# US 2004/0158138 A1 · Implantable monitoring probe > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2004/0158138 A1 - Document ID: US20040158138A1 - Status: Published application - Kind: A1 - Application number: 10/687,298 - Filed: 2003-10-16 - Published: 2004-08-12 - Earliest claimed: 1999-04-07 - Assignees: Endonetics, Inc. - Inventors: John T. Kilcoyne; Ross Tsukashima; George M. Johnson; Christopher Klecher - Web page: https://patentgrep.com/patent/US20040158138A1 ## CPC - A61B 1/00148: {using anchoring means} - A61B 1/041: {Capsule endoscopes for imaging} - A61B 5/0031: {Implanted circuitry} - A61B 5/073: {Intestinal transmitters} - A61B 5/14539: {for measuring pH} - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - A61B 5/42: {Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems (A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence)} - A61B 5/4233: {oesophagus} - A61B 5/6882: {Anchoring means} - A61B 5/0008: {Temperature signals} - A61B 5/037: {Measuring oesophageal pressure} - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Disclosed is an ambulatory system for monitoring one or more physiological parameters in a body lumen, such as the esophagus. The system includes an implantable probe having a sensor for the physiological parameter and a transmitter for transmitting data to an external receiver. The probe may be used for monitoring any of various physiological parameters, including pH, temperature, and pressure, within the esophagus or other body lumens. Methods and deployment catheters are also disclosed. ## Claims ### Claim 1 A method of attaching a device to a tissue surface inside of a patient, comprising the steps of: providing a device having a housing, a concavity on the housing, a window to permit visualization through the housing of the interior of the concavity, and a pin which is axially movable from a retracted position within the housing to an extended position which extends at least part way across the concavity; carrying the device on an introduction instrument into the body; positioning the device at an attachment site in the body such that the concavity is adjacent the tissue surface at the attachment site; drawing tissue into the concavity; visualizing tissue within the concavity through the window, and advancing the pin through the tissue to retain the device at the attachment site. ### Claim 2 (depends on 1) A method of attaching a device to a tissue surface inside of a patient as in claim 1, wherein the device further comprises a lumen in communication with the concavity, and the drawing tissue into the concavity step additionally comprises the step of applying suction to the lumen. ### Claim 3 (depends on 1) A method of attaching a device to a tissue surface inside of a patient as in claim 1, wherein the window comprises a transparent wall on the housing, and said visualizing tissue step comprises observing tissue through the wall of the housing. ### Claim 4 (depends on 1) A method of attaching a device to a tissue surface inside of a patient as in claim 1, wherein the carrying the device on an introduction instrument step comprises carrying the device by an endoscope. ### Claim 5 (depends on 1) A method of attaching a device to a tissue surface inside of a patient as in claim 1, wherein the pin comprises a material which degrades at the attachment site, and the method further comprises the step of permitting the pin to degrade, thereby releasing the device from the tissue surface. ### Claim 6 A method of attaching a device to a tissue surface inside of a patient, comprising the steps of: providing a device having a housing, a concavity on the housing, and a pin which is axially movable from a retracted position within the housing to an extended position which extends at least part way across the concavity; carrying the device on an introduction instrument into the body; positioning the device at an attachment site in the body such that the concavity is adjacent the tissue surface at the attachment site; drawing tissue into the concavity; and advancing the pin through the tissue to retain the device at the attachment site. ### Claim 7 (depends on 6) A method of attaching a device to a tissue surface inside of a patient as in claim 6, wherein the device further comprises a lumen in communication with the concavity, and the drawing tissue into the concavity step additionally comprises the step of applying suction to the lumen. ### Claim 8 (depends on 6) A method of attaching a device to a tissue surface inside of a patient as in claim 6, wherein the carrying the device on an introduction instrument step comprises carrying the device on an endoscope. ### Claim 9 (depends on 6) A method of attaching a device to a tissue surface in side of a patient as in claim 6, wherein the pin comprises a material which degrades at the attachment site, and the method further comprises the step of permitting the pin to degrade, thereby releasing the device from the tissue surface. ### Claim 10 A monitoring device for monitoring at least one physiological parameter at an attachment site in a body, comprising: a housing, having a tissue attachment surface; a pin which is movable from a retracted position to allow the tissue attachment surface to be brought into contact with tissue at a preselected attachment site, and an extended position in which it extends through tissue in contact with the attachment surface; and at least one physiological parameter detector carried by the housing. ### Claim 11 (depends on 10) A monitoring device as in claim 10, further comprising a concavity on the housing such that the tissue attachment surface is on a surface of the concavity. ### Claim 12 (depends on 10) A monitoring device as in claim 10, wherein the pin comprises a bioabsorbable material. ### Claim 13 (depends on 11) A monitoring device as in claim 11, further comprising a lumen in communication with the concavity, for connection to a vacuum to draw tissue into the concavity. ### Claim 14 (depends on 10) A monitoring device as in claim 10, wherein the physiological parameter detector comprises a pH detector. ### Claim 15 (depends on 10) A monitoring device as in claim 10, further comprising an RF transmitter for transmitting data generated by the physiological parameter detector. ### Claim 16 (depends on 10) A monitoring device as in claim 10, further comprising an electrical contact for contacting tissue in the body and transmitting data relating to the physiological parameter through the tissue. ### Claim 17 A method of remotely monitoring a physiological parameter in a body lumen of a patient, comprising the steps of: providing a device having a housing, a physiological parameter detector in the housing, a concavity on the housing, and a pin which is axially movable from a retracted position within the housing to an extended position which extends at least part way across the concavity; carrying the device on an introduction instrument into the body; positioning the device at an attachment site in the body such that the concavity is adjacent the tissue surface at the attachment site; drawing tissue into the concavity; advancing the pin through the tissue to retain the device at the attachment site; and monitoring at least one physiological parameter. ### Claim 18 (depends on 17) A method as in claim 17, wherein the attachment site is the surface of the esophagus. ### Claim 19 (depends on 17) A method as in claim 17, wherein the device further comprises a radiofrequency transmitter, and said physiological parameter data transduced by the detector is transmitted to a radiofrequency receiver and a recording device located outside the patient's body. ### Claim 20 (depends on 17) A method as in claim 17, wherein the device further comprises a microprocessor. ### Claim 21 (depends on 17) A method as in claim 17, wherein the device further comprises a digital recorder that records physiological parameter data. ### Claim 22 (depends on 21) A method as in claim 21, further comprising the step of transferring the physiological parameter data from the digital recorder to an external data retrieval device. ### Claim 23 (depends on 17) A method as in claim 17, wherein the physiological parameter is selected from the group consisting of pH, temperature, and pressure. ### Claim 24 (depends on 23) A method as in claim 23, wherein the physiological parameter data comprises data concerning at least two of said parameters. ### Claim 25 (depends on 23) A method as in claim 23, wherein the physiological parameter data comprises data concerning all three of said parameters. ### Claim 26 (depends on 17) A method as in claim 17, wherein the physiological parameter comprises the concentration of ions within a body fluid. ### Claim 27 (depends on 26) A method as in claim 26, wherein the ions are selected from the group consisting of sodium, potassium, calcium, magnesium, chloride, bicarbonate, and phosphate. ### Claim 28 (depends on 17) A method as in claim 17, wherein the physiological parameter comprises the concentration of a solute within a body fluid. ### Claim 29 (depends on 28) A method as in claim 28, wherein the solute is selected from the group consisting of glucose, bilirubin, creatinine, blood urea nitrogen, urinary nitrogen, renin, and angiotensin. ### Claim 30 (depends on 17) A method as in claim 17, further comprising the step of using a computer and a computer software program to analyze physiological parameter data obtained over a period of time. ### Claim 31 (depends on 30) A method as in claim 30, wherein the pin used for attaching said monitor to the lumen wall is made at least partially of dissolvable materials. ### Claim 32 A monitoring device for monitoring at least one physiological parameter at an attachment site in a body, comprising: a housing, having a tissue attachment surface; a pin which is movable from a retracted position to allow the tissue attachment surface to be brought into contact with tissue at a preselected attachment site, and an extended position in which it extends through tissue in contact with the attachment surface; and at least one physiological parameter detector carried by the housing. ### Claim 33 An implantable device for measuring at least one physiological parameter indicative of gastroesophageal reflux, the device comprising: a casing adapted to be implanted and secured within the body of the patient in a location wherein the surrounding environment provides the at least one physiological parameter indicative of gastroesophagael reflux; a sensor, positioned within the casing, the is adapted to measure the at least one physiological parameter indicative of gastroesophageal reflux; a transmitter, positioned within the casing, wherein the transmitter is adapted to send a parameter signal indicative of the measured at least one physiological parameter to a receiver located outside of the body of the patient; a power source, positioned within the casing, that provides power to the sensor and the transmitter; a processor, positioned within the casing, that periodically induces the sensor to obtain the at least one physiological parameter and periodically induces the transmitter to transmit a parameter signal indicative of the at least one physiological parameter, wherein the processor enables the delivery of power from the power source to the sensor during a first time interval during each measurement cycle when the sensor is sensing the at least one physiological parameter and wherein the processor enables the delivery of power from the power source to the transmitter during a second time interval during each measurement cycle when the transmitter is transmitting the parameter signal so that consumption of power by the sensor and the transmitter is reduced during intervals of each cycle other than the first and second interval respectively. ### Claim 34 (depends on 33) The implantable device of claim 33, wherein the sensor is comprised of a pH sensor that measures the pH of the fluid surrounding the casing when the casing is implanted in the patient's body. ### Claim 35 (depends on 34) The implantable device of claim 34, wherein the sensor is comprised of an ISFET transistor with an associated amplifier wherein the ISFET transistor is selectively activated in response to the pH of the fluid surrounding the casing such that the ISFET and the associated amplifier can provide a voltage signal to the microprocessor that is indicative of the pH of the surrounding fluid. ### Claim 36 (depends on 34) The implantable device of claim 34, wherein the sensor is comprised of an antimony electrode with an associated amplifier wherein the antimony electrode is selectively activated in response to the pH of the fluid surrounding the casing such that the antimony electrode and the associated amplifier can provide a voltage signal to the microprocessor that is indicative of the pH of the surrounding fluid. ### Claim 37 (depends on 33) The implantable device of claim 33, wherein the transmitter is comprised of an RF transmitter that transmits a digital signal indicative of the physiological parameter indicative of gastroesophageal reflux. ### Claim 38 (depends on 33) The implantable device of claim 33, wherein the processor initiates a measurement cycle wherein the sensor senses the physiological parameter and the transmitter transmits a parameter signal corresponding to the physiological parameter measured by the sensor approximately every 6 seconds. ### Claim 39 (depends on 38) The implantable device of claim 38, wherein the processor provides power to the sensor only during the first interval and provides power to the transmitter only during the second interval of the cycle so as to reduce power consumption during each cycle. ### Claim 40 (depends on 39) The implantable device of claim 39, wherein the first interval is approximately 20 ms in length and the second interval is approximately 60 ms in length. ### Claim 41 (depends on 33) The implantable device of claim 33, further comprising a non-volatile memory accessible by the processor, wherein the processor is adapted so that calibration information can be stored in the non-volatile memory prior to implantation of the device into the patient. ### Claim 42 (depends on 41) The implantable device of claim 41, wherein the parameter signals transmitted by the transmitter include the calibration data such that the receiver external to the patient receives a calibrated signal indicative of the physiological parameter indicative of gastroesophageal reflux. ### Claim 43 A method of measuring a physiological parameter indicative of gastroesophageal reflux using an implanted sensor, the method comprising: (a) providing power to a sensor circuit for a first time interval so as to obtain a parameter measurement indicative of gastroesophageal reflux; (b) ceasing providing power to the sensor circuit following the first time interval; (c) providing power to a transmitter circuit during a second time interval, following the first time interval so that a parameter signal indicative of the parameter measurement obtained by the sensor circuit can be transmitted to a receiver located outside of the body of the patient; and (d) ceasing providing power to the transmitter circuit following the second time interval. ### Claim 44 (depends on 43) The method of claim 43, wherein providing power to the sensor circuit comprises providing power to an ISFET transistor that is electrochemically activated by the pH of the fluid surrounding the implanted sensor and that produces a voltage signal that is proportionate to the pH of the fluid surrounding the implanted sensor. ### Claim 45 The method of 44, wherein power is provided to the sensor for approximately 20 ms during the first time interval. ### Claim 46 (depends on 44) The method of claim 44, further comprising providing a digital signal representative of the physiological parameter measured by the sensor so that providing power to the transmitter circuit results in the digital signal being transmitted to the receiver located outside of the body of the patient. ### Claim 47 (depends on 46) The method of claim 46, wherein providing power to the transmitter circuit during a second time interval comprises providing power to a RF transmitter. ### Claim 48 (depends on 47) The method of claim 47, wherein power is provided to the transmitter for approximately 60 ms during the second time interval. ### Claim 49 (depends on 43) The method of claim 43, wherein the acts (a) and (b) are periodically repeated every 6 seconds and steps (c) and (d) are periodically repeated every 12 seconds. ### Claim 50 A system for measuring physiological parameters in the body of a patient indicative of gastroesophageal reflux, the system comprising: a plurality of sensors adapted to be implanted in the body of the patient, wherein the plurality of sensors periodically measure a physiological parameter indicative of gastroesophageal reflux and wherein the plurality of sensors periodically transmit a signal indicative of the physiological parameter indicative of gastroesophageal reflux and wherein each signal includes an identifier indicative of the sensor from which each signal is sent; and a receiver that receives the signals from the plurality of transmitters and records the signals. ### Claim 51 (depends on 50) The system of claim 50, wherein each of the plurality of sensors includes a pH monitor and an RF transmitter. ### Claim 52 (depends on 51) The system of claim 51, wherein each sensor also includes a microprocessor that periodically receives a signal from the pH monitor and induces the RF transmitter to periodically send an RF signal indicative of the pH measured by the pH monitor. ### Claim 53 (depends on 52) The system of claim 52, wherein the microprocessor periodically enables the pH monitor during a first interval of each measurement cycle to obtain the pH signal and then disables the pH monitor during a second interval. ### Claim 54 (depends on 53) The system of claim 53, wherein the microprocessor enables the RF transmitter during the second interval and disables the RF transmitter during periods of each cycle other than the second interval and disables the pH monitor during periods of each cycle other than the first interval.