Esophageal stent including a valve member

Abstract

An example medical device is disclosed. The example medical device includes a tubular scaffold. The scaffold includes a longitudinal axis, an inner surface and an outer surface. The medical device also includes a flexible valve extending radially inward from the inner surface of the scaffold. The valve includes an annular chamber extending circumferentially around the inner surface of the scaffold and is configured to shift from a closed configuration to an open configuration.

What is claimed is: 
     
         1 . A method of manufacturing an expandable stent, the method comprising:
 positioning a mandrel within a lumen of a tubular scaffold, the mandrel including first and second end regions, and a middle region extending therebetween, the mandrel further including a recessed portion defining a recessed surface extending radially inward from an outer surface of the middle region, the tubular scaffold defined by a wall having an inner surface, an outer surface, and a plurality of apertures extending from the inner surface to the outer surface through the wall, wherein the recessed surface is spaced apart radially inward from the inner surface of a portion of the tubular scaffold extending across the recessed portion;   depositing a material through the plurality of apertures of the tubular scaffold such that the material contacts the recessed surface of the mandrel thereby forming an inner layer of material within the lumen of the tubular scaffold, wherein a portion of the inner layer of material forms a valve extending radially inward from the inner surface of the tubular scaffold, the valve having an outer surface spaced apart radially inward of and not in contact with the inner surface of the portion of the wall extending across the recessed portion; and   removing the mandrel.   
     
     
         2 . The method of  claim 1 , wherein the tubular scaffold is a monolithic structure formed from a cylindrical tube cut to form the plurality of apertures. 
     
     
         3 . The method of  claim 1 , wherein the tubular scaffold includes a plurality of filaments extending from the first end region to the second end region and arranged to define the plurality of apertures. 
     
     
         4 . The method of  claim 1 , wherein depositing the material forms the valve in a middle region of the tubular scaffold with first and second end regions of the tubular scaffold extending axially away from opposite ends of the valve. 
     
     
         5 . The method of  claim 1 , wherein the recessed portion extends circumferentially around a longitudinal axis of the mandrel and depositing the material forms the valve extending circumferentially around the tubular scaffold. 
     
     
         6 . The method of  claim 5 , wherein depositing further comprises depositing the inner layer of material on the inner surface of the tubular scaffold between a first circumferential location and a first end of the tubular scaffold and between a second circumferential location and a second end of the tubular scaffold. 
     
     
         7 . The method of  claim 6 , further comprising depositing an outer layer of material along the outer surface of the tubular scaffold from the first end of the tubular scaffold to the second end of the tubular scaffold. 
     
     
         8 . The method of  claim 7 , wherein depositing the outer layer results in the inner layer being circumferentially attached to the outer layer at the first circumferential location and circumferentially attached to the outer layer at the second circumferential location thereby forming an annular chamber. 
     
     
         9 . The method of  claim 8 , wherein the annular chamber extends circumferentially around a central longitudinal axis of the tubular scaffold. 
     
     
         10 . The method of  claim 8 , wherein forming the annular chamber results in the annular chamber being air-filled. 
     
     
         11 . The method of  claim 8 , wherein forming the annular chamber includes filling the annular chamber with a substance selected from the group consisting of liquids, gels and polymers. 
     
     
         12 . The method of  claim 1 , wherein the recessed portion includes a first conical section tapering from the outer surface of the middle region toward a central longitudinal axis of the mandrel, and a second section extending from the outer surface toward the central longitudinal axis at an angle, wherein depositing material forms the valve with a first conical section and a second section extending inward at the angle. 
     
     
         13 . The method of  claim 12 , wherein the angle is an acute angle, wherein depositing material forms the valve with a first conical section and a second section extending inward at the acute angle. 
     
     
         14 . The method of  claim 12 , wherein the angle is an obtuse angle, wherein depositing material forms the valve with a first conical section and a second section extending inward at the obtuse angle. 
     
     
         15 . The method of  claim 12 , wherein the second section of the recessed portion includes a surface texture and the first conical section of the recessed portion is devoid of the surface texture. 
     
     
         16 . The method of  claim 12 , wherein depositing material includes depositing a greater thickness of material on the second section of the recessed portion than on the first conical section. 
     
     
         17 . A method of manufacturing an expandable stent, the method comprising:
 positioning a mandrel within a lumen of a tubular scaffold, the mandrel including first and second flared end regions each having a first diameter, and a middle region extending therebetween with a second diameter smaller than the first diameter, the mandrel further including a recessed portion defining a recessed surface extending radially inward from an outer surface of the middle region, the tubular scaffold defined by a wall having an inner surface, an outer surface, and a plurality of apertures extending from the inner surface to the outer surface through the wall, wherein the recessed surface is spaced apart radially inward from the inner surface of a portion of the tubular scaffold extending across the recessed portion;   depositing a material through the plurality of apertures of the tubular scaffold continuously from the first flared end region to the second flared end region such that the material contacts the outer surface of the middle region and the recessed surface of the mandrel thereby forming an inner layer of material within the lumen of the tubular scaffold, wherein a portion of the inner layer of material forms a valve extending radially inward from the inner surface of the tubular scaffold, the valve having an outer surface spaced apart radially inward of and not in contact with the inner surface of the portion of the wall extending across the recessed portion;   depositing an outer layer of the material along an entirety of the tubular scaffold from the first flared end region to the second flared end region of the mandrel; and   removing the mandrel.   
     
     
         18 . The method of  claim 17 , wherein the recessed portion extends circumferentially around a longitudinal axis of the mandrel and depositing the material forms the valve extending circumferentially around the tubular scaffold. 
     
     
         19 . The method of  claim 17 , wherein the recessed portion includes a first conical section tapering from the outer surface of the middle region toward a central longitudinal axis of the mandrel, and a second section extending from the outer surface toward the central longitudinal axis at an angle, wherein depositing material forms the valve with a first conical section and a second section extending inward at the angle, wherein the second section of the recessed portion includes a surface texture and the first conical section of the recessed portion is devoid of the surface texture. 
     
     
         20 . A method of manufacturing an expandable stent, the method comprising:
 positioning a mandrel within a lumen of a tubular scaffold, the mandrel including first and second end regions, and a middle region extending therebetween, the mandrel further including a recessed portion defining a recessed surface extending circumferentially around a longitudinal axis of the mandrel and extending radially inward from an outer surface of the middle region, the tubular scaffold defined by a wall having an inner surface, an outer surface, and a plurality of apertures extending from the inner surface to the outer surface through the wall, wherein the recessed surface is spaced apart radially inward from the inner surface of a portion of the tubular scaffold extending across the recessed portion;   depositing a material through the plurality of apertures of the tubular scaffold such that the material contacts the recessed surface of the mandrel thereby forming an inner layer of material within the lumen of the tubular scaffold, wherein a portion of the inner layer of material forms a valve extending circumferentially and radially inward from the inner surface of the tubular scaffold, the valve having an outer surface spaced apart radially inward of and not in contact with the inner surface of the portion of the wall extending across the recessed portion;   depositing an outer layer of material along the outer surface of the tubular scaffold from the first end region to the second end region of the mandrel, resulting in the inner layer being circumferentially attached to the outer layer at a first circumferential location and circumferentially attached to the outer layer at a second circumferential location thereby forming an annular chamber; and   removing the mandrel.