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CARDIOVASCULAR GUIDING CATHETER
WITH HEAT EXCHANGE PROPERTIES AND
METHODS OF USE
CROSS REFERENCE TO RELATED 5
This application is a continuation-in-part of U.S. patent application Ser. No. 09/503,014 filed on Feb. 11, 2000, now U.S. Pat. No. 6,409,747, which is a continuation of U.S. patent application Ser. No. 09/063,984 filed on Apr. 21, 10 1998, now issued as U.S. Pat. No. 6,126,684, the disclosures of which are herein incorporated by reference in their entirety; and further, the present application is a continuation-in-part of U.S. patent application Ser. No. 09/565,039 filed on May 3, 2000, now U.S. Pat. No. 15 6,432,124, which is a continuation of U.S. patent application Ser. No. 09/375,079 filed on Aug. 16, 1999, now issued as U.S. Pat. No. 6,149,670, which is a continuation-in-part of U.S. patent application Ser. No. 09/266,452 filed on Mar. 11, 1999 now U.S. Pat. No. 6,458,150, which is a continuation- 20 in-part of U.S. patent application Ser. No. 09/253,109 filed on Feb. 19, 1999, now abandoned, which is a continuationin-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 disclosures of which are herein incorporated by reference in their entirety.
BACKGROUND OF THE INVENTION
The field of the present invention is apparatus and meth- 30 ods for providing access to a patient's central venous system and/or heart, and producing heat exchange with a body fluid flowing through the patient's central venous system.
Cardiovascular guiding catheters are typically used in patients undergoing heart surgery to provide a path through 35 a patient's vasculature through which other medical apparatus, such as other catheters or stent devices, may be advanced. Guiding catheters may also supply a conduit through which a contrast dye may be injected for diagnostic procedures, or through which other, smaller therapeutic 40 catheters may be placed and maneuvered toward the patient's heart. Conventional cardiovascular guiding catheters are typically about 5 to 10 French in size and have a flexible single-lumen elongated body extending 80 to 110 centimeters. They typically may be introduced through the 45 left or right coronary ostium, the subclavian or jugular veins, or through the femoral vein of the patient, serving to provide the caretaker with easy and convenient access to the patient's central blood supply via the central venous system. In this manner general access to the central blood supply is 50 gained, enabling, for example, delivery of drugs, constrast dyes, fluids, along with the gathering of patient blood for blood gas analysis and the like.
One specific application for a guiding catheter is in balloon angioplasty procedures. Balloon angioplasty is a 55 medical procedure used to widen narrowings in the coronary artery without surgery. The major challenge to angioplasty is clinical restenosis, or the re-narrowing of the blood vessel following the angioplasty procedure. Coronary stenting is a technique which mechanically props open the artery through 60 implementation of a small, latticed stainless steel tube at the site of the narrowing. The stainless steel tube—the stent—is pre-mounted on a coronary angioplasty balloon catheter. As the balloon catheter is inflated during angioplasty, the stent expands and is compressed against the artery walls. When 65 the balloon is deflated, the expanded stent remains implanted in the artery.
An introducer sheath may be inserted into a patient's vein to facilitate insertion of the guiding catheter. This sheath provides a direct and smooth pathway for the catheter to enter the artery. A coronary guiding catheter is inserted into the introducer sheath and may be advanced to the part of the aorta where the coronary arteries branch off to the heart. A hemostatic valve, which controls the flow of blood through the artery, is attached to the end of the coronary guiding catheter to allow for the insertion of coronary catheters. Note that a coronary guiding catheter is a conduit for the coronary guide wire and the coronary catheters to access the coronary artery. Coronary catheters rely on the support provided by the coronary guiding catheter.
A coronary guide wire is loaded into the coronary guiding catheter through the use of a guide wire introducer, and advanced to the cardiac vessel just past the narrowing. Coronary guide wires are used to support the coronary catheters as they are advanced across the artery narrowing. A torque device is placed on the end of the coronary guide wire and is used to steer the coronary guide wire to the artery until its tip is beyond the narrowing.
A coronary stent catheter is inserted at the distal end of the coronary guide wire and is advanced across the narrowing over the coronary guide wire through the guiding catheter.
After the plaque has been compressed and the artery has been opened sufficiently, the deflated coronary stent catheter may be withdrawn through the coronary guiding catheter, which itself is then removed.
In addition to using a guiding catheter to provide access to a patient's central venous system and/or heart, it may be desirable to reduce the patient's body temperature below normal body temperature so that the patient experiences hypothermia. Many advantages of hypothermia are known. By way of example, it has been found desirable to lower body temperature to reduce the metabolism of the body. This has been particularly desirable in surgical applications where the reduced metabolism has made it possible to more easily accommodate lengthy operative procedures. In cases of stroke and several other pathological conditions, hypothermia also reduces the permeability of the blood/brain barrier. It inhibits release of damaging neurotransmitters and also inhibits calcium-mediated effects. Hypothermia also inhibits brain edema and lowers intracranial pressure. In other cases, it may be desireable to cool a patient experiencing a fever so that the patient's body temperature returns to normal. Evidence suggests that cooling the body core is protective for the myocardium and the brain. Particularly, during accute myocardial infarction (AMI) and cardiac arrest (CA), the myocardium is deprived of adequate oxygen for extended periods of time and the brain is vulnerable to blood embolisms resulting from the impaired heart. These conditions can potentially be improved when the body is maintained at subnormal temperatures (32° C.-36° C.) during treatment. In treatment of myocardial infarction, angioplasty and stenting operations may also be included.
In yet other situations, it may be desirable to raise the patient's body temperature. Control of a patient's temperature may be problematic during hospital stays and particularly during active interventions such as surgery. The patient's body temperature may drift too low during surgery, potentially being deterimental to the patient's health. In such cases, body temperature may be artificially maintained at a normothermic temperature (approximately 98.6° R). With regard to heart surgery, it may be particularly desireable to cool a patient before and/or during heart surgery and re-warm the patient post-operatively.
Conventional therapies used to manage patient temperature include acetaminophen (Tylenol), cooling blankets, heating blankets such as warm water blankets, forced warm or cool air, heat lamps, endovascular catheters, ice packs, ice baths, cold or warm infusions, and cold saline rectal or 5 gastric ravages. With some of the conventional therapies, the warming or cooling rates are restricted by the body's ability to resist surface cooling or heating with vasodilation and sweating. The conventional approaches to cooling a patient also may require additional steps, may require excessive 10 time and may not provide for precise control of patient temperature over long periods of time. Further, some of these devices cover a significant portion of a patient's body, inhibiting access to the patient.
Other techniques for controlling patient temperature :5 employ intravascular heat exchange catheters that may be inserted into the patient's circulatory system. A relatively cool or warm fluid may be circulated through such catheters in a closed loop and exchange heat with blood flowing in the circulatory system, and may improve the patient's medical 20 outcome.
Carrying out both the guiding function of a cardiovascular guiding catheter and the heat transfer function of a heat exchange catheter conventionally requires the use of two separate devices. Compared with using a single catheter, 25 using both a heat exchange catheter and a cardiovascular guiding catheter would increase the complexity of the procedure, require addional steps to be carried out, and may require an additional incision.
In order to minimize the number of incisions and cardiovascular guiding catheter insertions into the patient's body and cool or heat the patient relatively quickly and in a controlled fashion, a cardiovascular guiding catheter may be configured to include a heat exchange capability. 35
By supplementing the known functions of a cardiovascular guiding catheter with the function of cooling or warming the patient's blood, a cardiovascular guiding catheter may take advantage of existing access to the venous system using a single, relatively small incision, reducing the risk of 40 additional complications. One access is through the iliac arteries. Additional access may be through the subclavian, jugular or femoral veins to the central blood supply, via the central venous system, and is therefore particularly expedient, permitting efficient cooling or warming of a 45 patient. The term central venous system generally relates to the portion of the venous system which returns blood to the right side of the heart, including the inferior and superior vena cava.
BRIEF SUMMARY OF THE INVENTION 50
It would be advantageous to provide a single cardiovascular guiding catheter that provides access to the patient's heart and bloodstream, facilitates guiding of other medical apparatus in the bloodstream, and provides intravascular 55 cooling and heating, thereby overcoming one or more problems associated with the related art.
The present invention is directed to a heat exchange cardiovascular guiding catheter and methods for its use. A heat exchange element or elements is combined with a guide 60 lumen and guide duct to provide efficient temperature control of a patient, to provide convenient access to the patient's heart and/or central venous system, and to provide a pathway through which medical apparatus may be advanced in the patient's bloodstream, all with a single catheter. Using a 65 single catheter allows both the heat transfer function and the guiding function to be carried out simultaneously and
reduces the complexity of providing the functions with two separate conventional devices.
In a first separate aspect of the invention, a heat exchange catheter comprises a guiding lumen and duct that facilitate insertion of medical apparatus in a patient's central venous system, and a heat exchange element that exchanges heat with the patient's blood so that a single cardiovascular guiding catheter carries out both the guiding function of a standard cardiovascular guiding catheter and the heat transfer function of a heat exchange catheter.
In a second separate aspect of the invention, a heat exchange cardiovascular guiding catheter comprises a generally tubular elongate body defining an inflow lumen, an outflow lumen, and at least one guide lumen. The inflow and outflow lumens supply heat exchange fluid to and from one or more heat exchange elements disposed about a distal, implantable portion of the catheter, while the guide lumen provides a pathway and access to the heart and/or central blood supply of the patient.
In a sixth separate aspect of the invention, a heat exchange cardiovascular guiding catheter is provided with multiple balloons (preferably three or four balloons) that are spaced along the elongated body to provide controlled and balanced heat transfer, with a gap between balloons to provide the catheter with flexibility.
In an eighth separate aspect of the present invention, it is contemplated that combinations of the foregoing separate aspects may be incorporated into a single embodiment.
Therefore, it is an object of the present invention to provide an improved heat exchange cardiovascular guiding catheter and a method for its use. Other and further objects and advantages will appear hereafter.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic side elevational view of a first embodiment of an intravenous cardiovascular guiding catheter;
FIG. 1A is a cross-sectional view of the intravenous cardiovascular guiding catheter of FIG. 1;
FIG. 2 is a schematic side sectional view of a distal portion of a second embodiment of an intravenous cardiovascular guiding catheter; and
FIG. 3 is a schematic side sectional view of a distal portion of a third embodiment of an intravenous cardiovascular guiding catheter having a heating element.
FIG. 4 shows an embodiment of a cardiovascular guiding catheter positioned in the ascending/descending aortic system.
FIG. 5 shows another embodiment of a cardiovascular guiding catheter.
DETAILED DESCRIPTION OF THE
The preferred embodiments will be described with reference to drawing figures, wherein like reference numerals are applied to like elements.
U.S. Pat. Nos. 6,146,411; 6,126,684; 6,299,599; 6,287, 326; and 6,149,670 each of which is hereby incorporated by reference, disclose systems employing heat exchange catheters that may be inserted into the body of a patient to exchange heat with the blood supply of the patient. The indwelling catheters of the referenced patents are disposed in a heat exchange relationship with the blood supply, and a heat exchange fluid is circulated through the catheters in a
closed loop. Outside the patient's body, the heat exchange fluid passes through a cooling or heating system to re-cool or re-heat the fluid. These catheters may change the patient's temperature and may thereby improve the patient's medical outcome. 5
The heat exchange capability and other advantages of the heat exchange catheters disclosed in the above-referenced patents may be implemented with a cardiovascular guiding catheter in the preferred embodiments here, so that a single device both accomplishes the functions of conventional 10 guiding catheters and effectively manages patient temperature. By supplementing the known functions of a guiding catheter with the function of cooling or warming the patient's blood, a single heat exchange cardiovascular guiding catheter may be used to access to the venous system and 15 cool or heat the patient through a single, relatively small incision, reducing the risk of complications. The access, typically through the femoral vein, is to the central blood supply, via the central venous system, and is therefore particularly expedient, permitting efficient cooling or warm- 20 ing of a patient. The term central venous system generally relates to the portion of the venous system which returns blood to the right side of the heart, including the inferior and superior vena cava.
FIGS. 1 and 1A depict one embodiment of a cardiovas- 25 cular guiding catheter 20 adapted to exchange heat with a body fluid flowing through a body conduit of a patient, such as blood in a patient's central venous system. The catheter 20 comprises an elongate body 22 having a substantially tubular configuration, a proximal portion 26 with a proximal 30 end 28, and a distal portion 30 with a distal end 31. When operatively disposed, the distal end 31 is disposed within the patient's body, and the proximal end 28 is disposed outside of the patient's body.
Referring also to FIG. 1A, which is a cross-sectional view 35 taken along line 33 of the catheter 20 of FIG. 1, the elongate body 22 includes an inflow lumen 32, an outflow lumen 34, a guide lumen 44 and two auxiliary lumens 42, 46. The various lumens 32, 34, 42, 44, 46 extend between the proximal portion 26 and the distal portion 30 of the elongate 40 body 22. External access to the inflow lumen 32 and outflow lumen 34 is provided by an inlet tube 52a and an outlet tube 52b. External access to the guide lumen 44 and two auxiliary lumens 42, 46 is supplied by a guide lumen fitting 74 through which medical apparatus could be introduced, and 45 auxiliary lumen fittings 76, 78.
The elongate body 22 preferably includes a reinforcing member that prevents the catheter from kinking when it flexes and may provide torsional stiffness for torqueability. In this embodiment, the reinforcing member 25 comprises a 50 wire embedded in and wound inside the material 23 of the elongate body in a series of turns. The part of the reinforcing member 25 indicated with a solid line is that portion which may be visible at the cross-section shown. Preferably, the member 25 is wound through at least a substantial portion of 55 the distal portion 30 of the catheter 20 because the distal portion 30 may be subjected to forces that might cause the catheter to kink in the absence of the member 25. The reinforcing member 25, however, does not extend to the distal end 31 of the elongate body 22 because the portion of 60 the elongate body 22 adjacent the distal end 31 preferably is flexible for maneuverability through the patient's vasculature. A reinforcing member may comprise any type of structure that inhibits kinking of the catheter 20, such as wire braiding in the elongate body or one or more longitudinal 65 slats embedded in the elongate body 22 or in one of the lumens 32, 34, 42, 44, 46.
In this embodiment, the elongate body 22 has a guide duct
70 at the distal end 31 of the elongate body 22 for providing communication between the guide lumen 44 and the patient's body conduit in which the catheter 20 may be inserted. Other guide ducts 71 may be disposed about a longitudinal side of the elongate body 22 near the distal end 31. A catheter may include any or all of the guide ducts 70,
71 shown, and may include additional guide ducts not shown.
Preferably, the guide lumen 44 or the guide lumen fitting 74 has a barrier 77 located proximally of the proximal-most guide duct 70, 71 to selectively block and/or restrict fluid flow through the lumen 44 or fitting 74. Such a barrier 77 may comprise a valve, such as a hemostasis valve, a plug or any other means for selectively blocking the guide lumen 44 or guide lumen fitting 74.
At least one heat exchange element 24, such as a fluidcarrying inflatable balloon, preferably is disposed proximally of at least one of the guide ducts 70, 71 and extends at least partially along the implantable, distal portion 30 of the elongate body 22. For illustrative purposes, this embodiment is shown to have only one heat exchange element 24. Preferably, however, a catheter has more than one heat exchange element (as will be described below in connection with other embodiments), and may have numerous heat exchange elements.
Heat exchange fluid (not shown) flows through the elongate body and through the heat exchange element 24 to heat or cool a patient. The heat exchange fluid is supplied through the inflow lumen 32 and enters the heat exchange element 24 through an inflow duct 50, then flows through the heat exchange element 24, and exits through an outflow duct 61. The heat exchange fluid is remotely cooled or heated outside of the catheter 20, such as by a temperature control system (not shown), as described in U.S. Pat. Nos. 6,146,411 and 6,019,783, both of which are incorporated by reference herein, and is conveyed to and from the catheter 20 via the inlet tube 52a and the outlet tube 52fc.
The particular heat exchange fluid selected is preferably biocompatible to avoid harm to the patient in the event of inadvertent rupture. Candidate materials include sterile saline and water, although other fluids having suitable viscosity, heat exchange and material compatibility characteristics can also be used.
The auxiliary lumens 42, 46 may serve one or more of a variety of functions, including providing a conduit for infusion of drugs such as chemotherapy, fluids and nutrition, providing access for syringes for sampling, and accommodating various sensors, such as a blood pressure sensors and thermistors to monitor the patient, thus generally providing access to the central blood supply as dictated by the particular application. The auxiliary lumens 42, 46 each preferably have an auxiliary duct 75, 72, 71 that provides fluid communication between each auxiliary lumen 42, 46 and the outside surface of the catheter 20 so that the auxiliary lumens 42, 46 provide access to the body conduit in which the catheter 20 is inserted. Although one auxiliary duct 75 is shown proximal of the heat exchange element 24 on the hidden side of the elongate body 22 (as indicated by dashed lines) and the other auxiliary duct 71, 72 is shown distal of the heat exchange element 24, the auxiliary ducts 75, 72, 71 alternately may be disposed at other locations on the the catheter 20. Further, the auxiliary lumens 42, 46 may be configured to receive a guidewire, which may be used to stiffen the catheter 20 during insertion and removed after insertion, or the guide lumen 44 may accommodate a
guidewire. While the catheter 20 depicted in FIG. 1 has two auxiliary lumens 42, 46, other numbers of auxiliary lumens are contemplated and may be suitable depending on the particular application.
The guide lumen 44 preferably occupies a subtantial 5 portion of the cross-sectional area of the elongate body 20 to provide adequate space for the insertion of medical apparatus. The various lumens 32, 34, 42, 44, 46, however, may have cross-sectional shapes and sizes different that those depicted in FIG. 1A as suitable for the particular application. 1Q
The catheter 20 preferably is formed of a polymer material 23 that defines the various lumens 32, 34, 42, 44, 46. A preferred material 23 is polyurethane, although other materials, such as nylon, polyethylene, PEBAX, PVC, Tygon® or the like may also be used. Considerations in selecting the appropriate material 23 include biocompatibility, flexibility, temperature change compatibility, and resistance to buckling.
As shown in FIG. 1, one or more depth markings 60, 62 may be disposed on the elongate body 22 to indicate the 2Q length of a portion of the catheter 20 that is inserted into the patient. Preferably, the depth markings 60, 62 are disposed at least on the proximal portion 26 of the elongate body 22 so that they are visible when the catheter 20 is inserted into the patient. The markings 60, 62 may indicate a length of the 2J catheter 20 measured from each marking 60, 62 to the distal end 31 of the catheter 20, and may be disposed at spaced intervals, such as one-centimeter intervals. Each marking 60, 62 may comprise any symbol that may be understood to represent a length or relative length or degree of intubation. 3Q One marking 60 is shown to comprise a numeral indicative of length (in centimeters, for example) from the marking 60 to the distal end 31 of the catheter. Other markings 62 may comprise dots, lines, hash marks or other marks.
The elongate body 22 may also include a distal indicator 35 64 that indicates the position of the distal end 31 of the elongate body 22. The distal indicator 64 preferably is disposed near the distal end 31 of the elongate body 22. The position of the distal indicator 64 inside the patient preferably may be determined using conventional medical 40 technology, such as X-ray technology or fluoroscopy. Information regarding the position of the distal end 31 of the elongate body 22 may aid proper placement of the catheter 20, so that the catheter 20 is inserted to a degree that maximizes the heat transfer rate without harming the patient. 45
The catheter 20 preferably includes an anchor configured for affixing the catheter 20 to the patient. As shown in FIG. 1, the anchor may comprise a suture fitting 80. The suture fitting 80 can be made integrally with the catheter 20, or it can be made as a separate plastic fitting and engaged with 50 the catheter 20. The suture fitting 80 includes two eyes 82, 84 through which sutures can be inserted and engaged with the patient or with a bandage or tape or other structure that is engaged with the patient. An anchor may be especially desirable in cases in which the catheter is inserted for an 55 extended period.
The implanted portion of the catheter 20 may also be thromboresistant. The thromboresistant property may be provided, for example, in the form of a coating having thromboresistant characteristics. The coating may include an 60 anticoagulant and/or be adapted to receive an electrical charge providing thromboresistance to the coating. Further, a hydrophilic coating may be applied to the catheter to discourage the adhesion of body fluids or tissue to the catheter. 65
Although FIG. 1 depicts a catheter with a single heat exchange element, a cardiovascular guiding catheter may be
provided with various numbers of heat exchange elements. FIG. 2 depicts a cross-section of a distal portion of a catheter 120 having three heat exchange elements 124,126,128. The principles described herein typically apply to catheters having any number of heat exchange elements.
The three heat exchange elements 124, 126, 128 are disposed proximally of the guide ducts 170, 171a, 171fc. Each heat exchange element 124, 126,128 preferably comprises a balloon that is inflatable from a deflated configuration, wherein the balloon lies substantially flush with the elongate body 122, to an operational configuration wherein the balloon is expanded away from the elongate body 122 by the pressure of the heat exchange fluid inside the balloon. The deflated configuration facilitates insertion and removal of the catheter 120, and the inflated configuration provides greater heat transfer capability.
Each heat exchange element 124, 126, 128 defines with the elongate body 122 a cavity 136,138,140. Heat exchange fluid (as indicated by the arrows) is circulated through the heat exchange elements 124, 126, 128 via the inflow lumen 132 and the outflow lumen 134. Heat exchange fluid introduced into the inflow lumen 132 flows through each inflow duct 150, 152, 154 and enters each cavity 136, 138, 140 of each heat exchange element 124, 126, 128. The heat exchange fluid flows through each heat exchange element 124, 126, 128 and exits each heat exchange element 124, 126,128 through each outflow duct 160,162,164. The heat exchange fluid then flows through the outflow lumen 134 toward the proximal end of the catheter 120. The elongate body 122 may also define auxiliary lumens like those described in connection with FIGS. 1 and 1A.
The inflow duct 150, 152, 154 of each heat exchange element 124,126,128 preferably is positioned distally of the corresponding outflow duct 160, 162, 164 to provide countercurrent flow, which facilitates the maximum heat exchange between the heat exchange fluid and the body fluid (e.g., blood). Further information regarding the structure, functions, positions and relative sizes of inflow ducts and outflow ducts is disclosed in U.S. Pat. No. 6,126,684.
The heat exchange fluid may be either relatively cool or relatively warm, depending on whether patient cooling or heating is desired. While in each cavity 136, 138, 140, the heat exchange fluid serves to provide a cold or warm fluid on an inner surface of each heat exchange element 124,126, 128. With a body fluid, such as blood, flowing exteriorly of each heat exchange element 124, 126, 128, heat transfer occurs across each heat exchange element 124, 126, 128, effectively cooling or heating the body of the patient. The temperature of the heat exchange fluid is remotely controlled in order to achieve a desired patient target temperature or temperature range.
Each heat exchange element 124, 126, 128 preferably comprises a balloon. Each balloon may be formed from a piece of flexible sheet material or extruded tubing formed into a molded balloon of the desired shape and size and then bound or otherwise fixed to the elongate body 122 to form each cavity 136, 138, 140. In one embodiment, each heat exchange element 124,126,128 is made of urethane, nylon, or PET and is thin-walled, i.e., has a wall thickness of less than three mils, and more preferably less than one and one-half mils. Further, each heat exchange element 124,126, 128 preferably is coated with an antimicrobial substance, as well as an anticlot substance, such as heparin.
One advantage of using multiple heat exchange elements 124, 126, 128 is that the flow and temperature of heat exchange fluid may be more readily controlled along the