US20020066458A1 - Central venous catheter with heat exchange membrane - Google Patents
Central venous catheter with heat exchange membrane Download PDFInfo
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- US20020066458A1 US20020066458A1 US10/057,334 US5733402A US2002066458A1 US 20020066458 A1 US20020066458 A1 US 20020066458A1 US 5733402 A US5733402 A US 5733402A US 2002066458 A1 US2002066458 A1 US 2002066458A1
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- patient
- catheter
- heat exchange
- temperature
- coolant
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
- A61F7/12—Devices for heating or cooling internal body cavities
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
- A61F7/12—Devices for heating or cooling internal body cavities
- A61F7/123—Devices for heating or cooling internal body cavities using a flexible balloon containing the thermal element
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
- A61F7/12—Devices for heating or cooling internal body cavities
- A61F2007/126—Devices for heating or cooling internal body cavities for invasive application, e.g. for introducing into blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/369—Temperature treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/36—General characteristics of the apparatus related to heating or cooling
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/0029—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/44—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for cooling or heating the devices or media
Definitions
- the present invention relates generally to methods and apparatus for cooling patients for therapeutic purposes, and more particularly to systems for establishing central venous access while providing a means for cooling a patient.
- the affected organ in any case, is the brain. Accordingly, systems and methods have been disclosed that propose cooling blood flowing to the brain through the carotid artery.
- An example of such systems and methods is disclosed in co-pending U.S. patent application Ser. No. 09/063,984, filed Apr. 21, 1998, now issued as U.S. Pat. No. 6,126,684, owned by the present assignee and incorporated herein by reference.
- various catheters are disclosed which can be advanced into a patient's carotid artery and through which coolant can be pumped in a closed circuit, to remove heat from the blood in the carotid artery and thereby cool the brain.
- the referenced devices have the advantage over other methods of cooling (e.g., wrapping patients in cold blankets) of being controllable, relatively easy to use, and of being capable of rapidly cooling and maintaining blood temperature at a desired set point.
- a heat exchange catheter preferably made of urethane, includes a catheter body defining at least a coolant supply lumen and a coolant return lumen.
- First and second heat exchange membranes are disposed along a distal portion of the catheter body, and the heat exchange membranes communicate with one or more of the lumens.
- coolant can be supplied to the heat exchange membranes via the coolant supply lumen and received from the heat exchange membranes via the coolant return lumen to effect a closed loop heat exchanger for cooling and/or warming a patient.
- the first and second heat exchange membranes define first and second interiors respectively communicating with first and second coolant supply ports in the coolant supply lumen.
- first and second coolant return ports are formed in the coolant return lumen, and coolant flows from the heat exchange membranes through the return ports.
- At least one anchor can be engaged with the catheter body to fasten the catheter to a patient.
- the catheter can define a drug delivery lumen and a guide wire lumen.
- a connector manifold can be engaged with the catheter body to interconnect the lumens with respective connector lines. More specifically, the connector manifold defines plural channels, and each channel establishes a respective pathway for fluid communication between a respective connector line and a respective lumen. As set forth in detail below, the anchor is on the connector manifold.
- At least one drug delivery port is formed in the catheter body.
- the drug delivery port is formed at a location that is between two adjacent heat exchange membranes to establish a pathway for fluid communication from the drug delivery lumen to a location outside the catheter body. If desired, additional drug delivery ports can be formed along the length of the catheter.
- a method for making a heat exchange catheter includes disposing a multi-lumen catheter body in a connector manifold mold, and disposing plural connector tubes in the connector manifold mold. Also, the method includes interconnecting a respective lumen with a respective connector tube using a mandrel, and then directing a plastic material into the connector manifold mold. The mandrels are then removed, such that a respective channel is defined between each respective lumen and its connector line.
- a method for treating a patient.
- the method includes advancing a heat exchange catheter device into the patient, and then circulating coolant through the catheter device while preventing infusion of the coolant directly into the patient's bloodstream.
- the catheter device includes a heat exchange region that is established by: one or more heat exchange membranes, or one or more hollow fibers, or one or more chamber-defining enclosures.
- a catheter configured as a Swan-Ganz catheter or central venous catheter has at least one balloon-like membrane distally located on the catheter for heating or cooling blood in a patient. More particularly, the membrane defines an interior communicating with a coolant supply lumen of the catheter and with a coolant return lumen of the catheter, to circulate coolant through the interior of the membrane.
- FIG. 1 is a perspective view of the present cooling catheter, schematically showing a medicament source and coolant source in an exploded relationship with the catheter;
- FIG. 2 is a cross-sectional view as seen along the line 2 - 2 in FIG. 1;
- FIG. 3 is a cross-sectional view as seen along the line 3 - 3 in FIG. 1;
- FIG. 4 is a top view of the interior of the connector manifold, as seen along the line 4 - 4 in FIG. 1.
- a therapeutic catheter system for establishing and maintaining hypothermia in a patient, or for attenuating a fever spike in a patient and then maintaining normal body temperature in the patient.
- the system 10 includes a cooling source 12 that can be a water-bath system or a TEC-based system such as either of the systems disclosed in co-pending U.S. patent application Ser. No. 09/220,897, filed Dec. 24,1998, now issued as U.S. Pat. No. 6,146,411, and incorporated herein by reference, or U.S. patent application Ser. No. 09/260,950, filed Mar.
- the coolant source provides coolant such as saline through a coolant supply line 14 , and coolant is returned to the source 12 via a coolant return line 16 .
- a catheter, generally designated 18 includes a source tube 20 terminating in a fitting such as a female luer fitting 22 . Also, the catheter 18 has a return tube 24 terminating in a fitting such a male luer fitting 26 .
- the fittings 22 , 26 can be selectively engaged with complementary fittings 28 , 30 of the lines 14 , 16 to establish a closed circuit coolant path between the catheter 18 and coolant source 12 .
- the catheter 18 includes a guide wire and primary infusion tube 32 that terminates in a fitting such as a female luer 34 .
- a guide wire 36 can be advanced through the tube 32 in accordance with central venous catheter placement principles, or medicament or other fluid can be infused through the guide wire and primary infusion tube 32 .
- a secondary infusion tube 38 with female luer fitting 40 can be selectively engaged with a medicament source 42 for infusing fluid from the source 42 through the secondary tube 38 .
- the tubes 20 , 24 , 32 , 38 are held in a distally-tapered connector manifold 44 .
- the connector manifold 44 establishes respective pathways for fluid communication between the tubes 20 , 24 , 32 , 38 and respective lumens in a catheter body 46 .
- a suture anchor 48 advantageously is formed on the connector manifold 44 for suturing the catheter 18 to a patient in accordance with central venous catheter operating principles.
- the suture anchor 48 includes opposed ears 50 formed with respective suture holes 52 .
- Other equivalent anchor structure can be used to hold the catheter 18 onto the patient, however, including surgical tape.
- the catheter is a so-called Swan-Ganz catheter, i.e., a catheter of the type disclosed in U.S. Pat. No. 3,995,623, incorporated herein by reference, the anchor 48 typically would not be provided.
- the catheter body 46 includes at least two lumens, and in the preferred embodiment the catheter body 46 includes at least four lumens. More specifically, the catheter body 46 defines a generally wedge- or triangular-shaped (in the transverse cross-section shown) coolant supply lumen 54 , a generally wedge-shaped coolant return lumen 56 , a round guide wire lumen 58 , and a wedge-shaped secondary infusion lumen 60 .
- the catheter can be a Swan-Ganz catheter, in which case additional lumens can be provided for Swan-Ganz catheter applications, including a lumen for inflating an anchoring balloon for holding the distal tip of the catheter in an appropriate blood vessel for various heart-related measurements and another lumen for holding a wire or wires that are attached to one or more distally-located sensors, such as temperature sensors, pressure sensors, gas sensors, and electrical sensors.
- additional lumens can be provided for Swan-Ganz catheter applications, including a lumen for inflating an anchoring balloon for holding the distal tip of the catheter in an appropriate blood vessel for various heart-related measurements and another lumen for holding a wire or wires that are attached to one or more distally-located sensors, such as temperature sensors, pressure sensors, gas sensors, and electrical sensors.
- the connector manifold 44 establishes a pathway for fluid communication between the coolant supply tube 20 and the coolant supply lumen 54 . Likewise, the connector manifold 44 establishes a pathway for fluid communication between the coolant return tube 24 and the coolant return lumen 56 . Further, the connector manifold 44 establishes a pathway for fluid communication between the guide wire and primary infusion tube 32 , and the guide wire lumen 58 , which terminates at an open distal hole 62 defined by a distally tapered and chamfered distal tip 63 of the catheter body 46 .
- the connector manifold 44 establishes a pathway for fluid communication between the secondary infusion tube 38 and the secondary infusion lumen 60 , which terminates at an infusion port 64 in a distal segment of the catheter body 46 . Additional ports can be provided for each lumen 58 , 60 along the length of the catheter.
- each heat exchange membrane is about six centimeters to seven and one-half centimeters in length, with the heat exchange membranes being longitudinally spaced from each other along the catheter body 46 in the preferred embodiment shown.
- the heat exchange membranes 66 , 68 extend along most or all of that portion of the catheter 46 that is intubated within the patient.
- the heat exchange membranes can be established by a medical balloon material.
- the heat exchange membranes 66 , 68 can be inflated with coolant from the coolant source 12 as supplied from the coolant supply lumen 54 , and coolant from the heat exchange membranes 66 , 68 is returned via the coolant return lumen 56 to the coolant source 12 .
- the heat exchange membranes In their inflated configurations, the heat exchange membranes define a diameter of about ten French, and preferably no more than twelve French.
- the heat exchange membranes 66 , 68 are relatively long and comparatively thin, to advantageously avoid excessively blocking blood flow through the vena cava while nevertheless effecting patient cooling.
- a wall 70 separates the coolant supply and return lumens 54 , 56 .
- a supply port 72 is formed in the catheter body 46 through which coolant from the supply lumen 54 can flow into the interior 74 of the heat exchange membrane 66 , as indicated by the arrows 76 .
- a return port 78 is formed in the catheter body 46 , and coolant can flow out of the heat exchange membrane 66 through the return port 78 and into the return lumen 56 , as indicated by the arrows 80 .
- the respective coolant supply port is distal to the respective coolant return port, to optimize fluid flow and heat transfer, although if desired the direction of fluid flow can be in the opposite direction.
- Both the coolant supply and coolant return lumens 54 , 56 terminate proximal to the distal tip 63 .
- the coolant return lumen 56 can terminate just distal of the coolant return port for the distal heat exchange membrane 68
- the coolant supply lumen can terminate just distal of the coolant supply port of the distal heat exchange membrane 68 .
- the catheter device 18 includes a heat exchange region established by one or more heat exchange membranes.
- the heat exchange region can be established by or one or more hollow fibers, or one or more chamber-defining enclosures, such as metal or plastic bellows-type enclosures.
- the components of the catheter 18 are made of urethane, and more preferably are made of an aromatic, polyether-based polyurethane, although other suitable materials can be used.
- the tubes 20 , 24 , 32 , 38 are made of Tecothane TT-1095A made by Thermedics, Inc. of Woburn, Mass.
- the heat exchange membranes 66 , 68 are made of Pellethane 2363-65D, made by Dow Chemical Corp.
- the catheter body 46 is made of Tecothane TT-2055D-B20 with Barium Sulfate radiopacifying agent incorporated into the polymer matrix for optimum visualizing during fluoroscopic maneuvering to a desired location.
- the catheter 18 can be coated with an anti-microbial agent and an anti-clotting agent if desired.
- the preferred connector manifold 44 is flat and wedge-shaped, with the distal end 82 of the connector manifold 44 being narrower than the proximal end 84 .
- plural channels 86 are established within the connector manifold 44 .
- each channel 86 establishes a respective pathway for fluid communication between a respective connector line 20 , 24 , 32 , 38 and a respective lumen 54 , 56 , 58 , 60 .
- the tubes 20 , 24 , 32 , 38 are closely juxtaposed to each other near the distal end 82 of the connector manifold 44 .
- the tubes 20 , 24 , 32 , 38 are positioned on what will become the interior of the connector manifold, and the catheter body 46 likewise is positioned on the connector manifold, closely spaced from the distal ends of the tubes.
- a respective mandrel is then advanced into each tube and the lumen of the catheter body 46 that is to communicate with the tube.
- plastic is directed over and around the tubes, mandrels, and catheter body 46 by insert molding. The mandrels are removed after the plastic hardens, establishing the channels 86 .
- the structure set forth above can be used in many medical applications to cool a patient and/or to maintain temperature in a normothermic or hypothermic patient, for purposes of improving the medical outcomes of patients on whom, e.g., aneurysm surgery is to be performed, preferably while the patient's temperature is below normal body temperature.
- the structure can then be used to rewarm the patient in a controlled manner by circulating warm coolant through the structure, or by otherwise regulating natural body rewarming by circulating coolant that is maintained at an appropriate cool (relative to normal body temperature) or warm (relative to normal body temperature) temperature through the structure.
- head trauma can be treated by and after lowering and maintaining the patient's temperature below normal body temperature.
- cardiac arrest can be treated while the patient's temperature is below normal body temperature.
- minimally invasive heart surgery can be performed on the patient while the patient's temperature is below normal body temperature.
- cardiac arrest in the patient can be treated by and while the patient's temperature is below normal body temperature.
- the present invention understands that for certain patients, e.g., stroke victims, it is important to maintain the temperature of a patient at or below normal body temperature, when the patient runs or attempts to run a fever. For severe ischemic stroke victims, the malady can be treated by maintaining the patient's body temperature at a hypothermic level.
- a temperature sensor 100 such as a thermistor or other suitable device can be attached to the catheter 18 as shown.
- the sensor 100 can be mounted on the catheter 18 by solvent bonding at a point that is proximal to the membranes 66 , 68 .
- the sensor 100 can be disposed in a lumen of the catheter 18 , or attached to a wire that is disposed in a lumen of the catheter 18 , with the sensor hanging outside the catheter 18 .
- a separate temperature probe can be used, such as the esophageal probe disclosed in co-pending U.S. patent application Ser. No. 09/282,971, filed Mar. 31, 1999, now issued as U.S. Pat. No.
- a rectal probe or tympanic temperature sensor can be used.
- the sensor is electrically connected to the coolant source 12 for control of the temperature of the coolant as described in the above-referenced '897 and '940 applications.
Abstract
A central venous catheter includes coolant supply and return lumens which communicate coolant to and from first and second heat exchange membranes arranged along the distal segment of the catheter. The coolant in the heat exchange membranes removes heat from the patient. Additional lumens are provided for conventional central venous catheter uses.
Description
- This application is a Divisional of U.S. patent application Ser. No. 09/305,613, filed on May 5, 1999, which is a Continuation-In-Part of U.S. patent application Ser. No. 09/253,109, filed on Feb. 19, 1999, now abandoned, which is a Continuation-In-Part of U.S. patent application Ser. No. 09/063,984, filed on Apr. 21, 1998, now issued as U.S. Pat. No. 6,126,684.
- The present invention relates generally to methods and apparatus for cooling patients for therapeutic purposes, and more particularly to systems for establishing central venous access while providing a means for cooling a patient.
- 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 is degraded if the patient's body temperature rises above normal (38° C.). It is further believed that the medical outcome for many such patients might be significantly improved if the patients were to be cooled relatively quickly for a short period, e.g., 24-72 hours. Apart from the therapeutic benefits of hypothermia, the outcomes for brain trauma or ischemia patients that develop fevers is worse than for patients that do not develop fevers. Consequently, temperature management for such patients is important, even when hypothermia is not to be used to treat the patients. Moreover, prophylactic short-term hypothermia might help patients undergoing minimally invasive heart surgery and aneurysm surgery.
- The affected organ, in any case, is the brain. Accordingly, systems and methods have been disclosed that propose cooling blood flowing to the brain through the carotid artery. An example of such systems and methods is disclosed in co-pending U.S. patent application Ser. No. 09/063,984, filed Apr. 21, 1998, now issued as U.S. Pat. No. 6,126,684, owned by the present assignee and incorporated herein by reference. In the referenced application, various catheters are disclosed which can be advanced into a patient's carotid artery and through which coolant can be pumped in a closed circuit, to remove heat from the blood in the carotid artery and thereby cool the brain. The referenced devices have the advantage over other methods of cooling (e.g., wrapping patients in cold blankets) of being controllable, relatively easy to use, and of being capable of rapidly cooling and maintaining blood temperature at a desired set point.
- As recognized in co-pending U.S. patent application Ser. No. 09/133,813, filed Aug. 13, 1998, now issued as U.S. Pat. No. 6,338,727, owned by the present assignee and incorporated herein by reference, the above-mentioned advantages in treating brain trauma/ischemic patients by cooling can also be realized by cooling the patient's entire body, i.e., by inducing systemic hypothermia. The advantage of systemic hypothermia is that, as recognized by the present assignee, to induce systemic hypothermia a cooling catheter or other cooling device need not be advanced into the blood supply of the brain, but rather can be easily and quickly placed into the relatively large vena cava of the central venous system.
- Moreover, since many patients already are intubated with central venous catheters for other clinically approved purposes anyway, providing a central venous catheter that can also cool the blood, if only to manage temperature and thereby ameliorate fever spikes, requires no additional surgical procedures for those patients. A cooling central venous catheter is disclosed in the present assignee's co-pending U.S. patent application Ser. No. 09/253,109, filed Feb. 19, 1999, now abandoned, and incorporated herein by reference. The present invention is directed to such a device.
- A heat exchange catheter, preferably made of urethane, includes a catheter body defining at least a coolant supply lumen and a coolant return lumen. First and second heat exchange membranes are disposed along a distal portion of the catheter body, and the heat exchange membranes communicate with one or more of the lumens. With this structure, coolant can be supplied to the heat exchange membranes via the coolant supply lumen and received from the heat exchange membranes via the coolant return lumen to effect a closed loop heat exchanger for cooling and/or warming a patient.
- Preferably, the first and second heat exchange membranes define first and second interiors respectively communicating with first and second coolant supply ports in the coolant supply lumen. Also, first and second coolant return ports are formed in the coolant return lumen, and coolant flows from the heat exchange membranes through the return ports. At least one anchor can be engaged with the catheter body to fasten the catheter to a patient.
- In addition to the coolant supply and return lumens, the catheter can define a drug delivery lumen and a guide wire lumen. A connector manifold can be engaged with the catheter body to interconnect the lumens with respective connector lines. More specifically, the connector manifold defines plural channels, and each channel establishes a respective pathway for fluid communication between a respective connector line and a respective lumen. As set forth in detail below, the anchor is on the connector manifold.
- To provide for infusing medicament into a patient while simultaneously cooling the patient, at least one drug delivery port is formed in the catheter body. Preferably, the drug delivery port is formed at a location that is between two adjacent heat exchange membranes to establish a pathway for fluid communication from the drug delivery lumen to a location outside the catheter body. If desired, additional drug delivery ports can be formed along the length of the catheter.
- In another aspect, a method for making a heat exchange catheter includes disposing a multi-lumen catheter body in a connector manifold mold, and disposing plural connector tubes in the connector manifold mold. Also, the method includes interconnecting a respective lumen with a respective connector tube using a mandrel, and then directing a plastic material into the connector manifold mold. The mandrels are then removed, such that a respective channel is defined between each respective lumen and its connector line.
- In another aspect, a method is disclosed for treating a patient. The method includes advancing a heat exchange catheter device into the patient, and then circulating coolant through the catheter device while preventing infusion of the coolant directly into the patient's bloodstream. Per the present invention, the catheter device includes a heat exchange region that is established by: one or more heat exchange membranes, or one or more hollow fibers, or one or more chamber-defining enclosures.
- In still another aspect, a catheter configured as a Swan-Ganz catheter or central venous catheter has at least one balloon-like membrane distally located on the catheter for heating or cooling blood in a patient. More particularly, the membrane defines an interior communicating with a coolant supply lumen of the catheter and with a coolant return lumen of the catheter, to circulate coolant through the interior of the membrane.
- 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:
- FIG. 1 is a perspective view of the present cooling catheter, schematically showing a medicament source and coolant source in an exploded relationship with the catheter;
- FIG. 2 is a cross-sectional view as seen along the line2-2 in FIG. 1;
- FIG. 3 is a cross-sectional view as seen along the line3-3 in FIG. 1; and
- FIG. 4 is a top view of the interior of the connector manifold, as seen along the line4-4 in FIG. 1.
- Referring initially to FIG. 1, a therapeutic catheter system, generally designated10, is shown for establishing and maintaining hypothermia in a patient, or for attenuating a fever spike in a patient and then maintaining normal body temperature in the patient. Commencing the description of the
system 10 at the proximal end, as shown thesystem 10 includes acooling source 12 that can be a water-bath system or a TEC-based system such as either of the systems disclosed in co-pending U.S. patent application Ser. No. 09/220,897, filed Dec. 24,1998, now issued as U.S. Pat. No. 6,146,411, and incorporated herein by reference, or U.S. patent application Ser. No. 09/260,950, filed Mar. 2, 1999, now issued as U.S. Pat. No. 6,019,783, also incorporated herein by reference. In any case, the coolant source provides coolant such as saline through acoolant supply line 14, and coolant is returned to thesource 12 via acoolant return line 16. A catheter, generally designated 18, includes asource tube 20 terminating in a fitting such as a female luer fitting 22. Also, thecatheter 18 has areturn tube 24 terminating in a fitting such a male luer fitting 26. Thefittings complementary fittings lines catheter 18 andcoolant source 12. - Additionally, the
catheter 18 includes a guide wire andprimary infusion tube 32 that terminates in a fitting such as afemale luer 34. Aguide wire 36 can be advanced through thetube 32 in accordance with central venous catheter placement principles, or medicament or other fluid can be infused through the guide wire andprimary infusion tube 32. Moreover, asecondary infusion tube 38 with female luer fitting 40 can be selectively engaged with amedicament source 42 for infusing fluid from thesource 42 through thesecondary tube 38. - As discussed further below, the
tubes connector manifold 44. As also set forth further below, theconnector manifold 44 establishes respective pathways for fluid communication between thetubes catheter body 46. - A
suture anchor 48 advantageously is formed on theconnector manifold 44 for suturing thecatheter 18 to a patient in accordance with central venous catheter operating principles. In one intended environment, thesuture anchor 48 includes opposedears 50 formed with respective suture holes 52. Other equivalent anchor structure can be used to hold thecatheter 18 onto the patient, however, including surgical tape. When the catheter is a so-called Swan-Ganz catheter, i.e., a catheter of the type disclosed in U.S. Pat. No. 3,995,623, incorporated herein by reference, theanchor 48 typically would not be provided. - In cross-reference to FIGS. 1 and 2, the
catheter body 46 includes at least two lumens, and in the preferred embodiment thecatheter body 46 includes at least four lumens. More specifically, thecatheter body 46 defines a generally wedge- or triangular-shaped (in the transverse cross-section shown)coolant supply lumen 54, a generally wedge-shapedcoolant return lumen 56, a round guide wire lumen 58, and a wedge-shapedsecondary infusion lumen 60. As mentioned above, however, the catheter can be a Swan-Ganz catheter, in which case additional lumens can be provided for Swan-Ganz catheter applications, including a lumen for inflating an anchoring balloon for holding the distal tip of the catheter in an appropriate blood vessel for various heart-related measurements and another lumen for holding a wire or wires that are attached to one or more distally-located sensors, such as temperature sensors, pressure sensors, gas sensors, and electrical sensors. - In any case, the
connector manifold 44 establishes a pathway for fluid communication between thecoolant supply tube 20 and thecoolant supply lumen 54. Likewise, theconnector manifold 44 establishes a pathway for fluid communication between thecoolant return tube 24 and thecoolant return lumen 56. Further, theconnector manifold 44 establishes a pathway for fluid communication between the guide wire andprimary infusion tube 32, and the guide wire lumen 58, which terminates at an opendistal hole 62 defined by a distally tapered and chamfereddistal tip 63 of thecatheter body 46. Also, theconnector manifold 44 establishes a pathway for fluid communication between thesecondary infusion tube 38 and thesecondary infusion lumen 60, which terminates at aninfusion port 64 in a distal segment of thecatheter body 46. Additional ports can be provided for eachlumen 58, 60 along the length of the catheter. - Referring now to FIGS. 1 and 3, at least proximal and distal thin-walled
heat exchange membranes catheter body 46 and are bonded to the outer surface of thecatheter body 46, with theinfusion port 64 being located between theheat exchange membranes catheter body 46 in the preferred embodiment shown. Essentially, theheat exchange membranes catheter 46 that is intubated within the patient. The heat exchange membranes can be established by a medical balloon material. - The
heat exchange membranes coolant source 12 as supplied from thecoolant supply lumen 54, and coolant from theheat exchange membranes coolant return lumen 56 to thecoolant source 12. In their inflated configurations, the heat exchange membranes define a diameter of about ten French, and preferably no more than twelve French. Thus, theheat exchange membranes - As shown in FIG. 3, a
wall 70 separates the coolant supply and returnlumens heat exchange membrane 66 as an example, asupply port 72 is formed in thecatheter body 46 through which coolant from thesupply lumen 54 can flow into the interior 74 of theheat exchange membrane 66, as indicated by thearrows 76. Moreover, areturn port 78 is formed in thecatheter body 46, and coolant can flow out of theheat exchange membrane 66 through thereturn port 78 and into thereturn lumen 56, as indicated by thearrows 80. As can be appreciated in reference to FIG. 3, for eachheat exchange membrane coolant return lumens distal tip 63. For example, thecoolant return lumen 56 can terminate just distal of the coolant return port for the distalheat exchange membrane 68, and the coolant supply lumen can terminate just distal of the coolant supply port of the distalheat exchange membrane 68. - In any case, it may now be appreciated that coolant is circulated through the
catheter device 18 in a closed loop. That is, infusion of the coolant directly into the patient's bloodstream is prevented. As detailed above, the catheter device includes a heat exchange region established by one or more heat exchange membranes. Alternatively, the heat exchange region can be established by or one or more hollow fibers, or one or more chamber-defining enclosures, such as metal or plastic bellows-type enclosures. - In the preferred embodiment, the components of the
catheter 18 are made of urethane, and more preferably are made of an aromatic, polyether-based polyurethane, although other suitable materials can be used. In a specific embodiment, thetubes heat exchange membranes catheter body 46 is made of Tecothane TT-2055D-B20 with Barium Sulfate radiopacifying agent incorporated into the polymer matrix for optimum visualizing during fluoroscopic maneuvering to a desired location. Thecatheter 18 can be coated with an anti-microbial agent and an anti-clotting agent if desired. - Now referring to FIG. 4, the details of the
connector manifold 44 can be seen. As shown, thepreferred connector manifold 44 is flat and wedge-shaped, with thedistal end 82 of theconnector manifold 44 being narrower than theproximal end 84. Within theconnector manifold 44,plural channels 86 are established. As can be appreciated in reference to FIG. 4, eachchannel 86 establishes a respective pathway for fluid communication between arespective connector line respective lumen connector manifold 44, thetubes distal end 82 of theconnector manifold 44. - In making the
connector manifold 44, thetubes catheter body 46 likewise is positioned on the connector manifold, closely spaced from the distal ends of the tubes. A respective mandrel is then advanced into each tube and the lumen of thecatheter body 46 that is to communicate with the tube. Next, plastic is directed over and around the tubes, mandrels, andcatheter body 46 by insert molding. The mandrels are removed after the plastic hardens, establishing thechannels 86. - As envisioned by the present invention, the structure set forth above can be used in many medical applications to cool a patient and/or to maintain temperature in a normothermic or hypothermic patient, for purposes of improving the medical outcomes of patients on whom, e.g., aneurysm surgery is to be performed, preferably while the patient's temperature is below normal body temperature. The structure can then be used to rewarm the patient in a controlled manner by circulating warm coolant through the structure, or by otherwise regulating natural body rewarming by circulating coolant that is maintained at an appropriate cool (relative to normal body temperature) or warm (relative to normal body temperature) temperature through the structure.
- As another example, head trauma can be treated by and after lowering and maintaining the patient's temperature below normal body temperature. Or, cardiac arrest can be treated while the patient's temperature is below normal body temperature. Yet again, minimally invasive heart surgery can be performed on the patient while the patient's temperature is below normal body temperature. And, cardiac arrest in the patient can be treated by and while the patient's temperature is below normal body temperature. Also, the present invention understands that for certain patients, e.g., stroke victims, it is important to maintain the temperature of a patient at or below normal body temperature, when the patient runs or attempts to run a fever. For severe ischemic stroke victims, the malady can be treated by maintaining the patient's body temperature at a hypothermic level.
- If desired, a
temperature sensor 100 such as a thermistor or other suitable device can be attached to thecatheter 18 as shown. Thesensor 100 can be mounted on thecatheter 18 by solvent bonding at a point that is proximal to themembranes sensor 100 can be disposed in a lumen of thecatheter 18, or attached to a wire that is disposed in a lumen of thecatheter 18, with the sensor hanging outside thecatheter 18. Alternatively, a separate temperature probe can be used, such as the esophageal probe disclosed in co-pending U.S. patent application Ser. No. 09/282,971, filed Mar. 31, 1999, now issued as U.S. Pat. No. 6,290,717, and incorporated herein by reference. As yet another alternative, a rectal probe or tympanic temperature sensor can be used. In any case, the sensor is electrically connected to thecoolant source 12 for control of the temperature of the coolant as described in the above-referenced '897 and '940 applications. - While the particular CENTRAL VENOUS CATHETER WITH HEAT EXCHANGE MEMBRANE as herein shown and described in detail is fully capable of attaining the above-described objects of the invention, it is to be understood that it is the presently preferred embodiment of the present invention and is thus representative of the subject matter which is broadly contemplated by the present invention, that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more”. All structural and functional equivalents to the elements of the above-described preferred embodiment that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless the element is expressly recited using the phrase “means for”.
Claims (10)
1. A method for making a heat exchange catheter device, comprising the acts of:
disposing a multi-lumen catheter body in a connector manifold mold;
disposing plural connector tubes in the connector manifold mold;
interconnecting a respective lumen with a respective connector tube using a mandrel;
directing a plastic material into the connector manifold mold; and
removing the mandrels such that a respective channel is defined between each respective lumen and its connector tube.
2. The method of claim 1 , further comprising the act of engaging at least one heat exchange membrane with a distal segment of the catheter body.
3. The method of claim 2 , wherein the catheter body is made of urethane.
4. A method for treating a patient, comprising the acts of:
advancing a heat exchange catheter device into the patient; and
circulating coolant through the catheter device while preventing infusion of the coolant directly into the patient's bloodstream, the catheter device including a heat exchange region established by: one or more heat exchange membranes, or one or more hollow fibers, or one or more chamber-defining enclosures.
5. The method of claim 4 , further comprising the act of performing aneurysm surgery while the patient's temperature is below normal body temperature.
6. The method of claim 4 , further comprising the act of treating head trauma in the patient while the patient's temperature is below normal body temperature.
7. The method of claim 4 , further comprising the act of treating cardiac arrest in the patient while the patient's temperature is below normal body temperature.
8. The method of claim 4 , further comprising the act of performing minimally invasive heart surgery on the patient while the patient's temperature is below normal body temperature.
9. The method of claim 4 , further comprising the act of treating cardiac malady in the patient while the patient's temperature is below normal body temperature.
10. The method of claim 4 , further comprising the act of maintaining the temperature of a patient at or below normal body temperature, when the patient runs or attempts to run a fever.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US10/057,334 US20020066458A1 (en) | 1998-04-21 | 2002-01-23 | Central venous catheter with heat exchange membrane |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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US09/063,984 US6126684A (en) | 1998-04-21 | 1998-04-21 | Indwelling heat exchange catheter and method of using same |
US25310999A | 1999-02-19 | 1999-02-19 | |
US09/305,613 US6368304B1 (en) | 1999-02-19 | 1999-05-05 | Central venous catheter with heat exchange membrane |
US10/057,334 US20020066458A1 (en) | 1998-04-21 | 2002-01-23 | Central venous catheter with heat exchange membrane |
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US09/305,613 Division US6368304B1 (en) | 1998-04-21 | 1999-05-05 | Central venous catheter with heat exchange membrane |
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US09/800,706 Expired - Lifetime US6749585B2 (en) | 1999-02-19 | 2001-03-07 | Central venous catheter with heat exchange membrane |
US10/057,334 Abandoned US20020066458A1 (en) | 1998-04-21 | 2002-01-23 | Central venous catheter with heat exchange membrane |
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US09/800,706 Expired - Lifetime US6749585B2 (en) | 1999-02-19 | 2001-03-07 | Central venous catheter with heat exchange membrane |
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AU (1) | AU4698800A (en) |
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Also Published As
Publication number | Publication date |
---|---|
WO2000066053A1 (en) | 2000-11-09 |
WO2000066053A8 (en) | 2001-06-28 |
EP1180005B1 (en) | 2009-09-30 |
JP4194243B2 (en) | 2008-12-10 |
EP1180005A1 (en) | 2002-02-20 |
EP1180005A4 (en) | 2007-03-21 |
JP2002542892A (en) | 2002-12-17 |
US20010010011A1 (en) | 2001-07-26 |
US6368304B1 (en) | 2002-04-09 |
AU4698800A (en) | 2000-11-17 |
DE60043059D1 (en) | 2009-11-12 |
WO2000066053A9 (en) | 2002-05-02 |
US6749585B2 (en) | 2004-06-15 |
ATE444049T1 (en) | 2009-10-15 |
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