Sensor-equipped and algorithm controlled direct mechanical ventricular assist device

Abstract

An apparatus for assisting the function of a heart disposed within a body. The apparatus can apply a compressive force and an expansive force to a portion of the outer wall of the heart. The apparatus can comprise a cup-shaped shell having an exterior wall, an interior wall, an apex, and an upper edge; a liner having an outer surface and an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell, thereby forming a cavity between the outer surface thereof and the interior wall of the shell; and a drive fluid within the cavity. The drive fluid can apply a force on a portion of the outer wall of the heart.

1 . An apparatus for assisting the function of a heart disposed within a body, the apparatus comprising: 
 a cup-shaped shell including an interior wall and an exterior wall;    a liner including an outer surface, portions of the outer surface joined to portions of the interior wall of the cup-shaped shell such that a cavity is formed between the outer surface and the interior wall; and    a seal including a base, a tapered midsection and a tip, the tip adapted to be deployed contiguously with the heart.    
   
   
       2 . The apparatus of  claim 1 , wherein the liner and the seal are unitary.  
   
   
       3 . The apparatus of  claim 2 , wherein the liner and the seal are formed by a molding process.  
   
   
       4 . The apparatus of  claim 2 , wherein the liner and the seal are of heat cured liquid silicone rubber.  
   
   
       5 . The apparatus of  claim 1 , wherein the seal further comprises a ring disposed proximate to the tip, and a mating groove formed in the exterior wall of the shell proximate to the seal.  
   
   
       6 . The apparatus of  claim 5 , further comprising: 
 a cavity disposed within the tapered midsection of the seal; and    a lumen connected to the cavity disposed within the tapered midsection and to a fluid source.    
   
   
       7 . The apparatus of  claim 1 , wherein the seal is biocompatible.  
   
   
       8 . The apparatus of  claim 1 , wherein the seal is biodegradable.  
   
   
       9 . The apparatus of  claim 1 , wherein the seal is detachable from the upper edge of the cup-shaped shell.  
   
   
       10 . The apparatus of  claim 1 , wherein the seal comprises a first therapeutic agent.  
   
   
       11 . The apparatus of  claim 10 , wherein the first therapeutic agent is diffused throughout the seal.  
   
   
       12 . The apparatus of  claim 10 , wherein the first therapeutic agent comprises a coating on the outer surface of the seal.  
   
   
       13 . The apparatus of  claim 10 , wherein a cavity is disposed within the seal, and the first therapeutic agent is disposed within the cavity disposed within the seal.  
   
   
       14 . The apparatus of  claim 10 , wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.  
   
   
       15 . The apparatus of  claim 10 , wherein the seal further comprises a second therapeutic agent.  
   
   
       16 . The apparatus of  claim 1 , wherein the seal has a textured outer surface.  
   
   
       17 . The apparatus of  claim 1 , wherein the liner is an elastic liner.  
   
   
       18 . The apparatus of  claim 17 , wherein the elastic liner is of silicone polymer.  
   
   
       19 . The apparatus of  claim 1 , wherein the liner is detachable from the interior wall of the cup-shaped shell.  
   
   
       20 . The apparatus of  claim 1 , wherein the liner comprises a first therapeutic agent.  
   
   
       21 . The apparatus of  claim 20 , wherein the first therapeutic agent is diffused throughout the liner.  
   
   
       22 . The apparatus of  claim 20 , wherein the first therapeutic agent comprises a coating on an inner surface of the liner.  
   
   
       23 . The apparatus of  claim 20 , wherein the liner comprises a first membrane and a second membrane, and the first therapeutic agent is disposed between the first and second membranes.  
   
   
       24 . The apparatus of  claim 20 , wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.  
   
   
       25 . The apparatus of in  claim 20 , wherein the liner further comprises a second therapeutic agent.  
   
   
       26 . The apparatus of  claim 1 , wherein the liner has a textured inner surface.  
   
   
       27 . The apparatus of  claim 1 , wherein the liner comprises: 
 a first membrane including an outer surface, an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell; and    a second membrane including an outer surface and an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell;    wherein the inner surface of the first membrane is contiguous with the outer surface of the second membrane.    
   
   
       28 . The apparatus of  claim 1 , wherein the liner is a rolling diaphragm liner.  
   
   
       29 . An apparatus for assisting the function of a heart disposed within a body, the apparatus comprising: 
 a cup-shaped shell including an interior wall, an exterior wall and an upper edge;    a liner including an outer surface, portions of the outer surface joined to the interior wall such that a cavity is defined between the outer surface and the interior wall; and    a seal joined to the upper edge, the seal unitary with the liner.    
   
   
       30 . The apparatus of  claim 29 , wherein the seal further comprises a base joined to the upper edge of the cup-shaped shell, a tapered midsection, and a tip, the tip adapted to be deployed contiguously against the heart.  
   
   
       31 . The apparatus of  claim 29 , wherein the liner and the seal are formed by a molding process.  
   
   
       32 . The apparatus of  claim 30 , wherein the liner and the seal are of heat cured liquid silicone rubber.  
   
   
       33 . The apparatus of  claim 30 , wherein the seal further comprises a ring disposed proximate to the tip and a mating groove formed in the exterior wall of the shell proximate to the seal.  
   
   
       34 . The apparatus of  claim 30 , further comprising a cavity disposed within the tapered midsection of the seal and a lumen connected to the cavity and to a fluid source.  
   
   
       35 . The apparatus of  claim 29 , wherein the seal is biocompatible.  
   
   
       36 . The apparatus of  claim 29 , wherein the seal is biodegradable.  
   
   
       37 . The apparatus of  claim 29 , wherein the seal is detachable from the upper edge of the cup-shaped shell.  
   
   
       38 . The apparatus of  claim 29 , wherein the seal comprises a first therapeutic agent.  
   
   
       39 . The apparatus of  claim 38 , wherein the first therapeutic agent is diffused throughout the seal.  
   
   
       40 . The apparatus of  claim 38 , wherein the first therapeutic agent comprises a coating on the outer surface of the seal.  
   
   
       41 . The apparatus of  claim 38 , wherein a cavity is disposed within the seal, and the first therapeutic agent is disposed within the cavity disposed within the seal.  
   
   
       42 . The apparatus of  claim 38 , wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.  
   
   
       43 . The apparatus of  claim 38 , wherein the seal further comprises a second therapeutic agent.  
   
   
       44 . The apparatus of  claim 29 , wherein the seal has a textured outer surface.  
   
   
       45 . The apparatus of  claim 29 , wherein the liner is an elastic liner.  
   
   
       46 . The apparatus of  claim 45 , wherein the elastic liner is of silicone polymer.  
   
   
       47 . The apparatus of  claim 29 , wherein the liner is detachable from the interior wall of the cup-shaped shell.  
   
   
       48 . The apparatus of  claim 29 , wherein the liner comprises a first therapeutic agent.  
   
   
       49 . The apparatus of  claim 48 , wherein the first therapeutic agent is diffused throughout the liner.  
   
   
       50 . The apparatus of  claim 48 , wherein the first therapeutic agent comprises a coating on an inner surface of the liner.  
   
   
       51 . The apparatus of  claim 48 , wherein the liner comprises a first membrane and a second membrane, and the first therapeutic agent is disposed between the first and the second membranes.  
   
   
       52 . The apparatus of  claim 48 , wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.  
   
   
       53 . The apparatus of  claim 48 , wherein the liner further comprises a second therapeutic agent.  
   
   
       54 . The apparatus of  claim 29 , wherein the liner has a textured inner surface.  
   
   
       55 . The apparatus of  claim 29 , wherein the liner comprises: 
 a first membrane including an outer surface, an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell; and    a second membrane including an outer surface, an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell;    wherein the inner surface of the first membrane is contiguous with the outer surface of the second membrane.    
   
   
       56 . The apparatus of  claim 29 , wherein the liner is a rolling diaphragm liner.