Two-way slit valve

Abstract

A slit valve 10 for use with an inflatable medical device having a flange surface 12 with an opening therein. The slit valve 10 has a valve body 14 connected to the flange surface 12 and a chamber formed in the valve body 14 for accepting an inflation tube 34 inserted through the opening in the flange surface 12. The slit valve 10 has a concave section at one or both ends, which are connected by a slit 24 formed in the valve body 14.

1 . A combination of a two-way medical valve and an inflation tube, comprising:
 an elastomeric slit valve having a valve body defining proximal and distal ends, and an opening at the proximal end, an internal chamber including a first chamber immediately adjacent and wider than the opening and a second chamber in open fluid communication with the first chamber, wherein the internal chamber in the valve body narrows between the first and second chambers to form a neck, and a normally closed slit formed in a solid portion of the valve body connecting a concave section at a distal end of the second chamber and the distal end of the valve body; and   an inflation tube having a lumen therethrough, the inflation tube defining an injection tip having a wedge shaped distal end, the injection tip further including an insertion stop located proximal to the distal end and a reduced diameter portion therebetween;   wherein the elastomeric valve body is adapted to receive the inflation tube such that fluid may be introduced into the internal chamber and at a threshold pressure differential across the slit open and pass distally through the slit, and wherein the slit also permits fluid to pass proximally therethrough upon a predetermined backflow pressure differential, and   wherein the insertion stop is sized to positively engage the opening and limit the distance to which the injection tip extends into the internal chamber, at which distance the wedge shaped distal end forms a seal within the narrow neck in the valve body.   
     
     
         2 . The combination of  claim 1 , wherein the inflation tube includes a flexible tube and the injection tip is a rigid piece having a barbed proximal end to retain the injection tip in fluid-tight engagement with the flexible tube. 
     
     
         3 . The combination of  claim 2 , wherein the flexible tube is provided with reference length markers. 
     
     
         4 . The combination of  claim 1 , wherein the distal end of the valve body defines a second concave section such that the slit connects the concave section of the second chamber and the second concave section. 
     
     
         5 . The combination of  claim 4 , wherein the shape of the second chamber relative to the second concave section is such that a smaller threshold pressure differential is required to open the slit and pass fluid distally therethrough than a backflow pressure differential required to open the slit and pass fluid proximally therethrough. 
     
     
         6 . The combination of  claim 5 , wherein the backflow pressure differential required to open the slit and pass fluid proximally therethrough is no more than 40 psi (2.81 Kg/cm 2 ). 
     
     
         7 . The combination of  claim 1 , wherein the proximal opening of the valve body is sized to form a second fluid seal against the reduced diameter portion of the injection tip. 
     
     
         8 . The combination of  claim 1 , wherein at least a portion of the first chamber substantially conforms to the wedge shaped distal end of the inflation tube. 
     
     
         9 . An inflatable medical implant having a two-way valve for accepting an inflation tube, comprising:
 an inflatable balloon formed of a flexible polymer material suitable for residence in the body;   a slit valve provided in a wall of the balloon, the slit valve comprising:
 an elastomeric valve body having a width and proximal and distal ends and received in an opening in the wall of the balloon; 
 a proximal flange at the proximal end of the valve body that conforms to an outer surface of the wall of the balloon and has an opening therein; 
 an open internal chamber formed within the valve body in open fluid communication with the flange opening, the internal chamber having a concave section at its distal end; and 
 a normally closed slit formed in a solid portion of the valve body connecting the concave section of the internal chamber and the distal end of the valve body, 
   wherein the valve body is adapted to receive an inflation tube through the flange opening such that fluid may be introduced into the internal chamber and at a threshold pressure differential across the slit open and pass distally through the slit and into the balloon, and wherein the slit also permits fluid to pass proximally therethrough upon a predetermined backflow pressure differential.   
     
     
         10 . The implant of  claim 9 , wherein the medical implant is a gastric balloon and the polymer material is suitable for residence in the stomach. 
     
     
         11 . The implant of  claim 9 , wherein the medical implant is a mammary implant and the polymer material is suitable for residence in a breast cavity. 
     
     
         12 . The implant of  claim 9 , wherein the medical implant is a tissue expander and the polymer material is suitable for residence in a breast cavity. 
     
     
         13 . The implant of  claim 9 , wherein the flange opening is smaller than the width of the immediately adjacent internal chamber. 
     
     
         14 . The implant of  claim 9 , wherein the internal chamber includes a proximal first chamber immediately adjacent the flange opening and a distal second chamber in open fluid communication with the first chamber, the concave section being located at a distal end of the second chamber, and wherein the internal chamber in the valve body narrows between the first and second chambers to form a neck. 
     
     
         15 . The implant of  claim 9 , wherein the distal end of the valve body defines a second concave section such that the slit connects the concave section of the internal chamber and the second concave section. 
     
     
         16 . The implant of  claim 15 , wherein the shape of the internal chamber relative to the second concave section is such that a smaller threshold pressure differential is required to open the slit and pass fluid distally therethrough than a backflow pressure differential required to open the slit and pass fluid proximally therethrough. 
     
     
         17 . The implant of  claim 16 , wherein the backflow pressure differential required to open the slit and pass fluid proximally therethrough is no more than 40 psi (2.81 Kg/cm 2 ). 
     
     
         18 . A medical system having an inflatable implant with a two-way valve for accepting an inflation tube, comprising:
 an inflatable implant formed of a flexible polymer material suitable for residence in the body;   slit valve provided in a wall of the flexible polymer material comprising an elastomeric valve body defining proximal and distal ends, the proximal end of the valve body having a proximal opening therein, an open internal chamber formed within the valve body being in open fluid communication with the proximal opening, the internal chamber having a concave section at its distal end, and a normally closed slit formed in a solid portion of the valve body connecting the concave section of the internal chamber and the distal end of the valve body; and   an inflation tube having a lumen therethrough, the inflation tube defining an injection tip having a distal end, the injection tip further including an insertion stop located proximal to the distal end,   wherein the elastomeric valve body is adapted to receive the inflation tube through the proximal opening such that fluid may be introduced into the internal chamber and at a threshold pressure differential across the slit open and pass distally through the slit and into the inflatable implant, and wherein the slit also permits fluid to pass proximally therethrough upon a predetermined backflow pressure differential, and   wherein the insertion stop is sized to positively engage the opening and limit the distance to which the injection tip extends into the internal chamber, at which distance the distal end is sized to form a first fluid seal with a portion of the internal chamber and remains spaced from the concave section.   
     
     
         19 . The system of  claim 18 , wherein the distal end of the injection tip is wedge shaped, and the injection tip further includes a reduced diameter portion located between the distal end thereof and the insertion stop, the proximal opening of the valve body being sized to form a second fluid seal against the reduced diameter portion of the injection tip. 
     
     
         20 . The system of  claim 18 , wherein the internal chamber includes a proximal first chamber immediately adjacent the proximal opening and a distal second chamber in open fluid communication with the first chamber, the concave section being located at a distal end of the second chamber, and wherein the internal chamber in the valve body narrows between the first and second chambers to form a neck that defines the portion of the internal chamber that forms the first fluid seal with the distal end of the injection tip. 
     
     
         21 . The system of  claim 18 , wherein the distal end of the valve body defines a second concave section such that the slit connects the concave section of the internal chamber and the second concave section. 
     
     
         22 . The system of  claim 21 , wherein the shape of the internal chamber relative to the second concave section is such that a smaller threshold pressure differential is required to open the slit and pass fluid distally therethrough than a backflow pressure differential required to open the slit and pass fluid proximally therethrough. 
     
     
         23 . The system of  claim 18 , wherein the inflation tube includes a flexible tube and the injection tip is a rigid piece, the flexible tube being provided with reference length markers. 
     
     
         24 . The system of  claim 18 , wherein the inflatable implant is a gastric balloon and the flexible polymer material is suitable for residence in the stomach. 
     
     
         25 . A method of inflating a medical implant with an inflation tube through a two-way valve, comprising:
 providing an inflatable implant formed of a flexible polymer material suitable for residence in the body, the implant including a slit valve provided in a wall of the flexible polymer material comprising an elastomeric valve body defining proximal and distal ends, the proximal end of the valve body having a proximal opening therein, an open internal chamber formed within the valve body being in open fluid communication with the proximal opening, the internal chamber having a concave section at its distal end, and a normally closed slit formed in a solid portion of the valve body connecting the concave section of the internal chamber and the distal end of the valve body;   providing an inflation tube having a lumen therethrough, the inflation tube defining an injection tip having a distal end, the injection tip further including an insertion stop located proximal to the distal end;   inserting the inflation tube through the proximal opening of the valve body until the insertion stop positively engages the proximal opening and limits the distance to which the injection tip extends into the internal chamber, at which distance the distal end is sized to form a first fluid seal with a portion of the internal chamber and remains spaced from the concave section;   delivering the inflatable implant with the inflation tube inserted in the valve body to a body cavity; and   introducing fluid through the inflation tube into the internal chamber until a threshold pressure differential across the slit causes the slit to open and permit fluid to pass distally therethrough into the inflatable implant.   
     
     
         26 . The method of  claim 25 , wherein the slit valve is a two-way valve such that in the absence of the inflation tube the slit also permits fluid to pass proximally therethrough upon a predetermined backflow pressure differential. 
     
     
         27 . The method of  claim 26 , wherein the distal end of the valve body defines a second concave section such that the slit connects the concave section of the internal chamber and the second concave section, and wherein the shape of the internal chamber relative to the second concave section is such that a smaller threshold pressure differential is required to open the slit and pass fluid distally therethrough than a backflow pressure differential required to open the slit and pass fluid proximally therethrough. 
     
     
         28 . The method of  claim 25 , wherein the injection tip further includes a reduced diameter portion located between the distal end thereof and the insertion stop, the proximal opening of the valve body being sized to form a second fluid seal against the reduced diameter portion of the injection tip. 
     
     
         29 . The method of  claim 28 , wherein the injection tip is held in place within the valve body such that a force of less than 4 lb (17.8 N) is required to disengage the injection tip from the valve body. 
     
     
         30 . The method of  claim 25 , wherein the inflatable implant is a gastric balloon and the flexible polymer material is suitable for residence in the stomach, and wherein the step of delivering the inflatable implant includes passing it through the esophagus.