Fixing device, in particular for fixing to vascular wall tissue

Abstract

An arrangement includes a first sleeve; a fixing device for fixing to vascular wall tissue; and a second sleeve. The fixing device includes a tubular element for accommodation within a passage surrounded by vascular wall tissue and is provided with fingers arranged distributed in the peripheral direction of the tubular element. The fingers have a first position in which they project radially outwards from the tubular element. The fingers are bent aside reversibly, against a resilient force, from the first position into a second position in which the projection of the fingers on a radial transverse surface of the tubular element is located essentially on and/or within the periphery of the tubular element. The fingers are fixed in the second position by the first sleeve in which the tubular element and fingers, which are in the second position, are accommodated to form a composite assembly.

1 . An arrangement comprising:
 a first sleeve;   a fixing device for fixing to vascular wall tissue; and   a second sleeve;   wherein the fixing device comprises a tubular element which can be accommodated within a passage surrounded by vascular wall tissue and is provided with fingers arranged distributed in the peripheral direction of the tubular element, the fingers having a first position in which they project outwards from the tubular element with respect to the axial direction of the tubular element in order to be able to fix the fixing device to the vascular wall tissue surrounding the passage;   wherein the fingers have been bent aside reversibly, against a resilient force, from the first position into a second position in which the projection of the fingers on a radial transverse surface of the tubular element is located essentially on and/or within the periphery of the tubular element;   wherein the fingers are fixed in said second position by the first sleeve in which the tubular element and the fingers, which are in the second position, are accommodated to form a composite assembly such that the tubular element and the fingers can be slid out of the sleeve by sliding the sleeve in the longitudinal direction of the tubular element, in order to allow the fingers to return to the first position under the influence of the resilient force generated on bringing the fingers from the first into the second position; and   wherein said composite assembly, formed by the first sleeve and fixing device accommodated therein with the fingers in second position, is kept in a compressed condition by the second sleeve surrounding the composite assembly such that after removing of the second sleeve an expanded condition of the composite assembly results.   
     
     
         2 . The arrangement according to  claim 1 ,
 wherein the fingers, in the second position, extend essentially axially.   
     
     
         3 . The arrangement according to  claim 2 ,
 wherein the fingers, in the first position, extend in the radial direction with respect to the tubular element.   
     
     
         4 . The arrangement according to  claim 1 ,
 wherein the fingers, in the second position, extend essentially axially; and   wherein the fingers, in the first position, extend in the radial direction with respect to the tubular element.   
     
     
         5 . The arrangement according to  claim 1 ,
 wherein the length of the circumference of the second sleeve is smaller than the circumference of the first sleeve.   
     
     
         6 . The arrangement according to  claim 1 ,
 wherein the fixing device is axially cut open.   
     
     
         7 . The arrangement according  claim 6 ,
 wherein the fixing device is held pinched together by the second sleeve, and the first sleeve lies along the inner side and outer side of the fixing device and is closed in circumferential direction.   
     
     
         8 . The arrangement according to  claim 6 ,
 wherein the first sleeve is axially cut open and the composite assembly, in the compressed condition, is wound in spiral form and held together in said spiral form by the second sleeve.   
     
     
         9 . The arrangement according to  claim 1 , wherein the fixing device and first sleeve are closed in peripheral direction. 
     
     
         10 . The arrangement according to  claim 1 ,
 wherein the fingers comprise bottom fingers arranged distributed in the peripheral direction of the tubular element and top fingers distributed in the peripheral direction of the tubular element, and wherein, in the first position, the bottom and top fingers are able to accommodate between them vascular wall tissue surrounding said passage.   
     
     
         11 . The arrangement according to  claim 10 ,
 wherein the bottom and/or top fingers, in their first position, define a flange surface extending uninterrupted or with interruptions around the tubular element.   
     
     
         12 . The arrangement according to  claim 10 ,
 wherein, in the first position, the axial spacing between the top and bottom fingers, in particular the ends thereof, is less than the thickness of the vascular wall tissue to be accommodated between them in order to be able to clamp the vascular wall tissue between the bottom and top fingers in the fitted position.   
     
     
         13 . The arrangement according to  claim 11 ,
 wherein, in the first position, the axial spacing between the top and bottom fingers, in particular the ends thereof, is less than the thickness of the vascular wall tissue to be accommodated between them in order to be able to clamp the vascular wall tissue between the bottom and top fingers in the fitted position.   
     
     
         14 . The arrangement according to  claim 10 ,
 wherein, in the first position, the bottom and top fingers are pretensioned and face towards one another.   
     
     
         15 . The arrangement according to  claim 11 ,
 wherein, in the first position, the bottom and top fingers are pretensioned and face towards one another.   
     
     
         16 . The arrangement according to  claim 12 ,
 wherein, in the first position, the bottom and top fingers are pretensioned and face towards one another.   
     
     
         17 . The arrangement according to  claim 13 ,
 wherein, in the first position, the bottom and top fingers are pretensioned and face towards one another.   
     
     
         18 . The arrangement according  claim 1 ,
 wherein the bottom fingers and/or the top fingers are made from a superelastic metal alloy or an alloy with a shape memory which has been activated/can be activated by heat, such as a nickel-titanium alloy, for example nitinol.   
     
     
         19 . The arrangement according to  claim 1 ,
 wherein the outer surface of the tubular element is concave.   
     
     
         20 . The arrangement according to  claim 1 ,
 wherein the second sleeve is closed in circumferential direction.   
     
     
         21 . The arrangement according to  claim 1 ,
 wherein the fingers are provided with anchoring means, such as barbs, points or roughenings, for anchoring in the valve annulus.   
     
     
         22 . The arrangement according to  claim 1 ,
 wherein the fixing device is one of the group comprising:   a vascular prosthesis; and   a cardiac prosthesis, such as a ring prosthesis or a heart valve prosthesis comprising a heart valve.   
     
     
         23 . The arrangement according to  claim 1 , further comprising a graft attached to the fixing device. 
     
     
         24 . A method of providing an arrangement according to one of the preceding claims, comprising the steps of:
 bending the bottom and top fingers aside against a resilient force from the first position into the second position;   fixing the bottom and top fingers in said second position by accommodating the tubular element and the bottom and top fingers in the first sleeve to form a composite assembly;   compressing the composite assembly into a compressed condition; and   keeping the composite assembly in compressed condition by surrounding the composite assembly by the second sleeve.