Surgery – Miscellaneous – Methods
Reexamination Certificate
1999-10-12
2003-11-25
Isabella, David J. (Department: 3738)
Surgery
Miscellaneous
Methods
Reexamination Certificate
active
06651671
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to surgical instruments, and more specifically, to surgical instruments for less-invasive surgery of the heart and great vessels, especially instruments for repair and replacement of heart valves.
BACKGROUND OF THE INVENTION
The present invention is directed to devices and techniques for the surgical treatment of heart valve disease, and particularly aortic valve disease. The aortic valve separates the left ventricle of the heart from the aorta, which carries oxygenated blood to the arterial system. Normally, when the left ventricle contracts during systole, the aortic valve opens to allow blood to flow into the aorta. During diastole, when the left ventricle returns to its uncontracted state, the aortic valve closes to prevent blood from flowing from the aorta back into the heart.
In aortic valve disease, the aortic valve is compromised due to calcification of the valve leaflets, congenital deformation of the valve, or other conditions such that the valve does not completely open or close normally. As a result, the valve restricts blood flow out of the heart during systole, or the valve allows blood flow back into the heart during diastole. If the condition becomes sufficiently severe, surgical treatment is frequently required.
Various surgical techniques have been used to repair aortic valves. In conventional “open-chest” approaches, a large opening is formed in the chest—known as a sternotomy or thoracotomy—the patient's heart is arrested while circulation is supported by a cardiopulmonary bypass system, an incision is formed in the aorta, and instruments are then used to decalcify the valve, to separate valve leaflets which are fused together, or to constrict the annulus of an enlarged valve. Less-invasive approaches to valve repair have also been proposed. Balloon valvuloplasty, for example, involves the use of a balloon catheter threaded from a peripheral artery into the aorta, and expansion of a balloon within the calcified aortic valve to separate the valve leaflets while the heart remains beating. Unfortunately, aortic valve repair techniques have not had long-lasting success in preventing recurrence of the disease, and eventual replacement of the valve is frequently required.
The most widely-accepted surgical technique for the treatment of severe aortic valve disease is aortic valve replacement. In aortic valve replacement surgery, the diseased aortic valve is replaced with a prosthetic valve, homograft, allograft, or other type of replacement valve. Conventional aortic valve replacement techniques require a sternotomy or thoracotomy to be formed so as to provide access into and visualization of the chest cavity. The patient is placed on cardiopulmonary bypass, and the heart is stopped using an aortic cross-clamp to block blood flow through the aorta while a cardioplegic fluid is injected into the aorta upstream of the cross-xclamp or into the coronary sinus on the venous side of the heart. An incision is then made in the ascending aorta near the aortic valve, and the native valve leaflets are removed using surgical scissors inserted through the aortic incision. Specialized instruments may also be used to debride the valve annulus. A replacement valve is then sutured in place at the native valve position.
While aortic valve replacement is frequently effective in treating aortic valve disease and can add ten or more years to the life of a patient having the disease, the procedure also suffers from significant drawbacks surrounding the invasiveness and trauma of the surgery. The large thoracotomy required by the procedure is highly invasive, produces a great deal of pain, heightens the risk of infection and other complications, increases costs, and lengthens hospital stay considerably.
What is needed, therefore, are devices and techniques for the surgical treatment of aortic valve disease, especially for performing aortic valve replacement, which do not suffer from the drawbacks of conventional open-chest aortic valve surgery. Most desirably, the devices and techniques should obviate the need for a sternotomy and minimize the size of any necessary thoracic incisions to eliminate the pain, trauma, risks, costs, and lengthy recovery time associated with conventional aortic valve surgery. At the same time, the devices and techniques should facilitate replacement of a diseased aortic valve with the same types of replacement valves which currently enjoy wide acceptance for aortic valve replacement, including mechanical valves, bioprosthetic valves, homografts, allografts, and others.
SUMMARY OF THE INVENTION
The invention provides devices and methods for performing heart valve surgery which eliminate the need for a median sternotomy or other type of thoracotomy. The devices and methods are particularly advantageous in that they facilitate surgical repair or replacement of a heart valve in a manner analogous to the widely-accepted surgical techniques used in open-chest valve repair or replacement, yet without the invasiveness, pain, risks, and recovery time of conventional techniques. Advantageously, the devices and methods facilitate replacement of a diseased heart valve using various types of commercially-available replacement valves with proven safety and effectiveness. The devices and methods of the invention are perhaps most useful for the repair and replacement of the aortic valve, but may be used for the surgical treatment of any of the valves of the heart, as well as in other surgical procedures within the heart and great vessels of the thorax.
In one aspect of the invention, a method is provided for accessing an internal chamber of a patient's heart through a vessel in fluid communication with the chamber. The method includes visualizing the vessel through a percutaneous access port between two adjacent ribs. An instrument is positioned into an inner lumen of the vessel through a penetration in a wall of the vessel. The proximal end of the instrument extends out of the patient's chest through a percutaneous access port between the ribs, and the proximal end of the instrument is then manipulated to position the distal end of the instrument through the vessel and into the internal chamber of the heart. With the instrument within the internal chamber, various types of inspection, diagnostic and interventional procedures may then be performed. All manipulations of the instrument are performed with the surgeon's hands outside of the patient's chest, and none of the ribs or the sternum are cut or removed during each step. Preferably, in fact, none of the ribs or the sternum are significantly retracted from their natural undeflected positions during the procedure. Visualization is accomplished either by looking directly into the chest through an access port between the ribs, by introducing a thoracoscope through such an access port and viewing a video image of the vessel and heart on a monitor, or by using other available less-invasive visualization devices.
In a preferred embodiment, the vessel is the aorta, the chamber is the left ventricle of the heart, and the distal end of the instrument is positioned into the aorta, through the aortic valve, and into the left ventricle. The instrument may then be used to perform a procedure in the heart or on the aortic valve itself. For example, the instrument could be used for repairing a diseased aortic valve, and may comprise a debridement device for removing calcium from the valve annulus or leaflets, a scissors for incising the leaflet commissures to separate the leaflets, a cutting device for resecting the valve leaflets, or a needle driver for applying a suture to the valve annulus to reduce the diameter of the valve.
In a particularly preferred embodiment, the instrument is used in the replacement of a diseased aortic valve. The instrument may be a scissors, rongeur, knife or other cutting instrument for removing the native valve leaflets, or a needle driver or other device for applying sutures to the native valve annulus which are used
Donlon Brian S.
Garrison Michi E.
Peters William S.
Rosenman Daniel C.
Stevens John H.
Heartport Inc.
Isabella David J.
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