Catheter delivery system for stent valve

Abstract

A delivery catheter for a stent. The delivery catheter may comprise a distal end and a proximal end. The distal end includes a stent attachment region adapted to receive a stent. The stent may be of the self-expanding type. The catheter further comprises a handle at its proximal end and at least one sheath which may at least partially circumferentially cover said stent such as to retain it in a collapsed configuration. The sheath is coupled at its proximal end to an actuator located on said handle portion. The catheter further comprises at least one radio-opaque indicator for indicating a rotational orientation of the delivery catheter and/or the stent when observed using medical imaging during implantation of the stent.

What is claimed: 
     
         1 . (canceled) 
     
     
         2 . A delivery catheter for a stent, the delivery catheter comprising a distal end and a proximal end, the distal end including a stent accommodation region for receiving a stent, and a sheath translatable between a closed position for at least partly covering the stent accommodation region, and an open position not substantially covering the stent accommodation region, wherein the sheath comprises a mouth region, the mouth region comprising a radio-opaque indicator for indicating an axial and/or rotational position of the mouth region of the sheath, the radio-opaque indicator comprising a pattern including at least one circumferential interruption, wherein the radio-opaque indicator has a shape comprising at least one of: generally circumferentially extending; predominantly circumferentially extending; split-ring shaped; C-shaped; an axial extent of less than about 5 mm. 
     
     
         3 . The delivery catheter of  claim 2 , wherein the radio-opaque indicator has an axial extent selected as at least one from: less than about 5 mm; less than about 4 mm; less than about 3 mm, less than about 2 mm; between about 1 mm and about 2 mm. 
     
     
         4 . The delivery catheter of  claim 2 , wherein the radio-opaque indicator comprises at least one body of metal or metal alloy. 
     
     
         5 . The delivery catheter of  claim 4 , wherein the radio-opaque indicator comprises a metal alloy comprising at least one of: platinum and iridium. 
     
     
         6 . The delivery catheter of  claim 2 , wherein the mouth region is configured to flare in response to a radially outward force exerted thereon from a stent at the stent-accommodation region. 
     
     
         7 . The delivery catheter of  claim 6 , wherein the circumferential interruption is configured to permit circumferential expansion of the mouth region of the sheath during flaring. 
     
     
         8 . The delivery catheter of  claim 7 , wherein the radio-opaque indicator is spaced from a peripheral edge of the mouth region, to permit circumferential expansion of the mouth region of the sheath during flaring. 
     
     
         9 . The delivery catheter of  claim 8 , wherein a second portion of the sheath is configured substantially not to flare in response to a radially outward force exerted thereon from a stent at the stent-accommodation region. 
     
     
         10 . The delivery catheter of  claim 2 , wherein the radio-opaque indicator is embedded within a laminate structure of the mouth portion of the sheath. 
     
     
         11 . A delivery catheter for a stent, the delivery catheter optionally according to  claim 2 , the delivery catheter comprising a distal end and a proximal end, the distal end including a stent accommodation region for receiving a stent, the catheter further comprising at least one radio-opaque indicator for indicating a rotational orientation of the delivery catheter and/or a stent-holder thereof, and/or the stent when observed using medical imaging during implantation of the stent. 
     
     
         12 . The delivery catheter of  claim 11 , wherein at least one radio-opaque indicator is configured to provide a visual indication of the rotational orientation when observed outside the body. 
     
     
         13 . The delivery catheter of  claim 11 , wherein at least one radio-opaque indicator comprises a feature that is substantially elongate in an axial direction of the delivery catheter. 
     
     
         14 . The delivery catheter of  claim 13 , further comprising a second feature that is substantially elongate in an axial direction of the delivery catheter. 
     
     
         15 . The delivery catheter of  claim 14 , wherein the second feature is distinct from the first feature by one or more selected from: (i) being spaced angularly from the first feature; (ii) being spaced angularly from the first feature by about 90 degrees; (iii) being spaced axially from the first feature; (iv) having a size different from the first feature; and/or (v) having a length different from the first feature. 
     
     
         16 . The delivery catheter of  claim 15 , wherein the first and second features are positioned adjacent to a stent holder of the delivery catheter. 
     
     
         17 . The delivery catheter of  claim 15 , further comprising a sleeve carrying the first and second features, the sleeve being distinct from a stent holder of the delivery catheter. 
     
     
         18 . The delivery catheter of  claim 17 , wherein the elongate feature comprises an elongate line extending in a direction parallel to, and preferably offset from, an axis of the delivery catheter 
     
     
         19 . The delivery catheter of  claim 18 , wherein at least one radio-opaque indicator comprises a feature extending generally circumferentially around the axis of the delivery catheter, and includes one or more patterns defining the rotation orientation. 
     
     
         20 . The delivery catheter of  claim 18 , comprising a first radio-opaque indicator including a feature that is substantially elongate in an axial direction of the delivery catheter, and a second radio-opaque indicator including a feature extending generally circumferentially around the axis of the delivery catheter, and one or more patterns defining the rotation orientation. 
     
     
         21 . The delivery catheter of  claim 20 , wherein the pattern comprises an interruption in the circumferential extent of the feature of the second radio-opaque indicator, the interruption being offset angularly around the axis of the delivery catheter with respect to the angular position of the first radio-opaque indicator.