Embolic protection system

Abstract

An embolic protection system comprises an embolic protection filter 1 having a collapsed delivery configuration and an expanded deployed configuration. The filter 1 is housed in the collapsed configuration in a reception space of a delivery catheter 20. The delivery catheter 20 containing the filter 1 is housed in a sealed sterile pouch 35. The filter 1 may be coated with a non-thrombogenic coating and an adhesion preventer 9 such as a silicon gel is used to substantially prevent adhesion of adjacent folds of the filter 1 when the filter is in the collapsed configuration in the delivery catheter 20.

1 . An embolic protection system comprising: 
 an embolic protection filter having a collapsed delivery configuration and an expanded deployed configuration;    a delivery catheter having a reception space, an embolic protection filter being housed in the collapsed configuration in the reception space of the delivery catheter; and    a sealed sterile pouch housing the delivery catheter containing the filter in the collapsed configuration.    
     
     
         2 . A system as claimed in  claim 1  wherein the filter in the collapsed configuration is at least partially folded.  
     
     
         3 . A system as claimed in  claim 2  wherein the system comprises an adhesion preventer to substantially prevent adhesion of adjacent folds of the filter to one another in the collapsed configuration.  
     
     
         4 . A system as claimed in  claim 3  wherein the adhesion preventing material is selected from one or more of: 
 a silicon fluid;  
 a silicon gel;  
 a lipid filled fluid/gel;  
 a heparin filled fluid/gel; and  
 an aqueous solution.  
 
     
     
         5 . A system as claimed in  claim 1  wherein the device comprises a collapsible body and a support structure to support the body in the expanded configuration.  
     
     
         6 . A system as claimed in  claim 5  wherein the collapsible body is located at least partially externally of the support structure.  
     
     
         7 . A system as claimed in  claim 5  wherein the support structure is located at least partially externally of the collapsible body.  
     
     
         8 . A system as claimed in  claim 3  wherein the adhesion preventer is applied to a surface of the filter.  
     
     
         9 . A system as claimed in  claim 1  wherein the filter has a biocompatible surface.  
     
     
         10 . A system as claimed in  claim 9  wherein the biocompatible surface is provided as a coating of biocompatible material on the filter.  
     
     
         11 . A system as claimed in  claim 10  wherein the biocompatible material is a hydrophilic coating.  
     
     
         12 . A system as claimed in  claim 9  wherein the biocompatible surface is provided on an external surface of the filter.  
     
     
         13 . A system as claimed in  claim 9  wherein the biocompatible surface is provided on an internal surface of the filter.  
     
     
         14 . A system as claimed in any of the claims  5  wherein adjacent folds of the filter are spaced-apart by one or more arms for extending between adjacent folds of the filter.  
     
     
         15 . A system as claimed in  claim 14  wherein the support structure comprises the arm.  
     
     
         16 . A system as claimed in  claim 14  wherein the arm is provided by a tool which is suitable to assist loading of the device into a catheter.  
     
     
         17 . A method for providing embolic protection during a vascular procedure comprising the steps of: 
 providing an embolic protection system comprising a sealed sterile pouch containing a delivery catheter with a reception space, an embolic protection filter being housed in the reception space in collapsed configuration;    opening the pouch; and    removing the delivery catheter containing the embolic protection filter in the collapsed configuration from the pouch.    
     
     
         18 . A method as claimed in  17  comprising the step of: 
 flushing the filter in the collapsed configuration within the delivery catheter.  
 
     
     
         19 . A method as claimed in  18  wherein the filter is flushed prior to sealing of the pouch.  
     
     
         20 . A method as claimed in  18  wherein the filter is flushed after removal of the delivery catheter containing the filter in the collapsed configuration from the pouch.  
     
     
         21 . A method as claimed in  claim 17  comprising loading the delivery catheter and filter onto a guidewire.  
     
     
         22 . A method as claimed in  claim 21  wherein the delivery catheter and filter are loaded onto a guidewire after removal of the delivery catheter containing the filter in the collapsed configuration from the pouch.  
     
     
         23 . A method as claimed in  claim 17  comprising loading the delivery catheter and filter into a guide catheter.  
     
     
         24 . A method as claimed in  claim 23  wherein the delivery catheter and filter are loaded into a guide catheter after removal of the delivery catheter from the pouch.  
     
     
         25 . A method as claimed in  claim 17  comprising the steps of: 
 advancing a guidewire through a vasculature;  
 crossing a desired treatment location with the guidewire;  
 advancing the delivery catheter and filter over the guidewire to deliver the filter to a desired location; and  
 deploying the filter from the delivery catheter at the desired location.  
 
     
     
         26 . A method as claimed in  claim 25  comprising the steps of: 
 introducing separate from the embolic protection filter an interventional device over the guidewire to the treatment location for carrying out the interventional procedure, embolic material generated during the treatment procedure being captured by the deployed filter; and  
 withdrawing the filter from the vasculature.  
 
     
     
         27 . A method as claimed in  claim 25  wherein the treatment location is a region of stenosis.  
     
     
         28 . A method as claimed in  claim 26  wherein the interventional procedure includes a balloon dilation of the stenosis while the filter is deployed.  
     
     
         29 . A method as claimed in  claim 26  wherein the interventional procedure includes placing a stent at the treatment location while the filter is deployed.  
     
     
         30 . A method as claimed in  claim 25  wherein the guidewire is withdrawn after withdrawal of the filter.  
     
     
         31 . A method as claimed in  claim 25  wherein the filter comprises a filter body and a filter frame which supports the filter body in the deployed configuration.  
     
     
         32 . A method as claimed in  claim 25  wherein the filter is slidably disposed on the guidewire when the filter is in the expanded deployed configuration.  
     
     
         33 . A method as claimed in  25  wherein the filter is rotatably disposed on the guidewire when the filter is in the expanded deployed configuration.  
     
     
         34 . A medical device movable between a collapsed configuration for transport through a vasculature and an expanded configuration for deployment in a vasculature, the device comprising: 
 a storage space for storing a biocompatible material during transport through a vasculature; and    means to deliver the biocompatible material from the storage space to a surface of the device when deployed in a vasculature.    
     
     
         35 . A device as claimed in  claim 34  wherein the storage space is provided in a wall of the device.  
     
     
         36 . A device as claimed in  claim 34  wherein the means to deliver the biocompatible material comprises one or more channels from the storage space to the surface of the device.  
     
     
         37 . A device as claimed in  claim 36  wherein the channel is a capillary channel.  
     
     
         38 . A device as claimed in  claim 34  wherein the biocompatible material is delivered to an external surface of the device.  
     
     
         39 . A device as claimed in  claim 34  wherein the biocompatible material is delivered to an internal surface of the device.  
     
     
         40 . A device as claimed in  claim 34  wherein the device comprises a delivery actuator to at least partially cause delivery of the biocompatible material from the storage space to the surface of the device.  
     
     
         41 . A device as claimed in  claim 40  wherein the actuator is at least partially of a temperature memory material.  
     
     
         42 . A device as claimed in  claim 34  wherein the biocompatible material is a hydrophilic material.  
     
     
         43 . A device as claimed in  claim 34  wherein the device is an embolic protection filter.  
     
     
         44 . A device as claimed in  claim 43  wherein the filter has an inlet end and an outlet end, the inlet end having one or more inlet openings sized to allow blood and embolic material enter the filter, the outlet end having a plurality of outlet openings sized to allow through passage of blood but to retain undesired embolic material within the filter.  
     
     
         45 . A method of loading a medical device into a catheter, the method comprising the steps of: 
 collapsing the medical device down to a wrapped configuration;    controlling the wrap of the medical device during collapse; and    positioning the medical device at least partially within the catheter.    
     
     
         46 . A method as claimed in  claim 45  wherein the medical device is at least partially collapsed down by passing the medical device through a funnel.  
     
     
         47 . A method as claimed in  claim 46  wherein the wrap of the medical device is at least partially controlled by formations on the funnel.  
     
     
         48 . A method as claimed in  claim 45  wherein the medical device is at least partially collapsed down by directing a jet of fluid over the medical device.  
     
     
         49 . A method as claimed in  claim 45  wherein the wrap of the medical device is at least partially controlled by directing a jet of fluid over the medical device.  
     
     
         50 . A method as claimed in  claim 45  wherein the medical device is at least partially collapsed during positioning of the medical device at least partially within the catheter.  
     
     
         51 . A system for loading a medical device into a catheter, the system comprising: 
 means to collapse a medical device down to a wrapped configuration; and    means to control the wrap of the medical device.    
     
     
         52 . A system as claimed in  claim 51  wherein the means to collapse comprises a funnel through which a medical device may be passed.  
     
     
         53 . A system as claimed in  claim 52  wherein the means to control the wrap comprises one or more formations on the funnel.  
     
     
         54 . A system as claimed in  claim 53  wherein the formation comprises an inward protrusion on a wall of the funnel.  
     
     
         55 . A system as claimed in  claim 54  wherein the protrusion is in the form of a finger extending from an end of the funnel.  
     
     
         56 . A system as claimed in  claim 55  wherein the finger extends generally longitudinally.  
     
     
         57 . A system as claimed in  claim 55  wherein the finger extends generally in a spiral.  
     
     
         58 . A system as claimed in  claim 55  wherein the finger extends from an outlet end of the funnel.  
     
     
         59 . A system as claimed in  claim 55  wherein the system comprises four fingers spaced-apart around the circumference of the funnel.  
     
     
         60 . A system as claimed in  claim 59  wherein the fingers are equi-spaced apart.  
     
     
         61 . A system as claimed in  claim 51  wherein the means to collapse comprises one or more fluid jets for directing a jet of fluid over the medical device.  
     
     
         62 . A system as claimed in  claim 51  wherein the means to control the wrap comprises one or more fluid jets for directing a jet of fluid over the medical device.  
     
     
         63 . A method of loading a medical device into a catheter, the method comprising the steps of: 
 collapsing the medical device;    positioning the collapsed medical device at least partially within the catheter; and    flushing a liquid through the catheter and the collapsed medical device.    
     
     
         64 . A method as claimed in  claim 63  wherein the method comprises the step of sealing the catheter with flushing liquid therein.  
     
     
         65 . A method of delivering a medical device to a desired location in a vasculature, the method comprising the steps of: 
 providing a catheter with a collapsed medical device positioned at least partially within the catheter;    flushing a liquid through the catheter and the collapsed medical device; and    introducing the catheter into a vasculature and advancing the catheter through the vasculature.    
     
     
         66 . A method as claimed in  claim 63  wherein the method comprises the step of monitoring the extent to which the collapsed medical device has been flushed.  
     
     
         67 . A method as claimed in  claim 66  wherein the flushing step is terminated when the collapsed medical device has been fully flushed.  
     
     
         68 . A method as claimed in  claim 63  wherein the liquid is flushed distally through the catheter.  
     
     
         69 . A method as claimed in  claim 63  wherein the liquid is flushed proximally through the catheter.  
     
     
         70 . A method as claimed in  claim 63  wherein the liquid is flushed through the catheter by creating a pressure differential across the collapsed medical device.  
     
     
         71 . A catheter having a reception space at a distal end of the catheter for receiving a collapsed medical device therein, a wall of the catheter around the reception space having flushing openings through the wall to facilitate flushing of a collapsed medical device in the reception space.  
     
     
         72 . A catheter as claimed in  claim 71  wherein the concentration of the flushing openings increases distally along the reception space.  
     
     
         73 . A catheter as claimed in  claim 71  wherein the concentration of the flushing openings increases proximally along the reception space.  
     
     
         74 . A catheter as claimed in  claim 71  wherein the concentration of the flushing openings increases from a centre of the reception space towards proximal and distal ends of the reception space.  
     
     
         75 . A catheter as claimed in  claim 71  wherein the catheter comprises means to indicate the extent of flushing of the reception space.  
     
     
         76 . A catheter as claimed in  claim 75  wherein the means to indicate comprises one or more perfusion openings in the catheter wall at an end of the reception space.  
     
     
         77 . A catheter as claimed in  claim 75  wherein the means to indicate is provided by a separate component.  
     
     
         78 . A catheter as claimed in  claim 77  wherein the means to indicate is provided by a stylet extendable through the catheter.  
     
     
         79 . A catheter as claimed in  claim 75  wherein the means to indicate comprises an element configured to change colour upon contact with a flushing liquid.  
     
     
         80 . A catheter as claimed in  claim 79  wherein the element comprises litmus.  
     
     
         81 . A catheter as claimed in  claim 71  wherein the catheter comprises a seal for sealing the reception space with a collapsed medical device and flushing liquid therein.  
     
     
         82 . A catheter as claimed in  claim 81  wherein the seal extends along substantially the full length of the catheter.  
     
     
         83 . A catheter assembly comprising a catheter as claimed in  claim 71  and a collapsible medical device receivable in the reception space of the catheter, the medical device having one or more flushing openings in a body of the medical device to facilitate flushing of the medical device when collapsed in the reception space.  
     
     
         84 . An assembly as claimed in  claim 83  wherein the medical device body comprises a coiled spring.  
     
     
         85 . A catheter assembly comprising: 
 a catheter having a reception space at a distal end of the catheter for receiving a collapsed medical device therein; and    means for reinforcing against creep a wall of the catheter around the reception space.    
     
     
         86 . An assembly as claimed in  claim 85  wherein the means for reinforcing reinforce the catheter wall against longitudinal creep.  
     
     
         87 . An assembly as claimed in  claim 85  or  86  wherein the means for reinforcing reinforce the catheter wall against radial creep.  
     
     
         88 . An assembly as claimed in  claim 85  to  87  wherein the means for reinforcing comprises a clamp for positioning around the catheter wall.  
     
     
         89 . An assembly as claimed in  claim 88  wherein the clamp comprises a sleeve.  
     
     
         90 . An assembly as claimed in  claim 88  wherein the assembly comprises a tray for the catheter, and the clamp is provided by the tray.  
     
     
         91 . An assembly as claimed in  claim 88  wherein the clamp is configured to provide non-uniform reinforcement along the catheter wall.  
     
     
         92 . An assembly as claimed in  claim 91  wherein the clamp comprises one or more formations to provide non-uniform reinforcement along the catheter wall.  
     
     
         93 . An assembly as claimed in  claim 85  wherein the means for reinforcing comprises one or more reinforcing elements in the catheter wall.  
     
     
         94 . An assembly as claimed in  claim 93  wherein the catheter wall is of a composite construction.  
     
     
         95 . A catheter assembly comprising: 
 a catheter having a reception space at a distal end of the catheter for receiving a collapsed medical device therein; and    means for elongating a medical device received in the reception space to resist creeping of the medical device.    
     
     
         96 . An assembly as claimed in  claim 95  wherein the means for elongating comprises a tensioning wire attachable to a medical device.  
     
     
         97 . A method of loading a medical device into a catheter, the method comprising the steps of: 
 collapsing the medical device;    positioning the collapsed medical device at least partially within the catheter; and    applying pressure to the catheter and/or to the collapsed medical device to distribute loading stresses on the catheter and/or on the collapsed medical device.    
     
     
         98 . A method as claimed in  claim 97  wherein the pressure is applied longitudinally.  
     
     
         99 . A method as claimed in  claim 97  wherein the pressure is applied radially.  
     
     
         100 . A method as claimed in  claim 97  wherein the applied pressure is substantially constant over time.  
     
     
         101 . A method as claimed in  claim 97  wherein the applied pressure varies over time.  
     
     
         102 . A method as claimed in  claim 101  wherein the applied pressure varies cyclically over time.  
     
     
         103 . A catheter assembly comprising: 
 a catheter having a reception space at a distal end of the catheter for receiving a collapsed medical device therein; and    means for applying pressure to a wall of the catheter around the reception space and/or to a collapsed medical device received in the reception space to distribute loading stresses in the catheter wall and/or the collapsed medical device.