VENTRICULAR PARTITIONING DEVICE
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 reinforced, expandable membrane which separates the productive and non-productive portions of the heart chamber and a support or spacing member extending between the reinforced membrane and the wall of the patient's heart chamber. The support or spacing member has a non-traumatic distal end to engage the ventricular wall.
1 . A device for increasing the ejection fraction of a patient's heart chamber, comprising:
a. a reinforced membrane component which has a proximal face and a distal face and which is configured to partition the patient's heart chamber into a main operational portion and a secondary, non-operational portion; and
b. a support component which is disposed in the non-productive portion of the heart chamber defined in part by the distal face of the reinforced membrane and which is configured to extend from the reinforced membrane to a region of the heart wall defining in part the heart chamber.
2 . The device of claim 1 wherein reinforced membrane has a contracted configuration about a center line axis and an expanded configuration in which the membrane periphery is radially expanded away from the center line axis.
3 . The device of claim 1 wherein the support component is at least in part an elongated stem.
4 . The device of claim 1 wherein the support component has a distal extremity which is configured to non-traumatically engage a region of the patient's ventricular wall defining in part the secondary non-operational portion of the heart chamber.
5 . The device of claim 4 wherein the distal extremity of the support component has at least one J-shaped bumper element.
6 . The device of claim 4 wherein the distal extremity has from two to four J-shaped elements.
7 . The device of claim 4 wherein the distal extremity has a coil shaped element.
8 . The device of claim 1 including a hub secured to a central location of the reinforced membrane.
9 . The device of claim 8 wherein the membrane is reinforced by a frame which is radially expandable at a proximal extremity thereof.
10 . The device of claim 9 wherein the radially expandable frame has a plurality of ribs.
11 . The device of claim 10 wherein the ribs have distal ends secured to the central hub.
12 . The device of claim 11 wherein the distal ends of the ribs are secured to the central hub to facilitate abduction of the free proximal ends away from a centerline axis to facilitate expansion of the reinforced membrane component.
13 . The device of claim 12 wherein the ribs have free proximal ends configured to engage the heart wall and secure the device within the heart chamber.
14 . The device of claim 13 wherein the free proximal ends of the ribs have tissue penetrating tips.
15 . The device of claim 9 wherein the membrane is secured to the ribs on a proximal side of the expandable frame.
16 . The device of claim 9 wherein the reinforced membrane component restricts the radial expansion of the free proximal ends of the ribs to an angle of about 60° to about 90° from a center line axis.
17 . The device of claim 16 wherein the radial expansion of the free proximal ends of the ribs are about 30° to about 60°.
18 . The device of claim 3 wherein the stem is configured to extend to the ventricular wall.
19 . The device of claim 1 wherein the support component is at least in part an inflatable member.
20 . The device of claim 1 wherein the membrane has radial dimensions from a center line axis of about 10 to about 160 mm.
21 . The device of claim 1 wherein the member has radial dimensions from a center line axis of about 5 to about 80 mm.
22 . The device of claim 9 wherein the frame has about 3 to about 30 ribs.
23 . The device of claim 9 wherein the frame has about 6 to about 16 ribs.
24 . The device of claim 9 wherein the expandable frame is self expanding.
25 . The device of claim 9 wherein the frame is formed of superelastic NiTi alloy which is in an austenite phase when unstressed.
26 . The device of claim 9 wherein the frame is in a stress maintained martensite phase when delivered through the patient's vasculature to the patient's heart chamber.
27 . The device of claim 1 wherein the membrane is formed at least in part of expanded fluoropolymer.
28 . The device of claim 27 wherein the expanded fluoropolymer is polytetrafluoroethylene.
29 . The device of claim 1 wherein the membrane is at least in part formed of a foraminous sheet.
30 . A method of treating a patient with congestive heart failure, comprising:
a. providing a reinforced membrane;
b. positioning the reinforced membrane within a chamber of the patient's heart with a peripheral edge of the reinforced membrane being secured to a wall defining at least in part the patient's heart chamber; and
c. spacing a central portion of the reinforced membrane from the heart wall.
31 . The method of claim 30 wherein the reinforced membrane is delivered in a folded configuration and expanded in position within the patient's heart wall.
32 . The method of claim 31 wherein the reinforced membrane is first positioned within an inner lumen of an elongated catheter and the catheter is percutaneously introduced into the patient's vasculature and advanced therein to the patient's heart chamber wherein the reinforced membrane is discharged from the catheter.
33 . The method of claim 31 wherein the edge of the reinforced membrane is secured to the heart wall defining at least in part the heart chamber by anchoring elements provided on the edge of the reinforced membrane.
34 . The method of claim 30 wherein the reinforced membrane is self expanding.
35 . A method of treating a patient with congestive heart failure, comprising the steps of:
a. providing a reinforced membrane;
b. positioning the reinforced membrane within a chamber of the patient's heart with a peripheral edge of the reinforced membrane being secured to a wall defining at least in part the patient's heart chamber; and
c. spacing a central portion of the reinforced membrane from the heart wall.