Vasoocclusion coil device having a core therein

Abstract

A coil-type vasoocclusion device ( 10 ) for establishing an embolus or vascular occlusion in a human or veterinary patient is adapted for introduction into the patient via a catheter ( 32 ). The device ( 10 ) first includes a coil ( 12 ) having proximal and distal coil ends ( 16,18 ) and a coil lumen ( 20 ). The device ( 10 ) also includes a core ( 22 ) disposed in at least part of the coil lumen ( 20 ), the core having proximal and distal core ends ( 24,26 ). Only one core end ( 24 or 26 ) is directly affixed to a respective end ( 16 or 18 ) of the coil ( 12 ); the other core end ( 26 or 24 ) is not directly connected to either end ( 16 or 18 ) of the coil ( 12 ). The core ( 22 ) is preferably nitinol in a superelastic state, being in other than its stress induced, martensitic condition. The device ( 10 ) can include a thrombogenic material ( 38 ) connected to or carried by the coil ( 12 ). The coil ( 12 ) is preferably adapted to achieve a suitable secondary shape ( 60 ) when deployed from the catheter ( 32 ). A medical device ( 40 ) combining the catheter ( 32 ), a pusher ( 34 ), a coupling ( 30 ) and the vasoocclusion device ( 10 ) is also disclosed. The vasoocclusion device ( 10 ) is easily repositioned in the vascular system, thereby ensuring proper deployment, and also enjoys a dislodging force about twice as great as comparable coil-type devices lacking the core ( 22 ), substantially or completely preventing migration of the device ( 10 ) after its deployment.

What is claimed is:  
     
         1 . A vasoocclusion device ( 10 ) for establishing an embolus or vascular occlusion in a vessel of a human or veterinary patient, the device ( 10 ) comprising: 
 a coil ( 12 ) having a proximal coil end ( 16 ), a distal coil end ( 18 ) spaced from the proximal coil end ( 16 ) and a coil lumen ( 20 ) defined therein extending between the proximal coil end ( 16 ) and the distal coil end ( 18 ); and    a core ( 22 ) disposed in at least part of the coil lumen ( 20 ), the core ( 22 ) having a proximal core end ( 24 ) and a distal core end ( 26 ); and    one portion of the core ( 22 ) affixed to the coil ( 12 ) at a selected location,    whereby the core ( 22 ) provides the coil ( 12 ) with an anchoring force in the vessel ( 42 ).    
     
     
         2 . The device ( 10 ) as set forth in  claim 1  wherein the coil lumen ( 20 ) possesses a defined cross-section, and the core ( 22 ) substantially fills the defined cross-section of the coil lumen ( 20 ).  
     
     
         3 . The device ( 10 ) as set forth in  claim 1  wherein the distal core end ( 26 ) is affixed to the distal coil end ( 18 ).  
     
     
         4 . The device ( 10 ) as set forth in  claim 3  wherein the distal core end ( 26 ) is soldered, welded or adhered to the distal coil end ( 18 ).  
     
     
         5 . The device ( 10 ) as set forth in  claim 1  adapted for introduction into the patient via a catheter ( 32 ), wherein the device ( 10 ) is detachably secured to the catheter ( 32 ).  
     
     
         6 . The device ( 10 ) as set forth in  claim 5  wherein the device ( 10 ) further comprises a reversible coupling ( 30 ) for detachably connecting the device ( 10 ) to the catheter ( 32 ) for introducing it into the patient.  
     
     
         7 . The device ( 10 ) as set forth in  claim 6  adapted for introduction into the patient via a pusher ( 34 ) contained in the catheter ( 32 ), wherein the coupling ( 30 ) detachably connects the device ( 10 ) to the pusher ( 34 ).  
     
     
         8 . The device ( 10 ) as set forth in  claim 1  wherein the core ( 22 ) comprises nitinol, another shape memory material, stainless steel or MP35N.  
     
     
         9 . The device ( 10 ) as set forth in  claim 1  wherein the core ( 22 ) comprises nitinol in a superelastic state.  
     
     
         10 . The device ( 10 ) as set forth in  claim 1  wherein the core ( 22 ) comprises nitinol in other than its stress induced, martensitic condition.  
     
     
         11 . The device ( 10 ) as set forth in  claim 1  wherein the coil ( 12 ) comprises a secondary nonlinear shape ( 60 ) when unstressed.  
     
     
         12 . The device ( 10 ) as set forth in  claim 11  wherein the secondary shape ( 60 ) is a saddle-type ( 62 ), helical type ( 64 ), vortex-type ( 66 ), irregular baffle-type ( 68 ) or fusiform helix-type ( 70 ) shape.  
     
     
         13 . The device ( 10 ) as set forth in  claim 11  wherein the secondary shape ( 60 ) is a substantially spherical secondary shape ( 72 ).  
     
     
         14 . The device ( 10 ) as set forth in  claim 13  wherein the substantially spherical secondary shape ( 72 ) is defined by circular loops ( 74 ) angularly spaced about an axis.  
     
     
         15 . The device ( 10 ) as set forth in  claim 13  wherein the substantially spherical secondary shape ( 72 ) is defined by D-shaped loops ( 78 ) angularly spaced about an axis.  
     
     
         16 . The device ( 10 ) as set forth in  claim 11  wherein the secondary shape ( 60 ) is an oval plate ( 84 ).  
     
     
         17 . The device ( 10 ) as set forth in  claim 16  wherein the oval plate secondary shape ( 84 ) is defined by a generally flattened array of loops of wire ( 14 ) and defining a plurality of holes through which other coils are deployable.  
     
     
         18 . The device ( 10 ) as set forth in  claim 1  further comprising a thrombogenic material ( 38 ) connected to or carried by the coil ( 12 ).  
     
     
         19 . The device ( 10 ) as set forth in  claim 18  wherein the thrombogenic material ( 38 ) comprises Dacron, cotton, silk, wool or polyester threads ( 44 ).  
     
     
         20 . The device ( 10 ) as set forth in  claim 1  the coil ( 12 ) comprises a wire ( 14 ) having a wire diameter of about 0.010 in. to about 0.032 in. (about 0.25 mm to about 0.81 mm).  
     
     
         21 . The device ( 10 ) as set forth in  claim 1  wherein the core ( 22 ) has a diameter of about 0.004 in. to about 0.015 in. (about 0.10 mm to about 0.38 mm).  
     
     
         22 . The device ( 10 ) as set forth in  claim 1  wherein the core is of nitinol and has a diameter of about 0.004 in. to about 0.006 in. (about 0.10 mm to about 0.15 mm), and the coil has a diameter of about 0.010 in. to about 0.015 in. (0.25 mm to 0.38 mm).  
     
     
         23 . The device ( 10 ) as set forth in  claim 1  wherein the core ( 22 ) includes at least one tapered end portion ( 46 ).  
     
     
         24 . The device ( 10 ) as set forth in  claim 23  wherein the core ( 22 ) includes two tapered end portions ( 46 ).  
     
     
         25 . The device ( 10 ) as set forth in  claim 1  wherein the core ( 22 ) defines alternating portions of larger ( 48 ) and smaller ( 50 ) diameters therealong having even and continuous transitions therebetween.  
     
     
         26 . The device ( 10 ) as set forth in  claim 11  wherein the secondary shape ( 36 ) of the coil ( 12 ) has a general outer dimension of about 3 mm to about 15 mm.  
     
     
         27 . The device ( 10 ) as set forth in  claim 11  wherein the coil ( 12 ) is about 2 to about 40 cm long when within a catheter.  
     
     
         28 . A vasoocclusion device ( 10 ) for establishing an embolus or vascular occlusion in a human or veterinary patient, the device ( 10 ) being adapted for introduction into the patient via a catheter ( 32 ), and the catheter ( 32 ) having a pusher ( 34 ) contained therein for deploying the device ( 10 ) from the catheter ( 32 ); the device ( 10 ) comprising: 
 a coil ( 12 ) having a proximal coil end ( 16 ), a distal coil end ( 18 ) spaced from the proximal coil end ( 16 ) and a coil lumen ( 20 ) defined therein extending between the proximal coil end ( 16 ) and the distal coil end ( 18 );    a core ( 22 ) disposed in at least part of the coil lumen ( 20 ), the core ( 22 ) having a proximal core end ( 24 ) and a distal core end ( 26 ); and    a thrombogenic material ( 38 ) connected to or carried by the coil ( 12 );    wherein one and only one of the proximal core end ( 24 ) and the distal core end ( 26 ) is directly affixed to a respective one of the proximal coil end ( 16 ) and the distal coil end ( 18 ), the other of the distal core end ( 26 ) and the proximal core end ( 24 ) not being directly affixed to either the distal coil end ( 18 ) or the proximal coil end ( 16 );    wherein the distal core end ( 26 ) is directly affixed to the distal coil end ( 18 ) by solder ( 28 ) or an adhesive;    wherein the core ( 22 ) comprises nitinol in a superelastic state, being in other than its stress induced, martensitic condition;    wherein the thrombogenic material ( 38 ) comprises Dacron, cotton, silk, wool or polyester threads ( 44 );    wherein the coil ( 12 ) comprises a wire ( 14 ) having a diameter of about 0.010 in. to about 0.032 in. (about 0.25 mm to about 0.81 mm);    wherein the core ( 22 ) has a diameter of about 0.004 in. to about 0.015 in. (about 0.10 mm to about 0.38 mm);    wherein the coil ( 12 ) is about 2 to about 40 cm long when constrained within a catheter; and    wherein the core ( 22 ) provides the coil ( 12 ) with an additional force assisting anchoring of the coil ( 12 ) in the human or veterinary patient when the coil ( 12 ) and the core ( 22 ) are deployed from the catheter ( 32 ).    
     
     
         29 . A medical device ( 40 ) for establishing an embolus or vascular occlusion in a vessel of a human or veterinary patient, comprising: 
 a coil ( 12 ) having a proximal coil end ( 16 ), a distal coil end ( 18 ) spaced from the proximal coil end ( 16 ) and a coil lumen ( 20 ) defined therein extending between the proximal coil end ( 16 ) and the distal coil end ( 18 );    a core ( 22 ) disposed in at least part of the coil lumen ( 20 ), the core ( 22 ) having a proximal core end ( 24 ) and a distal core end ( 26 );    one portion of the core ( 22 ) affixed to the coil ( 12 ) at a selected location,    a catheter ( 32 ) dimensioned to receive the coil ( 12 ) and the core ( 22 ) therein; and    a pusher ( 34 ) contained in the catheter ( 32 ), adapted to deploy the coil ( 12 ) and the core ( 22 ) from the catheter ( 32 );    wherein the core ( 22 ) provides the coil ( 12 ) with an anchoring force in the vessel when the coil ( 12 ) and the core ( 22 ) are deployed from the catheter ( 32 ).    
     
     
         30 . The device ( 10 ) as set forth in  claim 29  further comprising a coupling ( 30 ) for detachably connecting the coil ( 12 ) to the pusher ( 34 ).  
     
     
         31 . In a coil-type vasoocclusion device for establishing an embolus or vascular occlusion in a vessel of a human or veterinary patient, where the device comprises (a) a coil having a proximal coil end, a distal coil end spaced from the proximal coil end, a coil lumen defined therein extending between the proximal coil end and the distal coil end; and (b) a core disposed in at least part of the coil lumen, the core having a proximal core end and a distal core end; the improvement being characterized in that: 
 only one section of the coil is affixed to the coil at a selected location, wherein the core provides the coil with an anchoring force in the vessel.    
     
     
         32 . The device as set forth in  claim 31 , wherein one of the proximal core end and distal core end is affixed to a respective one of the proximal coil end and the distal coil end.  
     
     
         33 . A method of treating an aneurysm ( 86 ), comprising: 
 placing a first device ( 10 ) within the aneurysm ( 86 ), with the first device ( 10 ) in its unstressed state being sufficiently large when so placed such that it traverses a neck ( 88 ) of the aneurysm to extend beyond the periphery of the neck ( 88 ) and defines a plurality of holes extending through the first device permitting subsequent deployment therethrough of additional devices within the aneurysm ( 86 ).