EP1255582A1 - Catheter a ballonnet intra-aortique dote de caracteristiques de positionnement et de stabilite ameliorees - Google Patents

Catheter a ballonnet intra-aortique dote de caracteristiques de positionnement et de stabilite ameliorees

Info

Publication number
EP1255582A1
EP1255582A1 EP01905354A EP01905354A EP1255582A1 EP 1255582 A1 EP1255582 A1 EP 1255582A1 EP 01905354 A EP01905354 A EP 01905354A EP 01905354 A EP01905354 A EP 01905354A EP 1255582 A1 EP1255582 A1 EP 1255582A1
Authority
EP
European Patent Office
Prior art keywords
lumen
catheter
distal
balloon
blood
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP01905354A
Other languages
German (de)
English (en)
Inventor
Larry F. Mager
Jerome B. Riebman
Raymond S. Bertolero
Arthur A. Bertolero
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Endoscopic Technologies Inc
Original Assignee
Endoscopic Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Endoscopic Technologies Inc filed Critical Endoscopic Technologies Inc
Publication of EP1255582A1 publication Critical patent/EP1255582A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0029—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/279—Peristaltic pumps, e.g. roller pumps
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/35—Medical purposes thereof other than the enhancement of the cardiac output for specific surgeries, e.g. for Fontan procedure
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/274—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/833—Occluders for preventing backflow

Definitions

  • This invention relates to an improved multi-lumen balloon catheter for blocking the ascending aorta and delivering blood in a heart-surgery patient.
  • the human heart is a muscular pump having four separate cavities and a series of valves allowing blood to pass in one direction only. Mammals, including humans, have a double circulatory system. Blood that has released oxygen to the tissues (9 and 14) and has absorbed carbon dioxide from them (venous blood) is returned to the heart through the superior and the inferior venae cavae (11 and 10). This blood enters the right auricle (3), whose contractions cause the blood to pass through the tricuspid valve (16) in the right ventricle (1).
  • the contractions of the right ventricle pass the blood through the pulmonary semilunar valves (17) and along the two pulmonary arteries (5) into the lungs (6).
  • the blood is oxygenated and returns to the heart through the pulmonary veins (7) and thus enters the left auricle (4).
  • This chamber contracts and passes the blood through the bicuspid, or mitral, valve (15) into the left ventricle (2), whose contractions force the blood through the aortic semilunar valve (18) into the aorta (12 and 13), which is the biggest artery of the body and to other parts of the body through, i.e., the great arteries 8.
  • the right side of the heart serves mainly to pump deoxygenated blood through the lungs, while the left side pumps oxygenated blood throughout the rest of the body.
  • This is represented as a flow schematic in Figure 2, where similar numbers refer to similar parts of the heart.
  • the heart varies the output by varying the volume of blood admitted into the ventricles each time the latter are filled and also by varying the rate of contraction (faster or slower heartbeat).
  • the left side of the heart (left auricle and ventricle) has to circulate the blood through all parts of the body, except the lungs, and has thicker and more strongly muscular walls than the right side, which has to perform the pulmonary blood circulation only.
  • the left side and the right side must be accurately interadjusted, both with regard to the contraction rate of the respective chambers and with regard to the output of blood.
  • functional disorders of the heart it may be necessary to examine the heart to determine the problem and possibly perform surgery or provide treatment.
  • the types of examinations, treatments and operations that require some degree of cardioplegia or drug delivery and extracorporeal blood circulation include open heart surgery and less-invasive heart surgery to perform single or multiple coronary artery bypass operations, correct malfunctioning valves, etc. Others include, but are not limited to, myocardial revascularization, balloon angioplasty, correction of congenital defects, surgery of the thoracic aorta and great vessels, and neurosurgical procedures.
  • the extracorporeal blood circulation generally requires the use of some type of heart-lung machine, i.e., a cardiopulmonary machine. This has the threefold function of keeping the replacement blood in circulation by means of a pumping system, of enriching with fresh oxygen the blood of low oxygen content coming from the patient's body, and regulation of patient temperature.
  • the system shown in Figure 3 diagrammatically describes the manner in which such a machine works.
  • the venous blood, before it enters the right auricle of the heart is diverted into plastic tubes (20), generally by gravity flow.
  • the tubes are positioned to receive the blood from the superior and inferior venae cavae (shown as 11 and 10 in Figure 1).
  • This blood which has circulated through the body and consequently has a low oxygen content is collected in a reservoir (21).
  • a blood pump (22) is used to pump the blood through a heat exchanger (23) and artificial lung (24).
  • the heat exchanger (23) and artificial lung (24) may be one of several designs to regulate blood temperature and increase the oxygen content of the blood. Modern designs use advanced membrane technology to achieve the oxygenation, which is similar to the way red blood cells absorb oxygen from the human lung.
  • the oxygenated blood then passes through a filter (25) and is returned to the patient. Losses of blood occurring during the course of the operation are compensated by an additional blood reservoir (26). Collected blood is passed through a defoamer (27) and is likewise passed to the reservoir 21, heat exchanger (23) and artificial lung (24). Before starting the cardiopulmonary bypass machine the extracorporeal circuit is filled with one or two liters of saline solution. In circulating the oxygenated blood to the body from filter 25, it can be pumped through a line 28 by attaching the line to a catheter leading into the aorta or one of its major branches and pumping the blood through the catheter. However, when the heart is to be operated on, it must be free of blood and sometimes the heart beat must be reduced or stopped completely.
  • blood is prevented from entering the heart by blocking the ascending aorta 12 near the semilunar valve 18 while at the same time preventing blood from entering the right auricle 3 by withdrawing blood through the superior vena cavae 11 and inferior vena cavae and 10.
  • Blocking the ascending aorta may be achieved by clamping or preferably by balloon blockage.
  • a cardioplegia solution is administered locally to the heart to arrest the heart.
  • This patent describes a process for inducing cardioplegic arrest of a heart which comprises maintaining the patient's systemic circulation by peripheral cardiopulmonary bypass, occluding the ascending aorta through a percutaneously placed arterial balloon catheter, venting the left side of the heart, and introducing a cardioplegia agent into the coronary circulation.
  • a multichannel catheter is disclosed which provides channels for the cardioplegia solution, a fluid transportation to inflate the balloon and a lumina for instrumentation.
  • Further patents in this family include U.S. 5,725,496 and U.S. 5,971,973. Another example of a device is found in U.S. Pat. No. 5,478,309 issued 26
  • the devices disclosed have certain shortcomings that can be improved upon.
  • some of the designs of the balloon catheters can result in kinking of the line as it transcends the aortic arch to position the balloon. All of the designs use a catheter that is of the same cross-sectional diameter for the length of the catheter.
  • Some of the references suggest shaping (i.e., prebending) the distal end of the catheter on the theory that the shaping or precurving the catheter will aid in getting the tip to more easily transcend the aortic arch. This requires, however, that a straightening guide wire be used to keep the shaped distal end straight as it is pushed along the femoral artery towards the aortic arch.
  • the wire is withdrawn as it reaches the aortic arch to allow the shaped distal end to go around the arch. It has been discovered, however, that such shaping can have an adverse effect on positioning the balloon in the aortic arch — instead of centering the balloon, it tends to position off center and not properly block the arch.
  • One aspect of this invention is a balloon catheter for delivering blood to an animal while blocking the aortic arch between the great arteries and the coronary ostia.
  • the balloon catheter has a distal portion conjoined with a proximal portion.
  • the distal portion comprises:
  • the second lumen having an opening at the proximal end of the shaft and an opening in fluid communication with the interior of the inflatable balloon, and (e) the shaft having a non-traumatic distal tip and a length sufficient to traverse the aortic arch of a human.
  • the proximal portion comprises a multi-lumen blood delivery portion having distal and proximal ends and being conjoined with the proximal end of the shaft at the distal end of the multi-lumen blood delivery portion.
  • the multi-lumen blood delivery portion further comprises:
  • a first lumen defined by a surrounding wall extending the length of the multi-lumen portion and being closed at its distal end but open at its proximal end for receiving extracorporeal blood from a cardiopulmonary machine
  • a second lumen extending the length of the multi-lumen portion parallel to the first lumen but independent thereof and (ii) open at its distal end
  • third lumen that (i) is independent of and parallel to the first and second lumens, (ii) extends the length of the three-lumen portion, and (iii) is open at the distal end of the third lumen, wherein a plurality of outlet ports extend along the wall at the distal region of the proximal portion, the ports being in fluid communication solely with the interior of the first lumen.
  • proximal end of the distal portion is conjoined with the distal end of the proximal portion so that the first lumen of the distal portion is in fluid communication solely with the second lumen of the proximal portion and the second lumen of the distal portion is in fluid communication solely with the third lumen of the proximal portion.
  • Another aspect of this invention is a method for preparing a balloon catheter of this invention. The method comprises:
  • an elongated, flexible shaft having distal and proximal ends and further having at least two lumens extending about the length of the shaft independent of and parallel to each other,
  • the second lumen having an opening at the proximal end of the shaft and an opening in fluid communication with the interior of the inflatable balloon
  • the shaft having a non-traumatic distal tip and a length sufficient to traverse the aortic arch of a human
  • preparing a proximal portion of the catheter that comprises a multilumen blood delivery portion having distal and proximal ends and being suitable for conjoining with the proximal end of the shaft of (A) at the distal end of the multilumen blood delivery portion.
  • a multilumen blood delivery portion further comprises
  • a first lumen defined by a surrounding wall extending the length of the multi-lumen portion and being closed at its distal end but open at its proximal end for receiving extracorporeal blood from a cardiopulmonary machine
  • a second lumen extending the length of the multi-lumen portion parallel to the first lumen but independent thereof and (ii) open at its distal end
  • third lumen that (i) is independent of and parallel to the first and second lumens, (ii) extends the length of the three-lumen portion and (iii) is open at the distal end of the third lumen, wherein a plurality of outlet ports extend along the wall of the first lumen at the distal portion of the proximal portion, the ports in fluid communication solely with the interior of the first lumen; and (C) aligning the proximal end of the distal portion with the distal end of the proximal portion so that the first lumen of the distal portion aligns with the second lumen of the proximal portion and the second lumen of the distal portion aligns with the third lumen of the proximal portion; and (D) permanently conjoining the distal and proximal portions together so that the lumens aligned in part (C) above are in fluid communication with the other.
  • the first multi-lumen balloon catheter comprises: an elongated, flexible shaft having distal and proximal ends and further having at least two lumens extending about the length of the shaft independent of and parallel to each other, the first lumen having an opening at both the distal and proximal ends of the shaft, an inflatable balloon integrated into the shaft near the distal end of the shaft, a second lumen having an opening at the proximal end of the shaft and an opening in fluid communication with the interior of the inflatable balloon, the distal tip of the shaft having a blunt, nontraumatic design, and the shaft having a length sufficient to traverse the aortic arch of a human.
  • Still another aspect of this invention is multi-lumen blood delivery catheter having distal and proximal ends and being suitable for conjoining with multi-lumen shaft at the distal end of the first multi-lumen catheter, wherein the other multi-lumen shaft has at least one less lumen than the first multi-lumen catheter.
  • the multi-lumen blood delivery catheter comprises:
  • third lumen that (i) is independent of and parallel to the first and second lumens, (ii) extends the length of the multi-lumen catheter and (iii) is open at its distal end, wherein a plurality of outlet ports extend along the wall at the distal portion of the three-lumen catheter, the ports in fluid communication solely with the interior of the first lumen.
  • Another aspect of this invention is a balloon catheter for delivering blood to an animal while blocking the aortic arch between the great arteries and the coronary ostia.
  • the balloon catheter is designed for insertion through the base of a patient's aortic arch.
  • the catheter comprises a distal blood delivery section and proximal blood transport section.
  • the proximal blood transport section has distal and proximal ends and is conjoined with the proximal end of the distal blood delivery section at the distal end of the blood transport section.
  • the blood transport section further comprises (a) a first blood transport lumen defined by a surrounding wall extending the length of the blood transport section open at its proximal end for receiving extracorporeal blood from a cardiopulmonary machine and being open at its distal end, (b) a second lumen (i) extending the length of the blood transport section parallel to the first lumen but independent thereof and (ii) open at its distal end for delivering cardioplegia solution to the heart near the aortic root, and (c) third lumen that (i) is independent of and parallel to the first and second lumens, (ii) extends the length of the three-lumen portion, (iii) is open at its distal end, and (iv) communicates with the interior of an inflatable balloon integrated into the distal region of the blood transport section.
  • a first blood transport lumen defined by a surrounding wall extending the length of the blood transport section open at its proximal end for receiving extracorporeal blood from a cardiopulmonary machine and being open at its distal end
  • the distal blood delivery section comprises an extension of the first lumen of the blood transport section, the extension (i) being of a length to traverse at least a portion of the aortic arch, (ii) being in fluid communication with the first blood transport lumen, an (iii) having a plurality of outlet ports for delivery of blood in an antegrade fashion to the aorta.
  • the proximal end of the distal blood delivery section is conjoined with the distal end of the proximal blood transport section so that the extension of the first lumen is in fluid communication solely with the blood transport lumen of the proximal portion.
  • Still another aspect of the invention is a method of performing cardiovascular surgery on a patient having a need thereof using the balloon catheter for aortic insertion.
  • the method comprises (A) inserting the balloon catheter as described immediately above into the patient through the patient's aortic artery to position the balloon catheter so that the balloon is positioned in the ascending aorta between the patient's coronary ostia and great arteries and the blood delivery section is positioned to traverse a portion of the patient's aortic arch; (B) inflating the balloon with a fluid transported through the third-lumen to substantially block fluid communication between the patient's heart and the aorta; (C) providing cardioplegia through the second lumen of the blood transport section to the patient's heart to slow the heart rate; (D) circulating blood from a cardiopulmonary machine through the outlet ports of the blood delivery section of the first lumen to the patient's aorta and connected arteries; and (E) performing the cardiovascular surgery on the patient.
  • Figure 1 is a diagram of a mammal's heart and circulatory system showing the approximate configuration of the heart.
  • Figure 2 is a schematic representative of how a mammalian heart works without regard to its configuration.
  • Figure 3 is a schematic representation of how a cardiopulmonary machine works with a heart.
  • Figure 4 is a longitudinal cross-section view of the proximal portion of the balloon catheter of this invention showing the interrelationship between the major parts of the proximal portion.
  • Figure 5 A is a perpendicular cross-section taken along lines 5—5 of 4.
  • Figure 5B shows a closely related configuration taken along line 5—5 of Figure 4.
  • Figure 5C shows a slight modification of the cross-section taken along the line of 5— 5 of Figure 4.
  • Figure 5D shows a cross-section analogous to that of 5B, but where the proximal portion of the catheter of the invention has 4 lumens instead of 3.
  • Figure 5E shows a cross-section analagous to that of 5B, but where the proximal portion of the catheter of the invention has 3 lumens with the two smaller lumens positioned adjacent instead of 180° from each other as shown in 5A or 5B.
  • Figure 6A shows a cross-section of the longitudinal axis of a slightly different configuration of the proximal portion of the catheter of this invention.
  • Figure 6B shows a cross-section perspective of Figure 6A.
  • Figure 7 shows a perpendicular cross-section taken along lines 5—5 of Figure 4 and shows the size relationships between the various parts of the multi-channel catheter of this invention.
  • Figure 8 shows a cardiopulmonary system using the catheter of this invention.
  • Figure 9 is a representation of a preferred aspect of the balloon catheter of the invention having an internal obturator.
  • Figure 10A shows a preferred aspect of the balloon catheter of the invention having an internal obturator.
  • Figure 1 OB shows a close up, cross-section view of a portion of 10A.
  • Figure 11 shows a partial view of the balloon catheter of the invention having positioning indicators located along the proximal portion of the device.
  • Figure 12A shows a full length view of the obturator useful in this invention
  • Figure 12B shows a perpendicular cross-section taken along lines J--J of the full length obturator.
  • Figure 13 is a schematic representation of how the catheter of the invention works in a mammal's heart and circulatory system.
  • Figures 14A, 14B and 14C show cross-sectional views of the distal portion of the balloon catheter of this invention.
  • Figure 15 A, 15B and 15C show how the distal portion transcends the aortic arch.
  • Figure 16 shows the balloon catheter of this invention properly positioned within the ascending aortic arch.
  • Figure 17 shows an alternative view of a catheter that is inserted through the ascending aorta.
  • One aspect of this invention is a multi-lumen aortic balloon catheter having improved balloon positioning and stability characteristics. It can also be referred to as a remote access perfusion cannula.
  • the catheter is designed to assist surgeons in more effectively performing cardiovascular surgery, whether open-heart surgery or less invasive surgery. It is particularly valuable for cardiopulmonary bypass (CPB) surgery.
  • the catheter performs several functions. It is inserted into a femoral artery and threaded through the artery to the aortic arch where it is positioned so that the balloon is positioned in the ascending aorta. When the balloon is inflated, with saline for example, it blocks the aortic arch between the great arteries and the coronary ostia, thus blocking the flow of blood from the heart.
  • a preferred cylindrical design of the balloon provides very effective aortic occlusion.
  • a cardioplegia solution is delivered from an external source to the heart through an internal lumen in the catheter. This solution will slow or stop the heart.
  • Blood from a cardiopulmonary machine is transported through a blood flow lumen to be delivered antegrade flow throughout the arteries then returned to the cardiopulmonary machine from the inferior and superior vena cavae.
  • the inflated balloon also prevents the blood originating from the cardiopulmonary machine from reaching the heart.
  • the improved balloon positioning and stability characteristics are achieved by designing the catheter to have a distinct distal portion having fewer lumens than are present in a distinct proximal portion in which one of the lumens is a blood carrying lumen that does not extend into the distal portion.
  • the distal portion has less space devoted to lumens it is less likely to kink and its flexibility can be better controlled to more easily traverse the aortic arch.
  • the balloon design that ensures a greater longitudinal length of the inflated balloon than simply a globular design, the balloon is positioned more firmly with less stress to the ascending aorta tissues.
  • Another aspect of this invention is a multi-lumen aortic balloon catheter that is inserted through a patient's aorta. Again, the balloon is inflated between the ostia and great arteries to block flow of blood to and from the heart. Cardioplegia is delivered to the heart and blood from a cardiopulmonary machine is delivered antegrade to the aorta and connecting arteries.
  • the proximal portion and the distal portion will be discussed separately, then the combination of the two will be discussed.
  • the catheter is designed to be used in combination with a cardiopulmonary machine
  • CPM distal and proximal
  • Distal is further away and proximal is closer.
  • the proximal portion of the multi-lumen balloon catheter of this invention comprises at least one more lumen than the number of lumens in the distal portion (discussed hereinafter).
  • this will be 3 passageways, with a large, central passageway to maximize the flow of oxygenated blood from a cardiopulmonary machine. It is important to maximize the flow of blood through the large channel while minimizing the outside diameter of the catheter and thus provide adequate systemic extracorporeal blood flow for the vast majority of patients in which the catheter is used.
  • a majority, and preferably at least about 70% is allocated to this large passageway to maximize the flow.
  • the available passageway volume is used for the flow of perfused blood to the arterial side of a patient in need of supplementary, extracorporeal blood circulation.
  • the other channels at least two, comprise the remainder of the available volume (i.e., less than 50%, but generally about 10%-30%) with each channel preferably integrated into the wall of the large central passageway.
  • the available volume is determined by calculating the area of a cross-section of each longitudinal passageway and multiplying by the length. Since the length is about the same in each case, the relative volume for each channel will be directly proportional to the cross-sectional area of each passageway.
  • proximal portion of the multi-lumen catheter has distal and proximal regions and comprises a large central, first channel, i.e., a passageway or lumen.
  • This channel extends substantially the length of the proximal portion of the catheter, is closed at its distal end, but has a plurality of certain outflow openings for extracorporeal blood flow along its length towards the proximal region, as discussed in greater detail hereinafter.
  • the catheter has at least second and third channels, each of which extends the length of the catheter, parallel to the first channel but independent thereof. These additional channels are preferably integrated into the wall of the first channel.
  • the multi-lumen catheter further has a plurality of openings near the distal end of said catheter communicating with the first large channel. The openings are said to be "upstream" of the distal end of the proximal portion.
  • the length of the proximal portion will be less than 100 cm, preferably about 60-90 cm.
  • the multi-lumen catheter of the invention preferably comprises an obturator, i.e., a shaft that snugly fits into the length of the large, blood-carrying channel of the catheter.
  • the obturator may be viewed as a flexible shaft for slidingly and snugly fitting into the first large lumen for blood delivery.
  • the cross-sectional design corresponds to the cross-sectional design of the blood-delivery lumen.
  • the obturator is beveled at its distal end.
  • Various aspects of the obturator are shown in Figures 9-13, and are discussed in more detail hereinafter.
  • the distal portion of the catheter of this invention in its relaxed condition is preferably straight, that is, it is not shaped or preshaped in an attempt to have it conform to or approximate the aortic arch in some way.
  • pre-bent or preshaped catheters do not always orient the occlusion balloon in a position that allows the balloon to expand in a manner that ensures the balloon forces are perpendicular to the wall of the ascending aorta. This can then result in balloon instability due to the compliant nature of aortic occlusion balloons.
  • a preferred aspect of this invention is that the distal portion of the catheter is reduced in diameter from the proximal portion of the catheter.
  • the reduced diameter of the distal portion reflects the elimination of the space needed for the blood flow in the proximal portion of the catheter. By eliminating this space, the distal portion can be viewed as having less air space and greater solid mass, a combination that reduces the likelihood that the catheter will kink and/or twist while traversing the aortic arch.
  • FIGS 14A and 14C when the cross-section of the distal portion of the catheter is viewed, one can see in a preferred embodiment that there are only two lumens (also referred to as channels) 36' and 38' (corresponding to 36 and 38 in Figures 5 A and 5B), one for inflating the balloon and one for transporting cardioplegia solution or a guide wire to the tip of the catheter.
  • An additional lumen could be used for an optical cable, a pressure monitoring device or the like.
  • 3 lumens 36A', 36', and 38' are shown.
  • cross-sectional area i.e., the polymer used
  • 50% of the cross sectional area would be lumen or air. More preferred is that 60% or more is mass, and most preferred, at least 75% of the cross-sectional area is mass.
  • the dimensions of the distal portion and the internal lumens will be such that each will reasonably perform its functions.
  • the cross-sectional diameter of the distal portion along dotted line D-D in Figure 14C will be about 0.15 cm to about 0.30 cm, generally less than about 0.20 cm, e.g. about 0.197 cm.
  • the cross- sectional diameter of the larger lumen in Figure 14C along dotted line D'-D' is about 0.05 cm to about 0.10 cm, generally less than about 0.09 cm, e.g. about 0.085 cm.
  • the cross-sectional diameter of the smaller lumen in Figure 14C along dotted line D"- D" is about 0.02 cm to about 0.05 cm, generally less than about 0.045 cm, e.g. about 0.042 cm.
  • the distal portion of the catheter is flexible, is of a durometer rating that it easily bends when confronted by the aortic arch, and has a tip that is nontraumatic, i.e. the tip has a rounded or blunt (non-sharp) surface.
  • a tip that is nontraumatic i.e. the tip has a rounded or blunt (non-sharp) surface.
  • the rounded tip 90 of the distal portion will glide guided by the top of the aortic arch and will readily flex and traverse the arch to finally be positioned with the tip 90 pointed straight down as shown in Figure 15C.
  • the tip of the distal portion is then ideally positioned (straight) for the balloon, which is preferably cylindrical in shape as shown in Figure 16, to be oriented in a manner that, as the balloon inflates, forces are perpendicular to the walls of the ascending aorta. This results in an improvement in the ability of the occlusion balloon to effectively balance and equalize the opposing forces between the balloon and the wall of the ascending aorta.
  • Figure 16 shows an inflated balloon properly positioned using the catheter of this invention where both the distal portion and the proximal portion are shown.
  • the distal portion is sufficiently flexible as that it will bend but not kink at body temperature.
  • the Duromter rating will be about 60A to about 90A, preferably about 80A. In general, the length of this distal portion will be less than about 50 cm, preferably about 15-30 cm.
  • an inflatable balloon i.e., a non-porous sac, is integrated to the distal end of the catheter of the invention.
  • the balloon can be inflated and distended by pumping a fluid into its interior.
  • the balloon when inflated, will preferably have the distal side within a centimeter or less of the tip 128 of the device.
  • the interior of the inflatable balloon is in fluid communication with the channel 38' (in Figure 14 A) so that the balloon can be inflated or deflated by transporting fluid through the channel to the balloon to inflate it or sucking the fluid out to deflate the balloon.
  • the design of the balloon may be any design known in the art, such as that shown in U.S. Pat. Nos. 5,423,745; 5,516,336; 5,487,730; and 5,411,479, the pertinent parts of which are incorporated by reference. Other useful balloon components are commercially available to one of ordinary skill.
  • the distance between the proximal side 124 of the balloon and the distal side 125 be such that the surface contact with the interior wall of the ascending aorta wall be maximized. This helps ensure a tight seal to prevent leakage.
  • This longitudinal distance between 44 and 45 may be from about 10 mm to about 50 mm, preferably about 20 mm to about 30 mm, e.g. 24-26 mm.
  • the cross- sectional diameter of the inflated balloon will be the diameter of the patient's aorta and will vary from patient to patient.
  • the longitudinal distance is preferably greater than the diameter, thus the balloon will preferably be somewhat cylindrical in shape.
  • a useful filling volume of the balloon is 10 cc nominal to achieve the desires cylindrical shape (e.g. 26 mm) with a maximum inflation volume of about 35 cc. Maximum inflation pressure will generally not exceed 400 mmHg.
  • the design of the distal portion is such that the radial forces exerted by the tip of the catheter are less influenced by curvature or angulation of the shaft of the catheter. That is, there is a change (reduction) of structural rigidity of the catheter from the proximal end to the distal tip. This facilitates positioning of the catheter tip.
  • the balloon integrated around the catheter can be used to position (or control position) of the catheter in the desired orientation within the aorta. This "desired" position can be a central or eccentric location.
  • the shape, size, materials, mounting and physical characteristics of the balloon can be modified to control the desired positioning of the catheter within the blood vessel.
  • a spherical balloon known in the art (e.g., the Heartport catheter model #EARC-23EAC), concentrates and directs all of the force towards a smaller area of aortic wall near the apex of its curvature. While the magnitude of the concentrated force from a spherical balloon is equivalent, a distributed force resulting from a cylindrical balloon poses fewer problems in terms of balloon stability. This is due to the fact that the cylindrical balloons tend to naturally orient the forces perpendicular to the aortic wall by distributing the force over a larger surface area.
  • Applicant's preferred cylindrical balloon as shown in Figure 16 cannot "pivot" within the ascending aorta as easily as a spherical balloon because a cylindrical balloon increases surface contact with the wall of the ascending aorta and has, therefore, an increased propensity for stability.
  • Forces that influence the balloon stability included those of the balloon against the aortic wall, those of the wall against the balloon, and those exerted by the catheter shaft (e.g., leverage and torsion). These forces will continue to search for a point of balance until it is found. Until balance is obtained the balloon will remain unstable within the ascending aorta.
  • Applicant's preferred balloon as shown in Figure 16 is designed to be symmetrically integrated into the distal end of the catheter, thus providing the best opportunity to balance and equalize the opposing forces between the balloon and the wall of the ascending aorta.
  • Asymmetrically mounted balloons known in the art e.g., Heartport model #EARC-23 EAC
  • Balloon taper is preferably minimized in order to maintain cylindrical profiles as shown in Figure 16.
  • Tapered balloons may orient the catheter tip towards the outside of the aortic arch. As tapered the balloon is then inflated the inflation axis of the balloon (perpendicular to the catheter shaft) is not oriented perpendicular to the walls of the aortic arch. This then allows the balloon to continue its expansion, which in turn may force the catheter tip into the wall of the ascending aorta possibly resulting in occlusion of the exit orifice of the cardioplegia lumen.
  • Transesopohageal Echocardiography (TEE) monitoring is useful to monitor balloon occlusion function, while Fluoroscopic monitoring is recommended.
  • the surface of the balloon may be smooth, it may have a design on it that provides additional friction between the balloon surface and the internal surface of the aortic arch.
  • the balloon surface may have either depressions, or ridges in a design that helps maintain the balloon in position. It is preferable to have on the surface of the balloon certain ridges or bumps to provide additional friction for maintaining the position of the balloon in place and minimizing the disruption of plaque that may be present.
  • the volume of the balloon will be about 30 to about 100 cubic centimeters, preferably about 30-40 cc.
  • the length of the balloon from its proximal end 44 to its distal end 45 (Figure 16) will generally be about 1.5 cm to about 7.5 cm with about 2 to 3 cm being preferred. It will need to expand sufficiently to block the ascending aorta completely so that blood does not get to the arrested heart from the cardiopulmonary machine.
  • the combination of the distal and proximal portions, preferably with the obturator, comprise a device that may be a disposable, e.g., a flexible polyurethane device.
  • An inflatable polyurethane balloon is integrated at the distal region of the distal portion of the device.
  • Radio-opaque balloon indicator and insertion depth marks may be used to aid in positioning the device.
  • the materials used are non-pry ogenic.
  • the blood flow rates are one (1) to six (6) Liters per Minute. Maximum Recommended Blood Flow Rate is (5) Liters per Minute. See Figure 8, 13, and 16 for how the catheter is positioned in the aortic arch.
  • the catheter is made of physiologically acceptable material and is of a size suitable for insertion into a blood vessel of a mammal, particularly a human.
  • a mammal particularly a human.
  • at least some and preferably the majority of the plurality of openings communicating with the first large channel are elongate in shape with the length of the openings being substantially parallel to the length of the catheter.
  • the catheter shown as a preferred 3 -lumen catheter
  • the large first channel 34 is defined by the wall 32 of the catheter.
  • the second channel 36 and the third channel 38 are shown as being integrated into the wall of the first large channel.
  • the second and third channels are integrated with the wall 32 of the first channel 34 and are shown as having an interior wall portion 41 defining the smaller second and third channels.
  • the catheter of this invention is preferably designed to be inserted into a femoral artery of a human patient and advanced sufficiently to allow the distal portion to be positioned in the ascending aorta.
  • the openings 40 communicating with channel 34 are located on the proximal side (i.e., upstream) of the distal portion of the catheter that carries the balloon so that blood flows out of channel 34 through outlets 40 toward the great arteries.
  • the openings may spread along the length of the proximal portion. See Figure 16.
  • the total outflow capacity of the outlet ports 40 is generally greater than the inflow capacity of the blood flowing into the catheter. This will mean that total collective cross-sectional area of openings 40 will exceed the total cross-sectional area of channel 34.
  • the collective cross-sectional area of openings 40 one determines the area of each opening and adds the area of each opening.
  • the total area (i.e., outflow capacity) of the openings will exceed the cross-sectional area (i.e., inflow capacity) of channel 34 by at least a factor of 1.2. Having a factor of greater than about 2 is even more preferable.
  • each opening has a cross-sectional area of about 3-40 mm , preferably about 5 to about 20 mm 2 .
  • the total number of openings may be as few as 3 large openings up to about 20 openings of various shapes.
  • the shape of the openings 40 may be of any appropriate shape for the outflow of blood, it is preferable that some, generally a majority of the openings are elongate in shape. While the openings may be positioned in any configuration at the distal end of the catheter, for example, the longitudinal axis of the elongate openings may be positioned substantially parallel to the length of the catheter or at a slight angle such that it forms a helical design or the length could be perpendicular to the length of the catheter. However, it is preferred that the elongate openings have the length of the opening substantially parallel to the length of the catheter. The number of openings that can be present may vary from 3 to 20 or more.
  • the design of the openings 40 may generally be that of an oval, oblong, a rectangle, a trapezoid or some similar elongated design. In general, they will be approximately one cm to about four cm, preferably about 2.5 cm long with a width at the broadest portion of the opening no more than about 5 mm. By having a majority of (e.g., oval) openings and ensuring the outflow capacity exceeds the inflow capacity the sheer stress on the blood passing through the first channel 34 will be significantly reduced.
  • the flow rate through the large channel 34 may be up to six liters (L) per minute without having adverse affect on the blood due to too much shear stress on the red cells, platelets or white cells.
  • Having the elongate openings and proper outflow capacity also reduces the pressure drop between the proximal end where the catheter is attached to the cardiopulmonary machine and the exit at the openings 40.
  • the pressure drop will be under 300 millimeters of mercury and preferably under 200 millimeters of mercury.
  • the pressure drop can be further reduced by having additional holes towards the proximal end of the proximal portion but somewhere between the midpoint of the catheter and the distal end. This design is seen in Figure 16.
  • the size of the outlet ports increase in size the further away from the CPM. This tends to provide a more uniform dispersion of flow.
  • the maximum length of the multichannel catheter of this invention (including both distal and proximal portions) will be that length necessary to insert the catheter into the femoral artery of the patient and moving it up the artery to place the distal end having the balloon within the ascending aorta.
  • the length may be from about 40 centimeters up to about 120 centimeters or more.
  • the range will be about sixty to about one hundred centimeters with about eighty-five centimeters being an average length suitable for most people.
  • the outside diameter of the multichannel catheter of this invention will be such that it can be inserted and moved through the femoral artery of the patient and located in the ascending aorta as discussed above. Generally, this will have an outside diameter (OD) of no more than about 30 French, preferably of about 14 to 23 French with about 20 to 22 French outside diameter for the proximal portion fitting most patients.
  • the French scale is a scale used for denoting the size of catheters or other tubular instruments, with each unit being roughly equivalent to 0.33 millimeters (mm) in diameter. For example, 18 French indicates a diameter of about 6 millimeters while 20 French would indicate a diameter of about 6.6 millimeters.
  • the thickness of the wall 32 may be between about 0.2 mm to about 1.0 mm.
  • the inside diameter of channel 34 will generally not exceed about 28.2 French, and may vary from about 14.8-22.5 French. It is found that 15 FR for the distal portion and 22 FR for the proximal portion works well.
  • a second channel 36 is designed to introduce a cardioplegia solution, to evacuate fluid (i.e., vent the left ventricle), or to carry a guide wire or various types of probes or for treating the heart.
  • a cardioplegia solution to evacuate fluid (i.e., vent the left ventricle), or to carry a guide wire or various types of probes or for treating the heart.
  • catheter 30 has at least one opening at the distal end of catheter 30, which communicates with a corresponding channel in the distal portion of the catheter of this invention and leads to the distal tip of the distal portion of the catheter, which tip is downstream of the balloon.
  • This allows a cardioplegia solution, a guide wire or the appropriate fiberoptic cable to be inserted into the channel and moved through the channel out exit 128 in Figure 16 or exit 78 in Figure 8. It also allows for a negative pressure to be applied to vent the left ventricle of the heart, if desired.
  • the catheter of this invention is inserted percutaneously or by cutdown into the femoral artery of a patient and is threaded through the femoral artery to the ascending aorta to be positioned there. See Figure 8.
  • the catheter is positioned so that the balloon is positioned between the coronary ostia and the great arteries as shown in Figure 8.
  • the balloon is inflated to block the flow of blood into the heart from outflow openings 40 in Figure 4 or 77 in Figure 8.
  • Cardioplegia solution is administered through channel 36, 36' out opening 128 (Figure 16) or 78 in Figure 8 to arrest the heart. Blood is then circulated through channel 34 out openings 40 ( Figure 4) or 77 in Figure 8 to maintain circulation of oxygenated blood in the patient during the operation.
  • FIG. 5A through 5E and Figures 6A and 6B one can see a cross-sectional view taken along lines 5—5 in Figure 4.
  • the large central passageway 34 is defined by the wall 32 of the overall proximal portion of the catheter and that the channels 36 and 38 are integrated into the wall 32. They may be integrated so that they are positioned more interiorly as shown in Figure 5A or more exteriorly as shown in Figure 5B with cross-sectional diameters that are essentially a circle.
  • the cross-sectional of channels 36 and 38 may be elongated or oval.
  • Figure 5D shows a four-lumen cross- section.
  • the total volume of flow available for all passageways 34, 36 (and 36A) and 38 is divided as follows.
  • the volume for passageway 34 will make up a majority of the available volume, preferably be at least about seventy percent or more (e.g., up to about 90%) in order to achieve the advantages of this invention with the flow through passageways 36 and 38 being the minority, i.e., the remaining thirty percent or less (i.e., down to about 10%).
  • FIGS. 5A to 5C While generally, it is preferable to have the channels 36 and 38 opposed one hundred eighty degrees from each other as shown in FIGS. 5A to 5C, it may be possible to have them adjacent as shown in Figure 5E. Having them adjacent makes the preparation a bit more difficult than having them opposed as in Figures 5A, 5B and 5C.
  • Figures 6A and 6B show a representative cross-section and cross-section perspective view of the proximal portion of the catheter of this invention.
  • the ratio of the total volume of the cardioplegia channel 36 to the balloon inflating channel 38 will vary from about 1 :1 to about 4:1. So, for a multichannel catheter in which about 70% of the total available volume is provided for the channel 34 and about 30% of the total available volume is provided for channels 36 and 38, channel 36 will account for about 15% to about 24% with channel 38 accounting for about 15% to about 6%. Alternatively if channels 36 and 38 collectively account for about 10% of the total available volume then channel 36 will have about 5% to about 8% while channel 38 will have about 5% to about 2%.
  • Figure 7 one can see the relative proportions of the three channels of the multi-channel catheter of this invention. In the figures the abbreviations have the following meanings:
  • IWT 41 0.6-1.0 French (0.2-0.3 mm)
  • the catheter of this invention is able to handle a blood flow rate through the central channel 34 of about one-half up to about 6 liters per minute with the proper sizing and design. Generally, a flow of about 4.5 to 5 liters per minute is sufficient to handle the vast majority of circulatory needs required by patients having heart surgery performed. On the other hand, the flow of cardioplegia solution or drug-containing solution through channel 36 is generally about 100 to about 300 cubic centimeters (0.1-0.3 liters) per minute.
  • the balloon inflation channel 38 which is generally smaller than channel 36, will be of a size sufficient to carry balloon-inflating fluid, e.g., saline, to the balloon.
  • the volume of the balloon is generally about 40 cc to about 100 cc, generally about 60 cc.
  • channel 38 is of a size sufficient to carry that volume over a short period of time, i.e., less than a minute and generally less than about 10 seconds.
  • the volume of the balloon will be greater if the distal end of the multichannel catheter is tapered in the region covered by the balloon.
  • the catheter of this invention will need to be flexible enough to easily be inserted up through the femoral artery to be positioned in the ascending aorta.
  • the flexibility of the distal portion needs to be sufficient so that the catheter can bend but will not kink at body temperature. In general, this flexibility is determined by Durometer and will be in the 60A to 90A range. Generally, the Durometer reading of about 80A is preferable. It is preferable that the distal end where the balloon is located has the appropriate flexibility to allow the distal portion to transcend the aortic arch. This helps to position the catheter in the ascending aorta to ensure proper alignment of the balloon.
  • Eliminating the "blood flow" lumen causes increased flexibility without kinking due to increase in tolerated radius of curvature.
  • This increased flexibility and tighter curvature radius reduces the forces exerted at the tip of the catheter which oppose curvature of the catheter. This reduces the leverage forces exerted by the catheter on the balloon (those forces which cause the balloon to twist or turn in the aorta).
  • the device of the invention is generally indicated as 100 with the proximal portion being designated as 101 and the distal portion being designated as 102. At the distal portion of the device there is a balloon 103 which is integrated into the distal tip of the distal portion of the device. The distal portion is joined with the proximal portion at juncture 104 where the cross sectional diameter of the device will transition from a greater diameter of the proximal portion (for example 21 French to a smaller diameter of the distal portion (for example 15 French).
  • An inlet 105 for the oxygenated blood from a cardiopulmonary machine is shown, which inlet can be connected to the appropriate line of the machine to receive oxygenated blood that will ultimately be channeled into the large central channel for delivery to the arteries.
  • This channel is designated as 34 in Figures 4 through 7 and was discussed earlier in the application.
  • the outlet ports 106 are shown distributed along the distal region of the proximal portion of the device. These outlet ports are to allow the blood to escape once the catheter is properly positioned as shown in Figure 8.
  • the obturator has an enlarged handle 107 attached to the stem of the obturator 107 A that slidingly fits into the interior of channel 34 through entry points for the obturator 108.
  • the obturator When the obturator is fully inserted into the channel it will extend past the furthermost outlet port 106 nearly to the juncture 104.
  • the obturator is pulled out of the channel until the tip of the obturator reaches a position where blood can flow past the obturator and into the channel 34 and ultimately out the outlet port 106.
  • the obturator is shown in greater detail in Figure 12A where the handle 107 is shown along with the stem 107A.
  • the end of the obturator is a flat, blunt, or rounded end as compared to a sharp taper. This is to avoid damaging the interior of the channel particularly the end of the channel.
  • the cross section of the obturator shown in 12A at lines JJ is shown in 12B. The cross section will correspond approximately to the cross section shown in Figures 5A-5E, 6A-6B or 7.
  • the obturator fits slidingly and snugly within the large blood carrying channel and performs several functions.
  • the tip of the catheter device of the invention is inserted into the femoral artery while blood is being pumped by the heart.
  • the obturator As the device is inserted and reaches a point where the furthest outlet port 106 is inserted into the artery, if the obturator is not in place blood will flow into that port and out of the other ports and into the operating arena if all of the ports are not inserted at the same time. By having the obturator blocking the ports, the flow of the blood through the large channel from the heart is prevented. Once the device is inserted so that the most proximal outlet port 106 is fully located within the artery the obturator can start being withdrawn until the tip of the device is properly positioned to be between the coronary ostia and the great arteries such as the brachiocephalic artery.
  • the balloon can be inflated by sending a fluid such as saline through line 117 and entry port 118.
  • a valve 119 is situated at the entry point port to allow the saline to be turned on or off. The valving is such that fluid may be inserted through port 118 and withdrawn from that port or input through line 120.
  • the cardiaplegia coming out of tip 78 will reduce the rate of beating of the heart or stop the beating completely.
  • the cardiaplegia can be sent through inlet 113 through valve 114. If desired valve 114 can be adjusted so that the heart could be vented through outlet 115 by providing a slight vacuum to pull excess blood out of the area.
  • a guidewire may be inserted through line 116 through line 112 and through the internal channels 36 and 36'. Once the obturator has been fully withdrawn, CPM blood will flow into the blood carrying channel through port 105 and through flexible connection line 109 which may be connected by a slip fit or twist fit 110 and 111.
  • warning indicator 123 may indicate that the indicator is about 45 cm from the tip and a few centimeters from the nearest outlet port 106.
  • junction of lines 109, 111 and 112 the junction being shown as 122 there is a place for a serial number to indicate the number of the device that has been manufactured. Further details of Figure 9 can be seen in Figures 10A and 10B where like numerals refer to like parts of the invention.
  • FIG 16 one can see the device placed in the aortic arch with the balloon 103 blocking the ascending aorta and situated between the coronary ostia and the great arteries 126.
  • the distal portion 102 of the device is shown arched over the aortic arch 127.
  • the proximal portion of the device 101 is shown to be positioned relatively straight with the juncture 104 between the proximal and distal portions as shown.
  • Figure 13 is a simplified version showing a device in which the distal portion of the device is not reduced in diameter as compared to Figure 16.
  • the obturator is shown as having handle 107 and stem 107A which is shown as the shaded portion in the figure.
  • the obturator does not extend the full length of the device but instead the distal portion of the device that fits over the aortic arch does not have the obturator in and does not have the large first channel. Again the reason for this is to minimize the likelihood of kinking in the portion that goes over the aortic arch.
  • the multi-channel catheter of this invention has markings indicating its length measured from the distal end to various distances near the proximal end so that the physician knows exactly how far to insert the catheter of this invention. Having that information indicated on the catheter makes it easier for the physician to do the insertion and also reduces the need to use fluoroscopy to properly insert the catheter.
  • an ultrasound probe may be used to position the catheter of this invention where the catheter of this invention carries a detectable beam on the tip of the catheter.
  • Alternative methods may be employed for positioning the catheter, such as guidance by fluoroscopy or echocardiography, fiberoptic visualization through the catheter, magnetic or electronic guidance, or other means of insuring proper placement.
  • FIG. 17 An alternative design for a multi-lumen catheter of this invention is shown in Figure 17.
  • a balloon catheter for delivering blood to an animal, particularly a human is positioned to block the aortic arch between the great arteries 141 and the coronary ostia, not shown, by entering via the base of the aorta 144.
  • a proximal blood transport section of a multi-lumen catheter of this invention is shown as 130. It has distal and proximal ends and is conjoined with the proximal end of the distal blood delivery section 138 of the device.
  • a first blood transport lumen is defined by the surrounding wall extending the length of the blood transport section and is open for communication at its distal end as well as at its proximal end.
  • a cardiopulmonary machine is attached for circulating extracorporeal blood.
  • a second lumen extends the length of the blood transport section and is parallel in the first lumen but independent of it. This lumen is generally used for transporting cardioplegic solution and is open at its distal end as shown as 132 to allow cardioplegia solution to exit 132 for delivery to the base of the aorta and to the heart to slow or stop the heart.
  • a third lumen is located in the proximal blood transport section of the device.
  • the third lumen is independent of and parallel to the first and second lumens and extends the length of the three-lumen portion. It is open at the distal end and communicates with the interior of the inflatable balloon 133, which is integrated into the distal region of the blood transport section. One can see that the balloon 133 interior communicates with outlet 137 so that it can be inflated or deflated.
  • the balloon is integrated at the end of the distal section of the blood transport section having bonds 134 and 135 proximal and distal to the CPM.
  • the lumen leading to the interior of the balloon is shown as 136 by a dotted line indicating that the lumen is interior to the proximal blood transport section.
  • the distal blood delivery section 138 is shown as having ports 142 distributed along the length of this section.
  • This section is in communication with the first blood transport lumen of 130. It can be seen that at the distal end of the blood transport section 130 there is a transition zone indicated as 143 where the transition is from three to two-lumens, generally shown at 131 and from two to one lumen.
  • the distal blood delivery section 138 with the blood outlet, ports 142 extends distal to the balloon 133 and is positioned within the aortic arch 140. Generally, this will extend under the great arteries 141.
  • the cross-sectional area of outlet ports 142 will be greater than the cross sectional area of the blood transport lumen coming from the transport section 130 and continuing on to 138.
  • the device will be inserted through a trocar in the chest area to ultimately be inserted at the base of the aorta 144.
  • the second and third lumens for cardioplegia and delivery of fluid to the interior balloon are positioned to about 180° opposite each other.
  • the balloon 133 when inflated takes a cylindrical shape and has the size characteristics discussed herein.
  • the proximal portion 130 will have a preferred cross sectional diameter of about 20-22 French while the distal portion will be about 14-16 French.
  • the distal blood delivery section 138 is at a slight angle to the proximal blood transport section 130. This angle can be anywhere between 90-125° but preferably is at an angle of about 110-120°.
  • the angle at the transition zone 143 will be for example 115°, the angle being formed by the longitudinal axis of the blood transport section 130 relative to the longitudinal access of the proximal portion of the distal blood delivery section 138.
  • the material which is used to manufacture the multichannel catheter of this invention may be any material that is physiologically acceptable, that is, it is made of a material that will not have an adverse effect on the patient when used in the manner in which it is intended. Generally this will require the use of biocompatible material (i.e., the body will not react with it) for preparing the catheter of this invention. In addition, the material that is used must possess sufficient stability and flexibility to permit its use in accordance with the process of the invention. Various biocompatible polymers may be used. A polymer that is particularly valuable for preparing the catheter of this invention is polyvinyl chloride (PVC) blood tubing, that has been plasticized.
  • PVC polyvinyl chloride
  • the plasticizer which is used in the PVC is trioctyl trimellitate (TOTM) while the standard plasticizer di-(2-ethyl hexyl) phthalate (DEHP).
  • TOTM plasticizer is less extractable than DEHP and produces a better blood response.
  • Suitable PVC resin is available from Dow Chemical Corp., Midland, Mich., or Polymer Technology Group (P.T.G.) Inc., Emeryville, Calif.
  • Another polymer that is useful for preparing the multichannel catheter of this invention is medical grade polyurethane.
  • Other polymers may be prepared based on a family of polysiloxane- containing copolymers termed surface modified additions (SMAs).
  • copolymers may be blended with the base polymer before processing or coated on the blood contacting surface.
  • the SMA When blended with the base polymer the SMA will migrate to the polymer surface resulting in a high concentration of the SMA of that surface, which has fewer adverse reactions with the blood that contacts it.
  • device surfaces When coated, device surfaces are pure SMA. High surface concentration of the SMA are responsible for the improved biocompatibility of extracorporeal circuit components.
  • Plasticized PVC is particularly useful as the base polymer. A further description of these polymers is given in an article entitled "Surface Modifying Additives for Improved Device-Blood Compatibility" from ASAR Journal 1994 M619-M624 by Chi-Chun Tsai, et al. The article is incorporated herein by reference. Such polymers are available from P.T.G. Corp.
  • polyurethane-urea biomaterials that are segmented polyurethane (SPU) some of which have surface-modifying end groups (SMES) covalently bonded to the base polymer.
  • SPU segmented polyurethane
  • SMES surface-modifying end groups
  • the blood interacts with artificial surfaces of polymers in such a way that the blood coagulates on the surface creating thrombi.
  • thrombi can block the catheter or blood vessels, preventing the blood from flowing and causing oxygen depletion and nutrient starvation of the tissues.
  • An anti-thrombotic agent can be used to prevent the clots from forming.
  • Polymer modifications that permit an improvement in blood compatibility while maintaining acceptable levels of other fundamental properties include the treatment of surfaces with protein, the attachment of anti-thrombotic agents and the preparation of biomembrane-mimetic surfaces.
  • the preferred anti-thrombotic agent is the anti-coagulant heparin, which can be attached ionically or covalently. Preferably it is attached covalently.
  • the catheter of this invention may be used in several different ways.
  • the catheter may be introduced via a femoral artery, positioned as appropriate and attached to a cardiopulmonary bypass machine to circulate blood through the large central channel 34 and out openings 40.
  • a fine fiber optic cable may be threaded through second channel 36 to examine the aortic area of the heart.
  • the balloon may be inflated through channel 38 to block the ascending aorta, cardioplegia solution may be administered through channel 36 to arrest the heart, and oxygenated blood from a cardiopulmonary machine is pumped through channel 34 and openings 40 into the arterial pathway of the patient's circulatory system.
  • cardiovascular surgery is meant to include surgery to the heart or to the vascular system of a patient.
  • the catheter is particularly useful in cardiac surgery, whether open chest surgery or minimally invasive heart surgery, particularly CPB.
  • Such surgery may include, but are not limited to, the following: 1. Coronary artery revascularization such as:
  • Any atrial or ventricular septal defect repair such as by:
  • a significant advantage of the unique multichannel catheter of this invention is its ability to be adapted to be used in accordance with the needs of a patient.
  • a patient with symptomatic coronary artery disease undergoes a diagnostic evaluation to determine the type of treatment that best suits that patient's condition.
  • the physician may recommend surgical treatment, interventional cardiology treatment or some alternative treatment.
  • Interventional treatment may include percutaneous transluminal coronary angioplasty, atherectomy or the use of a stent to keep the vessels open.
  • Alternative treatment may include the use of a laser or myoplasty.
  • the multichannel catheter of this invention is particularly valuable in the further evaluation to determine the condition of the patient, the type of treatment recommended and the type of drugs that might be useful to administer to the patient.
  • the catheter is inserted into a femoral artery by percutaneous puncture or direct cut-down.
  • the distal end of the catheter, which carries the balloon, is inserted first and moved through the femoral artery to be positioned in the ascending aorta as discussed in more detail herein.
  • the catheter will have an obturator associated with it, which is used as discussed under the "Representative Use of the Catheter.”
  • the physician performing the work may wish to introduce instruments through the channel (36 in Figure 4) or other probes to allow observation or measurement of the internal condition of the artery, aortic arch and/or aortic semilunar valve.
  • a cardioscope, an electrophysiology probe, a transmyocardial revascularization probe, a radiation probe, or the like may also be inserted through channel 36. Once observations are made concerning the condition of the heart and associated arteries, the physician can then take additional steps.
  • a biologically active fluid directly to the heart or aorta using an appropriate liquid composition containing an active entity appropriate for the patient's condition.
  • the active entities in such a biologically active fluid include drugs (particularly those having cardiovascular effect) that are pharmaceutically acceptable small organic molecules, small polypeptide molecules, larger polypeptide molecules, and even a DNA or RNA that may be useful for gene therapy.
  • useful molecules include those useful as antianginals (e.g., organic nitrates, calcium channel blockers, .beta.-adrenergic antagonists) antihypertensive, antiarrhythmics, antihyperlipoproteinemias, myocardial contractile enhancers, anti- atherosclerotic agents, and the like.
  • Such fluids especially for cardioplegia can best be delivered through channel 36 in Figure 4, but alternatively can be delivered in the fluid used to inflate balloon 42 through channel 38 in Figure 4.
  • the material used for the balloon would be semipermeable to allow the drug to diffuse through the balloon membrane.
  • a drug having lipid-dissolving characteristics can be delivered through the balloon membrane.
  • the physician then can move on to the next steps.
  • least invasive surgery as discussed in U.S. Pat. No. 5,452,733, may be performed on a beating heart with no initial cardiopulmonary support, i.e., no blood would flow through the would continue to function. If at any time, the physician would decide that cardiopulmonary support would be needed, supplemental blood flow from a cardiopulmonary (heart/lung) machine could be started and work could be continued with a beating heart or a fibrillating heart.
  • cardioplegia solution is delivered to the heart through the channel 36 after balloon 42 is inflated to block the flow of blood to the heart from the cardiopulmonary machine.
  • the multichannel catheter of the invention can be used in least invasive surgical procedures as well as open chest surgery.
  • the multichannel catheter of this invention is particularly useful in performing heart surgery where the heart is arrested using a cardioplegic solution and blood is circulated to the patient via a cardiopulmonary bypass machine. In this case oxygenated blood is circulated through the large channel of the catheter of this invention.
  • the introduction of negative pressure on the venous drainage system may be used to enhance venous drainage and reduce the need to vent the right side of the heart.
  • the negative pressure may be maintained at the vena cavae regions (superior and inferior) using a centrifugal pump attached to a standard femoral venous cannula.
  • a system for performing such a process is depicted in Figure 8.
  • the process for performing surgery on a mammal's heart comprises a sequence of steps.
  • a single femoral access cannula is inserted into the mammal's femoral vein to position it so the distal open end of the cannula is adjacent the vena cava region of the mammal's heart and the proximal end of the cannula is attached to a cardiopulmonary bypass machine through a centrifugal pump wherein the cardiopulmonary bypass machine comprises a blood oxygenation means fluidly connected to the centrifugal pump.
  • a multichannel catheter of this invention is inserted into a femoral artery preferably having an obturator associated therewith, as discussed hereinafter.
  • the multichannel catheter is positioned within the subject's blood circulatory system such that the distal end of said catheter is positioned in the ascending aorta such that the first channel openings are located near the great arteries, the inflatable means is located on the cephalid side of the aortic valve and the distal end of the second channel is located proximate the aortic valve and downstream of the inflatable balloon.
  • a source of oxygenated blood from the cardiopulmonary machine is connected to the proximal end of said first (blood-carrying) channel of the catheter and a source of cardioplegia fluid is connected to the proximal end of said second channel.
  • a source of fluid is connected for inflating said inflatable means to the proximal end of said third channel and the inflatable means is inflated to block the flow of blood to the heart.
  • Cardioplegia solution is pumped into the heart to arrest the mammal's heart and oxygen-rich blood is pumped through said first channel out the first channel openings upstream of the balloon at a rate sufficient to maintain the subject's metabolism and perfusion while at the same time oxygen-depleted blood is removed from the mammal's vena cavae regions through the femoral vein cannula by applying a negative pressure using the centrifugal pump.
  • the physician can then perform a surgical operation on the heart as needed and said subject is maintained as needed.
  • the femoral vein is accessed percutaneously or by cut down using the appropriate size standard femoral access cannula 50 (such as an Research Medical Inc. #TF-030-050).
  • This cannula conducts de-oxygenated venous blood from the vena cava 51 to PVC tubing 52 (e.g., 0.5 inch inner diameter).
  • PVC tubing 52 e.g., 0.5 inch inner diameter.
  • This tubing is attached to the negative pressure (inlet) port 53 of a centrifugal pumping device 54 (such as the St. Jude Medical #2100CP); the positive pressure (outlet) port 55 of the centrifugal pumping device is connected via tubing 56 (0.5 inch ID PVC) to a venous reservoir system 57 (such as the COBE Cardiovascular, Inc. VRB 1800).
  • This configuration pulls blood from the vena cava 51 to the venous reservoir 57. Utilization of negative pressure in this manner to provide venous blood return eliminates the need to "vent” or empty the right heart. By using a centrifugal pump that reaches about -20 to about -50 mm of mercury (mm Hg), a sufficient negative pressure is maintained. The use of a closed reservoir system is preferred to eliminate air/blood interface and associated blood trauma.
  • the venous blood exits the reservoir through tube 58 (e.g., 3/8 inch ID PVC tubing) using pump 60. This tube 58 is connected to an oxygenator/heat exchanger means 59 (such as the COBE Cardiovascular, Inc.
  • the blood will be pumped through the membrane/heat exchanger by a roller pump device 60 (such as the COBE Cardiovascular, Inc. model #043-600- 000).
  • the oxygenator will oxygenate the blood and the heat exchanger will regulate blood temperature.
  • the oxygenated arterial blood will exit means 59 through tube 61 (such as 3/8 inch ID tubing), pass through an arterial filter 62 (such as a COBE Cardiovascular, Inc. Sentry #020-954-000) and be delivered into the femoral artery via the invention multichannel catheter 63.
  • all blood contact components are surface modified to reduce blood trauma, patient inflammatory response and requirements for patient anticoagulation.
  • the invention femoral artery catheter 63 provides flow of oxygenated blood to the aorta 64.
  • the invention catheter 63 is introduced into the femoral artery 65 percutaneously or by cut down.
  • the invention catheter 63 can be introduced alone or utilizing a guide wire and stylet.
  • the stylet provides assistance in allowing the device to transcend the aortic arch.
  • Accurate positioning of the balloon will differ from other positioning methods by utilizing measurement of the cardiac catheterization catheter. The appropriate distance will be determined and indicated on the femoral artery catheter 63 prior to insertion; the distance indicator markings 66 will provide simple and accurate balloon positioning. Accurate positioning of the balloon tip may also be enhanced or verified using visualization by transesophogial echo or fluoroscopy.
  • the invention catheter provides a flow of oxygenated blood to the aorta as part of the cardiopulmonary bypass process.
  • the catheter is of a length sufficient to extend from the insertion point in the femoral artery to the ascending aorta as shown in Figure 8, which length will vary depending on the size of the patient, as discussed hereinbefore.
  • the catheter has a proximal end 74 and a distal end 75.
  • the catheter has an inflatable balloon 76 located on the proximal side of the distal tip 78 for fixing the catheter within the ascending aorta.
  • a channel extends the length of the catheter to the balloon with an outlet port that communicates with the balloon interior so that the balloon can be filled with a fluid from a syringe-type inflation device 73 to occlude the ascending aorta as discussed herein.
  • the catheter also has (a) a blood delivery channel extending from the proximal end 74 to outlet ports 77 upstream of the balloon for delivering oxygenated blood and (b) a channel extending through the entire cannula with an outlet port at distal tip 78 for a guide wire and/or delivering a cardioplegia solution to the heart through stopcock 68 into inlet port 67 and from line 69.
  • the balloon catheter as described in the discussion of Figure 17 is inserted into the patient through the patient's aortic artery towards the root to position the balloon catheter so that the balloon is in the ascending aorta between the patient's coronary ostia and the great arteries 141.
  • the blood delivery extension 138 is positioned to traverse a portion of the aortic arch as shown in Figure 17.
  • the balloon 133 is expanded to substantially block fluid communication between the patient's heart and the aorta. Cardioplegia is provided through the lumen to exist 132 so that the cardioplegia is delivered to the heart to slow or stop the heart.
  • the cardiopulmonary machine is then circulated through the blood transport section 130 and to the blood delivery section 138 outlet ports 142 to the patient's aorta 144 and connected arteries. Finally, the cardiovascular surgery is performed on the patient as required and the process is then reversed with the balloon being deflated, cardioplegia stopped, and the device is withdrawn. The patient's heart is revived in accordance with the usual procedures.
  • the catheter is produced by introducing, e.g., 3 or 4 single lumen extruded tubings into a molded manifold which merges each of the single lumens (3) into the mulitlumen extrusion. See Figure(s) 5A-5D and 14A-14C.
  • the multilumen extrusion of the proximal portion is fused or bonded to the distal multilumen extrusion using mandrels which prevent closure of the continuing lumens.
  • a continuing lumen running the length of the device consists of, e.g., channel 38 of Figures 5 A, 5B or 5E, communicating with channel 38' of Figures 14A or 14C.
  • Another continuous lumen would consist of channels 36 of Figures 5A, 5B, or 5E communicating with channel 36' of Figures 14A and 14C.
  • channels 38, 36 and 36A communicate with 38', 36',and 36A'.
  • the balloon is fused or bonded onto the distal portion of the multilumen tubing which is designed to transcend the aortic arch.
  • the proximal portion of the multichannel catheter of this invention is prepared using any technique that provides the multichannel catheter herein described.
  • the second and third channels are integrated into the wall of the first channel. This may be done by forming the channels separately then conjoining them, i.e., by gluing or other means.
  • the multichannel catheter may be made through a mandrel-dipping technique, or preferably a continuous extrusion process. Extrusion involves forcing a fluid polymer material (as discussed above) through a suitably-shaped die to produce the cross-sectional shape, such as that depicted in FIGS. 5 A, 5B, 5C, 5D, 5E, and 6 or other suitable shape as described herein.
  • the extruding force may be exerted by any standard means known in the art such as by a piston or ram or by a rotating screw, which operates within a cylinder in which the polymeric material such as PVC or polyurethane is heated and fluidized.
  • the fluid material is then extruded through the die in a continuous flow.
  • the extrusion head will have a multitubular die to provide a continuous multichannel catheter, essentially as described herein.
  • a mandrel-dipping technique a mandrel having the desired size and cross section design is dipped in or drawn through a fluid polymeric material so that the mandrel is coated with the polymer.
  • the polymer is then dried on the mandrel and removed to give the desired design.
  • This technique may be done at commercial manufacturers, e.g., Extrusioneering, Temecula, Calif, and others.
  • the proximal portion of the multichannel catheter is formed, whether by extrusion or mandrel-dipping, it is cut to suitable lengths and treated to provide the further characteristics of the product to make it operable. Such treatment may occur in any particular order.
  • a plurality of openings (40 in Figures 4 or 68; 77 in Figure 8; 106 in Figures 9, 10A, 11, and 16) are formed near the distal end of the proximal portion of the catheter communicating with said first channel.
  • These openings are made in conformance with the designs discussed herein, and thus are preferably elongate in that the longitudinal axis of the elongate design may be helical or orthogonal, but is preferably substantially parallel to the longitudinal axis of the catheter itself.
  • the openings may be provided by suitably cutting or punching the elongate design into the wall of the catheter.
  • the design is approximately oval, rectangular, or the like with the length of the opening being about a size discussed hereinbefore.
  • the width of the opening will be such it will not weaken the structural integrity of the distal end of the proximal portion of the catheter.
  • FIGS. 8, 9 and 10 present various configurations for the positioning of the openings.
  • additional openings communicating with the first channel may be provided along the length of the catheter positioned between approximately the middle of the catheter and the elongate openings near the distal end. The openings are useful in reducing the pressure drop between the proximal end of the catheter and the distal openings to help reduce the sheer stress on the blood.
  • the distal portion of the catheter is similarly extruded to give a length having a cross-section show in Figures 14A, 14B and 14C.
  • the openings of the distal portion (e.g., 36' and 38' of 14A) that correspond to openings of the proximal portion (e.g., 36 and 38 of Figure 5 A) are aligned, mandrels are positioned to prevent a closure of the communicating lumens, and the distal and proximal portions are fused or bonded or otherwise permanently conjoined.
  • An inflatable means i.e., a balloon
  • a balloon is integrated into the distal end of the catheter such that the interior of the balloon communicates with the outlet of the balloon communicating channel to allow fluid to flow through the lumen and to the interior of the balloon.
  • this may be integrated by positioning a balloon having an opening corresponding to the opening to the appropriate channel and adhering the balloon to the distal end of the catheter. This adherence may be performed by using a suitable glue, solvent bond, light sensitive weld, or other suitable means known in the art for this purpose.
  • the material used for the inflatable means may be any suitable biocompatible material that is capable of being inflated and deflated a plurality of times. Polyurethane-based biocompatible polymers are preferred. These are described in the aforementioned article by Ward, et al.
  • This example provides a step-wise description of a representative use of the device of this invention that is inserted via the femoral artery.
  • a device of this invention Before a device of this invention is used in a patient in need of surgery suggested herein, the patient is screened to determine if surgery and usage of the device is appropriate. Preoperative screening of patients includes evaluation by sufficient methods (such as clinical examination, segmental doppler examination, aortogram) to exclude those with aortoiliac disease or anatomy that would preclude safe introduction of the balloon catheter into the aorta from a femoral artery. 2.
  • the patient is anesthetized, positioned, prepped and draped for cardiovascular surgery requiring cardiopulmonary bypass. Arterial pressure is monitored using a right and left brachial or radial artery pressure monitoring line, which should be continuously simultaneously monitored, sudden differences in right and left pressure may indicate balloon blockage of the innominate artery.
  • Intraoperative monitoring with transesophageal echocardiography is required. Fluoroscopy with capability of imaging the thoracic aorta may be used but is not an alternative to intraoperative monitoring with (TEE).
  • the aortic arch and ascending aorta should be evaluated for the presence of atherosclerotic disease associated with luminal projections, a contraindication for use of the catheter of this invention.
  • the aortic valve should be inspected for significant insufficiency, a contraindication for delivery of cardioplegia in the aortic root with the balloon catheter of this invention. 3.
  • the integrity of the occlusion balloon is checked by placing the distal end (balloon-tip) of the catheter into a basin of sterile saline solution while inflating the balloon with 20 c.c.s of air; if air bubbles are visualized leaking from balloon or balloon bond area replace cannula. The air should then be removed by gentle aspiration, completely collapsing the balloon against the main body of the arterial perfusion cannula. A 20cc or syringe filled with normal saline solution should be used to prime the balloon and it's inflation channel.
  • the patient is systemically anticoagulated as appropriate for cardiopulmonary bypass using heparin administered intravenously, with activated clotting times (ACT) determined in the routine fashion.
  • ACT activated clotting times
  • a short vascular cannula with hollow-needle obturator is inserted into the femoral artery, with free blood return verifying intralumenal tip location.
  • the needle obturator is removed, and a .035 x 180 cm stiff guide wire is introduced through the cannula and advanced cephalically up the aorta and across the aortic arch to position the tip in the ascending aorta; TEE imaging should be used to verify proper guide wire placement in the ascending aorta. Fluoroscopic visualization of the guide wire placement may also be used if desired.
  • the arterial catheter is advanced over the guide wire into the femoral artery through the short sheath.
  • the catheter (with obturator) is advanced in a retrograde fashion up the lilac artery, abdominal aorta and thoracic aorta.
  • the arterial catheter is guided over the aortic arch with imaging assistance and the tip of the cannula is advanced into the ascending aorta.
  • the position of the tip should be evaluated using TEE to verify that the tip is above and not interfering with the aortic valve. If Fluoroscopic visualization is desired; the radiopaque cannula marker at tip of the cannula can be used to assist placement.
  • the arterial perfusion lumen of the catheter is attached to the arterial blood supply line at 105 from the CPM, taking care not to introduce air at the site of connection (see Figures 9, 10A and 10B for diagram of port, lumen and component locations).
  • the inflation syringe filled with saline solution is attached via three-way valved manifold 119 (stopcock) to the occlusion balloon control lumen at 118.
  • Pressure line from suitable pressure monitoring device should be attached to remaining valve port 120 to monitor balloon inflation pressure (see Figures 9, 10A and 10B for diagram of port, lumen and component locations).
  • the aortic root lumen labeled "k” is attached via three-way valved manifold 114 (stopcock) to the cardioplegia solution delivery/vent line from the CPM through 113.
  • a pressure line from suitable pressure monitoring device should be attached to remaining valve port 114 to monitor cardioplegia or aortic root pressure.
  • the cardiopulmonary bypass machine vent line is equipped with a ventricular vent valve to prevent excessive negative pressure on the vent line (see Figures 9, 10A and 10B for diagram of port, lumen and component locations).
  • Cardioplegic solution line pressure, aortic root pressure and balloon inflation pressure are measured at the appropriate ports as indicated (see Figures 9, 10A and
  • Venous cannulation is performed by direct cannulation of the right atrium with single or dual-stage cannula, selected cannulation of the superior and inferior vena cavas, or cannulation of the right atrium via the femoral, jugular or subclavian vein. 13. Cardiopulmonary bypass is initiated.
  • the right and left radial/brachial pressure waveforms are closely monitored during inflation, and the position of the balloon observed with TEE. Any change in the right radial/brachial waveform (in comparison to the left) may indicate that the occlusion balloon is obstructing the origin of the innominate artery, requiring deflation and repositioning.
  • the right and left arterial waveforms are monitored and evaluated continuously during the period of balloon inflation. Any change in the right radial/brachial waveform (in comparison to the left) may indicate that the occlusion balloon is obstructing the origin of the innominate artery, requiring deflation and repositioning.
  • Cardioplegic solution is administered through the aortic root lumen as required to provide arrest. Prior to the delivery of cardioplegia, the aortic vent is stopped for 1- 2 minutes to allow accumulation of blood at the aortic root. The aortic root lumen is then cleared of air by gentle aspiration or gravity blood flow back through the lumen, then the cardioplegia solution can be administered through the lumen. The cardioplegia flow should begin slowly, and gradually be increased to the desired flow and pressure. The position of the occluding balloon should be closely observed for shifts during the delivery of cardioplegia, and verified again after cessation of the cardioplegia delivery.
  • the aortic root lumen may be opened to the CPB vent line when cardioplegia is not being administered.
  • a safety valve should be inserted into the vent line to prevent more than 80mmHg of vacuum. It is recommended that the surgical field be flooded with CO2 to prevent air introduction.
  • 17. When aortic occlusion is no longer required gently aspirate fluid from balloon until total volume used for inflation is returned to syringe; close stopcock to balloon inflation lumen to assure balloon is collapsed against cannula. Cannula may now be withdrawn at the conclusion of bypass. 18.
  • withdraw catheter to indicator mark indicating distal blood outlet port is two inches from arterial access incision, clamp cannula at indicator mark using tube-occluding forceps.
  • a sterile towel should be wrapped around catheter covering exposed portion of catheter between indicator mark and distal end of catheter; this will control blood loss during catheter withdrawal. If obturator reinsertion is desired, obturator may now be inserted back into catheter up to position of clamp. Clamp should be removed and obturator advanced to incision site. Catheter can now be withdrawn on to obturator and access incision closed. Should change out of the catheter be required during cardiopulmonary bypass:
  • Clamp arterial cannula at 3/8 tubing section provided for clamping.
  • Clamp cardiopulmonary bypass machine arterial line just distal of the arterial perfusion catheter connection. Separate connection between arterial perfusion catheter and cardiopulmonary bypass machine arterial line.
  • the arterial perfusion catheter (with obturator) is advanced in a retrograde fashion up the lilac artery, abdominal aorta and thoracic aorta.
  • the obturator can be removed from the catheter, which is de-aired by allowing back bleeding, and then clamped at the 3/8 tubing area provided for clamping.
  • the cardiopulmonary bypass machine arterial line may now be connected to the catheter, taking care not to introduce any air into the line while connecting. Bypass may now be reinitiated.
  • the arterial perfusion catheter should then be positioned and used as refe ⁇ ed to in directions for use items 7 through 18.

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Abstract

L'invention concerne un cathéter à ballonnet intra-aortique à plusieurs lumières. Ledit cathéter est conçu pour assister les chirurgiens dans la pratique, plus efficace, de la chirurgie cardio-vasculaire, notamment la circulation extracorporelle (CPB). Dans un premier aspect, le cathéter est inséré dans une artère fémorale, puis il est introduit par ladite artère jusque dans l'arc aortique, où il est positionné de manière que le ballonnet se trouve dans l'aorte descendante. Une fois gonflé, le ballonnet (de préférence, de configuration cylindrique) obture l'arc aortique entre les grandes artères et les ostia coronaires. Pour ralentir le coeur, on perfuse une solution cardioplégique dans le coeur via une lumière interne du cathéter. Le sang arrivant d'une machine cardio-pulmonaire circule dans une lumière d'écoulement sanguin du cathéter pour être délivré par flux antérograde dans toutes les artères. La partie distale du cathéter comporte moins de lumières que sa partie proximale. L'invention concerne également un cathéter aortique à ballonnet à plusieurs lumières selon un autre mode de réalisation, que l'on insère dans l'aorte du patient.
EP01905354A 2000-02-04 2001-02-02 Catheter a ballonnet intra-aortique dote de caracteristiques de positionnement et de stabilite ameliorees Withdrawn EP1255582A1 (fr)

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US18023300P 2000-02-04 2000-02-04
US180233P 2000-02-04
PCT/US2001/003395 WO2001056643A1 (fr) 2000-02-04 2001-02-02 Catheter a ballonnet intra-aortique dote de caracteristiques de positionnement et de stabilite ameliorees

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NL8901654A (nl) * 1989-06-29 1991-01-16 Cordis Europ Werkwijze voor het vervaardigen van catheter, en met deze werkwijze vervaardigde catheter.
AR245376A1 (es) 1991-02-25 1994-01-31 Liliana Rosa Grinfeld Y Robert Canula de perfusion arterial, para circulacion extracorporea y otros usos.
US5433700A (en) 1992-12-03 1995-07-18 Stanford Surgical Technologies, Inc. Method for intraluminally inducing cardioplegic arrest and catheter for use therein
US5452733A (en) 1993-02-22 1995-09-26 Stanford Surgical Technologies, Inc. Methods for performing thoracoscopic coronary artery bypass
US5458574A (en) 1994-03-16 1995-10-17 Heartport, Inc. System for performing a cardiac procedure
AU685161B2 (en) 1993-09-17 1998-01-15 Edwards Lifesciences Ag Endovascular system for arresting the heart
US5759170A (en) 1993-11-30 1998-06-02 Heartport, Inc. Method for intraluminally inducing cardioplegic arrest and catheter for use therein
AU691854B2 (en) 1993-12-03 1998-05-28 Edwards Lifesciences Ag Cardiopulmonary bypass system for closed-chest intervention
US5868703A (en) * 1996-04-10 1999-02-09 Endoscopic Technologies, Inc. Multichannel catheter
US6132397A (en) * 1997-05-01 2000-10-17 Chase Medical Inc. Integral aortic arch infusion clamp catheter
US6508777B1 (en) * 1998-05-08 2003-01-21 Cardeon Corporation Circulatory support system and method of use for isolated segmental perfusion
AU3859300A (en) * 1999-02-19 2000-09-04 Endoscopic Technologies, Inc. Multichannel catheter with obturator

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