Ventricular partitioning device

Abstract

This invention is directed to a partitioning device for separating a patient's heart chamber into a productive portion and a non-productive portion. The device is particularly suitable for treating patients with congestive heart failure. The partitioning device has a frame-reinforced, expandable membrane which separates the productive and non-productive portions of the heart chamber. The proximal ends of the ribs of the frame have tissue penetrating elements about the periphery thereof which are configured to penetrate tissue lining the heart wall at an angle approximately perpendicular to a longitudinal axis of the partitioning device. The partitioning device has a hub with a non-traumatic distal end to engage the ventricular wall.

1 . A device for treating a patient with congestive heart failure by partitioning a chamber of the patient's heart into a primary productive portion and a secondary non-productive portion, comprising: 
 a. a partitioning component which has an expandable frame formed of a plurality of ribs having distal ends secured to a central hub and free outwardly flared proximal ends and which has a proximal, pressure receiving face forming a recess in an expanded, deployed configuration defining in part the primary productive portion of the patient's heart chamber to be partitioned; and    b. a plurality of tissue penetrating securing elements disposed at free ends of the ribs configured to penetrate tissue lining the heart chamber at an angle essentially perpendicular to the center line axis of the partitioning device to secure the periphery of the partitioning device to the heart chamber.    
   
   
       2 . The device of  claim 1  wherein reinforced partitioning component has a contracted configuration for delivery to patient's heart chamber to be partitioned.  
   
   
       3 . The device of  claim 1  wherein the pressure receiving surface of the partitioning component is formed at least in part of a membrane.  
   
   
       4 . The device of  claim 3  wherein the membrane is foraminous.  
   
   
       5 . The device of  claim 3  wherein the membrane is formed at least in part of a polymeric fabric.  
   
   
       6 . The device of  claim 5  wherein the polymeric fabric of the membrane is secured to the ribs by polymeric material fused in the polymeric fabric.  
   
   
       7 . The device of  claim 6  wherein the distal ends of the ribs are configured to facilitate abduction of the free proximal ends of the ribs away from a centerline axis to facilitate expansion of the reinforced partitioning component.  
   
   
       8 . The device of  claim 6  wherein the free proximal ends of the ribs are outwardly curved.  
   
   
       9 . The device of  claim 8  wherein the free proximal ends of the ribs have tips which penetrate the tissue lining the heart chamber at an angle of not more than 30° away from a line perpendicular to the center line axis of the partitioning device.  
   
   
       10 . The device of  claim 1  wherein the pressure receiving surface has radial dimensions from a center line axis of about 10 to about 160 mm.  
   
   
       11 . The device of  claim 1  wherein the pressure receiving surface has radial dimensions from a center line axis of about 5 to about 80 mm.  
   
   
       12 . The device of  claim 1  wherein the frame has about 3 to about 30 ribs.  
   
   
       13 . The device of  claim 1  wherein the frame has about 6 to about 16 ribs.  
   
   
       14 . The device of  claim 1  wherein the expandable frame is self expanding.  
   
   
       15 . The device of  claim 1  wherein the frame is formed of superelastic NiTi, alloy which is in an austenite phase when unstressed.  
   
   
       16 . The device of  claim 1  wherein the frame is in a stress maintained martensite phase when delivered through the patient's vasculature to the patient's heart chamber.  
   
   
       17 . The device of  claim 3  wherein the membrane is formed at least in part of expanded fluoropolymer.  
   
   
       18 . The device of  claim 17  wherein the expanded fluoropolymer is polytetrafluoroethylene.  
   
   
       19 . A partitioning apparatus for a patients heart chamber to Improve cardiac ejection fraction, comprising: 
 a. a central hub component;    b. an expandable frame component having a plurality of ribs with free, outwardly flared proximal ends and distal ends secured to the central hub component;    c. a membrane component secured to the expandable frame ribs which defines a recessed, pressure receiving surface; and    d. tissue penetrating tips on a plurality of free, outwardly flared proximal ends which are configured to penetrate tissue lining the heart chamber to be partitioned at an angle essentially perpendicular to a center line axis of the partitioning device.    
   
   
       20 . The partitioning apparatus of  claim 30  wherein the hub has a non-traumatic distal tip to engage the region of the patients ventricular wall.  
   
   
       21 . The partitioning apparatus of  claim 30  wherein the non-traumatic distal tip has a bullet shape.  
   
   
       22 . The partitioning apparatus of  claim 30  wherein the membrane component is secured to the proximal side of the ribs.  
   
   
       23 . The partitioning apparatus of  claim 30  wherein the membrane component is secured to the distal side of the ribs.  
   
   
       24 . An intracorporeal delivery catheter for a ventricular partitioning device for treating a patient with CHF, comprising: 
 a. an elongated shaft which has proximal and distal ends, a port proximal to the distal end and an inner lumen In fluid communication with the port;    b. a releasable securing element on the distal end of the elongated shaft configured to secure and release a ventricular partitioning device; and    c. an inflatable member on a distal portion of the elongated shaft having an interior in fluid communication with the inner lumen in the elongated shaft through the port therein which Is configured to expand a reinforced membrane of the partitioning device.    
   
   
       25 . The intracorporeal delivery catheter of  claim 24  wherein the elongated shaft has an outer shaft member with an inner lumen and an inner shaft member disposed within the inner lumen of the outer shaft, which has proximal and distal end, which has a first inner lumen extending within the inner shaft to the port proximal to the distal end of the inner shaft member to provide inflation fluid to the interior of the inflatable member, which has a second port in the distal end thereof and a second inner lumen extending within the inner shaft to the port in the distal end thereof.  
   
   
       26 . The intracorporeal delivery catheter of  claim 25  including a torque shaft which has proximal and distal ends, which is rotatably disposed within the second inner lumen of the inner shaft member and which has the releasable securing element on the distal end thereof for securing and releasing a ventricular partitioning device.  
   
   
       27 . The intracorporeal delivery catheter of  claim 26  wherein the releasable securing element on the distal end of the torque shaft is a helical screw connection element.  
   
   
       28 . The intracorporeal delivery catheter of  claim 27  wherein the helical screw connection element on the distal end of the torque shaft is configured to engage a connector bar on the partitioning device.  
   
   
       29 . An intracorporeal delivery catheter for a ventricular partitioning device for treating a patient with CHF, comprising: 
 a. an elongated outer shaft with an inner lumen;    b. an inner shaft which is disposed within the inner lumen of the outer shaft, which has a first inner lumen extending within the inner shaft to a port proximal to the distal end thereof, which has a second inner lumen extending within the inner shaft to the distal end thereof; a balloon mounted on a distal portion of the inner shaft having an interior in fluid communication with the first inner lumen through the port;    c. a torque shaft which has proximal and distal ends, which is rotatably disposed within the second inner lumen of the inner shaft, which has a screw connection element on the distal end thereof extending out of the distal end of the inner shaft and configured to receive a partitioning device; and    d. an inflation port in fluid communication with the first inner lumen of the inner shaft for delivery of inflation fluid therethrough to the interior of the balloon.    
   
   
       30 . An Intracorporeal partitioning component comprising: 
 a. a frame having a plurality of ribs with radially extending proximal ends and with distal ends secured to a hub; and    b. at least one porous sheet material secured to the ribs of the frame by fused thermoplastic material within the porous sheet material.    
   
   
       31 . The intracorporeal partitioning component of  claim 30  wherein at least one porous sheet is secured to the upper portion of the ribs of the frame and at least one sheet is secured to the lower portion of the ribs of the frame by thermoplastic material within the porous sheets.  
   
   
       32 . A method of securing a porous polymeric sheet material to rib components of a frame structure, comprising: 
 a. sliding a thermoplastic tube over one or more rib components of the frame;    b. applying a porous sheet to the ribs covered with the thermoplastic polymeric tubes to form an assembly; and    c. heating the assembly to fuse the polymeric material of the thermoplastic tubes within the porous sheet.    
   
   
       33 . The method of  claim 32  wherein a porous sheet is applied to the upper surface of the frame.  
   
   
       34 . The method of  claim 32  wherein a porous sheet is applied to the lower surface of the frame.  
   
   
       35 . The method of  claim 32  wherein a first porous sheet is applied to the upper surface of the frame and a second porous sheet is applied to the lower surface of the frame.  
   
   
       36 . The method of  claim 35  wherein the assembly is placed onto a receiving platen of a press and a hot pressing platen is pressed against the assembly to fuse the thermoplastic polymeric material on the ribs of the frame within one or both of the porous membranes.  
   
   
       37 . A method of treating a patient with congestive heart failure by partitioning the patient's heart chamber, comprising: 
 a. providing a reinforced membrane having a first contracted configuration for delivery to the patient's heart chamber and a second expanded configuration for deployment within the patient's heart chamber;    b. advancing the reinforced membrane in the first contracted configuration into the chamber of the patient's heart;    c. inflating an inflatable member disposed within the membrane to expand the reinforced membrane to the second expanded configuration to facilitate securing the reinforced membrane within the patient's heart chamber to partition the chamber into a primary productive portion and a secondary non-productive portion.    
   
   
       38 . The method of  claim 37  wherein the reinforced membrane is advanced into the patient's heart chamber through an inner lumen of a delivery catheter.  
   
   
       39 . The method of  claim 38  wherein the inflatable member is positioned on a distal portion of the delivery catheter.  
   
   
       40 . The method of  claim 37  wherein the expanding inflatable member secures a peripheral edge of the reinforced membrane to a wall defining at least in part the patients heart chamber.  
   
   
       41 . The method of  claim 37  wherein a central portion of the expanded reinforced membrane is spaced from a wall defining in part the patients heart chamber.  
   
   
       42 . The method of  claim 38  wherein the reinforced membrane is positioned within an inner lumen of the delivery catheter in the first contracted configuration, and advanced therein to a discharge port in the distal end of the delivery catheter and discharged from the discharge port into the patient's heart chamber where the contracted reinforced membrane expands to the second expanded configuration due at least in part to the expanding inflatable member.  
   
   
       43 . The method of  claim 38  wherein the delivery catheter is percutaneously introduced into the patient's vasculature and advanced therein until the distal end of the delivery catheter is disposed within the patients heart chamber.  
   
   
       44 . The method of  claim 40  wherein the edge of the reinforced membrane is secured to a wall defining at least in part the heart chamber by anchoring elements provided on the edge of the reinforced membrane.  
   
   
       45 . The method of  claim 37  wherein the reinforced membrane is in part self expanding.  
   
   
       46 . A method of treating a patient with congestive heart failure, comprising: 
 a. providing an expandable reinforced membrane having a periphery with a plurality of anchoring elements thereon;    b. advancing the reinforced membrane in a contracted configuration within the patients vasculature until the reinforced member is disposed within a chamber of the patient's heart; and    c. inflating a balloon within the contracted reinforced membranes to expand the reinforced membrane into an expanded configuration within the heart chamber to secure the periphery of the reinforced membrane to the heart wall by the anchoring elements on the periphery of the reinforced membrane.    
   
   
       47 . A method of treating a patient with congestive heart failure, comprising the steps of: 
 a. providing an expandable reinforced membrane having a periphery with a plurality of anchoring elements thereon;    b. advancing the reinforced membrane in a contracted configuration within the patient's vasculature until the reinforced member is disposed within a chamber of the patient's heart; and    c. inflating a balloon within the contracted reinforced membranes to expand the reinforced membrane into an expanded configuration within the heart chamber to secure the periphery of the reinforced membrane to the heart wall by the anchoring elements on the periphery of the reinforced membrane.    
   
   
       48 . An intracorporeal product comprising: 
 a. a first component configured for intracorporeal deployment; and    b. at least one sheet of ePTFE material secured to the first component by fused thermoplastic material therebetween.    
   
   
       49 . The intracorporeal product of  claim 30  wherein a second ePTFE sheet is secured to the first component by thermoplastic material within the porous sheets.  
   
   
       50 . A method of making an intracorporeal product securing a porous polymeric sheet material to rib components of a frame structure, comprising: 
 a. providing a ePTFE sheet;    b. providing an intracorporeal component;    c. deploying a thermoplastic element over at least part of the intracorporeal component;    d. applying the ePTFE sheet to at least a portion of the intracorporeal component covered by the at least one thermoplastic element to form an assembly; and    e. heating the assembly to fuse the thermoplastic material and secure the ePTFE sheet to the intracorporeal component.    
   
   
       51 . The method of  claim 50  wherein the ePTFE sheet is applied to an upper surface of the intracorporeal component.  
   
   
       52 . The method of  claim 50  wherein the ePTFE sheet is applied to a lower surface of the intracorporeal component.  
   
   
       53 . The method of  claim 51  wherein a second ePTFE sheet is applied to the lower surface of the intrecorporeal component.  
   
   
       54 . The method of  claim 50  wherein pressure is applied to the assembly at elevated temperature to fuse the thermoplastic polymeric material and secure the ePTFE sheet to the intracorporeal component.