Surgery – Instruments – Sutureless closure
Reexamination Certificate
2000-04-05
2004-02-24
Woo, Julian W. (Department: 3731)
Surgery
Instruments
Sutureless closure
C606S139000, C606S205000, C606S216000
Reexamination Certificate
active
06695866
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to the repair of mitral and tricuspid valves exhibiting valve regurgitation. More particularly, the invention relates to apparatus and methods suitable for a less invasive repair of a mitral or tricuspid heart valve.
Mitral regurgitation, i.e., backward leakage of blood at the mitral heart valve, results in reduced pumping efficiency. Furthermore, compensatory mechanisms such as hypertrophy and dilation of the ventricle suggest early treatment to prevent progressive deterioration of ventricular function. Diagnosis of mitral regurgitation can be performed using visualization with transesophageal echocardiography or by echocardiography. In particular, defective leaflet coaptation and the site and direction of the regurgitant flow can be examined to evaluate likely modes of failure.
Mitral valve prolapse, i.e., myxomatous degeneration of mitral valve leaflets, is the most common cause of mitral regurgitation in North America. Rheumatic heart disease was the most common cause of mitral regurgitation in the U.S.A. thirty years ago and is still the most common cause of mitral regurgitation in developing countries. Chronic rheumatic heart disease results in retraction, deformity and rigidity of one or both mitral valve cusps as well as structural abnormalities in the commissures, chordae tendinae and papillary muscles. Ischemic mitral regurgitation (IMR), i.e., anemia of the valve tissue due to reduced arterial blood flow feeding the valve tissue, is the second most common cause of mitral valve regurgitation. Studies suggest that annular irregularities and posterior papillary muscle fibrosis with scarring of the underlying ventricular wall may be associated with IMR.
Many cases of mitral regurgitation can be repaired by modifications of the original valve in a procedure generally referred to as valvuloplasty. These repair procedures typically involve a full sternotomy and quadrangular resection of the anterior leaflet, while on cardiopulmonary bypass. Repairs can also involve reattachment of chordae tendinae, which tether the valve leaflets, or removal of leaflet tissue to correct misshapen or enlarged valve leaflets. In some cases, the base of the valve is secured using an annuloplasty ring. Valves that are heavily calcified or significantly compromised by disease may need to be replaced.
As an alternative to these repair techniques, an edge-to-edge suturing of the anterior and posterior mitral valve leaflets can be performed. Commonly referred to as a “bow-tie” repair, edge-to-edge suturing ensures leaflet coaptation without performing a quadrangular resection of the anterior leaflet. The bow-tie repair generally involves the use of a centrally located suture, although a suture can be placed close to a commissure, or multiple sutures can be used to complete the repair. A centrally placed suture creates a double orifice valve, which resembles a bow-tie.
The bow-tie repair procedure has been applied using invasive procedures by placing the patient on extracorporeal circulation. An incision is made to provide access into the left atrium of the heart. Following suturing, the atrium is closed. Such repairs can result in a significant decrease in mitral regurgitation along with a corresponding increase in the ejection fraction.
SUMMARY OF THE INVENTION
In a first aspect, the invention relates to a kit including a cardiac catheter and a leaflet fastener applicator. The cardiac catheter generally has suitable dimensions for deployment and insertion into a human heart,in the vicinity of the mitral or tricuspid valve. The leaflet fastener applicator generally has a size allowing insertion through the cardiac catheter and is capable of holding portions of opposing heart valve leaflets.
In another aspect, the invention relates to a method of repairing the mitral or tricuspid valve of a beating heart, the method including:
a) inserting the distal end of a catheter into the heart to provide access to the valve; and
b) fastening together portions of leaflets of the valve using a leaflet fastener applicator inserted through the catheter.
In another aspect, the invention relates to a device including a catheter and a leaflet fastener applicator. The catheter has a proximal end, a distal end and suitable dimensions for insertion into a heart. The leaflet fastener applicator passes through the catheter such that an actuating element projects from the proximal end of the catheter while a fastening element projects from the distal end of the catheter.
In another aspect, the invention relates to a heart valve leaflet fastener including two pairs of arms. Each pair of arms is of a suitable size for fastening heart valve leaflets together. The two pairs of arms are capable of fastening two adjacent leaflets.
In another aspect, the invention relates to a heart valve gripper/fastener applicator including a gripper and a fastener applicator wherein the gripper and the fastener applicator extend from a single shaft.
In another aspect, the invention relates to a heart valve leaflet fastener applicator including two opposing jaws. One of the jaws has a site for holding a tack, and the second jaw has a site for holding a cap.
In another aspect, the invention relates to a gripper including a plunger that slides over an inner shaft, and arms having suitable dimensions for gripping heart valve leaflets. The plunger slides such that the interaction of heart valve leaflets with the plunger directs the leaflets toward the arms.
In another aspect, the invention relates to a fastener applicator including a first shaft, a first portion of a button clip having a sharp projection for piercing a heart valve leaflet, a second shaft that slides over the first shaft, and a second portion of the button clip having an opening to engage the projection of the first portion of the button clip. The second portion of the button clip slides over the first shaft and not over the second shaft such that the second shaft can direct the second portion toward the first portion.
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Bergman Darrin J.
Hinnenkamp Thomas F.
Holmberg William R.
Kuehn Stephen T.
Moore Scott D.
Altera Law Group LLC
Finucane Hallie A.
St. Jude Medical Inc.
Woo Julian W.
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