Suture organizing device for surgical retractor and methods...

Surgery – Specula – Retractor

Reexamination Certificate

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Reexamination Certificate

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06450951

ABSTRACT:

FIELD OF INVENTION
The present invention relates to a suture organizing device for use with surgical retractors and devices for stabilizing a predetermined area of the body during a surgical procedure, more particularly to a suture organizing device for use on a surgical retractor and devices used in connection with minimally invasive coronary artery bypass grafting surgical procedures or heart valve procedures.
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 leading to the heart.
One technique for treating such a blockage or restriction is a surgical procedure known as a coronary artery bypass graft procedure, which is more commonly known as “a heart bypass” operation. The surgical correction of occluded or stenosed coronary arteries by means of bypass grafting are probably still 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 from another part of the body for grafting or detaches one end of an artery and connects that end past the obstruction while leaving the other end attached to the arterial supply. When using a vein from another part of the body, the surgeon installs this portion at points that bypass the obstruction. In both cases, the objective is to restore normal blood flow to the heart.
In addition, when using this 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 several procedures necessary 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, expensive 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 the method of choice for therapy of atherosclerosis occlusions for several reasons. The transluminal approach is a less invasive technique that subjects the patient to reduced trauma and less recovery time, especially when compared to bypass grafts that utilize autologous tissue, such as saphenous vein grafts. Also, the patient often suffers complications at the donor site of the graft that may be worse than the sternotomy and anastomosis.
Although PTCA procedures are often successful, complications such as restenosis or thrombosis and embolism can occur. Restenosed vessels may also require surgical intervention for correction.
In recent years, and in an effort to reduce expense, risk and trauma to the patient, physicians have turned to less invasive and less traumatic surgical approaches to the heart. With such procedures, the heart is preferably 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. Because these procedures are performed while the heart muscle is continuing to beat, the blood continues to flow and the heart continues to move in three dimensional movement while the surgeon is attempting to sew the graft in place. Also, the surgical procedure to install the graft requires placing a series of sutures through an extremely small vessel and onto tissue that continues to move during the procedure. It is necessary that these sutures be fully and securely placed so the graft is firmly in position and does not leak.
There 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 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 the 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. 5,875,782 granted to Ferrari et al. and U.S. Pat. No. 5,894,843 granted to Benetti et al. an apparatus for stabilizing the predetermined area on a heart or other organ of a patient to enable a surgical procedure on a beating heart. The apparatus includes a bifurcated member having two elongated prongs and an elongated handle. The handle segment can be movably attached to a rib retractor so that a person is not required to hold the handle segment. In one disclosed embodiment, the apparatus further includes a device to hold the bifurcated member in a position against the surface of the heart sufficiently so that a stabilizing force is applied against the heart and contraction of the heart does not cause either vertical or horizontal motion at the target site during the surgical procedure.
There also is described in U.S. Pat. No. 5,836,311 granted to Borst et al. an apparatus for stabilizing the predetermined area on a heart or other organ of a patient to enable a surgical procedure on a beating heart. The apparatus includes a single legged or bifurcated member having a plurality of suction members thereon which are attached to the surface of the heart using suction pressure. The arm portion of this device can be movably attached to a rib retractor or other surgical device so a person is not required to hold the handle segment and the suction device may be locked into position against the surface of the heart.
In each of the above-described procedures, access to the heart tissue is an important consideration. Therefore, it is desirable to provide a suture organizing device to provide a quick and convenient way to organize and retain various sutures that are use to retain tissue such as pericardial tissue away from the operative field. Furthermore, during heart valve procedures, it is desirable to retain sutures in an organized manner to ensure that the proper sutures are tied together and that the sutures are not tangled during the valve sewing process and that all needles and sutures are accounted for at the end of the procedure.
U.S. Pat. No. 4,185,636 granted to Gabbay et al., discloses a commonly available suture organizer that is used in heart valve procedures to keep the sutures organized. This device includes a plurality of arcuate members that are attachable to the surgical drape. The arcuate members include slots therein to receive and retain the sutures therein as that the surgeon sews the heart valve in place. U.S. Pat. No. 4,492,229 granted to Grunwald discloses a device for attaching the “Gabbay-Frater” type of suture device to the top surface of a surgical retractor.
It desirable to provide a new system and devices related thereto for organizing sutures used in a coronary bypass procedure and in heart valve surgery and methods related thereto. With the recent advances in heart surgery procedures, it is important to provide systems that assist in reducing the time necessary to perform the surgery and to assist in keeping potential areas of confusion to a minimum. It is particularly desirable to provide such a system and devices thereto that are less compl

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