Sutureless gastroesophageal anti-reflux valve prosthesis and tool for peroral implantation thereof

Claim 2

A sutureless, perorally insertable anti-reflux valve prosthesis, comprising: a cylindrical housing constructed of a memory material comprising a metal mesh; a mounting ring fixed to the housing; a one-way sleeve valve depending from the mounting ring within the cylindrical housing; and a plurality of longitudinally aligned stays operatively associated with the sleeve and disposed within the cylindrical housing for inhibiting inversion of the sleeve.

Claim 3

The anti-reflux valve prosthesis of claim 1 wherein the metal mesh further comprises an interior surface and an exterior surface, the exterior surface being textured to facilitate anchoring of the prosthesis, and the interior surface being smooth to facilitate orthograde passage of foods and liquids therethrough.

Claim 4

The anti-reflux valve prosthesis of claim 1 wherein the memory material is selected from the group consisting of nickel, titanium alloy, spring steel, and plastic.

Claim 5

The anti-reflux valve prosthesis of claim 1 wherein the memory material is encased in silicone.

Claim 6

The anti-reflux valve prosthesis of claim 1 wherein the cylindrical housing has an enlarged upper end.

Claim 7

The anti-reflux valve prosthesis of claim 5 wherein the cylindrical housing further comprises an enlarged lower end.

Claim 8

The anti-reflux valve prosthesis of claim 1 further comprising an array of tissue anchors having spikes for piercing and engaging the lumen wall of an esophagus and fixing the mounting ring in the lumen of the esophagus.

Claim 9

The anti-reflux valve prosthesis of claim 1 further comprising an anti-inversion support having two ends, one end of which is fixed to the one-way valve and the other end of which is fixed to the wall of the lower end of the cylindrical housing to prevent the valve from inverting.

Claim 10

The anti-reflux valve prosthesis of claim 1 , further comprising: an overtube for holding the cylindrical housing in a radially compressed condition at a distal end of the overtube for peroral insertion down an esophageal lumen; a stylet indwelling in the overtube in releasable operative engagement with the housing to eject the housing from the distal end of the overtube.

Claim 11

The anti-reflux valve prosthesis of claim 9 further comprising a balloon at a distal end of the stylet in the cylindrical housing, wherein the balloon is in fluid communication with a central longitudinal passage in the stylet for introducing fluid into the balloon to facilitate expansion of the housing to its normal cross-section following ejection of the housing from the overtube, and for removing said fluid from the balloon to allow retraction of the balloon from the housing into the overtube.

Claim 12

An anti-reflux valve prosthesis comprising: a cylindrical housing having an enlarged upper end, a lower end, and an interior defined by an interior wall, the cylindrical housing constructed of a memory material having a normal cross-section, such that when a force, applied to the housing to make the cross-section smaller, is removed, the housing returns to its normal cross-section or is expandable to its normal cross-section; a mounting ring fixed to the wall of the upper end of the housing; a one-way valve depending from the mounting ring within the interior of the cylindrical housing comprising a sleeve and a plurality of longitudinal stays associated therewith; and an optional anti-inversion support having two ends, one end of which is fixed to a lower end of the one-way valve and the other end of which is fixed to the wall of the lower end of the cylindrical housing.

Claim 13

An anti-reflux valve prosthesis comprising: a cylindrical housing having an enlarged upper end, a lower end, and an interior defined by an interior wall, the cylindrical housing constructed of a memory material having a normal cross-section, such that when a force, applied to the housing to make the cross-section smaller, is removed, the housing returns to its normal cross-section or is expandable to its normal cross-section; a mounting ring fixed to the wall of the upper end of the housing; a one-way valve depending from the mounting ring within the interior of the cylindrical housing comprising a sleeve and a plurality of longitudinal stays associated therewith; and an optional anti-inversion support having two ends, one end of which is fixed to a lower end of the one-way valve and the other end of which is fixed to the wall of the lower end of the cylindrical housing.

Claim 14

The anti-reflux valve prosthesis of claim 11 wherein the memory material is a metal mesh.

Claim 15

The anti-reflux valve prosthesis of claim 11 wherein the metal mesh further comprises an interior surface and an exterior surface, the exterior surface being textured to facilitate anchoring of the prosthesis, and the interior surface being smooth to facilitate orthograde passage of foods and liquids therethrough.

Claim 16

The anti-reflux valve prosthesis of claim 11 wherein the memory material is selected from the group consisting of nickel, titanium alloy, spring steel, and plastic.

Claim 17

The anti-reflux valve prosthesis of claim 11 wherein the memory material is encased in silicone.

Claim 18

The anti-reflux valve prosthesis of claim 11 wherein the housing further comprises a tissue anchor array.

Claim 19

The anti-reflux valve prosthesis of claim 11 comprising a plurality of the anti-inversion supports.

Claim 20

The invention of claim 11 wherein the lower end of the cylindrical housing comprises a bell shaped lower end.

Claim 21

The invention of claim 18 further comprising a tissue anchor array adjacent the lower end of the cylindrical housing.

Claim 24

The method of claim 20 wherein the insertion is effected with the valve prosthesis in an overtube, the positioning includes ejecting the valve prosthesis from the overtube, and the expanding optionally comprises inflating a balloon inside the valve prosthesis.

Claim 25

The method of claim 20 wherein the prosthesis includes an array of tissue anchors and the method further comprises inserting the tissue anchors in the lumen of the esophagus to fix the prosthesis in place.

Claim 26

The method of claim 22 wherein the mounting ring is disposed at an upper end of the cylindrical housing and the one-way valve is a sleeve valve having longitudinal stays to prevent inversion of the valve.

Claim 27

The method of claim 20 wherein the mounting ring is disposed at an upper end of the cylindrical housing.

Claim 28

A sutureless, perorally insertable anti-reflux valve prosthesis, comprising: a cylindrical housing constructed of a memory material; a mounting ring fixed to the housing; a one-way valve depending from the mounting ring within the cylindrical housing; and an anti-inversion support having two ends, one end of which is fixed to the one-way valve and the other end of which is fixed to a wall of a lower end of the cylindrical housing to prevent the valve from inverting.

Claim 29

A sutureless, perorally insertable anti-reflux valve prosthesis, comprising: a cylindrical housing constructed of a memory material; a mounting ring fixed to the housing; a one-way valve depending from the mounting ring within the cylindrical housing; and an anti-inversion support having two ends, one end of which is fixed to the one-way valve and the other end of which is fixed to a wall of a lower end of the cylindrical housing to prevent the valve from inverting.