|Publication number||US7052508 B2|
|Application number||US 10/716,801|
|Publication date||30 May 2006|
|Filing date||18 Nov 2003|
|Priority date||7 Oct 1999|
|Also published as||DE1223901T1, EP1223901A1, US6325818, US6676690, US20010032004, US20040102827, WO2001026590A1|
|Publication number||10716801, 716801, US 7052508 B2, US 7052508B2, US-B2-7052508, US7052508 B2, US7052508B2|
|Original Assignee||Innercool Therapies, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (99), Non-Patent Citations (72), Classifications (10), Legal Events (9) |
|External Links: USPTO, USPTO Assignment, Espacenet|
Inflatable heat transfer apparatus
US 7052508 B2
An apparatus having an inflatable balloon near a distal end of a multi-lumen catheter, with a plurality of blood flow passageways formed through the interior of the balloon from a proximal face of the inflated balloon to a distal face of the inflated balloon. A heat transfer solution is introduced through a supply lumen of the catheter to inflate the balloon in a selected blood vessel; this allows blood to flow through the blood flow passageways of the balloon, from one exterior face of the balloon to another exterior face. The heat transfer solution continues to circulate around the blood flow passageways inside the balloon, to change the blood temperature, eventually exiting the balloon through a return lumen of the catheter.
1. A cooling apparatus for causing patient hypothermia, comprising:
a flexible catheter;
an inflatable balloon attached near a distal end of said catheter;
at least one blood flow passageway formed through the interior of said balloon, said at least one blood flow passageway extending from a proximal blood flow port in a proximal exterior face of said balloon to a distal blood flow port in a distal exterior face of said balloon;
a cooling fluid supply lumen formed in said catheter;
a cooling fluid supply port in said catheter, connecting said cooling fluid supply lumen to the interior of said balloon;
a cooling fluid return lumen formed in said catheter; and
a cooling fluid return port in said catheter, connecting the interior of said balloon
to said cooling fluid return lumen, wherein said at least one blood flow passageway is formed from a polymer film.
2. A cooling apparatus as recited in claim 1, wherein said at least one blood flow passageway is formed from a metallized polymer film having metal layers formed on both interior and exterior surfaces.
3. A cooling apparatus as recited in claim 1, wherein said at least one blood flow passageway is formed from a polymer film loaded with metal particles.
4. An apparatus as recited in claim 1, wherein said balloon is inflatable to a substantially cylindrical shape.
5. An apparatus as recited in claim 1, wherein said at least one blood flow passageway assumes a substantially tubular shape upon inflation of said balloon.
6. An apparatus as recited in claim 1, further comprising a guidewire lumen formed in said catheter.
7. An apparatus as recited in claim 1, further comprising a plurality of blood flow passageways formed through the interior of said balloon, each of said blood flow passageways extending from a proximal blood flow port in a proximal exterior face of said balloon to a distal blood flow port in a distal exterior face of said balloon.
8. An apparatus as recited in claim 1, wherein said at least one blood flow passageway is formed from a material having high thermal conductivity.
9. A method of changing the temperature of a patient, comprising:
providing an apparatus having a flexible multi-lumen catheter, an inflatable balloon attached near a distal end of said catheter, and at least one blood flow passageway formed through the interior of said balloon from a proximal blood flow port in a proximal exterior face of said balloon to a distal blood flow port in a distal exterior face of said balloon;
introducing said apparatus through the vascular system of a patient to a selected location in a blood vessel;
introducing a heat transfer fluid through a first lumen of said catheter to the interior of said balloon, thereby inflating said balloon to contact the walls of said selected blood vessel, and thereby allowing blood flow through the interior of said at least one blood flow passageway;
circulating said heat transfer fluid through the interior of said balloon and out of said balloon through a second lumen of said catheter, thereby changing the temperature of the wall of said at least one blood flow passageway, while maintaining said balloon in said inflated state; and
changing the temperature of said blood flowing through said selected blood vessel by contact with the wall of said at least one blood flow passageway.
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. application Ser. No. 09/885,655, filed on Jun. 20, 2001, now U.S. Pat. No. 6,676,690, which is a continuation of U.S. application Ser. No. 09/414,184, for “Inflatable Cooling Apparatus for Selective Organ Hypothermia”, filed Oct. 7, 1999, now U.S. Pat. No. 6,325,818.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
BACKGROUND OF THE INVENTION
1. Field of the Invention
The current invention relates to selective cooling, or hypothermia, of an organ, such as the brain, by cooling the blood flowing into the organ. This cooling can protect the tissue from injury caused by anoxia or trauma.
2. Background Information
Organs of the human body, such as the brain, kidney, and heart, are maintained at a constant temperature of approximately 37° C. Cooling of organs below 35° C. is known to provide cellular protection from anoxic damage caused by a disruption of blood supply, or by trauma. Cooling can also reduce swelling associated with these injuries.
Hypothermia is currently utilized in medicine and is sometimes performed to protect the brain from injury. Cooling of the brain is generally accomplished through whole body cooling to create a condition of total body hypothermia in the range of 20° to 30° C. This cooling is accomplished by immersing the patient in ice, by using cooling blankets, or by cooling the blood flowing externally through a cardiopulmonary bypass machine.
Total body hypothermia to provide organ protection has a number of drawbacks. First, it creates cardiovascular problems, such as cardiac arrhythmias, reduced cardiac output, and increased systemic vascular resistance. These side effects can result in organ damage. These side effects are believed to be caused reflexively in response to the reduction in core body temperature. Second, total body hypothermia is difficult to administer. Immersing a patient in ice water clearly has its associated problems. Placement on cardiopulmonary bypass requires surgical intervention and specialists to operate the machine, and it is associated with a number of complications including bleeding and volume overload. Third, the time required to reduce the body temperature and the organ temperature is prolonged. Minimizing the time between injury and the onset of cooling has been shown to produce better clinical outcomes.
Some physicians have immersed the patient's head in ice to provide brain cooling. There are also cooling helmets, or head gear, to perform the same. This approach suffers from the problems of slow cool down and poor temperature control due to the temperature gradient that must be established externally to internally. It has also been shown that complications associated with total body cooling, such as arrhythmia and decreased cardiac output, can also be caused by cooling of the face and head only.
Selective organ hypothermia has been studied by Schwartz, et. al. Utilizing baboons, blood was circulated and cooled externally from the body via the femoral artery and returned to the body through the carotid artery. This study showed that the brain could be selectively cooled to temperatures of 20° C. without reducing the temperature of the entire body. Subsequently, cardiovascular complications associated with total body hypothermia did not occur. However, external circulation of the blood for cooling is not a practical approach for the treatment of humans. The risks of infection, bleeding, and fluid imbalance are great. Also, at least two arterial vessels must be punctured and cannulated. Further, percutaneous cannulation of the carotid artery is very difficult and potentially fatal, due to the associated arterial wall trauma. Also, this method could not be used to cool organs such as the kidneys, where the renal arteries cannot be directly cannulated percutaneously.
Selective organ hypothermia has also been attempted by perfusing the organ with a cold solution, such as saline or perflourocarbons. This is commonly done to protect the heart during heart surgery and is referred to as cardioplegia. This procedure has a number of drawbacks, including limited time of administration due to excessive volume accumulation, cost and inconvenience of maintaining the perfusate, and lack of effectiveness due to temperature dilution from the blood. Temperature dilution by the blood is a particular problem in high blood flow organs such as the brain. For cardioplegia, the blood flow to the heart is minimized, and therefore this effect is minimized.
Intravascular, selective organ hypothermia, created by cooling the blood flowing into the organ, is the ideal method. First, because only the target organ is cooled, complications associated with total body hypothermia are avoided. Second, because the blood is cooled intravascularly, or in situ, problems associated with external circulation of blood are eliminated. Third, only a single puncture and arterial vessel cannulation is required, and it can be performed at an easily accessible artery such as the femoral, subclavian, or brachial. Fourth, cold perfusate solutions are not required, thus eliminating problems with excessive fluid accumulation. This also eliminates the time, cost, and handling issues associated with providing and maintaining cold perfusate solution. Fifth, rapid cooling can be achieved. Sixth, precise temperature control is possible.
The important factor related to catheter development for selective organ hypothermia is the small size of the typical feeding artery, and the need to prevent a significant reduction in blood flow when the catheter is placed in the artery. A significant reduction in blood flow would result in ischemic organ damage. While the diameter of the major vessels of the body, such as the vena cava and aorta, are as large as 15 to 20 mm., the diameter of the feeding artery of an organ is typically only 4.0 to 8.0 mm. Thus, a catheter residing in one of these arteries cannot be much larger than 2.0 to 3.0 mm. in outside diameter. The small size of the feeding artery also limits the size and type of heat transfer element that can safely be used.
A catheter based on the circulation of water or saline operates on the principle of transferring heat from the blood to raise the temperature of the water. Therefore, it is essential to use a heat transfer element that transfers heat from the blood to the cooling fluid as efficiently as possible, while restricting the flow of blood as little as possible. So, it would be beneficial to have a heat transfer apparatus that can be inserted percutaneously into an artery of restricted size, that can efficiently transfer heat, and that will not significantly limit the flow rate of blood in the artery during application of cooling.
BRIEF SUMMARY OF THE INVENTION
The present invention is a cooling apparatus comprising a flexible catheter which can be inserted through the vascular system of a patient to a feeding artery, with an inflatable balloon heat exchanger near the distal end of the catheter. The present invention also encompasses a method for using such a device to perform selective organ cooling. After placement in the selected feeding artery, the heat exchanger balloon is inflated by pressurization with a saline solution, via a supply lumen in the catheter. The heat exchanger balloon has one or more blood passageways passing through it, from a proximal aspect of the balloon to a distal aspect of the balloon. When the heat exchanger balloon is inflated to contact the wall of the artery in which it is placed, each of the blood passageways comprises a tube having an inlet in one face of the heat exchanger balloon and an outlet in another face of the heat exchanger balloon, thereby allowing blood to continue flowing through the artery after inflation of the balloon. The blood passageway tubes can be constructed of a material having a relatively high thermal conductivity, such as a thin metallized polymer, such as a film with one or more metallized surfaces. Alternatively, the blood passageway tubes can be constructed of a metal-loaded polymer film. Further, the entire heat exchanger balloon can be constructed of such a material, in order to maximize the cooling capacity of the heat exchanger.
After inflation of the heat exchanger balloon, the saline solution, which is chilled by an external chiller, continues circulating through the interior of the heat exchanger balloon, around the blood passageway tubes, and back out of the balloon through a return lumen in the catheter. This cools the blood passageway tubes, which in turn cool the blood flowing through them. This cooled blood then flows through the selected organ and cools the organ.
The device can also incorporate a lumen for a guidewire, facilitating the navigation of the catheter through the vascular system of the patient.
The novel features of this invention, as well as the invention itself, will be best understood from the attached drawings, taken along with the following description, in which similar reference characters refer to similar parts, and in which:
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
FIG. 1 is a perspective view of the device of the present invention in place in a common carotid artery of a patient;
FIG. 2 is a perspective view of the device shown in FIG. 1, with additional details of construction;
FIG. 3 is a transverse section view of the device shown in FIG. 2, along the section line 3—3; and
FIG. 4 is a partial longitudinal section view of the device shown in FIG. 2, showing the flow path of the cooling fluid.
DETAILED DESCRIPTION OF THE INVENTION
As shown in FIG. 1, the cooling apparatus 10 of the present invention includes a flexible multilumen catheter 12, an inflatable balloon 14, and a plurality of blood flow passageways 16 through the balloon 14. The balloon 14 is shown in an inflated state, in a selected position in a common carotid artery CC.
The balloon 14 is attached near a distal end of the flexible catheter 12. The catheter 12 can have at least a cooling fluid supply lumen 18 and a cooling fluid return lumen 20, with the cooling fluid supply lumen 18 preferably being located substantially within the cooling fluid return lumen 20. The catheter 12 can also have a guidewire lumen 22, for the passage of a guidewire 24, as is known in the art.
The balloon 14 can be formed from a flexible material, such as a polymer. The balloon 14 can be constructed to assume a substantially cylindrical shape when inflated, with a proximal aspect 15 and a distal aspect 17. The balloon 14 can have a plurality of tubular shaped blood flow passageways 16 formed therethrough, from the proximal aspect 15 to the distal aspect 17. The tubular walls of the passageways 16 constitute a heat transfer surface, for transferring heat from the blood to the cooling fluid. The flexible material of the tubular passageways 16 can be, at least in part, a metallized material, such as a film coated with a thin metal layer, either internally, externally, or both, to aid in heat transfer through the passageway walls. Alternatively, the tubular passageways 16 can be constructed of a metal-loaded polymer film. Further, the remainder of the balloon 14 can be coated with a thin metallized layer, either internally, externally, or both, or a metal-loaded polymer film. The proximal aspect 15 and the distal aspect 17 of the balloon can also constitute a heat transfer surface, for transferring heat from the blood to the cooling fluid. The guidewire lumen 22 of the catheter 12 can also pass through the balloon 14, from the proximal aspect 15 to the distal aspect 17.
As shown in FIG. 2, each tubular passageway 16 has a proximal port 26 in a proximal face 28 on the proximal aspect 15 of the balloon 14, and a distal port 30 in a distal face 32 on the distal aspect 17 of the balloon 14. A cooling fluid supply port 34 near the distal end of the cooling fluid supply lumen 18 supplies chilled saline solution from a chiller (not shown) to the interior of the balloon 14, surrounding the blood flow passageways 16. A cooling fluid return port 36 in the cooling fluid return lumen 20 returns the saline solution from the interior of the balloon 14 to the chiller. Relative placement of the cooling fluid ports 34, 36 can be chosen to establish flow counter to the direction of blood flow, if desired.
FIG. 3 shows the proximal aspect 15 of the balloon 14 and gives a view through the blood flow passageways 16, illustrating the general arrangement of the blood flow passageways 16, cooling fluid supply lumen 18, cooling fluid return lumen 20, and guidewire lumen 22, within the outer wall 38 of the balloon 14. FIG. 4 is a side elevation view of the apparatus 10, with a partial longitudinal section through the balloon wall 38, showing one possible arrangement of the cooling fluid supply port 34 and the cooling fluid return port 36 within the balloon 14.
In practice, the balloon 14, in a deflated state, is passed through the vascular system of a patient on the distal end of the catheter 12, over the guidewire 24. Placement of the guidewire 24 and the balloon 14 can be monitored fluoroscopically, as is known in the art, by use of radiopaque markers (not shown) on the guidewire 24 and the balloon 14. When the balloon 14 has been positioned at a desired location in the feeding artery of a selected organ, such as in the common carotid artery feeding the brain, fluid such as saline solution is supplied through the cooling fluid supply lumen 18. This fluid passes through the cooling fluid supply port 34 into the interior of the balloon 14, surrounding the tubular passageways 16, to inflate the balloon 14. Although the balloon 14 can be formed to assume a substantially cylindrical shape upon unconstrained inflation, the balloon 14 will essentially conform to the shape of the artery within which it is inflated. As the balloon 14 inflates, the blood flow passageways 16 open, substantially assuming the tubular shape shown.
When the balloon 14 has been properly inflated, blood continues to flow through the feeding artery CC by flowing through the blood flow passageways 16, as indicated, for example, by the arrows in FIG. 1. The size and number of the blood flow passageways 16 are designed to provide a desired amount of heat transfer surface, while maintaining a suitable amount of blood flow through the feeding artery CC. Return flow to the chiller can be established, to allow flow of cooling fluid through the cooling fluid return port 36 and the cooling fluid return lumen 20 to the chiller. This establishes a continuous flow of cooling fluid through the interior of the balloon 14, around the blood flow passageways 16. The return flow is regulated to maintain the balloon 14 in its inflated state, while circulation of cooling fluid takes place. The saline solution is cooled in the chiller to maintain a desired cooling fluid temperature in the interior of the balloon 14, to impart a desired temperature drop to the blood flowing through the tubular passageways 16. This cooled blood flows through the feeding artery to impart the desired amount of cooling to the selected organ. Then, cooling fluid can be evacuated or released from the balloon 14, through the catheter 12, to deflate the balloon 14, and the apparatus 10 can be withdrawn from the vascular system of the patient.
While the particular invention as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages hereinbefore stated, it is to be understood that this disclosure is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended other than as described in the appended claims.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US1011606||5 Mar 1910||12 Dec 1911||Jacob A Fulton||Appliance for subjecting portions of the human system to heat or cold.|
|US2077453||29 Mar 1934||20 Apr 1937||American Anode Inc||Therapeutical appliance|
|US2148541||10 Dec 1935||28 Feb 1939||Dierker Hugh E||Colon therapy device and applicator therefor|
|US2308484||16 Jan 1939||19 Jan 1943||Davol Rubber Co||Catheter|
|US2374609||5 Sep 1942||24 Apr 1945|| ||Heating apparatus|
|US2466042||26 Aug 1947||5 Apr 1949||Nechtow Mitchell J||Internal heat-treatment device|
|US2615686||29 May 1948||28 Oct 1952||Servel Inc||Heat transfer device|
|US2672032||19 Oct 1951||16 Mar 1954||Edward Towse Robert Albert||Carcass freezing device|
|US2913009||16 Jul 1956||17 Nov 1959||Calumet & Hecla||Internal and internal-external surface heat exchange tubing|
|US3125096||7 Jul 1961||17 Mar 1964|| ||Compressor|
|US3298371||11 Feb 1965||17 Jan 1967||Arnold S J Lee||Freezing probe for the treatment of tissue, especially in neurosurgery|
|US3425419||2 Jul 1965||4 Feb 1969||Angelo Actis Dato||Method of lowering and raising the temperature of the human body|
|US3460538||20 Oct 1967||12 Aug 1969||Edward T Armstrong||Hypothermia apparatus and method for treating the human body and the like|
|US3504674||22 Dec 1966||7 Apr 1970||Emil S Swenson||Method and apparatus for performing hypothermia|
|US3604419||19 Sep 1968||14 Sep 1971||Technion Res & Dev Foundation||Apparatus for urinary bladder treatment|
|US3612175||1 Jul 1969||12 Oct 1971||Olin Corp||Corrugated metal tubing|
|US3768484||6 Oct 1972||30 Oct 1973||Lawrence A Robert||Gastric cooling apparatus|
|US3839621||11 Aug 1972||1 Oct 1974||H Hariu||Body heating device|
|US3865116||9 Apr 1973||11 Feb 1975||Brooks Harold W||Method of controlling tissue hypothermia|
|US3888259||21 Aug 1973||10 Jun 1975||Miley Robert C||Hypothermia system|
|US3971383||29 Apr 1975||27 Jul 1976||Erbe Elektromedizin Kg||Cryogenic surgical instrument|
|US4038519||15 Nov 1974||26 Jul 1977||Rhone-Poulenc S.A.||Electrically heated flexible tube having temperature measuring probe|
|US4072146||8 Sep 1976||7 Feb 1978||Howes Randolph M||Venous catheter device|
|US4153048||14 Sep 1977||8 May 1979||Cleveland Clinic Foundation||Thermodilution catheter and method|
|US4160455||13 Jul 1977||10 Jul 1979||Ferranti Limited||Heater for heating fluid in a body cavity|
|US4190033||21 Jul 1978||26 Feb 1980||Foti Thomas M||Closed flow caloric test method|
|US4216767||15 Feb 1978||12 Aug 1980||Machida Endoscope Co., Ltd.||Endoscope with closed pressurized inner cavity|
|US4231425||27 Feb 1978||4 Nov 1980||Engstrom William R||Extracorporeal circuit blood heat exchanger|
|US4241729||21 Jul 1978||30 Dec 1980||Machida Endoscope Co., Ltd.||Endoscope with gas-tight cap permitting pressurization|
|US4275734||12 Aug 1977||30 Jun 1981||Valleylab, Inc.||Cryosurgical apparatus and method|
|US4298006||30 Apr 1980||3 Nov 1981||Research Against Cancer, Inc.||Systemic hyperthermia with improved temperature sensing apparatus and method|
|US4318722||9 Apr 1980||9 Mar 1982||Gerald Altman||Infrared radiation cooler for producing physiologic conditions such as a comfort or hypothermia|
|US4323071||19 May 1980||6 Apr 1982||Advanced Catheter Systems, Inc.||Vascular guiding catheter assembly and vascular dilating catheter assembly and a combination thereof and methods of making the same|
|US4427009||30 Jun 1981||24 Jan 1984||Minnesota Mining And Manufacturing Company||Integrated cardioplegia delivery system|
|US4445500||30 Sep 1982||1 May 1984||Thomas Jefferson University||Stroke treatment utilizing extravascular circulation of oxygenated synthetic nutrients to treat tissue hypoxic and ischemic disorders|
|US4464172||6 Jan 1981||7 Aug 1984||Lichtenstein Eric Stefan||Computer-control medical care system|
|US4483341||9 Dec 1982||20 Nov 1984||Atlantic Richfield Company||Therapeutic hypothermia instrument|
|US4484586||1 Nov 1982||27 Nov 1984||Berkley & Company, Inc.||Hollow conductive medical tubing|
|US4497890||8 Apr 1983||5 Feb 1985||Motorola, Inc.||Process for improving adhesion of resist to gold|
|US4502286||4 Aug 1983||5 Mar 1985||Hitachi, Ltd.||Constant pressure type boiling cooling system|
|US4569355||28 May 1982||11 Feb 1986||Hemodynamics Technology, Inc.||Method and apparatus for monitoring and diagnosing peripheral blood flow|
|US4581017||7 Mar 1983||8 Apr 1986||Harvinder Sahota||Catheter systems|
|US4602642||23 Oct 1984||29 Jul 1986||Intelligent Medical Systems, Inc.||Method and apparatus for measuring internal body temperature utilizing infrared emissions|
|US4655746||2 Dec 1985||7 Apr 1987||Target Therapeutics||Catheter device|
|US4672962||7 Oct 1985||16 Jun 1987||Cordis Corporation||Plaque softening method|
|US4731072||2 Jul 1982||15 Mar 1988||Mcneilab, Inc.||Apparatus for heating or cooling fluids|
|US4739492||21 Feb 1985||19 Apr 1988||Cochran Michael J||Dialysis machine which verifies operating parameters|
|US4745922||11 Jul 1986||24 May 1988||Taylor Kenneth G||For immobilizing a person's neck and inducing hypothermia|
|US4747826||6 Jan 1986||31 May 1988||University Of Pittsburgh||Rapid venous infusion system|
|US4748979||13 Apr 1987||7 Jun 1988||Cordis Corporation||To be inserted into the lumen of a blood vessel|
|US4750493||28 Feb 1986||14 Jun 1988||Brader Eric W||Cooling extracranial tissues|
|US4762129||15 Nov 1985||9 Aug 1988||Tassilo Bonzel||Dilatation catheter|
|US4762130||15 Jan 1987||9 Aug 1988||Thomas J. Fogarty||Catheter with corkscrew-like balloon|
|US4781799||8 Dec 1986||1 Nov 1988||Xerox Corporation||Electroforming apparatus and process|
|US4796640||13 Jan 1984||10 Jan 1989||American Hospital Supply Corporation||Apparatus with fast response thermistor|
|US4817624||20 Dec 1985||4 Apr 1989||The General Hospital Corporation||Mini-bolus technique for thermodilution cardiac output measurements|
|US4819655||4 Aug 1987||11 Apr 1989||Webler William E||Injectateless thermal cardiac output determination method and apparatus|
|US4820349||21 Aug 1987||11 Apr 1989||C. R. Bard, Inc.||Dilatation catheter with collapsible outer diameter|
|US4860744||2 Nov 1987||29 Aug 1989||Raj K. Anand||Thermoelectrically controlled heat medical catheter|
|US4863442||14 Aug 1987||5 Sep 1989||C. R. Bard, Inc.||Soft tip catheter|
|US4883455||13 Sep 1988||28 Nov 1989||Minnesota Mining And Manufacturing Company||Cardioplegia administration set|
|US4894164||27 Oct 1987||16 Jan 1990||Fresenius Ag||Apparatus for treating blood in an extracorporeal circuit|
|US4904237||16 May 1988||27 Feb 1990||Janese Woodrow W||Apparatus for the exchange of cerebrospinal fluid and a method of treating brain and spinal cord injuries|
|US4920963||4 Apr 1988||1 May 1990||Brader Eric W||Apparatus for preventing brain damage during cardiac arrest, CPR or severe shock|
|US4951677||21 Mar 1988||28 Aug 1990||Prutech Research And Development Partnership Ii||Acoustic imaging catheter and the like|
|US4964409||31 Aug 1989||23 Oct 1990||Advanced Cardiovascular Systems, Inc.||Flexible hollow guiding member with means for fluid communication therethrough|
|US4973493||15 Oct 1987||27 Nov 1990||Bio-Metric Systems, Inc.||Method of improving the biocompatibility of solid surfaces|
|US4979959||5 May 1989||25 Dec 1990||Bio-Metric Systems, Inc.||Photochemical bonding|
|US5000734||26 Jan 1989||19 Mar 1991||Georges Boussignac||Probe intended to be introduced within a living body|
|US5002531||6 Jun 1987||26 Mar 1991||Tassilo Bonzel||Dilation catheter with an inflatable balloon|
|US5014695||25 Oct 1989||14 May 1991||Benak Arnold M||Kidney cooling jacket|
|US5018521||8 Nov 1988||28 May 1991||Campbell William P||Method of and apparatus for increased transfer of heat into or out of the body|
|US5019075||31 Jul 1990||28 May 1991||The Beth Israel Hospital||Method and apparatus for angioplasty|
|US5024668||20 Jan 1987||18 Jun 1991||Rocky Mountain Research, Inc.||Retrograde perfusion system, components and method|
|US5041089||8 Sep 1988||20 Aug 1991||Devices For Vascular Intervention, Inc.||Vascular dilation catheter construction|
|US5046497||19 Dec 1988||10 Sep 1991||Millar Instruments, Inc.||Structure for coupling a guidewire and a catheter|
|US5078713||30 Nov 1989||7 Jan 1992||Spembly Medical Limited||Cryosurgical probe|
|US5089260||11 May 1990||18 Feb 1992||Emory University||Method of treating ischemic tissue|
|US5092841||17 May 1990||3 Mar 1992||Wayne State University||Method for treating an arterial wall injured during angioplasty|
|US5106360||11 Feb 1991||21 Apr 1992||Olympus Optical Co., Ltd.||Thermotherapeutic apparatus|
|US5106368||20 Apr 1990||21 Apr 1992||Cook Incorporated||Collapsible lumen catheter for extracorporeal treatment|
|US5108390||14 Nov 1988||28 Apr 1992||Frigitronics, Inc.||Flexible cryoprobe|
|US5110721||10 Feb 1989||5 May 1992||The Research Foundation Of State University Of New York||Method for hypothermic organ protection during organ retrieval|
|US5112438||29 Nov 1990||12 May 1992||Hughes Aircraft Company||Photolithographic method for making helices for traveling wave tubes and other cylindrical objects|
|US5117822||5 Apr 1991||2 Jun 1992||Laghi Aldo A||Silicone heart spoon|
|US5147355||23 Sep 1988||15 Sep 1992||Brigham And Womens Hospital||Cryoablation catheter and method of performing cryoablation|
|US5149321||10 Oct 1990||22 Sep 1992||Klatz Ronald M||Brain resuscitation device and method for performing the same|
|US5150706||15 Aug 1991||29 Sep 1992||Cox James L||Cooling net for cardiac or transplant surgery|
|US5151100||3 Jul 1990||29 Sep 1992||Boston Scientific Corporation||Heating catheters|
|US5151578||29 Aug 1991||29 Sep 1992||Phillips Jerry G||Anisotropically bendable heating pad|
|US5156151||15 Feb 1991||20 Oct 1992||Cardiac Pathways Corporation||Endocardial mapping and ablation system and catheter probe|
|US5180364||3 Jul 1991||19 Jan 1993||Robert Ginsburg||Valved self-perfusing catheter guide|
|US5190539||10 Jul 1990||2 Mar 1993||Texas A & M University System||Micro-heat-pipe catheter|
|US5191883||22 May 1990||9 Mar 1993||Prutech Research And Development Partnership Ii||Device for heating tissue in a patient's body|
|US5196024||3 Jul 1990||23 Mar 1993||Cedars-Sinai Medical Center||Balloon catheter with cutting edge|
|US5211631||24 Jul 1991||18 May 1993||Sheaff Charles M||Patient warming apparatus|
|US5219326||5 May 1992||15 Jun 1993||Hattler Brack G||Inflatable percutaneous oxygenator|
|USRE31873||19 Jan 1983||30 Apr 1985|| ||Venous catheter device|
|USRE33911||27 Mar 1986||5 May 1992||Advanced Cardiovascular Systems, Inc.||Catheter guide wire with short spring tip and method of using the same|
|1||Alfonsi, P., D. I. Sessler, B. Du Manoir, J-C. Levron, J-P. Le Moing, M. Chauvin, The Effects of Meperidine and Sufentanil on the Shivering Threshold in Postoperative Patients, Anesthesiology, Jul. 1998, 89(1):43-48.|
|2||Ambrus; The Biphasic Nature and Temperature Dependence of the Activation of Human Plasminogen by Urokinase; May 1979; pp. 339-347; Research Communications in Chemical Pathology and Pharmacology, vol. 24, No. 2.|
|3||Anon, "Automatic feedback instrumentation for hospital room utilizing microsensors," IBM Technical Disclosure Bulletin (abs.), 29(3): 1 page, Aug. 1986.|
|4||Behmann, F.W., et al.; << Heat Generation Control during Artificial Hypothermia: I: Experimental Examination of the Influence of Anesthetic Depth; Pflügers Archiv, Bd. 266, S. 408-421 (1958) (German article with English translation).|
|5||Behmann, F.W., et al.; Intravascular Cooling, a Method to Achieve Controllable Hypothermia; Pflügers Archive, vol. 263, pp. 145-165 (1956) (German article with English translation).|
|6||Behmann, F.W.; "Heat Generation Control during Artificial Hypothermia, an article about the economic problem of trembling stages"; Pflügers Archive, vol. 263, pp. 166-187 (1956) (German article with English translation).|
|7||Behmann, F.W.; "Regulation of heat production in experimental hypothermia of homothermal animals"; Naunyn Schmiedebergs Arch Exp Pathol Pharmakol; 228 (1-2): 126-128 (1956). (German article with English translation).|
|8||Behmann, F.W; "Heat Generation Control during Artificial Hypothermia: II. Theoretical Examinations"; Pflügers Archiv, Bd. 266, S. 422-446 (1958) (German article with English translation).|
|9||Benzinger, T.H.; On Physical Heart Regulation and Sense of Temperature in Man; Naval Medical Research Institute; Physiology; Vol. 45; pp. 645-659; (Feb. 26, 1959).|
|10||Bigelo; Hypothermia, Its Possible Role in Cardiac Surgery; Nov. 1959; pp. 849-866; Annals of Surgery, vol. 132, No. 5.|
|11||Brengelmann, George L.; Specialized Brain Cooling in Humans?; The FASEB Journal; vol. 7; pp. 1148-1153 (Sep. 1993).|
|12||Buggy, D., P. Higgins, C. Moran, F. O'Donovan, and M. McCarroll, Clonidine at Induction Reduces Shivering after General Anaesthesia, 1997, pp. 263-267, Can. J. Anaesth., vol. 44, No. 3.|
|13||Cabanac, M., Selective Brain Cooling and Thermoregulatory Set-Point, 1998, pp. 3-13, Journ. of Basic & Clinical Physiology & Pharmacology, vol. 9, N. 1.|
|14||Cabanac, M.; Selective Brain Cooling in Humans: fancy or fact?; The FASEB Journal; vol. 7; pp. 1143-1147 (Sep. 1993).|
|15||Capogna, G. and D. Celleno, I. V. Clonidine for Post-Extradural Shivering in Parturients: A Preliminary Study, Brit. Journ. of Anaesth., vol. 71.|
|16||Carrol et al. "A comparison of measurements from a temporal artery thermometer and a pulmonary artery thermistor-preliminary results," Fax correspondence dated Oct. 19, 2001.|
|17||Cheatle; Cryostripping the Long and Short Saphenous Veins; Jan. 1993; one page; Br. J. Surg., vol. 80.|
|18||Cheng, C. , T. Matsukawa, D. I. Sessler, M. Ozaki, A. Kurz, B. Merrifield, L. Hank, and P. Olofsson, Increasing Mean Skin Temperature Linearly Reduces the Core-Temperature Thresholds for Vasoconstriction and Shivering in Humans, May 1995, pp. 1160-1168, Anesthesiology, vol. 82, N. 5.|
|19||Colvett, K. T., A. F. Althausen, B. Bassil, N. M. Heney, F. V. McGovern, H. H. Young, II, D. S. Kaufman, A. L. Zietman, and W. U. Shipley, Opportunities with Combined Modality Therapy for Selective Organ Preservation in Muscle-Invasive Bladder Cancer, 1996, pp. 201-208, Journ. of Surgical Oncology, vol. 63.|
|20||DeFord et al. "Design and evaluation of closed-loop feedback control of minimum temperatures in human intracranial tumours treated with interstitial hyperthermia," Med. & Biol. Eng. & Comput. 29:197-206, Mar. 1991.|
|21||Deklunder, G., M. Dauzat, J-L. Lecroart, J-J. Hauser, and Y. Houdas, "Influence of Ventilation of the Face on Thermoregulation in Man during Hyper- and Hypothermia," Eur. J. Appl. Physiol., 1991, 62:342-348.|
|22||Dexter; Blood Warms as It Blows Retrograde from a Femoral Cannulation Site to the Carotid Artery During Cardiopulmonary Bypass; Nov. 1994; pp. 393-397; Perfusion, vol. 9, No. 6.|
|23||Gentilello, L. M., "Advances in the Management of Hypothermia," Horizons in Trauma Surgery, 75(2):243-256, Apr. 1995.|
|24||Giesbrecht, G. G., M. S., L. Goheen, C. E. Johnston, G. P. Kenny, G. K. Bristow, and J. S. Hayward, Inhibition of Shivering Increases Core Temperature Afterdrop and Attenuates Rewarming in Hypothermic Humans, 1997, 0161-7567:1630-1634, The American Physiological Society.|
|25||Gillinov; Superior Cerebral Protection with Profound Hypothermia During Circulatory Arrest; Nov. 1992; pp. 1432-1439; Ann. Thorac. Surg., vol. 55.|
|26||Giuffre, M., J. Finnie, D. A. Lynam, and D. Smith, Rewarming Postoperative Patients: Lights, Blankets, or Forced Warm Air, Dec. 1991, pp. 387-393, Journ. of Post Anaesthesia Nursing, vol. 6, N. 6.|
|27||Guffin, A., D. Girard, andJ. A. Kaplan, Shivering Following Cardiac Surgery: Hemodynamic Changes and Reversal, Feb. 1987, pp. 24-28, Journ. of Cardiothoracic Anesthesia, vol. 1, N. 1.|
|28||Haley, E. C. et al. "A Randomized Trial of Tirilazad Mesylate in Patients with Acute Stroke (RANTTAS)," Stroke, 27(9):1453-1458, 1996.|
|29||Hederer, G., et al.; "Animal Experiment Observations Regarding Cardiac Surgery under Intravascular Hypothermia"; Labgebbedjs Arch. U. Dtsch. A. Chir., Bd. 283, S. 601-625 (1957) (German article with English translation).|
|30||Higazi; The Effect of Ultrasonic Irradiation and Temperature on Fibrinolytic Activity in Vitro; Aug. 1992; p. 251-253; Thrombosis Research, vol. 69, No. 2.|
|31||Iaizzo, Facial Warming Increases the Threshold for Shivering, 1999; pp. 231-239, Journ. of Neurosurgical Anesthesiology, vol. 11, No. 4.|
|32||Imamaki; Retrograde Cerebral Perfusion with Hypothermic Blood Provides Efficient Protection of the Brain; Jul. 1995; pp. 325-333; Journal of Cardiac Surgery, vol. 10, No. 4, Part 1.|
|33||Jolin; Management of a Giant Intracranial Aneurysm Using Surface-Heparinized Extracorporeal Circulation and Controlled Deep Hypothermic Low Flow Perfusion; Aug. 1992; pp. 756-760; Acta Anaesthesiologica Scandinavia.|
|34||Jos R.C. Janse, Ph.D., et al. (1997) Near Continuous Cardiac Output b Thermodilution. Journal of Clinical Monitoring 13:233-239.|
|35||Keegan, M. T. et al. Shivering Complicating the Treatment of Neurologically Impaired Surgical and Intensive Care Unit Patients, Anesthesiology, 91(3):874-876, Sep. 1999,.|
|36||Kimoto; Open Heart Surgery under Direct Vision with the Aid of Brain-Cooling by Irrigation; Jul. 1955; pp. 592-603; Surgery, vol. 39, No. 4.|
|37||Kogaku "Sensor technology to control artificial organs," KLA, 22(4):295-300, Aug. 1984 (in Japanese).|
|38||Kurz, Martin, et al.; "Naloxone, Meperidine, and Shivering."; Anesthesiology: 79 (6):1193-1201; Dec. 1993.|
|39||Lennon, R. L., M. P. Hosking, M. A. Conover, and W. J. Perkins, Evaluation of a Forced-Air System for Warming Hypothermic Postoperative Patients, 1990, pp. 424-427, Anesth. Analg., vol. 70.|
|40||Leslie, K., D. I. Sessler, A. R. Bjorksten, M. Ozaki, T. Matsukawa, and M. Schroeder, Propofol Causes a Dose-Dependent Decrease in the Thermoregulatory Threshold for vasoconstriction but has Little Effect on Sweating, Aug. 1994, pp. 353-360, vol. 81, N. 2.|
|41||Maas, C. Intermittent Antegrade Selective Cerebral Perfusion during Circulatory Arrest for Repair of Aortic Arch. Perfusion, vol. 12, No. 2, pp. 127-132, 1997.|
|42||Marekovic, Z.; Abstract of Renal Hypothermia in Situ by Venous Passages: Experimental Work on Dogs; 1980; Eur Urol 6(2); 1 page.|
|43||Matsukawa, T., A. Kurz, D. I. Sessler, A. R. Bjorksten, B. Merrifield, and C. Cheng, Propofol Linearly Reduces the Vasoconstriction and Shivering Thresholds, May 1995, pp. 1169-1180, Anesthesiology, vol. 82, N. 5.|
|44||Meden, P., K. Overgaard, H. Pedersen, G. Boysen, Effect of Hypothermia and Delayed Thrombolysis in a Rat Embolic Stroke Model, 1994, pp. 91-98, Acta Neurol. Scand. vol. 90.|
|45||Meden; Effect of Hypothermia and Delayed Thrombolysis in a Rat Embolic Stroke Model; Dec. 1993; pp. 91-98, Acta Neurologica Scandinavica.|
|46||Meden; The Influence of Body Temperature on Infarct Volume and Thrombolytic Therapy in a Rat Embolic Stroke Model; Feb. 1994; pp. 131-138; Brain Research, vol. 647.|
|47||Milleret, Rene; La cryo-chirurgie danes les varices des mimbres inferieurs; Angiologie; Supplement au No. 110.|
|48||Milleret; Abstract of Cryosclerosis of the Saphenous Veins in Varicose Reflux in the Obese and Elederly; 10.1981; one page; Phlebologie, vol. 34, No. 4.|
|49||Möller et al. "Temperature control and light penetration in a feedback interstitial laser thermotherapy system," Int. J. Hyperthermia, 12(1):49-63, 1996.|
|50||Olshausen et al. "An isothermal flowmeter with improved frequency response for measuring tissue blood flow," Pflügers Arch. 367:97-102, 1976.|
|51||Pais, S. O., K. D. Tobin, C. B. Austin, and L. Queral, Percutaneous Insertion of the Greenfield Inferior Vena Cava Filter: Experience with Ninety-Six Patients, Oct. 1988, pp. 460-464, Journ. of Vascular Surg., vol. 8, N. 4.|
|52||Parkins; Brain Cooling in the Prevention of Brain Damage During Periods of Circulatory Occlusion in Dogs; Apr. 1954; pp. 284-289; Annals of Surgery, vol. 140, No. 3.|
|53||Patton, J. H, T. C. Fabian, M. A. Croce, G. Minard, F. E. Pritchard, and K. A. Kudsk, Prophylactic Greenfield Filters: Acute Complications and Long-Term Follow-Up, Aug. 1996; pp. 231-237; Journ. of Trauma: Injury, Infection, and Critical Care, vol. 41, N.2.|
|54||Piepgras; Rapid Active Internal Core Cooling for Induction of Moderate Hypothermia in Head Injury by Use of an Extracorporeal Heat Exchanger; Feb. 1998; pp. 311-318; Neurosurgery, vol. 42, No. 2.|
|55||Rijken; Plasminogen Activation at Low Temperatures in Plasma Samples Containing Therapeutic Concentrations of Tissue-Type Plasminogen Activator or Other Thrombolytic Agents; Oct. 1989; pp. 47-52; place of publication unknown.|
|56||Rohrer, M. J. and A. M. Natale, Effect of Hypothermia on the Coagulation Cascade, Oct. 1992, pp. 1402-1405, Critical Care Medicine, vol. 20, No. 10.|
|57||Schmid-Elsaesser, R. et al. (1999), Combination Drug Therapy and Mild Hypothermia: A Promising Treatment Strategy for Reversible, Focal Cerebral Ischemia, Stroke, 1891-1899, Jun.|
|58||Schwartz, A.E. et al.; (1996); Isolated cerebral hypothermia by single carotid artery perfusion of extracorporeally cooled blood in baboons; Neurosurgery 39(3):577-582.|
|59||Schwartz; Cerebral Blood Flow during Low-flow Hypothermic Cardiopulmonary Bypass in Baboons; Jun. 1994; pp. 959-964; Anesthesiology, vol. 81, No. 4.|
|60||Schwartz; Selective Cerebral Hypothermia by Means of Transfemoral Internal Carotid Artery Catheterization; May 1996; pp. 571-572; Radiology, vol. 201, No. 2.|
|61||Sessler, Daniel I.; "Mild Perioperative Hypothermia"; The New England Journal of Medicine; 336:1730-1737; Jun. 12, 1997.|
|62||Sharkey, A., J. M. Lipton, M. T. Murphy, and A. H. Giesecke, Inhibition of Postanesthestic Shivering with Radiant Heat, Feb. 1987, pp. 249-252, Anesthesiology, vol. 66, N. 2.|
|63||Shiraki, K., N. Konda, and S. Sagawa, Esphageal and Tympanic Temperature Responses to Core Blood Temperature Changes during Hyperthermia, J. Appl. Physiol. 61(1):98-102 (1986).|
|64||Simon, M., C. A. Athanasoulis, D. Kim, F. L. Steinberg, D. H Porter, B. H. Byse, S. Kleshinski, S. Geller, D. E. Orron, and A. C. Waltman; Simon Nitinol Inferior Vena Cava Filter: Initial Clinical Experience, Jul. 1989, pp. 99-103; Radiology.|
|65||Steen; The Detrimental Effects of Prolonged Hypothermia and Rewarming in the Dog; Aug. 1979 ;pp. 224-230; Anesthesiology, vol. 52, No. 3.|
|66||Vandam; Hypothermia; Sep. 1959; pp. 546-553; The New England Journal of Medicine.|
|67||Villamaria, F. J., C. E. Baisden, A. Hillis, M. H. Rajab, and P. A. Rinaldi, "Forced-Air Warming is No More Effective than Conventional Methods for Raising Postoperative Core Temperature After Cardiac Surgery," Journ. Cardiothoracic and Vascular Anesth., 11(6):708-711, Oct. 1997.|
|68||White; Cerebral Hypothermia and Circulatory Arrest; Jul. 1978; pp. 450-458; Mayo Clinic Proceedings, vol. 53.|
|69||Yenari; Thrombolysis with Tissue Plasminogen Activator (TPA) is Temperature Dependent; Jul. 1994; pp. 475-481; Thrombosis Research, vol. 77, No. 5.|
|70||Yoshihara; Changes in Coagulation and Fibrinolysis Occurring in Dogs during Hypothermia; Aug. 1984; pp. 503-512; Thrombosis Research, vol. 37, No. 4.|
|71||Zarins; Circulation in Profound Hypothermia; Nov. 1972; pp. 97-104; Journal of Surgical Research, vol. 14, N. 2.|
|72||Zweifler, R. M. and D. I. Sessler, "Thermoregulatory Vasoconstriction and Shivering Impede Therapeutic Hypothermia in Acute Ischemic Stroke Patients," Journ. Stroke and Cerebrovascular Diseases, 6(2):100-104, 1996.|
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