Surgery – Specula – Retractor
Reexamination Certificate
1999-02-26
2001-03-27
Smith, Jeffrey A. (Department: 3732)
Surgery
Specula
Retractor
C600S235000
Reexamination Certificate
active
06206827
ABSTRACT:
The present invention relates to an apparatus and method for stabilizing an area of tissue during a surgical procedure. More precisely, the present invention is directed to an apparatus and method to manipulate and locally stabilize an anastomotic site during a beating heart coronary artery bypass grafting procedure.
BACKGROUND OF THE INVENTION
Various cardiovascular procedures have been performed for many years typically by opening the sternum (referred to as a median sternotomy), and connecting the patient to cardiopulmonary bypass equipment to maintain the circulation of oxygenated blood throughout the patient's circulatory system. In this manner, the heart can be stopped and various surgical procedures performed such as coronary artery bypass grafting and replacement of aortic, mitro, and other heart valves. Numerous other surgical procedures have been performed in a similar manner.
During minimally invasive coronary artery bypass procedures using the beating heart approach, the region of the heart which receives the graft vessel must be stabilized. Presently, this is often performed by threading two suture or silicone rubber strands through the myocardium with curved needles, on either side of the recipient coronary artery at the site of the distal anastomosis. The silicone strands are tensioned to lift the heart and to hold the coronary artery stationary. Suture or silicone strands with curved needles swaged on one end are available for this use.
Placement of the suture or silicone loops may be somewhat difficult, as the heart is beating. The tip of the needle must be placed on the heart, and rotation of the surgeon's wrists must be performed to insert the needle through the myocardium. Unpredictable motion of the epicardial surface during needle placement may cause laceration of the heart or puncture of a coronary artery. It is therefore useful to stabilize the anastomotic area during the surgical procedure.
There are devices and methods that facilitate the performance of cardiac procedures such as heart valve repair and replacement, coronary artery bypass grafting, and the like, using minimally invasive techniques to eliminate the need for a gross thoracotomy. For example, U.S. Pat. No. 5,425,705 to Evard et al. discloses an apparatus and method for thoracoscopically arresting the heart and establishing cardiopulmonary bypass, thus facilitating a variety of less-invasive surgical procedures on and within the heart and great vessels of the thorax. In one embodiment, Evard provides a thoracoscopic system for arresting a patient's heart including a clamp configured for introduction into the patient's thoracic cavity through a percutaneous intercostal penetration in the patient's chest. The clamp is positionable about the patient's ascending aorta between the coronary arteries and the brachiocephalic artery. The clamp is coupled to the distal end of an elongated handle for manipulating the clamp from a location outside of the patient's thoracic cavity. It is known to use surgical clips or clamps for the purpose of clamping vessels or manipulating tissue. Typically, such clamps have a pair of movable jaws biased by a spring into a closed position, allowing the clamp to be placed on a vessel or portion of tissue and be firmly retained thereon. Examples of such clamps can be found in U.S. Pat. No. 4,932,955 to Merz et al.; U.S. Pat. No. 4,605,990 to Wilder et al.; 5,074,870 to Von Zeppelin; U.S. Pat. No. 3,809,094 to Cook; U.S. Pat. No. 4,404,677 to Springer; U.S. Pat. No. 4,051,844 to Chiulli; and U.S. Pat. No. 4,988,355 to Leveen et al.
Outside of the field of cardiac surgery, U.S. Pat. No. 5,415,666 to Gourlay et al. discloses a tethered clamp retractor used for tissue manipulation. The tissue manipulation system includes a tethered clamp, a clamp applicator for positioning the clamp through a trocar sleeve and applying the clamp to a tissue location in the abdominal cavity, and a rigid positioning shaft for engaging the clamp and/or tether to manipulate the clamp.
In view of the shortcomings of the prior art devices, there is a specific need for an apparatus and method for locally stabilizing an anastomotic site during a beating heart coronary artery grafting procedure.
SUMMARY OF THE INVENTION
The present invention is directed to a system and method for locally stabilizing an anastomotic site of a beating heart during a cardiac surgical procedure. In a preferred embodiment, the present invention system includes a pad of bioabsorbable adhesive attached to an area of cardiac tissue, means for controlling the pad and thereby manipulating the area of cardiac tissue to create a locally stable area, and means for bonding the pad to the area of tissue. A retractor is used to grasp the means for controlling the pad, which means may be a rigid control arm. In a preferred method of the present invention, the procedure comprises exposing and drying off the anastomotic area of the heart's surface, placing a structural component or pad in the form of a bioabsorbable glue to tissue adjacent the coronary artery, letting the glue cure, attaching a retractor to the structural component or pad, and manipulating the structural component to minimize movement and stabilize the anastomotic site surrounding the artery.
In an alternative embodiment, the present invention provides a system for locally stabilizing the myocardium adjacent to an anastomotic site of a coronary artery of a beating heart during a surgical procedure, the system having a first helix-shaped fastener inserted into the myocardium adjacent the coronary artery, a second helix-shaped fastener inserted into the myocardium adjacent the coronary artery, and at least one suture attached to each of the first and second helix fasteners whereby the sutures are tensioned to stabilize the myocardium and the coronary artery.
In the exemplary embodiment, the present invention employs a strand of suture attached to the helix-shaped fastener. The helix-shaped fastener is inserted into the myocardium adjacent the anastomotic site of the coronary artery by means of a mechanical insertion device. A second helix-shaped fastener is inserted on the opposite side of the artery and tension is applied to suspend and stabilize the anastomotic site. Because the helix-shaped fastener involves placement of the tip of the device on the heart and depression of the insertion device handle, it is faster and simpler than use of the conventional curved needle insertion. The helix-shaped fastener advances axially, similar to that of a corkscrew, into the myocardium, and the rotational maneuver of a conventional needle placement is avoided. In the preferred embodiment, the helix-shaped fastener is manufactured form a rigid, bioabsorbable material. Rigidity of the fastener is required to allow insertion into the myocardium; use of a bioabsorbable material allows the fastener to be left in the heart tissue following coronary bypass without need for its removal. The suture attached to the fastener may also be bioabsorbable, such that following use, the suture may be cut close to the fastener and the remaining short end left behind as well.
The sutures may be attached to a frame outside the surface of the skin of the patient; the frame may encircle the limited thoracotomy, or sternotomy used for cardiac access. Alternatively, the sutures may be attached to a frame which in turn is attached to the operating table. It is anticipated that two helix-shaped fasteners be used on opposite sides of a coronary artery for stabilization, although additional helix-shaped fasteners may be added as needed.
These and other advantages of the present invention will become apparent from the following detailed description thereof when taken in conjunction with the accompanying exemplary drawings.
REFERENCES:
patent: 4051842 (1977-10-01), Hazel et al.
patent: 4430991 (1984-02-01), Darnell
patent: 4492229 (1985-01-01), Grunwald
patent: 5148806 (1992-09-01), Fukui et al.
patent: 5415666 (1995-05-01), Gourlay et al.
patent: 5425705 (1995-06-01
Brown Peter S.
Chin Albert K.
Kovac Tim J.
Fenwick & West LLP
Guidant Corporation
Smith Jeffrey A.
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