Artificial Venous Valve with Discrete Shaping Members

Abstract

The invention relates to a prosthetic valve for regulating flow through a body lumen. The medical device comprises discrete shaping members, a flexible covering, and a valve member. The discrete shaping members are operatively attached to the flexible covering, such that the medical device may exhibit low radial force and dynamic movement.

1 . A prosthetic valve for implantation in a body vessel having an expanded configuration and a compressed configuration, the prosthetic valve comprising:
 a flexible covering having a proximal covering end, a distal covering end, a luminal surface, an abluminal surface, and an axial length extending between the proximal covering end and distal covering end, the flexible covering defining an interior lumen, the flexible covering having a longitudinal axis extending between the proximal covering end and the distal covering end and a circumference extending around the abluminal surface;   a plurality of discrete shaping members attached only to the flexible covering, each of the discrete shaping members comprising a longitudinal strut extending along the flexible covering and being substantially parallel to the longitudinal axis; and   at least one valve member operatively connected to the luminal surface, the at least one valve member adapted to modify fluid flow through the interior lumen.   
     
     
         2 . The prosthetic valve of  claim 1 , wherein the plurality of discrete shaping members is adapted to create an artificial sinus around the valve member. 
     
     
         3 . The prosthetic valve of  claim 1 , wherein each of the plurality of discrete shaping members is attached to the abluminal surface. 
     
     
         4 . The prosthetic valve of  claim 1 , wherein the plurality of discrete shaping members are adapted to move circumferentially relative to one another along the abluminal surface of the flexible covering when the prosthetic valve is moved between the compressed configuration and the expanded configuration. 
     
     
         5 . The prosthetic valve of  claim 1 , wherein each discrete shaping member is bowed. 
     
     
         6 . The prosthetic valve of  claim 1 , further comprising a first stent attached near the proximal covering end and a second stent attached near the distal covering end. 
     
     
         7 . The prosthetic valve of  claim 1 , wherein at least one discrete shaping member comprises an energy-sensitive material. 
     
     
         8 . The prosthetic valve of  claim 7 , wherein the energy-sensitive material increases in temperature when an energy source is applied thereto, the energy source selected from the group consisting of radiofrequency energy, electrical energy, ultrasound energy, laser energy, microwave energy, and electromagnetic energy. 
     
     
         9 . The prosthetic valve of  claim 1 , wherein the flexible covering abluminal surface comprises a bioadhesive. 
     
     
         10 . The prosthetic valve of  claim 9 , wherein the bioadhesive comprises a bioadhesive curable by ultraviolet light exposure. 
     
     
         11 . The prosthetic valve of  claim 1 , wherein the discrete shaping members are selected from the group consisting of stainless steel, nitinol, tantalum, a nonmagnetic nickel-cobalt-chromium-molybdenum alloy, platinum, titanium, a suitable biocompatible alloy, a suitable biocompatible polymer, a suitable biocompatible material, and a combination thereof. 
     
     
         12 . The prosthetic valve of  claim 1 , wherein the flexible covering comprises a material selected from the group consisting of biocompatible polyurethane, polyethylene terephthalate, polytetrafluoroethylene, and extracellular matrix material. 
     
     
         13 . The prosthetic valve of  claim 1 , wherein the prosthetic valve further comprises anchoring devices. 
     
     
         14 . A prosthetic valve for implantation in a body vessel having an expanded configuration and a compressed configuration, the prosthetic valve comprising:
 a flexible covering defining a body region surrounding an interior lumen extending between a proximal covering end and a distal covering end, the flexible covering having an axial length extending between the proximal covering end and the distal covering end, a luminal surface defining the interior lumen, an abluminal surface, a longitudinal axis extending between the proximal covering end and the distal covering end, and a circumference extending around the abluminal surface;   a plurality of discrete shaping members individually attached to only the flexible covering, each of the discrete shaping members comprising a longitudinal strut extending along the flexible covering and being substantially parallel to the longitudinal axis, the plurality of discrete shaping members being adapted to move circumferentially relative to one another along the abluminal surface of the flexible covering when the prosthetic valve is moved between the compressed configuration and the expanded configuration; and   at least one valve member operatively connected to the luminal surface, the at least one valve member adapted to modify fluid flow through the interior lumen;   wherein the interior lumen has a larger cross-sectional area in at least a portion surrounding the at least one valve member than at the proximal covering end and the distal covering end to create an artificial sinus; and   wherein the plurality of discrete shaping members is adapted to create an artificial sinus around the valve member.   
     
     
         15 . The prosthetic valve of  claim 14 , further comprising a first stent attached near the proximal covering end and a second stent attached near the distal covering end. 
     
     
         16 . The prosthetic valve of  claim 1 , wherein the discrete shaping members are selected from the group consisting of stainless steel, nitinol, tantalum, a nonmagnetic nickel-cobalt-chromium-molybdenum alloy, platinum, titanium, a suitable biocompatible alloy, a suitable biocompatible polymer, a suitable biocompatible material, and a combination thereof. 
     
     
         17 . The prosthetic valve of  claim 1 , wherein the flexible covering comprises a material selected from the group consisting of biocompatible polyurethane, polyethylene terephthalate, polytetrafluoroethylene, and extracellular matrix material. 
     
     
         18 . A prosthetic valve for implantation in a body vessel having an expanded configuration and a compressed configuration, the prosthetic valve comprising:
 a flexible covering defining a body region surrounding an interior lumen extending between a proximal covering end and a distal covering end, the flexible covering having an axial length extending between the proximal covering end and the distal covering end, a luminal surface defining the interior lumen, an abluminal surface, a longitudinal axis extending between the proximal covering end and the distal covering end, and a circumference extending around the abluminal surface;   a plurality of discrete shaping members individually attached to only the flexible covering, each of the discrete shaping members comprising a longitudinal strut extending along the flexible covering and being substantially parallel to the longitudinal axis, the plurality of discrete shaping members being adapted to move circumferentially relative to one another along the abluminal surface of the flexible covering when the prosthetic valve is moved between the compressed configuration and the expanded configuration;   a first stent attached near the proximal covering end;   a second stent attached near the distal covering end; and   at least one valve member operatively connected to the luminal surface, the at least one valve member adapted to modify fluid flow through the interior lumen;   wherein the interior lumen has a larger cross-sectional area in at least a portion surrounding the at least one valve member than at the proximal covering end and the distal covering end to create an artificial sinus; and   wherein the plurality of discrete shaping members is adapted to create an artificial sinus around the valve member.   
     
     
         19 . The prosthetic valve of  claim 18 , wherein the discrete shaping members are selected from the group consisting of stainless steel, nitinol, tantalum, a nonmagnetic nickel-cobalt-chromium-molybdenum alloy, platinum, titanium, a suitable biocompatible alloy, a suitable biocompatible polymer, a suitable biocompatible material, and a combination thereof. 
     
     
         20 . The prosthetic valve of  claim 18 , wherein the flexible covering comprises a material selected from the group consisting of biocompatible polyurethane, polyethylene terephthalate, polytetrafluoroethylene, and extracellular matrix material.