The present application relates generally to patient temperature control systems.
It has been discovered that the medical outcome for a patient suffering from severe brain trauma or from ischemia caused by stroke or heart attack or cardiac arrest is improved if the patient is cooled below normal body temperature (37° C.). Furthermore, it is also accepted that for such patients, it is important to prevent hyperthermia (fever) even if it is decided not to induce hypothermia. Moreover, in certain applications such as post-CABG surgery, skin graft surgery, and the like, it might be desirable to rewarm a hypothermic patient.
As recognized by the present application, the above-mentioned advantages in regulating temperature can be realized by cooling or heating the patient's entire body using a closed loop heat exchange catheter placed in the patient's venous system and circulating a working fluid such as saline through the catheter, heating or cooling the working fluid as appropriate in an external heat exchanger that is connected to the catheter. The following U.S. patents, all of which are incorporated herein by reference, disclose various intravascular catheters/systems/methods for such purposes: U.S. Pat. Nos. 6,881,551 and 6,585,692 (tri-lobe catheter), U.S. Pat. Nos. 6,551,349 and 6,554,797 (metal catheter with bellows), U.S. Pat. Nos. 6,749,625 and 6,796,995 (catheters with non-straight, non-helical heat exchange elements), U.S. Pat. Nos. 6,126,684, 6,299,599, 6,368,304, and 6,338,727 (catheters with multiple heat exchange balloons), U.S. Pat. Nos. 6,146,411, 6,019,783, 6,581,403, 7,287,398, and 5,837,003 (heat exchange systems for catheter), U.S. Pat. No. 7,857,781 (various heat exchange catheters).
The details of the present invention, both as to its structure and operation, can best be understood in reference to the accompanying drawings, in which like reference numerals refer to like parts, and in which:
A catheter includes a proximal segment having a supply lumen configured to receive working fluid from a heat exchange system and a return lumen configured to return working fluid to the heat exchange system. The catheter also includes a distal segment in fluid communication with the proximal segment and defining plural spaced apart discrete loops, each communicating with the supply lumen and each being connected to an adjacent loop by a substantially straight connector segment.
The loops when inflated with working fluid can be toroidal-shaped, disk-shaped, rectangular-shaped or triangular-shaped. Each loop can define a proximal surface and a distal surface parallel to the proximal surface and oriented transversely to a long axis of the return tube. The distal-most loop can be connected to the return lumen.
Each individual loop may include a supply port communicating with the supply lumen and a fluid channel defined by the loop and a return port communicating with the supply lumen and with the fluid channel of the loop, such that working fluid can circulate through the fluid channel from the supply port to the return port. The ports can be closely juxtaposed with each other and straddle a separator such that working fluid must flow from the supply port substantially completely through the fluid channel to the return port.
In an aspect, a catheter includes a series of hollow loops arranged along a tube for carrying working fluid from a heat exchange system to exchange heat with a patient in whom the catheter is advanced. When inflated, the loops are oriented transverse to a long axis of the catheter throughout their respective outer peripheries and are parallel to each other. The loops circumscribe a hollow passageway through which blood can flow. The loops are configured such that blood can also flow around the outer peripheries of the loops.
In an aspect, a method includes providing a heat exchange catheter with a supply lumen configured for receiving working fluid from a heat exchange system and a return lumen configured for returning working fluid to the heat exchange system. The method also includes providing plural discrete loops on the catheter receiving working fluid from the supply lumen and circulating returning working fluid through the loop. The loops are spaced from each other and connected to each other only by a flexible tube.
Referring initially to
As shown, working fluid such a refrigerant may be circulated between the heat exchange system 12 and catheter 10 through supply and return lines 16, 18 that connect to the proximal end of the catheter 10 as shown. Note that as used herein, “proximal” and “distal” in reference to the catheter are relative to the system 12. A patient temperature signal from a catheter-borne temperature sensor may be provided to the system 12 through an electrical line 20 or wirelessly if desired. Alternatively, a patient temperature signal may be provided to the system 12 from a separate esophageal probe or rectal probe or tympanic sensor or bladder probe or other temperature probe that measures the temperature of the patient 14.
The catheter 10, in addition to interior supply and return lumens through which the working fluid is circulated, may also have one or more infusion lumens connectable to an IV component 22 such as a syringe or IV bag for infusing medicaments into the patient, or an instrument such as an oxygen or pressure monitor for monitoring patient parameters, etc.
The catheter 10 can be positioned typically in the vasculature of the patient 14 and more preferably in the venous system of the patient 14 such as in the inferior vena cava through a groin insertion point or the superior vena cava through a neck (jugular or subclavian) insertion point.
Now referring to
Returning to
In the embodiment shown, each loop 102 defines a proximal surface and a distal surface parallel to the proximal surface and oriented transversely to a long axis of the return tube 108. The loop 102 in
In this embodiment, all but the distal-most loop receives working fluid from the supply lumen 106 on one side of the supply lumen 106 and returns it to the supply lumen 106 on the opposite side of the supply lumen 106, with the supply lumen 106 being provided with a divider 118 between the two sides to ensure that working fluid flows from the supply lumen 106, into the supply port 112 of the loop 102, around the loop 102, out of the return port 114, and back into the supply lumen 106. The distal-most loops has a return port 114 connected to a return lumen 108, which conveys the working fluid proximally back through the catheter 100 to the heat exchange system 12. In other embodiments, instead of being radially offset, the supply port 112 and return port 114 of a loop 102 may be slightly axially staggered as shown in
Note that each loop 102 in the example shown thus receives coolant from the supply lumen 106 and returns it to the supply lumen 106, except the distal-most loop, whose return port is connected to the return lumen 108. Note that in addition to the separator 116 within each loop 102 to separate the supply port 112 from the return port 114, there is also the blockage 118 in the catheter supply lumen 106 to ensure all coolant in the supply lumen 106 flows through the first loop, back into the supply lumen 106 to the next loop, through the second loop, and so on. Also note that the flow can be reversed, i.e., the distal most loop can receive working fluid first before all other loops through an elongated straight supply lumen, with the working fluid then being fed back through the other loops in a proximal direction. In the first case all loops 102 get fed from the supply lumen 106 and the last loop feeds it back to the return lumen 108; in the second case the distal loop gets fed from the supply lumen 106, feeding back the fluid through the return lumen 108 through each subsequent loop in sequence from distal to proximal.
In the embodiment of the catheter 100 shown in
While the particular INTRAVASCULAR HEAT EXCHANGE CATHETER WITH MULTIPLE SPACED APART DISCRETE COOLANT LOOPS is herein shown and described in detail, it is to be understood that the subject matter which is encompassed by the present invention is limited only by the claims.
Number | Name | Date | Kind |
---|---|---|---|
1459112 | Mehl | Jun 1923 | A |
1857031 | Schaffer | May 1932 | A |
2663030 | Dahlberg | Dec 1953 | A |
2673987 | Upshaw et al. | Apr 1954 | A |
3225191 | Calhoun | Dec 1965 | A |
3369549 | Armao | Feb 1968 | A |
3425419 | Dato | Feb 1969 | A |
3504674 | Swenson | Apr 1970 | A |
3726269 | Webster, Jr. | Apr 1973 | A |
3744555 | Fletcher et al. | Jul 1973 | A |
3751077 | Hiszpanski | Aug 1973 | A |
3937224 | Uecker | Feb 1976 | A |
3945063 | Matsuura | Mar 1976 | A |
4038519 | Foucras | Jul 1977 | A |
4065264 | Lewin | Dec 1977 | A |
4103511 | Kress et al. | Aug 1978 | A |
4126132 | Portner et al. | Nov 1978 | A |
4153048 | Magrini | May 1979 | A |
4173228 | Van Steenwyk et al. | Nov 1979 | A |
4181132 | Parks | Jan 1980 | A |
4298006 | Parks | Nov 1981 | A |
4459468 | Bailey | Jul 1984 | A |
4532414 | Shah et al. | Jul 1985 | A |
4554793 | Harding, Jr. | Nov 1985 | A |
4581017 | Sahota | Apr 1986 | A |
4638436 | Badger et al. | Jan 1987 | A |
4653987 | Tsuji et al. | Mar 1987 | A |
4661094 | Simpson | Apr 1987 | A |
4665391 | Spani | May 1987 | A |
4672962 | Hershenson | Jun 1987 | A |
4754752 | Ginsburg et al. | Jul 1988 | A |
4787388 | Hofmann | Nov 1988 | A |
4813855 | Leveen et al. | Mar 1989 | A |
4849196 | Yamada et al. | Jul 1989 | A |
4852567 | Sinofsky | Aug 1989 | A |
4860744 | Johnson et al. | Aug 1989 | A |
4906237 | Johansson et al. | Mar 1990 | A |
4941475 | Williams et al. | Jul 1990 | A |
5037392 | Hillstead | Aug 1991 | A |
5092841 | Spears | Mar 1992 | A |
5103360 | Maeda | Apr 1992 | A |
5106360 | Ishiwara et al. | Apr 1992 | A |
5192274 | Bierman | Mar 1993 | A |
5195965 | Shantha | Mar 1993 | A |
5211631 | Sheaff | May 1993 | A |
5269758 | Taheri | Dec 1993 | A |
5281215 | Milder | Jan 1994 | A |
5304214 | DeFord et al. | Apr 1994 | A |
5342301 | Saab | Aug 1994 | A |
5344436 | Fontenot et al. | Sep 1994 | A |
5370675 | Edwards et al. | Dec 1994 | A |
5383856 | Bersin | Jan 1995 | A |
5403281 | O'Neill et al. | Apr 1995 | A |
5433740 | Yamaguchi | Jul 1995 | A |
5437673 | Baust et al. | Aug 1995 | A |
5458639 | Tsukashima et al. | Oct 1995 | A |
5466208 | Ginsburg | Jan 1996 | A |
5486207 | Mahawili | Jan 1996 | A |
5507792 | Mason et al. | Apr 1996 | A |
5531714 | Dahn et al. | Jul 1996 | A |
5531776 | Ward et al. | Jul 1996 | A |
5624392 | Saab | Apr 1997 | A |
5634907 | Rani et al. | Jun 1997 | A |
5643315 | Daneshvar | Jul 1997 | A |
5676670 | Kim | Oct 1997 | A |
5701905 | Esch | Dec 1997 | A |
5709564 | Yamada et al. | Jan 1998 | A |
5709654 | Klatz et al. | Jan 1998 | A |
5716386 | Ward et al. | Feb 1998 | A |
5730720 | Sites et al. | Mar 1998 | A |
5733319 | Neilson et al. | Mar 1998 | A |
5737782 | Matsuura et al. | Apr 1998 | A |
5776079 | Cope et al. | Jul 1998 | A |
5788647 | Eggers | Aug 1998 | A |
5837003 | Ginsburg | Nov 1998 | A |
5862675 | Scaringe et al. | Jan 1999 | A |
5895418 | Saringer | Apr 1999 | A |
5908407 | Frazee et al. | Jun 1999 | A |
5957963 | Dobak, III | Sep 1999 | A |
5980561 | Kolen et al. | Nov 1999 | A |
6019783 | Philips et al. | Feb 2000 | A |
6042559 | Dobak, III | Mar 2000 | A |
6051019 | Dobak, III | Apr 2000 | A |
6059825 | Hobbs et al. | May 2000 | A |
6096068 | Dobak, III et al. | Aug 2000 | A |
6110139 | Loubser | Aug 2000 | A |
6117065 | Hastings et al. | Sep 2000 | A |
6117105 | Bresnaham et al. | Sep 2000 | A |
6124452 | Di Magno | Sep 2000 | A |
6126684 | Gobin et al. | Oct 2000 | A |
6146141 | Schumann | Nov 2000 | A |
6146411 | Noda et al. | Nov 2000 | A |
6148634 | Sherwood | Nov 2000 | A |
6149670 | Worthen et al. | Nov 2000 | A |
6149677 | Dobak, III | Nov 2000 | A |
6231594 | Dae | May 2001 | B1 |
6283940 | Mulholland | Sep 2001 | B1 |
6287326 | Pecor | Sep 2001 | B1 |
6299599 | Pham et al. | Oct 2001 | B1 |
6338727 | Noda et al. | Jan 2002 | B1 |
6383144 | Mooney et al. | May 2002 | B1 |
6409747 | Gobin et al. | Jun 2002 | B1 |
6416533 | Gobin et al. | Jul 2002 | B1 |
6428563 | Keller | Aug 2002 | B1 |
6450990 | Walker et al. | Sep 2002 | B1 |
6464716 | Dobak, III et al. | Oct 2002 | B1 |
6520933 | Evans et al. | Feb 2003 | B1 |
6527798 | Ginsburg et al. | Mar 2003 | B2 |
6530946 | Noda et al. | Mar 2003 | B1 |
6544282 | Dae et al. | Apr 2003 | B1 |
6551309 | Le Pivert | Apr 2003 | B1 |
6554791 | Cartledge et al. | Apr 2003 | B1 |
6589271 | Tzeng et al. | Jul 2003 | B1 |
6605106 | Schwartz | Aug 2003 | B2 |
6610083 | Keller et al. | Aug 2003 | B2 |
6620131 | Pham et al. | Sep 2003 | B2 |
6620187 | Carson et al. | Sep 2003 | B2 |
6620188 | Ginsburg et al. | Sep 2003 | B1 |
6624679 | Tomaivolo et al. | Sep 2003 | B2 |
6635079 | Unsworth et al. | Oct 2003 | B2 |
6679906 | Hammack et al. | Jan 2004 | B2 |
6685733 | Dae et al. | Feb 2004 | B1 |
6702840 | Keller et al. | Mar 2004 | B2 |
6706060 | Tzeng et al. | Mar 2004 | B2 |
6716188 | Noda et al. | Apr 2004 | B2 |
6719723 | Wemeth | Apr 2004 | B2 |
6719779 | Daoud | Apr 2004 | B2 |
6726653 | Noda et al. | Apr 2004 | B2 |
6733517 | Collins | May 2004 | B1 |
6740109 | Dobak, III | May 2004 | B2 |
6749625 | Pompa et al. | Jun 2004 | B2 |
6796995 | Pham et al. | Sep 2004 | B2 |
6799342 | Jarmon | Oct 2004 | B1 |
6843800 | Dobak, III | Jan 2005 | B1 |
6887263 | Bleam et al. | May 2005 | B2 |
6893419 | Noda et al. | May 2005 | B2 |
6969399 | Schock et al. | Nov 2005 | B2 |
7001417 | Elkins | Feb 2006 | B2 |
7001418 | Noda | Feb 2006 | B2 |
7014651 | Worthen et al. | Mar 2006 | B2 |
7510569 | Dae et al. | Mar 2009 | B2 |
7666215 | Callister et al. | Feb 2010 | B2 |
7822485 | Collins | Oct 2010 | B2 |
7846193 | Dae et al. | Dec 2010 | B2 |
7857781 | Noda et al. | Dec 2010 | B2 |
8105262 | Noda et al. | Jan 2012 | B2 |
8105263 | Noda et al. | Jan 2012 | B2 |
8105264 | Noda et al. | Jan 2012 | B2 |
8109894 | Noda et al. | Feb 2012 | B2 |
20010031946 | Walker et al. | Oct 2001 | A1 |
20010047196 | Ginsburg et al. | Nov 2001 | A1 |
20020013569 | Sterman et al. | Jan 2002 | A1 |
20020022823 | Luo et al. | Feb 2002 | A1 |
20020145525 | Friedman et al. | Oct 2002 | A1 |
20020183692 | Callister | Dec 2002 | A1 |
20020198579 | Khanna | Dec 2002 | A1 |
20030036496 | Elsner et al. | Feb 2003 | A1 |
20040089058 | De Hann et al. | May 2004 | A1 |
20040102825 | Daoud | May 2004 | A1 |
20040210231 | Boucher et al. | Oct 2004 | A1 |
20050156744 | Pires | Jul 2005 | A1 |
20070007640 | Harnden et al. | Jan 2007 | A1 |
20070076401 | Carrez et al. | Apr 2007 | A1 |
20070276461 | Andreas et al. | Nov 2007 | A1 |
20080177230 | Walker et al. | Jul 2008 | A1 |
20090082857 | Lashinski et al. | Mar 2009 | A1 |
20100228192 | O'Dea et al. | Sep 2010 | A1 |
20130090593 | Dabrowiak | Apr 2013 | A1 |
20130178923 | Dabrowiak | Jul 2013 | A1 |
Number | Date | Country |
---|---|---|
19531935 | Feb 1997 | DE |
2040169 | Aug 1980 | GB |
1183185 | Feb 1985 | GB |
2212262 | Jul 1989 | GB |
2383828 | Jul 2003 | GB |
09-215754 | Aug 1997 | JP |
10-0127777 | May 1998 | JP |
10-305103 | Nov 1998 | JP |
9001682 | Feb 1990 | WO |
9304727 | Mar 1993 | WO |
9400177 | Jan 1994 | WO |
9401177 | Jan 1994 | WO |
9725011 | Jul 1997 | WO |
9824491 | Jun 1998 | WO |
9840017 | Sep 1998 | WO |
0010494 | Mar 2000 | WO |
0113809 | Mar 2001 | WO |
0164146 | Sep 2001 | WO |
0176517 | Oct 2001 | WO |
0183001 | Nov 2001 | WO |
Entry |
---|
F.W. Behmann, E. Bontke, “Die Regelung der Wärmebildung bei künstlicher Hypothermie”, Pffügers Archiv, Bd. 266, S. 408-421 (1958). |
F.W. Behmann, E. Bontke, “Intravasale Kühlung”, Pffügers Archiv, Bd. 263, S. 145-165 (1956). |
Wilhelm Behringer, Stephan Prueckner, Rainer Kenter, Samuel A. Tisherman, Ann Radovsky, Robert Clark, S. William Stezoski, Heremy Henchir, Edwin Klein, Peter Safar, “Rapid Hypothermic Aortic Flush Can Achieve Survival without Brain Damage after 30 Minutes Cardiac Arrest in Dogs”, anesthesiology, V. 93, No. 6, Dec. 2000. |
Dorraine Day Watts, Arthur Trask, Karen Soeken, Philip Predue, Sheilah Dols, Christopher Kaufman; “Hypothermic Coagulopathy in trauma: Effect of Varying levels of Hypothermia on Enzyme Speed, Platelet Function, and Fibrinolytic Activity”. The Journal of Trauma: Injury, Infection, and Critical Care, Vo. 44, No. 5 (1998). |
Number | Date | Country | |
---|---|---|---|
20140094880 A1 | Apr 2014 | US |
Number | Date | Country | |
---|---|---|---|
61707107 | Sep 2012 | US |