System for improving cardiac function

• US 20060264980A1
• Filed: 05/12/2003
• Published: 11/23/2006
• Est. Priority Date: 08/09/1999
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cardiokinetix Incorporated
• Inventors: Khairkhahan, Alexander, Nikolic, Serjan D., Sharkey, Hugh R.
• Granted Patent: US 8,257,428 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/12095 Threaded connection

Abstract

A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge.

Claims

21-23. -23. (canceled)

24. An apparatus for improving cardiac function of a patient'"'"'s heart, comprising:

a. a frame which includes

i. a plurality of central frame segments surrounding a central axis, the central segments having first and second ends, the first ends being pivotally connected to a central portion of the frame; and

ii. a plurality of outer frame segments having first and second ends, the first ends being pivotally secured to the second ends of the central segments;

b. a membrane secured to the frame such that movement of the second ends of the central segments away from the central axis causes the membrane to unfold, the unfolding of the membrane causing the outer segments to pivot relative to their respective central segments away from the central axis and movement of the second ends of the central segments toward the central axis causes the membrane to fold, the folding of the membrane causing the outer segments to pivot relative to their respective central segments toward the central axis; and

c. an anchor connected to the frame which is insertable into heart tissue of the patient'"'"'s heart chamber to secure the cardiac device within the patient'"'"'s heart chamber.

25. The apparatus of claim 24, wherein the frame includes at least three central segments and at least three outer segments.

26. The apparatus of claim 25, wherein the membrane is stretched between the central and the outer segments.

27. The apparatus of claim 26, wherein the anchor is secured directly to the frame.

28. An apparatus for improving cardiac function, comprising:

a. a frame;

b. a membrane, having an inner surface, secured to the frame, the membrane and the frame jointly forming a cardiac device being moveable between a collapsed and an expanded state, in the collapsed state at least a portion of the inner surface of the membrane facing a vertical axis of the cardiac device and the cardiac device being insertable into a ventricle of a heart, in the expanded state the portion of the inner surface of the membrane facing away from a vertical axis and being in contact with a patient'"'"'s heart tissue and the cardiac device being in a selected position in the ventricle ; and

c. an anchor connected to the cardiac device which is insertable into the patient'"'"'s heart tissue to secure the cardiac device in the selected position in the ventricle.

29. The apparatus of claim 28, wherein the cardiac device collapses toward the vertical axis and expands away from the vertical axis.

30. The apparatus of claim 29, wherein the membrane folds toward the vertical axis when the cardiac device collapses and unfolds away from the vertical axis when the cardiac device expands.

31. The apparatus of claim 30, wherein the frame formed of an alloy selected from the group consisting of nickel titanium and stainless steel.

32. The apparatus of claim 31, wherein the membrane is formed of at least in part of ePTFE.

33. The apparatus of claim 32, wherein the anchor has a sharp end.

34. An apparatus for treating a patient'"'"'s heart to improve the patient'"'"'s cardiac function, comprising:

a. a frame being expandable in a selected position to a pre-set shape in a ventricle of the patients heart;

b. a formation on the frame; and

c. an anchoring device which has an anchor element and which is configured to be engaged with and rotatable relative to the formation on the frame to rotate the anchor element relative to the frame, causing the anchor element to be inserted into heart tissue defining at least in part the ventricle to secure the frame in a selected position within the ventricle.

35. The apparatus of claim 34, where the anchoring device engages the formation such that a first rotation of the anchoring device causes the anchor element to move away from the frame and a second rotation of the anchoring device causes the anchor element to move towards the frame.

36. The apparatus of claim 35, wherein the formation is a pin.

37. The apparatus of claim 36, wherein the anchor is a screw.

38. An apparatus for improving a patient'"'"'s cardiac function, comprising:

a. at least a primary expandable frame being in a selected position in a ventricle of a heart when expanded;

b. an anchor connected to the frame, the anchor being insertable into a patient'"'"'s heart tissue to secure the primary frame within the ventricle;

c. a frame-side engagement component connected to the primary frame;

d. a membrane; and

e. a membrane-side engagement component being engageable with the frame-side engagement component, the engagement securing the membrane to the frame.

39. The apparatus of claim 38, including a secondary expandable frame being in a selected position in the ventricle of the heart when expanded, the secondary frame being secured to the membrane and connected to the membrane-side engagement component thereby interconnecting the membrane to the membrane side engagement component.

40. The apparatus of claim 39, wherein the anchor is connected to the at least one of the frames.

41. The apparatus of claim 40, wherein the primary frame has a central portion and the frame-side engagement component is connected to the primary frame at the central portion of the primary frame.

42. The apparatus of claim 41, wherein the secondary frame has a central portion and the membrane-side engagement component is connected to the secondary frame at the central portion of the secondary frame.

43. The apparatus of claim 42, including an active anchor being connected to the frame-side engagement component such that a first movement of the frame-side engagement component causes the active anchor to enter the patient'"'"'s heart tissue and a second movement of the frame-side engagement component causes the active anchor to withdraw from the patient'"'"'s heart tissue.

44. The apparatus of claim 43, including a passive anchor being connected to at least one of the frames such that the passive anchor enters the patient'"'"'s heart tissue when the frame expands.

45. An apparatus for improving cardiac function, comprising:

a. a flexible liner;

b. a membrane secured to the liner, the membrane and the liner jointly forming a cardiac device being moveable between a collapsed and an expanded state, in the collapsed state the cardiac device being insertable into a ventricle of a heart, in the expanded state the cardiac device being in a selected position in the ventricle, the liner covering a wall in the ventricle and the membrane separating the ventricle into a main productive portion and a secondary non-productive portion; and

c. an anchor connected to the cardiac device, the anchor being insertable into a patient'"'"'s heart tissue of the heart to secure the cardiac device to the patient'"'"'s heart tissue in the selected position in the ventricle.

46. The apparatus of claim 45, wherein the flexible liner includes a plurality of lengths of strand being connected at endpoints thereof.

47. The apparatus of claim 46, including a frame secured to the cardiac device and connected to the anchor thereby interconnecting the cardiac device and the anchor.

48. The apparatus of claim 47, including a frame-side engagement component being connected to the cardiac device and an active anchor being connected to the frame-side engagement component such that a first movement of the frame-side engagement component causes the active anchor to enter the patient'"'"'s heart tissue and a second movement of the frame-side engagement component causes the active anchor to withdraw from the patient'"'"'s heart tissue.

49. The apparatus of claim 48, including a passive anchor being connected to the cardiac device such that the passive anchor enters the pa tent'"'"'s heart tissue when the cardiac device expands.

50. An apparatus for improving cardiac function, comprising:

a. an expandable frame-reinforced membrane being in a selected position in a ventricle of a heart and having an outer edge when expanded, the outer edge defining a non-planar cross section of an inner wall of the ventricle; and

b. an anchor connected to the frame which is configured to secure the frame-reinforced membrane to the patient'"'"'s heart tissue in the selected position in the ventricle.

51. The apparatus of claim 50, wherein the frame-reinforced membrane separates the ventricle into a main productive portion and a secondary non-productive portion.

52. The apparatus of claim 51, wherein the frame-reinforced membrane has a vertical axis and the outer edge of the frame-reinforced membrane has a diameter, the diameter intersecting the vertical axis at an angle other than 90 degrees.

53. An apparatus for improving cardiac function, comprising:

a. an anchor being insertable into ventricular tissue of a patients heart to secure the anchor to the within a ventricle of the heart;

b. an anchor-side engagement component being secured to the anchor;

c. an expandable frame-reinforced membrane being in a selected position in the ventricle when expanded; and

d. a frame-side engagement component being secured to the frame-reinforced membrane and being engageable with the anchor-side engagement component, the engagement securing the frame-reinforced membrane to the anchor in the selected position in the ventricle.

54. The apparatus of claim 53, wherein the membrane is secured to the frame.

55. The apparatus of claim 54, wherein a first movement of the anchor-side engagement component causes the anchor to enter the patient'"'"'s heart tissue and a second movement of the anchor-side engagement component causes the anchor to withdraw from the patient'"'"'s heart tissue.

56. The apparatus of claim 55, wherein a first movement of the frame-side engagement component causes the frame-side engagement component to engage the anchor-side engagement component and a second movement of the frame-side engagement component causes the frame-side engagement component to disengage the anchor-side engagement formation.

57. The apparatus of claim 56, wherein the disengagement releases the frame-reinforced membrane from the anchor.

58. An apparatus for improving a patient'"'"'s cardiac function, comprising:

a. a flexible body;

b. a reinforced membrane connected to the flexible body, the membrane and the flexible body jointly forming a cardiac device being moveable between a collapsed and an expanded state, in the collapsed state the cardiac device being insertable into a ventricle of the patient'"'"'s heart, in the expanded state the cardiac device being in a selected position in the ventricle; and

c. an anchor connected to the cardiac device, the anchor being insertable into the patient'"'"'s heart tissue to secure the cardiac device to the patient'"'"'s heart tissue in the selected position in the ventricle.

59. The apparatus of claim 58, wherein the membrane is reinforced by a frame having a distal section and wherein the membrane is secured to the frame and the body has a proximal and a distal end, the proximal end of the body being secured to the distal section of the frame and the distal end of the body being connected to the anchor.

60. The apparatus of claim 59, wherein the body is cylindrical with a diameter of between about 0.5 mm and 6 mm and a height of between about 1 mm and 100 mm.

61. The apparatus of claim 60, wherein the cardiac device has a vertical axis.

62. The apparatus of claim 60, wherein the body has a proximal opening at the proximal end, a distal opening at the distal end, and a passageway therethrough connecting the proximal and distal openings.

63. The apparatus of claim 62, wherein the body can bend at an angle of up to about 120 degrees from the vertical axis.

64. A device for improving a patient'"'"'s cardiac function, comprising:

a. a collapsible and expandable frame having first and second portions, the frame being insertable into a ventricle of the patient'"'"'s heart when collapsed, when expanded the frame being in a selected position in the ventricle and the second portion of the frame covering a wall in the ventricle;

b. a membrane secured to the frame such that the membrane divides the ventricle into at least a main productive portion and a non-productive portion when the frame is expanded, the frame and the membrane jointly forming a cardiac device; and

c. an anchor connected to the cardiac device, the anchor being insertable into the patient'"'"'s heart tissue to secure the cardiac device in the selected position in the ventricle.

65. The device of claim 64, wherein the frame includes a plurality of segments, each segment having an inner and outer portion connected at ends thereof the outer portions being at an angle to the inner portions.

66. The device of claim 65, wherein the membrane is secured to the inner and outer portions of the segments.

67. The device of claim 66, including a plurality of anchors being connected to at least one segment such that when the frame expands the anchors enter the patient'"'"'s heart tissue in a first direction, and when the frame folds the anchors withdraw from the patient'"'"'s heart tissue in a second direction approximately 180 degrees from the first direction.

68. The device of claim 67, wherein some of the anchors extend in a third direction.

69. A system for improving a patient'"'"'s cardiac function, comprising:

a. a collapsible and expandable frame, when collapsed the frame being insertable into a selected position in a ventricle of the patient'"'"'s heart through an opening in the heart having a small cross-dimension, when expanded in the selected position the frame having a large cross-dimension; and

b. an anchor connected to the frame, being insertable into a myocardium of the heart to secure the frame to the myocardium in the selected position.

70. The system of claim 69, wherein the opening is an incision in a wall of the patient'"'"'s heart.

71. The system of claim 70, wherein the anchor includes a plurality of strands woven through the myocardium such that the opening is closed.

72. A system for improving cardiac function, comprising:

a. an external actuator;

b. an elongate manipulator having a tube suitable to be inserted into a ventricle of a heart to a selected position and a deployment member positioned therein slidable between a first and second position, the deployment member having proximal and distal ends, the distal end being within the tube when the deployment member is in the first position and out of the tube when the deployment member is in the second position, the deployment member being connected to the external actuator at the proximal end thereof;

c. a deployment-side engagement component on the distal end of the deployment member;

d. a frame-side engagement component being engageable with the deployment-side engagement component, the engagement securing the deployment-side engagement component to the frame-side engagement component such that a movement of the external actuator causes the engagement components to disengage, the disengagement releasing deployment-side engagement component from the frame-side engagement component;

e. a frame being connected to the frame-side engagement component, the frame being moveable between a collapsed and an expanded state, the frame being connected to the deployment member in the collapsed state with a small cross-dimension when the deployment member is in the first position and the frame is within the tube, the frame being shaped such that when the deployment member is moved to the second position and the frame exits the tube, the frame expands to the expanded state with a large cross-dimension and when the deployment member is moved back to the first position, the frame collapses to the collapsed state as the frame enters the tube; and

f. an anchor connected to the frame being insertable into a myocardium of the heart to secure the frame to the myocardium of the heart such that the deployment mechanism can be removed from the heart, the anchor entering the myocardium in a first direction when the frame expands and withdrawing from the myocardium in a second direction when the frame collapses, the withdrawal releasing the frame from the myocardium.

73. The apparatus of claim 72, wherein the external manipulator includes an anchor deployment knob and a detachment knob.

74. The apparatus of claim 73, wherein the deployment member includes an anchor shaft having proximal and distal ends and a detachment shaft having proximal and distal ends, the proximal end of the anchor shaft being connected to the anchor deployment knob, the proximal end of the detachment shaft being connected to the detachment knob.

75. The apparatus of claim 74, wherein the deployment side engagement component includes a deployment-side anchor formation connected to the distal end of the anchor shaft and a deployment-side detachment formation connected to the distal end of the detachment shaft.

76. The apparatus of claim 75, wherein the frame-side engagement component includes a frame-side anchor formation being connected to the anchor and a frame-side detachment formation on the frame, the frame-side anchor formation being engageable with the deployment-side anchor formation, the frame-side detachment formation being engageable with the deployment-side detachment formation, a first movement of the detachment knob causing the deployment-side detachment formation to engage the frame-side detachment formation, the engagement securing the frame to the deployment member, a first movement of the anchor deployment knob causing the anchor to enter the myocardium and a second movement of the anchor deployment knob causing the anchor to withdraw from the myocardium, a second movement of the detachment knob causing the deployment-side detachment formation to disengage the frame-side detachment formation, the disengagement releasing the frame from the deployment member.

77. The apparatus of claim 76, wherein the anchor shaft and the detachment shaft are coaxial.

78. The apparatus of claim 77, wherein the anchor shaft is an inner torque shaft and the detachment shaft is an outer torque shaft.

79. A system for partitioning a patient'"'"'s heart chamber in the treatment of congestive heart failure, comprising:

a. a deployable partitioning device having

i. a reinforced membrane component which has a contracted configuration and an expanded configuration and which has at least one anchoring member to secure the reinforced membrane component within the patient'"'"'s heart chamber,

ii. a driving hub component secured to a central portion of the reinforced membrane, and

iii. a stem component which extends distally from the reinforced membrane and which has a proximal end secured to the driving hub and a distal end configured to engage a portion of the patient'"'"'s heart wall; and

b. a deploying system to place the deployable partitioning device within a patients heart chamber to separate the heart chamber into a productive portion and a non-productive portion and which has a manipulatable handle, an elongated drive mechanism that is secured by it'"'"'s proximal portion to the handle and which has an engaging member on its distal end for engaging the driving hub on the reinforced membrane.

80. The system of claim 79 wherein the reinforced membrane comprises a radially expandable frame formed in part by a plurality of ribs.

81. The system of claim 80 wherein the ribs have first ends which are secured to the hub and second ends which are free.

82. The system of claim 81 wherein the ribs are configured so that the free second ends expand radially away from a longitudinal axis and contract toward the longitudinal axis.

83. The system of claim 82 wherein the ribs of the frame form a proximal face and the membrane is secured to the proximal face.

84. The system of claim 79 wherein the reinforced membrane has a plurality of anchors about a peripheral edge of the reinforced membrane which are configured to penetrate into the patient'"'"'s heart tissue to position the reinforced membrane within the patient'"'"'s heart chamber.

85. The system of claim 84, wherein the anchors around the reinforced membrane have sharp ends to facilitate penetration into the patients heart tissue.

86. The system of claim 83, wherein the membrane folds toward the longitudinal axis when the reinforced membrane collapses and unfolds away from the longitudinal axis when the reinforced membrane expands.

87. The system of claim 80, wherein the ribs of the frame are formed of at least one alloy selected from the group consisting of nickel titanium alloy and stainless steel.

88. The system of claim 79, wherein the membrane is formed at least in part of ePTFE.

89. The system of claim 79 wherein the stem has an inner lumen extending to an open end.

90. The system of claim 79 wherein the distal end of the stem has a tissue penetrating anchor member.

91. The system of claim 90 wherein the tissue penetrating anchor member at the distal end of the stem includes a floating collar which is slidably disposed within the inner lumen of the stem and which has a distally extending helical coil with a tissue penetrating tip secured to the collar.

92. The system of claim 91 wherein the engaging member on the distal end of the elongated drive mechanism is configured to engage the floating collar and to rotate the collar to drive the tissue penetrating tip of the attached helical coil into the patient'"'"'s heart tissue.

94. A system for treating a patient'"'"'s heart, comprising:

a. a deployable partitioning device having

i. a reinforced membrane component which has a contracted delivery configuration and an expanded deployed configuration and which has at least one anchoring member to secure the reinforced membrane component within the patient'"'"'s heart chamber in the expanded deployed configuration, and

ii. a driving hub component secured to the reinforced membrane; and

b. a deployment system which is configured to place the deployable partitioning device within a patient'"'"'s heart chamber, deploy the device within the heart chamber to separate the heart chamber into a productive portion and a non-productive portion and which has an elongated deployment mechanism with a manipulatable proximal end, and a distal end with an engaging member for engaging the driving hub of the partitioning device to facilitate delivery of the partitioning device to a location within the patient'"'"'s heart chamber.

1. A system for treating a patient'"'"'s heart to improve cardiac function, comprising:

a. at least one external actuator;

b. an elongate manipulator connected to the external actuator;

c. a manipulator-side engagement component on a distal end of the elongate manipulator;

d. a collapsible and expandable reinforced membrane;

e. a engagement component on the reinforced membrane releasably engageable with the manipulator-side engagement component so that the external actuator can steer the reinforced membrane when collapsed into a ventricle of a heart whereafter the reinforced membrane is expanded; and

f. at least one anchor connected to the reinforced membrane, movement of the external actuator allowing for (i) insertion of the anchor into heart tissue defining in part the ventricle, (ii) subsequent withdrawal of the anchor out of the heart tissue, (iii) subsequent re-insertion of the anchor into the heart tissue, the insertion securing the reinforced membrane to the heart tissue in a selected position, and (iv) subsequent disengagement of the manipulator-side engagement component from the engagement component of the reinforced membrane, the disengagement releasing the reinforced membrane from the elongate manipulator.

2. The system of claim 1, wherein the reinforced membrane has a frame that has a collapsed configuration suitable for being inserted into the ventricle of the heart through a tubular passage of a delivery catheter and expanded configuration when deployed in the ventricle.

3. The system of claim 2, wherein the frame includes a plurality of segments extending from a central portion of the frame.

4. The system of claim 2, wherein the frame is formed at least in part of nickel titanium.

5. The system of claim 2, wherein the frame is formed at least in part of stainless steel.

6. The system of claim 3, wherein the membrane is stretched between the plurality of segments of the frame when the membrane partitions the ventricle into a main productive portion and a secondary non-productive portion.

7. The system of claim 6, wherein the membrane is formed at least in part of ePTFE.

8. The system of claim 6, wherein the membrane is in the form of a mesh.

9. The system of claim 6, wherein the plurality of segments include first portions and second portions connected at ends thereof such that the second portions are at an angle to the first portions.

10. The system of claim 9, wherein the first portions of the frame are proximal portions and the second portions are distal portions.

11. The system of claim 2, wherein the frame has a diameter between about 10 mm and about 100 mm when expanded.

12. The system of claim 2, including at least one active anchor and at least one passive anchor.

13. The system of claim 12, wherein the insertion of the passive anchor is in a first direction and the withdrawal of the passive anchor is in a second direction, the second direction being substantially 180 degrees from the first direction.

14. The system of claim 13, including a first passive anchor extending in the first direction and a second passive anchor extending in a third direction.

15. The system of claim 13, wherein the active and passive anchors have sharp ends that penetrate heart tissue defining at least in part the patients ventricle.

16. The system of claim 15, including a tubular passage with a distal end suitable to be inserted into the heart tissue defining the patient'"'"'s ventricle.

17. The system of claim 16, wherein the elongate manipulator includes a frame member with a proximal and a distal end and an anchor member with a proximal and a distal end, the frame and anchor members being moveable through the tubular passage.

18. The system of claim 17, wherein the frame has a stem with an anchoring formation on the distal end thereof.

19. The system of claim 18, wherein the stem component has an actuator element configured to be engaged by the distal end of the drive mechanism and an anchor element on the distal end thereof.

20. The system of claim 19, wherein distal movement of the drive mechanism causes the anchor element to be inserted into heart tissue defining at least in part the patient'"'"'s heart chamber to secure the frame within the patient'"'"'s heart chamber.

93. The system of claim 20 wherein a second movement of the drive mechanism causes the partitioning device to be discharged from the deploying system.

95. The system of claim 94 wherein the driving hub engaging member of the deploying device is a helical screw.

96. The system of claim 95 wherein the driving hub has an inner bar configured to be engaged by the helical screw of the deploying device.

97. The system of claim 96 wherein the deployment mechanism has an outer tubular torque shaft.

98. The system of claim 97 wherein the deployable partitioning device has a tissue engaging member distal to the hub which is configured to be secured to tissue of the heart chamber.

99. The system of claim 98 wherein the tissue engaging member is a helical screw.

100. The system of claim 99 wherein the helical screw of the tissue engaging member has a pointed free distal end configured to penetrate into tissue of the heart chamber.

101. The system of claim 100 wherein the deployable partitioning device has a distal extending stem having a hollow interior.

102. The system of claim 101 wherein the tissue engaging member is secured to a hub within the hollow interior of the stem.

103. The system of claim 102 wherein the hub to which the tissue engaging member is secured floats within the hollow interior of the stem.

104. The system of claim 102 wherein the hub to which the tissue engaging member is secured has an engagement pin extending across the hub.

105. The system of claim 104 wherein a fixed hub having an engagement pin is fixed within a distal portion of the stem.

106. The system of claim 105 wherein the tissue engaging helical screw secured to the floating hub within the stem is configured to slidably engage the engagement pin of the hub fixed within the stem distal to having a engagement pin.

107. The system of claim 106 wherein the deployment mechanism has an inner torque member which is rotationally disposed within the outer torque member and which has a key member on a distal extremity of the inner torque member.

108. The system of claim 107 wherein the key member on the distal extremity of the inner torque member interfits in a passageway of the floating hub defined in part by the engagement pin thereof whereby rotation of the inner torque member rotates the floating hub and the helical screw secured thereto.

108-1. The system of claim 107 wherein the helical screw secured to the floating hub is driven out the distal end of the stem when rotated by the inner torque member due to the slidable engagement with the engagement pin of the hub fixed within the stem.

109. A deployable partitioning device for treating a patient'"'"'s heart, comprising:

a. a reinforced membrane component which has a contracted delivery configuration and an expanded deployed configuration and which has at least one anchoring member to secure the reinforced membrane component within the patient'"'"'s heart chamber in the expanded deployed configuration, and

b. a driving hub component secured to the reinforced membrane component

110. The deployable partitioning device of claim 109 wherein a stem component extends distally from the driving hub component and has a distal end configured to engage a portion of the patient'"'"'s heart wall.

111. The partitioning device of claim 109 wherein the reinforced membrane comprises a radially expandable frame formed in part by a plurality of ribs.

112. The partitioning device of claim 111 wherein the ribs have first ends which are secured to the hub and second ends which are free.

113. The partitioning device of claim 112 wherein the ribs are configured so that the free second ends expand radially away from a longitudinal axis and contract toward the longitudinal axis.

114. The partitioning device of claim 111 wherein the ribs of the frame form a proximal face and the membrane is secured to the proximal face.

115. The partitioning device of claim 109 wherein the reinforced membrane has a plurality of anchors about a peripheral edge of the reinforced membrane which are configured to penetrate into the patients heart tissue to position the reinforced membrane within the patient'"'"'s heart chamber so as to partition the heart chamber into productive and non-productive portions.

116. The partitioning device of claim 115, wherein the anchors around the reinforced membrane have sharp ends to facilitate penetration into tissue defining the patient'"'"'s heart chamber.

117. The partitioning device of claim 109, wherein the membrane folds toward the longitudinal axis when the reinforced membrane collapses and unfolds away from the longitudinal axis when the reinforced membrane expands.

118. The partitioning device of claim 111, wherein the ribs of the frame are formed of at least one alloy selected from the group consisting of nickel titanium alloy and stainless steel.

119. The partitioning device of claim 109, wherein the membrane is formed at least in part of ePTFE.

120. The partitioning device of claim 110 wherein the stem has an inner lumen extending to an open distal end.

121. The partitioning device of claim 109 wherein the distal end of the stem has a tissue penetrating anchor member.

122. The partitioning device of claim 121 wherein the tissue penetrating anchor member at the distal end of the stem includes a floating hub which is slidably disposed within the inner lumen of the stem and which has a distally extending helical coil with a tissue penetrating tip secured to the floating hub.

123. A deployment system which is configured to place a deployable medical device with a driving hub within an intracorporeal site within a patients body, to deploy the device within the intracorporeal site into an operative configuration and which has an elongated deployment mechanism with a manipulatable proximal end, and a distal end with an engaging member for engaging the driving hub of the medical device to facilitate delivery of the device to the intracorporeal site within the patients body.

124. The system of claim 123 wherein the driving hub engaging member of the deployment device is a helical screw.

125. The system of claim 124 wherein the driving hub has an inner pin configured to be slidably engaged by the helical screw of the deploying device.