Surgery – Instruments
Reexamination Certificate
2001-06-27
2003-07-15
Dvorak, Linda C. M. (Department: 3739)
Surgery
Instruments
C604S513000, C604S539000, C604S174000, C604S164040, C606S108000
Reexamination Certificate
active
06592573
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates broadly to surgical instruments and systems. More particularly, this invention relates to heart stabilizers for stabilizing the coronary artery. More particularly, the invention relates to such stabilizing being adapted to pass through a port during the surgery.
2. State of the Art
Substantially all coronary artery bypass (CAB) procedures are performed via an open chest method. In the procedure, the chest is opened through an incision in the middle of the chest, called a sternotomy, and the ribs are retracted and held stably open with a retractor. This provides a sufficient amount of access to the heart. The heart is then arrested and the blood flow is rerouted through a heart-lung machine. The bypass procedure is then performed, and once complete, the heart is then restarted and blood is permitted to flow through the “bypass”. While this procedure is the norm, it is far from desirable. First, arresting the heart is a dangerous procedure and can lead to serious complications and even death. Second, the procedure requires a sternotomy, which is painful and traumatic. Because of this incision the recovery time is relatively long and the patient is left with a permanent large scar.
More recently, some surgeons have performed coronary artery bypass surgery on a beating heart. The chest is opened via a sternotomy and retracted. Using a device called a heart stabilizer, the surgical site on the heart is essentially immobilized for suturing. The heart stabilizer is typically anchored to the retractors which are in turn anchored to the walls of the chest at the site of the incision. Direct access to the surgical site as well as immobilization of the surgical site are key to the surgery. These factors allow the surgeon to perform a suture or other operation with precision. While the methodology is effective and eliminates the potential complications of arresting the heart, the drawbacks associated with the sternotomy remain.
It has recently been proposed by others to perform a closed chest bypass procedure on the beating heart. However, the proposal has not been followed by any concrete directions on how to satisfactorily perform the procedure. In addition, the inventors of the present application have recognized that the closed chest procedure has a number of hurdles to overcome. First, it is necessary to stabilize the heart such that the location requiring the bypass does not significantly move during the procedure. Second, while open chest procedure are accompanied by a retractor and instrument supporting framework, in a closed chest procedure, there is no such framework for holding the instruments required for the procedure. In addition, there is no suitable stable port device adapted to securely support instruments passing therethrough. Third, when performing any surgery through a port, the instruments used to work at the surgical site are relatively long compared to open chest instruments. The distance from the surgeons's hand to the tip of the instrument where the work is being performed can be many times greater than in conventional surgery. This increase in length amplifies normal hand tremor and any errors in motion.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide a less traumatic instrument access to the surgical site.
It is another object of the invention to provide a port device which is easy to insert into the body, and particularly into the chest wall.
It is a further object of the invention to provide a port device with a high degree of stability.
It is an additional object of the invention to provide a heart stabilizer which can be inserted through the port device and which is adapted to stabilize a portion of a beating heart such that coronary artery bypass surgery can be performed on the portion of the heart.
It is also an additional object of the invention to provide a heart stabilizer which can be manipulated via a proximal handle external of the port device.
It is still another object of the invention to provide an instrument stabilization system which minimizes unwanted motion of the tips of instrument performing the procedure.
It is still a further object of the invention to provide an instrument stabilization system which can be coupled to the port device.
It is yet another object of the invention to provide a system of components which cohesively operates together to facilitate port off-pump coronary artery bypass surgery on a beating heart.
It is yet a further object of the invention to provide a method of performing port off-pump coronary artery bypass surgery on a beating heart.
In accord with these objects, which will be discussed in detail below, a system for performing port off-pump beating heart coronary artery bypass surgery is provided. The system includes three primary subsystems: a port device, a heart stabilizer, and an instrument stabilizer.
The port device is insertable between the ribs of the patient and functions as an entry way for each instrument necessary for the procedure, e.g., optics, graspers, needle holders, suction/irrigation tubes, stabilizers. According to a currently preferred embodiment, the port device includes a tubular port body having a plurality of circumferential grooves along its length, a slit ball provided about the port body and having ratchet springs which engage within the grooves of the port body, and a base defining a socket in which the slit ball is provided. The base includes a clamping system which compresses the ball to lock the ball at a selected orientation within the socket and also immobilizes the port body relative to the ball. The distal end of the port body includes a pair of swivels rotatably attached thereto. A removable obturator extends within the port body and can be manipulated to cause the swivels to rotate between a closed position (in which the swivels are oriented substantially parallel to the axis of the port body), and an open position (in which the swivels are directed outward from the port body and form a crossbar) and back again. The port body is sized to be inserted through a pair of ribs in a chest wall of a patient.
In another embodiment, the proximal portion of the tubular body includes a plurality of thread grooves extending at least partially about a circumference of the body as well as a means to permit the heart stabilizer, the instrument stabilizer, or another device to be releasably secured to the port. The distal portion of the tubular body is coupled to a swivel adapted to be moved between a first orientation in which the swivel extends in substantially a same direction as the body, and a second orientation at an angle relative to, and preferably substantially perpendicular to, the first orientation.
According to certain embodiments of the port device, a washer is positioned on the body between the swivel and the proximal portion of the body, and a locknut is threadably engaged in the thread grooves. When the tubular body is inserted between two ribs in the chest wall of the patient, the swivel is then opened into the second orientation and the washer is moved along the body to position the chest wall between the swivel and the washer. The locknut is then tightened about the body to clamp the washer against the chest wall and stably secure the tubular body within the chest wall.
According to other embodiments of the port device, a platform movable along the length of the port body includes adjustable legs and feet. The legs are adjusted such that the feet contact the chest wall and clamp the chest wall between the feet and the swivel. In addition, the legs may be adjusted to provide the body in a desired angle relative to the chest wall. According to preferred aspects of these embodiments of the port device, the platform may be ratcheted relative to the port body and the feet may be ratcheted relative to the platform to permit rapid adjustment of the port relative to the patient. In addition, preferably three legs are provided to aid in stability of the port on the bod
Castañeda Javier E.
de la Torre Ralph
Francese Jose Luis
Palmer Matthew A.
Gordon & Jacobson P.C.
Popcab, LLC
Ram Jocelyn
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