Systems and methods for delivering prosthetics to treat a cardiac valve
Apparatus for repairing a cardiac valve, e.g., a tricuspid valve, are provided. The apparatus may include a prosthetic device coupled to an elongated support to suspend and maintain the prosthetic device within the cardiac valve. The support may include a proximal, delivery portion detachably coupled a distal, implantable portion coupled to the prosthetic device, and two or more adjustable bends to facilitate navigation through the patient's anatomy. The adjustable bends may be selectively adjusted, components of the distal, implantable portion may be locked to each other, and the proximal, delivery portion may be detached from the distal, implantable portion responsive to actuation at a handle operatively coupled to the support. The prosthetic device may be formed of biocompatible material coupled to a frame, and may have prosthetic leaflets that allow blood flow in one direction during, e.g., diastole, but prevent blood regurgitation during, e.g., systole.
1 . A system for implanting a therapeutic heart valve device at a native heart valve of a patient's heart, the system comprising:
a prosthetic device configured to be implanted at the native heart valve; and
a support configured to maintain the prosthetic device at the native heart valve, the support comprising:
a first adjustable bend comprising a preformed bend and configured to be actuated to adjust a position of the prosthetic device along a first plane; and
a second adjustable bend proximal to the first adjustable bend, the second adjustable bend configured to be actuated to adjust the position of the prosthetic device along a second plane,
wherein an orientation of the first plane is dependent on the position of the prosthetic device along the second plane.
2 . The system of claim 1 , wherein the first and second adjustable bends are configured to be actuated to adjust the position of the prosthetic device along the first and second planes to facilitate navigation of the prosthetic device through the patient's inferior vena cava (IVC) and right atrium to the patient's tricuspid valve.
3 . The system of claim 1 , wherein the support comprises:
an elongated rail extending concentrically through and configured to be coupled to the prosthetic device, the elongated rail comprising the preformed bend and having a first flexibility;
a first shaping catheter slidably disposed over the elongated rail such that movement of the first shaping catheter over the preformed bend of the elongated rail adjusts an angle of the first adjustable bend, the first shaping catheter having a second flexibility less flexible than the first flexibility.
4 . The system of claim 3 , wherein the first shaping catheter comprises a distal portion having a first stiffness and a proximal portion having a second stiffness more stiff than the first stiffness, such that movement of the distal portion of the first shaping catheter over the preformed bend does not adjust the angle of the first adjustable bend, whereas movement of the proximal portion of the first shaping catheter over the preformed bend adjusts the angle of the first adjustable bend, thereby minimizing damage to the support.
5 . The system of claim 3 , wherein the elongated rail comprises the second adjustable bend having a second preformed bend, and wherein the support further comprises a second shaping catheter slidably disposed over the first shaping catheter such that movement of the second shaping catheter over the second preformed bend of the elongated rail adjusts an angle of the second adjustable bend, the second bend shaping catheter having a third flexibility less flexible than the second flexibility.
6 . The system of claim 5 , wherein the second shaping catheter comprises a distal portion having a first stiffness and a proximal portion having a second stiffness more stiff than the first stiffness, such that movement of the distal portion of the second shaping catheter over the second preformed bend does not adjust the angle of the second adjustable bend, whereas movement of the proximal portion of the second shaping catheter over the second preformed bend adjusts the angle of the second adjustable bend, thereby minimizing damage to the support.
7 . The system of claim 5 , wherein the support comprises a valve support catheter slidably disposed over the second shaping catheter and coupled to the prosthetic device, the valve support catheter having a fourth flexibility more flexible than the first flexibility, such that movement of the valve support catheter relative to the native heart valve adjusts a depth of the prosthetic device relative to the native heart valve without adjusting, or minimally adjusting, the position of the first and second adjustable bends.
8 . The system of claim 5 , wherein the elongated rail comprises an elongated rail distal portion extending concentrically through and coupled to the prosthetic device and an elongated rail proximal portion, the elongated rail distal portion configured to be attached to the elongated rail proximal portion during delivery of the prosthetic device, and detached from the elongated rail proximal portion for implantation of the elongated rail distal portion and the prosthetic device.
9 . The system of claim 8 , wherein the first shaping catheter comprises a first shaping catheter distal portion and a first shaping catheter proximal portion, the first shaping catheter distal portion configured to be attached to the first shaping catheter proximal portion during delivery of the prosthetic device, and detached from the first shaping catheter proximal portion for implantation of the first shaping catheter distal portion.
10 . The system of claim 9 , wherein the first shaping catheter distal portion comprises a lock configured to lock the first shaping catheter distal portion to the elongated rail distal portion.
11 . The system of claim 10 , wherein the second shaping catheter comprises a second shaping catheter distal portion and a second shaping catheter proximal portion, the second shaping catheter distal portion configured to be attached to the second shaping catheter proximal portion during delivery of the prosthetic device, and detached from the second shaping catheter proximal portion for implantation of the second shaping catheter distal portion.
12 . The system of claim 11 , wherein the second shaping catheter distal portion comprises a lock configured to lock the second shaping catheter distal portion to the first shaping catheter distal portion.
13 . The system of claim 1 , wherein the prosthetic device comprises a spine configured to be coupled to a distal region of the support via a spine connector.
14 . The system of claim 13 , wherein the spine connector comprises a plurality of ridges disposed at a proximal region of the spine, and wherein the support is configured to expand responsive to an external stimulus, such that the distal region of the support is configured to be disposed over the plurality of ridges in an expanded state and coupled to the proximal region of the spine via an interference fit between an inner surface of the distal region of the support and the plurality of ridges upon removal of the external stimulus.
15 . The system of claim 13 , wherein the spine connector comprises an elongated rod having a proximal end coupled to the distal region of the support and a distal end comprising one or more collapsible prongs, the one or more collapsible prongs comprising a protrusion, and wherein a distal region of the spine comprises one or more grooves configured to receive the protrusion when the one or more collapsible prongs are in an expanded state, such that the spine is configured to be disposed over the distal end of the spine connector when the one or more collapsible prongs are in a collapsed state until a proximal end of the spine abuts an abutment disposed at the distal region of the support and the protrusion engages the one or more grooves in the expanded state, thereby preventing axial and rotational movement between the spine and the spine connector.
16 . The system of claim 13 , wherein the spine connector comprises an elongated rod having a proximal end coupled to the distal region of the support and a distal end configured to be coupled to a plug having a distal abutment, such that the spine is configured to be disposed over the distal end of the spine connector until a proximal end of the spine abuts a proximal abutment disposed at the distal region of the support, and wherein the plug is configured to be coupled to the distal end of the elongated rod, such that the proximal and distal abutments prevent relative axial and rotational movement between the spine and the spine connector.
17 . The system of claim 1 , further comprising a stent configured to anchor the support to a blood vessel coupled to the heart.
18 . The system of claim 17 , further comprising:
a stent tube slidably disposed over the support, a first portion of the stent tube pivotally coupled to a first portion of the stent, a second portion of the stent tube moveably coupled to a second portion of the stent such that movement of the second portion of the stent tube along the second portion of the stent causes the stent tube to pivot about the first portion of the stent to thereby adjust an angle of the second adjustable bend.
19 . The system of claim 18 , wherein the second portion of the stent comprises a rail such that the second portion of the stent tube is moveable along the rail.
20 . The system of claim 17 , further comprising:
a stent tube slidably disposed over the support, the stent tube comprising a first portion pivotally coupled to a first portion of the stent and a second portion configured to freely move relative to the stent such that the stent tube pivots about the first portion of the stent responsive to movement of the prosthetic device throughout multiple cardiac cycles.
21 . The system of claim 17 , further comprising:
a stent tube slidably disposed over the support, the stent tube comprising a first portion rigidly coupled to a first portion of the stent and a second portion rigidly coupled to a second portion of the stent such that the stent tube does not move relative to the stent throughout multiple cardiac cycles.
22 . The system of claim 17 , wherein the stent comprises a stent spine having one or more flexible guiding portions configured to transition between a radially collapsed state and a radially expanded state, the system further comprising:
a stent support catheter slidably disposed over the one or more flexible guiding portions in the radially expanded state,
wherein the one or more flexible guiding portions are biased toward the radially collapsed state, such that the one or more flexible guiding portions are configured to receive the support therethrough in the radially expanded state within the stent support catheter, and upon removal of the stent support catheter, the one or more flexible guiding portions are configured to clamp the support.
23 . The system of claim 22 , wherein the stent spine comprises a central guiding portion configured to be slidably disposed within the stent support catheter, the central guiding portion configured to receive the support therethrough.
24 . The system of claim 23 , wherein the one or more flexible guiding portions comprise at least one of one or more proximal flexible guiding portions disposed on the stent spine proximal to the central guiding portion or one or more distal flexible guiding portions disposed on the stent spine distal to the central guiding portion.
25 . The system of claim 17 , wherein the stent comprises a stent spine having one or more flexible guiding portions configured to transition between a radially collapsed state and a radially expanded state, and wherein an outer surface of the support comprises one or more grooves configured to receive the one or more flexible guiding portions, the system further comprising:
a stent support catheter slidably disposable between the support and the one or more flexible guiding portions in the radially expanded state,
wherein the one or more flexible guiding portions are biased toward the radially collapsed state, such that the stent support catheter is configured to maintain the one or more flexible guiding portions in the radially expanded state as the stent support catheter receives the support therein, and upon removal of the stent support catheter, the one or more flexible guiding portions are configured to transition to the radially collapsed state within the one or more grooves to thereby prevent axial movement between the stent spine and the support.
26 . The system of claim 17 , wherein the stent comprises a stent spine having one or more compliant rings, the system further comprising:
a stent support catheter configured to be received through and expand the one or more compliant rings to a radially expanded state, the stent support catheter configured to slidably receive the support therein,
wherein, upon removal of the stent support catheter, the one or more compliant rings are configured to clamp the support.
27 . The system of claim 17 , wherein the stent comprises a stent tube slidably disposed over the support, and wherein an outer surface of a proximal region of the support comprises a first threaded surface, the system further comprising:
a rotatable driver disposed within the stent tube, the rotatable driver having a lumen sized and shaped to receive the proximal region of the support therein, an inner surface of the rotatable driver comprising a second threaded surface configured to rotatably engage with the first threaded surface of the proximal region of the support,
wherein the rotatable driver is axially controlled relative to the stent tube and the support is rotationally fixed relative to the stent tube, such that rotation of the rotatable driver causes translational movement of the support relative to the stent tube via the first and second threaded surfaces.
28 . The system of claim 27 , wherein the rotatable driver comprises a shoulder portion, wherein the outer surface of the proximal region of the support comprises a rail portion, and wherein the stent tube comprises:
one or more pairs of inward facing flaps configured to lock the shoulder portion of the rotatable driver to axially control the rotatable driver relative to the stent tube; and
one or more inward facing tabs configured to slidably engage with the rail portion to rotationally fix the support relative to the stent tube.
29 . The system of claim 27 , wherein the rotatable driver comprises a shoulder portion, and wherein an inner surface of the stent tube comprises a groove sized and shaped to receive the shoulder portion therein to thereby axially control the rotatable driver relative to the stent tube.
30 . The system of claim 17 , wherein the stent comprises an expandable wire frame having a proximal draping portion and distal draping portion, the distal draping portion comprising more flexibility than the proximal draping portion of the expandable wire frame.
31 . The system of claim 30 , wherein the expandable wire frame comprises strut rings each extending around a circumference of the stent, wherein the strut rings in the distal draping portion are thinner than the strut rings in the proximal draping portion.