Embolic protection system

Abstract

A catheter system 1 has an internal reception space for an embolic protection filter 10 to enable the filter 10 to be transported through a vasculature 20 and a treatment means such as a stent 15 to facilitate treatment. The catheter system may be used for retrieval of a filter 10 and stenting of a lesion with a stent 15 . The procedure may also involve post dilatation using an on-board balloon 16.

1 . A catheter having an expansible internal reception space for receiving an embolic protection filter and for transporting the filter through a vasculature; and the catheter comprising a treatment device to facilitate treatment of a site in a vasculature,
 wherein the catheter has an outer tubular body and an inner member extending at least partially through the outer body, the outer body having an expansible distal tip, and the inner member being movable proximally relative to the outer body from an introduction configuration to a retrieval configuration to facilitate retrieval of an embolic protection filter into the reception space;   the inner member has a proximal end and a distal end, the proximal end of the inner member has a first constant diameter, and the distal end of the inner member has a second constant diameter, the first constant diameter being larger than the second constant diameter;   a distal tip of the inner member tapers distally inwardly, the inwardly tapering distal tip of the inner member being located on the inner member at a location distal of the treatment device during the introduction configuration, the treatment device is mounted on the distal end of the inner member, and a diameter of the distal tip is greater than the diameter second constant diameter;   the filter is separate from and slidable relative to the inner member and the outer tubular body;   a distal end of the distal tip provides a proximal stop for the filter;   the distal tip is adapted to slide completely within the outer body in the introduction configuration; and   the distal tip comprises an engagement element adapted for retrieval of the filter.   
     
     
         2 . A catheter as claimed in  claim 1  wherein the catheter comprises a delivery catheter,
 wherein the catheter has an outer tubular body and an inner member extending at least partially through the outer body, the inner member being is movable distally relative to the outer body to deploy an embolic protection the filter from within the reception space. 
 
     
     
         3 . A catheter as claimed in  claim 1  wherein the catheter defines a guidewire lumen extending at least partially therethrough for passing the catheter over a guidewire,
 wherein the guidewire lumen extends only partially through the catheter to facilitate passing the catheter over a guidewire in a rapid exchange manner. 
 
     
     
         4 . A catheter as claimed in  claim 2  wherein the treatment device is at least partially provided on the inner member. 
     
     
         5 . A catheter as claimed in  claim 2  wherein in the introduction configuration, the treatment device protrudes from a distal end of the outer body. 
     
     
         6 . A catheter as claimed in  claim 2  wherein the treatment device is at least partially provided on the outer tubular body. 
     
     
         7 . A catheter as claimed in  claim 6  wherein the treatment device is provided at a necked down portion of the outer tubular body. 
     
     
         8 . A catheter as claimed in  claim 6  wherein the catheter comprises a cover around the treatment device in the introduction configuration. 
     
     
         9 . A catheter as claimed in  claim 8  wherein the cover is moveable proximally to uncover the treatment device. 
     
     
         10 . A catheter as claimed in  claim 8  wherein the cover comprises a sheath. 
     
     
         11 . A catheter as claimed in  claim 10  wherein the sheath extends along the full length of the outer tubular body. 
     
     
         12 . A catheter as claimed in  claim 10  wherein a distal end of the sheath tapers distally inwardly. 
     
     
         13 . A delivery and deployment catheter system comprising: a filter catheter section; a filter mounted in the filter catheter section, the filter being movable on release from the filter catheter section from a collapsed delivery configuration to an expanded deployment configuration, a stent catheter section; a stent mounted in the stent catheter section, the stent being movable on release from the stent catheter section from a retracted delivery configuration to an expanded deployment configuration; and having a guidewire lumen for receiving a guidewire through the catheter sections; the stent catheter section and associated stent being movable along the guidewire independently of the deployed filter for sequential deployment of the filter and stent. 
     
     
         14 . A catheter system as claimed in  claim 13  including at least one stop for limiting longitudinal movement of the filter and/or the stent relative to the guidewire. 
     
     
         15 . A catheter system as claimed in  claim 14  wherein the stop is a filter stop for limiting movement of the filter in the proximal direction. 
     
     
         16 . A catheter system as claimed in  claim 14  wherein the stop is a stent stop for limiting movement of the stent in the proximal direction. 
     
     
         17 . A catheter system as claimed in  claim 13  wherein the stent catheter section is located proximal to the filter catheter section. 
     
     
         18 . A catheter system as claimed in  claim 17  wherein an outer sheath comprises the filter catheter section and the stent catheter section. 
     
     
         19 . A catheter system as claimed in  claim 18  wherein an inner tube extends axially through the outer sheath. 
     
     
         20 . A catheter system as claimed in  claim 19  wherein the guidewire extends through the inner tube. 
     
     
         21 . A catheter system as claimed in  claim 19  wherein a distal end of the inner tube provides a proximal stop for the filter. 
     
     
         22 . A catheter system as claimed in  claim 19  wherein the inner tube has an abutment to provide a proximal stop for the stent. 
     
     
         23 . A catheter system as claimed in  claim 13  wherein the stent catheter section is located distal to the filter catheter section. 
     
     
         24 . A catheter system as claimed in  claim 23  wherein the stent catheter section comprises an outer stent retaining sheath for the stent and the filter catheter section comprises an outer filter retaining sheath for the filter. 
     
     
         25 . A catheter system as claimed in  claim 24  wherein a first ring is mounted on the guidewire intermediate the stent and the filter to provide a proximal stop for the stent. 
     
     
         26 . A catheter system as claimed in  claim 24  wherein a second ring is mounted on the stent retaining sheath proximal of the filter to provide a proximal stop for the filter. 
     
     
         27 . A catheter system as claimed in  claim 1  wherein the filter has a carrier with a guide olive mounted at the distal end thereof, the guide olive being configured to engage with the distal end of the catheter section in the collapsed configuration of the filter body to provide a smooth transition between the catheter section and the guidewire tip. 
     
     
         28 . A catheter as claimed in  claim 1  wherein the filter has a proximal and a distal end, inlet openings being positioned at the proximal end and outlet holes being positioned at the distal end. 
     
     
         29 . A catheter system as claimed in  claim 1  wherein the filter element has a proximal and a distal end, inlet openings being positioned at the distal end and outlet holes being positioned at the proximal end. 
     
     
         30 . A catheter as claimed in  claim 28  wherein the filter is a self-expanding filter. 
     
     
         31 . A catheter as claimed in  claim 30  wherein the treatment device is a self-expanding stent. 
     
     
         32 . A catheter as claimed in  claim 30  wherein the treatment device is a balloon expandable stent. 
     
     
         33 . A catheter system comprising a filter delivery catheter and a treatment device delivery catheter, the filter delivery catheter comprising a filter retaining sheath and a shaft extending from the sheath, the treatment device delivery catheter comprising a treatment device retaining sheath and a shaft extending from the sheath, the treatment device delivery catheter shaft being extendable through the filter delivery catheter. 
     
     
         34 . A catheter system as claimed in  claim 33  wherein the treatment device is a stent. 
     
     
         35 . A method for carrying out a procedure at a treatment site in a vasculature comprising the steps of:
 providing a catheter comprising a tubular member having a distal space, the distal space comprising a first portion and a second portion, the first portion being adjacent to and distal of the second portion;   providing a treatment device loaded into the second portion of the distal space of the catheter;   providing an embolic protection device loaded into the first portion of the distal space of the catheter; the embolic protection device having a collapsed configuration for transport through the vasculature and an expanded deployed configuration for collecting emboli released during a procedure;   advancing the catheter to a treatment site in the vasculature;   deploying the embolic protection device from the first portion of the distal space in the catheter, the deployed filter taking up an expanded emboli-collecting configuration distal to the treatment location; and   deploying the treatment device from the second portion of the distal space in the catheter to carry out a procedure at the treatment site.   
     
     
         36 . A method as claimed in  claim 35  comprising retrieving the embolic protection device into the reception space of the catheter after completion of the procedure. 
     
     
         37 . A method as claimed in  claim 35  comprising advancing a guidewire through the vasculature so that a distal tip of the guidewire is located distal of the treatment location, and then advancing the catheter over the guidewire. 
     
     
         38 . A method as claimed in  claim 35  wherein the treatment device comprises a balloon. 
     
     
         39 . A method as claimed in  claim 38  wherein the balloon is an angioplasty balloon. 
     
     
         40 . A method as claimed in  claim 35  wherein the treatment device comprises a stent. 
     
     
         41 . A method as claimed in  claim 40  wherein the stent is a self expanding stent. 
     
     
         42 . A method as claimed in  claim 40  wherein the stent is a balloon expandable stent. 
     
     
         43 . A method as claimed in  claim 35  wherein the treatment device is mounted on an inner member. 
     
     
         44 . A method as claimed in  claim 43  comprising engaging the embolic protection device with the inner member to deploy the embolic protection device. 
     
     
         45 . A method as claimed in  claim 43  wherein the inner member defines a centering member. 
     
     
         46 . A method for carrying out a procedure at a treatment site in a vasculature comprising the steps of:
 providing a catheter system comprising a filter delivery catheter and a treatment device delivery catheter, the filter delivery catheter comprising a filter retaining sheath and a shaft extending from the sheath, the treatment device delivery catheter comprising a treatment device retaining sheath and a shaft extending from the sheath, the treatment device delivery catheter shaft extending through the filter delivery catheter sheath and shaft;   providing a treatment device loaded into the treatment device delivery sheath;   providing an embolic protection device loaded into the filter sheath, the embolic protection device having a collapsed configuration for transport through the vasculature and an expanded deployed configuration for collecting emboli released curing a procedure;   advancing the catheter system to a treatment site in the vasculature;   deploying the embolic protection device from the filter sheath, the deployed filter taking up an expanded emboli-collecting configuration; and   deploying the treatment device from the sheath of the treatment device delivery catheter.   
     
     
         47 . A method as claimed in  claim 46  comprising retrieving the embolic protection device into the reception space of the catheter after completion of the procedure. 
     
     
         48 . A method as claimed in  claim 46  comprising advancing a guidewire through the vasculature so that a distal tip of the guidewire is located distal of the treatment location, and then advancing the catheter over the guidewire. 
     
     
         49 . A method as claimed in  claim 46  wherein the treatment device comprises a balloon. 
     
     
         50 . A method as claimed in  claim 49  wherein the balloon is an angioplasty balloon. 
     
     
         51 . A method as claimed in  claim 46  wherein the treatment device comprises a stent. 
     
     
         52 . A method as claimed in  claim 51  wherein the stent is a self expanding stent. 
     
     
         53 . A method as claimed in  claim 51  wherein the stent is a balloon expandable stent. 
     
     
         54 . A method as claimed in  claim 46  wherein the treatment device is mounted on an inner member. 
     
     
         55 . A method as claimed in  claim 54  comprising engaging the embolic protection device with the inner member to deploy the embolic protection device.