INTRA-AORTIC BALLOON COUNTERPULSATION WITH CONCURRENT HYPOTHERMIA

Abstract

Devices, systems and methods for treating disorders characterized by low cardiac output. The devices, systems and methods use intra-aortic balloon counterpulsation in combination with hypothermia of all or a portion of a human or veterinary patient's body to improve coronary perfusion and cardiac output. To effect the hypothermia, a heat exchange catheter may be positioned in the a patient's vasculature separately from the intra-aortic balloon counterpulsation catheter. Alternatively, a combination Intra-aortic balloon counterpulsation/heat exchange catheter may be utilized. Such combination catheter comprises a) a catheter sized for insertion into the aorta, b) a counterpulsation balloon and c) a heat exchanger. A drive/control system receives temperature and electrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger.

Claims

1.-25. (canceled)

26. A catheter device comprising: an elongate catheter having a proximal end and a distal end, said catheter being advancable, distal-end-first, into the aorta of a human or veterinary patient; a counterpulsation balloon useable for effecting intra-aortic balloon counterpulsation; and, a heat exchanger useable to cool at least a portion of the patient's body

27. A device according to claim 26 wherein the heat exchanger comprises a heat exchanger through which heat exchange fluid is circulated.

28. A device according to claim 27 wherein said heat exchanger comprises a heat exchange balloon.

29. A device according to claim 28 wherein the heat exchanger comprises a single-lobed heat exchange balloon.

30. A device according to claim 28 wherein the heat exchanger comprises a multi-lobed heat exchange balloon.

31. A device according to claim 26 wherein at least a portion of the heat exchanger is metallic.

32. A device according to claim 28 wherein the heat exchange balloon and the counterpulsation balloon comprise a single balloon that is useable for both counterpulsation and heat exchange.

33. A device according to claim 26 wherein the heat exchanger comprises a heat exchange surface and wherein the device further comprises a flow disruption surface associated with the heat exchange surface, the flow disruption surface being configured to disrupt the laminarity of blood flow adjacent to the heat exchange surface, thereby enhancing the efficiency by which the heat exchanger exchanges heat with the flowing blood.

34. A device according to claim 26 wherein the counterpulsation balloon is positioned at a first location on the catheter and the heat exchanger comprises a heat exchange surface located at a second location on the catheter.

35. A device according to claim 34 wherein the first location is closer to the distal end of the catheter than the second location.

36. A device according to claim 34 wherein the second location is closer to the distal end of the catheter than the first location.

37. A device according to claim 34 wherein the heat exchanger and the counterpulsation balloon comprise a single balloon which is a) configured and useable to effect intra-aortic counterpulsation and b) receives a heat exchange medium such that heat is exchanged between the heat exchange medium and the blood, through at least a portion of the balloon.

38. A system comprising a heat exchange/intra-aortic counterpulsation catheter device according to claim 26, further in combination with: apparatus attachable to the catheter and useable to cause a) inflation and deflation of the counterpulsation balloon in response to the patient's cardiac cycle to effect intra-aortic balloon counterpulsation that results in a beneficial effect on the patient and b) at least cooling of the heat exchanger to cause cooling of at least a portion of the patient's body to a temperature that is at least 1 degree C. below normothermia.

39. A catheter device comprising: an elongate catheter; a counterpulsation balloon on the catheter; a heat exchanger on the catheter; at least one inflation/deflation lumen extending through the catheter for passing inflation fluid into and out of the counterpulsation balloon; and inflow and outflow lumens extending through the catheter for circulation of a heat exchange medium through the heat exchanger.

40. A device according to claim 39 wherein the heat exchanger comprises a balloon through which the heat exchange medium circulates.

41. A device according to claim 39 wherein the counterpulsation balloon and the heat exchanger comprise separate structures, the counterpulsation balloon being positioned at a first location on the catheter and the heat exchanger being positioned at a second location on the catheter.

42. A device according to claim 41 wherein the first location is closer to a distal end of the catheter than the second location.

43. A device according to claim 41 wherein the second location is closer to a distal end of the catheter than the first location.

44. A device according to claim 39 wherein the heat exchanger and the counterpulsation balloon comprise a single balloon which provides both counterpulsation and heat exchange.

45. A system comprising a device according to claim 39 further in combination with: apparatus attachable to the catheter and useable to cause a) inflation and deflation of the counterpulsation balloon and b) circulation of heat exchange medium through the heat exchanger.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIGS. 1-4b, attached hereto, show examples or embodiments of the methods and apparatus of the present invention, as follows:

[0022] FIG. 1 is a diagram of a human body showing relevant portions of the cardiovascular system including the heart (H), aorta (A) and femoral artery (FA).

[0023] FIG. 2 is a cut-away view of the heart (H) and great vessels, showing the coronary arteries (CA), aortic arch (AA), brachiocephalic trunk (BCT), left common carotid artery (LCC) and left subclavian artery (LSA).

[0024] FIG. 3 is a schematic diagram of an intra-aortic balloon/heat exchanger catheter (10) of the present invention positioned withing the aorta (A) and connected to driving/control apparatus (30) that control and operate the catheter's counterpulsation balloon (14) and heat exchanger (16).

[0025] FIG. 3a is a cut away view of portion 3a of FIG. 3, showing one example of the manner in which the heat exchanger 16 my be constructed.

[0026] FIG. 3b is a cross sectional view through line 3b-3b of FIG. 3.

[0027] FIG. 4 is a schematic diagram of the thoracic aorta of a human patient wherein an alternative embodiment of a balloon/heat exchanger catheter (10a) of the present invention is positioned.

[0028] FIG. 4a is a schematic diagram of the thoracic aorta of a human patient wherein yet another alternative embodiment of a balloon/heat exchanger catheter (10a) of the present invention is positioned.

[0029] FIG. 4b is an enlarged sectional view of the heat exchanger of the catheter (10b) shown in FIG. 4a.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

[0030] The following detailed description is provided for the purpose of describing only certain embodiments or examples of the invention and is not intended to describe all possible embodiments and examples of the invention.

[0031] With reference to FIGS. 1-4b, a balloon/heat exchanger catheter 10, 10a, 10b of the present invention generally comprises an elongate catheter body 12, 12a, 12b having a heat exchanger 16, 16a, 16b and a counterpulsation balloon 14, 14a, 14b positioned thereon. As may be seen from the cross-section of FIG. 3B, the catheter body 12, 12a, 12b proximal to the heat exchanger 16, 16a, 16b comprises a gas inflation/deflation lumen 52 through which gas or other suitable fluid is alternately infused and withdrawn to effect inflation and deflation of the counterpulsation balloon 14, 14a, 14b as well as heat exchange fluid inflow and outflow lumens 54, 56 through which heat exchange fluid is circulated through the heat exchanger 16, 16a, 16b. Preferably, the heat exchange fluid inflow lumen 54 is connected to the proximal end of the heat exchanger 16, 16a, 16b and the heat exchange fluid outflow lumen 56 is connected to the distal end of the heat exchanger 16, 16a, 16b, thereby causing the heat exchange fluid to flow through the heat exchanger 16, 16a, 16b in a direction opposite the direction in which blood is flowing through the patient's aorta.

[0032] In some embodiments, such as that shown in FIG. 3, the counterpulsation balloon 14, may be positioned on a portion of the catheter body 12 that is distal to the heat exchanger 16. In other embodiments, such as those shown in FIGS. 4a and 4b, the counterpulsation balloon 14a, 14b may be positioned on a portion of the catheter body that is proximal to the heat exchanger 16a, 16b. Additionally, hybrids or combinations of these designs may also be employed wherein one or more heat exchangers may be positioned proximal and distal to the counterpulsation balloon.

[0033] The catheter body 12, 12a, 12b has multiple lumens as needed to permit the passage of balloon inflation fluid (e.g., carbon dioxide or helium) into and out of the counterpulsation balloon 14, 14a, 14b and the passage of energy or heated/cooled thermal exchange fluid into the heat exchanger 16, 16a, 16b. In this regard, the heat exchanger preferably comprises at least one heat exchange surface that is in contact with a heat exchange lumen through which a heated or cooled heat exchange medium (e.g., saline solution) may be passed. In the particular embodiments shown in the figures, the heat exchange surface comprises the blood-contacting outer surfaces of helical tubes 20 (FIGS. 3, 3a and 4) or straight tubes 48 through which the heat exchange medium is circulated. In other embodiments, not shown, the heat exchanger may comprises a thermoelectric element or chemically cooled member mounted within or on the catheter body and connected to the extracorporeal drive/control apparatus 30 by a wire or other communication pathway that extends through the catheter body 12 to deliver electrical current, chemical activators or other forms of energy to the heat exchanger for the purpose of causing the heat exchanger to warm and/or cool as needed to maintain the desired temperature.

[0034] The drive/control apparatus 30 is useable to drive and control the heat exchanger 16, 16a, 16b and the counterpulsation balloon 14, 14a, 14b. With respect to controlling and driving of the heat exchanger 16, 16a, 16b, the drive/control apparatus 30 comprises a heater/cooler 34 for causing the heat exchanger 16, 16a, 16b, to heat or cool as needed. Generally, the drive/control apparatus 30 comprises a controller 32 such as a microprocessor or computer, a heater/cooler 34 for heating and cooling the heat exchanger 16, 16a, 16b, a temperature monitoring apparatus for providing a temperature signal 38 to the controller 32 and an electrocardiogram (ECG) monitoring apparatus for providing an ECG signal to the controller 32.

[0035] Specific examples of the types of apparatus that comprise the heater/cooler 34 and the portions or function of the controller 32 that control the heat exchanger 16, 16a, 16b and temperature probes that provide the temperature signal 40 are described in the above-incorporated PCT International Publication WO2000/10494. It is presently preferred that the patient's esophageal temperature be measured by a temperature probe positioned in the esophagus and that the temperature signal received by the controller 32 receive a signal 40 indicative of such monitored esophageal temperature. A desired target temperature is set or inputted into the controller 32 and the controller 32 is programmed to cause the heater/cooler to heat or cool the heat exchanger 16, 16a, 16b to maintain the monitored temperature at or near the desired target temperature.

[0036] With respect to driving (e.g., inflating and deflating) and controlling of the counterpulsation balloon 14, 14a, 14b, the drive/control apparatus 30 comprises a pump (IABP) for pumping inflation fluid into and out of the counterpulsation balloon at specific times in relation to the cardiac cycle or ECG. Specific examples of the IABP and the other components/functions of the controller 32 used to drive and control the counterpulsation balloon 14, 14a, 14b and means for providing and processing the ECG signal 40 are described in U.S. Pat. No. 3,504,662 (Goetz et al.) and U.S. Pat. No. 3,504,662 (Jones), the entireties of which are expressly incorporated herein by reference.

[0037] It will be appreciated that, in embodiments such as those shown in FIGS. 4-4b, wherein the heat exchanger 16a, 16b is located on the catheter distal to the counterpulsation balloon 14a, 14b, it may be necessary or desirable for the heat exchanger 16a, 16b to reside within the arch of the aorta AA in order for the counterpulsation balloon 14a, 14b to be optimally positioned within the thoraco-abdominal aorta A inferior to the left subclavian artery LSA, but still superior to other branches of the aorta such as the superior mesenteric and renal arteries. In such cases, it may be desirable to construct or utilize the heat exchanger 16a, 16b in a way that avoids blocking or disrupting flow into the coronary ostia CO, brachiocephalic trunk BCT, left common carotid artery LCA and/or left subclavian artery LSA. As shown in FIG. 4, this may be accomplished by simply causing the heat exchanger 16a to be smaller in diameter than the lumen of the aortic arch AA such that flow space exists around the heat exchanger 16 and the coronary ostia CO, brachiocephalic trunk BCT, left common carotid artery LCA and/or left subclavian artery LSA remain unobstructed. Another approach, as shown in FIGS. 4a-4b, is to construct the heat exchanger 16b such that its heat exchange elements 48, when fully deployed and operational, cannot obstruct or block the coronary ostia CO, brachiocephalic trunk BCT, left common carotid artery LCA and/or left subclavian artery LSA. In the particular embodiment shown in FIGS. 4a-4b, the distal portion of the catheter body 12b is preformed to a J shape and the heat exchanger 16b comprises a plurality of arcuate heat exchange tubes 48 that are disposed on the underside US of the J shaped catheter body 12 such that the heat exchange tubes 48 remain adjacent the wall of the aorta A that is opposite the brachiocephalic trunk BCT, left common carotid artery LCA and/or left subclavian artery LSA.

[0038] The cooling of the patient's body may cause some shivering to occur, if the patient's core body temperature is cooled to less than about 35.5 C. In such cases, it may be desirable to administer an anti-shivering treatment to prevent or lessen the shivering and enhance the patient's comfort. Such anti-shivering treatment may comprise the mere application of warmth to the patient's skin as may be accomplished by a warming blanket of the type commonly used in hospitals. Alternatively or additionally, such anti-shivering treatment may comprise the administration of drugs or agents to minimize or prevent the shivering response. Examples of agents that are useable for this purpose are described in the above-incorporated U.S. Pat. No. 6,231,594 (Dae et al.). For example, an anti-shivering treatment may comprise the steps of: [0039] (i) administering an initial bolus dose of a first anti-thermoregulatory response agent to the patient (for example an oral dose of a serotonin 5 HT1a receptor agonist such as 60 mg of buspirone); [0040] (ii) administering a subsequent dose of a second anti-thermoregulatory response agent to the patient (for example an initial intravenous dose of an opioid receptor agonist such as 50 mg of meperidine administered by slow push followed by a similar second dose); and [0041] (iii) administering a further dose of the second anti-thermoregulatory response agent by constant IV administration (for example, constant IV administration of about 25 mg/hr of meperidine).
Alternatively, another anti-shivering treatment that may be more suitable for longer term use (e.g., more than 24 hours) comprises the following steps: [0042] (i) administering a first dose of an anti-thermoregulatory response agent to the patient (for example an intravenous dose of an opioid receptor agonist such as 50 mg of meperidine administered by slow push and infused over about 5 minutes); [0043] (ii) administering a second dose of the anti-thermoregulatory response agent to the patient (for example, about 15 minutes after the initial administration of meperidine, an additional 50 mg of meperidine is administered by slow IV push); [0044] (iii) administering a third dose of the anti-thermoregulatory response agent by constant IV administration (for example, constant IV administration of about 25 mg/hr of meperidine maintained for the duration of the time that the patient's temperature is below the shivering threshold); [0045] (iv) an intravenous temperature control catheter of the general type described above is introduced into the vasculature of the patient and the heat exchange region of the catheter is placed in the IVC and cooling is begun at the maximum rate. The patient is thereafter maintained at a therapeutically low temperature even below the shivering threshold.

[0046] Another class of anti-shivering drugs that may be particularly useful are the alpha-adrenergic receptor agonists, such as dexmedetomidine and clonidine.

[0047] Although several illustrative examples of means for practicing the invention are described above, these examples are by no means exhaustive of all possible means for practicing the invention. For example, as described in the Summary of the Invention, instead of using a combination heat exchange/IABP catheter as shown in the drawings, a standard or conventional IABP catheter may be used and a separate heat exchange catheter may be deployed in the aorta or elsewhere, such as in the inferior vena cava or venous vasculature, to effect the desired cooling of the patient's heart, other body parts or entire body. Other modifications to the embodiment shown in the drawings are also possible. The scope of the invention should therefore be determined with reference to the appended claims, along with the full range of equivalents to which those claims are entitled.