Surgery – Instruments – Sutureless closure
Reexamination Certificate
1999-04-05
2003-03-25
Jackson, Gary (Department: 3731)
Surgery
Instruments
Sutureless closure
Reexamination Certificate
active
06537299
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical and surgical devices and methods thereof. Specifically, the present invention relates to an intravascular hemostasis device and method used to create a blood-free area in a portion of a blood vessel, such as the aorta, or a body organ, during a medical or surgical procedure, such as a proximal anastomosis procedure, while still permitting the flow of blood within the vessel.
BACKGROUND OF THE INVENTION
A manifestation of coronary artery disease is the build-up of plaque on the inner walls of the coronary arteries, which causes narrowing or complete closure of these arteries, resulting in insufficient blood flow. This deprives the heart muscle of oxygen and nutrients, leading to ischemia, possible myocardial infarction and even death. Surgery to alleviate this problem often involves creating an anastomosis between a coronary artery and a graft vessel to restore a blood flow path to essential tissues. An anastomosis is a surgical procedure by which two vascular structures, such as a graft vessel and a coronary artery, are interconnected.
Conventional coronary bypass graft procedures require that a source of arterial blood be prepared for subsequent bypass connection to the diseased artery. An arterial graft can be used to provide a source of blood flow, or a free vessel graft may be used and connected at the proximal end to a source of blood flow. Preferably, the source of blood flow is any one of a number of existing arteries that are dissected in preparation for the bypass graft procedure. In many instances, it is preferred to use either the left or right internal mammary artery. In multiple bypass procedures, it may be necessary to use free vein graft vessels such as the saphenous vein of the leg or the cephalic or basilic veins in the arm. Alternatively, free arterial grafts can be used when the leg or arm veins are unavailable or are unsuitable, such as the gastroepiploic artery in the abdomen, and other arteries harvested from the patient's body. Synthetic graft materials, such as Dacron or Gortex grafts, can be used as well. If a free graft vessel is used, the upstream end (proximal) of the dissected vessel, which is the arterial blood source, will be secured to the aorta to provide the desired bypass blood flow in a proximal anastomosis procedure, and the downstream end (distal) of the dissected vessel will be connected to the target vessel in a distal anastomosis procedure.
Currently, the conventional practice in performing coronary artery bypass graft surgical procedures is to open the chest by making a longitudinal incision along the sternum (e.g., a partial or median sternotomy), placing the patient on a cardiopulmonary bypass (CPB) (heart-lung) machine, stopping the heart from beating by administering a conventional cardioplegia solution (e.g., a potassium chloride solution) to the heart, and then attaching the coronary artery bypass graft(s) to the coronary arteries (and/or aorta in the case of the proximal end of a free graft vessel). The heart-lung machine is needed to maintain the blood circulation through the patient and to provide gas and heat exchange surfaces. However, there are numerous complications associated with conventional open-chest procedures, many of which are related to the use of a heart-lung machine. The use of a heart-lung machine has been shown to be the cause of many of the complications that have been reported in conventional coronary artery bypass graft procedures, such as complement and neutrophil activation, adverse neuropsychologic effects, coagulopathy, and even stroke. The period of CPB should be minimized, if not avoided altogether, to reduce patient morbidity.
A current trend in coronary artery bypass graft surgery is to utilize a minimally invasive surgical technique. Minimally invasive techniques (i.e., surgical techniques that avoid the partial or median sternotomy and/or the use of CPB) have been developed to attempt to reduce or eliminate some of the more serious complications of conventional open-chest cardiac surgery techniques, such as the morbidity associated with the use of CPB. One approach to minimally invasive cardiac surgery is an endoscopic procedure in which access to the heart is gained through several small openings, or ports, in the chest wall of a patient. The endoscopic method allows surgeons to stop the heart without cracking the chest by utilizing a series of internal catheters to stop blood flow through the aorta and to administer a conventional cardioplegia solution (e.g., a potassium chloride solution) to facilitate stopping the heart. The cardioplegia solution paralyzes the electrical activity of the heart and renders the heart substantially totally motionless during the surgery. The endoscopic approach utilizes groin cannulation to establish CPB which takes over the function of the heart and lungs by circulating oxygenated blood throughout the body. After CPB is started, an intraaortic balloon catheter that functions as an internal aortic clamp by means of an expandable balloon at its distal end is used to occlude blood flow in the ascending aorta from within. A full description of an example of one preferred endoscopic technique is found in U. S. Pat. No. 5,452,733, the complete disclosure of which is incorporated by reference herein. A primary drawback of endoscopic cardiac surgery procedures, however, is that such procedures do not avoid the damaging effects of CPB generally described above.
An approach to minimally invasive cardiac surgery that avoids CPB and aortic cross-clamping is minimally invasive direct coronary artery bypass grafting (MIDCAB) on a beating heart. Using this method, the heart typically is accessed through a minithoracotomy (i.e., a 6 to 8 cm incision in the patient's chest) which also avoids the sternal splitting incision of conventional cardiac surgery. The heart may also be accessed through a partial or median sternotomy in an off-pump coronary artery bypass graft (OPCAB) technique which gives the surgeon greater direct acces to the heart. In both the MIDCAB and OPCAB procedures, the anastomosis procedure is then performed under direct vision on the beating heart without the use of CPB or potassium chloride cardioplegia. However, there are many obstacles to precise coronary anastomosis during MIDCAB or OPCAB on a beating heart. In particular, the constant translational motion of the heart and bleeding from the opening in the coronary artery hinder precise suture placement in the often tiny coronary vessel.
In response to problems associated with the above-described minimally invasive surgical techniques, a new minimally invasive surgical platform known as the Transarrest™ platform has been developed to minimize the cardiac motion of the beating heart while avoiding the need for CPB, aortic cross-clamping and conventional cardioplegia. The Transarrest™ platform employs a novel pharmaceutical approach to stabilizing the heart. This revolutionary pharmaceutical approach to cardiac stabilization is fully described in co-pending patent application for “Compositions, Apparatus and Methods For Facilitating Surgical Procedures,” Ser. No. 09/131,075, filed Aug. 7, 1998 and invented by Francis G. Duhaylongsod, M.D, the entire contents of which are expressly incorporated by reference herein. As described therein, pharmaceutical compositions, devices, and methods are provided which are useful for medical and surgical procedures which require precise control of cardiac contraction, such as minimally invasive coronary bypass procedures. Generally, the Transarrest™ platform involves the administration of a novel cardioplegia solution which provides for precise heart rate and rhythm control management while maintaining the ability of the heart to be electrically paced (i.e., which does not paralyze the electrical activity of the heart as with conventional cardioplegia solutions). Specifically, the novel cardioplegia solution comprises a pharmaceutical composition which is capable of inducing reversible ventricu
Hogendijk Michael
Narciso, Jr. Hugh L.
Paspa Paul M.
Ethicon Inc.
Jackson Gary
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