Surgery – Specula – Retractor
Reexamination Certificate
2002-04-01
2004-06-22
O'Connor, Cary E. (Department: 3732)
Surgery
Specula
Retractor
C600S228000, C600S229000, C606S023000, C607S108000
Reexamination Certificate
active
06752759
ABSTRACT:
FIELD OF INVENTION
The present invention relates to surgical retractors and devices for stabilizing a predetermined area of the body during a surgical procedure, more particularly to a stabilizer used in connection with a retractor that is preferably used in coronary artery bypass grafting surgical procedures, and more specifically to a cooled stabilizer attached to a rigid or flexible arm for providing a chilled stabilization surface in contact with body tissue.
BACKGROUND OF THE INVENTION
Diseases of the cardiovascular system affect millions of people each year and are a cause of death for large numbers of people in the United States and throughout the world. A particularly prevalent form of cardiovascular disease involves a reduction in the blood supply to the heart caused by atherosclerosis (coronary artery disease) or other conditions that create a restriction in blood flow at a critical point in the cardiovascular system affecting blood flow to the heart.
One technique for treating such a blockage or restriction is a surgical procedure known as a coronary artery bypass graft (CABG) procedure, which is commonly performed while using a heart-lung machine (“on-pump”), but can also be performed without the heart-lung machine (“off-pump”). The surgical correction of occluded or stenosed coronary arteries by means of bypass grafting is among the most common procedures performed today, especially when multiple grafts are needed.
In the coronary artery bypass graft procedure, the surgeon either removes a portion of a vein or artery from another part of the body for grafting or detaches one end of a local artery, e.g., the left internal mammary artery (LIMA) or the right internal mammary artery (RIMA), and connects that end past the obstruction in the coronary artery while leaving the other end attached to the arterial supply. When using a vein or artery from another part of the body, the surgeon provides arterial supply from the aorta and connects to a point that bypasses the obstruction. In both cases, the objective is to bypass the obstruction and restore normal blood flow to the heart.
In addition, when using the on-pump CABG technique, the surgeon makes a long incision down the middle of the chest, saws through the sternum, spreads the two halves of the sternum apart and then performs the necessary procedures to connect the surgical patient to a cardiopulmonary bypass machine to continue the circulation of oxygenated blood to the rest of the body while the heart is stopped and the graft is being sewn in place. Although such a procedure is one common technique for treatment, the procedure is lengthy, traumatic, costly and can damage the heart, the central nervous system, and the blood supply.
Interventional techniques, such as percutaneous transluminal angioplasty (PTCA), have gained popularity as an alternative method of therapy for atherosclerosis. PTCA is a minimally invasive technique that subjects the patient to reduced trauma and reduced recovery time, especially when compared to on-pump CABG techniques.
Although PTCA procedures are often successful, complications can arise, such as restenosis or thrombosis and embolism. Restenosed vessels often require surgical intervention for correction. The surgical correction of restenosis, like the conventional coronary bypass surgical procedure, previously required the heart to be stopped and the patient placed on heart/lung bypass.
In recent years, and in an effort to reduce cost, risk, and trauma to the patient, physicians have turned to minimally or less invasive surgical approaches to the heart bypass procedure, such as intercostal and endoscopic access to the surgical site. With such off-pump CABG procedures, the heart is beating during the surgical procedure. Thus, there is no need for any form of cardiopulmonary bypass, and there is no need to perform the extensive surgical procedures necessary to connect the patient to such a bypass machine.
Such attempts at performing minimally invasive bypass grafting on a beating heart, however, have been characterized as tedious, dangerous and difficult because of the delicate nature of the surgical procedure, the lack of adequate access to the coronary vessels, and the lack of an ability to adequately stabilize and reduce tissue movement at the graft site. Because these procedures are performed while the heart continues to beat, the blood continues flowing and the heart continues moving in three-dimensional movement while the surgeon attempts to sew the graft in place.
There is disclosed in U.S. Pat. No. 6,348,036 to Looney et al. a surgical retractor and a tissue stabilization device for locally stabilizing a predetermined area of the body. The retractor includes a rail system having two arms and a rack segment interconnecting the two arms for maintaining a desired spacing therebetween. A stabilization arm having a handle segment connects the retractor with the stabilization device. The handle segment is attachable to the retractor by a connector such as a mounting mechanism or a sled member. The stabilization device is pivotally retained at a distal end of the stabilization arm. A bottom surface of the stabilization device can include a textured surface to facilitate engagement with tissue at the predetermined area.
There also is disclosed in U.S. Pat. No. 6,102,854 to Cartier et al. a sternal retractor including a rack bar and two arms attached to rails, and an arm mounted on the rails. A “contacting means” or stabilizer includes two parallel contacting arms that define an area where a targeted artery is engaged between the arms. Silastic tapes can be wrapped around the targeted artery, thereby restricting blood flow in the arterial window.
There also is disclosed in U.S. Pat. No. 5,730,757 an access platform for the dissection of an internal mammary artery. The described access platform has first and second blades interconnected to a spreader member that laterally drives the blades apart or together, and support pads interconnected to the first blade. A torsional member is operably interconnected to the first blade and the spreader member, and is used to vertically displace the first blade in either direction, thus increasing the surgeon's working space and visual access for dissection of the internal mammary artery. A tissue retractor interconnected to the blades is used to draw the soft tissue around the incision away from the surgeon's work area. It is further provided that the access platform can include a port that can be used to mount a heart stabilizer instrument.
There also is described in U.S. Pat. No. 6,306,085 granted to Farascioni; U.S. Pat. No. 6,036,641 to Taylor et al.; U.S. Pat. No. 5,875,782 granted to Ferrari et al.; U.S. Pat. No. 6,033,362 granted to Cohn; U.S. Pat. No. 6,102,854 granted to Cartier et al.; U.S. Pat. No. 5,894,843 granted to Benetti et al.; European Application EP 0 993 806; PCT Publication WO 01/17437; PCT Publication WO 00/62680; and PCT Publication WO 01/58361 various devices for stabilizing a predetermined area on the heart or other organ of a patient, e.g., to enable a surgical procedure on the beating heart. Some of these devices include a stabilizer attached to an elongated arm, which can be movably attached to a rib retractor so that a person is not required to hold the arm. However, none of these devices disclose a chilled surface in contact with the heart for providing traction and quiescence, and that are capable of inducing hemostasis in a targeted area of tissue.
One example of a device for cooling the heart is U.S. Pat. No. 5,117,822 to Laghi, which discloses a spoon-like device including a handle part and a cradling part. The cradling part conforms to the shape of the human heart and serves to separate the heart from the walls of the thoracic cavity. Chilled saline solution is pumped through a passageway in the handle and seeps out through perforations onto the heart itself. Most of the saline solution forms a puddle in the thoracic cavity and is aspirated by a vacuum manifold.
Another example of a device for cooling th
Martin Thomas E.
Valerio Michael A.
Dechert LLP
O'Connor Cary E.
Ryan John W.
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