Endo-leak free aortic adapter assembly and method of device delivery

Abstract

An aortic adapter assembly is provided, including a T-shaped flow connector, including: an inserted conduit portion, having a blood-contacting surface which is smooth; an extruded neck portion, wherein the inserted conduit portion is joined with the extruded neck portion; and a truss, disposed in the inserted conduit portion; wherein the T-shaped flow connector has a polymeric elastomer reinforced by the truss having a Nitinol material; wherein the inserted conduit portion has an inner wall which is gradually thinning at two conduit ends of the inserted conduit portion, with a proper distance of a tip of the conduit end to the outmost boundary of the truss, and the conduit end possesses a compliance-matching effect to an implant site artery; wherein a proximal end of the extruded neck portion is configured to be joined with an inlet adapter of a blood pump. The aortic adapter assembly is accompanied with a quick-connector type coupler and a deployment method to accomplish an insertion type flow communication between a ventricular assist device and the human circulation.

What is claimed is: 
     
         1 . An aortic adapter assembly, for an implantable ventricular assist device, comprising:
 a T-shaped flow connector, including: 
 an inserted conduit portion and an extruded neck portion; wherein the inserted conduit portion is joined with the extruded neck portion; both having a blood-contacting surface which is smooth; and 
 a truss, disposed in the inserted conduit portion; 
 wherein the T-shaped flow connector has a polymeric elastomer reinforced by the truss having a Nitinol material; 
 wherein the inserted conduit portion has a wall which is gradually thinning at two conduit ends of the inserted conduit portion, with a proper distance of a tip of the conduit end to the outmost boundary of the truss, and the conduit end possesses a compliance-matching effect to an implant site artery; 
 wherein a proximal end of the extruded neck portion is configured to be joined with an inlet adapter of a blood pump. 
   
     
     
         2 . The aortic adapter assembly as claimed in  claim 1 , wherein the truss is co-injected and embedded in the wall of the inserted conduit portion of the flow connector. 
     
     
         3 . The aortic adapter assembly as claimed in  claim 2 , wherein the polymer substrate is a silicone material. 
     
     
         4 . The aortic adapter assembly as claimed in  claim 2 , wherein the polymer substrate is a mold injectable polyurethane. 
     
     
         5 . The aortic adapter assembly as claimed in  claim 2 , wherein a structural compliance of the embedded truss and a structural compliance of the polymer substrate are substantially equal to each other. 
     
     
         6 . The aortic adapter assembly as claimed in  claim 1 , wherein the gradually thinning conduit ends are sharp-edged. 
     
     
         7 . The aortic adapter assembly as claimed in  claim 1 , wherein the extruded neck portion has a shallow inclined surface to match with an inlet adapter of the blood pump, and an inner diameter of the extruded neck portion is slightly smaller than an inner diameter of the inlet adapter of the blood pump. 
     
     
         8 . The aortic adapter assembly as claimed in  claim 7 , wherein the shallow inclined surface is inclined relative to an extending direction of the inserted conduit portion. 
     
     
         9 . The aortic adapter assembly as claimed in  claim 1 , wherein the truss has a plurality of wavy structures. 
     
     
         10 . The aortic adapter assembly as claimed in  claim 1 , wherein the extruded neck portion includes: 
 a neck body; and   an extension part, disposed on the neck body, wherein the extension part protrudes from the neck body, and the maximum inner diameter of the extension part is larger than the maximum inner diameter of the neck body.   
     
     
         11 . The aortic adapter assembly as claimed in  claim 10 , wherein when the extruded neck portion is joined with the inlet adapter of a blood pump, the extension part snuggly embraces the inlet adapter, and the neck body is disposed around by the inlet adapter. 
     
     
         12 . The aortic adapter assembly as claimed in  claim 1 , further comprising a coupler, wherein the coupler includes:
 a flange base;   a pair of collars, mounted rotatably on the flange base; and   a latch, being able to lock the collars;   wherein the collars have internal grooves which can clamp the T-shaped flow connector with a controlled compression to seal the T-shaped flow connector.   
     
     
         13 . The aortic adapter assembly as claimed in  claim 12 , wherein each of the collars has a flange contour that enables a simultaneous engagement of the collars with respect to a rim of the flange base. 
     
     
         14 . The aortic adapter assembly as claimed in  claim 12 , wherein the latch is made of a leaf spring that assures the coupler be locked without concern of incidental disengagement. 
     
     
         15 . The aortic adapter assembly as claimed in  claim 12 , wherein the coupler further includes a hinge joint disposed on the flange base, and the collars are pivotally connected to the hinge joint and rotatable to the hinge joint and the flange base. 
     
     
         16 . The aortic adapter assembly as claimed in  claim 15 , wherein the hinge joint is located at the first side of the flange base, and the latch is located on a second side of the flange base, wherein the second side is opposite to the first side. 
     
     
         17 . The aortic adapter assembly as claimed in  claim 16 , wherein the latch has a slot which can be engaged with a ramp on the opposite collar. 
     
     
         18 . The aortic adapter assembly as claimed in  claim 12 , wherein the flange base has a substantially circular-shaped structure, and each collar has an arc-shaped structure. 
     
     
         19 . A blood pump device, for an implantable ventricular assist device, comprising:
 a blood pump, having an inlet adapter, wherein the inlet adapter has a cone-shaped beak;   an aortic adapter assembly, for an implantable ventricular assist device, comprising: 
 a T-shaped flow connector, including: 
 an inserted conduit portion and an extruded neck portion; wherein the inserted conduit portion is joined with the extruded neck portion; both having a blood-contacting surface which is smooth; and 
 a truss, disposed in the inserted conduit portion; 
 
   wherein the T-shaped flow connector has a polymeric elastomer reinforced by the truss having a Nitinol material;   wherein the inserted conduit portion has an inner wall which is gradually thinning at two conduit ends of the inserted conduit portion, with a proper distance of a tip of the conduit end to the outmost boundary of the truss, and the conduit end possesses a compliance-matching effect to an implant site artery;   wherein a proximal end of the extruded neck portion is configured to be joined with the inlet adapter of a blood pump;   wherein the cone-shaped beak is able to fit with the proximal end of the extruded neck portion.   
     
     
         20 . The blood pump device as claimed in  claim 19 , wherein the inner diameter of the inlet adapter is slightly larger than the inner diameter of the neck portion of the flow connector. 
     
     
         21 . A method of implanting a flow connector assembly as claimed in  claim 1 , with an artery, the method comprising:
 crimping the flow connector into a delivery configuration; wherein the size of the delivery configuration is at least half of the diameter of the original flow connector; and   inserting the delivery configuration of the flow connector into an artery having an access hole punched in the arterial wall;   releasing the inserted delivery configuration of the flow connector; wherein the released flow connector is self-expandable to its original deployed form; and   coupling the deployed flow connector with a ventricular assist device to assist circulation in the patient.