Patent Application
20160183819
The disclosed technology relates to the field of medical devices, in particular devices capable of sensing physiologic data based on sensors incorporated into a catheter or implant adapted to reside in any of a urinary tract, gastrointestinal tract, rectal location, pre-peritoneal or other implanted site.
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each such individual publication or patent application were specifically and individually indicated to be so incorporated by reference.
The Foley catheter, named for Dr. Frederick Foley who first described a self-retaining balloon catheter in 1929, has been in use since the 1930's, in a form nearly identical to its early models. In its most basic form, a Foley catheter has proximal portion that remains outside the body, a length that traverses the urethra, and a distal end that resides in the urinary bladder. The Foley catheter is held in place by an inflatable balloon that stabilizes the device in place, and prevents inadvertent withdrawal from the bladder. A typical Foley catheter includes at least two lumens along its length; one lumen serves as a conduit that drains the bladder, and the second lumen serves as a fluid conduit that allows the balloon to be controllably inflated and deflated.
Various developments have added diagnostic functionality to Foley type catheters, including the ability to measure pressure and temperature. For example, U.S. Pat. No. 5,389,217 of Singer discloses a catheter with oxygen sensing capability. U.S. Pat. No. 5,916,153 of Rhea and U.S. Pat. No. 6,434,418 of Neal both disclose a pressure sensor associated with a Foley type catheter. U.S. Pat. No. 6,602,243 to Noda discloses a temperature sensor associated with a Foley type catheter.
The Foley catheter, widespread in use, having a low cost, and easily put in place by health care professionals may offer still further opportunity as a vehicle for deriving critical diagnostic information. The technology disclosed herein provides for the delivery of highly resolved and previously unavailable diagnostic information, as may be derived from a Foley catheter with pressure sensing capability.
The disclosed technology relates to a Foley type catheter for sensing physiologic data from the urinary tract of a patient, the physiologic data particularly including those gathered by high fidelity pressure sensing and transduction into signals suitable for processing. In some embodiments, the pressure-sensing Foley type catheter may further be enabled to sense temperature and analytes of clinical significance.
Generally, one variation of a fluid pressure sensing assembly may comprise a catheter (such as a Foley type catheter) having a length and an expandable retention member located near or at a distal end of the catheter, the catheter defining a drainage lumen at least partially through the catheter length such that a distal end of the drainage lumen terminates at a drainage opening defined near or at the distal end of the catheter, a fluid chamber defining a receiving channel and a port fluidly coupled to the drainage lumen such that the receiving channel is in fluid communication with the drainage opening, and a pressure sensing mechanism located within the fluid chamber, wherein a fluid introduced into the drainage opening is received within the receiving channel and impinges upon the pressure sensing mechanism.
In use, the catheter may be positioned within a body lumen (as further described here) and a fluid from the body lumen may be introduced through the drainage opening and into the drainage lumen. The fluid may be received through a port fluidly coupled to the drainage lumen and into a receiving channel of a fluid chamber which is positioned external to the body lumen and the fluid pressure may be detected from the fluid impinging upon a pressure sensing mechanism located within the fluid chamber.
In another embodiment of the pressure sensing apparatus, a pressure sensing catheter having a pressure sensing mechanism may be located near or at a distal end of the pressure sensing catheter, wherein the pressure sensing catheter has a diameter sized for insertion within the drainage lumen. In this variation, the pressure sensing catheter may be positioned within the drainage lumen and detect the fluid pressure when the fluid from the body lumen is introduced through the drainage opening and into the drainage lumen.
Embodiments of the disclosed technology include an air handling system. Such embodiments may be configured for autopriming of the balloon. Embodiments may further include features that prevent clogging by an air bubble and/or water droplet prevention. Water droplet prevention feature may include a hydrophilic fiber. Embodiments may further include a detection and warning system to alert for the presence of a clog, air bubble or water.
Embodiments of the Foley type catheter include a pressure sensor having a pressure interface disposed at a distal end of the catheter, a pressure transducer at a proximal end of the catheter, and a fluid column disposed between the pressure interface and the pressure transducer. When an embodiment of catheter is appropriately or functionally inserted into the urinary tract of a patient and the distal end is residing in the bladder, the pressure transducer can transduce pressure impinging on it from the pressure interface into a chronological pressure profile. The pressure profile has sufficient resolution to be processed into one or more distinct physiologic pressure profiles, including peritoneal pressure, respiratory rate, and cardiac rate.
In some particular embodiments of the Foley type catheter, the pressure profile generated by the pressure sensor has sufficient resolution such that, when sampled by a transducer at a frequency of at least about 1 Hz, it can be processed to yield a relative pulmonary tidal volume profile. In still further embodiments of the Foley type catheter, the pressure profile generated by the pressure sensor has sufficient resolution such that, when sampled by a transducer at a frequency of at least about 5 Hz, it can be processed to yield physiologic pressure profiles selected from a group consisting of cardiac output, relative cardiac output, and absolute cardiac stroke volume.
In various embodiments of the catheter, the fluid within the fluid column may include a gas, such as air or carbon dioxide, or it may include a liquid. In some embodiments wherein the fluid column includes a liquid, such liquid may include urine, as sourced from the bladder.
In various embodiments of the catheter, the pressure interface may include an elastic membrane or a substantially inelastic membrane. In some embodiments, the pressure interface is substantially homogeneous across its surface area. In other embodiments, the pressure interface can be heterogeneous, having regions that vary in composition or thickness, or having features that provide an elasticity bias.
In particular embodiments of the catheter, the pressure interface includes an expandable balloon. Such an expandable balloon may include either an elastic membrane or a substantially inelastic membrane. Embodiments of the balloon, particularly those having an inelastic membrane, upon expansion, the balloon has a volume in the range of about 0.1 cc to about 2 cc. Other embodiments of the balloon, upon expansion, may have larger volumes, for example, in a range of about 2 cc to about 5 cc, or in a range of about 5 cc to about 250 cc, a volume that is greater than 250 cc. In another aspect, upon inflation, embodiments of the balloon may have a diameter that ranges between about 6 mm and 8 mm.
In various embodiments of the catheter, the pressure interface includes a membrane arranged across an opening. In such embodiments, the membrane is sufficiently elastic to respond to an internal-external pressure differential across its surface.
In some embodiments, the Foley type catheter further includes a temperature sensor to monitor a body core temperature of the patient. In these embodiments, the physiologic data from the temperature sensor in the system may be used to monitor body temperature and to feedback control delivery of a hypothermic treatment regimen. Temperatures sensors appropriate for the Foley type catheter may be of any conventional type, including by way of example, a thermistor, a thermocouple, or an optical temperature sensor.
In some embodiments, the Foley type catheter further includes one or more analyte sensors. Analyte sensors included in the scope of the disclosed technology include sensors for analytes of any clinical significance. For broad examples, such analytes may include any analyte selected from a group including pH, a gas, an electrolyte, a metabolic substrate, a metabolite, an enzyme, or a hormone. By way of particular examples, such analyte sensor may be able to sense any of a metabolic substrate or a metabolite, the analytes may include glucose or lactic acid. By way of example of a hormone, the analyte may include cortisol.
In some embodiments, the Foley type catheter further includes one or more electrodes arranged as electrical activity sensors. Such electrical activity sensors may deliver physiologic data that can be transformed to yield an electrocardiogram (EKG) or an electrogastrogram (EGG).
In some embodiments, the Foley type catheter further includes a light source and a light sensor, the sensor configured to capture light emitted from the light source. In some embodiments, by way of example, the light source and the light sensor may be configured to operate as a pulse oximeter, the light sensor being able to deliver a signal that can be transduced into a pulse rate. In another example, the light source and the light sensor may be configured to operate as an analyte sensor.
Some embodiments of the Foley type catheter may further include an expandable pressure-delivery balloon disposed on the catheter so as, upon expansion, to contact a wall of the bladder or the urethra; and a light source and a light sensor disposed proximate the tissue-compressing balloon. The pressure delivery balloon, the light source, and the light sensor may be arranged such that when the expandable pressure balloon is expanded so as to blanche a tissue surrounding it as detected by the light sensor, a light-based signal from the light sensor may be processed to yield a perfusion pressure on a urinary bladder wall or a urethra.
Some embodiments of the disclosed technology relate to a Foley type catheter for sensing pressure-based physiologic data from the urinary tract of a patient having a pressure sensor that includes a pressure interface and a transducer, the sensor not including a pressure-transmitting column. These embodiments typically have a pressure sensing mechanism or transducer proximate the pressure interface. Such pressure sensors may include, by way of example, any of a piezoelectric electric mechanism, an optical sensing mechanism, a microelectricalmcchanical (MEMS) mechanism, or an acoustic wave sensing mechanism. When the catheter is appropriately or functionally inserted into the urinary tract and the distal end is residing in the bladder, the pressure sensor can transduce pressure impinging on it from the pressure interface into a chronological pressure profile, the pressure profile having sufficient resolution to allow differentiation into one or more physiologic pressure profiles selected from the group consisting of peritoneal pressure, respiratory rate, and cardiac rate.
The disclosed technology relates to a Foley type catheter for sensing pressure-based physiologic data from the urinary tract of a patient, as summarized above, but further being enabled to sense a physiologic response to the delivery of pressure, and thereby to determine tissue perfusion pressures. Embodiments of the Foley type catheter include a pressure sensor having a pressure interface disposed at a distal end of the catheter, a pressure transducer at a proximal end of the catheter, and a fluid column disposed between the pressure interface and the pressure transducer. Embodiments of this type further include an expandable pressure-delivery balloon disposed on the catheter so as, upon expansion, to contact a wall of the bladder or the urethra, and a light source and a light sensor disposed proximate the tissue-compressing balloon. When an embodiment of catheter is appropriately or functionally inserted into the urinary tract with the distal end residing in the bladder, the pressure transducer can transduce pressure impinging on it from the pressure interface into a chronological pressure profile. The pressure profile has sufficient resolution to be processed into one or more distinct physiologic pressure profiles, including peritoneal pressure, respiratory rate, and cardiac rate. And when the expandable pressure balloon is expanded so as to blanche a tissue surrounding it (as detected by the light sensor), a light-based signal emanating from the light sensor may be processed to yield a perfusion pressure on a urinary bladder wall or a urethra.
The disclosed technology further relates to a system for sensing and processing physiologic data from the urinary tract of a patient, the physiologic data particularly including those gathered by high fidelity pressure sensing and transduction into signals suitable for processing; these embodiments will now be summarized. In some embodiments, the pressure-sensing Foley type system may further be enabled to sense and process temperature data and/or analyte data of clinical significance; these features and embodiments will be summarized further, below.
Thus, particular embodiments of the disclosed technology relate to a system for sensing pressure-based physiologic data from the urinary tract of a patient. Embodiments of the system include a Foley type catheter with a pressure sensor having a pressure interface disposed at a distal end of the catheter, a pressure transducer at a proximal end of the catheter, and a fluid column disposed between the pressure interface and the pressure transducer. When the catheter is appropriately or functionally inserted into the urinary tract and the distal end is residing in the bladder, the pressure transducer can transduce pressure impinging on it from the pressure interface into a chronological pressure profile. Embodiments of the system further include a data processing apparatus in communication with the pressure transducer so as to be able to acquire the physiological data. Embodiments of the data processing apparatus are configured to process the chronological pressure profile into one or more physiologic pressure profiles from the group including peritoneal pressure, respiratory rate, and cardiac rate.
In particular embodiments of the system, the pressure transducer is operable to sample pressure impinging on it at a rate of at least about 1 Hz. In embodiments such as these, the data processing apparatus may be configured to determine relative pulmonary tidal volume. In other particular embodiments of the system, the pressure transducer is operable to sample pressure impinging on it at a rate of at least about 5 Hz. In embodiments such as these, the data processing apparatus may be configured to determine any of cardiac output, relative cardiac output, or absolute cardiac stroke volume.
In particular embodiments of the system, the Foley type catheter may further include a temperature sensor to monitor body temperature. In embodiments such as these, the data processing apparatus may be further configured to acquire and process signals from temperature sensor.
In other embodiments of the system, the Foley type catheter may further include one or more analyte sensors. In embodiments such as these, the data processing apparatus is further configured to acquire and process signals from the one or more analyte sensors.
In some embodiments of the system, the data processing apparatus includes a stand-alone console. In some embodiments, the stand-alone console includes a bedside unit that is dedicated to monitoring a single patient. In some of these types of embodiments, the communication between the pressure transducer and the data processing apparatus is wireless.
In some embodiments of the system, the data processing apparatus includes a networked computer. In some of these types of embodiments, the networked computer is able to track data from a plurality of patients.
In particular embodiments of the system, the data processing apparatus may include both a stand-alone console and a networked computer. In some of these types of embodiments of this type, the stand-alone console and the networked computer are in communication with each other. In particular embodiments, the in communication between the stand-alone console and the networked computer is wireless.
In some embodiments of the system, the data processing apparatus may include a memory into which a normal range of values for the physiologic data may be entered, and the data processing apparatus may be configured to initiate an alarm when physiologic data of the patient are outside such range of normal values.
In some embodiments of the system, the data processing apparatus may include a memory configured to receive patient-specific clinical data from a source external to the Foley type catheter, and the data processing apparatus may be configured to integrate such external data and the Foley type catheter-derived physiologic data.
Some embodiments of the system may include a controller in communication with the data processing apparatus. In such embodiments, the controller may be configured to tune a level of pressure being applied through the fluid column against the proximal side of the pressure interface. Aspects of tuning the pressure level being applied distally against the pressure interface are expanded on below, in the context of summarizing methods provided by the disclosure. Further, in embodiments of the catheter that include a pressure delivery balloon that may be used in a method to measure tissue perfusion pressure, the controller may be configured to controllably expand such pressure delivery balloon.
In some embodiments of the system, the physiologic data from the pressure sensor may be used to track clinical parameters relevant to monitoring intraabdominal hypertension (IAH) or abdominal compartment syndrome (ACS). In other embodiments of the system, the physiologic data from the pressure sensor may be used to track clinical parameters relevant any of monitoring cardiac status, respiratory status, the onset and progression of hemorrhage or shock, patient bodily movement, or intestinal peristalsis.
As noted above, some embodiments of the disclosed technology relate to a system for sensing pressure-based and temperature-based physiologic data from the urinary tract of a patient, such system including a Foley type catheter with a pressure sensor and a temperature sensor. Embodiments of the pressure sensor have a pressure interface disposed at a distal end of the catheter, a pressure transducer at a proximal end of the catheter, and a fluid column disposed between the pressure interface and the pressure transducer. When the catheter is appropriately or functionally inserted into the urinary tract and the distal end is residing in the bladder, the pressure transducer transduces pressure impinging on it from the fluid column into physiological data comprising a chronological pressure profile. Embodiments of the system further include a data processing apparatus in communication with the pressure transducer so as to be able to acquire the physiological data. Embodiments of the data processing apparatus are configured to process the chronological pressure profile into one or more physiologic pressure profiles from the group including peritoneal pressure, respiratory rate, and cardiac rate. Embodiments of the data processing apparatus are further configured to acquire and process signals from the temperature sensor, such signals reporting the core body temperature of the patient.
Some embodiments of the disclosed technology relate to a system for sensing pressure-based and analyte-based physiologic data from the urinary tract of a patient, such system including a Foley type catheter with a pressure sensor and one or more analyte sensors. Embodiments of the pressure sensor have a pressure interface disposed at a distal end of the catheter, a pressure transducer at a proximal end of the catheter, and a fluid column disposed between the pressure interface and the pressure transducer. When the catheter is appropriately or functionally inserted into the urinary tract and the distal end is residing in the bladder, the pressure transducer transduces pressure impinging on it from the fluid column into physiological data comprising a chronological pressure profile. Embodiments of the system further include a data processing apparatus in communication with the pressure transducer so as to be able to acquire the physiological data. Embodiments of the data processing apparatus are configured to process the chronological pressure profile into one or more physiologic pressure profiles from the group including peritoneal pressure, respiratory rate, and cardiac rate. Embodiments of the data processing apparatus are further configured to acquire and process analyte signals from the one or more analyte sensors, such signals reporting the level of one or more analytes within the urinary tract.
As noted above, some embodiments of the disclosed technology relate to a system for sensing pressure-based, temperature-based, and analyte-based physiologic data from the urinary tract of a patient, such system including a Foley type catheter with a pressure sensor, a temperature sensor, and one or more analyte sensors. Embodiments of the pressure sensor have a pressure interface disposed at a distal end of the catheter, a pressure transducer at a proximal end of the catheter, and a fluid column disposed between the pressure interface and the pressure transducer. When the catheter is appropriately or functionally inserted into the urinary tract and the distal end is residing in the bladder, the pressure transducer transduces pressure impinging on it from the fluid column into physiological data comprising a chronological pressure profile. Embodiments of the system further include a data processing apparatus in communication with the pressure transducer so as to be able to acquire the physiological data. Embodiments of the data processing apparatus are configured to process the chronological pressure profile into one or more physiologic pressure profiles from the group including peritoneal pressure, respiratory rate, and cardiac rate. Embodiments of the data processing apparatus are further configured to acquire and process signals from the temperature sensor, such signals reporting the core body temperature of the patient. Embodiments of the data processing apparatus are further configured to acquire and process analyte signals from the one or more analyte sensors, such signals reporting the level of one or more analytes within the urinary tract.
In some embodiments of the system, the physiologic data from the any one or more of the sensors (pressure sensor, temperature sensor, and/or analyte sensor) may be used to track clinical parameters particularly relevant to monitoring clinical conditions brought about by metabolic diseases or diseases with pathophysiologic metabolic symptoms. For example, embodiments of the system may be used to monitor clinical parameters relevant to kidney function or diabetes. In other embodiments of the method, the physiologic data from the sensors, the pressure sensor in particular, may be used to monitor body movement.
Some embodiments of the system include a fluid-collecting receptacle to collect urine drained from the bladder, and the receptacle may include a fluid volume measuring system. In some of such embodiments, the fluid volume measuring system is configured to deliver data from which a urine output rate may be determined. Embodiments of the fluid volume measuring systems may include any of a weight-sensitive system, a fluid height sensing system, a mechanical mechanism, or an optically-sensitive system.
Some embodiments of the fluid-collecting receptacle may include a chemical analyte measuring system to identify and/or quantitate analytes such as those summarized for the Foley type catheter itself. More specifically, as example, analyte sensors may be sensitive to any one or more analytes selected from a group consisting of bacteria, blood, hemoglobin, leukocyte esterase, glucose, and particulate matter.
Some embodiments of the fluid-collecting receptacle may include an RFID chip for identification of the receptacle in communications with a data processing apparatus, or for conveying sensed data to the data processing apparatus.
Some embodiments of the system may include a docking station to accommodate the collecting receptacle, wherein the docking station and the collecting receptacle are in electrical communication with each other. Communication between the docking station and the collecting receptacle may occur by way of a data transmission line connecting the docking station to the console, or it may occur by way of a wireless communication system.
Some embodiments of the system may include a fluid infusion apparatus, with the data processing apparatus being configured to control the activity of the fluid infusion apparatus in response to physiologic data processed by the data processing apparatus.
Some embodiments of the disclosed technology relate to a method for monitoring physiologic data from the urinary tract of a patient. These physiologic data particularly include pressure-based data, but may further include temperature-based data and analyte-based data. In still further embodiments, delivery of pressure in combination with light-based data to yield tissue perfusion pressure values.
Embodiments of the method include providing a physiologic data monitoring system that includes a Foley type catheter and a data processing apparatus. Embodiments of the Foley type catheter have a pressure sensor, the pressure sensor having a pressure interface disposed at a distal end of the catheter, a pressure transducer at a proximal end of the catheter, and a fluid column disposed between the pressure interface and the pressure transducer, the pressure transducer being able to transduce pressure impinging on it from the fluid column into physiological data comprising a chronological pressure profile. The method may further include inserting the Foley type catheter in the urinary tract such that the pressure interface is residing within the patient's bladder; transferring pressure sensed in the bladder into a transducible chronological pressure profile; and processing the chronological pressure profile into one or more physiologic pressure profiles selected from the group consisting of peritoneal pressure, respiratory rate, and cardiac rate.
Some embodiments of the method include tuning or priming a level of pressure being applied from a proximal side of the pressure interface of a Foley type catheter toward equivalence with a baseline physiologic pressure being applied to a distal side of the pressure interface. Tuning pressure refers generally to either increasing or decreasing pressure applied to the proximal side of the pressure interface. Proximal, in this context, refers to the side of the pressure interface facing outward from the body (within the communicating fluid column), and toward the main body of the catheter or an operator handling the catheter. In one aspect, tuning the pressure level may refer to priming the fluid column from the proximal end of the column, directing pressure toward the distal end of the column. In another aspect, tuning the pressure level may refer to releasing or bleeding pressure from the proximal end of the column, as may be appropriate, for example, if pressure in the column overshoots a desired pressure level, or if pressure from within the bladder were to decrease. Embodiments of the method may further include repeating the tuning step, as needed, to maintain equivalence between the level of pressure being applied from the proximal side of the pressure interface and the baseline physiologic pressure being applied to a distal side of the pressure interface.
Embodiments of the tuning step of the method may include monitoring a physiologic pressure profile, and adjusting the pressure being applied from a proximal side of the pressure interface to a level such that a quality of a physiologic pressure profile being processed by the system is optimized. By way of example, the amplitude of pressure waves associated with the respiratory rate may be monitored. A high amplitude pressure profile may be considered optimal in that it is generally associated with conditions of equivalence between baseline pressure on either side of the pressure interface. In another aspect, a high amplitude pressure profile may be considered optimal because, other factors being equal, a high amplitude signal permits a higher level of resolution of real differences that may appear in signal level. In some embodiments, the monitoring step may be performed automatically by the data processor, and the adjusting step may be performed by an automatic controller in communication with the data processor.
The desire to prime the catheter is driven, at least in part, by leakage of gas from the fluid column. It has been observed, for example, that a Foley type catheter, per embodiments of the disclosed technology, that comprises a thin silicone membrane (e.g., a membrane with a thickness of 0.003 inch) leak about 2 cc of air per hour when under 15 mm Hg of pressure.
Some embodiments of the method may include applying pressure to the proximal side of the pressure interface by delivering gas under pressure a space proximal to the pressure interface. Delivering gas to the space proximal the pressure interface may be considered priming the space or tuning the space so as to equilibrate or substantially equilibrate pressure on either side of the pressure interface. The source of the gas, per embodiments of the technology, may be a compressed gas cylinder, or may be a pump using atmospheric air or other fluid. Any suitable biologically compatible gas may be used, including, by way of example, air or carbon dioxide.
In some embodiments of the method, appropriate for those in which the pressure interface includes a balloon formed from an inelastic membrane, the method further includes priming the fluid column from the proximal end of the catheter to maintain the balloon at a size that places no substantial strain on the inelastic membrane.
In some embodiments of the method, appropriate for those in which the pressure interface includes a balloon formed from an inelastic membrane having a total surface area, the method further include inflating the balloon to a level such that the total surface area of the membrane is substantially taut.
Some embodiments of the method include sampling the pressure profile impinging on the transducer at a frequency of at least 1 Hz, the method further comprising quantifying respiratory excursions relative to a baseline magnitude of excursions proximate the time of catheter insertion. These embodiments may particularly include monitoring the relative amplitude of respiratory pressure wave excursions, and relating such relative amplitude to relative respiratory tidal volumes.
Some embodiments of the method include sampling the pressure profile impinging on the transducer at a frequency of at least 5 Hz, the method further including quantifying peaks on the respiratory pressure wave that are associated with the cardiac rate. In particular embodiments of this type, against a background of a substantially stable peritoneal pressure, the method may further include determining any of cardiac output, relative cardiac output, respiratory tidal volume, or absolute cardiac stroke volume.
In some embodiments of the method, the one or more physiologic pressure profiles yielded by processing the chronological pressure profile may provide for monitoring of body movement. Monitoring body movement may be of particular benefit for bed-ridden patients, for example, who have a decubitis ulcer, or are at risk of developing such an ulcer when a portion of the body, such as a bony prominence, rests too long in a pressured position without movement that would relieve such pressure. Accordingly, monitoring body movement may include notifying a health care provider of the level of movement of a patient who is at risk of developing a decubitis ulcer, or at risk of exacerbating an existing decubitis ulcer. In addition, monitoring of patient activity may also affirmatively report the presence of movement. In this case, a patient that is a fall risk can be monitored for activity that may indicate an attempt to rise from their bed. This may signal an alert and prevent their mobility without assistance.
In some embodiments of the method, wherein the Foley type catheter has an expandable pressure delivery balloon, a light source and a light sensor proximate the expandable pressure balloon (the light sensor configured to capture light from the light source) the method may further include inflating the pressure delivery balloon to a desired pressure, and monitoring the pressure within the expandable balloon to determine the pressure level required to blanche the tissue, said blanching pressure being reflective of a tissue perfusion pressure.
In some embodiments of the method, wherein the Foley type catheter has a temperature sensor, the method may further include monitoring the body temperature of the patient. In some embodiments of the method, wherein the Foley type catheter further comprises an analyte sensor, the method further may further include monitoring a level of the analyte within the urine of the patient.
Embodiments of the disclosed technology include a method of mining data from pressure/acoustic signal. Such data may include values for parameters such as intraabdominal pressure, heart rate and stroke volume/cardiac output, respiratory rate and tidal volume, bowel activity, patient movement detection, behavioral compliance (periodic movement and/or immobility), seizure or shivering detection, cough frequency and severity, speech detection, and sleep duration and sleep quality. Dehydration may also be determined by monitoring respiratory rate, heart rate, blood pressure, temperature etc. Internal bleeding may also be determined by detecting increases in intraabdominal pressure. Blood volume changes as low as 50 cc or lower may be able to be detected.
Embodiments of the disclosed technology can determine the effectiveness of chest compressions during CPR or other lifesaving activities.
Embodiments of the disclosed technology may include product expiration technologies so that the products are not used for too long a period or re-used if disposable. For example, products may include a mechanical or electrical kill switch, which may be based on time frame, time frame from initial use, number of uses etc. Products may also be labeled with Radio-frequency identification (RFID) to prevent re-use. In some embodiments the controller reports and/or displays how long the catheter has been in use.
Embodiments of the disclosed technology may be configured for automation of feedback to control another device. Such automated aspects may include ventilator settings based on intraabdominal pressure (IAP), IV fluid infusion based on based on IAP, pressure-based diagnostics, drug delivery i.e., shivering prevention, paralytics, etc., temperature control as may be applied to fever prevention or therapeutic hypothermia, triggering urine flow with increased bladder pressure (which may be advantageous for allowing for natural downstream sweeping of bacteria and for reducing risk of infection), base station alerts with centralized reporting and data collection and synchronization with mobile alerts, and signal analysis and/or predictive algorithms to provide useful clinical data from sensors.
Embodiments of the disclosed technology may be configured for sensing in urine or on urinary tissues such as the urethral mucosa. Sensing capabilities to be applied to the urethral mucosa may include pH, microdialysis, pyruvatc, lactate, pO2, pCO2, perfusion index, near-infrared spectroscopy, laser Doppler flowmetry, urethral capnography, and orthogonal polarization spectroscopy, temperature, pulse oximetry, perfusion pressure, detection and prevention of infection, and detection of analytes that are informative regarding health status of the patient such as (merely by way of example) procaleitonin, lactoferrin, leukocyte esterase, specific gravity, pH, protein, glucose, ketones, blood, leukocyte esterase, nitrite, bilirubin, urobilinogen, ascorbic acid.
Embodiments of the disclosed technology include a device for sensing in the bladder or urethra, wherein the device may sense any one or more of temperature, acoustic detection of body sounds and sound transmission (such as those that may occur during speech, apnea, sleep apnea, respiratory wheezes/rhonchi, pneumonia, asthma, ARDS, cardiac tamponade, murmur), pulse oximetry, perfusion pressure, electrocardiogram, electromyogram, or pressure.
Various embodiments may be applied to any cavity or lumen (GI, urinary, gynecologic). Embodiments may further include implantable sensors (pre-peritoneal, bladder wall, etc.) and free floating sensors (GI tract, bladder, etc.). Pressure sensors included within the scope of the disclosed technology may be of any conventional type, such as those configured for air, fluid, or solid state transmission. Embodiments of the technology may include a battery backup that allows travel with patient. Embodiments may include a controller with its own display and alerts.
Embodiments of the disclosed technology include embodiments where the retention balloon is only slightly inflated in order to increase balloon sensitivity to small changes in pressure. This may allow for finer measurements of micro parameters, such as heart rate, relative stroke volume, relative cardiac output, respiratory rate, and relative tidal volume.
Embodiments of the disclosed technology include a fully implantable device or a device fully enclosed in a luminal site (temporary or long-term) and may be used to sense any of the parameters disclosed above, and report these parameters externally to provide diagnostic information to the healthcare provider. Implantable embodiments may be enabled with pressure sensing capability as well as one or more analyte sensing capabilities, and further may be enabled with data processing capabilities to yield values for various physiologic parameters, as has been described herein, in the context of the sensing Foley catheter embodiments.
Implantable embodiments may employ a balloon positioned in the pre-peritoneal space. The balloon may be in fluid communication with a pressure sensor within the device and the pressure reported, intermittently or continuously, externally. The implantable device may also be rechargeable and may report any parameters mentioned herein. In particular, the implantable device, or an external controller, may be capable of extracting information from the pressure signal to give an indicator of respiratory rate, cardiac rate and/or relative cardiac output or relative stroke volume. The implantable device may be placed fully within the preperitoneal space or may be partially or fully placed within the subcutaneous space. The device may be recharged transdermally, possibly in its preperitoneal site or via a tethered antenna implanted closer to the skin. The device may have its battery changed once every few years or may be inductively powered or recharged by a custom belt that may be worn over the device for all or part of the day. The device may have therapeutic abilities and be able to perform an action based on sensed parameters. In addition to calling help, the device may be able to deliver a shock in response to changes in cardiac output, stroke volume, and/or heart rate sensed by the device or deliver a drug in response to any changes in the sensed parameters. The device may also communicate with the patient through a receiver or smart phone which may allow for automatic uploading of data to a healthcare provider. The device can be implanted anywhere in the body. In a preferred embodiment, for optimal acoustic and pressure data, the device may be placed in the pre-peritoneal space superior to the umbilicus just below the xiphoid. This embodiment may measure respiratory rate, cardiac rate, relative cardiac output, relative stroke volume, patient activity level, or peristaltic activity and data processing by way of algorithms may be applied to yield clinically applicable information. By applying the algorithms of this present technology (for example, by selectively filtering the noise, extracting frequencies, or reporting certain frequencies as physiologic signals), each of these parameters may be obtained from the peritoneal pressure signal.
Other body sounds, such as bowel sounds, heart sounds, and respiratory sounds may also be transmitted and detected in order to detect pathology related to changes in these sounds (for example, bowel obstruction, pneumonia, or decreased cardiac output). In some embodiments, the device has adequate hoop strength to support an acoustic/pressure sensing membrane to ensure that capsular contracture does not occur. In these embodiments the hoop may be constructed of nitinol to allow for its compression into a small delivery package. The preperitoneal space may be dissected using a blunt dissection tool at an angle to the peritoneal lining and the device deployed into this space by expansion into a larger configuration. In some embodiments, this design may also include a small catheter for accessing the peritoneal cavity to sense analytes within the peritoneal fluid and/or deliver compounds to this space. Implantable embodiments may be used as long-term implants monitoring chronic conditions (ie monitoring for fluid on the lungs, cardiac output, etc. for congestive heart failure, monitoring heart rate and respiratory rate for any condition that can cause acute decompensation, etc.) while allowing the patient to remain ambulatory. The implantable device may be positioned close to any organ of interest (i.e. over lower quadrants for monitoring of bowel sounds).
Embodiments of the disclosed technology include embodiments where temperature is measured and tracked over time. Also, acceleration data may be recorded and used to measure patient activity levels. Acceleration data may also be combined with other data, such as pressure and acoustic data, to more accurately identify events such as coughs or sneezes and filter out external artifacts. In other embodiments, the device may have offset electrodes to measure electrical cardiac activity. In other embodiments, the device may also have a glucose sensor that can continuously track the patient's blood glucose levels.
Embodiments of the disclosed technology include acoustic detection of body sounds and sound transmission through the use of a microphone and/or an acoustic signal generator and/or other technologies disposed within the sensing catheter or implant. Acoustic sound detection may also allow for the detection of speech, sleep apnea, sleep stage characterization, respiratory wheezes/rhonchi, pneumonia, asthma, acute respiratory distress, or other abnormal respiratory sounds, intestinal sounds, or cardiac sounds. Acoustic sound detection may also be used to detect changes in heart sounds that may occur with progression or onset of an illness (ie the third heart sound) or changes in bowel sounds that may indicate progression or onset of an illness (ie high pitched bowel sounds with bowel obstruction in high risk candidates).
Embodiments of the disclosed technology include embodiments which are able to detect indicators or markers of infection, such as, by way of example, urine nitrates, urine pH, glucose, leukocyte esterase, etc. These markers may be continuously or intermittently monitored. In these embodiments, a change in such infection markers in the urine may be detected and reported to prompt further investigation of a potential urinary tract infection and/or removal or replacement of the catheter. A catheter with this sensing capability may be able to be left in place for a longer duration for some patients, such as those considered at risk but who have not yet shown signs of infection. A shorter implantation period may be appropriate for patients who have already been diagnosed with an infection, in which case the catheter may be useful for monitoring resolution of an infection while the patient is being treated.
These embodiments allow infections to be prevented and/or treated early and have the potential to allow optimal residence time for each individual catheter versus the relatively arbitrary recommendation to remove and replace all Foley catheters after 7 days of dwell time. Urinary tract infections may also be rapidly detected and treated, thus resulting in a shorter overall hospital stay for these patients. Sensors within the catheter or within the collection reservoir may also detect urine flow rate (catheter or reservoir based), bacteria presence, procaleitonin, lactoferrin, leukocyte esterase, specific gravity, pH, protein, glucose, ketones, blood, leukocyte esterase, nitrite, bilirubin, urobilinogen, ascorbic acid. The pressure sensor may also allow for triggering of urine flow with increased bladder pressure, which mimics the natural flow of urine and sweeps bacteria downstream (and may reduce infection). In this scenario, a valve may be incorporated into the urine outflow line that may be intermittently opened and closed based on bladder pressure.
These embodiments may allow rinsing lavage of the bladder, so as to treat infection or other insult or injury to the bladder. A lavage may serve, for example, to cleanse the bladder interior of bacteria or blood clots. Further, anti-infective agents may be delivered through embodiments of the disclosed catheter.
A balloon or an infusion catheter that slowly infuses fluid may also be used to sense peritoneal or intraabdominal or other pressure through placement in peritoneal sites other than the bladder, such as the rectum or stomach. Regardless of where the sensing occurs (bladder, rectum, stomach, etc.) or whether the pressure transmission medium is liquid or air, the method of determining parameters such as respiratory rate, cardiac rate, relative cardiac output, relative stroke volume, patient activity level, or peristaltic activity, data processing by way of algorithms may be applied to yield clinically applicable information. By applying the algorithms of this present technology (for example, by selectively filtering the noise, extracting frequencies, or reporting certain frequencies as physiologic signals), each of these parameters can be obtained from this peritoneal pressure signal. Other body sounds, such as bowel sounds, heart sounds, and respiratory sounds may also be transmitted and detected in order to detect pathology related to changes in these sounds (for example, bowel obstruction, pneumonia, or decreased cardiac output).
In some embodiments, noise filtering may have requirements particular physiological pressure measurements. For example, noise in this situation may include patient coughing, moving, or other types of noise not normally found in signal filtering algorithms. Some embodiments may, for example, measure heart rate and then use this rate to determine a physiological range for acceptable heart rate. If the heart rate is measured beyond this range (either above or below it), the controller may determine that the signal is noisy and either ignore it, or apply noise filtering technology to the signal. The same method may be applied to other, somewhat predictable, signals, such as respiratory rate, respiratory pressure, IAP, etc.
Other signal filtering techniques may be used to distinguish between noise and actual signal. For example, the respiratory frequency and the heart frequency signals are generally distinct from each other. However, under certain circumstances, the frequencies may overlap. In this situation other factors may need to be considered in the pressure signal analysis algorithm, for example signal amplitude.
Some embodiments of the disclosed system may be functionally directed to the delivery of therapeutic hypothermia. In this clinical application, the catheter may be equipped to measure bladder pressure, as above, measure urethral temperature, and be able to drain urine and add fluid to the bladder. In this embodiment, the catheter may be used to warm or cool the patient (mild to moderate hyperthermia or mild to moderate hypothermia) via the infusion of a warm or cold fluid as appropriate. In the generation of mild to moderate hypothermia, the bladder may be evacuated then refilled to a set pressure with an ice-cold medium (a cold fluid, or a chilled slurry or slush) while the core body temperature is monitored. In this embodiment, an initial fill of the bladder with cold medium may be sufficient to generate the desired degree of hypothermia, or the temperature of the fluid may be tracked (in some embodiments, by way of a second temperature sensor in the bladder) and evacuated once it rises above a set temperature (e.g., 15° C.). If the desired patient temperature has not yet been reached, the bladder may then be refilled with the liquid/slurry and evacuated until the patient has achieved their target temperature.
In some embodiments, the therapeutic hypothermia process is automated by the system, requiring only that a clinician insert a sensing Foley catheter embodiment, and then connecting the catheter to the temperature control system and/or any patient monitor that the clinician desires. In some embodiments, the infused fluid is a slush to take advantage of the much greater watt extraction capabilities of slush in comparison to a cold fluid. In some embodiments, the sensing Foley catheter is able to sense one or more of the other parameters mentioned above (such as respiratory rate, or oximetry) during and following this therapy. The cold medium (slush and/or fluid) may be used to induce hypothermia, and the bladder may be evacuated once the target temperature is reached. As the body temperature rises, the slush and/or fluid may be introduced into the bladder then evacuated, again, as the target temperature is reached. In this embodiment, the resting state of the bladder is the evacuated state and it only contains chilled fluid or ice when the body is not within target temperature range. In some embodiments, the slush may be formed on-demand in a manner that allows it to be carried into the field or ambulance, and then created on-site, in order to treat trauma or injury as it occurs. This on-demand aspect of the method embodiment may involve a pre-frozen block of ice that is shaved or ground, or a compressed gas source that vents into the liquid, thereby causing a rapid drop in temperature. This compressed gas embodiment may be used either to generate a slush, or to cool the medium while allowing it to remain a liquid.
A similar technique may be used with certain embodiments to induce hyperthermia with a warm or hot liquid.
Variations of the embodiments described above for use in the bladder, may be reconfigured and/or resized for application in other luminal body sites such as the stomach, esophagus, small intestine, large intestine or rectum. In some embodiments, these data may be obtained through invasive access of the peritoneal cavity, cerebrospinal space or pleural space, ideally in instances where accessing these spaces is already performed for another purpose.
Some embodiments of the device may incorporate mechanisms to keep the urine lumen, or other lumen, clear of blockages in order to maintain an empty, flaccid bladder and avoid false positive IAP measurements. These blockages may be caused by airlocks in the drainage tube or by crystals, blood clots, or other physical blockages. Any of the embodiments to keep the line clear as described in Burnett PCT/US2013/060003, herein incorporated by reference, would be suitable. In one embodiment, this is accomplished with active line clearing, such as a bellows to provide negative pressure or a pump to clear obstructions. This embodiment allows for clearing of both airlocks and physical blockages. In another embodiment, the line clearing is passive, and may be accomplished with vents that allow air to escape the drainage line instead of forming airlocks. In yet another embodiment, the LAP measurements from the present device may be combined with urine output measurements obtained with the Burnett device, in any manner they have disclosed.
Some embodiments of the disclosed technology may comprise methods of pressure measurement in other anatomic locations and/or combined with existing medical devices. In one embodiment, the pressure-sensing system of the present invention may be used with ascites shunts in order to ensure that the shunt is draining and has not become obstructed. In another embodiment, the pressure-sensing system may be used with dialysis catheters. In another embodiment, the system may be used with insulin delivery catheters. Generally, the system may be used with any shunting, infusing, or other similar applications where fluid blockage may be of a concern and a pressure measurement would help identify whether a blockage has occurred.
Embodiments of the disclosed technology may integrate with, or link to other medical system, including an Electronic Health Record (EHR), Electronic Medical Record (EMR), clinical trial software, research software, medical monitoring systems, EKG systems, infusion systems, drug delivery systems, heart rate monitor systems, body vital sign monitoring systems, respiratory rate systems, etc. For example, pressure data collected from any of the embodiments discussed herein may be imported into, or integrated with an EMR so that a physician has a full picture of a patient. Any other data collected and/or analyzed by the disclosed embodiments can be used in a similar way. For example, a user may analyze clinical trial data which has been integrated with a controller incorporated into one of the disclosed embodiments. The user may view individual patient data to determine if there is any data to support abnormal heart rate, abdominal pressure, urine flow etc. Integration with an EHR may be done via a standard web browser using html and frames/windows/window areas, or XML or using any other appropriate standard or technology.
Data from disclosed embodiments, either alone, or in conjunction with data from integrated systems, may be stored, tracked and/or mined. The disclosed systems may “learn” from the stored data in such a way to provide recommendations on treatment or diagnoses. Systems may be networked so that data from more than one patient can be aggregated and used for this purpose. For example, embodiments of the disclosed technology may analyze data from multiple patients who have an elevated respiration rate, an elevated heart rate, and/or increased intraabdominal pressure. By analyzing data from these patients in conjunction with data from the EHR, embodiments of the disclosed technology may be able to determine that patients with this data profile, are more likely to have a particular disease and may therefor recommend a blood test, or may automatically perform a urine analyte test.
In the same way, an upward trending temperature in conjunction with one or more other measured parameters may be an indication of infection. Additional tests, or an infusion, may be recommended or performed on the patient automatically or with user confirmation.
Data may also be tracked to determine the time until obstruction and/or infection for one patient, or across multiple patients.
Embodiments of the technology include a sterile to non-sterile attachment between the catheter device and the pressure transducer. Since the catheter may be sterile and disposable and the pressure transducer may not be sterile nor disposable, it is important to be able to connect the two components without increasing the risk of infection to the patient. Filter paper, such as 0.2 micron filter paper, or other suitable material, may cover the portion of the catheter where the pressure transducer connects to the catheter.
Embodiments of the technology may include a pressure sensor and logic to manage the balloon inflation of the retention balloon in addition to the pressure balloon. In some embodiments the retention balloon can serve as both a retention balloon and a pressure balloon, this may be particularly applicable when only IAP is being measured. In other embodiments, the retention balloon can sense pressure and the logic of the controller can detect when the pressure of the retention balloon falls outside expected ranges, and may alert the user in some way, such as an alarm. For example, if the catheter is tugged, or the patient tries to remove it, the pressure in the retention balloon will increase. This increase in pressure could be programmed to sound an alarm. In another example, a technician may attempt to inflate the retention balloon before the catheter tip is fully placed within the bladder. In this case, if the retention balloon were inflated in the urethra, the pressure would be higher than normal and an alarm or other alert could result. Acceptable retention balloon pressure ranges may be determined by tracking retention balloon pressures across several patients to determine the normal range of pressures. Pressures outside of this range may be programmed to send/sound an alert, or to automatically reduce the balloon pressure.
Pressure sensing can also be used in either the retention balloon or pressure balloon to detect bladder spasms. A sudden, or repeated, change in pressure could be an indication of bladder spasm. The controller may be programmed to send an alert, or to change the pressure of the balloon when an apparent bladder spasm is occurring.
Embodiments of the technology may include acoustic sensing to determine the size and/or volume of the bladder. This technology may be useful in determining the air in the bladder, or the Gastric Residual Volume (GRV). Bladder size may be measured by creating and sensing acoustic waves and determining the time between wave emission and wave sensing after the wave has bounced off of the bladder wall. This measurement may be performed at one or more than one location within the bladder.
Another method of measuring bladder volume includes measuring the temperature change within the bladder using an embodiment of the present invention after introduction of a cool or warm fluid. The time it takes to warm or cool the fluid in the bladder is related to the bladder volume.
Embodiments of the technology may include self cleaning technologies. For example, a Foley catheter system may be automatically flushed with saline. A Foley catheter may also be purged by using natural bladder pressure, or by various pumping/pressure mechanisms disclosed herein.
Embodiments of the technology may include the ability to detect deficient connections within the system. For example, mechanical sensors may detect integrity of the connections between any components of the system. Alternatively, connection integrity may be sensed through small pressure changes, or other pressure sensors.
Embodiments of the technology may include alternative materials for the Foley catheter system. For example, the catheter shaft, or part of the catheter shaft, may include an outer, inner or embedded braid or other more rigid material to prevent the catheter from kinking. For example, the pressure lumen may have a more rigid inner surface, such as a polymer, braid etc. The added rigidity may also increase the sensitivity of pressure measurements through the lumen.
Embodiments of the technology include an implantable sensor for vital sign monitoring, as particularly suitable for a patient in battlefield or transport setting, prior to being secured into a hospital setting.
Embodiments of the technology include a free-floating transmitting bladder embodiment. Embodiments of the technology include a free-floating transmitting stomach embodiment. Embodiments of the technology include an ingestible, self-destructing capsule. Embodiments of the technology include vagina, stomach, intestine, esophagus, or a rectum sensor.
Embodiments of the technology include a catheter for sensing physiological data from a urinary tract of a patient comprising a pressure sensor comprising a pressure interface disposed at a distal end of the catheter, a first pressure transducer at a proximal end of the catheter, and a first fluid column disposed between the pressure interface and the first pressure transducer, a second pressure transducer at the proximal end of the catheter and a second fluid column disposed between the pressure interface and the second pressure transducer, wherein, when the catheter is inserted into the urinary tract and the distal end is residing in the bladder, the first pressure transducer can transduce pressure impinging on it from the pressure interface into a first chronological pressure profile, and the second pressure transducer can transduce pressure impinging on it from the pressure interface into a second chronological pressure profile.
Embodiments include a catheter where the first fluid column and the second fluid column are separate fluid columns for the length of the catheter.
Embodiments include a catheter where the first fluid column and the second fluid column are separate fluid columns for part of the length of the catheter, and the same fluid column for part of the length of the catheter.
Embodiments include a catheter where the first fluid column and the second fluid column are the same fluid column for the length of the catheter.
Embodiments include a catheter where the pressure interface comprises a balloon.
Embodiments include a catheter where at least one fluid column is in communication with a physical filter.
In some embodiments, the bedside console or controller is portable and able to travel with the patient Embodiments of console may be attachable to a patient's bed or an IV pole, or a wall mount; it typically has its own display, and is able to provide critical alerts. Some embodiments of console may be adapted to be able to operate on a battery backup for 4 or more hours, as for example when wall power is unavailable or has been lost. This portability feature of console is advantageous in situations where patients are typically not being electronically monitored, such as when a patient is in transit from his or her bed to another location. Embodiments of console may also be configured to communicate to a base station with alerts and centralized reporting and data collection. A controller or base station may also generate mobile alerts that may be sent to nurses or healthcare provider. Signal analysis and/or predictive algorithms may also be used to provide useful clinical data from sensors.
Embodiments of the receptacle may include a capability to report sensing data to the bedside console, locally (e.g., by beeping) or centrally via piping data to a central information collection area. For example, an alert may be triggered if urine output drops below 30 cc/hr. in post-operative setting or below any otherwise predetermined threshold. Embodiments of the receptacle may connect to a docking station through electrical contacts; data communication among embodiments of the receptacle, docking station, and a console or central computer may also be wireless. If a docking station is used, it may detect urine output based on weight or pressure of the receptacle that is applied to base.
Embodiments of the urine collecting receptacle may include disposable or durable optical, electrical or chemical sensors capable of sensing and measuring urine content of analytes such as glucose, electrolytes, bacteria, hemoglobin, or blood. Embodiments of the receptacle may include an interface with specifically designed area of the urine receptacle to allow for this measurement, such as an optically clear window for optical measurement of blood. Embodiments of the receptacle docking station may also grasp or accommodate the urine receptacle in any manner so long as it secures the receptacle. The docking station or the receptacle may include an inductive antenna or RFID capabilities to allow for wireless querying and reporting of the level of urine or other fluid collection.
The embodiment of
Various internal lumens traverse the length of the catheter, such as an air or fluid 24 that communicates with a bladder retention balloon 36. A urine drainage lumen 23 has a distal opening 41 that resides in the bladder portion 12 of the catheter, and has an opening at the proximal end 14 of the catheter. As seen in
An inflatable pressure-sensing balloon 38 (
Pulse oximetry elements allow for a determination of blood oxygen concentration or saturation, and may be disposed anywhere along the urethral length of the catheter. In some embodiments, the sensor or sensors are disposed within the tubing of the device to ensure approximation to the urethral mucosa. With this technology, a healthcare provider can decompress the bladder with a urinary catheter and obtain pulse oximetry data in a repeatable and accurate manner. The power source for pulse oximetry may be incorporated within the urinary collecting receptacle or within the catheter itself. In some embodiments, the pulse oximeter is reusable and the catheter interface is disposable; in this arrangement the pulse oximeter is reversibly attached to the disposable catheter and removed when oxygen measurements are no longer desired. Embodiments of the sensing Foley catheter may include an optically transparent, or sufficiently transparent, channel for the oximetry signal, such as a fiber-optic cable, transparent window, and an interface for the reusable oximeter. This method and device for urethral pulse oximetry may be used in conjunction with any of the other embodiments detailed herein or may be a stand-alone device.
Embodiments of the sensing Foley catheter may be able to sense any one or more of a plurality of clinically relevant parameters, such as included in the following examples: urine pH, urine oxygen content, urine nitrate content, respiratory rate, heart rate, perfusion pressure of the bladder wall or the urethral wall, temperature inside the bladder or the urethra, electro-cardiography via sensors on the bladder wall or the urethra, respiratory volume, respiratory pressure, peritoneal pressure, urine glucose, blood glucose via urethral mucosa and/or bladder mucosa, urine proteins, urine hemoglobin, blood pressure. In some embodiments, the catheter can sense multiple parameters, but some embodiments may be limited to as few as a single parameter for focused applications (for example, respiratory rate in a patient in respiratory distress). The respiratory rate, relative tidal volume, peritoneal pressure, heart rate and/or relative cardiac output may be measured simultaneously, as well, by connecting a balloon with a flaccid wall or semi-tense wall to an external pressure sensor via a lumen that may be filled with liquid and/or gas.
These parameters may be measured, alone or in concert with other parameters, through the use of pressure measurement modalities other than the external pressure sensor. These may include: a deflecting membrane inside of the catheter, MEMs technology, a catheter-based sensor and/or other embodiments.
Relative cardiac output and relative tidal volume may also be calculated, based on the deflection of the pressure sensor and/or other force gauge. If sampled with sufficient frequency (e.g., 1 Hz or greater), respiratory excursions can be quantified in a relative manner to the amplitude of the excursions at the time of catheter placement. Larger excursions generally relate to heavier breathing, or in the setting of an upward drift in the baseline, a higher peritoneal pressure. The small peaks on the oscillating respiratory wave, caused by the pumping heart, may be tracked as well by using faster sampling rates (e.g., 5 Hz or greater), and the amplitude of this wave may be used, in the setting of a relatively constant peritoneal pressure, to determine the relative cardiac output, in the setting of a known, stable peritoneal pressure, absolute stroke volume and/or cardiac output.
The disclosed technology captures a high-resolution chronological profile (pressure as a function of time) of peritoneal pressure that can be transduced and processed into distinct pressure profiles assignable to particular physiologic sources, including peritoneal pressure, respiratory rate, and cardiac rate. By tracking the pressure profile at a sufficiently rapid sampling rate, as provided by the technology, the pressure profile can be further resolved into relative pulmonary tidal volume, cardiac output, relative cardiac output, and absolute cardiac stroke volume.
Accordingly, aspects of the disclosed technology relate to fidelity and resolution of a pressure signal generated in response to changes in pressure within the bladder, such changes being reflective of a pressure profile within the peritoneal cavity, such pressure profile including cumulative input from the aforementioned physiologic sources. Aspects of the technology further relate to fidelity and resolution of the transduction of the pressure signal into a highly resolvable electrical signal. Aspects of the technology relate still further to processing the totality of the electrical signal profile, a surrogate for the pressure profile within the peritoneal cavity, into component profiles that can be assigned to the physiologic sources.
The sensitivity of an inflated balloon as a pressure sensor is a function, in part, of the pressure differential across the balloon membrane as a baseline condition. The balloon has the greatest sensitivity to pressure when the baseline pressure differential is near zero. As the baseline pressure differential increases, the sensitivity of the pressure-sensing balloon degrades. Accordingly, the disclosed technology provides an automatic priming method that maintains the balloon in an inflated state, but with a minimal pressure differential.
Embodiments of the technology include a pressure interface as may be represented by a balloon having either a compliant membrane or a non-compliant membrane. In general, considerations related to optimizing the pressure around the pressure interface of the device are informed by Boyle's ideal gas law, the relationship between stress and strain as described by Hooke, and by application of Young's modulus. The conditions for optimal sensitivity of a compliant balloon and a non-compliant balloon are slightly different, although, in general, the sensitivity of each is best served by P1 and P2 being approximately equal. A non-compliant balloon maximum sensitivity is achieved when P1 is only slightly above P2. For a compliant balloon, the maximum sensitivity is achieved when P1 is slightly above P2 at the low end of the (linear) elastic region of the spring constant of the compliant balloon material.
To effectively capture physiologic pressure profiles, the profiles need to be sampled at a rate that is sufficient to resolve the inherent frequency of changes in the profile. This consideration is informed by the Nyquist-Shannon sampling theorem, which states that a sampling frequency of at least 2B samples/second is required to resolve an event that runs at a frequency of B cycles/second. As applied to a physiologic pressure cycle, for example, a cardiac rate of 70 beats/minute requires a sampling rate of at least 140 samples/minute to effectively capture the cycle. This relationship underlies aspects of the disclosed technology that specify the sampling rate particularly required to capture physiologic pressure cycles such as relative pulmonary tidal volume, cardiac output, relative cardiac output, and absolute cardiac stroke volume.
Expandable pressure sensing balloons, per embodiments of the technology, may assume one of at least two basic forms, type 1 or type 2. In balloon embodiments of type 1, which may be generally likened to a conventional party balloon, the pressure-sensing balloon is formed from or includes a compliant or elastic membrane. Accordingly, the surface area of the membrane expands or contracts as a function of the expansion of the balloon. The elasticity of the membrane determines various features of the balloon, as a whole, at different levels of expansion. Upon expansion, the balloon, if unconstrained, maintains a substantially constant or preferred form or shape, as determined by the mandrel upon which the balloon is formed. Upon expansion of the balloon from a minimal volume to its maximal volume, the membrane of the balloon maintains a level of tautness. Within the limits of elasticity of the compliant membrane, an increase in pressure during inflation results in a consequent expansion of volume. The balloon, on the whole may be considered partially compliant in that its shape responds to spatial constraints that it may encounter upon expansion or inflation, however the balloon does have a preferred or native shape, and such shape preference prevents a level of shape compliance or conformability such as that shown by a balloon of type 2.
In balloon embodiments of type 2, the expandable pressure-sensing balloon is formed from or includes a non-compliant, or non-elastic membrane, or a membrane that is substantially non-compliant or non-elastic. Accordingly, the surface area of the membrane does not expand or contract in accordance with the level of balloon expansion. Type 2 pressure-sensing balloons may be generally likened to a conventional Mylar® balloon. The inelasticity of the membrane determines various features of the balloon, as a whole, at different levels of expansion. Upon expansion of the balloon from a minimal volume to a level near its maximal volume, the membrane of the balloon is supple, and has a level of slackness. Expansion of a type 2 balloon occurs by way of outwardly directed smoothing of wrinkles and folds in the membrane. Deflation or compression of a type 2 balloon occurs by way of generally inwardly directed wrinkling and infolding. When a type 2 balloon is fully inflated (or substantially inflated) without being in a confining space, it assumes a preferred or native shape as determined by the geometry of the membrane or fabric of the balloon. However, in a state of partial inflation, the balloon, as a whole, is highly supple and conformable, broadly taking the shape as may be dictated by a confining space.
Expandable pressure sensing balloons, per embodiments of the technology, may also include features of both of the two basic forms, type 1 or type 2. In these embodiments, the membrane may include regions that are elastic (like type 1) and regions that are inelastic (like type 2). A balloon of this hybrid type would, as a whole, behave in a manner drawing from behavioral aspects of both type 1 and type 2 balloons, as described above. Further, type 1 balloons may be formed with a membrane that is not of a homogeneous composition or thickness. In such embodiments, regions of different thickness or composition could have varying degrees of elasticity, thus affecting the behavior of these regions during expansion of the balloon. In still other embodiments, elasticity of the membrane may have a bias or polarity that tends to permit elasticity in one or more directions, and tends to disallow elasticity in one or more other directions.
An aspect of the disclosed technology that is particularly advantageous in achieving a high resolution signal from which pressure profiles from particular physiologic sources (such as peritoneal pressure, respiratory rate, and cardiac rate, relative pulmonary tidal volume, cardiac output, relative cardiac output, and absolute cardiac stroke volume) may be monitored relates to adjusting and maintaining a balance of pressure on either side of the pressure interface represented by the membrane of the pressure sensing balloon. This balance of pressure may be referred to as a pressure differential of zero, or as a zero pressure gauge. Pressure impinging on the external face of balloon (facing the internal aspect of the bladder) is subject to change according to the physiology of the patient. Pressure on the internal face of the balloon (which is in fluid communication with the fluid column) is subject to degradation because of fluid leakage and imperfect seals.
Upon first insertion of the Foley type catheter, external pressure is typically applied to the fluid column and against the pressure interface to a first approximation of pressure being exerted on the pressure interface from within the bladder. Pressure signals, as measured across a pressure interface, have a maximal amplitude when the pressure differential is zero. Accordingly, the amplitude of a pressure signal can be used to tune the pressure being applied from the fluid column against the pressure interface. This process of applying an appropriate amount of pressure against the interface may be referred to as priming the fluid column or priming the balloon. Inasmuch as pressures on either side of the pressure interface may change, as described above, the fluid column may need to be reprimed or re-tuned, from time to time. The necessity of repriming can be monitored by testing small changes in pressure so as to achieve maximal amplitude of a pressure signal profile.
Embodiments of the disclosed system and method include automatic pressure tuning by a controller. Accordingly, the tuning system can detect the optimum target pressure and volume to inflate the balloon by monitoring sensed pressure signals and adding or removing air or fluid volume as needed. For example, upon insertion of the catheter, a pressure tuning circuit that regulates the balloon volume and pressure may inflate the balloon until it detects a physiologic-sourced pressure rate. Upon sensing that rate, the pressure tuning controller may add or subtract minute amounts of air in a routinized sequence until the amplitude of the sensed wave is greatest. The control feedback loop between the optimally tuned pressure (manifesting as balloon pressure and volume) and the sensed physiologic pressure profile iterates continuously and or as needed to ensure high fidelity measurement of the physiologic data. In some embodiments, automatic pressure tuning may be performed in the apparent background while the physiologic data is being transmitted and displayed; in other embodiments the system may suspend transmission of physiologic data during a pressure tuning sequence.
Embodiments of the disclosed technology include a gas delivery system that can deliver gas in a priming operation, whereby pressure can be applied to a fluid column proximal to the proximal-facing aspect of the pressure interface. A source of gas, such as compressed air or liquid is held in a storage tank. Using CO2 as an example, CO2 is controllably released from the storage tank through a pressure regulator that can step pressure in the tank (for example, pressure of about 850 psi) down to the range of about 1 psi to about 2 psi. Released gas passes through a filter and a pressure relief valve set at about 2.5 psi. The pressure relief valve is a safety feature that prevents flow through of gas at a level greater than 2.5 psi in the event of failure of the upstream regulator. CO2 exiting the pressure relief valve next passes through a first solenoid-controlled fill valve to enter the catheter line, ultimately filling the balloon that comprises the pressure-sensing interface. Pressure within the balloon is allowed to rise to a level as high as 30 mm Hg, whereupon the first solenoid-controlled valve closes. A second solenoid-controlled valve, distal to the first valve operates as a drain valve, which can release pressure from the catheter to a target pressure. Alternatively, the drain valve may be activated until a respiratory waveform is detected after which the balloon will be optimally primed and the valve will be closed. The drain valve may be subject to proportional control, operably based on voltage or pulse-width modulation (PWM), which allows a drain rate sufficiently slow that the target pressure is reached and the valve can be closed prior to overshoot. Alternatively, a peristaltic or other air pump may be utilized to fill the balloon with room air.
Intrabdominal pressure or bladder pressure, as sensed by an embodiment of the disclosed technology, may also be used to detect the level of patient movement (as may vary, for example, between substantially no movement to a high level of movement) and to report the movement level to a healthcare provider. A short burst of peaks and valleys in bladder pressure activity can serve as a proxy for body movement in that such a bladder pressure profile is a strong indicator that the patient is using their abdominal muscles, as, for example, to sit up or get out of bed. This embodiment may be of particular benefit for patients that are at risk of falling. In a patient that is a fall-risk, a healthcare provider may be notified that the patient is sitting up and respond accordingly. Alternatively, the device may be used to report inactivity of a patient and/or lack of patient movement.
Embodiments of the technology may also report patient movement in the detection or diagnosis of seizure disorder. In this embodiment, the pressure variations may trigger an EEG or recording equipment to allow for intense period of monitoring during an episode suspected of being a seizure. In addition, or alternatively, a pressure sensor, acoustic sensor or other sensors may be used to detect bowel activity, including peristalsis, patient movement, seizure activity, patient shivering, frequency of coughing, severity of coughing, sleep duration, sleep quality, speech detection, patient compliance (movement or lack thereof), and may alert the healthcare provider that the patient has not moved and must be turned or rolled. This movement-related information may also be relayed to a hypothermia device, a drug delivery device or other device to control or mitigate seizure activity, shivering and/or coughing.
Embodiments of the technology may also automatically adjust intravenous fluid or drug infusion rates based on feedback from the cardiac output or respiratory rate sensed. In one such embodiment, a patient-controlled analgesia pump may be deactivated if a respiratory rate drops too low. Respiratory depression can be fatal in this group and this safeguard would prevent overdose. An automated feedback system may also be advantageous in a large volume resuscitation procedure, wherein fluid infusion can be tailored based on intraabdominal pressure to prevent abdominal compartment syndrome by sounding an alert and slowing infusion rates as the intraabdominal pressure rises. Yet another automated feedback feature may provide direct feedback to a ventilator system to provide the optimal pressure of ventilated gas. In the setting of increased abdominal pressure, typical ventilator settings do not provide sufficient respiration for the patient. An automated adjustment of the ventilator settings based on intraabdominal pressure feedback from this embodiment may advantageously provide for optimal patient ventilation. Embodiments of the technology may also be applied as a correction in the application or understanding of other diagnostic measurements. For example, central venous pressure may be dramatically distorted in the setting of elevated intraabdominal pressure. Providing direct access to these data by the central venous pressure reporting system allows for the automatic correction and accurate reporting of this critical physiologic parameter. Embodiments of the technology may also be used in a variety of other ways to automate therapy including infusion of fluids that may further include active agents, such as pressors or diuretics in response to increased or decreased cardiac output.
In some embodiments, the Foley type catheter is configured to report the presence of a water droplet or other obstruction in an air-filled lumen, and then handle or resolve the droplet. In a hypothermic setting, in particular, moisture in an air lumen can condense and form obstructive water droplets. Water droplets in an air-filled lumen (or air bubbles in a water-filled lumen) can disturb or complicate pressure signals due to the surface tension of the water. Accordingly, a pressure-transmission lumen in some embodiments of the disclosed technology may include a hydrophilic feature (such as a coating on the wall of the lumen itself, or a hydrophilic fiber running the length of the lumen) to wick moisture away from the lumen in order to maintain a continuous, uninterrupted air channel. In some embodiments, a hygroscopic composition (silica gel, for example) may be used in line with the air infusion line or within the air infusion lumen itself to capture water or humidity. In some embodiments, a hygroscopic composition may be included within the catheter so that the air infusion circuit need not be serviced to replace this material.
In some embodiments of the disclosed technology, air may also be intermittently (and automatically) infused and extracted into the pressure-sensing balloon so that the balloon is in a constant state of being optimally primed, as described in further detail above. In the case of the wicking fiber or hydrophilic coating in the lumen, the air extraction may also contribute to removing and trapping any water from the air line. In the instance of a liquid-filled lumen, a hydrophilic fiber or a hydrophilic coating on the inside of the pressure lumen will provide similar benefit in allowing this lumen to handle an air bubble. In this instance, an air bubble may distort the signal, but the air water interface surface tension is defused by a hydrophilic coating in the lumen of the catheter.
Additionally, a custom extrusion and lumen shape may also be used to prevent obstruction in the case of liquid and/or air-filled lumens. In some embodiments of the technology, for example, a Foley type catheter may have a lumen that is stellate in cross sectional profile. Such a lumen is generally immune from obstruction by a water droplet, as the droplet tends to cohere to itself and push away from the hydrophobic walls. This behavior tends to disallow filling of a cross-sectional space, and allows for an air channel to remain patent around the water droplet and communicate to the sensor. The same logic applies to an air bubble in water in a hydrophilic, stellate water lumen. In this instance the hydrophilic liquid will cling to the walls and allow for a continuous water column that excludes the air bubble to the center of the lumen. The same applies for a hydrophobic liquid in a hydrophobic lumen. In some embodiments, the catheter may include an air channel, and a sensor incorporated within the catheter itself or a fluid lumen that is capable of transmitting the pressure back to a sensor.
In some embodiments, the sensing Foley catheter may include a blood pressure sensing element that may take any of several forms. In one embodiment, a blood pressure sensing element includes a pressure delivery balloon 32 (either a separate, dedicated balloon or a balloon in fluid communication with a device retention balloon or a pressure sensing balloon) that can be optically analyzed as it is inflated to determine at which pressure the vessels within the bladder or urethra are blanched and blood flow is stopped. This approach provides a reading of the perfusion pressure of the tissue abutting the pressure delivery balloon, such reading reflective of both the systemic blood pressure and vascular resistance. This embodiment of a perfusion pressure device may be used to provide early detection or monitoring of a variety of acute or emergent medical conditions such as sepsis, shock, hemorrhage, and can be particularly advantageous in detecting these conditions at an early stage. In predicting sepsis, embodiments of the invention may be capable of receiving white blood cell count information to better predict sepsis.
Other modalities may be used to detect that the tissue has been blanched or ischemic, as well, with the common methodological aspect being that of the intermittent inflation within the lumen, body cavity or bodily tissues to provide the compression of the vasculature. Embodiments of this device and associated methods may also be used to detect perfusion pressure in other areas of the body with an intermittently inflatable member and optical detection of blood flow or the presence of blood.
Tissue perfusion information may also be provided by way of sensors disposed on the shaft of the catheter such that they contact the urethral wall when the catheter is in place. These sensing technologies may include microdialysis, pyruvate, lactate, pO2, pCO2, pH, perfusion index, near-infrared spectroscopy, laser Doppler flowmetry, urethral capnography, and orthogonal polarization spectroscopy. Any of these tests may also be performed on the urine or the bladder wall itself to generate measurements of tissue perfusion.
Embodiments of a sensing Foley catheter have been used to collect data from a human subject (
The data shown in
Embodiments of the disclosed technology include a device utilizing a very small lumen for air transmission.
This data indicates the appropriateness of using the embodiment of the pressure transduction system in a small diameter pediatric catheter down to a size as small as 4F. Due to the lack of requirement for structural integrity that is found with the retention balloons (due to their higher pressure), the pressure lumen can easily be accommodated even in a 4F or 6F catheter that is typically provided without a retention balloon due to size constraints. In this embodiment, as well, the tip of the catheter can be lower profile than the rest of the Foley to allow for a consistently small diameter even with addition of the pressure sensing balloon. Thus, the catheter of the present invention is uniquely suited to the pediatric indication where there is a dire need for more appropriate, less invasive monitoring methods. In another embodiment, the retention balloon itself can be used as the pressure balloon, in order to minimize the number of required lumens. In one embodiment, the retention balloon is used in its fully inflated state, and is only used to track macro trends in IAP. In another embodiment, the retention balloon is only slightly inflated in order to increase balloon sensitivity to small changes in pressure. This embodiment allows for finer measurements of micro parameters, such as heart rate, relative stroke volume, relative cardiac output, respiratory rate, and relative tidal volume. A smaller pressure lumen also allows for more space in a larger catheter for other technologies, such as sensors etc.
A smaller pressure lumen also allows the tip of the catheter to be lower profile than the rest of the Foley type catheter to allow for a consistently small diameter even with addition of the pressure sensing balloon.
Embodiments of the disclosed technology may include embodiments which use the retention balloon itself as the pressure sensing balloon. This minimizes the number of required lumens allowing the overall outside diameter of the Foley type catheter to be smaller. For example, the retention balloon can be used in its fully inflated state, and used primarily to track macro trends in TAP.
Embodiments of the disclosed technology may include embodiments in which the pressure sensor is a mechanical pressure sensor, such as those using fiberoptic, strain gage, magnetic, resonant, and/or other suitable technologies.
One embodiment of the sensing Foley catheter system also includes an automated drainage line-clearing device. The drainage line is the tube that connects the Foley catheter to the drainage bag.
In another embodiment, the clearing mechanism comprises a coating on the inside of the drainage tube to reduce surface tension and facilitate drainage. In one aspect, said coating is a hydrophobic polymer, including but not limited to PTFE or FEP.
In yet another embodiment, the clearing mechanism comprises a tubular hydrophobic vent filter (not shown) that can be inserted into the drainage lumen of the device such that air will be evacuated throughout its length. A segmental hydrophobic vent can also be incorporated at set intervals to ensure that air is evacuated from the tube as it passes these regions. While others have attempted to prevent air locks with a hydrophobic vent filter at the interface of the Foley catheter and drainage tube, this approach still results in air locks regularly if the vent is not at the zenith of the drainage tube and pointed downward (such that the drainage tube end of the vent is below the Foley catheter side). In the preferred design the hydrophobic vent will be interspaced at minimum of 1-2 foot intervals to prevent submersion of the vents in urine (a problem that found with the currently-used urinary catheter which is vented only at the Foley adapter). By providing redundancy the present invention prevents the failure of the vent due to submersion since all of the intermittent vents would have to be submerged which is not possible, based on our bench top tests with a redundant loop. In the ideal configuration the vent will be a PTFE or cPTFE material and will be affixed with a barb and or grommetted into the tube at intervals to allow for easy manufacturability. In an alternative embodiment, the vent takes the form of a slit or spiral that runs the length of the drainage tube, thereby allowing air to escape the tube at any point. This prevents the drainage tube from being positionally dependent when preventing and/or eliminating airlocks.
In an alternative embodiment, air locks are prevented by means of an extendable drainage tube (not shown), which prevents pockets of air from forming in the high portions of the tube and urine from gathering in the low portions. An extendable tube prevents this from occurring by keeping the tube as straight as possible between the urinary catheter and the collection bag. In one aspect, the extendable drainage tube is composed of multiple telescopic sections that can be extended or collapsed to match the distance from the patient to the collection bag. In another aspect, the drainage tube is pleated to form an accordion, which can be extended or collapsed as necessary. In yet another aspect, the tube is coiled. In yet another aspect, the drainage tube is retractable by means of a spring coil that wraps the tubing around a wheel to achieve the appropriate length.
In another embodiment, the clearing mechanism comprises a tube with an inner diameter less than 0.25 inches as the drainage tube (not shown), such that no air pockets are able to move up the length of the tube. This is possible due to the surface tension within the smaller tubes, which prevent movement of fluid when one end of the tube is closed to atmosphere (as in the case of the bladder). Thus, the drainage tube always remains full of urine, and for each volume of urine produced the same volume of urine must exit the drainage tube, as urine is incompressible. In another embodiment, the inner diameter is less than 0.125 inches. In another aspect, said drainage tube acts as a siphon and provides a small, safe amount of vacuum to the bladder.
The use of small-diameter tubing also results in a smaller volume of residual urine in the drainage tube compared with the prior art. Having a smaller residual volume is preferential, as it allows urine to move more quickly from the patient's bladder to the collection vessel. The speed of this transport is important in order to take measurements of the urine that has been produced more recently. This is particularly important for patients with low rates of urine production, as it takes their urine even longer to be transported from the bladder to the collection vessel. For example, for a patient producing only 10 mL/hr of urine with a standard drainage tube (around 40 mL residual volume), measurements of their urine in the collection vessel will lag true urine production by 4 hours. By contrast, with smaller tubing (such as tubing having around 5 mL residual volume), measurements will only lag true production by 30 minutes.
In another embodiment, shown in
In another embodiment, air locks are removed through use of a pulsatile mechanical, vibratory acoustic, thermal, or electromagnetic stimulus that results in movement of the drainage tubing and/or the fluid within. This vibration, in combination with the pressure gradient driving the urine preferentially from the patient to the urine drainage bag, allows the urine to move forward in small increments until the resistance of the air lock has been overcome. At this point, a siphon is created and normal drainage can resume. The pulsatile stimulus is effective due to the hysteresis involved in the flow of the urine in the presence of a pressure gradient. Small movements of the urine due to energy pulses will have a net effect of moving the urine away from the patient. In one aspect using pulsatile energy, a vibratory stimulus is employed. The vibratory stimulus described can be created using a coin vibration motor, eccentric motor, or other similar means.
As an alternative to the vibratory stimulus, the drainage tube may be pinched or rolled intermittently, which has a similar net effect of moving the urine away from the patient due to hysteresis. This pinching or rolling may be achieved using a peristaltic-like mechanism, slider-crank mechanism, or other similar means. An alternative approach would be to use a pneumatic or hydraulic pump to cycle compression and decompression, like a sphygmomanometer, on different sections of the tube to mimic manual milking of the tube. This approach is distinct from the automated massaging or squeezing described above, in that only a slight pulse of stimulus is required. The pulsatile approach, then, can avoid generating vacuum in the bladder, which may adversely affect bladder tissue. The vibratory or pinching stimulus may be placed near the patient, near the drainage tube, or anywhere in between.
In another aspect using pulsatile energy, an acoustic stimulus is employed. The acoustic stimulus may be of a subsonic frequency designed to agitate the fluid but not the patient (due to the stimulus being below the range of hearing). The stimulus may also be in the sonic range or even in the supersonic range to achieve higher energy delivery. In 5 the acoustic embodiment, the pressure waves will be transmitted down the fluid column generating the same hysteresis effect.
In another aspect using pulsatile energy, an electromagnetic stimulus is employed. The electromagnetic stimulus may be a cuff or other device external to the drainage tube that creates pulses of electromagnetic energy. This energy has an effect on the salts in the urine, effectively agitating it slightly toward the drainage bag. The principles underlying this method are that of an electromagnetic pump, which is used in other applications. The electromagnetic approach takes advantage of the same hysteresis effect as the other approaches, and has the same effect of removing air locks by agitating the urine toward the drainage back until a siphon effect is achieved.
In another aspect using pulsatile energy, a thermal stimulus is employed. The thermal stimulus may be used to rapidly heat and cool a small portion of the drainage tubing, thereby expanding and contracting the urine or air within. In the expansion phase, the leading edge of the urine or air preferentially expands toward the drainage bag, due to the pressure gradient. Similarly, in the contraction phase, the tailing edge of the urine or air moves toward the drainage bag. The thermal stimulus thus takes advantage of the same hysteresis effect as the other approaches. Rapid heating of the urine or air can be achieved with a heating coil, chemical reaction, or other similar means, while rapid cooling of the urine or air can be achieved with a Peltier cooler, chemical reaction, gas expansion, or other similar means.
In another embodiment the mechanical, acoustic, electromagnetic, thermal, vibratory or pinching stimulus may be continuous, scheduled, or sensor-based. In the continuous embodiment, the stimulus is always on. In the scheduled embodiment, the stimulus repeats itself after a given time period, such as, but not limited to, every 1 minute, 5 minutes, 10 minutes, 30 minutes, or 1 hour. In the sensor-based embodiment, the mechanical, acoustic, electromagnetic, thermal, vibratory or pinching stimulus is applied whenever an air lock is suspected or detected based on urine output and sensed pressures. This detection can be accomplished in a variety of ways, including, but not limited to, a flow sensor, an optical sensor that distinguishes between urine and air, or an in-line oxygen sensor. Furthermore, each of these embodiments could be expected to interfere with pressure measurements in the sample collection vessel described below and will preferably be performed immediately after 5 a siphon activation to allow for minimization of the risk of missing a vessel emptying or interfering with a specific gravity measurement.
Preferably, an entire drain tube will be cleared with one roll; at a minimum, one half of a drain tube height should be cleared, given a maximum air lock height. Advantageously, these rollers can handle high viscosity urine. The rollers comprise cam profiles that may be round or oval—which can provide varying pressure for clearing clots. Should a blood clot obstruction occur at a Foley catheter inlet hole, the rollers can be used to temporarily reverse the flow of urine to dislodge the clot, or (as previously described) intentional vibration of the fluid column can be used to dislodge the clot. The roller position can be selectively controlled so as to avoid “parking” on tubes. This ensures that flow is completely unobstructed from the bladder to the drainage bag. Controlling the parked location can be accomplished with any suitable means, including, but not limited to a stepper motor, current sensing of the motor (current will drop when the rollers are not compressing the tubes), a limit switch, an encoder, magnetic positioning, detection of a change in tube diameter as it is compressed, and/or pressure sensors on the lumen or roller. However, in certain instances, parking the rollers on the tubing may be beneficial for selectively limiting the flow if it is too high for the chamber to handle, particularly when first intubating the bladder. In these instances, selective control of the roller position will be used to ensure one of the tubes is compressed. The rollers can be activated manually, using a timed means, or automatically triggered if, based on the number or urine drips in a chamber, no urine output is detected for a specified number of minutes. Suction trauma to the soft tissues is prevented by setting the roller speed is set so that is occurs slowly enough to remain quasi-static. In the event 5 of an air lock with an empty bladder, for example, in one embodiment the roller would pull gentle suction on one tube, but the suction transmitted to the bladder would be limited by the ability of fluid to move from one tube to the other by virtue of their being joined at the proximal end of the tube where it connects to the Foley catheter.
In another embodiment, a pressure sensing lumen may be incorporated into the tubing to allow for measurement of pressure within the drain tube, Foley catheter or bladder itself. This pressure measurement can be used to control the pump or line clearing mechanism to allow for effective air lock removal without the generation of negative pressure and suction trauma in the bladder. This device may also be used in combination with a pressure sensing Foley catheter. This combination will allow for the effective measurement of true bladder pressure and activation of the pump to ensure that the sensed bladder pressure is truly a result of intra-abdominal hypertension and not the result of a confounding air lock.
The sensing balloon of the Foley can also be incorporated proximally into the Foley catheter or be attached to the drainage tube in order to minimize the intravesical profile of the device. The sensing lumen could also be another lumen in the tube that conducts the pressure through the lumen to the pressure sensor and roller pump. In the absence of an air lock, the pressure seen in fluid communication with the inside of the bladder is actually a vacuum. In order to provide an accurate measurement of bladder pressure in the setting of a siphon effect (i.e. with a vented Foley drain system or in the absence of any air lock) the pumping mechanism can actually be driven backwards until it has offset the siphon effect. There will still be no net movement of fluid in this scenario and the pump action will be increased until further increases do not generate an increase in sensed pressure. At this point the true bladder pressure can be read and the flow from the bladder can be allowed to resume.
In yet another embodiment (not shown), the present invention and the pressure-sensing Foley catheter can be used together to detect and clear obstructions from blood clots or other obstructions. During milking of the drainage tube, if the pressure in the drainage tube spikes while the pressure within the bladder remains unchanged, this is indicative of a blockage between the bladder and the termination of the pressure sensing lumen. To clear this blockage, additional negative pressure can be generated using the massaging rollers until the pressure suddenly drops and matches the pressure within the bladder. This is indicative that the blockage has been cleared. In yet another embodiment, blockages such as those from blood clots can be prevented by ensuring that the inner diameter of the drainage lumen/tube only gets larger or remains the same size from the bladder to the drainage bag. When the opposite occurs, this creates the potential for bottlenecks that can become a site for obstruction.
The small volume bursts of fluid may be from around 0.2 cc to around 0.4 cc. The small volume bursts of fluid may be from around 0.1 cc to around 0.5 cc. The small volume bursts of fluid may be up to around 0.5 cc. The small volume bursts of fluid may be up to around 1.0 cc.
The minute amounts of air or fluid may be from around 0.2 cc to around 0.4 cc. The minute amounts of air or fluid may be from around 0.1 cc to around 0.5 cc. The minute amounts of air or fluid may be up to around 0.5 cc. The minute amounts of air or fluid may be up to around 1.0 cc.
Although
The pressure sensor on the pressure sensing catheter may be near the distal end of the pressure sensing catheter, or it may be anywhere along the length of the catheter. The pressure sensor may be a pressure sensing balloon, or it may be any type of pressure sensor. In the case of a pressure sensing balloon, the inflated balloon may be smaller than the inner diameter of the urine drainage lumen of the Foley type catheter, or the inflated balloon may be large enough to fill the urine drainage lumen of the Foley type catheter.
The inflated pressure sensing balloon may fill the urine drainage lumen of the Foley type catheter allowing for better pressure measurements. The pressure sensing balloon may be periodically deflated or partially deflated to allow urine to flow from the bladder through the Foley type catheter. The controlling of the pressure sensing balloon inflation cycle may be controlled by the controller of the present invention.
The outer diameter of the inflated pressure sensing balloon may less be than about 5 mm, alternatively the outer diameter of the pressure sensing catheter may be less than about 4 mm, alternatively the outer diameter of the pressure sensing catheter may be less than about 3 mm, alternatively the outer diameter of the pressure sensing catheter may be less than about 2 mm, alternatively the outer diameter of the pressure sensing catheter may be less than about 1 mm.
Pressure measurements can be taken over time using the pressure sensing catheter and analyzed in any of the ways disclosed herein. To improve pressure measurements, drainage port 3020 may be periodically closed or blocked. Blocking of drainage port 3020 may be done mechanically, with a stopcock or valve, or automatically, for example with a solenoid valve connected to the controller. An advantage of this embodiment is that pressure sensing catheter 3008 can be used with any Foley type catheter to measure pressure. In addition, pressure sensing catheter 3008 can be inserted and removed from a Foley type catheter after the Foley type catheter is already in place in the patient's bladder.
Pressure balloon port hole 3106 is in communication with the pressure fluid lumen which is in fluid communication with pressure line 3108. Fluid drainage line 3110 is in fluid communication with the one or more fluid drainage holes 3102.
As described herein, pressure line 3108 is in fluid communication with a pressure transducer or other type of pressure sensor.
Fluid drainage line 3110 may be used with any of the clearing mechanisms described herein. For example, a rolling mechanism, similar to that shown in
By monitoring the pressure within the chest cavity, or other body cavity, fluid drainage may be monitored and action taken if drainage is not adequate. For example, in addition to a flattening of the pressure wave described above, a sustained increase of pressure within the body cavity may be an indication that fluid drainage is not adequate. A sustained decrease in pressure within the body cavity may be an indication that fluid drainage is no longer necessary.
A pressure sensing balloon is shown here, but any suitable type of pressure sensor may be used.
In the case of a chest drainage tube, a retention balloon is not necessary because the chest tube is likely sutured or otherwise fixed to the outer chest wall after insertion. This may also be the case for other types of drainage tubes, such as a wound drainage tube. The pressure sensing balloon/mechanism may sense anatomical pressures to determine anatomical information such as peritoneal pressure, respiratory rate, and cardiac rate. In addition or alternatively, the pressure sensing balloon/mechanism may sense the presence of clots, or other blockages which prevent the drainage tube from draining adequately.
In another embodiment, a physical filter may be used at any location along the length of a sensing lumen. For example, a filter may be placed between a pressure sensing lumen and a pressure transducer. A filter may remove a signal offset allowing a more sensitive sensor to be used. A filter may be made of any suitable material, such as polymer foam.
Any of the priming protocols disclosed here, or any combination thereof may be used in any of the embodiments of the invention.
Although the pressure sensing balloon and/or sensor is shown distal to the retention balloon in some of the figures herein, the pressure sensing balloon and/or sensor may also be proximal to the retention balloon.
Embodiments of the invention include a pressure sensing balloon incorporated into a chest tube or breathing tube to monitor pressure in the lungs and/or chest. Similar to other embodiments disclosed herein, a pump, vacuum, roller device or other technology may be used to help clear the chest tube of fluids and/or other blockages. Chest flow fluid volume (gas and/or liquid) may be measured using technologies disclosed herein.
Example of Data Processing System
As shown in
Typically, the input/output devices 3210 are coupled to the system through input/output controllers 3209. The volatile RAM 3205 is typically implemented as dynamic RAM (DRAM) which requires power continuously in order to refresh or maintain the data in the memory. The non-volatile memory 3206 is typically a magnetic hard drive, a magnetic optical drive, an optical drive, or a DVD RAM or other type of memory system which maintains data even after power is removed from the system. Typically, the non-volatile memory will also be a random access memory, although this is not required.
While
Some portions of the preceding detailed descriptions have been presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations are the ways used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is here, and generally, conceived to be a self-consistent sequence of operations leading to a desired result. The operations are those requiring physical manipulations of physical quantities.
It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless specifically stated otherwise as apparent from the above discussion, it is appreciated that throughout the description, discussions utilizing terms such as those set forth in the claims below, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.
The techniques shown in the figures can be implemented using code and data stored and executed on one or more electronic devices. Such electronic devices store and communicate (internally and/or with other electronic devices over a network) code and data using computer-readable media, such as non-transitory computer-readable storage media (e.g., magnetic disks; optical disks; random access memory; read only memory; flash memory devices; phase-change memory) and transitory computer-readable transmission media (e.g., electrical, optical, acoustical or other form of propagated signals—such as carrier waves, infrared signals, digital signals).
The processes or methods depicted in the preceding figures may be performed by processing logic that comprises hardware (e.g. circuitry, dedicated logic, etc.), firmware, software (e.g., embodied on a non-transitory computer readable medium), or a combination of both. Although the processes or methods are described above in terms of some sequential operations, it should be appreciated that some of the operations described may be performed in a different order. Moreover, some operations may be performed in parallel rather than sequentially.
Unless defined otherwise, all technical terms used herein have the same meanings as commonly understood by one of ordinary skill in the medical arts. Specific methods, devices, and materials are described in this application, but any methods and materials similar or equivalent to those described herein can be used in the practice of the present invention. While embodiments of the invention have been described in some detail and by way of illustrations, such illustrations are for purposes of clarity of understanding only, and are not intended to be limiting. Various terms have been used in the description to convey an understanding of the invention; it will be understood that the meaning of these various terms extends to common linguistic or grammatical variations thereof. Further, while some theoretical considerations may have been advanced in furtherance of providing an understanding of the technology, the appended claims to the invention are not bound by such theory. Moreover, any one or more features of any embodiment of the invention can be combined with any one or more other features of any other embodiment of the invention, without departing from the scope of the invention. Still further, it should be understood that the invention is not limited to the embodiments that have been set forth for purposes of exemplification, but is to be defined only by a fair reading of claims appended to the patent application, including the full range of equivalency to which each element thereof is entitled.
This application is a continuation of International Application No. PCT/US2014/044565 filed Jun. 27, 2014, which claims the benefit of priority to U.S. Provisional Application No. 61/840,408 filed Jun. 27, 2013, U.S. Provisional Application No. 61/893,816 filed Oct. 21, 2013, and Provisional Application No. 61/959,144 filed Aug. 16, 2013, each of which is incorporated herein by reference in its entirety. This application is also related to PCT/US12/028071 filed Mar. 7, 2012, which is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61840408 | Jun 2013 | US | |
| 61893816 | Oct 2013 | US | |
| 61959144 | Aug 2013 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2014/044565 | Jun 2014 | US |
| Child | 14978785 | US |
