CA2525433A1 - A system for improving cardiac function - Google Patents
A system for improving cardiac function Download PDFInfo
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- CA2525433A1 CA2525433A1 CA002525433A CA2525433A CA2525433A1 CA 2525433 A1 CA2525433 A1 CA 2525433A1 CA 002525433 A CA002525433 A CA 002525433A CA 2525433 A CA2525433 A CA 2525433A CA 2525433 A1 CA2525433 A1 CA 2525433A1
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- frame
- anchor
- membrane
- patient
- heart
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
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- A—HUMAN NECESSITIES
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- A61B17/0057—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
- A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
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- A61B17/0057—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
- A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00579—Barbed implements
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- A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
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- A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00597—Implements comprising a membrane
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/0057—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
- A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00615—Implements with an occluder on one side of the opening and holding means therefor on the other
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- A61B17/0057—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
- A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00632—Occluding a cavity, i.e. closing a blind opening
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- A61B2017/0649—Coils or spirals
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
- A61B2017/12095—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 (90)
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.
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 patient's 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.
21. 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.
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.
22. The apparatus of claim 21, wherein the frame includes at least three central segments and at least three outer segments.
23. The apparatus of claim 22, wherein the membrane is stretched between the central and the outer segments.
24. The apparatus of claim 23, wherein the anchor is secured directly to the frame.
25. 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.
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.
26. The apparatus of claim 25, wherein the cardiac device collapses toward the vertical axis and expands away from the vertical axis.
27. The apparatus of claim 26, 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.
28. The apparatus of claim 27, wherein the frame formed of an alloy selected from the group consisting of nickel titanium and stainless steel.
29. The apparatus of claim 28, wherein the membrane is formed of at least in part of ePTFE.
30. The apparatus of claim 29, wherein the anchor has a sharp end.
31. 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 patient's 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.
a. a frame being expandable in a selected position to a pre-set shape in a ventricle of the patient's 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.
32. The apparatus of claim 31, 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.
33. The apparatus of claim 32, wherein the formation is a pin.
34. The apparatus of claim 33, wherein the anchor is a screw.
35. 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.
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.
36. The apparatus of claim 35, 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.
37. The apparatus of claim 36, wherein the anchor is connected to the at least one of the frames.
38. The apparatus of claim 37, 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.
39. The apparatus of claim 38, 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.
40. The apparatus of claim 39, 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.
41. The apparatus of claim 40, 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.
42. 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.
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.
43. The apparatus of claim 42, wherein the flexible liner includes a plurality of lengths of strand being connected at endpoints thereof.
44. The apparatus of claim 43, including a frame secured to the cardiac device and connected to the anchor thereby interconnecting the cardiac device and the anchor.
45. The apparatus of claim 44, 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.
46. The apparatus of claim 43, including a passive anchor being connected to the cardiac device such that the passive anchor enters the patient's heart tissue when the cardiac device expands.
47. 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.
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.
48. The apparatus of claim 47, wherein the frame-reinforced membrane separates the ventricle into a main productive portion and a secondary non-productive portion.
49. The apparatus of claim 48, 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 degrees.
50. An apparatus for improving cardiac function, comprising:
a. an anchor being insertable into ventricular tissue of a patient's 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.
a. an anchor being insertable into ventricular tissue of a patient's 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.
51. The apparatus of claim 50, wherein the membrane is secured to the frame.
52. The apparatus of claim 51, 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.
53. The apparatus of claim 52, 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.
54. The apparatus of claim 53, wherein the disengagement releases the frame-reinforced membrane from the anchor.
55. 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.
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.
56. The apparatus of claim 55, 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.
57. The apparatus of claim 56, 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.
44 55. The apparatus of claim 57, wherein the cardiac device has a vertical axis.
59. The apparatus of claim 57, 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.
60. The apparatus of claim 59, wherein the body can bend at an angle of up to about 120 degrees from the vertical axis.
61. 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.
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.
62. The device of claim 61, 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.
63. The device of claim 62, wherein the membrane is secured to the inner and outer portions of the segments.
64. The device of claim 63, 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.
65. The device of claim 64, wherein some of the anchors extend in a third direction.
66. 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.
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.
67. The system of claim 66, wherein the opening is an incision in a wall of the patient's heart.
68. The system of claim 67, wherein the anchor includes a plurality of strands woven through the myocardium such that the opening is closed.
69. 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.
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.
70. The apparatus of claim 69, wherein the external manipulator includes an anchor deployment knob and a detachment knob.
71. The apparatus of claim 70, 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.
72. The apparatus of claim 71, 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.
73. The apparatus of claim 72, 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.
74. The apparatus of claim 73, wherein the anchor shaft and the detachment shaft are coaxial.
75. The apparatus of claim 74, wherein the anchor shaft is an inner torque shaft and the detachment shaft is an outer torque shaft.
76. A system for partitioning a patient's heart chamber in the treatment of congestive heart failure, comprising:
a. a deployable partitioning device having 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 patient's 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.
a. a deployable partitioning device having 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 patient's 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.
77. The system of claim 76 wherein the reinforced membrane comprises a radially expandable frame formed in part by a plurality of ribs.
78. The system of claim 77 wherein the ribs have first ends which are secured to the hub and second ends which are free.
79. The system of claim 78 wherein the ribs are configured so that the free second ends expand radially away from a longitudinal axis and contract toward the longitudinal axis.
80. The system of claim 79 wherein the ribs of the frame form a proximal face and the membrane is secured to the proximal face.
81. The system of claim 76 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 head chamber.
82. The system of claim 81, wherein the anchors around the reinforced membrane have sharp ends to facilitate penetration into the patient's heart tissue.
83. The system of claim 80, 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.
84. The system of claim 77, 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.
85. The system of claim 76, wherein the membrane is formed at least in part of ePTFE.
86. The system of claim 76 wherein the stem has an inner lumen extending to an open end.
87. The system of claim 76 wherein the distal end of the stem has a tissue penetrating anchor member.
88. The system of claim 87 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.
89. The system of claim 88 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.
90. The system of claim 20 wherein a second movement of the drive mechanism causes the partitioning device to be discharged from the deploying system.
Priority Applications (1)
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-
2003
- 2003-05-12 US US10/436,959 patent/US8257428B2/en active Active
-
2004
- 2004-05-11 JP JP2006532969A patent/JP4879744B2/en not_active Expired - Fee Related
- 2004-05-11 EP EP04760989A patent/EP1643915B1/en not_active Not-in-force
- 2004-05-11 AT AT04760989T patent/ATE408377T1/en active
- 2004-05-11 DE DE602004016663T patent/DE602004016663D1/en active Active
- 2004-05-11 DK DK04760989T patent/DK1643915T3/en active
- 2004-05-11 AU AU2004238353A patent/AU2004238353B2/en not_active Ceased
- 2004-05-11 CA CA2789113A patent/CA2789113A1/en not_active Abandoned
- 2004-05-11 ES ES04760989T patent/ES2314425T3/en active Active
- 2004-05-11 CA CA2525433A patent/CA2525433C/en not_active Expired - Fee Related
- 2004-05-11 WO PCT/US2004/014782 patent/WO2004100803A1/en active Application Filing
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2007
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- 2007-05-07 US US11/800,998 patent/US8747454B2/en not_active Expired - Lifetime
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2008
- 2008-11-10 US US12/268,346 patent/US8192478B2/en not_active Expired - Lifetime
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2011
- 2011-05-11 JP JP2011106162A patent/JP2011200659A/en active Pending
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US20060264980A1 (en) | 2006-11-23 |
CA2789113A1 (en) | 2004-11-25 |
EP1643915B1 (en) | 2008-09-17 |
US20070213815A1 (en) | 2007-09-13 |
US8257428B2 (en) | 2012-09-04 |
JP2011200659A (en) | 2011-10-13 |
US20090062601A1 (en) | 2009-03-05 |
JP4879744B2 (en) | 2012-02-22 |
DE602004016663D1 (en) | 2008-10-30 |
AU2004238353B2 (en) | 2011-05-19 |
US8747454B2 (en) | 2014-06-10 |
EP1643915A1 (en) | 2006-04-12 |
US8657873B2 (en) | 2014-02-25 |
ATE408377T1 (en) | 2008-10-15 |
AU2004238353A1 (en) | 2004-11-25 |
WO2004100803A1 (en) | 2004-11-25 |
CA2525433C (en) | 2012-11-13 |
US20070213578A1 (en) | 2007-09-13 |
ES2314425T3 (en) | 2009-03-16 |
US8192478B2 (en) | 2012-06-05 |
DK1643915T3 (en) | 2009-01-26 |
JP2007502689A (en) | 2007-02-15 |
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