Method and barrier for limiting fluid movement through a tissue rent

Abstract

A method and device provides for limiting fluid movement through a rent in a membranous tissue by forming a biocompatible and biodegradable barrier at the site of the rent. The barrier is formed by inserting into the rent a plug that includes connected water-swellable parts, so that within a short time following placement of the plug at the site the swellable parts expand in situ to form the barrier and occlude the rent. As fluids near the site are taken up by the swellable material, the material expands rapidly to fill the rent, engaging the marginal surfaces of the membrane near the edges of rent and forming a secure barrier at the site. All the materials of the plug are biocompatible and, over a period of time that allows for healing of the rent, all the components of the barrier are completely degraded without leaving any residual material at the site.

1 . A method for limiting fluid movement through a rent in a membranous tissue in a body, comprising placing within the rent a plug that includes connected water-swellable parts.  
   
   
       2 . The method of  claim 1  wherein placing the plug within the rent comprises passing the plug to the rent within a lumen of a catheter extending from an introduction site through intervening tissue to the site of the rent, and wherein the membrane comprises a dura mater and the rent is a dural defect.  
   
   
       3 . A method for limiting fluid movement through a rent in the dura mater, comprising providing a plug comprising swellable parts joined by a connector, and placing the plug within the rent such that at least one of the swellable parts is within a subarachnoid space and at least one other one of the swellable parts is positioned in an epidural space, and the connector traverses the rent in the dura mater, wherein placing the plug within the rent comprises passing the plug to the rent within a lumen of a catheter extending from an introduction site through intervening tissue to the site of the rent.  
   
   
       4 . The method of  claim 3  wherein the rent is an intracranial dural defect.  
   
   
       5 . The method of  claim 2  wherein the membrane comprises a dura mater and the rent is a dural defect.  
   
   
       6 . The method of  claim 5  wherein the rent is an intraspinal dural defect.  
   
   
       7 . The method of  claim 5  wherein the rent is an intracranial dural defect.  
   
   
       8 . A biocompatible and physiologically degradable plug body for insertion into a tissue rent for forming a barrier to fluid movement through the rent, comprising a swellable portion including at least two connected water-swellable parts.  
   
   
       9 . The plug body of  claim 8  wherein the water-swellable parts are end portions of a dumbbell-shaped body formed entirely of a water-swellable material.  
   
   
       10 . The plug body of  claim 8  wherein the water-swellable parts are beads formed on a connecting filament.  
   
   
       11 . The plug body of  claim 8  wherein the swellable parts are formed of a material selected so that the swellable parts can increase in size by at least 1.2 times in a transverse dimension.  
   
   
       12 . The plug body of  claim 8  wherein the swellable parts are formed of a material selected so that the swellable parts can increase in size by at least 1.5 times in a transverse dimension.  
   
   
       13 . The plug body of  claim 8  wherein the swellable parts are formed of a material selected so that the swellable parts can increase in size by at least 2 times in a transverse dimension.  
   
   
       14 . The plug body of  claim 8  wherein the swellable parts are formed of a material selected so that the swellable parts can increase in size by 1.2 to 3 times in a transverse dimension.  
   
   
       15 . The plug body of  claim 8  wherein the swellable parts are formed of a material comprising a biocompatible and biodegradable water-swellable polymer.  
   
   
       16 . The plug body of  claim 8  wherein the swellable parts are formed of a material comprising a water-swellable polymer of biological origin.  
   
   
       17 . The plug body of  claim 15  wherein the water-swellable polymer comprises a gelatin, a collagen, a cellulose, an agarose, a hyaluronate, or a combination thereof.  
   
   
       18 . The plug body of  claim 15  wherein the water-swellable polymer is derived from biological tissue.  
   
   
       19 . The plug body of  claim 15  wherein the water-swellable polymer is made by a biosynthesis process.  
   
   
       20 . The plug body of  claim 15  wherein the swellable parts are formed of a material comprising a water-swellable polymer of nonbiological origin.  
   
   
       21 . The plug body of  claim 20  wherein the water-swellable polymer comprises a poly(vinyl alcohol), a polyethylene oxide, or a combination thereof.  
   
   
       22 . The plug body of  claim 8  wherein the swellable parts are formed of a material comprising a foamed gel, or a sponge or mesh.  
   
   
       23 . The plug body of  claim 8  wherein the swellable parts are formed of a material comprising a hydrogel.  
   
   
       24 . The plug body of  claim 10  wherein the connecting filament is formed of a biocompatible and biodegradable non water-swellable material.  
   
   
       25 . The plug body of  claim 24  wherein the connecting filament is formed of a material comprising a biocompatible and biodegradable non water-swellable polymer.  
   
   
       26 . The plug body of  claim 25  wherein the non water-swellable polymer comprises a polyglycolate or a polylactate or a polydioxanone, or a combination thereof.  
   
   
       27 . The plug body of  claim 10  wherein the filament is a monofilament.  
   
   
       28 . The plug body of  claim 10  wherein the filament is a sterile filament prepared from collagen derived from a healthy mammal, capable of being biodegraded by living mammalian tissue.  
   
   
       29 . The plug body of  claim 10  wherein the filament is a sterile synthetic polymer filament, capable of being biodegraded by living mammalian tissue.  
   
   
       30 . The plug body of  claim 10  wherein the filament comprises an absorbable suture material.  
   
   
       31 . The plug body of  claim 10  wherein the water swellable parts have a generally spheroidal shape.  
   
   
       32 . The plug body of  claim 10  wherein the water swellable parts are elongated in an axial direction.  
   
   
       33 . The plug body of  claim 10  wherein the water swellable parts have a polygonal shape.  
   
   
       34 . The plug body of  claim 10  wherein the water swellable parts have a discoid shape.  
   
   
       35 . The plug body of  claim 10  wherein the water swellable parts have an ovoid shape.  
   
   
       36 . The plug body of  claim 8  wherein the swellable parts are small enough in a dimension transverse to a lengthwise axis of the plug body so that the plug body can be passed readily within the lumen of a selected needle or catheter.  
   
   
       37 . The plug body of  claim 8  wherein a maximum transverse dimension of the swellable parts is less than 1.5 millimeters.  
   
   
       38 . The plug body of  claim 8  wherein a maximum transverse dimension of the swellable parts is less than 0.2 millimeters.  
   
   
       39 . The plug body of  claim 8  wherein the swellable portion has a length at least 6 millimeters.  
   
   
       40 . The plug body of  claim 39  wherein the swellable portion has a length at least 10 millimeters.  
   
   
       41 . The plug body of  claim 8  wherein the swellable portion has a length at most 20 millimeters.  
   
   
       42 . The plug body of  claim 41  wherein the swellable portion has a length at most 12 millimeters.  
   
   
       43 . The plug body of  claim 8  wherein the swellable portion has a length in the range 10 to 12 millimeters.  
   
   
       44 . The plug body of  claim 10  wherein the connecting filament is sufficiently stiff that it can serve as a stylet.  
   
   
       45 . The plug body of  claim 10  wherein the connecting filament extends axially for a length beyond the swellable portion.  
   
   
       46 . The method of  claim 1  wherein the rent is a defect in a wall of the gastrointestinal tract.  
   
   
       47 . The method of  claim 1  wherein the rent is a defect in a wall of the urinary bladder.