Everted filter device

Abstract

Everting filter devices and methods for using the devices, including using the devices as intra-vascular filters to filter thrombus, emboli, and plaque fragments from blood vessels. The filter devices include a filter body nominally tubular in shape and having a large proximal opening. The filter body can extend from a proximal first end region distally over the non-everted exterior surface of the filter, further extending distally to a distal-most region, then converging inwardly and extending proximally toward the filter second end region, forming a distal everted cavity. The degree of eversion of the filter can be controlled by varying the distance between the filler first end region near the proximal opening and the closed second end region. Bringing the filter first and second end regions closer together can bring filter material previously on the non-everted filter exterior to occupy the distal-most region. The everting process can also bring filter material previously in the distal-most position further into the distal everted cavity. The filter devices can be used to remove filtrate from body vessels, with the filtrate eventually occluding the distal-most region. The filter can then be further everted, bringing fresh, unoccluded filter material into place to provide additional filter capacity. Some everting filters have the capability of switching between occluding and filtering modes of operation, thereby allowing a treating physician to postpone the decision to use filtering or occluding devices until well after insertion of the device into the patient's body.

What is claimed is:  
     
         1 . A filter device for filtering a body vessel fluid in a patient's body, the vessel having interior walls, the filter device comprising: 
 a filter body having an open proximal end region and a closed, everted distal end region, the filter body being formed of a porous mesh, the mesh defining a filter body interior and exterior, wherein the everted distal end region has an exterior distal everted cavity;    a first elongate member having a distal region operably coupled to the filter body distal end region; and    means for changing the degree of eversion of the filter body by changing the distance between the filter body proximal and distal end regions.    
     
     
         2 . A filter device as in  claim 1 , wherein the means for changing the degree of eversion includes the filter body being biased to expand radially outward against the vessel interior walls to hold the filter body in place, wherein the means for changing the degree of eversion also includes means for moving the first elongate member and coupled filter body distal end region.  
     
     
         3 . A filter device as in  claim 2 , wherein the first elongate member is a tether and the means for moving the first elongate member includes the first elongate member having a proximal region accessible from outside the patient's body.  
     
     
         4 . A filter device as in  claim 2 , wherein the first elongate member is a shaft and the means for moving the first elongate member includes the first elongate member having a proximal region accessible from outside the patient's body.  
     
     
         5 . A filter device as in  claim 1 , further comprising a second elongate member operably coupled to the filter body proximal end region, wherein the means for changing the degree of eversion also includes means for moving the first and second elongate members.  
     
     
         6 . A filter device as in  claim 5 , wherein the second elongate member is a shaft and the means for moving the first and second elongate members includes the first and second elongate members each having a proximal region accessible from outside the patient's body.  
     
     
         7 . A filter device as in  claim 5 , wherein the first and second elongate members are shafts and the means for moving the first and second elongate members includes the first and second elongate members each having a proximal region accessible from outside the patient's body.  
     
     
         8 . A filter device as in  claim 5 , wherein the second elongate member is a shaft having a lumen therethrough having the first elongate member slidably disposed within, and the means for moving the first and second elongate members includes the first and second elongate members each having a proximal region accessible from outside the patient's body.  
     
     
         9 . A filter device as in  claim 5 , wherein the second elongate member is a tether having a distal region operably coupled to the filter body proximal end region, wherein the first elongate member is a shaft having a lumen therethrough having the second elongate member slidably disposed within, and the means for moving the first and second elongate members includes the first and second elongate members each having a proximal region accessible from outside the patient's body.  
     
     
         10 . A filter device as in  claim 1 , wherein the porous mesh is self-expanding.  
     
     
         11 . An everted filter device comprising: 
 an elongate member having a proximal portion and a distal portion, the distal portion having a proximal region a distal region, and an outer surface; and    a mesh filter body having an average pore size, the filter body having a first end region slidably secured to the elongate member distal portion proximal region, a filter body second end region opposite the first end region fixedly secured to the elongate member distal portion distal region, a filter body intermediate region disposed between the filter body first and second end regions, and at least one proximal opening having a size at least five times the average filter body pore size,    wherein the filter body has an everted distal exterior cavity having a length,    wherein the filter body distal cavity length can be varied by varying the distance between the filter body first and second end regions.    
     
     
         12 . A device as in  claim 11 , wherein the mesh filter body has at least two proximal openings having a size at least five times the average pore size.  
     
     
         13 . A device as in  claim 11 , wherein the filter body has an exterior surface and an interior surface, wherein the filter body exterior surface is operably coupled to and faces the elongate member outer surface.  
     
     
         14 . A device as in  claim 13 , wherein the filter body second end region exterior surface is directly fixed to the elongate member distal portion distal region outer surface.  
     
     
         15 . A device as in  claim 13 , wherein the filter body second end region exterior surface is fixed to the elongate member distal portion distal region with a distal band.  
     
     
         16 . A device as in  claim 11 , wherein the filter body proximal end region is slidably secured to the elongate member with a proximal band fixedly secured to the filter body first end region wherein the proximal band is slidably disposed over the elongate member.  
     
     
         17 . A device as in  claim 11 , wherein the filter body distal everted cavity is formed by the filter body second end region interior surface being secured to and facing the elongate member distal portion distal region outer surface, such that a distal cavity proximal most extent is formed by the filter body exterior surface, wherein the filter body is biased to assume the everted shape when unconstrained.  
     
     
         18 . A device as in  claim 17 , wherein the filter body second end region is secured to the elongate member distal portion distal region with a distal band disposed over the filter body second end region.  
     
     
         19 . A device as in  claim 11 , further comprising an atraumatic tip extending distally from the elongate member.  
     
     
         20 . A device as in  claim 11 , wherein the filter body is biased to expand radially outward to anchor the filter body to an enclosing vessel wall.  
     
     
         21 . A device as in  claim 11 , wherein the elongate member is a shaft.  
     
     
         22 . A device as in  claim 11 , wherein the device has a proximal band slidably disposed over the elongate member, wherein the band has an inner surface facing the elongate member, an outer surface forming the band exterior, and an intermediate region between the inner surface and outer surface, wherein the filter body first end region is secured within the proximal band intermediate region.  
     
     
         23 . A device as in  claim 22 , wherein the proximal band is formed of an inner proximal band and outer proximal band, having the filter body first end region disposed between the inner and outer proximal bands.  
     
     
         24 . A device as in  claim 11 , wherein the elongate member is a shaft having a lumen therethrough.  
     
     
         25 . A device as in  claim 11 , wherein the filter body is heat set to evert when unconstrained.  
     
     
         26 . A device as in  claim 11 , wherein the filter body is self-expanding.  
     
     
         27 . A method for capturing a filtrate material from a fluid in a body vessel, the method comprising the steps of 
 providing a filter device including an elongate member having a proximal portion and a distal portion, the distal portion having a proximal region, and a distal region,    the filter device further including a mesh filter body formed of a filter material having an average pore size, the filter body having a first end region slidably secured to the elongate member distal portion proximal region, a filter body second end region opposite the first end region fixedly secured to the elongate member distal portion distal region, a filter body intermediate region disposed between the filter body first and second end regions, the filter body extending distally from the proximal opening and everting over a distal-most region to converge radially inwardly and proximally to form an exterior distal everted cavity, and at least one proximal opening having a size at least five times the average filter body pore size;    advancing the filter body to a vessel region to be filtered;    deploying the filter device in a first configuration where the filter body has a first collection region of filter material occupying the distal-most region; and    collecting the filtrate in the filter body first collection region.    
     
     
         28 . A method as in  claim 27 , further comprising relocating the first collection region from the distal-most region to a more proximal region and moving a second collection region to occupy the distal-most region by changing the degree of eversion of the filter body by varying the distance between the filter body first and second regions.  
     
     
         29 . A method as in  claim 28 , wherein the relocating step includes increasing the distance between the filter body first and second regions to bring filter material from the distal cavity to occupy the distal-most region and to bring the first collection region radially outside of and proximal of the distal cavity.  
     
     
         30 . A method as in  claim 29 , wherein the increasing distance step includes distally advancing the filter body second end region.  
     
     
         31 . A method as in  claim 29 , wherein the method includes providing the filter body biased to expand radially against the vessel wall to anchor the filter body, wherein the increasing distance step includes distally advancing the filter body second end region relative to the anchored filter body first end region.  
     
     
         32 . A method as in  claim 28 , wherein the relocating step includes decreasing the distance between the filter body first and second regions to bring filter material from proximal of and radially outside the distal-most region to occupy the distal-most region and to bring the first collection region into the distal cavity.  
     
     
         33 . A method as in  claim 32 , wherein the decreasing distance step includes proximally retracting the elongate member.  
     
     
         34 . A method as in  claim 32 , wherein the decreasing distance step includes proximally retracting the filter body second end region.  
     
     
         35 . A method as in  claim 32 , wherein the method includes providing the filter body biased to expand radially against the vessel wall to anchor the filter body, wherein the decreasing distance step includes proximally retracting the filter body second end region relative to the anchored filter body first end region.  
     
     
         36 . An everted filter device comprising: 
 a first shaft having a proximal portion and a distal portion, the distal portion having a distal region;    a second shaft having a proximal portion, a distal portion, the distal portion having a distal region and a proximal region; and    a filter body formed of a porous mesh material having an average pore size, a first end region secured to the first shaft distal portion distal region, the filter body having a second end region secured to the second shaft distal portion distal region, the filter body having at least one proximal opening having an opening size at least five times the filter body average pore size, wherein the filter body distal region is everted when unconstrained to form an exterior distal everted cavity.    
     
     
         37 . A device as in  claim 36 , wherein the second shaft is slidably coupled to the first shaft.  
     
     
         38 . A device as in  claim 37 , wherein the first shaft has a lumen therethrough having the second shaft slidably disposed within.  
     
     
         39 . A device as in  claim 37 , wherein the second shaft includes a curved region disposed distally of the first and second shaft slidable coupling and biased to assume a curved shape when unconstrained.  
     
     
         40 . A device as in  claim 37 , wherein the second shaft extends distally and transversely away from the first shaft slidable coupling to inhibit proximal movement of the second shaft.  
     
     
         41 . A device as in  claim 37 , wherein the second shaft extends distally and transversely away from the first shaft coupling to limit proximal movement of the second shaft.  
     
     
         42 . A device as in  claim 36 , wherein the second shaft is slidably coupled to the first shaft through a frictional lock giving tactile indication through the second shaft of translational movement of the second shaft relative to the first shaft.  
     
     
         43 . A device as in  claim 36 , wherein the second shaft is slidably coupled to the first shaft through a frictional lock limiting translational movement of the second shaft relative to the first shaft.  
     
     
         44 . A device as in  claim 36 , wherein the mouth region includes a loop secured to at least part of the mouth region, wherein the loop includes a first portion disposed through the body proximal mouth region and a second portion disposed between the first shaft and the filter body proximal mouth region, wherein the loop is slidably disposed within the filter body proximal mouth region, such that the body proximal opening may be decreased in size by proximally retracting the loop relative to the body proximal mouth region.  
     
     
         45 . A device as in  claim 36 , wherein the porous mesh is self-expanding.  
     
     
         46 . An everted filter device comprising: 
 a shaft having a proximal portion, a distal portion, the distal portion having a distal region; and    a porous mesh filter body having a first end region, a second end region, and an intermediate region disposed between the first and second end regions, the body having a proximal opening having a cross sectional area at least about five times the average pore cross sectional area of the filter body, wherein the opening is disposed within a proximal mouth region;    wherein the shaft is coupled to the filter body second end region, and the shaft distal region is coupled to the filter body proximal mouth region with at least two elongate fastening members.    
     
     
         47 . A device as in  claim 46 , wherein the fastening members are struts acting to hold the filter body proximal opening in an open configuration.  
     
     
         48 . A device as in  claim 46 , wherein the fastening members are tethers and the filter body is biased to hold the filter body proximal opening in an open configuration.  
     
     
         49 . A device as in  claim 46 , wherein the filter body is biased remain in the open position through the biasing action of a proximal loop secured to the body proximal mouth region.  
     
     
         50 . A device as in  claim 46 , wherein the fastening members are tethers having distal regions and the shaft has a lumen therethrough, wherein the tethers are operably coupled at the distal regions to the body proximal mouth region and extend proximally into the shaft lumen.  
     
     
         51 . A device as in  claim 50 , wherein the tethers extend through the lumen to the shaft proximal region such that the tethers are accessible for manipulation from the shaft proximal region.  
     
     
         52 . A device as in  claim 46 , wherein the porous mesh is self-expanding.  
     
     
         53 . An everted occluding/perfusing device comprising: 
 a first shaft having a proximal portion and a distal portion, the distal portion having a distal region;    a second shaft having a proximal portion, a distal portion, the distal portion having a distal region and a proximal region; and    a mesh body having an average pore size, a first end region secured to the first shaft distal portion distal region, the mesh body having a second end region secured to the distal shaft distal portion distal region, the mesh body having at least one proximal opening having an opening size at least five times the mesh body average pore size, the mesh body having an interior and a exterior, wherein the mesh body distal region is everted when unconstrained to form a distal-most region and converges inwardly and proximally to form an exterior distal everted cavity,    wherein the mesh body has a perfusing portion and an occluding portion disposed over the mesh body such that changing the degree of eversion of the mesh body changes the device between the occluding and perfusing portions being disposed in the distal-most region of the mesh body.    
     
     
         54 . A device as in  claim 53 , wherein the occluding portion is disposed near the mesh body second end, wherein the perfusing portion is disposed between the occluding portion and the mesh body first end region, such that moving the mesh body second end region toward the body first end region acts to further evert the mesh body and cause the occluding region to form the distal cavity wall while causing the perfusing portion to occupy the distal-most region of the occluding/perfusing device.  
     
     
         55 . A device as in  claim 53 , wherein the perfusing portion is disposed nearer the body second end region and the occluding portion is disposed between the perfusing portion and the body first end region, such that moving the body second end region toward the body first end region acts to further evert the mesh body and cause the perfusing portion to form the distal cavity wall while causing the occluding portion to occupy the distal-most region of the occluding/perfusing device.  
     
     
         56 . A device as in  claim 53 , wherein the mesh body perfusing portion is formed of filter material, the filter material having an average pore size of less than about 500 microns.  
     
     
         57 . A device as in  claim 54 , further comprising a distal fluid port disposed in the first shaft for allowing fluid infusion through the port and into the mesh body interior.  
     
     
         58 . A device as in  claim 54 , further comprising a fluid infusion lumen disposed along the first shaft and is in fluid communication with a distal fluid port for allowing fluid infusion through the port and into the mesh body interior.  
     
     
         59 . A device as in  claim 58 , wherein the fluid infusion lumen is disposed within the first shaft.  
     
     
         60 . A method for filtering filtrate material from a body vessel fluid, the method comprising the steps of: 
 providing a filter device including a filter body having a proximal opening disposed within a proximal mouth region, a closed everted distal region having a exterior distal everted cavity and a distal-most region, wherein the filter body has a filtering portion and an occluding portion oriented so that the filter body can be manipulated between an occluding mode and a filtering mode by changing the degree of eversion of the filter body, the filter device further including an elongate first member having a proximal end region, a proximal region and a distal region, the elongate first member distal region being coupled to the filter body closed everted region;    advancing the filtering device filter body to the body vessel region to be filtered;    manipulating the filter body to a first configuration so that the distal-most region of the filter body is occupied by the filter body occluding portion to substantially occlude flow of the vessel fluid;    changing the degree of eversion of the filter body so that the distal-most region of the filtering device is occupied by the filter body filtering portion to capture the filtrate; and    filtering the body vessel fluid to collect filtrate in the filter body distal-most region.    
     
     
         61 . A method as in  claim 60 , wherein the filter device further comprises a second elongate member having a proximal region and a distal region, wherein the filter body proximal region is coupled to the second elongate member distal region, wherein the changing degree of eversion step includes changing the distance between the first and second elongate member distal regions, to change the distance between the filter body first and second end regions.  
     
     
         62 . A method as in  claim 60 , wherein the filter body is biased to expand radially against an enclosing body vessel wall to anchor the filter body, wherein the changing degree of eversion step includes changing the distance between the first elongate member distal region and the filter body proximal mouth region, to change the distance between the filter body first and second end regions.  
     
     
         63 . A method as in  claim 62 , wherein the changing distance step includes manipulating the first elongate member from the first elongate member proximal portion end to urge the elongate member distal region proximally.  
     
     
         64 . A method for delivery an agent to a body vessel interior region, the method comprising the steps of: 
 providing an infusion device including a filter body having a proximal opening disposed within a proximal mouth region, a closed everted distal region having a distal exterior everted cavity and a distal-most region, wherein the filter body has a filtering portion and an occluding portion oriented so that the filter body can be manipulated between an occluding mode and a filtering mode by changing the degree of eversion of the filter body, the infusion device further including an elongate first member having a proximal region and a distal region, the elongate first member distal region being coupled to the filter body closed everted region, the infusion device further including an infusion lumen disposed along the first elongate member and in fluid communication with a distal port;    advancing the infusion device filter body to the body vessel region to be treated;    manipulating the infusion device to a first configuration where the filter body has a region of occluding material occupying the distal-most region to reduce flow through the vessel and wherein the filter body has a region of filtering material facing the vessel interior walls to allow agent flow through the filtering material vessel walls; and    infusing the agent through the infusion lumen into the filter body interior to allow the agent to contact the vessel walls through the porous material.    
     
     
         65 . A method as in  claim 64 , wherein the infusion lumen is disposed within the first elongate member and the infusing step includes infusing the agent through the first elongate member.  
     
     
         66 . A method as in  claim 65 , wherein the infusion device further comprises a second elongate member having a distal region coupled to the filter body first end region, wherein the second elongate member is a tube having the first elongate member slidably disposed within and wherein the infusion lumen is an annular lumen disposed within the tube about the first elongate member, wherein the infusing step includes infusing the agent through the annular lumen.  
     
     
         67 . A filter device comprising: 
 a first shaft having a proximal portion and a distal portion, the distal portion having a distal region;    a second shaft having a proximal portion and a distal portion, the distal portion having a distal region and a proximal region; and    a porous filter body having an average pore size, a first end region secured to the first shaft distal portion distal region, the filter body having a second end region secured to the second shaft distal portion distal region, the filter body having at least one proximal opening having an opening size at least five times the filter body average pore size, wherein the filter body distal region is everted when unconstrained to form an exterior distal everted cavity,    wherein at least one of the first or second shafts has a lumen therethrough in fluid communication with an inflatable envelope disposed within the filter body, wherein the inflatable envelope has a distal waist region and a proximal waist region, wherein the balloon has an inflated configuration for substantially occluding the filter body interior and a second configuration substantially less occluding than the first occluding configuration.    
     
     
         68 . A method for occluding and filtering a vessel region, the method comprising the steps of: 
 providing a filter device including: 
 a first shaft having a proximal portion and a distal portion, the distal portion having a distal region;  
 a second shaft having a proximal portion, a distal portion, the distal portion having a distal region and a proximal region; and  
 a porous mesh filter body having an average pore size, a first end region secured to the first shaft distal portion distal region, the filter body having a second end region secured to the second shaft distal portion distal region, the filter body having at least one proximal opening having an opening size at least five times the filter body average pore size, wherein the filter body distal region is everted when unconstrained to form an exterior distal everted cavity,  
 wherein at least one of the first or second shafts has a lumen therethrough in fluid communication with an inflatable envelope disposed within the filter body, wherein the inflatable envelope has a distal waist region and a proximal waist region, wherein the balloon has an inflated configuration for substantially occluding the filter body interior and a second configuration substantially less occluding than the first occluding configuration;  
 advancing the filter device to a region to be filtered;  
 inflating the balloon to substantially occlude the vessel; and  
 uninflating the balloon to allow greater body fluid passage around the balloon.  
   
     
     
         69 . A method as in  claim 68 , wherein the occlusion step is performed after the filtering step.  
     
     
         70 . A method for removing blockage material from a vessel, the method comprising the steps of: 
 providing a filter device including: 
 a first shaft having a proximal portion and a distal portion, the distal portion having a distal region,  
 a second shaft having a proximal portion, a distal portion, the distal portion having a distal region and a proximal region, and  
 a filter body having an average pore size, a first end region secured to the first shaft distal portion distal region, the filter body having a second end region secured to the second shaft distal portion distal region, the filter body having at least one proximal opening having an opening size at least five times the filter body average pore size, wherein the filter body distal region is everted when unconstrained to form an exterior distal everted cavity, and  
 a proximal loop disposed near the filter body proximal mouth region;  
 deploying the filtering device distally of the blockage material in a configuration where the proximal loop is in a substantially open configuration; and  
 proximally retracting the proximal loop over the blockage material such that the blockage material is at least partially captured within the filter interior while elongating the porous mesh filter.  
   
     
     
         71 . A method as in  claim 70  further comprising allowing the second shaft to remain substantially in place while retracting the first shaft to elongate and increase the length of the filter body during the blockage material capture method.  
     
     
         72 . A method as in  claim 70  further comprising providing a capture tube having a lumen through at least a capture tube distal region, the method further comprising the step of proximally retracting the filter body having the blockage material within the capture tube distal region.  
     
     
         73 . A method as in  claim 70 , wherein the blockage material includes thrombus and the proximally retracting step includes proximally retracting the loop over the thrombus.