Surgery – Blood drawn and replaced or treated and returned to body – Constituent removed from blood and remainder returned to body
Reexamination Certificate
1998-10-07
2001-09-25
Ruhl, Dennis (Department: 3761)
Surgery
Blood drawn and replaced or treated and returned to body
Constituent removed from blood and remainder returned to body
C604S004010, C604S509000, C604S096010
Reexamination Certificate
active
06293920
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a system of venous perfusion and arterial perfusion catheters for use in obtaining total cardiopulmonary bypass support and isolation of the heart during the performance of heart surgery with provisions for proximal aortic occlusion, aortic root cardioplegia delivery, aortic root venting, and left ventricular decompression without the necessity for a conventional open chest operation.
BACKGROUND OF THE INVENTION
Each year cardiopulmonary bypass permits over 500,000 patients worldwide with disabling heart disease to undergo therapeutic cardiac operations. The essential goals of cardiopulmonary bypass for heart surgery are to provide life-support functions, a motionless, decompressed heart, and a dry, bloodless field of view for the surgeon.
In a basic heart-lung life-support system oxygen-poor blood is diverted from the venous circulation of the patient and is transported to the heart-lung machine where reoxygenation occurs, carbon dioxide is discarded and heat regulation (warming or cooling) is accomplished. This processed blood is then returned (perfused) into the patient's arterial circulation for distribution throughout the entire body to nourish and maintain viability of the vital organs. Although current venous diversion and arterial perfusion methods can be combined with other measures to effectively isolate the heart for cardiac surgery, they are associated with disadvantages and limitations which contribute significantly to patient morbidity, mortality, and health care costs. It is thus desirable to develop improved cardiopulmonary bypass devices and methods that are safer, less traumatic, and more cost effective.
In the prior art, the method of collecting oxygen-depleted venous return blood from a patient for transportation to the cardiopulmonary bypass pump (heart-lung machine) for re-oxygenation and temperature regulation consisted of three different techniques: (1) a single venous catheter was inserted directly into the right atrium; (2) two catheters were directed via right atrial insertion selectively into the superior vena cava and inferior vena cava; (3) the third technique required the venous catheters to be inserted through peripheral vein access sites with the distal tip of the catheter(s) thereafter positioned either in the right atrium and/or superior vena cava/inferior vena cava areas.
In the techniques where catheters were inserted via the right atrium, the surgeon had available three options of catheter types. Firstly, a simple type where all of the orifices or openings for passage of blood into the catheter were positioned within the atrial chamber; or secondly, a two-stage type wherein some openings were positioned in the atrial chamber and others were located at the tip of the catheter device and positioned in the inferior vena cava; or thirdly, where two individual catheters were inserted at separate sites into the right atrial chamber or caval (inferior vena cava/superior vena cava) structures and selectively directed so that all orifices or openings for passage of blood were positioned within the superior vena cava or the inferior vena cava respectively. Direct insertion of catheters into the right atrium or vena cava results in direct surgical trauma due to the holes which must be cut in these structures for catheter entry. A circular, purse-string suture, an atrial vascular clamp for controlling bleeding and closing the hole, adds to the operative time and the cost of the procedure. Surgical wounds in the atrium, inferior vena cava, or superior vena cava have the potential for causing complications including, but not limited to, hemorrhagic bleeding, cardiac rhythm disturbances, air embolism (introduction of air into the cardiac chambers), and extensive surgical adhesions. Furthermore, this approach requires a major invasive breast-bone splitting (sternotomy) or rib spreading (thoracotomy) surgical procedure to reach the atrium and make the insertion.
Cardiopulmonary bypass support can be either partial where only a portion of the blood returning via the superior vena cava (upper body) and inferior vena cava (lower body) into the right atrium is diverted into the pump (heart-lung machine); or, total, wherein all, blood returning via the superior vena cava and inferior vena cava is diverted away from the right atrium into the pump. There are clinical situations where it is advantageous to divert all venous return blood away from the heart. Total cardiopulmonary bypass contributes to cardiac decompression and decreases the detrimental effects of myocardial distention. Furthermore, it provides the surgeon with superior operating visibility of structures within the cardiac chambers which can be obscured if a substantial volume of blood is allowed to enter the heart. There are two methods in the prior art for achieving total cardiopulmonary bypass. The first required placement of tourniquet loops around the superior vena cava and inferior vena cava catheters. The loops are snugly tightened around the catheters in order to prevent blood from entering the atrium. In the second method, occlusion balloons mounted on selective superior vena cava and inferior vena cava catheters were inflated to prevent blood from reaching the right atrium. Both of these methods for total cardiopulmonary bypass capability require major surgical thoracotomy or sternotomy for access to the right atrium and caval structures. Direct surgical dissection of the inferior vena cava, superior vena cava, and right atrium for catheter insertion and tourniquet loop positioning not only adds to the operative time but also increases the risks of injury to these structures which could lead to bleeding, cardiac rhythm disturbances and scarring.
Although peripherally inserted venous drainage catheters of the prior art avoid direct cardiac trauma and can be placed without a major invasive chest incision (sternotomy or thoracotomy), they are not capable of establishing the condition of total cardiopulmonary bypass.
The technique of the present invention is to insert the venous catheters through a peripheral vein access site and thereafter position the drainage orifices in the superior vena cava and inferior vena cava areas. The catheter(s) features inflatable occlusion balloons that allow the choice of either partial (balloons deflated) or total (balloons inflated) cardiopulmonary bypass support. The insertion site(s) may be individual or a combination of choices of the femoral veins, iliac veins, subclavian veins, axillary veins, and internal jugular veins. The use of this technique has the advantage of avoiding a major chest incision as well as surgical trauma to the right atrium, superior vena cava and inferior vena cava. This eliminates costly surgical instruments, sutures, tourniquets, and operative time associated with the conventional approaches.
In the prior art, the method of delivery of oxygen-rich (arterial-ized) temperature-regulated blood from the cardiopulmonary bypass pump to the arterial circulation of the patient consisted of two different techniques: 1.) a simple, single lumen catheter (cannula) was inserted directly into the aorta (most often the ascending aorta). To make such an insertion, however, access to the aortic wall could only be achieved through a major invasive chest incision such as thoracotomy or sternotomy. Direct surgical trauma to the aorta occurs as a result of the hole which must be cut in the aorta for catheter entry. This hole is surgically repaired after removal of the catheter at the end of the operation but leaves potential for major post-operative bleeding. Other catastrophic complications related to direct insertion of catheters into the aorta include: (a) the risk of splitting the three layers of the aortic wall apart (known as aortic dissection) and (b), the risk of disruption of cholesterol and/or calcium deposits from the innermost layer of the aortic wall at the site of entry which can then be carried into the blood stream to occlude flow in distal arterial branches and reduce function in
Coleman Ronald L.
Jimison James
Sweezer William Penn
Heartport Inc.
Hoekendijk Jens E.
Ruhl Dennis
LandOfFree
Catheter system and method for providing cardiopulmonary... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Catheter system and method for providing cardiopulmonary..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Catheter system and method for providing cardiopulmonary... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2471161