Externally expandable heart valve anchor and method
The invention includes methods of and apparatus for endovascularly replacing a heart valve of a patient. One aspect of the invention provides a method including the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; and applying an external non-hydraulic or non-pneumatic actuation force on the anchor to change the shape of the anchor, such as by applying proximally and/or distally directed force on the anchor using a releasable deployment tool to expand and contract the anchor or parts of the anchor.
1 . A method for endovascularly replacing a heart valve of a patient, the method comprising:
endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; and
applying an external non-hydraulic or non-pneumatic actuation force on the anchor to change the shape of the anchor.
2 . The method of claim 1 wherein the replacement valve is coupled to the anchor, the delivering step comprising endovascularly delivering the coupled anchor and replacement valve to the vicinity of the heart valve.
3 . The method of claim 2 wherein the delivering step comprises endovascularly delivering the anchor and replacement valve to the vicinity of the heart valve in a catheter having a diameter no more than 21 french.
4 . The method of claim 1 wherein the heart valve comprises an aortic valve, the delivering step comprising endovascularly delivering the expandable anchor and replacement valve to the vicinity of the aortic valve along a retrograde approach.
5 . The method of claim 1 wherein the applying step comprises applying a proximally directed force on the anchor.
6 . The method of claim 5 wherein the step of applying a proximally directed force comprises applying a proximally directed force on the anchor to move a distal end of the anchor proximally.
7 . The method of claim 5 wherein the step of applying a proximally directed force comprises applying a proximally directed force on the anchor to move a distal end of the anchor proximally to expand the anchor.
8 . The method of claim 5 wherein the step of applying a proximally directed force comprises applying a proximally directed force on the anchor to move a proximal end of the anchor proximally.
9 . The method of claim 5 wherein the step of applying,a proximally directed force comprises applying a proximally directed force on the anchor to move a proximal end of the anchor proximally to contract the anchor.
10 . The method of claim 1 wherein the applying step comprises applying a distally directed force on the anchor.
11 . The method of claim 10 wherein the step of applying a distally directed force comprises applying a distally directed force on the anchor to move a proximal end of the anchor distally.
12 . The method of claim 10 wherein the step of applying a distally directed force comprises applying a distally directed force on the anchor to move a proximal end of the anchor distally to expand the anchor.
13 . The method of claim 1 further comprising applying a radially outwardly directed force on the anchor to expand the anchor.
14 . The method of claim 13 wherein the step of applying a radially outwardly directed force comprises expanding a balloon within the anchor.
15 . The method of claim 14 wherein the step of expanding a balloon comprises expanding a balloon to apply a force of at least one pound on tissue surrounding the anchor.
16 . The method of claim 1 wherein the applying step comprises applying the external non-hydraulic or non-pneumatic actuation force on the anchor to expand the anchor.
17 . The method of claim 16 further comprising locking the anchor in an expanded configuration.
18 . The method of claim 17 wherein the locking step comprises releasing a lock prevention element.
19 . The method of claim 1 further comprising permitting the anchor to self-expand prior to applying the actuation force.
20 . The method of claim 1 further comprising registering the anchor with an anatomical landmark in an anchor location and deploying the anchor at the anchor location.
21 . The method of claim 20 wherein the registering step comprises contacting tissue of the heart valve to resist movement of the anchor in at least a proximal or a distal direction prior to deploying the anchor.
22 . The method of claim 21 wherein the contacting step comprises contacting a native valve leaflet with a registration element extending from a catheter.
23 . The method of claim 21 wherein the contacting step comprises contacting a native valve leaflet with registration element extending from the anchor.
24 . The method of claim 1 further comprising expanding the anchor to apply 1 to 2 pounds of anchoring force on tissue surrounding the anchor.
25 . The method of claim 24 further comprising locking the anchor after the expanding step.
26 . The method of claim 25 wherein the locking step comprises releasing a lock prevention element.
27 . Apparatus for endovascularly replacing a patient's heart valve comprising:
a replacement valve;
an anchor; and
a deployment tool adapted to apply a non-hydraulic or non-pneumatic actuation force on the anchor to reshape the anchor.
28 . The apparatus of claim 27 wherein the deployment tool is adapted to deliver a proximally directed actuation force on the anchor.
29 . The apparatus of claim 28 wherein the deployment tool comprises a control member adapted to move a distal end of the anchor proximally.
30 . The apparatus of claim 28 wherein at least a portion of the anchor is adapted to expand in response to application of the proximally directed actuation force.
31 . The apparatus of claim 28 wherein the deployment tool comprises a control member adapted to move a proximal end of the anchor proximally.
32 . The apparatus of claim 28 wherein at least a portion of the anchor is adapted to contract in response to application of the proximally directed actuation force.
33 . The apparatus of claim 27 wherein the deployment tool is adapted to deliver a distally directed actuation force on the anchor.
34 . The apparatus of claim 33 wherein the deployment tool comprises a control member adapted to move a proximal end of the anchor distally.
35 . The apparatus of claim 33 wherein at least a portion of the anchor is adapted to expand in response to application of the distally directed actuation force.
36 . The apparatus of claim 27 further comprising a releasable connection between the deployment tool and the anchor.
37 . The apparatus of claim 27 wherein the anchor comprises self-expanding shape memory material.
38 . The apparatus of claim 27 further comprising an anchor lock adapted to lock the anchor in a deployed configuration.
39 . The apparatus of claim 38 further comprising a lock prevention element actuatable from outside the patient.
40 . The apparatus of claim 27 wherein the anchor comprises barbs adapted to penetrate tissue when the anchor is in an expanded configuration.
41 . The apparatus of claim 27 further comprising a registration element adapted to determine a position of the replacement valve with respect to the heart valve.
42 . The apparatus of claim 41 further comprising a catheter adapted to deliver the anchor and the replacement valve to a vicinity of the heart valve, the registration element being disposed on the catheter.
43 . The apparatus of claim 41 wherein the registration element is disposed on the anchor.
44 . The apparatus of claim 41 wherein the registration element is adapted to extend radially outward from the anchor to entrap at least part of the heart valve.
45 . Apparatus for endovascularly replacing a patient's heart valve, the apparatus comprising:
an anchor having a collapsed delivery configuration and an expanded deployed configuration; and
a replacement valve coupled to the anchor,
wherein the anchor comprises enhanced radial strength in the expanded deployed configuration as compared to the collapsed delivery configuration due to imposed foreshortening.
46 . The apparatus of claim 45 further comprising a locking mechanism for maintaining imposed foreshortening.
47 . The apparatus of claim 46 , wherein the apparatus is configured for retrieval prior to actuation of the locking mechanism.
48 . The apparatus of claim 46 , wherein the locking mechanism is configured to maintain a degree of imposed foreshortening selected in vivo.
49 . The apparatus of claim 45 further comprising a delivery system configured for percutaneous delivery, deployment and foreshortening of the anchor.
50 . The apparatus of claim 49 further comprising a leaflet engagement element coupled to the delivery system to provide positive registration of the apparatus relative to an anatomical landmark.
51 . The apparatus of claim 49 , wherein the delivery system is releasably coupled to the anchor in a manner facilitating dynamic repositioning and retrieval of the anchor post-deployment.
52 . The apparatus of claim 45 , wherein the anchor is at least partially covered by a biocompatible film.
53 . The apparatus of claim 45 , wherein the replacement valve comprises a valve chosen from the group consisting of mechanical valves, biologic valves, and combinations thereof.
54 . The apparatus of claim 45 , wherein the anchor is fabricated from materials chosen from the group consisting of self-expanding materials, balloon-expandable materials, and combinations thereof.
55 . The apparatus of claim 45 , wherein the anchor further comprises barbs adapted to engage tissue at the heart valve when the anchor is disposed in the expanded deployed configuration.
56 . The apparatus of claim 45 further comprising a leaflet engagement element coupled to the anchor to provide positive registration of the apparatus relative to anatomical landmarks.
57 . The apparatus of claim 45 , wherein the anchor further comprises an element configured to reduce paravalvular leakage or regurgitation.
58 . A method for endovascularly replacing a patient's heart valve, the method comprising:
providing apparatus comprising an expandable anchor having a replacement valve coupled thereto;
endovascularly delivering the apparatus to a vicinity of the heart valve in a collapsed delivery configuration;
expanding the apparatus to a partially deployed configuration; and
actively foreshortening the anchor to a fully deployed configuration comprising enhanced radial strength, such that the anchor displaces the patient's heart valve, and the replacement valve regulates blood flow.
59 . The method of claim 58 further comprising maintaining imposed foreshortening via a locking mechanism.
60 . The method of claim 58 further comprising dynamically repositioning the apparatus.
61 . The method of claim 58 further comprising retrieving the apparatus.
62 . The method of claim 58 further comprising positively registering the apparatus relative to anatomical landmarks.
63 . The method of claim 58 , wherein endovascularly delivering the apparatus further comprises endovascularly delivering the apparatus in a retrograde fashion.
64 . (Canceled)
65 . (Canceled)