Blood vessel occlusion device

Abstract

Various blood vessel occlusion devices including plugs ( 102, 500, 600, 700 ), or at least portions thereof, are made of silicone or other biocompatible material and each including a pilot hole ( 210, 516, 624, 716 ) which permits an insertion device ( 300 ) to be used to insert the plugs into the blood vessel. The plugs allow blood vessels to be rapidly occluded. Certain embodiments of the plug may be used to permanently seal the blood vessel, while other embodiments of the plug are designed to temporarily occlude a blood vessel. The plugs are designed to be effective even in cases of deposits in the artery.

1 . A device for occluding a blood vessel having an interior diameter, comprising: 
 a body comprising a forward section having a tapered outer surface, a flexible large-diameter section disposed proximally adjacent said forward section and having a first cross-sectional diameter greater than the interior diameter of the blood vessel, and a rear section disposed proximally adjacent said large-diameter section and having a second cross-sectional diameter substantially less than said first cross-sectional diameter; and    removal means attached to said rear section and extending behind said body, said removal means adapted for being held and pulled in order to remove said body from the blood vessel.    
   
   
       2 . The device according to  claim 1 , wherein: 
 said removal means is a thread attached to said rear section.    
   
   
       3 . The device according to  claim 1 , which is inserted into the blood vessel by use of an insertion device, further comprising: 
 said body has a longitudinal axis and said rear section has a pilot hole along said longitudinal axis for receiving the insertion device.    
   
   
       4 . The device according to  claim 1 , wherein: 
 said flexible large-diameter section is capable of flexing in a first direction when said body is inserted into the blood vessel in order to reduce a diameter of said device during insertion, and is capable of flexing in a second direction opposite said first direction when said body is removed from the blood vessel in order to reduce said diameter of said device during removal.    
   
   
       5 . The device according to  claim 1 , wherein: 
 said body comprises a unitary piece of elastomeric biocompatible material formed via molding.    
   
   
       6 . The device according to  claim 5 , wherein: 
 said elastomeric biocompatible material comprises silicone.    
   
   
       7 . The device according to  claim 1 , wherein: 
 said large-diameter section comprises a disc-like section.    
   
   
       8 . The device according to  claim 7 , further comprising: 
 an annular recess formed on a bottom side of said disc-like section to facilitate flexing of said disc-like section.    
   
   
       9 . The device according to  claim 1 , wherein: 
 said forward section of said body increases in diameter from a forward rounded tip back toward said flexible large-diameter section.    
   
   
       10 . The device according to  claim 2 , wherein: 
 said rear section comprises at least one substantially flat wall proximally disposed from said large diameter section, said wall defining at least one hole for receiving said thread.    
   
   
       11 . The device according to  claim 10 , wherein: 
 said at least one hole is formed by piercing said wall with a needle.    
   
   
       12 . The device according to  claim 2 , wherein: 
 said rear section defines at least one hole for receiving said thread.    
   
   
       13 . The device according to  claim 1 , further comprising: 
 an insert disposed alone a central axis of said body and mechanically attached to said body.    
   
   
       14 . The device according to  claim 13 , wherein: 
 said insert is formed from a hard material relative to said body.    
   
   
       15 . The device according to  claim 14 , wherein: 
 said insert includes an eyelet for receiving said removal means.    
   
   
       16 . The device according to  claim 14 , wherein: 
 said insert includes a plurality of barbs which engage said body.    
   
   
       17 . The device according to  claim 14  which is inserted into the blood vessel by use of an insertion device, wherein: 
 said insert has a longitudinal axis and a pilot hole along said longitudinal axis for receiving the insertion device.    
   
   
       18 . The device according to  claim 17 , wherein: 
 said insert includes a top rounded portion and a shaft, said body coupled around said shaft.    
   
   
       19 . The device according to  claim 13 , further comprising: 
 said insert is a sliding insert disposed along a central axis of the device, said sliding insert including a top rounded portion, a coupling shaft, a bulbous section and a bottom section.    
   
   
       20 . The device according to  claim 19  which is inserted into the blood vessel by use of an insertion device, wherein: 
 said bottom section of said sliding insert includes a pilot hole for receiving the insertion device, said body is substantially umbrella-shaped and formed from an elastomeric biocompatible material that surrounds said coupling shaft and that has a tapered structure that accepts said bulbous section when said sliding insert is moved forward along a longitudinal axis of said body by the insertion device such that said bulbous section supports said body in an expanded state whereby a diameter of said body is increased.    
   
   
       21 . The device according to  claim 20 , wherein: 
 said bottom section of said sliding insert includes an eyelet for receiving said removal means, wherein when an axial force on said removal means is exerted whereby the sliding insert moves backward along the central axis with respect to said body such that said bulbous section does not support said body, thereby placing said body in a relaxed state wherein said diameter of said body is decreased.    
   
   
       22 . The device according to  claim 21 , wherein: 
 said removal means is a thread that passes through said eyelet.    
   
   
       23 . Apparatus for occluding a blood vessel having an interior diameter, comprising: 
 a) a plug device including 
 (i) a body comprising a forward section having a tapered outer surface, a flexible large-diameter section disposed proximally adjacent said forward section and having a first cross-sectional diameter greater than the interior diameter of the blood vessel, and a rear section disposed proximally adjacent said large-diameter section, and  
 (ii) removal means attached to said rear section and extending behind said body, said removal means adapted for being held and pulled in order to remove said body from the blood vessel; and  
   b) an insertion device having means to attach said body to the insertion device.    
   
   
       24 . The apparatus according to  claim 23 , wherein: 
 said rear section has a pilot hole which receives said means to attach.    
   
   
       25 . An apparatus according to  claim 24 , wherein: 
 said insertion device comprises a needle, a tubular needle guard surrounding said needle, said needle fitting into said pilot hole of said rear section, and a spring-biased lever operable to retract said needle into said tubular needle guard.    
   
   
       26 . An apparatus according to  claim 23 , wherein: 
 said plug device includes an insert formed of hard material relative to said body, said insert extending along a longitudinal axis of said plug device, said insert including a pilot hole receiving said means to attach.    
   
   
       27 . An apparatus according to  claim 26 , wherein: 
 said insertion device comprises a needle, a tubular needle guard surrounding said needle, said needle fitting into said pilot hole of said insert, and a spring-biased lever operable to retract said needle into said tubular needle guard.    
   
   
       28 . An apparatus according to  claim 23 , wherein: 
 said plug device is mounted on said insertion device.    
   
   
       29 . A kit including at least one insertion device according to  claim 23  and a plurality of plug devices according to  claim 23 .  
   
   
       30 . A kit including a plurality of insertion devices according to  claim 23  and a plurality of plug devices according to claims  23  mounted on said plurality of insertion devices.  
   
   
       31 . A device for occluding a blood vessel having an interior diameter, comprising: 
 a body comprising a tapered outer surface and a flexible large diameter section having a diameter greater than the interior diameter of the blood vessel; and    an insert into said body comprising a plurality of spring-biased prongs extending beyond said body and radially outward with respect to a central axis of said device.    
   
   
       32 . The device according to  claim 31 , wherein: 
 said body includes an exterior surface layer of elastomeric biocompatible material supported by an interior frame structure.    
   
   
       33 . The device according to  claim 32 , wherein: 
 said frame structure includes projections that extend radially inward toward said central axis of said device, said insert being held in place by said projections.    
   
   
       34 . The device according to  claim 32 , wherein: 
 said elastomeric biocompatible material comprises silicone.    
   
   
       35 . The device according to  claim 31  which is inserted into the blood vessel by use of an insertion device, wherein: 
 said insert includes a pilot hole for receiving said insertion device.    
   
   
       36 . Apparatus for occluding a blood vessel having an interior diameter, comprising: 
 a) a plug device including a body comprising a tapered outer surface and a flexible large-diameter section having a diameter greater than the interior diameter of the blood vessel, and an insert into said body comprising a plurality of spring-biased prongs extending beyond said body and radially outward with respect to a central axis of said device; and    b) an insertion device having means for attaching said plug device to said insertion device.    
   
   
       37 . An apparatus according to  claim 36 , wherein: 
 said insert includes a pilot hole for receiving said insertion device, and    said insertion device comprises a needle, a tubular needle guard surrounding said needle, said needle fitting into said pilot hole of said insert, and a spring-biased lever operable to retract said needle into said tubular needle guard.    
   
   
       38 . A method of occluding a blood vessel having an interior diameter, the method comprising: 
 providing a plug body comprising a forward section having tapered outer surface, a flexible large-diameter section disposed proximally adjacent said forward section and having a first cross-sectional diameter greater than the interior diameter of the blood vessel, and a rear section disposed proximally adjacent said large-diameter section and having a second cross-sectional diameter substantially less than said first cross-sectional diameter, said plug body having a central axis;    substantially aligning said central axis of said plug body with a longitudinal axis of a portion of said blood vessel;    applying an axial force to insert said plug body into said portion of said blood vessel with said flexible large diameter section flexing; and    removing said axial force such that a wall section of said blood vessel grasps onto said plug body to hold it in place.    
   
   
       39 . A method of occluding a blood vessel according to  claim 38 , wherein: 
 the axial force is applied with an insertion device having means to attach said rear section to the insertion device.    
   
   
       40 . A method of occluding a blood vessel according to  claim 39 , wherein: 
 the insertion device comprises a needle, a tubular needle guard surrounding the needle, the tubular needle guard fitting into a pilot hole of the rear section, and a spring-biased lever operable to retract the needle into the tubular needle guard to release an attached plug body,    the method further comprising the step of operating said lever to release said plug body.    
   
   
       41 . A method of occluding a blood vessel according to  claim 38 , wherein: 
 said plug body further comprises removal means for applying an axial force to said plug body to thereby remove said plug body from said lumen,    the method further comprising the step of cooperating with said removal means to apply said axial force to said plug body to thereby remove said plug body from said lumen.    
   
   
       42 . A method of occluding a blood vessel according to  claim 41 , wherein: 
 said removal means comprises a thread attached to said plug body.    
   
   
       43 . The device according to  claim 4 , wherein: 
 said flexible large-diameter section is capable of flexing in said second direction with a greater range than in said first direction.    
   
   
       44 . A device for occluding a blood vessel having an interior diameter, comprising: 
 a body comprising a forward section having a tapered outer surface, and a large diameter section adjacent said forward section having a diameter greater than the interior diameter of the blood vessel; and    an insert disposed along a central axis of said body and mechanically attached to said body, wherein said insert is formed from a hard material relative to said body.    
   
   
       45 . The device according to  claim 44 , wherein: 
 said body comprises an elastomeric biocompatible material and said insert comprises metal.    
   
   
       46 . The device according to  claim 45 , wherein: 
 said elastomeric biocompatible material of said body comprises silicone and said metal of said insert comprises titanium.    
   
   
       47 . The device according to  claim 44 , which is inserted into the blood vessel by use of an insertion device, further comprising: 
 said insert has a longitudinal axis and a pilot hole along said longitudinal axis for receiving the insertion device.