Surgery – Instruments – Sutureless closure
Reexamination Certificate
1999-10-13
2001-11-06
Recla, Henry J. (Department: 3731)
Surgery
Instruments
Sutureless closure
Reexamination Certificate
active
06312447
ABSTRACT:
CROSS-REFERENCE TO RELATED APPLICATIONS
Not Applicable.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
Not Applicable.
FIELD OF THE INVENTION
The invention relates generally to cardiac treatment devices and techniques, and in particular, to methods and devices for diagnosis and repair of mitral valve defects such as mitral valve regurgitation.
BACKGROUND OF THE INVENTION
The mitral valve is one of four heart valves that direct blood through the two sides of the heart. The mitral valve itself consists of two leaflets, an anterior leaflet and a posterior leaflet, each of which are passive in that the leaflets open and close in response to pressure placed on the leaflets by the pumping of the heart.
Among the problems that can develop or occur with respect to the mitral valve is mitral valve regurgitation (MR), in which the mitral valve leaflets become unable to close properly, thus causing leakage of the mitral valve. Severe mitral regurgitation is a serious problem which, if left untreated, can adversely affect cardiac function and thus compromise the patient's quality of life and life-span.
Currently, mitral regurgitation is diagnosed by many indicators, and the mechanism of mitral regurgitation can be accurately visualized by transesophageal echocardiography. The most prevalent and widely accepted current technique to correct mitral regurgitation is to repair the mitral valve via open heart surgery while a patient's heart is stopped and the patient is on cardiopulmonary bypass, a highly invasive procedure that has inherent risks.
Nonetheless, this invasive technique for repairing mitral regurgitation is currently favored because it allows for complete visualization of the mitral valve without the accompanying distraction and disruption of a beating heart, and because it is believed to allow for repair of the mitral valve with an unmatched degree of certainty and accuracy. Non-surgical, percutaneous repair of the mitral valve is not currently utilized because of the perceived difficulty of effecting repair of the mitral valve while the heart is not arrested, and because of the limited amount of space in and around the mitral valve in which to route a repair device or devices.
Accordingly, it would be desirable to provide a less invasive yet equally effective procedure for repairing a mitral valve.
It also would be desirable to provide a procedure for diagnostic manipulation of the mitral valve in order to effectuate mitral valve regurgitation repair.
SUMMARY OF THE INVENTION
These and other desirable objects are attained by a catheter system and catheterization procedure of the present invention, wherein a catheter is configured for percutaneous access to the atrium along the venous system of a patient, and for subsequent positioning of the catheter in between the mitral valve leaflets. The tip of the catheter has a structure defining suction or reverse flow directed radially into the catheter on opposite sides thereof. The catheter suction system captures the rapidly moving leaflets of the mitral valve while the heart is non-arrested such that functioning of the heart is uninterrupted and unaffected. The captured mitral valve leaflets are immobilized and juxtaposed to each other in a small region at the suction catheter tip, simulating an Alfieri mitral valve stitch as discussed in the article of Fucci, C. et al. in
European Journal of Cardio-thoracic Surgery,
9 (1995), pages 621-7 and in the article of Maisano, F. et al. in
European Journal of Cardio-thoracic Surgery,
13 (1998), pages 240-246. Preferably, simultaneous transesophageal echocardiography (TEE) provides visualization of the catheter tip placement, confirmation of the immobilization of the mitral valve leaflets and determination of the effectiveness of subsequent stitch position on mitral valve leakage. A fastener such a staple or a shape memory rivet is then placed in the juxtaposed immobilized leaflets to effect the repair of the mitral valve. This repair technique should be particularly effective when the mechanism of mitral regurgitation (MR) is mitral valve prolapse or flail of a mitral leaflet.
In one embodiment of the present invention, the catheter includes an extendable guide wire assembly. Once the mitral valve leaflets are captured via suction from the catheter, the guide wire is advanced forward from a distal tip of the catheter into the ventricle and a second percutaneous assembly is advanced via an arterial route to capture the end of the guide wire and to draw the guide wire out from the heart to guide an endovascular stapler. The stapler is then advanced along the guide wire into position at the immobilized leaflets to staple the leaflets together from the opposite side.
In additional embodiments of the present invention, the catheter assembly itself may apply a fastener from the a trial side. This fastener may be a wire rivet having shape memory coils that assume a form to effect permanent fastening. Particular coil configurations may spread their ends, or may shorten a middle portion to draw captured tissue flaps together, or both. In one of these embodiments, a small balloon or diverter body at the tip of the catheter defines lateral suction paths for effectively positioning the captured leaflets and also serves to direct the fastener through the opposed leaflets. The balloon is then deflated such that the flaps are drawn together and the fastener can reassume its memory shape. In another of these embodiments, a helical shape memory coil fastener carried in the catheter tip is ejected such that it winds through the opposed leaflets with its axis parallel to the plane of the junction.
In any of the embodiments of the present invention, a separate lumen or small pressure chamber at the tip may apply a glue or cement between the captured leaflets to further stabilize the junction.
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Ho (Jackie)Tan-Uyen T.
Nutter & McClennen & Fish LLP
Recla Henry J.
The General Hospital Corporation
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