Surgery – Instruments – Sutureless closure
Patent
1994-05-27
1997-07-01
Dawson, Glenn
Surgery
Instruments
Sutureless closure
606151, A61B 1708
Patent
active
056433174
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
This invention relates in general to closure prostheses which might find application for transcatheter placement within the heart to close congenital and operative cardiovascular defects.
Examples of such cardiovascular defects include those which result in an abnormal opening in the cardiovascular system and permit deleterious shunting of blood thereacross, such as atrial and ventricle septum defects and patent ductus arteriosus. To minimize the risk of mortality associated with surgery, transcatheter techniques have been developed to introduce closure devices for sealing such defects. One example of such a device is described in Blake, U.S. Pat. No. 4,007,743. Blake discloses a pair of umbrella-like closure devices which include resilient ring sections to automatically open the struts of the umbrella as the devices are pushed out of their respective catheters. King et al., U.S. Pat. No. 3,874,388, similarly discloses a pair of umbrella-like closure devices which interconnect after placement to seal across a defect.
These and other such devices rely on the caudal and cranial ends of the device being larger than the opening of the defect itself to physically trap the device across the opening. To accommodate transcatheter delivery techniques, the resulting device configurations have become unduly mechanical in nature, often including multiple components or requiring sequential delivery. Also, many of these devices require assembly across the defect after delivery, thereby increasing the complexity of the transcatheter equipment and delivery process.
A need therefore exists for an improved closure device. Such a device would be of a compact, unitary construction, therefore permitting the device to be delivered intact using transcatheter techniques. Also, such a device would be delivered from a sheath or catheter in a one-step procedure, rather than requiring sequential delivery. Similarly, such a device would be manually controlled after delivery to ensure proper placement and sealing across the defect. Preferably, the device would also be self-centering to facilitate proper delivery and placement across the defect.
SUMMARY OF THE INVENTION
A flexible closure prosthesis and transcatheter delivery system are disclosed, wherein the closure prosthesis seals across an opening of a fluid passageway within a living body. The closure prosthesis includes a flexible sealing element and a flexible restraining element attached to the sealing element. Delivery of the closure prosthesis is accomplished using a hollow sheath and a pusher catheter slidable within the sheath. Filament means are employed for resiliently bending the closure prosthesis, wherein the filament means releasably connect the closure prosthesis to the pusher catheter. The closure prosthesis is resiliently compressible into a first insertion form constrained within the sheath for placement adjacent the opening, wherein the closure prosthesis resiliently expands after release from the sheath into a first larger form. The closure prosthesis is resiliently compressible into a second insertion form constrained by the filament means for placement across the opening, wherein the closure prosthesis resiliently expands after release from the filament means into a second larger operational form and wherein the sealing element seals across the opening and the restraining element restrains the closure prosthesis in place across the opening.
A method for delivering a closure prosthesis is also disclosed, including the steps of connecting a closure prosthesis to a pusher catheter, inserting the closure prosthesis and the pusher catheter into a sheath adjacent the opening, the closure prosthesis resiliently compressing into a first insertion form constrained within the sheath, releasing the closure prosthesis from the sheath, the closure prosthesis resiliently expanding into a first larger form adjacent the opening, resiliently compressing the closure prosthesis into a second insertion form, the restraining element being resiliently
REFERENCES:
patent: 3874388 (1975-04-01), King et al.
patent: 4007743 (1977-02-01), Blake
patent: 4744364 (1988-05-01), Kensey
patent: 4852568 (1989-08-01), Kensey
patent: 4890612 (1990-01-01), Kensey
patent: 5041093 (1991-08-01), Chu
patent: 5108420 (1992-04-01), Marks
patent: 5254133 (1993-10-01), Seid
William J. Rashkind, M.D., Charles E. Mullins, M.D., Willam E. Hellenbrand, M.D., and Mary Angela Tait, B.S., Nonsurgical Closure of Patent Ductus Arteriosus: Clinical Application of the Rashkind PDA Occluder System, Circulation, vol. 74, No. 3, p. 583, Mar. 1987.
James E. Lock, M.D., John T. Cockerham, M.D., John F. Keane, M.D., John P. Filey, M.D., Paul E. Wakely, Jr., M.D., and Kenneth E. Fellows, M.D., Transcatheter Umbrella Closure of Congenital Heart Defects, Circulation, vol. 75, No. 3, p. 593, Mar. 1987.
E.B. Sideris, M.D., S.E. Sideris, R.N., J.P. Fowlkes, RDMS, R.L. Ehly, RT, J.E. Smith, R.N. and R.E. Guide, M.D., Transvenous Atrial Spetal Defect Occlusion in Piglets With a "Buttoned" Double-Disk Device, Jan., Circulation, vol. 81, No. 1, pp. 314 and 312, 1990.
Jonathan J. Rome, M.D., John F. Keane, M.D., Stanton B. Perry, M.D., Philip J. Spevak, M.D., and James E. Lock, M.D., Double-Umbrella Closure of Atrial Defects, Circulation, vol. 82, No. 3, p. 751, Sep. 1990.
Albert P. Rocchni, M.D., Transcatheter Closure of Atrial Septal Defects, Circulation, vol. 82, p. 1044, 1990.
Toshio Yamaguchi, Haruhito Fukuoka, Kazuo Yamamoto, Shizutomo Katsuta, and Mitsushige Ohta, Transfemoral Closure of Patent Ductus Arteriosus: An Alternative to Surgery in Older Patients, CardioVascular and Interventional Radiology, p. 291, 1990.
New Technique for Transcatheter Closure of Patent Ductus Arteriosus, p. 156 .
Pavcnik Dusan
Wallace Sidney
Wright Kenneth C.
Dawson Glenn
William Cook Europe S.A.
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