WO2000009200A1 - Procedes et appareil intravasculaires permettant d'isoler et de refroidir selectivement le systeme vasculaire au cours d'interventions chirurgicales - Google Patents

Procedes et appareil intravasculaires permettant d'isoler et de refroidir selectivement le systeme vasculaire au cours d'interventions chirurgicales Download PDF

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Publication number
WO2000009200A1
WO2000009200A1 PCT/US1999/004345 US9904345W WO0009200A1 WO 2000009200 A1 WO2000009200 A1 WO 2000009200A1 US 9904345 W US9904345 W US 9904345W WO 0009200 A1 WO0009200 A1 WO 0009200A1
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Prior art keywords
blood
cerebral vasculature
artery
oxygenated
medium
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PCT/US1999/004345
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English (en)
Inventor
Denise R. Barbut
Russel H. Patterson
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Coaxia, Inc.
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Publication date
Application filed by Coaxia, Inc. filed Critical Coaxia, Inc.
Priority to AU28820/99A priority Critical patent/AU2882099A/en
Priority to EP99909663A priority patent/EP1027097A4/fr
Publication of WO2000009200A1 publication Critical patent/WO2000009200A1/fr

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    • 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
    • A61M1/3621—Extra-corporeal blood circuits

Definitions

  • the present invention relates generally to medical devices and methods. More particularly, the present invention relates generally to methods, systems, and kits for protracting perfusing and optionally cooling the cerebral vasculature of a patient with oxygenated blood or other media.
  • Cerebral ischemia i.e., reduction or cessation of blood flow to the cerebral tissue
  • Focal cerebral ischemia refers to reduced perfusion to the cerebral tissue resulting from a partial or complete occlusion in the intracranial or extracranial cerebral arteries, e.g., stroke, subarachnoid hemorrhage spasms, iatrogenic vasospasm.
  • Global cerebral ischemia refers to reduced perfusion to the cerebral tissue resulting from systemic circulatory failure caused by, e.g., cardiac arrest, shock, circulatory arrest, and septicemia.
  • Cardiac arrest is a major contributor to global cerebral ischemia. Cardiac arrest refers to cessation or significant reduction of a patient's cardiac output and effective circulation to vital organs, most importantly the brain. Cardiac arrest can result from a number of causes, such as electrical dysfunction, mechanical failure, circulatory shock, or an abnormality in ventilation. Within minutes of blood flow cessation, tissue becomes ischemic (oxygen deprived), particularly in the heart and brain. Brain tissue is perhaps most immediately at risk, with severe, irreversible damage occurring minutes after the initial cardiac arrest. Patients in cardiac or circulatory arrest are usually treated by a combination of forced ventilation of the lungs and forced compression of the heart.
  • CPR cardiopulmonary resuscitation
  • ACS Advanced cardiac support
  • open chest massage of the heart may be performed, particularly in a hospital setting where skilled surgeons may be present. Open chest heart massage is probably the most effective technique at resuscitating a patient and avoiding ischemic brain damage, but the technique is quite invasive and not available in most emergency situations.
  • CPR and other techniques which are directed at mechanical heart compression and lung ventilation do not usually provide adequate brain oxygenation.
  • vasoconstrictors e.g., epinephrine
  • conventional cardiac resuscitation techniques will provide no more than 1 /min of total blood circulation (with only about 200 ml/min passing through the cerebral vasculature) and no more than 5 to 15 mmHg of blood pressure.
  • Normal circulation and blood pressure are 5 ilmin and 80 to 100 mmHg, respectively, with about 1 ilmin passing through the cerebral vasculature.
  • Such flows are usually not adequate at normothermia.
  • Even when CPR techniques are applied within the first several minutes of a cardiac arrest the percentage of patients who survive without significant brain damage is very low. Significantly, most patients suffering from cardiac arrest die because of cerebral hypoperfusion.
  • Surgical procedures on the aorta are required for the treatment of a number of conditions, such as aortic aneurysms, occlusional diseases, aortic dissection, and the like.
  • Exemplary procedures include conventional aortic aneurysm repair and grafting, endarterectomy for the treatment of aortic atheroma, stenting for the treatment of aortic atheroma or dissection, and the like.
  • Such procedures frequently require that the aorta be surgically opened to permit reconstruction or other surgical modification.
  • Surgically accessing and opening the aorta will usually further require that the patient's circulation be arrested, i.e., blood flow through the aorta cannot be accommodated while the aorta is being surgically accessed.
  • Cessation of systemic circulation places a patient at great risk, particularly in the cerebral vasculature where ischemia can rapidly lead to irreversible brain damage.
  • a number of techniques have been proposed to at least partially protect a patient having arrested circulation during a variety of aortic procedures. It will be appreciated that conventional cardiopulmonary bypass (CABG) techniques will generally not be useful when the aorta does not remain in tact. Thus, various alternative protective protocols have been proposed.
  • CABG cardiopulmonary bypass
  • Retrograde aortic perfusion can be used when a procedure is being performed on the aorta between the heart and the aortic arch.
  • the aorta is clamped beneath the aortic arch and retrograde aortic perfusion established, typically via femoral access.
  • retrograde perfusion can continue throughout the procedure since the operative site within the aorta is isolated by the clamp.
  • RAP is disadvantageous in a number of respects.
  • retrograde perfusion often results in significant cerebral embolization from dislodgment of atheromatous material in the descending aorta and aortic arch.
  • hypothermic circulatory arrest HCA relies on inducing marked hypothermia in the entire body prior to stopping blood circulation altogether. Circulation remains stopped during the entire aortic procedure, thus placing the patient at significant risk of ischemia (despite the hypothermia).
  • HCA has also been associated with systemic coagulopathy (impaired coagulation) in a significant number of patients. Coagulopathy can require blood and plasma transfusion, both of which have been associated with the risk of viral infection. Aortic surgery performed with HCA has a very high morbidity, typically about 20%.
  • HCA may be combined with retrograde cerebral venous perfusion (RCP).
  • RCP cerebral venous perfusion
  • a catheter is placed in the superior vena cava and oxygenated blood introduced. Flow is established in a retrograde direction up the vena cava into the brachial and jugular veins.
  • very little of the oxygenated blood will reach the cerebral vessels for a number of reasons. For example, as much as 85% of the blood will enter the brachial veins and go to the arms with as little as 205 of the blood entering the brain.
  • the jugular venous valves may inhibit the blood from reaching the cerebral vessels.
  • SCP selective antegrade cerebral perfusion
  • the method and systems of the present invention should be suitable for use with patients undergoing cardiac and vascular procedures where it is desirable to perfuse and/or isolate the cerebral vasculature. At least some of these objectives will be met by the invention of the present application. For these reasons, it would be desirable to provide improved methods, systems, and kits for protecting the brain and cerebral vasculature during the performance of surgical procedures on the aorta. In particular, it would be desirable to provide for cerebral perfusion which is both antegrade and continuous throughout performance of the aortic procedure and which would enable profound cerebral hypothermia without systemic hypothermia. It would be further desirable to provide for improved isolation of the cerebral vasculature. Still more preferably with minimum and ideally no external clamping.
  • a cold oxygenated medium usually autologous blood
  • cerebral vasculature of patients suffering from global ischemia caused by, e.g., cardiac arrest, shock, circulatory arrest, and septicemia; focal ischemia caused by stroke, subarachnoid hemorrhage spasms, iatrogenic vasospasm; or, cerebral edema, e.g., head trauma.
  • the method, systems, and kits are useful not only in providing selective isolated cerebral perfusion during all conditions of cerebral ischemia, but also in reducing the dosage of vasoconstrictors required to achieve a desired perfusion pressure.
  • the methods of the present invention may combine or otherwise rely on cooling of the patient's head and cerebral vasculature in treatment of both global and focal cerebral ischemia to inhibit tissue damage resulting from lack or limitation of cerebral blood circulation.
  • the oxygenated medium which is circulated as part of the methods of the present invention will be cooled in order to cool the brain tissue and reduce the risk of ischemic damage.
  • the patient's head may be cooled even prior to initiating perfusion of externally oxygenated, optionally cooled blood.
  • the cooled blood can be used to externally cool the patient's head during the treatment protocol, e.g., by passing the blood through a helmet or other structure which permits the blood to selectively cool the head. This selective isolated cooling of the head and/or cerebral vasculature is desirable and preferred over systemic cooling, since coagulopathy, poor healing, cardiac arrhythmia and cardiac arrest can ensue as a result of systemic cooling.
  • the methods of the present invention for improving cerebral perfusion comprise accessing at least one extracranial vein, such as the internal jugular vein, the femoral vein, and/or the subclavian vein, and accessing at least one artery which feeds the cerebral vasculature through incisions on any extracranial artery, such as the common carotid artery, the internal carotid artery, the femoral artery, or the subclavian artery.
  • the methods comprise assessing at least one thing at location(s) which drain at least a portion of the cerebral vasculature, such as the internal jugular vein and/or external jugular vein, and assessing at least one artery which feeds the cerebral vasculature through incisions on any extracranial artery, such as the common carotid artery, the internal carotid artery, the femoral artery, or the subclavian artery.
  • access will usually be provided by a percutaneous needle stick as described in more detail below.
  • the access When performed in conjunction with aortic arch or other cardiac surgery, in contrast, the access will usually be provided via surgical exposure of the target vein(s) and artery(ies).
  • a cooled oxygenated medium is flowed from the arterial access location through the cerebral vasculature to the venous access location in order to perfuse the cerebral vasculature with the cooled oxygenated medium.
  • Even cooling only one carotid artery will cool both hemispheres in most patients.
  • Effusate can be re warmed prior to reintroduction of the rest of the body can be kept warm with, e.g., a warming blanket.
  • the vein(s) and artery(ies) are chosen to provide access to at least a major portion of the blood circulation through the cerebral vasculature.
  • Suitable veins include the internal and/or external jugular vein, the superior vena cava, the femoral vein, and the like.
  • Suitable arteries include the common carotid arteries, the external and internal carotid artery, the femoral artery, and the like.
  • Preferred venous access sites lie within the internal jugular vein or femoral vein and preferred arterial access sites lie within the common carotid artery or femoral artery.
  • a flow of cooled oxygenated medium is initiated at a rate sufficient to provide oxygen and to cool the brain tissue to below normal body temperature. Greater benefit is achieved with greater cooling.
  • the rate will depend on the amount of oxygen being carried by the oxygenated medium, typically being in the range from 0.1 ilmin to 1.5 Vmin, typically from 0.2 ilmin to 1 Vmin.
  • the rate will typically be in the range from 0.2 £/min to 1 ⁇ /min; the temperature will be 7°C to 35°C.
  • the access blood vessel(s) near the access sites in order to prevent flow away from the cerebral vasculature. That is, at the venous access site(s), the vein will be occluded in order to inhibit flow caudal to the access location. If the jugular artery is used, it may be desirable to prevent cool blood from entering the rest of the body. If the femoral artery is used, blood will be possibly prewarmed, and no occlusive device is required. At the arterial access site(s), the artery will be occluded to inhibit cold blood from flowing into the aorta.
  • the oxygenated and cooled medium will consist essentially of blood, usually patient autologous blood, and the blood will be recirculated from the venous access location to the arterial access location using a pump. It is not, however, a requirement to pump the oxygenated and cooled medium, as blood can be delivered into an artery after it is taken out of a vein.
  • the oxygenated medium may comprise a synthetic oxygen carrier, such as a perfluorocarbon, or other synthetic blood substitute material.
  • synthetic oxygen carriers may be combined with patient or non- autologous blood.
  • the synthetic oxygen carriers may be pre-oxygenated and flowed through the cerebral vasculature only once. In such cases, a large reservoir of the synthetic oxygen carrier may be provided, passed through the cerebral vasculature, and collected as it passes out of the venous access site. In this instance, it will be removed from the jugular veins and discarded; this requires two carotid arteries and two jugular veins, and is not the preferred method.
  • the synthetic oxygen medium optionally combined with blood, may be extracorporally recirculated and oxygenated as described above for autologous blood.
  • the oxygenated medium may have other biologically active agents combined therewith.
  • drugs and biological agents which inhibit deterioration of brain tissue in cases of limited oxygen supply may be utilized.
  • Such compositions include NMDA receptor-inhibitors, calcium-channel blockers, anticoagulants, glutamate inhibitors, free-radical inhibitors, vasodilators, nitrous oxide and the like.
  • the present invention still further provides improved methods for selective isolated cerebral perfusion in patients with global or focal ischemia.
  • Such improved methods comprise isolating at least a portion of the patient's cerebral vasculature from the remainder of patient circulation, typically by partitioning using occlusion balloons as described in more detail hereinafter.
  • Patient blood is oxygenated and recirculated through the isolated vasculature in order to inhibit ischemia and resulting damage to brain tissue while steps are taken to treat the cardiac arrest.
  • improved antegrade cerebral perfusion or cooling with an oxygenated medium comprises introducing the oxygenated medium, typically autologous blood, to a carotid artery to establish antegrade flow into the cerebral vasculature.
  • the oxygenated medium after it has passed through the cerebral vasculature, is collected through a jugular vein.
  • Such improved methods may be used with both once-through perfusion using a synthetic oxygen carrier and/or heterologous oxygenated blood. More usually, such improved methods will be used with extracorporeal recirculation and oxygenation of autologous blood.
  • Systems according to the present invention for recirculating and oxygenating blood in the cerebral vasculature of a patient comprise a venous cannula, an arterial cannula, a pump, occluding or partial occluding balloons, and an oxygenator.
  • the venous cannula typically has a lumen diameter in the range from 2 mm to 4 mm and may include a distal occlusion balloon for jugulars, wherein the cannula and balloon are sized to access and occlude a vein which drains the cerebral vasculature, typically a jugular vein.
  • the arterial cannula typically has a lumen diameter in the range from 2 mm to 4 mm and also has a distal occlusion balloon, and the cannula and balloon are sized to access and occlude an artery which feeds the cerebral vascular, typically the common carotid artery.
  • the pump may be connected between the venous cannula and the arterial cannula to circulate blood from the venous cannula to the arterial cannula, typically at a flow rate in the ranges determined by the temperature.
  • the oxygenator processes the externally circulating blood to provide a desired degree of oxygenation, also within the ranges set forth above.
  • kits including a venous cannula sized to access a vein which drains the cerebral vasculature and an arterial cannula sized to access an artery which feeds the cerebral vasculature.
  • kits will further include instructions for use according to any of the methods set forth above.
  • the kits may comprise a package for holding all or a portion of the kit components, typically in a sterile condition. Typical packages include trays, pouches, boxes, tubes, and the like.
  • the cannulas will each have an occlusion balloon sized to occlude the respective blood vessel lumen into which they are placed.
  • kit components include oxygenated medium, drugs to be delivered via the flowing blood or other oxygenated medium, catheters for connecting the cannulas to an extracorporeal recirculation oxygenation cooling system, cassettes for use with such extracorporeal recirculation systems, cooling elements, thermometers, pressure transducers, and the like.
  • methods, systems, and kits are provided for isolating and perfusing the cerebral vasculature, usually to facilitate access to a patient's aorta, during performance of a diagnostic or interventional procedure on the aorta, more usually during performance of an open surgical interventional procedure on the aorta, such as repair of an aortic aneurysm, dissections, reconstruction of the aorta, endarterectomy, or the like.
  • the heart will usually be arrested during open surgical procedures where the aorta is opened and procedure is performed within the lumen of the aorta. In some instances, however, the heart may remain beating while the procedure is performed intravascularly, i.e.
  • the methods of the present invention will serve primarily to isolate the cerebral vasculature and prevent gaseous and atheromatous emboli from entering the cerebral vasculature while the vasculature is perfused with an oxygenated medium.
  • Methods according to the present invention comprise internally occluding blood flow to the arterial cerebral vasculature at a location(s) above the aortic arch.
  • blood flow to the right cerebral vasculature will be internally occluded.
  • blood flow to both the right and left cerebral vasculature is internally occluded.
  • Such internal occlusion is usually accomplished using an expansible occluder or partial occluder with central lumen, such as an inflatable balloon positioned at the distal end of a catheter, cannula, or other access device.
  • the access device further provides for perfusion of an oxygenated medium into the occluded artery distal to the point of occlusion, e.g., the device may have a lumen which delivers the medium at a suitable positive pressure.
  • Occlusion of blood flow from the aortic arch and perfusion of oxygenated medium to the arterial cerebral vasculature may be accomplished in a number of ways, e.g., by occluding the right common carotid artery or by occluding an upstream portion of the brachiocephalic artery which-feeds the right carotid artery.
  • the oxygenated medium can be perfused distally of the balloon or other occluding device so that it flows up through the right common carotid artery into the cerebral vasculature.
  • Occlusion of blood flow from the aortic arch and perfusion of oxygenated medium to the left arterial cerebral vasculature may be effected within the left common carotid artery, the left subclavian artery, and/or the left vertebral artery.
  • blood or other oxygenated medium is introduced into the left subclavian artery, it may further be desirable to inhibit blood flow into the arm, e.g., by internally or externally occluding the left subclavian artery at a point which prevents such blood flow.
  • occluding balloons will be positioned within the brachiocephalic artery, the left common carotid artery, and the left subclavian artery. Both the right subclavian artery and the left subclavian artery will be blocked, preferably with external tourniquets on the arms. Blood or other oxygenated medium will then be perfused into the arterial cerebral vasculature to points immediately upstream of each of the occluding balloons, preferably using lumens or other infusion components incorporated within the occluding devices themselves. Inhibition of blood flow down into the arms is beneficial since it redirects the blood or other oxygenated medium back into the cerebral arterial vasculature.
  • any one of the brachiocephalic artery at a point close to the aortic arch and to intravascularly advance an occluding balloon or other devise to a desired point of occlusion.
  • Access to the occlusion site and the target artery may be obtained in a variety of ways.
  • the target artery may be surgically exposed when the chest and neck are opened as part of a procedure being performed on the aortic arch.
  • the target sites can be accessed by conventional cut-down procedure or a needle-based procedure, such as the Seldinger technique.
  • the arterial vasculature can be accessed at a point remote from the desired point of occlusion, e.g. in the femoral artery or in an artery of the arm, such as the axillary or brachial artery.
  • the balloon or other occluding member on the catheter may then be intravascularly advanced from the access location to the desired point of occlusion in a conventional manner, e.g. over a guidewire under fluoroscopic observation.
  • An approach to a desired occlusion point within the brachiocephalic artery and/or the right common carotid artery from an artery in the arm may be preferred since no catheter would be present in the aortic arch itself.
  • the oxygenated medium will usually be blood, more usually being autologous blood obtained from the patient being treated.
  • patient blood will be recirculated through a conventional blood pump and oxygenator so that the patient may be continuously supplied with oxygen in the perfused cerebral vasculature.
  • the blood or other oxygenated medium will also be cooled in order to induce selective hypothermia within the cerebral vasculature.
  • a preferred hypothermic temperature for the brain will be in the range from 7°C to 35°C, more preferably from 9°C to 30°C. The actual temperature which is maintained will depend both on the temperature and the flow rate of the oxygenated medium, with higher flow rates generally requiring less cooling to achieve the target hypothermic temperature.
  • Useful flow rates for the oxygenated medium will be in the range from 300 ml/minutes to 1500 ml/minutes, typically from 400 ml/minute to 1000 ml/minute without hypothermia, and from 80 ml/minute to 600 ml/minute, typically from 150 ml/minute to 400 ml/minute with hypothermia induced in the patient.
  • the patient requires progressively less oxygen with increased hypothermia, allowing the flow rates of oxygenated cooled medium to be decreased.
  • a sufficient flow of the oxygenated medium should be maintained, however, in order to maintain the desired level of hypothermia.
  • Suitable temperatures will be in the range from 8°C to 35°C, typically from 14°C to 30°C. It will be appreciated, of course, that the values of temperature, flow rate, and degree of oxygenation will be quite interdependent in that particular optimum values might be selected for individual patients and/or for different procedures.
  • the methods of the present invention will-find their greatest use in open and thoracoscopic surgical procedures where the aorta is exposed and surgically opened to permit performance of the desired procedure.
  • the heart will be arrested and the perfusion of the oxygenated medium will be relied on to achieve adequate oxygenation of the brain tissue and to avoid deleterious ischemia.
  • the flow rates and temperatures set forth above will be sufficient to both achieve adequate perfusion and avoid ischemia.
  • occlusion of carotid artery(ies) will be maintained for a minimum amount of time after heart function has been reestablished, typically for at least about 2 minutes, preferably for at least about 5 minutes, in order to permit atheromatous debris and air to be cleared from the aorta and away from the brain.
  • Occlusion of the selected arteries with the expansible occluder may be achieved in a variety of ways. Usually, in open surgical procedures, the outside of the target artery(ies) will be surgically exposed, permitting surgical incisions through the arterial wall(s). The expansible occluder may then be introduced through the incision, expanded, and perfusion of oxygenated medium established through the occluder. Alternatively, the expandable occluders may be introduced percutaneously through the patient's neck and to the selected artery(ies) using conventional access techniques, such as the Seldinger technique.
  • the expansible occluders will typically but not necessarily include catheters, cannulas, or other devices which permit the perfusion of the oxygenated medium through the expansible member and into the carotid artery for perfusion of the cerebral vasculature. It will also be possible to utilize separate devices for occlusion and for the perfusion of oxygenated medium. Fore example, it would be possible to employ an external clamp on the target artery and to utilize a separate needle or other cannula for infusion the oxygenated medium upstream of the clamp. The use of clamps, however, is generally not preferred since they can cause the release of significant amounts of atheromatous debris when released.
  • occluder(s) and infusion needles/cannulas where the points of occlusion and infusion of oxygenated medium could be close together or spaced-apart.
  • devices with more than one occlusion balloons and/or more than one infusion lumens in order to occlude and/or infuse oxygenated medium to different points in the vasculature from a single incision site.
  • the occlusion and perfusion devices may be introduced intravascularly through sites remote from the aortic arch.
  • intravascular catheters may be introduced by conventional techniques through the femoral arteries and advanced to the target cerebral arteries using conventional techniques. Such access routes, will necessarily involve passing the catheters through the aortic arch itself. Thus, in many instances, it will be undesirable to use such intravascular techniques since they will lay within the regions where the procedure is being performed. Intravascular access could also be achieved in a retrograde manner through the axillary and brachial arteries as discussed above.
  • the oxygenated medium perfused into the arterial cerebral vasculature will generally flow through the anterior and posterior regions of the brain and into the venous system of the brain. From the venous system, the oxygenated medium will flow outwardly from the brain, primarily from the jugular veins.
  • the oxygenated medium from the brain from at least one of the right and left internal jugular veins, preferably from both internal jugular veins, or from the superior vena cava into which the-jugular veins drain.
  • This blood can then be returned to the extracorporeal blood pump, oxygenated, and cooled before return to the patient's arterial cerebral vasculature.
  • a very small portion of the blood or other oxygenated medium perfused into the brain through the cerebral arteries may leak back into the aortic arch through the left vertebral artery if the left subclavian artery is not occluded. This leakage, typically in an amount from 5 ml/minute to 25 ml/minute, can be suctioned or otherwise collected by the surgeon and returned to the extracorporeal circulation system.
  • the brain and cerebral vasculature are at greatest risk from embolization and ischemia during the performance of aortic procedures which require arresting of the heart.
  • Other portions and tissues within the body are also at significant risk and in some cases it may be desirable to establish a perfusion of oxygenated medium through the noncerebral vasculature, in particular the vasculature in the lower portion of the patient's body.
  • oxygenated blood or other medium can be introduced into the aorta below the aortic arch, where the aortic arch is isolated using an expansible occluder or other conventional occlusion device.
  • the oxygenated medium will thus flow to the lower portion of the patient's body where it will collect in the venous system and be returned towards the patient's heart through the inferior vena cava.
  • the blood or other oxygenated medium may be collected and returned to an extracorporeal oxygenation, pumping, and optional cooling circuit.
  • kits including one or more expansible occluders adapted to occlude selected artery(ies) as described above.
  • kits will further include instructions for use according to any of the methods set forth above.
  • the kit may comprise a package for holding all or a portion of the kit components, typically in a sterile condition. Typical packages include trays, pouches, boxes, tubes, and the like.
  • the cannulas will each have an occlusion balloon sized to occlude the respective blood vessel lumen into which they are placed.
  • kit components include oxygenated medium, drugs to be delivered via the flowing blood or other oxygenated medium, catheters for connecting the cannulas to an extracorporeal recirculation oxygenation cooling system, cassettes for use with such extracorporeal recirculation systems, cooling elements, thermometers, pressure transducers, and the like.
  • FIG. 1 is a schematic illustration of a patient's head illustrating arterial and venous access sites suitable for use in the methods of the present invention.
  • Figs. 2A and 2B illustrate the use of a pair of access cannulas for perfusing oxygenated medium through the cerebral vasculature of a patient according to the methods of the present invention.
  • Fig. 3 illustrates a preferred system constructed in accordance with the principles of the present invention.
  • Fig. 4 illustrates an exemplary kit constructed in accordance with the principles of the present invention.
  • Fig. 5 illustrates the great vessels that exit and enter the heart and which are relevant to the occlusion and circulation patterns of the present invention.
  • Figs. 6A-6E illustrate the use of differing arrangements of expansible occluders for occluding and directing the flow of oxygenated medium to the cerebral arteries according to the methods of the present invention.
  • Fig. 7 illustrates the occlusion pattern of Fig. 6, with further occlusion of the internal jugular veins to collect oxygenated medium flowing from the venous structure of the brain.
  • Fig. 8 illustrates an alternate occlusion pattern for collecting oxygenated medium from the brain, where the superior vena cava is occluded and all medium flowing into the superior vena cava collected.
  • Fig. 9 illustrates an occlusion pattern according to the present invention where the lower vasculature of the patient is occluded and perfused with oxygenated medium.
  • Fig. 10 is a schematic illustration of a patient undergoing an aortic procedure with an oxygenated medium being supplied according to the scheme set forth in Figs. 8 and 9.
  • Fig. 11 illustrates a kit constructed in accordance with the principles of the present invention.
  • the cerebral vasculature includes all arteries and veins leading into or from the patient's head, particularly including the common carotid arteries, the external and internal carotid arteries, and all smaller arteries which branch from the main arteries leading into the head. In some cases, particularly in open surgical procedures, access may be established in the aortic arch and innominate (brachycephalic trunk) artery as well. Cerebral veins include the external and internal jugular veins, the superior vena cava, and the smaller veins which feed into the primary veins draining the cerebral vasculature.
  • Preferred access points should be at locations in the vasculature which permit relatively direct percutaneous introduction of a needle, cannula, or other access conduit through which the flow of oxygenated medium will be established.
  • Exemplary access sites are in those regions of the internal jugular vein IJV and common carotid artery CCA which are readily located and accessed through a patient's neck, as illustrated in Fig. 1.
  • Suitable perfusion pressures are in the range from 250 mmHg, preferably from 30 mmHg to 160 mmHg.
  • the ipsilateral hemisphere will thus be perfused in an antegrade direction while the contralateral hemisphere and territories supplied by the posterior circulation will be perfused in a retrograde direction.
  • the blood will then flow into the cerebral venous vasculature from where it may be collected at one or two venous access sites. In this way, the entire brain can be perfused with oxygenated and optionally cooled blood or other oxygenated medium.
  • Figs. 2A and 2B access will usually be established using cannulas 10 and 20, each having inflatable isolation balloons 12 and 22 near their distal ends, respectively.
  • the cannulas 10 and 20 are needles having sharpened distal tips such that the needles may be penetrated through the patient's skin S without the need to employ separate stylets, needles, or other access means.
  • the treating personnel are thus able to locate the appropriate access points on the patient's neck or other location and directly introduce the cannulas 10 and 20 so that their distal tips lie within the lumens of the artery A and vein V, respectively.
  • the treating professional may access the artery and/or vein through a small incision or puncture allowing introduction of a blunt cannula or other access tube.
  • the balloons 12 and 22 will be inflated, as illustrated in Fig. 2B.
  • the balloons 12 and 22 partition the cerebral vasculature so that oxygenated medium introduced through the arterial cannula 10 will travel upwardly into the cerebral vasculature and will be inhibited from flowing downwardly to the arterial system below the head.
  • the balloon 22 on the venous cannula 20 will prevent the outflow of blood or other oxygenated medium from the cerebral vasculature from flowing downwardly from the head, allowing efficient collection of the outflow by the cannula 20.
  • Either or both of catheters 10 and 20 may be further equipped with a second lumen which terminates distally at suction port 13 and 23, respectively.
  • suction port 13 can remove carotid debris after balloon inflation.
  • the methods of the present invention may rely on providing relatively large volumes of oxygenated medium, such as a pre-oxygenated carrier, such as a perfluorocarbon, or pre-oxygenated heterologous blood, and flowing the oxygenated medium through the arterial cannula 10, through the cerebral vasculature, and out the venous cannula 20 in a once-through manner. The oxygenated medium passing out of the venous cannula will not be recirculated.
  • a pre-oxygenated carrier such as a perfluorocarbon, or pre-oxygenated heterologous blood
  • the methods of the present invention will rely on circulating the oxygenated medium from the venous cannula 20 back to the arterial cannula 10.
  • a system 50 as illustrated in Fig. 3.
  • the system 50 includes a pump 52, typically a peristaltic pump, a cooler 54, a temperature gauge 56, and a port 58 for infusing cerebral protective agents and/or other drugs or biologically active substances.
  • a pump 52 typically a peristaltic pump
  • a cooler 54 typically a temperature gauge 56
  • a port 58 for infusing cerebral protective agents and/or other drugs or biologically active substances.
  • Such systems are analogous to the cardiopulmonary bypass systems used in heart and vascular surgery. Suitable portable bypass pumps and oxygenators are described in U.S.
  • the systems described in these patents, however, are generally intended for maintaining artificial circulation through all or a substantial portion of the patient's entire vasculature.
  • the systems of the present invention will generally be modified to provide blood or other oxygenated medium at lower flow rates within the ranges set forth above.
  • Optional features of the cannulas 10 and 20 illustrated in Fig. 3 include separate inflation conduits 13 and 23 for inflating balloons 12 and 22, respectively.
  • the inflation conduits may be connected to syringes or other conventional devices for selectively inflating the balloons after the cannulas 10 and 12 have been properly positioned within the target blood vessels.
  • ports 14 and 24 may be provided near the sharpened distal tips of the cannulas 10 and 12, respectively.
  • the distal tips of the cannulas could simply have a chamfered, sharpened distal tip where flow passes directly out the tip.
  • the cannulas 10 and 12 could be provided with simple stylets which permit self- introduction. After introduction, the stylets could be quickly removed to provide an open flow lumen at the tip.
  • kits according to the present invention will comprise at least cannulas 10 and 20 and instructions for use (IFU) 75.
  • the cannulas 10 and 20 will be suitable for connection to an extracorporeal flow system 50, or for connection to a reservoir of oxygenated medium, depending on the intended use.
  • the instructions for use 75 will set forth any of the methods described above.
  • the catheters 10 and 20 and instructions for use 75 will be packaged together in a suitable package 80, such as a pouch, tray, box, tube, or the like, optionally, the instructions for use may be printed in whole or in part on a portion of the packaging 80.
  • a suitable package 80 such as a pouch, tray, box, tube, or the like
  • the instructions for use may be printed in whole or in part on a portion of the packaging 80.
  • at least the catheters 10 and 20 will be sterilely maintained within the package 80.
  • kits components which could be placed within the package 80 include oxygenated medium, cerebral protective agents and/or other drugs, additional catheters for connecting the cannulas to system 50 or other extracorporeal apparatus, replaceable cassettes for system 50 which permit replacement of all system components which directly contact the blood, and the like.
  • Oxygenated blood from the heart normally flows upwardly through the aortic arch and then downward to the lower portions of the body through the thoracic aorta.
  • Three major arteries extend upwardly from the top of the aortic arch.
  • the brachiocephalic artery branches into the right carotid artery and the right subclavian artery.
  • the left carotid artery and left subclavian artery extend directly from the aortic arch and do not have a common portion. Together, the right common carotid artery and left common carotid artery provide oxygenated blood to most parts of the head and neck.
  • the methods of the present invention will rely on internally occluding blood flow from the aortic arch to at least one common carotid artery, and preferably both common carotid arteries.
  • Occlusion of blood flow from the aortic arch to the right common carotid artery may be effected by occluding the blood flow lumen in the brachiocephalic artery and/or the right common carotid artery itself.
  • Occlusion of the left common carotid artery will take place in a lumen of the left common carotid artery itself, and optionally either or both of the right and left vertebral arteries may also be directly or indirectly occluded.
  • Blood or other oxygenated medium will be provided to the cerebral arterial vasculature through at least some of the occluded arteries by perfusing a medium to the artery(ies) at a point distal to the occlusion.
  • the carotid arteries supply most of the blood flow to the brain, it will not be necessary to occlude the vertebral arteries and/or provide oxygenated blood to the brain through the vertebral arteries. While some leakage of blood back to the aorta may occur through the vertebral arteries, such leakage is minor and can be removed from the aortic arch using conventional suction devices.
  • an occlusion balloon could be located within the lumen of the right subclavian artery to point downstream from the right vertebral artery branch.
  • a catheter having a pair of balloons could be used, where one balloon occludes within the brachiocephalic artery and a second, more distal balloon occludes within the right subclavian artery.
  • Occlusion of the left vertebral artery may be effected in either the left subclavian artery, usually at a point near the branch with the aortic arch, or within the left vertebral artery itself. Occlusion within the left subclavian artery is generally preferred since it will inhibit passage of atheromatous material into the entire arterial structure branching from the left subclavian artery. Moreover, by perfusing oxygenated medium beyond the point of occlusion, that medium will flow into the left vertebral artery to supply the left cerebral arterial vasculature. Loss of blood to the patient's arm can be inhibited by applying a tourniquet to the left arm.
  • the venous system of the brain drains primarily through the right internal jugular vein and the left-internal jugular vein. These veins, in turn, drain into the superior vena cave where the oxygen-depleted blood is returned to the heart. Blood supplied to the lower body through the thoracic aorta returns to the heart through the inferior vena cava.
  • a first exemplary method for accessing an aorta comprises internally occluding the right common carotid artery at a point above the aortic arch.
  • the occlusion may be achieved using expansible occluders, such as balloon-tipped cannula 10 which is placed in a lumen of the right common carotid artery.
  • the balloon may be any conventional type of balloon commonly used for blood lumen occlusion, e.g., being elastomeric balloons having a generally spherical geometry.
  • the balloons will be expandable to a size in the range from 3 mm to 20 mm, typically at a relatively low inflation pressure on the order of 2 atmospheres to 5 atmospheres.
  • the expansible occluders may be introduced surgically, percutaneously, or intravascularly, as discussed above.
  • the surgeon accessing the aorta will extend the incision so that the exterior surfaces of each carotid artery are exposed.
  • a small surgical incision can then be made and the exposed wall of the artery and the occlusion balloon introduced in a conventional manner.
  • the balloon may be percutaneously introduced via a cut-down procedure or using a needle, guidewire, and appropriate insertion sheath using conventional techniques, such as the Seldinger technique.
  • the oxygenated medium may be introduced through the cannula, typically within the flow rate and temperature ranges set forth above. It will also be desirable to monitor and control the pressure of the oxygenated medium being introduced.
  • the blood may be introduced in a continuous, non-pulsatile flow.
  • the oxygenated medium will be provided only to the right arterial cerebral vasculature.
  • those arteries are placed at risk at receiving atheromatous material, particularly when heart function is reestablished.
  • Oxygenated medium may then be perfused through either or both of the cannulas 10 and 12, preferably through both.
  • cannulas 10, 12, 14, and 16 may be disposed within the lumens of the right common carotid artery, left common carotid artery, right vertebral artery, and left vertebral artery, respectively, as shown in Fig. 6C.
  • Such an arrangement is advantageous because it both reduces the risk of entry of atheromatous material into the cerebral vasculature and provides for multiple access points for introducing oxygenated medium to the cerebral vasculature.
  • cannulas shown in Fig. 6C is not optimum for at least two reasons. First, it requires the use of four separate cannulas. Second, atheromatous material from the aortic arch can enter both the right subclavian artery and the left subclavian artery since the entry points to these arteries are not occluded. Thus, an improved arrangement of multiple cannulas is shown in Fig. 6D. There, a first balloon-tipped cannula 100 is placed into the brachiocephalic artery and positioned to perfuse oxygenated medium to the cerebral vasculature through both the right common carotid artery and right vertebral artery.
  • Loss of oxygenated medium to the right arm may be inhibited by placing a tourniquet 102 on the arm.
  • a second balloon-tipped catheter 12 may be placed in the left common carotid artery, generally as described above.
  • a third balloon-tipped catheter 104 is placed in the left subclavian artery relatively near the branch point from the aortic arch. Placement near the aortic arch branch will enhance the isolation of the arterial system branching from the left subclavian artery.
  • oxygenated medium perfused distally of the balloon-tipped cannula 104 will flow upwardly through the left vertebral artery into the left cerebral arterial vasculature. Loss of such oxygenated medium may be inhibited by placing a second tourniquet 106 on the patient's left arm.
  • the balloon-tipped cannulas have included only single balloons and have been introduced through the vascular wall at a point immediately adjacent to the point of occlusion. As discussed above, however, the cannulas need not be introduced adjacent to the point of occlusion nor do they need to be simple, single-balloon catheters.
  • An alternative balloon-tipped catheter arrangement employing a cannula 120 having a pair of a balloons 122 and 124 as illustrated in Fig. 6E.
  • the cannula 120 may be introduced in a retrograde fashion through the right subclavian artery, optionally from an artery of the arm, such as the axillary artery or the brachial artery.
  • the cannula 120 is advanced so that the distal-most balloon 124 is disposed within the lumen of the brachiocephalic artery.
  • By inflating the balloon 124 blood flow from the aortic arch to the vasculature above the brachiocephalic artery is occluded.
  • By inflating balloon 122 blood flow through the right subclavian artery at points distal to the branch of the right vertebral artery is also occluded.
  • Perfusion ports 123 are provided on the cannula 120 between the distal-most balloon 124 and second balloon 122, and oxygenated medium may be introduced through the perfusion ports to flow to both the right vertebral artery and the right common carotid artery.
  • the second balloon-tipped catheter 12 will be disposed within the left common carotid artery and further optionally (although not shown) one or more balloon-tipped catheters may be used to occlude flow to the left vertebral artery, as shown in either Figs. 6C or 6D.
  • the oxygenated medium is autologous patient blood, it will be necessary to collect at least a portion of the oxygen-depleted blood after it has passed through the cerebral vasculature and to return that blood to the patient after filtering, reoxygenation, and optional cooling.
  • the blood may be collected in the venous vasculature which drains the brain, typically by placing a pair of expansible occluders 20 and 22 into the right internal jugular vein and left internal jugular vein, respectively, as illustrated in Fig. 7.
  • the expansible occluder 20 and 22 may be constructed similarly to the expansible occluders 10 and 12, but will include distal tips 24 and 26, respectively, having a plurality of ports adapted to collect the oxygen depleted blood as it flows toward the heart.
  • the superior vena cava may be blocked with a single expansible occluder 30, as illustrated in Fig. 8.
  • the blood or other oxygen depleted medium collected in the venous side of the vasculature will be returned to an extracorporeal system for reoxygenation, pumping, and optional cooling, as will be described in more detail in connection with Fig. 10 below.
  • the expansible occluders 20, 22, and 30, will be sized and adapted to be surgically or percutaneously introduced to the associated vein.
  • the present invention also provides for optional perfusion of non-cerebral portions of the patient vasculature, particularly the lower body vasculature as illustrated in Fig. 9.
  • the lower body vasculature may be perfused by introducing blood or other oxygenated medium into the descending aorta using an expansible occluder 40, typically a balloon catheter, optionally a balloon catheter adapted for introduction through the femoral artery in a conventional manner.
  • the expansible occluder 40 will include flow ports, which are disposed below the balloon when a catheter is placed within the thoracic aorta.
  • the oxygenated medium will flow downwardly from the balloon into the lower arterial vasculature.
  • the oxygen depleted blood or other medium will flow into the venous system and ultimately upwardly through the inferior vena cava.
  • an expansible occluder 50 within the lumen of the inferior vena cava may be occluded and the return blood flow collected.
  • the collected blood may then be circulated through an extracorporeal recirculation system, as described in more detail in connection with Fig. 10.
  • a patient P is undergoing an open surgical procedure through a sternotomy S which exposes the aortic arch AA and the superior vena cava SVC.
  • Expansible occluders 10 and 12 are then placed into the right and left common carotid arteries, respectively, and connected brachiocephalic to an extracorporeal oxygenator and pump 70.
  • Expansible occluder 30 (as illustrated in Fig. 8) is introduced to the superior vena cava SVC and also connected to the external oxygenator and pump 70.
  • Blood is introduced to the common carotid arteries through the expansible occluders 10 and 12 and return to the external oxygenator and pump through the expansible occluder 30.
  • a reservoir of blood is maintained within the external oxygenator and pump 70 so that sufficient blood will remain in circulation even as a certain amount of blood is lost since it flows outwardly to points other than the superior vena cava.
  • perfusion and oxygenation of the lower portion of the patient P is accomplished using expansible occluders 40 and 50 which are introduced intravascularly according to conventional techniques, such as the Seldinger technique.
  • expansible occluders 40 and 50 which are introduced intravascularly according to conventional techniques, such as the Seldinger technique.
  • the cerebral vasculature and lower body vasculature may be continuously perfused with oxygenated blood while blood is kept out of the aorta and the aorta may be opened for performing a desired procedure.
  • the patient's heart will be arrested using conventional techniques.
  • the hear will be catheterized and cooled, and supplied with cardioplegia, according to known techniques.
  • the aorta typically at the aortic arch, may then be opened and a desired procedure performed.
  • cardioplegia will be stopped-the heart will be warmed, and heart function reestablished.
  • a particular advantage of the present invention is that the cerebral vasculature may continue to be isolated during the period immediately following cessation of bypass and reestablishment of heart function. It will be appreciated that any procedure performed in and around the aorta may leave significant debris in the aortic lumen presenting a substantial risk of embolization to the patient.
  • kits according to the present invention will comprise at least one expansible occluder 10, usually comprising at least two expansible cannulas 10 and 12, as illustrated, instructions for use (IFU) 75.
  • the expansible occluders 10 and 12 will be suitable for connection to an extracorporeal flow system 70 (Fig. 10), or for connection to a reservoir of oxygenated medium, depending on the intended use.
  • the instructions for use 75 will set forth any of the methods described above.
  • the expansible occluders 10 and 12 and instructions for use 75 will be packaged together in a suitable package 80, such as a pouch, tray, box, tube, or the like.
  • the instructions for use may be printed in whole or in part on a portion of the packaging 80.
  • at least the expansible occluders 10 and 12 will be sterilely maintained within the package 80.
  • kit components which could be placed within the package 80 include oxygenated medium, cerebral protective agents and/or other drugs, additional catheters for connecting the cannulas to system 70 or other extracorporeal apparatus, replaceable cassettes for system 70 which permit replacement of all system components which directly contact the blood, and the like.

Abstract

Les patients chez qui la circulation du système vasculaire cérébral est ralentie à la suite d'un ictus, en raison d'un arrêt cardiaque, d'un choc ou d'un traumatisme crânien ou du fait d'une intervention chirurgicale sur un anévrisme ou l'aorte, subissent un traitement consistant à irriguer avec un milieu oxygéné un site d'accès artériel dans le site veineux du système vasculaire cérébral et à recueillir ledit milieu par un site d'accès du site veineux du système vasculaire cérébral. Habituellement, le milieu oxygéné froid contient du sang autologue et le sang est remis en circulation pendant un laps de temps suffisant pour permettre le traitement de la cause profonde du ralentissement de la circulation. Le sang remis en circulation est non seulement oxygéné mais également refroidi pour permettre un traitement hypothermique destiné à sauvegarder le tissu cérébral. On met en oeuvre l'isolement et le refroidissement du système vasculaire cérébral chez les patients qui subissent une intervention chirurgicale de l'aorte ou autre en provoquant une occlusion interne d'au moins l'artère carotide commune droite au dessus de l'arc aortique et en effectuant une perfusion de sang afin d'irriguer le système vasculaire cérébral artériel.
PCT/US1999/004345 1998-08-12 1999-02-26 Procedes et appareil intravasculaires permettant d'isoler et de refroidir selectivement le systeme vasculaire au cours d'interventions chirurgicales WO2000009200A1 (fr)

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AU28820/99A AU2882099A (en) 1998-08-12 1999-02-26 Intravascular methods and apparatus for isolation and selective cooling of the cerebral vasculature during surgical procedures
EP99909663A EP1027097A4 (fr) 1998-08-12 1999-02-26 Procedes et appareil intravasculaires permettant d'isoler et de refroidir selectivement le systeme vasculaire au cours d'interventions chirurgicales

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US9621898P 1998-08-12 1998-08-12
US60/096,218 1998-08-12
US25696599A 1999-02-24 1999-02-24
US09/256,965 1999-02-24

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Publication number Priority date Publication date Assignee Title
EP2286866A2 (fr) * 2001-08-22 2011-02-23 Gore Enterprise Holdings, Inc. Appareil et procédés permettant de traiter les accidents vasculaires cérébraux et de contrôler les caractéristiques du débit sanguin cérébral

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