US20030114835A1 - Temperature sensor adapter for Foley catheters - Google Patents
Temperature sensor adapter for Foley catheters Download PDFInfo
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- US20030114835A1 US20030114835A1 US10/349,972 US34997203A US2003114835A1 US 20030114835 A1 US20030114835 A1 US 20030114835A1 US 34997203 A US34997203 A US 34997203A US 2003114835 A1 US2003114835 A1 US 2003114835A1
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- temperature
- control unit
- catheter
- set forth
- temperature sensors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00022—Sensing or detecting at the treatment site
- A61B2017/00084—Temperature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
- A61B2017/00119—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22065—Functions of balloons
- A61B2017/22068—Centering
Definitions
- This invention relates to Foley Catheters, and particularly Foley Catheters having temperature sensors.
- Foley catheters typically include a soft, thin rubber tube with a balloon on one end. The catheter is threaded through the urinary duct (urethra) and into the bladder to drain urine from the bladder.
- a Foley catheter is typically used when normal urination is disrupted by an infection, a swollen prostate gland, bladder stones, or, sometimes, an injury. In very sick people, a catheter may be used to keep track of urine production.
- a typical Foley catheter has drainage lumen, and an inflation lumen for inflating and deflating the balloon.
- the balloon is normally deflated until properly positioned in a patient's bladder. Once the catheter is properly positioned, the inflation lumen delivers fluid to inflate the balloon. The inflated balloon holds the catheter in place.
- the bladder is an accepted situs for core body temperature measurements. Accordingly, some Foley catheters include a temperature sensor included on the end of the catheter. A wire connects the sensor, via the catheter, to externally located monitoring devices.
- One drawback to Foley catheters with a temperature sensor is that the sensor may fail. When the sensor fails, the failed catheter may have to be replaced. This not only compounds patient discomfort, but also increases the risk of injury and infection for the patient. A further risk is that the failure will not be detected and that other systems might depend on the erroneous temperature sensor reading. For example, a patient heating or cooling system may fail to properly operate when relying on temperature measurement provided by a failed temperature sensor.
- a Foley catheter having redundant temperature sensors includes a catheter body with a proximal end and a distal end, an inflatable balloon disposed near the distal end, an inflation lumen extending from the proximal end to the balloon for inflating and deflating the balloon, a drainage lumen extending from the proximal end to the distal end, at least one temperature sensor lumen extending from the proximal end to the distal end, and at least two temperature sensors, each having a wire and a sensor element, the sensor elements being disposed in the distal end of the catheter body and the wires extending through the catheter body drainage lumen.
- the temperature sensors electronically couple with a control unit, which obtains a primary temperature reading from one of the temperature sensors and obtains a secondary temperature reading from the other temperature sensors.
- the control unit compares the primary and secondary temperature reading to determine a difference.
- the control unit establishes a threshold.
- the threshold is the maximum acceptable difference between the primary and secondary temperature readings.
- This threshold is set manually by an operator.
- the control unit also includes an alarm so that when the difference between the primary and secondary temperature readings exceeds the threshold, the control unit activates the alarm.
- the alarm is audible according to one aspect of the invention and is sounded on a speaker in communication with the control unit.
- the alarm includes a video display and activation of the alarm provides a video signal to the video display.
- the alarm simply shuts the control unit off.
- a method of using a Foley catheter with redundant temperature sensors in accordance with the invention includes the steps of introducing a Foley catheter into the bladder of a patient and using the Foley catheter to drain urine from the bladder. The method also includes electronically coupling the temperature sensors to a control unit and activating the control unit to obtain the primary temperature reading and the secondary temperature reading from the redundant temperature sensors.
- Obtaining two, or more, temperature readings facilitates redundancy.
- One aspect of the invention includes the step of comparing the primary temperature reading and the secondary temperature reading to determine whether both sensors are operational.
- Another aspect of the invention includes three temperature sensors and an appropriate methodology for detecting sensor failure.
- Three sensors enables continued operation of the control unit to achieve meaningful temperature readings notwithstanding the failure of one of the temperature sensors. It can be appreciated that there are a variety of control and feedback methods that can accomplish continuous operation of the catheter, sensors and control unit during a failure of one of the sensors.
- determining whether both sensors are operational is accomplished by comparing the primary temperature reading and the secondary temperature reading to determine a difference between the primary and secondary temperature readings.
- the control unit deactivates when the difference exceeds the threshold.
- the sensors operate with an accuracy of +/ ⁇ 0.1 degree Fahrenheit. Accordingly a temperature difference of a whole degree, for example, or more would typically indicate failure of one of the sensors.
- the controller establishes a temperature threshold within the range of 0.5-2 degrees Fahrenheit. More preferably, however, the temperature threshold is about 1 degree Fahrenheit so that the redundant sensors would operate safely in conjunction with a heat exchange catheter system for regulating patient body temperature.
- FIG. 1 is a perspective view of a Foley catheter and the adapter in accordance with the present invention.
- FIG. 2 is a perspective view of a Foley catheter inserted into a patient and the adapter in accordance with the present invention.
- FIG. 3 is a cross-sectional view of the catheter body as seen along the line 3 - 3 in
- FIG. 4 is an exploded cross-sectional view of the cap and fitting in accordance with the present invention.
- FIG. 5 is a cross-sectional view of the cap operatively engaged with the fitting as seen along the line 4 - 4 of FIG. 2.
- FIG. 6 is a method in accordance with the present invention.
- FIG. 7 is a system in accordance with the present invention.
- FIG. 1 shows a Foley catheter generally designated with the reference numeral 10 .
- the catheter 10 includes a catheter body 12 with a proximal end 14 and a distal end 16 .
- the catheter 10 also includes a balloon 18 , an inflation lumen 20 , a drainage lumen 22 , and an adapter 24 .
- the balloon 18 is deflated for insertion into a patient.
- the balloon 18 is disposed near the distal end 16 .
- the inflation lumen 20 extends within the catheter body 12 from the proximal end 14 to the balloon 18 , in fluid communication with the balloon 18 , for inflating and deflating the balloon 18 .
- the catheter drainage lumen 22 extends from the proximal end 14 to the distal end 16 .
- the distal end 16 includes an opening 26 in fluid communication with the drainage lumen 22 to facilitate drainage of urine from the bladder of a patient.
- the adapter 24 has a drainage lumen 30 , a temperature sensor lumen 32 and a connector 25 .
- the connector 25 attaches to the proximal end 14 of the catheter body 12 .
- the connector 25 establishes fluid communication between the adapter drainage lumen 30 and the catheter drainage lumen 22 .
- the connector 25 is tapered and includes ribs 27 for insertion and press-fit into the proximal end 14 of the catheter body 12 .
- the adapter temperature sensor lumen 32 includes a fitting 34 and a cap 36 .
- the temperature sensor 38 has a wire 40 and a distally located sensor element 33 (FIG. 2).
- the fitting 34 is fixed on the temperature sensor lumen 32 of the adapter 24 .
- the fitting 34 receives the cap 36 .
- the cap 36 and a portion of the fitting 34 are threaded to enable the cap 36 to rotate onto the fitting 34 .
- the cap 36 is rotatable to adjustably torque the cap 36 onto the fitting 34 .
- the temperature sensor wire 40 normally slides through the cap 36 , the fitting 34 , the connector 25 , and the catheter drainage lumen 22 .
- the temperature sensor 38 includes a distally mounted temperature sensor element 33 (FIG. 2) that seats in the distal end 16 of the catheter body 12 . Rotating the cap 36 with respect to the fitting 34 selectively anchors the wire 40 with respect to the adapter 24 to prevent movement of the sensor element 33 .
- FIG. 2 shows the Foley catheter 10 inserted into the bladder 42 of a patient.
- the Foley catheter 10 includes an integrated temperature sensor 46 with an integrated sensor element 35 disposed at the distal end 16 of the catheter body 12 .
- the catheter 10 is introduced into the bladder 42 of a patient.
- the balloon 18 inflates to hold the catheter 10 in the bladder 42 .
- Urine drains from the bladder 42 through the opening 26 and via the catheter drainage lumen 22 .
- the integrated sensor 46 with the sensor element 35 senses the patient's bladder temperature.
- the adapter 24 attaches to the proximal end 14 of the catheter body 12 .
- An operator manually advances the temperature sensor wire 40 to slide the temperature sensor wire 40 and sensor element 33 via the drainage lumen, towards the distal end 16 of the catheter body 12 .
- the temperature sensor wire 40 slides the temperature sensor element 33 fully to the distal end 16 of the catheter body 12 .
- the integrated temperature sensor 46 fails. This failure is detected.
- the Foley catheter 10 remains in the bladder 42 .
- the adapter 24 of the present invention then attaches to the proximal end 14 of the catheter and the sensor 38 with the sensor element 33 advances through the drainage lumen of the Foley catheter 10 to position the sensor element 33 in the distal end 16 of the catheter body 12 .
- the sensor element 35 and the sensor element 33 are collocated for redundancy and improved accuracy.
- the sensor elements 33 and 35 provide a primary and secondary measure, respectively, of core body temperature.
- the secondary measure of temperature is used in conjunction with primary temperature measurements for improved temperature sensing accuracy and reliability.
- Collocated temperature sensor elements 33 and 35 are also useful for communicating with discrete monitoring and data compilation devices requiring temperature input, such as a discrete patient data recorder and a medical device, for examples.
- sensor element collocation may not be required in some systems.
- the sensors can be located in serial alignment on the catheter 10 .
- a further alternative includes proximally locating the sensors.
- the temperature adapter 24 and Foley catheter 10 are used in conjunction with vascular heat exchange catheter. It can be appreciated that core body temperature measurements are important to facilitate proper functioning of any system that regulates the core body temperature of a patient. Accordingly, redundant bladder temperature measurements with collocated sensor elements 33 and 35 , is desirable to minimize any risk or inconvenience associated with temperature monitoring failure.
- the temperature sensor elements 33 and 35 electronically couple with a control unit, which obtains a primary temperature reading from one of the temperature sensor elements and obtains a secondary temperature reading from the other temperature sensor elements.
- the control unit compares the primary and secondary temperature reading to determine a difference.
- Foley catheters can be used to drain urine for several weeks.
- An integrated temperature sensor 46 may fail during this period.
- a method in accordance with the present invention enables an introduced Foley catheter having a failed integrated temperature sensor 46 to be used continuously for draining urine notwithstanding failure of the integrated temperature sensor 46 .
- the steps of maintaining the catheter 10 in the bladder 42 and attaching the adapter 24 to the proximal end 14 and advancing the adapter temperature sensor 38 provides a secondary measure of temperature without requiring the unpleasant steps of removal and replacement of the Foley catheter 10 .
- FIG. 3 shows the catheter body 12 having three lumens, the inflation lumen 20 , the drainage lumen 22 , and an integrated temperature sensor lumen 48 .
- the temperature sensor lumen 48 houses the wire 46 of the integrated temperature sensor 46 .
- the wire 40 of the adapter temperature sensor 38 is positioned freely in the drainage lumen 22 .
- FIG. 4 shows the cap 36 , the fitting 34 and a seal 56 .
- the cap 36 has internal threads 50 and the fitting 34 has external threads 52 .
- the cap 36 has an axis and includes an axially disposed post 54 .
- the seal 56 seats within the fitting 34 .
- the post 54 defines a portion of a channel 58 .
- the channel 58 extends axially through the cap 36 , the fitting 34 and the seal 56 .
- the temperature sensor wire 40 normally slides through the channel 58 when the cap 36 and the fitting 34 loosely engage, or disengage.
- the seal 56 is generally cylindrical in shape and circumscribes the wire 40 .
- the wire 40 is lubricated to facilitate sliding when the cap 36 loosely fits on the fitting 34 .
- the fitting 34 defines an annular flange 62 so that when the cap 36 threads on to the fitting 34 , the post 54 of the cap 36 presses the seal 56 against the annular flange 62 . Rotation of the cap 36 with respect to the fitting 34 deforms the seal 56 , which grips the wire 40 and thereby selectively anchors the wire 40 with respect to the cap 36 and the fitting 34 .
- FIG. 5 shows the cap 36 engaging the fitting 34 .
- the cap 36 rotates to compress the seal 56 against the flange 62 .
- the seal 56 circumscribes the wire 40 so that compressing the seal 56 anchors the wire 40 .
- FIG. 6 shows a method generally designated with the reference numeral 68 .
- the method includes the steps of introducing a Foley catheter 70 having redundant temperature sensors into the bladder of a patient for the purpose of measuring patient core body temperature.
- the next step includes using the Foley catheter to drain urine 72 from the bladder.
- the step of activating a control unit 74 follows.
- the sensors measure temperature 76 within the bladder of the patient and the control unit reads the temperature measurements.
- the next step performed by the control unit is to monitor the temperature sensors for operability and accuracy and decide if sensors are operational 78 . If the sensors are both operational and provide consistent temperature readings, the control unit continues operation. However when the sensors measure a temperature difference greater than an established threshold between the sensors, the control unit assumes that one sensor has failed and activates an alarm 80 . Once the alarm is activated, the control unit performs the step of deactivating the control unit 82 .
- control unit will also activate an alarm 80 and deactivate the control unit 82 when one of the sensors fails to provide a signal.
- the draining step 72 and the activating step occur in parallel.
- the alarm step 80 and the deactivation step 80 occur in parallel.
- FIG. 7 shows a system generally designated with the reference numeral 88 .
- the system includes a heat exchange catheter system 90 , a control unit 92 with an alarm 94 , a display 96 and a speaker 98 .
- the system 88 also includes a Foley catheter system 100 having redundant temperature sensors 102 and 104 .
- the control unit 92 operates the heat exchange catheter system 90 and monitors Foley catheter system 100 .
- the control unit 92 regulates operation of the heat exchange catheter system 90 to maintain patient temperature, to heat the patient, or to cool the patient.
- the control unit 92 relies on patient core body temperature, or local body temperature, measurements from temperature sensors 102 and 104 .
- the core body temperature measurement is provided to the control unit 92 by the Foley catheter system 100 .
- the Foley catheter system 100 includes a Foley catheter having two integrated temperature sensors 104 and 102 .
- the sensors 102 and 104 electronically communicate with the control unit 92 to provide redundant temperature measurement signals to the control unit 92 .
- the control unit establishes a threshold. When signals from the sensor 102 and 104 are indicative temperatures beyond the established threshold, then the control unit 92 assumes that one of the sensors is non-operational and shuts down the heat exchange catheter system 90 . Likewise when one of the temperature sensors 102 or 104 completely fails, yielding no temperature signal, then the control unit 92 shuts down the heat exchange catheter system 90 .
- the control unit 92 includes the alarm 94 , which includes the display 96 and the speaker 98 . Activating the alarm 94 either displays a notice on the display 96 , or projects sound through the speaker 98 , or both, to notify an operator when a sensor 102 or 104 has failed. By default, the control unit 92 shuts down the heat exchange catheter system 90 and deactivates itself when either of the sensors 102 or 104 fail.
- a typical patient temperature regulation system includes a venous catheter having a heating and/or cooling element.
- the catheter inserts into a patient's central venous system to warm and/or cool the blood.
- the warmed/cooled blood circulates within the patient to effect the patient core body temperature.
- the core body temperature is measured using a Foley catheter and adaptor as described herein.
- a heat exchange catheter and system are described in U.S. Pat. Nos. 6,146,411 and 6,126,684, the disclosures of which are incorporated herein by reference.
- One heat exchange catheter includes lumens for circulating heat exchange fluid within the catheter. This creates a closed system heat exchanger so that circulation of heat exchange fluid within the catheter cools/warms the blood of the patient.
- a system employing the heat exchange catheter has a temperature measurement device and a control unit. The control unit regulates the rate of flow of the heat exchange fluid as well as the temperature of the fluid. The control unit also monitors the temperature sensors in an embodiment of the invention having redundant temperature sensors.
- a feedback loop established between the Foley catheter-based temperature sensor elements of the present invention is used to regulate the heat exchange fluid temperature of the closed system, and the rate of heat exchange fluid flow.
- the present invention is anticipated to be used in conjunction with a patient temperature regulation system, it can be appreciated that it can be used in any of a number of systems.
- the present invention can be used in virtually any surgical procedure requiring a measurement of a patient's core body temperature.
Abstract
A Foley catheter has redundant temperature sensors to enable use of the Foley catheter with a patient heating system, such as one relying on a vascular heat exchange catheter. The temperature sensors electronically couple with a control unit, which obtains a primary temperature reading from one of the temperature sensors and obtains a secondary temperature reading from the other temperature. The control unit compares the primary and secondary temperature reading to determine a sensor temperature difference. When the sensor temperature difference exceeds a predetermined value, then the control unit activates an alarm, shuts down the patient heating system, or both.
Description
- This patent application is a continuation-in-part of U.S. Patent Application serial No. 60/256,083, filed on Dec. 15, 2000.
- This invention relates to Foley Catheters, and particularly Foley Catheters having temperature sensors.
- The disclosures of U.S. Pat. No. 6,019,783, issued Feb. 1, 2000, U.S. Pat. No. 6,126,684, issued Oct. 3, 2000, and U.S. Pat. No. 6,146,411, issued Nov. 14, 2000, are incorporated herein by reference.
- Foley catheters typically include a soft, thin rubber tube with a balloon on one end. The catheter is threaded through the urinary duct (urethra) and into the bladder to drain urine from the bladder. A Foley catheter is typically used when normal urination is disrupted by an infection, a swollen prostate gland, bladder stones, or, sometimes, an injury. In very sick people, a catheter may be used to keep track of urine production.
- A typical Foley catheter has drainage lumen, and an inflation lumen for inflating and deflating the balloon. The balloon is normally deflated until properly positioned in a patient's bladder. Once the catheter is properly positioned, the inflation lumen delivers fluid to inflate the balloon. The inflated balloon holds the catheter in place.
- There are risks associated with the use of a Foley catheter. For example, the bladder or urethra could be injured when the Foley catheter is inserted. Infection is also possible. Patients may find the process of insertion of a Foley catheter unpleasant and sometimes painful.
- The bladder is an accepted situs for core body temperature measurements. Accordingly, some Foley catheters include a temperature sensor included on the end of the catheter. A wire connects the sensor, via the catheter, to externally located monitoring devices.
- One drawback to Foley catheters with a temperature sensor is that the sensor may fail. When the sensor fails, the failed catheter may have to be replaced. This not only compounds patient discomfort, but also increases the risk of injury and infection for the patient. A further risk is that the failure will not be detected and that other systems might depend on the erroneous temperature sensor reading. For example, a patient heating or cooling system may fail to properly operate when relying on temperature measurement provided by a failed temperature sensor.
- What is desired is a way to measure a patient's core body temperature while minimizing patient discomfort and risk of injury. What is also desired is a way of assuring integrity of core body temperature measurements.
- A Foley catheter having redundant temperature sensors includes a catheter body with a proximal end and a distal end, an inflatable balloon disposed near the distal end, an inflation lumen extending from the proximal end to the balloon for inflating and deflating the balloon, a drainage lumen extending from the proximal end to the distal end, at least one temperature sensor lumen extending from the proximal end to the distal end, and at least two temperature sensors, each having a wire and a sensor element, the sensor elements being disposed in the distal end of the catheter body and the wires extending through the catheter body drainage lumen.
- The temperature sensors electronically couple with a control unit, which obtains a primary temperature reading from one of the temperature sensors and obtains a secondary temperature reading from the other temperature sensors. The control unit compares the primary and secondary temperature reading to determine a difference.
- The control unit establishes a threshold. The threshold is the maximum acceptable difference between the primary and secondary temperature readings. This threshold, according to one aspect of the invention, is set manually by an operator. The control unit also includes an alarm so that when the difference between the primary and secondary temperature readings exceeds the threshold, the control unit activates the alarm.
- The alarm is audible according to one aspect of the invention and is sounded on a speaker in communication with the control unit. According to another aspect of the invention, the alarm includes a video display and activation of the alarm provides a video signal to the video display. In yet another embodiment, the alarm simply shuts the control unit off.
- A method of using a Foley catheter with redundant temperature sensors in accordance with the invention includes the steps of introducing a Foley catheter into the bladder of a patient and using the Foley catheter to drain urine from the bladder. The method also includes electronically coupling the temperature sensors to a control unit and activating the control unit to obtain the primary temperature reading and the secondary temperature reading from the redundant temperature sensors.
- Obtaining two, or more, temperature readings facilitates redundancy. One aspect of the invention includes the step of comparing the primary temperature reading and the secondary temperature reading to determine whether both sensors are operational.
- Another aspect of the invention includes three temperature sensors and an appropriate methodology for detecting sensor failure. Three sensors enables continued operation of the control unit to achieve meaningful temperature readings notwithstanding the failure of one of the temperature sensors. It can be appreciated that there are a variety of control and feedback methods that can accomplish continuous operation of the catheter, sensors and control unit during a failure of one of the sensors.
- According to an aspect of the invention having two sensors, determining whether both sensors are operational is accomplished by comparing the primary temperature reading and the secondary temperature reading to determine a difference between the primary and secondary temperature readings. The control unit deactivates when the difference exceeds the threshold. Preferably, the sensors operate with an accuracy of +/−0.1 degree Fahrenheit. Accordingly a temperature difference of a whole degree, for example, or more would typically indicate failure of one of the sensors.
- According to an embodiment of the invention the controller establishes a temperature threshold within the range of 0.5-2 degrees Fahrenheit. More preferably, however, the temperature threshold is about 1 degree Fahrenheit so that the redundant sensors would operate safely in conjunction with a heat exchange catheter system for regulating patient body temperature.
- FIG. 1 is a perspective view of a Foley catheter and the adapter in accordance with the present invention.
- FIG. 2 is a perspective view of a Foley catheter inserted into a patient and the adapter in accordance with the present invention.
- FIG. 3 is a cross-sectional view of the catheter body as seen along the line3-3 in
- FIG. 4 is an exploded cross-sectional view of the cap and fitting in accordance with the present invention.
- FIG. 5 is a cross-sectional view of the cap operatively engaged with the fitting as seen along the line4-4 of FIG. 2.
- FIG. 6 is a method in accordance with the present invention.
- FIG. 7 is a system in accordance with the present invention.
- FIG. 1 shows a Foley catheter generally designated with the
reference numeral 10. Thecatheter 10 includes acatheter body 12 with aproximal end 14 and adistal end 16. Thecatheter 10 also includes aballoon 18, aninflation lumen 20, adrainage lumen 22, and anadapter 24. - The
balloon 18 is deflated for insertion into a patient. Theballoon 18 is disposed near thedistal end 16. Theinflation lumen 20 extends within thecatheter body 12 from theproximal end 14 to theballoon 18, in fluid communication with theballoon 18, for inflating and deflating theballoon 18. - The
catheter drainage lumen 22 extends from theproximal end 14 to thedistal end 16. Thedistal end 16 includes anopening 26 in fluid communication with thedrainage lumen 22 to facilitate drainage of urine from the bladder of a patient. - The
adapter 24 has adrainage lumen 30, atemperature sensor lumen 32 and aconnector 25. Theconnector 25 attaches to theproximal end 14 of thecatheter body 12. Theconnector 25 establishes fluid communication between theadapter drainage lumen 30 and thecatheter drainage lumen 22. Preferably theconnector 25 is tapered and includesribs 27 for insertion and press-fit into theproximal end 14 of thecatheter body 12. - The adapter
temperature sensor lumen 32 includes a fitting 34 and acap 36. Thetemperature sensor 38 has awire 40 and a distally located sensor element 33 (FIG. 2). The fitting 34 is fixed on thetemperature sensor lumen 32 of theadapter 24. Preferably the fitting 34 bonds to thetemperature sensor lumen 32. The fitting 34 receives thecap 36. Thecap 36 and a portion of the fitting 34 are threaded to enable thecap 36 to rotate onto the fitting 34. Thecap 36 is rotatable to adjustably torque thecap 36 onto the fitting 34. - The
temperature sensor wire 40 normally slides through thecap 36, the fitting 34, theconnector 25, and thecatheter drainage lumen 22. Thetemperature sensor 38 includes a distally mounted temperature sensor element 33 (FIG. 2) that seats in thedistal end 16 of thecatheter body 12. Rotating thecap 36 with respect to the fitting 34 selectively anchors thewire 40 with respect to theadapter 24 to prevent movement of thesensor element 33. - FIG. 2 shows the
Foley catheter 10 inserted into thebladder 42 of a patient. TheFoley catheter 10 includes anintegrated temperature sensor 46 with anintegrated sensor element 35 disposed at thedistal end 16 of thecatheter body 12. - During normal operation of the
Foley catheter 10, thecatheter 10 is introduced into thebladder 42 of a patient. Theballoon 18 inflates to hold thecatheter 10 in thebladder 42. Urine drains from thebladder 42 through theopening 26 and via thecatheter drainage lumen 22. Theintegrated sensor 46 with thesensor element 35 senses the patient's bladder temperature. - The
adapter 24 attaches to theproximal end 14 of thecatheter body 12. An operator manually advances thetemperature sensor wire 40 to slide thetemperature sensor wire 40 andsensor element 33 via the drainage lumen, towards thedistal end 16 of thecatheter body 12. Preferably, thetemperature sensor wire 40 slides thetemperature sensor element 33 fully to thedistal end 16 of thecatheter body 12. - According to one method of using the invention, the
integrated temperature sensor 46 fails. This failure is detected. TheFoley catheter 10 remains in thebladder 42. Theadapter 24 of the present invention then attaches to theproximal end 14 of the catheter and thesensor 38 with thesensor element 33 advances through the drainage lumen of theFoley catheter 10 to position thesensor element 33 in thedistal end 16 of thecatheter body 12. - The
sensor element 35 and thesensor element 33 are collocated for redundancy and improved accuracy. Thesensor elements - Collocated
temperature sensor elements - It can be appreciated that sensor element collocation may not be required in some systems. For example, the sensors can be located in serial alignment on the
catheter 10. A further alternative includes proximally locating the sensors. - According to one aspect of the invention, the
temperature adapter 24 andFoley catheter 10 are used in conjunction with vascular heat exchange catheter. It can be appreciated that core body temperature measurements are important to facilitate proper functioning of any system that regulates the core body temperature of a patient. Accordingly, redundant bladder temperature measurements with collocatedsensor elements - In one embodiment, the
temperature sensor elements - Foley catheters can be used to drain urine for several weeks. An
integrated temperature sensor 46, may fail during this period. In one embodiment, a method in accordance with the present invention enables an introduced Foley catheter having a failedintegrated temperature sensor 46 to be used continuously for draining urine notwithstanding failure of theintegrated temperature sensor 46. The steps of maintaining thecatheter 10 in thebladder 42 and attaching theadapter 24 to theproximal end 14 and advancing theadapter temperature sensor 38 provides a secondary measure of temperature without requiring the unpleasant steps of removal and replacement of theFoley catheter 10. - FIG. 3 shows the
catheter body 12 having three lumens, theinflation lumen 20, thedrainage lumen 22, and an integrated temperature sensor lumen 48. The temperature sensor lumen 48 houses thewire 46 of theintegrated temperature sensor 46. Thewire 40 of theadapter temperature sensor 38 is positioned freely in thedrainage lumen 22. - FIG. 4 shows the
cap 36, the fitting 34 and aseal 56. Thecap 36 hasinternal threads 50 and the fitting 34 hasexternal threads 52. Thecap 36 has an axis and includes an axially disposedpost 54. Theseal 56 seats within the fitting 34. Thepost 54 defines a portion of achannel 58. Thechannel 58 extends axially through thecap 36, the fitting 34 and theseal 56. Thetemperature sensor wire 40 normally slides through thechannel 58 when thecap 36 and the fitting 34 loosely engage, or disengage. - According to an aspect of the invention, the
seal 56 is generally cylindrical in shape and circumscribes thewire 40. Thewire 40 is lubricated to facilitate sliding when thecap 36 loosely fits on the fitting 34. - The fitting34 defines an
annular flange 62 so that when thecap 36 threads on to the fitting 34, thepost 54 of thecap 36 presses theseal 56 against theannular flange 62. Rotation of thecap 36 with respect to the fitting 34 deforms theseal 56, which grips thewire 40 and thereby selectively anchors thewire 40 with respect to thecap 36 and the fitting 34. - FIG. 5 shows the
cap 36 engaging the fitting 34. Thecap 36 rotates to compress theseal 56 against theflange 62. Theseal 56 circumscribes thewire 40 so that compressing theseal 56 anchors thewire 40. - FIG. 6 shows a method generally designated with the
reference numeral 68. The method includes the steps of introducing aFoley catheter 70 having redundant temperature sensors into the bladder of a patient for the purpose of measuring patient core body temperature. The next step includes using the Foley catheter to drainurine 72 from the bladder. - Once the Foley catheter is in place in the patient and operates, the step of activating a
control unit 74 follows. The sensors measuretemperature 76 within the bladder of the patient and the control unit reads the temperature measurements. - The next step performed by the control unit is to monitor the temperature sensors for operability and accuracy and decide if sensors are operational78. If the sensors are both operational and provide consistent temperature readings, the control unit continues operation. However when the sensors measure a temperature difference greater than an established threshold between the sensors, the control unit assumes that one sensor has failed and activates an
alarm 80. Once the alarm is activated, the control unit performs the step of deactivating thecontrol unit 82. - It can be appreciated that the control unit will also activate an
alarm 80 and deactivate thecontrol unit 82 when one of the sensors fails to provide a signal. - According to one aspect of the invention the draining
step 72 and the activating step occur in parallel. According to a further aspect of the invention, thealarm step 80 and thedeactivation step 80 occur in parallel. - FIG. 7 shows a system generally designated with the
reference numeral 88. The system includes a heatexchange catheter system 90, acontrol unit 92 with analarm 94, adisplay 96 and aspeaker 98. Thesystem 88 also includes aFoley catheter system 100 havingredundant temperature sensors control unit 92 operates the heatexchange catheter system 90 and monitorsFoley catheter system 100. - The
control unit 92 regulates operation of the heatexchange catheter system 90 to maintain patient temperature, to heat the patient, or to cool the patient. Thecontrol unit 92 relies on patient core body temperature, or local body temperature, measurements fromtemperature sensors control unit 92 by theFoley catheter system 100. TheFoley catheter system 100 includes a Foley catheter having twointegrated temperature sensors - The
sensors control unit 92 to provide redundant temperature measurement signals to thecontrol unit 92. The control unit establishes a threshold. When signals from thesensor control unit 92 assumes that one of the sensors is non-operational and shuts down the heatexchange catheter system 90. Likewise when one of thetemperature sensors control unit 92 shuts down the heatexchange catheter system 90. - The
control unit 92 includes thealarm 94, which includes thedisplay 96 and thespeaker 98. Activating thealarm 94 either displays a notice on thedisplay 96, or projects sound through thespeaker 98, or both, to notify an operator when asensor control unit 92 shuts down the heatexchange catheter system 90 and deactivates itself when either of thesensors - An anticipated use for the invention described herein is in conjunction with a patient temperature regulation system having a heat exchange catheter. A system having a heat exchange catheter is described generally in U.S. Pat. Nos. 6,146,411 and 6,019,783, the disclosures of which are incorporated by reference. A feedback loop between the temperature sensor of the Foley catheter and the patient temperature regulation system is established.
- A typical patient temperature regulation system includes a venous catheter having a heating and/or cooling element. The catheter inserts into a patient's central venous system to warm and/or cool the blood. The warmed/cooled blood circulates within the patient to effect the patient core body temperature. In accordance with the present invention, the core body temperature is measured using a Foley catheter and adaptor as described herein.
- A heat exchange catheter and system are described in U.S. Pat. Nos. 6,146,411 and 6,126,684, the disclosures of which are incorporated herein by reference. One heat exchange catheter includes lumens for circulating heat exchange fluid within the catheter. This creates a closed system heat exchanger so that circulation of heat exchange fluid within the catheter cools/warms the blood of the patient. A system employing the heat exchange catheter has a temperature measurement device and a control unit. The control unit regulates the rate of flow of the heat exchange fluid as well as the temperature of the fluid. The control unit also monitors the temperature sensors in an embodiment of the invention having redundant temperature sensors.
- A feedback loop established between the Foley catheter-based temperature sensor elements of the present invention is used to regulate the heat exchange fluid temperature of the closed system, and the rate of heat exchange fluid flow.
- While the present invention is anticipated to be used in conjunction with a patient temperature regulation system, it can be appreciated that it can be used in any of a number of systems. For example, the present invention can be used in virtually any surgical procedure requiring a measurement of a patient's core body temperature.
Claims (20)
1. A Foley catheter having redundant temperature sensors, comprising:
a catheter body with a proximal end and a distal end;
an inflatable balloon disposed near the distal end;
an inflation lumen extending from the proximal end to the balloon for inflating and deflating the balloon;
a drainage lumen extending from the proximal end to the distal end;
at least one temperature sensor lumen extending from the proximal end to the distal end; and
two temperature sensors, each temperature sensor having a sensor element disposed in the distal end of the catheter body and a wire extending from each sensor element to the proximal end of the catheter body via the temperature sensor lumen.
2. A Foley catheter having redundant temperature sensors as set forth in claim 1 , further comprising a control unit, the temperature sensors electronically couple with the control unit, the control unit obtains a primary temperature reading from one of the temperature sensors and obtains a secondary temperature reading from the other temperature.
3. A Foley catheter having redundant temperature sensors as set forth in claim 2 , wherein the control unit compares the primary and secondary temperature reading to determine a difference.
4. A Foley catheter having redundant temperature sensors as set forth in claim 3 , wherein the control unit includes an alarm and establishes a threshold, whereby when the sensor temperature exceeds the threshold, the control unit activates the alarm.
5. A Foley catheter having redundant temperature sensors as set forth in claim 4 , wherein the alarm is audible.
6. A Foley catheter having redundant temperature sensors as set forth in claim 4 , wherein the alarm includes a video display and activation of the alarm provides a video signal to the video display.
7. A method of using a Foley catheter with redundant temperature sensors, comprising:
introducing a Foley catheter into the bladder of a patient, the Foley catheter includes catheter body with a proximal end, a distal end a drainage lumen extending between the proximal end and the distal end for draining urine from the bladder, and redundant temperature sensors;
draining urine from the bladder via the drainage lumen;
electronically coupling the temperature sensors to a control unit;
activating the control unit to obtain a primary temperature reading and a secondary temperature reading from the temperature sensors.
8. A method as set forth in claim 7 , further comprising:
comparing the primary temperature reading and the secondary temperature reading to determine whether both sensors are operational.
9. A method as set forth in claim 7 , further comprising:
comparing the primary temperature reading and the secondary temperature reading to determine a difference between the primary temperature reading and the second temperature reading.
10. A method as set forth in claim 9 , further comprising:
establishing a threshold; and
deactivating the control unit when the difference exceeds the threshold.
11. A method as set forth in claim 10 , wherein the threshold is within the range of 0.5-2 degrees Fahrenheit.
12. A method as set forth in claim 10 , wherein the threshold is about 1 degree Fahrenheit.
13. A method as set forth in claim 7 , wherein the Foley catheter includes a balloon positioned at the distal end and an inflation lumen, the method includes inflating the balloon via the inflation lumen to hold the catheter in the bladder.
14. A method for measuring and regulating patient temperature comprising:
introducing a heat exchange catheter into the vasculature of a patient;
introducing a Foley catheter having redundant temperature sensors into the bladder of the patient;
draining urine from the bladder via the drainage lumen;
electronically connecting a control unit with the temperature sensors;
measuring patient core body temperature with the temperature sensors; and
determining if one of the temperature sensors has failed.
15. A method as set forth in claim 14 further comprising obtaining a primary temperature reading and a secondary temperature reading from the temperature sensors.
16. A method as set forth in claim 15 , further comprising:
comparing the primary temperature reading and the secondary temperature reading to determine a difference between the primary temperature reading and the secondary temperature reading.
17. A method as set forth in claim 16 , further comprising:
establishing a threshold; and
activating an alarm when the difference between the primary temperature and the secondary temperature exceeds the threshold.
18. A method as set forth in claim 16 , further comprising:
establishing a threshold; and
deactivating the control unit when the difference between the primary temperature and the secondary temperature exceeds the threshold.
19. A method as set forth in claim 18 , wherein the threshold is within the range of 0.5-2 degrees Fahrenheit.
20. A method as set forth in claim 18 , wherein the threshold is about 1 degree Fahrenheit.
Priority Applications (1)
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US10/349,972 US20030114835A1 (en) | 2000-12-15 | 2003-01-24 | Temperature sensor adapter for Foley catheters |
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US25608300P | 2000-12-15 | 2000-12-15 | |
US09/816,288 US6602243B2 (en) | 2000-12-15 | 2001-03-21 | Foley catheter having redundant temperature sensors and method |
US10/349,972 US20030114835A1 (en) | 2000-12-15 | 2003-01-24 | Temperature sensor adapter for Foley catheters |
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US09/816,288 Division US6602243B2 (en) | 2000-12-15 | 2001-03-21 | Foley catheter having redundant temperature sensors and method |
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US10/012,929 Abandoned US20020077680A1 (en) | 2000-12-15 | 2001-12-10 | Temperature sensor adapter for foley catheters |
US10/349,972 Abandoned US20030114835A1 (en) | 2000-12-15 | 2003-01-24 | Temperature sensor adapter for Foley catheters |
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US10/012,929 Abandoned US20020077680A1 (en) | 2000-12-15 | 2001-12-10 | Temperature sensor adapter for foley catheters |
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Also Published As
Publication number | Publication date |
---|---|
US20020077680A1 (en) | 2002-06-20 |
US6602243B2 (en) | 2003-08-05 |
WO2002047742A2 (en) | 2002-06-20 |
US20020082587A1 (en) | 2002-06-27 |
WO2002047742A3 (en) | 2003-08-21 |
AU2002232502A1 (en) | 2002-06-24 |
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