System and method for reshaping heart

Abstract

The present teachings provide systems, devices, and methods for treating the heart and reducing valve regurgitation. A delivery catheter is used to advance a balloon to a treatment site outside the heart. The balloon includes a flexible outer layer encasing a primary cavity and a secondary cavity outside of the primary cavity. The secondary cavity contains a tissue-binding adhesive. While the balloon is at the treatment site, an injection medium is introduced into the primary cavity in a manner that inflates the balloon from a collapsed delivery profile into an inflated deployment profile, and squeezes the tissue-binding adhesive out of the secondary cavity. Other embodiments are also described.

1 . A method for internal use outside a heart of a subject, the method comprising:
 using a delivery catheter, advancing a balloon to a treatment site outside the heart, the balloon including:
 a flexible outer layer encasing a primary cavity and a secondary cavity outside of the primary cavity, the secondary cavity containing a tissue-binding adhesive; and 
   while the balloon is at the treatment site, introducing an injection medium into the primary cavity, in a manner that:
 inflates the balloon from a collapsed delivery profile into an inflated deployment profile, and 
 squeezes the tissue-binding adhesive out of the secondary cavity. 
   
     
     
         2 . The method according to  claim 1 , wherein:
 a portion of the outer layer encasing the secondary cavity defines a plurality of pores; and   introducing the injection medium into the primary cavity comprises introducing the injection medium into the primary cavity such that the tissue-binding adhesive is squeezed out of the secondary cavity via the pores.   
     
     
         3 . The method according to  claim 1 , further comprising disengaging the delivery catheter from the balloon and withdrawing the delivery catheter from the subject. 
     
     
         4 . The method according to  claim 1 , wherein the step of introducing comprises:
 introducing a first portion of the injection medium into the primary cavity such that the primary cavity reaches a first inflation pressure at which the balloon assumes the inflated deployment profile but that does not squeeze the tissue-binding adhesive out of the secondary cavity, and   subsequently, introducing a second portion of the injection medium into the primary cavity such that the primary cavity reaches a second inflation pressure that is greater than the first inflation pressure, and at which the tissue-binding adhesive is squeezed out of the secondary cavity.   
     
     
         5 . The method according to  claim 1 , wherein inflating the balloon from the collapsed delivery profile into the inflated deployment profile comprises inflating the balloon into a flat shape. 
     
     
         6 . The method according to  claim 5 , wherein the step of inflating comprises inflating the balloon such that the balloon has an overall width of 2 mm-4 cm and an overall height of 4 mm-6 cm. 
     
     
         7 . The method according to  claim 5 , wherein the step of inflating comprises:
 inflating the balloon, during a first step of inflation, to the flat shape, and   further inflating the balloon, during a subsequent step of inflation in which the balloon expands by increasing in thickness.   
     
     
         8 . The method according to  claim 1 , wherein:
 the balloon includes an expandable barrier between the primary cavity and the secondary cavity; and   the step of introducing the injection medium comprises, while the balloon is at the treatment site, introducing the injection medium into the primary cavity in a manner that:
 inflates the balloon from the collapsed delivery profile into the inflated deployment profile such that the barrier expands more than a portion of the outer layer encasing the secondary cavity, and 
 squeezes the tissue-binding adhesive out of the secondary cavity. 
   
     
     
         9 . The method according to  claim 8 , wherein the step of introducing the injection medium comprises, while the balloon is at the treatment site, introducing the injection medium into the primary cavity in a manner that inflates the balloon from the collapsed delivery profile into the inflated deployment profile such that:
 the barrier expands more than a portion of the outer layer encasing the secondary cavity, and   the primary cavity expands at a greater rate than the secondary cavity and squeezes the tissue-binding adhesive out of the secondary cavity.   
     
     
         10 . The method according to  claim 1 , wherein:
 introducing the injection medium into the primary cavity comprises introducing the injection medium into the primary cavity via an injection catheter; and   the method further comprises, while the balloon remains at the treatment site, and prior to introducing the injection medium into the primary cavity, placing the injection catheter into fluid communication with the primary cavity but not with the secondary cavity.   
     
     
         11 . The method according to  claim 10 , further comprising:
 detaching the injection catheter from the balloon; and   withdrawing the injection catheter from the subject.   
     
     
         12 . The method according to  claim 11 , further comprising, prior to the step of withdrawing:
 reattaching the injection catheter to the balloon; and   using the injection catheter, adjusting pressure within the balloon.   
     
     
         13 . The method according to  claim 10 , wherein placing the injection catheter into fluid communication with the primary cavity comprises coupling the injection catheter to an injection port that is:
 in fluid communication with the primary cavity, and   not in fluid communication with the secondary cavity.   
     
     
         14 . The method according to  claim 13 , wherein:
 the injection port comprises a valve; and   the step of coupling comprises coupling the injection catheter to the injection port such that a distal end portion of the injection catheter opens the valve.   
     
     
         15 . The method according to  claim 1 , wherein:
 the treatment site is outside a right side of the heart, and   advancing the balloon to the treatment site comprises advancing the balloon to outside the right side of the heart.   
     
     
         16 . The method according to  claim 15 , wherein:
 the treatment site is between the right side of the heart and a sternum of the subject, and   the step of advancing comprises advancing the balloon to a space between the right side of the heart and the sternum of the subject.   
     
     
         17 . The method according to  claim 16 , wherein:
 the outer layer defines:
 a first balloon component, and 
 a second balloon component, larger than the first balloon component, and bonded to the first balloon component at a seam, and 
   the step of advancing comprises positioning the balloon such that the first balloon component is disposed against an outside of a right atrium of the heart, and the second balloon component is disposed against an outside of a right ventricle of the heart.   
     
     
         18 . The method according to  claim 16 , wherein:
 the outer layer defines:
 a first balloon component, and 
 a second balloon component, bonded to the first balloon component at a waist of the balloon, and 
   the step of advancing comprises positioning the balloon such that the waist is disposed against the heart outside a tricuspid valve of the heart.