Irrigator for use with surgical retractor and tissue...

Surgery – Specula – Retractor

Reexamination Certificate

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Details

C600S231000, C600S205000

Reexamination Certificate

active

06364833

ABSTRACT:

FIELD OF INVENTION
The present invention relates to an irrigation system for use with surgical retractors and devices for stabilizing a predetermined area of the body during a surgical procedure. The present invention is even more particularly directed to an irrigation system used in connection with cardiac procedures including coronary artery bypass grafting surgical procedures and valve replacement or repair procedures, and more specifically to an irrigation system for use with surgical retractors and stabilizing devices configured for use with each other for such surgical 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, particularly 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 conventional technique, the surgeon makes a long incision down the middle of the chest, saws through the sternum and spreads the two halves of the stemum apart. The surgeon 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 of the patient.
In an effort to reduce expense, risk and trauma to the patient, physicians have also turned to minimally invasive surgical approaches to the heart, such as intercostal and endoscopic access to the surgical site. With such 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.
Many attempts at performing minimally invasive bypass grafting on a beating heart, however, have been thought of as being tedious, dangerous and difficult because of the delicate nature of the surgical procedure, the lack of adequate access and visibility through a reduced surgical field, and the lack of a convenient way to adequately stabilize and reduce tissue movement at the graft site. 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 desired position against the surface of the heart so that 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
With any of these mechanical stabilization approaches, it is important to maintain a clear field of view for the surgeon to assist in the precise dissection of the surrounding tissue and placement of the sutures for the anastomosis. Additionally, if the surgical field is not clear, it is possible that the surgeon will not be able to adequately assess the viability of the blood vessel for the subsequent procedure. In the past, this has been accomplished by having the nurse squirt fluid onto the surgical field using a syringe containing normal saline. This practice requires the nurse to continually stop whatever else she is doing to locate and pick up the syringe and then squirt a small amount of fluid onto the surgical site as requested by the surgeon. Alternately, a separate device known as a blower/mister may be used to clear the surgical site. This device is a hand held device that is connected to a source of carbon dioxide or saline. Use of this device allows the nurse to direct the tip of the device to the desired area, but it is yet another instrument that is positioned in the surgical field and it requires the nurse to discontinue doing whatever else they may be doing to turn the device on, adjust the flow and move it to the desired location.
There is a continuing need however for improved devices and methods for providing the surgeon with an easier way to perform a very complicated surgical procedure while providing devices and methods that are inexpensive, safe and reliable.
SUMMARY OF THE INVENTION
The present invention features a system for aspirating a surgical field while retracting, stabilizing or manipulating a predetermined area of a body. The overall system includes a surgical retractor, a stabilization arm or apparatus and a tissue support or stabilization device with an irrigator thereon, and methods of us

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