light is emitted by an excitation emitter (not shown) that enters the cell 134. The cell 134 has surface receptors that are integral to the membrane proteins of the cell. When the signal (e.g., light) interacts with the receptors, they stimulate a signaling response that may also include a DNA / RNA response, which in turn forms a triggering mechanism that causes proteins to be synthesized by the cell 134. This may also trigger direct protein conformational changes that are independent of protein synthesis that can be detected. The proteins have certain physical properties, including the ability to fluoresce upon absorption of light of a particular wavelength. The more protein present in the cell 134, the higher the fluorescence intensity. In an alternative embodiment, a detection protein such as green fluorescent protein (GFP) from jellyfish may be attached to the protein (although other detection agents may be used). In an alternative embodiment, an intracytoplasmic dye may be used instead of GFP.

[0037] The electronic component 114 of the first device 110 may further include a reader to detect and / or decode the light emitted from the cells 134. The reader detects and / or decodes the light emitted from the cells 134 to monitor physiological changes in the patient. The cells 134 provide sensory individual cellular responses that can be measured by the electronic component 114, such as pressure and deformation changes in the cell structure, optical changes elicited by the cells, etc. Due to the ability to detect and measure these various cellular responses, the first device 101 provides a wide range of clinical applications in which it can be used. The first device 101, such as the first device 101 of the present invention, is individually adapted to measure various physiological changes in the patient.

[0038] The first device 101 may further include a radio frequency identification (RFID) tag 160 for remotely storing and receiving data. The RFID tag 160 is a small object, such as, for example, an adhesive sticker, that may be attached to or incorporated into the implantable device 110 of the present invention. As shown in Figures 3B and 3C, the primary enclosure 124 of the container 122 may include a slot 162 for receiving the RFID tag 160. There are passive and active RFID tags. Passive RFID tags are small devices that are generally used in simpler tracking and monitoring applications at shorter ranges than active tags. Passive tags generally operate at a maximum range of 3-5 meters, and hundreds can generally be read simultaneously within 3 meters of the reader. Passive tags do not use batteries, as they are powered by radio waves from an RFID tag reader. These devices are therefore generally less expensive, smaller than active tags, and can last for longer periods of time. Active RFID tags have a power source, such as, for example, a battery, and generally have a longer range and larger memory than passive tags. For example, active tags typically operate at a range of up to 100 meters, and typically thousands of tags can be read simultaneously within 100 meters of a reader. For further details regarding passive and active RFID tags, see http: / / RFID-Handbook.com, which is incorporated herein by reference. It should be understood that any type of identification tagging may be used, including bar codes or other electronic means.

[0039] In embodiments, the second device 103 may be the same or substantially the same as the first device 103. In other embodiments, the second device 103 may be different from the first device 103. 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 may be implanted or placed in a human.

[0040] As shown in Figure 9, the first device 101 and the second device 103 can engage in bidirectional communication by transmission of one or more signals 107 through at least a portion of a patient's body between the first device 101 and the second device 103. In an embodiment, the bidirectional communication includes transmitting and receiving signals. According to an embodiment of the present invention, the signals may be electromagnetic radiation signals. In an embodiment, the electromagnetic radiation signals may include infrared, visible light, radio waves, microwaves, ultraviolet, x-rays, gamma rays, ultrasound signals, or combinations thereof.

[0041] In an embodiment, the electromagnetic radiation signal 107 may travel through the body with minimal interference from surrounding tissues or organs. For example, the electromagnetic radiation signal 107 may travel through muscle, organs such as the lungs and heart, bone, cartilage, or any other tissue in the body while experiencing minimal interference and / or loss in wavelength frequency. In an embodiment, the loss in wavelength frequency is expected to 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, it should be understood by one of ordinary skill in the art that the amount of loss is minimal and does not affect the operation of the invention of the present application.

[0042] In an embodiment, the signal is encoded using frequency and / or amplitude modulation. In this manner, the signal 107 may convey data to the receiver 105, such as blood pressure, heart rate, ECG, body temperature, blood glucose levels, genetic and protein changes, local cellular changes, etc., that reflect changes in systemic disease or health conditions or other body parameters. In an embodiment, the electromagnetic radiation signal includes infrared, ultrasound signals, combinations thereof, or any other signal known in the art. In an embodiment, the electromagnetic radiation signal has a resolution of about 1×10 -8 ~1×10 -1The wavelength may have a frequency in the range of 100 Hz. Of course, one skilled in the art should understand that the wavelength may vary.

[0043] After traveling through the body, the signal 107 may then be transmitted to a receiver 105 that detects the signal 107, as shown in Figure 9. Additionally, the receiver 105 may decode or demodulate the signal 107 to receive data encoded in the signal 107 and may compare the signal 107 to a reference signal to diagnose a disease or condition. In response to the detected signal 107, the receiver 105 may initiate an action. The action may include adjusting the patient's medical treatment (i.e., drug delivery), activating an alarm, transmitting information to a physician, etc.

[0044] 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 delivery application. For example, an intrabody drug delivery device may be implanted in a patient. The receiver 105 may be coupled to the drug delivery device. In response to the signal 107, the receiver 105 may instruct the drug delivery device to release a drug into the body. A sensor may then detect the efficacy of the drug and allow the user to trigger the release of another dose. Such a system may enable patient targeted therapy. This may be particularly useful for patients with chronic diseases, such as, for example, diabetes patients or patients undergoing cancer treatment.

[0045] In other applications, the implantable device 101 may be used for health monitoring. As with the above applications, 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 personnel who can review the data and assess the best possible future course of treatment.

[0046] In a further application, embodiments of the disclosed implantable device 101 may be used to diagnose health conditions. Currently, health care professionals may only be able to diagnose symptoms and diseases after reviewing and analyzing data such as the results of blood draws, x-rays, computed tomography, magnetic resonance imaging, and the like. Without being limited by theory, it is believed that a symptom or disease may have a distortion signal 107. In a healthy individual, the signal 107 may be transmitted differently than an unhealthy individual. Using embodiments of the disclosed system, the difference in the signal 107 or transmission rate may alert a health care professional to possible damage, disease, or symptoms.

[0047] The implantable device 110 of the present invention may also provide information for use by other medical devices, such as, for example, a ventricular assist device to alter cardiac flow and parameters to maximize cardiac output. Alternatively, the implantable device 110 may be used to modulate blood pressure and central nervous system reflexes, such as the baroreceptor reflex system, from peripheral nervous system points or directly from the brain itself. It may also be used to predict events such as ventricular fibrillation or onset of seizure activity in the brain by detecting changes in neurotransmitters that can only be detected by living tissue.

[0048] The implantable device 110 of the present invention can stimulate tissue with sub-threshold pacing and determine the response of cells 134 to obtain data regarding cellular perception of physiological processes in the body. For example, in response to an event, the cells may slightly increase the electrical frequency of depolarization, but the first device 101 may increase the sensitivity of detection by stimulating the cells 132 and examine the response of the cells 132 to the stimulation as a way to interpret the signal. The stimulation triggers a response from the cells, depending on the application. This evoked response provides information regarding the condition the cells are sensing.

[0049] Numerous modifications and alternative embodiments of the present invention will be apparent to those skilled in the art in view of the above description. Accordingly, this description is to be construed as merely illustrative, with the purpose of teaching those skilled in the art the best mode for carrying out the invention. Details of construction may vary substantially without departing from the spirit of the invention, and the exclusive right of all modifications that come within the scope of the appended claims is reserved. Although embodiments have been described herein in a manner that allows a clear and concise specification to be written, it is contemplated and understood that the embodiments may be variously combined or separated without being separated from the invention. It is intended that the present invention be limited only to the extent required by the appended claims and the applicable rules of law.

[0050] Moreover, the following claims are intended to encompass all of the general and specific features of the invention described herein and the full scope of the invention which is said to fall between the lines as a matter of language.

Claims

1. 1. An implantable device for use in monitoring physiological changes in a patient, comprising: a container adapted to be implanted within a patient's body; a chamber having a cell layer and capable of being fixed to the container; a light source for shining light onto the cell layer; a reader for detecting and / or decoding signals from the cell layer to monitor physiological changes in the patient.

16. A device comprising:

2. The device of claim 1 , wherein the container is tubular, rectangular, square, or any other shape.

3. The device of claim 1 , wherein the container is adapted to be implanted in each of intravascular, extravascular, and perivascular spaces within the patient's body.

4. The device of claim 1 , wherein the chamber comprises a body adapted to be secured to the container.

5. The device of claim 1 , wherein the chamber comprises a biological component.

6. The device of claim 5 , wherein the biological component comprises a cell layer having cells pre-placed on or within the device prior to implantation.

7. The device of claim 6 , wherein the pre-positioned cells are adapted to respond to physiological signals from the patient.

8. The device of claim 1 , wherein the chamber further comprises a first membrane and a second membrane on either side of the biological component.

9. The device of claim 8 , wherein the first membrane is a non-porous membrane on which the cell layer is pre-disposed.

10. The device of claim 8 , wherein the first membrane is made of glass.

11. The device of claim 8 , wherein the first film is adjacent to the light source.

12. 10. The device of claim 8, wherein the second membrane is a porous membrane that allows selective passage of fluids and nutrients through the cell layer.

13. The device of claim 8 , wherein the second membrane is distal to the light source.

14. The device of claim 1 , wherein the light source causes specific cells in the cell layer to glow by shining light onto the cell layer.

15. The device of claim 1 , wherein the device is capable of wireless communication.

16. The device of claim 1 , wherein the device is capable of engaging in bidirectional communication by transmission of one or more signals through at least a portion of the patient's body.

17. The device of claim 16 , wherein the bidirectional communication includes transmitting and receiving electromagnetic radiation signals.

18. The signal is approximately 1×10 －８～ 1x10 －１ 20. The device of claim 16, wherein the device is transmitted at a wavelength frequency in the Hz range.

19. 20. The device of claim 17, wherein the electromagnetic radiation signal comprises an infrared, visible light, radio wave, microwave, ultraviolet, x-ray, gamma ray, ultrasonic signal, or a combination thereof.

20. 20. The device of claim 17, wherein the electromagnetic radiation signal travels through the body with minimal interference from the surrounding tissues or organs.

21. The device of claim 1 , wherein the signals measure blood pressure, ECG, heart rate, body temperature, blood glucose levels, genetic and protein changes, localized cellular changes that reflect changes in systemic disease or health conditions, or combinations thereof.

22. The device of claim 1 , wherein the signal is transmitted to an external receiver.

23. 24. The device of claim 23, wherein the receiver compares the signal to a reference signal to diagnose a disease or condition.

24. The device of claim 22 , wherein the receiver decodes the signal to trigger an event.

25. The device of claim 24 , wherein the event may include adjusting a medical treatment of the patient.

26. A chamber for use in monitoring physiological changes in the patient, comprising: a body capable of being secured to a container for implantation within a patient's body; an opening in the body; a biological component disposed within the body, the biological component comprising a cell layer having cells pre-positioned on or within the device prior to implantation; wherein the pre-positioned cells are adapted to respond to a physiological signal from a patient.

27. 27. The chamber of claim 26, wherein the body is tubular, rectangular, square, or any other shape.

28. 27. The chamber of claim 26, wherein the body is made of plastic, stainless steel, polyamide, Teflon, polymer, or other synthetic or biological materials.

29. 27. The chamber of claim 26, wherein the body is made from a single piece of material.

30. 27. The chamber of claim 26, wherein the body is made of two pieces of material secured together.

31. 27. The chamber of claim 26, wherein the body has at least one opening.

32. 27. The chamber of claim 26, wherein the biological component is disposed within the opening.

33. 27. The chamber of claim 26, wherein the biological component further comprises a first membrane and a second membrane on either side of the biological component.

34. 34. The chamber of claim 33, wherein the first membrane is non-porous.

35. 34. The chamber of claim 33, wherein the first membrane is made of glass.

36. 34. The chamber of claim 33, wherein the second membrane is porous to allow selective passage of fluids and nutrients through the cell layer.

37. 27. The chamber of claim 26, wherein the opening has a wall on one side for immobilizing the cell layer within the biological component.

38. 40. The chamber of claim 37, wherein the wall has angled sides.

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