Medical article for implantation into the vascular system of a p

Details Medical article for implantation into the vascular system of a p Medical article for implantation into the vascular system of a p

1995-06-07

1997-11-04

Buiz, Michael

Surgery

Instruments

Internal pressure applicator

623 11, 623 12, A61M 2900, A61F 204

Patent

active

056834110

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/DK95/00147 filed Jun. 4, 1995.
The invention relates to a medical article for implantation into the vascular system of a patient, comprising a self expanding body shaped substantially into the form of a body of revolution, the surface of which is defined by wire members forming cells of a generally polygonal shape over at least a part of said surface.
Medical implantation articles to which the invention pertains have found wide-spread use in percutaneous vascular and cardiac surgery and comprise in particular intravenous filter devices for the capture of thrombi in major veins such as the lower caval vein and occlusion devices for permanent or temporary obturation of a vessel lumen or permanent occlusion of defects in vascular walls such as an ASD (atrial septal defect) in the atrial septum, a PDA (Patent Ductus Arteriosus) defect or other defects in vascular walls such as the inlet of an exfoliative aneurism of the aorta or a puncture hole in connection with angiographic investigation.
Intravenous filters for capture of thrombi have become known in many different configurations and shapes.
FR-A-2567407 discloses an umbrella-type filter comprising a number of radial legs interconnected at their ends by a semi-spherical filter membrane permeable to the blood flow.
This prior art device requires a comparatively large diameter delivery system involving a considerable risk for traumatization of the femoral or subclavian veins used for percutaneous introduction. Correct localization in the caval vein is rather difficult and unreliable and a further drawback follows from the impossibility of withdrawing the filter in cases where such withdrawal is dictated by a clinical indication.
From Radiology, 1985, 156, pages 315 to 320 a filter in the form of the body of revolution made from wire members forming a cellular surface is known. This prior art device suffers from the drawback that captured thrombi will tend to collect in the peripheral or parietal zone of the filter, whereby the efficiency of operation is impaired. Also for this prior art filter a considerable risk for traumatization of vessels during introduction prevails and it is not possible to withdraw the filter.
Also medical articles of the kind referred to for occlusion of vessels or holes in vascular walls have become known in different configurations and shapes.
From Ann.Radiology, 1981, vol. 24, no. 5, pages 396 to 399 a vessel occlusion device is known having the shape of a spring spiral. With this device it has turned out to be difficult and complicated to obtain full and effective closing of a vessel lumen and the device suffers moreover from the drawback of a significant risk of displacement from the site of implantation due to blood flow or pulsation of vascular walls.
A prior art occlusion device known from SU inventors certificate No. 810246 comprises a body of revolution formed by an inflated balloon with a catheter. For this device non-uniform inflation of the balloon will result in insufficient sealing of the body against the vascular walls adjoining the duct to be closed and the occlusion will be of a rather poor quality and ineffective.
Further prior art occlusion devices for sealing cardiovascular defects comprise the shunt defect closure devices disclosed in U.S. Pat. Nos. 3,874,388 and 4,007,743. Both of these prior art devices comprise a pair of umbrella-like elements, which only after localization at the site of the defect are locked together in face to face relationship to close the defect from opposite sides.
In an article "Non-surgical closure of patent ductus arteriosus: Clinical Application of the Rashkind PDA occluder system", circulation 75 No. 3, March 1987 an occluder system is described comprising two polyurethane discs mounted on two opposing umbrella-like three-armed spring assemblies. Whereas the need for assembling the two assemblies after installation has in this case been avoided this has been obtained at the expense of a rather complicated delivery system and procedure.
A similar draw

REFERENCES:
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patent: 4619246 (1986-10-01), Molgaard-Nielsen et al.
patent: 4643184 (1987-02-01), Mobin-Uddin
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patent: 5064435 (1991-11-01), Porter
Frasson, F. et al.,"Embolization of renal Tumors," Ann. Radiology, 1981, vol. 24, No. 5, pp. 396-398.
Rashkind, W.J. et al., "Nonsurgical closure of patent ductus arteriosus: clinical application of the Rashkind PDA Occluder System," Circulation, vol. 75, No. 3, Mar. 1987, pp. 583-592.
Gunther, Rolf. W., et al., "Vena Caval Filter to Prevent Pulmonary Embolism: Experimental Study," Radiology, Aug. 1995, vol. 156, No. 2, pp. 315-320.

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