Patent Application
20110288432
This invention relates generally to devices and methods for medical treatment and more particularly to devices and methods for monitoring body temperature and for effecting control of body temperature.
In the practice of clinical medicine and surgery, numerous situations arise in which it is desirable to determine or monitor the core body temperature of a human or veterinary patient. Various devices have heretofore been proposed for use in measuring or monitoring core body temperature, including intravascular thermistors or temperature probes that may be inserted into blood vessels to measure or monitor the temperature of blood flowing through such blood vessels.
In recent years, endovascular heat exchange catheters and related apparatus have been developed for heating or cooling the bodies of patients and/or for maintaining the patient's core body temperature within a desired temperature range. Examples of such endovascular heat exchange catheters and related apparatus include those described in U.S. Pat. No. 5,486,208 (Ginsburg), PCT International Publication WO OO/10494 (Machold et al.), U.S. Pat. No. 6,264,679 (Keller et al.), PCT International Publication Nos. WO-00/10494 (Radiant Medical, Inc.) and WO 01/58397 (Radiant Medical, Inc.), all of which are expressly incorporated herein by reference.
In some instances, the core body temperature of the patient is monitored and such monitored core body temperature is used as a basis for feedback control of the heat exchange catheter so as to maintain the patient's body temperature within a pre-set or desired temperature range. Examples of such feedback control systems are described and/or claimed in U.S. Pat. Nos. 5,837,003 (Ginsburg) and 6,149,673 (Ginsburg) and PCT International Patent Publication No. WO-00/10494 (Radiant Medical, Inc.), which are expressly incorporated herein by reference.
Although the prior art has included various types of indwelling temperature measuring devices, none of those prior art devices are believed to be optimally designed for use in all patients and all clinical conditions. Specifically, there exists a need in the art for an introduce sheath/temperature probe assembly whereby a tubular introducer sheath may be inserted into a blood vessel and a temperature measuring probe may be inserted through that introducer sheath for the purpose of measuring or monitoring the temperature of the patient's blood flowing through the blood vessel into which the introducer sheath is inserted.
The present invention provides an introducer sheath/temperature probe assembly for measuring the blood temperature of a human or veterinary patient. The introducer sheath/temperature probe assembly comprises a) a tubular introducer sheath that is insertable into a blood vessel and b) a temperature measuring probe that is insertable into the lumen of the introducer sheath. When the temperature probe is inserted into the lumen of the introducer sheath, one or more temperature sensors (e.g., thermistors) mounted on or in the temperature probe will sense the temperature of the patient's blood flowing through the blood vessel into which the introducer sheath is inserted. An atraumatic tip member may be formed on or attached to the distal end of the temperature probe and such atraumatic tip member may be allowed to protrude beyond the distal end of the introducer sheath to deter trauma or injury to the inner surface of the blood vessel wall. The temperature probe may include a single temperature sensor or a plurality of temperature sensors to provide one or more signals indicative of the blood temperature. In use, when the probe is deployed through the introducer, the probe may be positioned so that the atraumatic tip is extending out the distal end of the introducer sheath and the sensor or sensors may be located within the introducer sheath.
If there are more than one sensor, they may be placed side-by side in the probe or may be longitudinally arranged. Also in cases where two or more temperature sensors are included in or on the probe, such temperature signals may be checked against one another to ensure accuracy of the temperature measurement. If the difference between the temperature measured by the multiple sensors is less than a maximum allowable differences, the temperatures measured by the sensors may be averaged to arrive at a current sensed temperature. Alternatively, one of the sensors may be predesignated as the “driver” sensor and the signal from that sensor may be the temperature signal that is used by the controller as the patient temperature. In yet another embodiment, the two or more temperature signals may be checked against each other and if the difference is within the acceptable limit, the controller may select which signal to use as the representative signal of the patient temperature. For example, if the controller is cooling the patient, the controller may select the cooler of two signals to avoid over cooling the patient, or if the patient is warming, the controller may select the warmer of two signals to avoid over warming the patient. On the other hand, if the temperatures measured by the sensors differ by more than a maximum allowable temperature difference, such may be taken as an indication of a sensor malfunction or inaccurate measurement and an alarm may be provided to the operator or the entire system may be shut down.
Further in accordance with the present invention, there is provided a body temperature control system which comprises an introducer sheath/temperature probe assembly of the foregoing character further in combination with a heat exchange catheter that is insertable into the patient's vasculature to heat and/or cool the patient's blood. In this body temperature control system, the current body temperature measured by the temperature probe may be utilized as a basis for feedback control of the heat exchange catheter to warm or cool the patient's body to a desired target temperature and to thereafter maintain the patient's body at or near the desired target temperature for a desired period of time.
Further in accordance with this invention, a method is provided for determining the core body temperature by obtaining a temperature signal from a temperature probe within an introducer sheath located within one of the great veins, e.g. the inferior vena cava, the superior vena cava, the right and left femoral veins, the subclavian veins and the jugular veins.
Further aspects and advantages of the present invention will be recognized and understood by those of skill in the art upon reading of the detailed description and examples of the invention set forth herebelow and in the accompanying drawings.
The introducer sheath component 10A, as shown in
The temperature probe component 10B, as shown in
With particular reference to the cross sections shown in
When the temperature probe 32 is inserted through the proximal opening 15 of the introducer hub 14, through the hemostatic valve 20 and through the lumen of the introducer cannula to its operative position within the introducer cannula 12, the cap member 34 may be screwed onto the proximal end of the introducer hub 15 such that the engagement surfaces 33A and 33B engage one another and hold the cap member 34 on the introducer hub 14. A gripping member 35, such as a compressible 0-ring or Tui Borst valve having an opening of variable diameter may be mounted within the cap member 34 such that the probe 32 extends through a central opening within the gripping member 34. As the cap member 34 is advanced and tightened (e.g, screwed onto) the proximal aspect of the introducer hub 14 as shown in
The length, diameter and relative stiffness of the introducer cannula 12, probe 32 and the probe's atraumatic tip member 46 may vary, depending on the type and size of blood vessel into which the assembly 10 is to be inserted. In applications wherein the assembly 10 is to be inserted into a femoral vein or femoral artery, the introducer cannula will preferably be 7.5-14 cm in length, 2 French to 6 French in inner diameter and may be made of high density polyethylene or other suitable material having a Durometer hardness of about 72D, and the probe 32 will preferably be of a length and diameter that allows it to fit snugly but slidably within the lumen of the introducer cannula 12. In such femoral embodiments, the probe's atraumatic tip member 46 will preferably be approximately 5 cm in length and will be made of material having a Durometer hardness of 25D-35D and configured to minimize trauma to the blood vessel wall (e.g., having a rounded, blunt distal tip). It is preferable that all or substantially all of the atraumatic tip member 46 protrude beyond the distal end DE of the cannula 12. The temperature sensors 40A, 40B are preferably positioned on or in the probe 32 proximal to the atraumatic tip member 46 and are housed within the cannula 21 when the probe 32 is fully advanced to its operative position with its atraumatic distal tip member 46 protruding out of the distal end of the cannula 12. To facilitate such positioning of the temperature probe 32 within the lumen of the introducer cannula 12, a mark 37 may be formed on the tube 36 such that the temperature probe 32 may be advanced into the cannula 12 until the mark 37 is at a predetermined location relative to the cap member 34 (e.g., where the mark 37 if immediately adjacent to the flat proximal surface 34PS of the cap member 34) and the cap member 34 may then be tightened, thereby holding the probe 32 within the cannula 12 in a position where the atraumatic tip member 46 protrudes out of the distal end of the cannula 12 but the probe's sensors 42A, 42B remain positioned within the cannula 12.
Thereafter, as shown in
Thereafter, as shown in
Various types of heat exchange catheters and related apparatus may be used in conjunction with the introducer sheath/temperature probe assembly 10 to alter and/or control the temperature of all or a portion of the body of a human or veterinary patient. Examples of such heat exchange catheters and related apparatus are described in U.S. Pat. Nos. 6,149,676 and 6,149,676 and co-pending U.S. patent application Ser. No. 09/138,830, 09/563,946 and 09/707,257, the entireties of which are expressly incorporated herein by reference.
The re-usable heater/cooler/control unit 270 includes an outer housing 284 having a cassette insertion slot 285 into which the heat exchange cassette 276 may be inserted. A heater/cooler 288 such as a thermoelectric plate, a pump driver 290, and a microprocessor controller 292 are positioned within the housing 284. In addition, a manual input unit 294 enables an operator to enter desirable operating parameters into the microprocessor controller 292, for example a pre-selected target body temperature. Each of the electronic devices provided within the control unit 270 communicate through suitable wiring or other connections. Additionally, a wire 36 or other connection (e.g., a wireless connection or fiber optic connection) connects the temperature probe component 30 of the introducer sheath/temperature probe assembly 10 to the microprocessor controller 292, another wire or other connection (e.g., a wireless connection or fiber optic connection) connects a heat transfer fluid temperature and/or flow rate sensor 261 mounted on or in the heat exchange catheter 260 such that a signal indicating the temperature and or flow rate of the heat exchange fluid entering and/or exiting the heat exchange catheter 260 is received by the microprocessor controller 292 and another wire or other connection (e.g., a wireless connection or fiber optic connection) connects the optional additional body temperature sensor(s) 265 (if any) to the microprocessor controller 292. In this manner, the microprocessor controller 292 receives signals or information indicating at least 1) the patient's body temperature as sensed by the introducer sheath/temperature probe assembly 10 and any optional additional body temperature sensors 265, 2) the target body temperature and any other parameters or targets (e.g., maximum rate of cooling or warming) input by the operator through the manual input unit 294, 3) the temperature and/or flow rate of thermal transfer fluid through the heat exchange catheter 260 as sensed by temperature and/or flow rate sensor 261. As those of skill in the art will appreciate, other sensed or operator-input parameters or variables may also be received by the microprocessor controller 292.
The heat exchange catheter 260 may comprise any suitable type of catheter designed to exchange heat with the patients blood, including those heat exchange catheters described in U.S. Pat. No. 5,486,208 (Ginsburg), PCT International Publication WO 00/10494 (Machold et al.), U.S. Pat. No. 6,264,679 (Keller et al.), PCT International Publication Nos. WO-00/10494 (Radiant Medical, Inc.) and WO 01/58397 (Radiant Medical, Inc.) U.S. Pat. No. 5,411,392 (Saab), U.S. Pat. No. 6,126,684 (Gobin et al.) And U.S. Pat. No. 6,096,068 (Dobak et al.) the entireties of which are expressly incorporated herein by reference. One presently preferred heat exchange catheter 260 for use with this system 101 is shown in
Two way flow conduit 267 has inflow and outflow lumens (not shown) extending therethrough. Bifurcations are formed on both ends of the two way flow conduit 267, as shown in
As shown in
In typical use, the heat exchange catheter 260 with its heat exchange balloon 268 in a non-inflated, collapsed state, is percutaneously inserted using a Seldinger technique into a femoral vein of the patient. The heat exchange catheter is then advanced to a position wherein the heat exchange balloon 268 is positioned within the patient's inferior vena cava (IVC). An introducer sheath/temperature probe assembly 10 of the present invention is inserted into the other femoral vein (or any other suitable blood vessel wherein the blood temperature is representative of the body temperature that the operator desires to control or alter. In many applications, the operator will desire to alter or control the patient's core body temperature and, thus, it will be desirable to insert the introducer sheath/temperature probe assembly 10 into a major blood vessel wherein the flowing blood is at or near the patient's core body temperature (e.g., femoral vein, femoral artery, external jugular vein, subclavian vein, etc.).
A bag or vessel 278 containing a suitable heat transfer fluid, such as sterile 0.9% NaCl solution, is attached to the proximal inflow furcation of the two way flow conduit 267, as shown in
The cassette 276 is inserted into the cassette receiving slot 285 such that the cassette is positioned adjacent to the heater/cooler 288 and the pump driver 290 engages the pump 293.
The connector or plug 38 of the introducer sheath/temperature probe assembly 10 is connected to a corresponding receptacle on the controller 292 of the heating/cooling/control unit 270 and the operator inputs the target body temperature into the input apparatus 294.
The system 101 is then energized and the controller receives the temperature signals from the temperature sensors 40A, 40B within the probe 32 and compares the sensed temperatures. If the difference between the temperatures sensed by the first sensor 40A and the second sensor 40 B is greater than the preset allowable difference (e.g., 1 degree difference) the controller will issue a warning signal to the operator and/or will automatically shut down or prevent start up of the pump driver 290, thereby stopping or preventing any heat transfer fluid from being circulated through the heat exchange balloon 268. If, on the other hand, the difference between the temperatures sensed by the first sensor 40A and the second sensor 40 B is no more than a preset allowable difference (e.g., 1 degree) the controller will average the two sensed temperatures and that average will be taken as the current measured body temperature to use as the “driver” temperature.
Alternatively, the controller may compare the two signals, and if they are within the predetermined range (e.g. 1 degree C. or 10% or some other appropriate criteria) the controller may ignore one and use the temperature signal from the other as the temperature signal to drive the controller. As yet another alternative, the controller may compare the two signals and select one based on some other criteria, for example if the controller is cooling the patient's body, the controller may select the cooler of the two temperatures as the “driver” temperature to use, and thus avoid overcooling the patient, or if the controller is warming, it may select the warmer of the two as the “driver” temperature signal. If three signals are compared, the controller could also use the median temperature signal as the “driver” signal. These and other similar methods of comparing and using multiple temperature signals are all anticipated by this invention.
The controller 292 then compares this current measured body temperature to the target body temperature that had been entered by the operator and if the current measured body temperature is different from the target temperature, the controller will cause the heater/cooler to either heat or cool the heat transfer fluid within the cassette 276 and/or will adjust the rate at which the driver 290 drives the pump 293 such that the temperature of the heat transfer fluid being circulated through the heat exchange balloon 268 and/or the rate at which the heat transfer fluid is circulated through the heat exchange balloon 268 will cause warming or cooling of the patient's blood until the current measured body temperature reaches the target temperature. The controller 292 may be specifically programmed to minimize or prevent overshoot of the target temperature as described in U.S. Pat. Nos. 5,837,003 (Ginsburg) and 6,149,673 (Ginsburg) and PCT International Patent Publication No. WO-00/10494 (Radiant Medical, Inc.), the entire disclosures of which are expressly incorporated herein by reference. After the target body temperature has been attained, the controller will continuously or periodically redetermine the current measured body temperature and will cause corresponding adjustments in the heater/cooler and or pump driver 290 to maintain the patient's body temperature at or near the target temperature (e.g., target temperature+ or −0.5 degrees C.).
While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, while remaining within the scope of the present invention. Accordingly, the scope of the invention should therefore be determined with reference to the appended claims, along with the full range of equivalents to which those claims are entitled.
This application is a continuation of U.S. application Ser. No. 11/709,108 filed Feb. 20, 2007 and issued as U.S. Pat. No. 7,946,996 on May 24, 2011, which is a continuation of U.S. patent application Ser. No. 10/238,925 filed Sep. 10, 2002 and issued as U.S. Pat. No. 7,186,222 on Mar. 6, 2007, the entire disclosure of each such prior application being expressly incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10238925 | Sep 2002 | US |
| Child | 13115000 | US | |
| Parent | 11709108 | Feb 2007 | US |
| Child | 10238925 | US |
