Devices and methods for controlling expandable prosthesis during develoyment

Abstract

Prosthesis delivery devices and methods are provided that enable precise control of prosthesis position during deployment. The prosthesis delivery devices may carry multiple prostheses and include deployment mechanisms for delivery of a selectable number of prostheses. Control mechanisms are provided in the prosthesis delivery devices that control either or both of the axial and rotational positions of the prostheses during deployment. This enables the deployment of multiple prostheses at a target site with precision and predictability, eliminating excessive spacing or overlap between prostheses. In particular embodiments, the prostheses of the invention are deployed in stenotic lesions in coronary or peripheral arteries, or in other vascular locations.

1 . A prosthesis delivery catheter comprising: 
 an outer shaft forming a first lumen;    a plurality of self-expanding tubular prostheses carried within the first lumen, the prostheses being adapted to radially expand upon deployment from the first lumen; and    a movable coil member interactive with the prostheses to control expansion of the prostheses when the prostheses are deployed from the first lumen.    
     
     
         2 . The prosthesis delivery catheter of  claim 1 , wherein the coil member is removable from the deployed prostheses by rotating the coil member.  
     
     
         3 . The prosthesis delivery catheter of  claim 1 , wherein the prostheses have sidewalls with a plurality of openings, the coil member being threaded through the openings.  
     
     
         4 . The prosthesis delivery catheter of  claim 1 , wherein the prostheses comprise a plurality of struts, at least one of the struts being bent inwardly, the coil member being threaded through the inwardly bent struts.  
     
     
         5 . The prosthesis delivery catheter of  claim 1 , wherein the coil member is radially expandable to allow controlled expansion of the prostheses.  
     
     
         6 . The prosthesis delivery catheter of  claim 3 , wherein a distal portion of the coil member is retractable into the outer shaft following deployment of the selected number of prostheses.  
     
     
         7 . The prosthesis delivery catheter of  claim 1 , wherein the prostheses are disposed within the coil member.  
     
     
         8 . The prosthesis delivery catheter of  claim 1 , wherein the coil member comprises a plurality of loops forming a helix.  
     
     
         9 . The prosthesis delivery catheter of  claim 8 , wherein between 2 and 6 loops are disposed in each prosthesis.  
     
     
         10 . The prosthesis delivery catheter of  claim 8 , wherein more than 6 loops are disposed in each prosthesis.  
     
     
         11 . The prosthesis delivery catheter of  claim 1 , wherein the coil member comprises a plurality of loops contacting each other to form a continuous tube.  
     
     
         12 . The prosthesis delivery catheter of  claim 1 , further comprising a deployment mechanism for deploying a selected number of prostheses from the inner lumen.  
     
     
         13 . The prosthesis delivery catheter of  claim 12 , wherein the deployment mechanism comprises a pushing element slidably disposed in the first lumen, the pushing element being in engagement with at least one of the prostheses to advance the prostheses distally relative to the outer shaft.  
     
     
         14 . The prosthesis delivery catheter of  claim 13 , wherein adjacent ends of adjacent prostheses are interleaved to resist rotation of the prostheses relative to each other.  
     
     
         15 . The prosthesis delivery catheter of  claim 14 , wherein a distal end of the pushing element is interleaved with a proximal end of a proximal-most prosthesis to resist rotation of the prostheses.  
     
     
         16 . The prosthesis delivery catheter of  claim 1 , wherein the coil member is configured to maintain rotational position of the prostheses relative to each other.  
     
     
         17 . A prosthesis delivery catheter for delivering prostheses into a vessel lumen comprising: 
 an outer shaft forming a first lumen;    an inner shaft slidably disposed within the first lumen;    an evertible tube having a first end coupled with a distal end of the outer shaft and a second end coupled with a distal end of the inner shaft; and    a plurality of self-expanding tubular prostheses carried within the evertible tube, the prostheses being adapted to radially expand upon deployment from the evertible tube,    wherein moving the outer shaft proximally relative to the inner shaft everts a distal portion of the evertible tube so as to deploy one or more of the prostheses.    
     
     
         18 . The prosthesis delivery catheter of  claim 17 , wherein an inner surface of the inner shaft comprises at least one adherent element for releasably holding the prostheses to the inner surface.  
     
     
         19 . The prosthesis delivery catheter of  claim 18 , wherein the adherent element comprises a tacky surface coating.  
     
     
         20 . The prosthesis delivery catheter of  claim 18 , wherein the adherent element comprises a softenable material into which the prostheses are removably embedded.  
     
     
         21 . The prosthesis delivery catheter of  claim 18 , wherein the adherent element comprises a plurality of inwardly-facing protrusions positioned to extend through openings in the prostheses.  
     
     
         22 . The prosthesis delivery catheter of  claim 21 , wherein the protrusions have a shape selected from the group consisting of mushroom-shaped, L-shaped, T-shaped, hook-shaped, rounded, spiked, pyramidal, barbed, arrow-shaped and linear.  
     
     
         23 . The prosthesis delivery catheter of  claim 18 , wherein the adherent element comprises a structure selected from the group consisting of bumps, bristles, spines, ridges ribs, waves, grooves, pits, channels, detents and random surface irregularities.  
     
     
         24 . A method of delivering one or more prostheses to a treatment site in a vessel comprising: 
 positioning a delivery catheter at the treatment site, the delivery catheter carrying a plurality of self-expanding prostheses;    selecting a desired number of the prostheses to deploy;    deploying the desired number of prostheses from the delivery catheter into the vessel, each prosthesis expanding into contact with the vessel upon deployment;    controlling axial displacement of each of the selected number of prostheses relative to the delivery catheter during deployment of the prostheses with an expandable coil member coupled with the prostheses; and    removing the expandable coil member from the deployed prostheses.    
     
     
         25 . A method as in  claim 24 , wherein removing the coil member comprises rotating the coil member.  
     
     
         26 . A method as in  claim 25 , wherein the coil member is helically threaded through the prostheses, and rotating the coil member unthreads the coil member from one or more prostheses.  
     
     
         27 . A method as in  claim 24 , further comprising controlling rotational displacement of the selected number of prostheses relative to the delivery catheter during deployment of the prostheses.  
     
     
         28 . A method as in  claim 27 , wherein the rotational displacement is controlled by interleaving adjacent ends of adjacent prostheses and interleaving a proximal end of a proximal-most prosthesis with a portion of the catheter device.  
     
     
         29 . A method as in  claim 24 , wherein a distal portion of the coil member expands with the selected number of prostheses.  
     
     
         30 . A method of delivering one or more prostheses to a treatment site in a vessel comprising: 
 positioning a delivery catheter at the treatment site, the delivery catheter carrying a plurality of self-expanding prostheses within an evertible tube;    selecting a desired number of the prostheses to deploy; and    everting a distal portion of the evertible tube to deploy the desired number of prostheses from the delivery catheter into the vessel, each prosthesis expanding into contact with the vessel upon deployment.    
     
     
         31 . A method as in  claim 30 , wherein the distal portion of the evertible tube is everted by sliding an outer shaft of the catheter device relative to an inner shaft of the catheter device.  
     
     
         32 . A method as in  claim 31 , wherein a distal end of the outer shaft is coupled with a distal end of the evertible tube, and wherein sliding the outer shaft proximally relative to the inner shaft causes the distal end of the evertible tube to bend outward and fold over on itself.  
     
     
         33 . A method as in  claim 30 , further comprising controlling axial displacement of each of the selected number of prostheses relative to the delivery catheter during deployment of the prostheses by contacting an adherent inner surface of the evertible tube with the prostheses.  
     
     
         34 . A method as in  claim 33 , wherein the adherent surface maintains engagement with the prostheses until the distal portion of the evertible tube is peeled away from the prostheses.  
     
     
         35 . A method as in  claim 33 , wherein the adherent surface comprises a friction-inducing coating or friction-inducing surface feature.  
     
     
         36 . A method as in  claim 33 , wherein contacting the adherent surface with the prostheses comprises releasably coupling one or more retention structures on the inner surface with the prostheses.  
     
     
         37 . A method as in  claim 33 , wherein contacting the adherent surface with the prostheses comprises embedding the prostheses in a deformable material on the adherent inner surface.  
     
     
         38 . A prosthesis delivery catheter comprising: 
 an outer shaft having a distal end and a first lumen;    a plurality of self-expanding tubular prostheses carried within the first lumen, the prostheses being adapted to radially expand upon deployment from the first lumen; and    a control member extending distally from the distal end of the outer shaft and defining an interior communicating with the first lumen for receiving one or more of the prostheses, the control member having an undeflected shape when not engaged by any of the prostheses and being configured to deflect radially outwardly when engaged by a prosthesis during the expansion thereof, the control member being configured to resiliently return to the undeflected shape when the prosthesis is removed from the interior.    
     
     
         39 . The prosthesis delivery catheter of  claim 38 , wherein the control member comprises a plurality of tines arranged in a generally cylindrical pattern, the tines being outwardly deflectable as the prostheses expand.  
     
     
         40 . The prosthesis delivery catheter of  claim 39 , wherein the control member further comprises a web extending between the tines.  
     
     
         41 . The prosthesis delivery catheter of  claim 40 , wherein the web is a distensible elastomer.  
     
     
         42 . The prosthesis delivery catheter of  claim 38 , wherein the control member comprises a radially distensible elastomeric tube.  
     
     
         43 . The prosthesis delivery catheter of  claim 38 , further comprising: 
 an inner shaft slidable relative to the outer shaft; and    a nose piece at the distal end of the inner shaft disposed distally of the control member, the nose piece having a proximal opening adapted to receive a distal end of the control member.    
     
     
         44 . The prosthesis delivery catheter of  claim 43 , wherein the control member comprises a plurality of tines arranged in a generally cylindrical pattern, the tines having inwardly-oriented distal tips for positioning in the proximal opening of the nose piece.  
     
     
         45 . The prosthesis delivery catheter of  claim 38 , wherein the control member is adapted to be slidably removed from the prosthesis following the expansion thereof.  
     
     
         46 . The prosthesis delivery catheter of  claim 38 , wherein the prostheses are adapted for deployment in groups of at least two at a single treatment site.  
     
     
         47 . The prosthesis delivery catheter of  claim 46 , wherein each of the prostheses has axially extending elements configured to interleave with axially extending elements on an adjacent prosthesis.  
     
     
         48 . The prosthesis delivery catheter of  claim 47 , wherein the control member is adapted to control expansion of the prostheses such that the axially extending elements remain interleaved when at least two prostheses are deployed adjacent to each other.  
     
     
         49 . The prosthesis delivery catheter of  claim 38 , further comprising a pusher slidably disposed within the first lumen, the pusher engaging at least one of the prostheses to deploy the prostheses from the first lumen.