U.S. patent application number 16/442504 was filed with the patent office on 2020-09-17 for a2 clip for side-delivered transcatheter mitral valve prosthesis.
The applicant listed for this patent is VDYNE, LLC. Invention is credited to MARK CHRISTIANSON, SCOTT KRAMER, ROBERT VIDLUND.
Application Number | 20200289259 16/442504 |
Document ID | / |
Family ID | 1000005059747 |
Filed Date | 2020-09-17 |
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United States Patent
Application |
20200289259 |
Kind Code |
A1 |
CHRISTIANSON; MARK ; et
al. |
September 17, 2020 |
A2 Clip for Side-Delivered Transcatheter Mitral Valve
Prosthesis
Abstract
The invention relates to an A2 clip for a side-delivered
prosthetic mitral valve where the A2 clip is extended using a guide
wire to capture native mitral leaflet and/or chordae tissue and
withdrawing the guide wire contracts the A2 clip and pins the
native tissue against the subannular sidewall of the prosthetic
valve.
Inventors: |
CHRISTIANSON; MARK;
(PLYMOUTH, MN) ; VIDLUND; ROBERT; (FOREST LAKE,
MN) ; KRAMER; SCOTT; (Maple Grove, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
VDYNE, LLC |
Maple Grove |
MN |
US |
|
|
Family ID: |
1000005059747 |
Appl. No.: |
16/442504 |
Filed: |
June 16, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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62818109 |
Mar 14, 2019 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2220/0033 20130101;
A61F 2210/0014 20130101; A61F 2/2418 20130101; A61F 2250/0098
20130101; A61F 2/2439 20130101; A61F 2220/0008 20130101; A61F
2230/0069 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A side-delivered prosthetic heart valve having an anterior
leaflet anchoring tab component, comprising: (i) a self-expanding
annular outer support frame, said annular support frame having a
central channel and an outer perimeter wall circumscribing a
vertical y-axis in an expanded configuration, said outer perimeter
wall having an anterior side, a posterior side, a distal side and a
proximal side, (ii) an integrated subannular anterior leaflet
anchoring system mounted on the anterior side of the outer
perimeter wall, wherein the system comprises an anterior clip
sleeve having a pre-loaded anterior clip disposed within a lumen of
the sleeve, the pre-loaded anterior clip comprising an elongated
loop or tab, wherein said anterior clip is compressed or folded
within the sleeve and a distal portion of the anterior clip presses
against the outer perimeter wall when said anterior clip is
compressed or folded, and wherein said anterior clip is extended or
unfolded when released from the sleeve along the cylindrical axis
for capture of native leaflet or chordae tissue, wherein the
anterior clip engages with a guide wire during deployment to an
extended or unfolded position allowing the anterior clip to capture
native leaflet and/or native chordae, and upon withdrawal of the
guide wire, the native leaflet and/or native chordae are sandwiched
between the anterior clip and the outer perimeter wall of the
annular support frame; (iii) a collapsible flow control component
mounted within the annular support frame, the annular outer support
frame and the collapsible flow control component comprising
diamond- or eye-shaped wire cells made from heat-set Nitinol and
configured to be foldable along a z-axis from a rounded or
cylindrical configuration to a flattened cylinder configuration
having a width of 8-12 mm, and compressible along a vertical y-axis
to a shortened configuration having a height of 8-12 mm, the
collapsible flow control component having a leaflet frame with 2-4
flexible leaflets mounted thereon, wherein the 2-4 leaflets are
configured to permit blood flow in a first direction through an
inflow end of the collapsible flow control component and block
blood flow in a second direction, opposite the first direction,
through an outflow end of the collapsible flow control component;
(iv) a distal anchoring tab mounted on a distal side of the annular
outer support frame, wherein the distal anchoring tab is an
elongated member attached at a first end to the outer perimeter
wall of the annular support frame and has an unattached second end
that is heat set to a folded position to press against the outer
perimeter wall, wherein the distal anchoring tab engages with a
guide wire during deployment to an opened configuration, wherein
the distal anchoring tab in the opened configuration tracks over
the guide wire allowing the distal anchoring tab to capture native
leaflet and/or native chordae, and upon withdrawal of the guide
wire releasing the distal anchoring tab to the folded position, the
native leaflet and/or native chordae are sandwiched between the
folded distal anchoring tab and the outer perimeter wall of the
annular outer support frame; wherein the valve is compressible to a
compressed configuration for introduction into the body using a
delivery catheter for implanting at a desired location in the body,
said compressed configuration is oriented along a horizontal x-axis
at an intersecting angle of between 45-135 degrees to the vertical
y-axis, and expandable to an expanded configuration having the
horizontal x-axis at an intersecting angle of between 45-135
degrees to the vertical y-axis, wherein the horizontal x-axis of
the compressed configuration of the valve is substantially parallel
to a length-wise cylindrical axis of the delivery catheter, wherein
the valve has a height of about 5-60 mm and a diameter of about
25-80 mm.
2. (canceled)
3. The valve of claim 1, wherein the anterior clip has a
radio-opaque marker.
4. The valve of claim 1, wherein the anterior clip comprises
braided polyethylene, treated pericardial tissue, ePTFE, or
Nitinol.
5. The valve of claim 1, wherein the annular outer support frame is
comprised of a plurality of compressible wire cells having a
orientation and cell geometry substantially orthogonal to the
vertical y-axis to minimize wire cell strain when the annular outer
support frame is configured in a vertical compressed configuration,
a rolled compressed configuration, or a folded compressed
configuration.
6. The valve of claim 1, wherein the annular outer support frame
has a lower body portion and an upper collar portion, wherein the
lower body portion in an expanded configuration forms a shape
selected from a funnel, cylinder, flat cone, or circular
hyperboloid, and wherein said annular outer support frame is
comprised of a braided, wire, or laser-cut wire frame, and said
annular outer support frame is covered with a biocompatible
material, and wherein wherein the annular outer support frame has a
diameter R of 40-80 mm, a diameter r of 20-60 mm, and a height of
5-60 mm.
7. The valve of claim 1, wherein the annular outer support frame
has an inner surface and an outer surface, said inner surface and
said outer surface covered with a biocompatible material selected
from the following consisting of: the inner surface covered with
pericardial tissue, the outer surface covered with a woven
synthetic polyester material, and both the inner surface covered
with pericardial tissue and the outer surface covered with a woven
synthetic polyester material.
8. The valve of claim 1, wherein the valve in an expanded
configuration has a vertical y-axis that is substantially parallel
to the first direction.
9. The valve of claim 1, wherein the flow control component has an
internal diameter of 20-60 mm and a height of 10-40 mm, and a
plurality of leaflets of pericardial material joined to form a
rounded cylinder at an inflow end and having a flat closable
aperture at an outflow end.
10. The valve of claim 1, wherein the flow control component is
supported with one or more longitudinal supports integrated into or
mounted upon the flow control component, the one or more
longitudinal supports selected from rigid or semi-rigid posts,
rigid or semi-rigid ribs, rigid or semi-rigid battons, rigid or
semi-rigid panels, and combinations thereof.
11. The valve of claim 1, wherein the distal anchoring tab is
comprised of wire loop, a wire frame, a laser cut frame, an
integrated frame section, or a stent, and the distal anchoring tab
extends from about 10-40 mm away from the distal side of the
annular outer support frame.
12. The valve of claim 1, further comprising an upper distal
anchoring tab attached to a distal upper edge of the annular outer
support frame, the upper distal anchoring tab comprised of wire
loop, a wire frame, a laser cut frame, an integrated frame section,
or a stent, and extends from about 2-20 mm away from the annular
outer support frame.
13. The valve of claim 1, comprising at least one tissue anchor
connected to the annular outer support frame for engaging native
tissue.
14. The valve of claim 1, wherein the outer perimeter wall
comprises a front wall portion that is a first flat panel and a
back wall portion that is a second flat panel, and wherein a
proximal fold area and a distal fold area each comprise a sewn
seam, a fabric panel, a rigid hinge, or a flexible fabric span
without any wire cells.
15. The valve of claim 1, wherein the annular outer support frame
is comprised of compressible wire cells selected from the group
consisting of braided-wire cells, laser-cut wire cells,
photolithography produced wire cells, 3D printed wire cells, wire
cells formed from intermittently connected single strand wires in a
wave shape, a zig-zag shape, or spiral shape, and combinations
thereof.
16. A method for orthogonal delivery of implantable prosthetic
heart valve to a patient, the method comprising the steps:
advancing a guide wire to an atrium, through the annular plane at
an antero-posterior commissure, to a position behind a native
posterior leaflet of a native heart valve of the patient; advancing
the prosthetic heart valve of claim 1 in a delivery catheter to the
atrium of the patient, said prosthetic heart valve in a compressed
configuration for side delivery, wherein the distal anchoring tab
is threaded onto the guide wire, and wherein the anterior clip is
optionally threaded onto the guide wire; releasing the prosthetic
heart valve of claim 1 from the delivery catheter, wherein the
distal anchoring tab is in an open configuration and tracks over
the guide wire during release; advancing the prosthetic heart valve
over the guide wire to move the distal anchoring tab to the
position behind a native posterior leaflet and to seat the
prosthetic heart valve into the native annulus; withdrawing the
guide wire to a first distal tab release position to release the
distal anchoring tab to the folded position allowing the distal
anchoring tab to capture native leaflet and/or native chordae, and
sandwich the native leaflet and/or chordae between the folded
distal anchoring tab and the outer perimeter wall of the annular
outer support frame; and optionally withdrawing the guide wire to a
second anterior clip release position to release the anterior clip
to an open position allowing the anterior clip to capture native
leaflet and/or native chordae, and sandwich the native leaflet
and/or chordae between the anterior clip and the outer perimeter
wall of the annular outer support frame.
17. The method of claim 16, wherein releasing the prosthetic heart
valve from the delivery catheter is selected from the steps
consisting of: (i) pulling the prosthetic heart valve out of the
delivery catheter using a rigid elongated pushing rod/draw wire
that is releasably connected to a distal side of the prosthetic
heart valve, wherein advancing the pushing rod away from the
delivery catheter pulls the compressed prosthetic heart valve out
of the delivery catheter, or (ii) pushing the prosthetic heart
valve out of the delivery catheter using a rigid elongated pushing
rod that is releasably connected to a proximal side of the
prosthetic heart valve, wherein advancing the pushing rod out of
from the delivery catheter pushes the compressed prosthetic heart
valve out of the delivery catheter.
18. The method of claim 16, comprising the additional step of
anchoring one or more tissue anchors attached to the prosthetic
heart valve into native tissue.
19. The method of claim 16, comprising the additional step of
rotating the prosthetic heart valve using a steerable catheter
along an axis parallel to a plane of the native valve annulus.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] Provided by Application Data Sheet per USPTO rules.
STATEMENT REGARDING FEDERALLY SPONSORED R&D
[0002] Provided by Application Data Sheet per with USPTO rules.
NAMES OF PARTIES TO JOINT RESEARCH AGREEMENT
[0003] Provided by Application Data Sheet per with USPTO rules.
REFERENCE TO SEQUENCE LISTING
[0004] Provided by Application Data Sheet per USPTO rules.
STATEMENT RE PRIOR DISCLOSURES
[0005] Provided by Application Data Sheet per USPTO rules.
BACKGROUND OF THE INVENTION
Field of the Invention
[0006] The invention relates to an extendable A2 clip for a
side-delivered transcatheter mitral valve replacement
(A61F2/2412).
Description of the Related Art
[0007] In 1952 surgeons implanted the first mechanical heart valve,
a ball valve that could only be placed in the descending aorta
instead of the heart itself. For this reason it did not fully
correct the valve problem, only alleviate the symptoms. However it
was a significant achievement because it proved that synthetic
materials could be used to create heart valves.
[0008] In 1960, a new type of valve was invented and was
successfully implanted. This valve is the Starr-Edwards ball valve,
named after its originators. This valve was a modification of
Hufnagel's original valve. The ball of the valve was slightly
smaller and caged from both sides so it could be inserted into the
heart itself.
[0009] The next development was tilting disc technology which was
introduced in the late 1960s. These valves were a great improvement
over the ball designs. The tilting dic technology allowed blood to
flow in a more natural way while reducing damage to blood cells
from mechanical forces. However, the struts of these valves tended
to fracture from fatigue over time. As of 2003, more than 100,000
Omniscience and 300,000 Hall-Kaster/Medtronic-Hall tilting disc
valves were implanted with essentially no mechanical failure.
[0010] In 1977, bi-leaflet heart valves were introduced by St.
Jude. Similar to a native heart valve, blood flows directly through
the center of the annulus of pyrolytic carbon valves mounted within
nickel-titanium housing which makes these valves superior to other
designs. However, a downside of this design is that it allows some
regurgitation. A vast majority of mechanical heart valves used
today have this design. As of 2003, more than 1.3 million St. Jude
valves were deployed and over 500,000 Carbomedics valves with no
failures to leaflets or housing. It should be noted that the human
heart beats about 31 million times per year.
[0011] Development continues with compressible valves that are
delivered via a catheter instead of requiring the trauma and
complications of open heart surgery. This means that a cardiologist
trained in endoscopy can, in theory, deploy a heart valve
replacement during an outpatient procedure. However, transcatheter
valves are often delivered by perforating the apex of the heart to
access the ventricle, and the perforation is often used to anchor
an annular valve replacement.
[0012] Additionally, a problem with stent-style replacement valves
is that they often continue to have the regurgitation or leakage
problems of prior generations of valves, as well as require
expensive materials engineering in order to cope with the 100's of
millions of cycles encountered during just a few years of normal
heart function. Accordingly, there is still a need for alternative
and simpler solutions to addressing valve-related heart
pathologies.
BRIEF SUMMARY OF THE INVENTION
[0013] The present invention is directed to an A2 clip for a
side-delivered prosthetic mitral valve where the A2 clip extends
with or without a guide wire to capture and pin native mitral
leaflet and/or chordae tissue against the subannular sidewall of
the prosthetic valve.
[0014] Use of an side-delivered transcatheter mitral valve
replacement allows a very large diameter valve to be delivered and
deployed from the inferior vena cava trans-septally into the mitral
valve, e.g. has a height of about 5-60 mm and a diameter of about
25-80 mm, without requiring an oversized diameter catheter and
without requiring delivery and deployment from a catheter at an
acute angle of approach.
[0015] Side-delivered mitral valves have a collapsible outer frame
and collapsible inner flow control component that are foldable
along a horizontal axis (z-axis, axis parallel to central axis of
delivery catheter) and compressible along a vertical axis
(y-axis).
[0016] Accordingly, the present invention is directed to a
side-delivered mitral valve having an A2 anterior leaflet anchoring
tab component, comprising:
[0017] (i) a self-expanding annular outer support frame, said
annular support frame having a central channel and an outer
perimeter wall circumscribing a central vertical y-axis in an
expanded configuration, said outer perimeter wall having an
anterior side, a posterior side, a distal side and a proximal
side,
[0018] (ii) an integrated subannular A2 anterior leaflet anchoring
system mounted on the anterior side of the outer perimeter wall,
wherein the system comprises
[0019] an A2 clip sleeve having a pre-loaded A2 clip disposed
within a lumen of the sleeve, the pre-loaded A2 clip comprising an
elongated loop or tab, wherein said A2 clip is compressed or folded
within the sleeve and a distal portion of the A2 clip presses
against the perimeter wall when said A2 clip is compressed or
folded, and wherein said A2 clip is extended or unfolded when
released from the sleeve along the cylindrical axis for capture of
native leaflet or chordae tissue,
[0020] wherein the A2 clip is self-actuated by release of hold-down
element or engages with a guide wire during deployment to an
extended or unfolded position allowing the A2 clip to capture
native leaflet and/or native chordae, and upon withdrawal of the
guide wire, the native leaflet and/or native chordae are sandwiched
between the A2 clip and the perimeter wall of the annular support
frame;
[0021] (iii) a collapsible flow control component mounted within
the annular support frame,
[0022] the outer support frame and the leaflet frame comprising
diamond- or eye-shaped wire cells made from heat-set
[0023] Nitinol and configured to be foldable along a z-axis from a
rounded or cylindrical configuration to a flattened cylinder
configuration having a width of 8-12 mm, and compressible along a
vertical axis y-axis to a shortened configuration having a height
of 8-12 mm,
[0024] the collapsible (inner) flow control component having a
leaflet frame with 2-4 flexible leaflets mounted thereon, wherein
the 2-4 leaflets are configured to permit blood flow in a first
direction through an inflow end of the flow control component and
block blood flow in a second direction, opposite the first
direction, through an outflow end of the flow control
component;
[0025] (iv) a distal anchoring tab mounted on the distal side of
the annular support frame, wherein the tab is an elongated member
attached at a first end to the perimeter wall of the annular
support frame and has an unattached second end that is heat set to
a folded position to press against the perimeter wall, wherein the
tab engages with a guide wire during deployment to an opened
configuration, wherein the tab in the opened configuration tracks
over the guide wire allowing the tab to capture native leaflet
and/or native chordae, and upon withdrawal of the guide wire
releasing the tab to the folded position, the native leaflet and/or
native chordae are sandwiched between the folded tab and the
perimeter wall of the annular support frame;
[0026] wherein the valve is compressible to a compressed
configuration for introduction into the body using a delivery
catheter for implanting at a desired location in the body, said
compressed configuration is oriented along a horizontal x-axis at
an intersecting angle of between 45-135 degrees to the central
vertical y-axis, and expandable to an expanded configuration having
a horizontal x-axis at an intersecting angle of between 45-135
degrees to the central vertical y-axis,
[0027] wherein the horizontal x-axis of the compressed
configuration of the valve is substantially parallel to a
length-wise cylindrical axis of the delivery catheter,
[0028] wherein the valve has a height of about 5-60 mm and a
diameter of about 25-80 mm.
[0029] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the A2 clip has a
radio-opaque marker.
[0030] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the A2 clip comprises
braided polyethylene, treated pericardial tissue, ePTFE, or
Nitinol.
[0031] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the annular support frame
is comprised of a plurality of compressible wire cells having a
orientation and cell geometry substantially orthogonal to the
central vertical axis to minimize wire cell strain when the annular
support frame is configured in a vertical compressed configuration,
a rolled compressed configuration, or a folded compressed
configuration.
[0032] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the annular support frame
has a lower body portion and an upper collar portion, wherein the
lower body portion in an expanded configuration forms a shape
selected from a funnel, cylinder, flat cone, or circular
hyperboloid.
[0033] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein said annular support frame
is comprised of a braided, wire, or laser-cut wire frame, and said
annular support frame is covered with a biocompatible material.
[0034] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the annular support frame
has a side profile of a flat cone shape having a diameter R of
40-80 mm, a diameter r of 20-60 mm, and a height of 5-60 mm.
[0035] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the annular support frame
has an inner surface and an outer surface, said inner surface and
said outer surface covered with a biocompatible material selected
from the following consisting of: the inner surface covered with
pericardial tissue, the outer surface covered with a woven
synthetic polyester material, and both the inner surface covered
with pericardial tissue and the outer surface covered with a woven
synthetic polyester material.
[0036] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the annular support frame
has a side profile of an hourglass shape having a top diameter R1
of 40-80 mm, a bottom diameter R2 of 50-70 mm, an internal diameter
r of 20-60 mm, and a height of 5-60 mm.
[0037] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the valve in an expanded
configuration has a central vertical y-axis that is substantially
parallel to the first direction.
[0038] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the flow control component
has an internal diameter of 20-60 mm and a height of 10-40 mm, and
a plurality of leaflets of pericardial material joined to form a
rounded cylinder at an inflow end and having a flat closable
aperture at an outflow end.
[0039] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the flow control component
is supported with one or more longitudinal supports integrated into
or mounted upon the flow control component, the one or more
longitudinal supports selected from rigid or semi-rigid posts,
rigid or semi-rigid ribs, rigid or semi-rigid battons, rigid or
semi-rigid panels, and combinations thereof.
[0040] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the distal anchoring tab is
comprised of wire loop, a wire frame, a laser cut frame, an
integrated frame section, or a stent, and the distal anchoring tab
extends from about 10-40 mm away from the distal side of the
annular support frame.
[0041] In another preferred embodiment, the invention provides a
valve as described and claimed, further comprising an upper distal
anchoring tab attached to a distal upper edge of the annular
support frame, the upper distal anchoring tab comprised of wire
loop, a wire frame, a laser cut frame, an integrated frame section,
or a stent, and extends from about 2-20 mm away from the annular
support frame.
[0042] In another preferred embodiment, the invention provides a
valve as described and claimed, comprising at least one tissue
anchor connected to the annular support frame for engaging native
tissue.
[0043] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the outer perimeter wall
comprises a front wall portion that is a first flat panel and a
back wall portion that is a second flat panel, and wherein a
proximal fold area and a distal fold area each comprise a sewn
seam, a fabric panel, a rigid hinge, or a flexible fabric span
without any wire cells.
[0044] In another preferred embodiment, the invention provides a
valve as described and claimed, wherein the annular support frame
is comprised of compressible wire cells selected from the group
consisting of braided-wire cells, laser-cut wire cells,
photolithography produced wire cells, 3D printed wire cells, wire
cells formed from intermittently connected single strand wires in a
wave shape, a zig-zag shape, or spiral shape, and combinations
thereof.
[0045] In another preferred embodiment, the invention provides a
method for side delivery of implantable prosthetic mitral valve to
a patient, the method comprising the steps:
[0046] advancing a guide wire trans-septally to the left atrium,
through the annular plane at the A1/P1 commissure, to a position
behind a native P2 leaflet of a mitral valve of the patient;
[0047] advancing the valve of claim 1 in a delivery catheter to the
left atrium of the patient, said valve in a compressed
configuration for side-delivery, wherein the distal anchoring tab
is threaded onto the guide wire, and wherein the A2 clip is
optionally threaded onto the guide wire;
[0048] releasing the prosthetic mitral valve from the delivery
catheter, wherein the tab is in an open configuration and tracks
over the guide wire during release;
[0049] advancing the prosthetic mitral valve over the guide wire to
move the tab to the position behind the native posterior leaflet
and to seat the prosthetic mitral valve into the native
annulus;
[0050] withdrawing the guide wire to a first distal tab release
position to release the distal tab to the folded position allowing
the tab to capture native leaflet and/or native chordae, and
sandwich the native leaflet and/or chordae between the folded tab
and the perimeter wall of the annular support frame; and
optionally
[0051] withdrawing the guide wire to a second A2 clip release
position to release the A2 clip to the open position allowing the
A2 clip to capture native leaflet and/or native chordae, and
sandwich the native leaflet and/or chordae between the A2 clip and
the perimeter wall of the annular support frame.
[0052] In another preferred embodiment, the invention provides a
method as described and claimed, wherein releasing the valve from
the delivery catheter is selected from the steps consisting of: (i)
pulling the valve out of the delivery catheter using a rigid
elongated pushing rod/draw wire that is releasably connected to the
distal side of the valve, wherein advancing the pushing rod away
from the delivery catheter pulls the compressed valve out of the
delivery catheter, or (ii) pushing the valve out of the delivery
catheter using a rigid elongated pushing rod that is releasably
connected to the proximal side of the valve, wherein advancing the
pushing rod out of from the delivery catheter pushes the compressed
valve out of the delivery catheter.
[0053] In another preferred embodiment, the invention provides a
method as described and claimed, comprising the additional step of
anchoring one or more tissue anchors attached to the valve into
native tissue.
[0054] In another preferred embodiment, the invention provides a
valve as described and claimed, comprising the additional step of
rotating the heart valve prosthesis using a steerable catheter
along an axis parallel to the plane of the valve annulus.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF DRAWING
[0055] FIG. 1 is an illustration of a SIDE PERSPECTIVE view of a
sidely deliverable transcatheter heart valve with an extendable
self-contracting distal anchoring tab. FIG. 1 shows collapsible
flow control component mounted within the annular outer support
frame, the collapsible (inner) flow control component having
leaflet frame with 2-4 flexible leaflets mounted thereon, the
leaflet frame foldable along a z-axis from a cylindrical
configuration to a flattened cylinder configuration and
compressible along a vertical axis (y-axis) to a shortened
configuration, according to the invention.
[0056] FIG. 2 is an illustration of a top view of a native mitral
valve showing approximate locations of leaflet areas A1-A2-A3 and
P1-P2-P3.
[0057] FIG. 3 is an illustration of a side perspective view of a
valve having an A2 clip in the folded position.
[0058] FIG. 4 is an illustration of a side perspective view of a
valve having an A2 clip in the extended position.
[0059] FIG. 5 is an illustration of a side perspective view of a
valve having an A2 clip in the re-folded position after capturing
anterior leaflet and/or chordae tissue, especially the A2
leaflet.
[0060] FIG. 6 (a)-(d) is an illustration of an A2 clip in a pocket
or sleeve that would be mounted on the perimeter wall of the outer
frame. FIG. 6(a) shows an A2 clip stowed in the pocket before
deployment. FIG. 6(b) shows an A2 clip extended in an ventricular
direction along the central axis. FIG. 6(c) shows an A2 clip
completely unfolded for capturing anterior tissue. FIG. 6(d) shows
a retracted, re-folded A2 clip in a position after capture of
tissue where the tissue (not shown) is pinned against the perimeter
wall of the outer frame.
[0061] FIG. 7(a)-(h) is an illustration of a variety of anchor loop
configurations contemplated for use as a distal portion of the A2
clip.
[0062] FIG. 8 is an illustration of a TOP view of a mitral valve
and shows guide wire directing the replacement valve to the A1
leaflet with the valve in a compressed intra-catheter
configuration, according to the invention.
[0063] FIG. 9 is an illustration of a TOP view of a mitral valve
and prosthetic valve with an overwire tab positioning the valve
into the A1 area, and the valve in a partial deployment stage being
partially expelled, according to the invention.
[0064] FIG. 10 is an illustration of a TOP PERSPECTIVE view of a
prosthetic valve that is fully expelled and positioned temporarily
at an upwards angle with a distal anchoring tab in the A1 area, and
a proximal collar above the mitral valve allowing for the new
prosthetic valve to engage the blood flow while the native mitral
valve continues to operate, just prior to the proximal side being
shoe-horned into place, for a non-traumatic transition from native
valve to prosthetic valve, according to the invention.
[0065] FIG. 11 is an illustration of a TOP view of a prosthetic
valve deployed in the native annulus (not visible--in dashed line),
according to the invention.
[0066] FIG. 12 is an illustration of a SIDE PERSPECTIVE view of a
prosthetic valve deployed in the native annulus (not visible) with
an A2 clip in the extended position, according to the
invention.
[0067] FIG. 13 is an illustration of a SIDE PERSPECTIVE view of an
embodiment of a prosthetic valve having an A2 clip integrated into
the sidewall of the A2 facing side of the outer frame of the valve
with the A2 clip in the retracted position, according to the
invention.
[0068] FIG. 14(a)-(c) is a series of illustration showing capture
of the native tissue by the extendable self-contracting tab. FIG.
14(a) shows part 1 of a sequence of a distal tab tracking over the
guide wire. FIG. 14(b) shows part 2 of a sequence showing
withdrawal of the guide wire and self-contracting curvature of the
distal tab.
[0069] FIG. 14(c) shows the distal tab pulling the native tissue
against the outer wall of the prosthetic valve. FIG. 14(d) shows
completed capture of the native tissue and anchoring of the
valve.
[0070] FIG. 15 is an illustration of a TOP view of a
side-deliverable valve having the distal tab/securement arm, and
additional anchoring elements.
[0071] FIG. 16 is an illustration of a SIDE PERSPECTIVE view of an
exploded view of an embodiment having three leaflet cusp or pockets
mounted within a foldable and compressible inner wire frame, the
inner is mounted within an outer wire frame which has a collar
component attached circumferentially at a top edge of the outer
wire frame, an integrated A2 clip, a distal tab component, and a
mesh component, according to the invention.
[0072] FIG. 17 is an illustration of a SIDE PERSPECTIVE view of a
side deliverable transcatheter heart valve with an integrated A2
clip in a folded configuration along the z-axis (front to back when
viewed from the broader side) according to the invention.
[0073] FIG. 18 is an illustration of a SIDE PERSPECTIVE view of a
side deliverable transcatheter heart valve in a vertically
compressed configuration according to the invention.
[0074] FIG. 19 is an illustration of a SIDE PERSPECTIVE view of a
side deliverable transcatheter heart valve with an integrated A2
clip, partially loaded into a delivery catheter, according to the
invention.
[0075] FIG. 20 is an illustration of an END view of a delivery
catheter showing the loaded valve, according to the invention.
[0076] FIG. 21 is an illustration of a TOP view of the folded,
compressed valve being expelled from the delivery catheter, in a
partial position to allow expansion of the leaflets and the inner
frame prior to seating in the native annulus.
[0077] FIG. 22 is an illustration of a TOP PERSPECTIVE view of an
inner leaflet frame in a cylinder configuration, shown at the
beginning of a process permitting folding and compression of the
inner frame, according to the invention.
[0078] FIG. 23 is an illustration of a TOP PERSPECTIVE view of an
inner leaflet frame in a partially folded configuration with the
wireframe sidewalls rotating or hinging at their lateral connection
points, shown as a partial first step in a process permitting
folding and compression of the inner frame, according to the
invention.
[0079] FIG. 24 is an illustration of a SIDE view of an inner
leaflet frame in a completely folded configuration with the
wireframe sidewalls rotated or hinged at their lateral connection
points, shown as a completed first step in a process permitting
folding and compression of the inner frame, according to the
invention.
[0080] FIG. 25 is an illustration of a SIDE view of an inner
leaflet frame in a folded and vertically compressed configuration
with the wireframe sidewalls vertically compressed in a pleated or
accordion configuration, shown as a second step in a process
permitting folding and compression of the inner frame, according to
the invention.
[0081] FIG. 26 is an illustration of a SIDE view of an inner
leaflet frame as a linear wireframe sheet before further assembly
into a cylinder structure, according to the invention.
[0082] FIG. 27 is an illustration of a SIDE PERSPECTIVE view of an
inner leaflet frame in a cylinder or cylinder-like (conical, etc)
configuration, according to the invention.
[0083] FIG. 28 is an illustration of a SIDE PERSPECTIVE view of a
band of percardial tissue that is configured in a cylinder shape
with leaflet pockets sewn into a structural band, according to the
invention.
[0084] FIG. 29 is an illustration of a SIDE view of a band of
percardial tissue with leaflet pockets sewn into a structural band,
before assembly into a cylindrical leaflet component and mounting
on an inner frame to form a collapsible (foldable, compressible)
flow control component, according to the invention.
[0085] FIG. 30 is an illustration of a BOTTOM view of a band of
percardial tissue with leaflet pockets sewn into a structural band,
before assembly into a cylindrical leaflet component and mounting
on an inner frame to form a collapsible (foldable, compressible)
flow control component, according to the invention.
[0086] FIG. 31 is an illustration of a SIDE PERSPECTIVE view of
part of a band of percardial tissue with a single leaflet pocket
sewn into a structural band, showing an open bottom edge and a
sewn, closed top parabolic edge, according to the invention.
[0087] FIG. 32 is an illustration of a BOTTOM view of a cylindrical
leaflet component showing partial coaptation of the leaflets to
form a closed fluid-seal, according to the invention.
[0088] FIG. 33 is an illustration of a TOP PERSPECTIVE view of an
outer frame with an integrated A2 clip in a partially folded
configuration with the wireframe sidewalls rotating or hinging at
their lateral connection points, shown as a partial first step in a
process permitting folding and compression of the inner frame,
according to the invention.
[0089] FIG. 34 is an illustration of a SIDE view of an outer frame
with an integrated A2 clip in a completely folded flat
configuration with the wireframe sidewalls rotated or hinged at
their lateral connection points, shown as a completed first step in
a process permitting folding and compression of the inner frame,
according to the invention.
[0090] FIG. 35 is an illustration of a SIDE view of an outer frame
with an integrated A2 clip in a folded and vertically compressed
configuration with the wireframe sidewalls vertically compressed in
a pleated or accordion configuration, shown as a second step in a
process permitting folding and compression of the inner frame,
according to the invention.
[0091] FIG. 36 is an illustration of a TOP view of a valve
partially expelled from a delivery catheter, with a distal tab
leading the valve (along guide wire not shown) to the deployment
location, with distal flow control component beginning to open and
showing two of three leaflets opening from a folded, lie-flat
configuration with the third leaflet opening from a folded
configuration where it is folded back on itself when in the
delivery catheter, according to the invention.
[0092] FIG. 37 is an illustration of a TOP view of a valve
compressed (orthogonally loaded, or loaded for side-delivery)
within a delivery catheter with a first tab extending forward along
a x-axis and a second trailing tab extending backwards along the
x-axis, according to the invention.
[0093] FIG. 38 is an illustration of an embodiment having multiple
anterior side extendable clips mounted on the anterior-facing
perimeter sidewall of the outer frame.
[0094] FIG. 39 is an illustration showing a process of using a
distal tab and an A2 clip to capture native tissue, according to
the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0095] The invention is directed to a dual-tab transcatheter heart
valve replacement that is a low profile, side delivered implantable
prosthetic heart valve having an ring-shaped or annular support
frame, an inner 2- or 3-panel sleeve, and an elongated sub-annular
distal anchoring tab extending around and capturing the posterior
leaflet.
[0096] The embodiments herein and the various features and
advantageous details thereof are explained more fully with
reference to the non-limiting embodiments that are illustrated in
the accompanying drawings and detailed in the following
description. Descriptions of well-known components and processing
techniques are omitted so as to not unnecessarily obscure the
embodiments herein. The examples used herein are intended merely to
facilitate an understanding of ways in which the embodiments herein
may be practiced and to further enable those of skill in the art to
practice the embodiments herein. Accordingly, the examples should
not be construed as limiting the scope of the embodiments
herein.
[0097] Rather, these embodiments are provided so that this
disclosure will be thorough and complete, and will fully convey the
scope of the invention to those skilled in the art. Like numbers
refer to like elements throughout. As used herein the term "and/or"
includes any and all combinations of one or more of the associated
listed items.
[0098] The terminology used herein is for the purpose of describing
particular embodiments only and is not intended to limit the full
scope of the invention. As used herein, the singular forms "a",
"an" and "the" are intended to include the plural forms as well,
unless the context clearly indicates otherwise. It will be further
understood that the terms "comprises" and/or "comprising," when
used in this specification, specify the presence of stated
features, integers, steps, operations, elements, and/or components,
but do not preclude the presence or addition of one or more other
features, integers, steps, operations, elements, components, and/or
groups thereof.
[0099] Unless defined otherwise, all technical and scientific terms
used herein have the same meanings as commonly understood by one of
ordinary skill in the art. Nothing in this disclosure is to be
construed as an admission that the embodiments described in this
disclosure are not entitled to antedate such disclosure by virtue
of prior invention. As used in this document, the term "comprising"
means "including, but not limited to."
[0100] Many modifications and variations can be made without
departing from its spirit and scope, as will be apparent to those
skilled in the art. Functionally equivalent methods and apparatuses
within the scope of the disclosure, in addition to those enumerated
herein, will be apparent to those skilled in the art from the
foregoing descriptions. Such modifications and variations are
intended to fall within the scope of the appended claims. The
present disclosure is to be limited only by the terms of the
appended claims, along with the full scope of equivalents to which
such claims are entitled. It is to be understood that this
disclosure is not limited to particular methods, reagents,
compounds, compositions or biological systems, which can, of
course, vary. It is also to be understood that the terminology used
herein is for the purpose of describing particular embodiments
only, and is not intended to be limiting.
[0101] With respect to the use of substantially any plural and/or
singular terms herein, those having skill in the art can translate
from the plural to the singular and/or from the singular to the
plural as is appropriate to the context and/or application. The
various singular/plural permutations may be expressly set forth
herein for sake of clarity.
[0102] It will be understood by those within the art that, in
general, terms used herein, and especially in the appended claims
(e.g., bodies of the appended claims) are generally intended as
"open" terms (e.g., the term "including" should be interpreted as
"including but not limited to," the term "having" should be
interpreted as "having at least," the term "includes" should be
interpreted as "includes but is not limited to," etc.). It will be
further understood by those within the art that virtually any
disjunctive word and/or phrase presenting two or more alternative
terms, whether in the description, claims, or drawings, should be
understood to contemplate the possibilities of including one of the
terms, either of the terms, or both terms. For example, the phrase
"A or B" will be understood to include the possibilities of "A" or
"B" or "A and B."
[0103] In addition, where features or aspects of the disclosure are
described in terms of Markush groups, those skilled in the art will
recognize that the disclosure is also thereby described in terms of
any individual member or subgroup of members of the Markush
group.
[0104] As will be understood by one skilled in the art, for any and
all purposes, such as in terms of providing a written description,
all ranges disclosed herein also encompass any and all possible
subranges and combinations of subranges thereof. Any listed range
can be easily recognized as sufficiently describing and enabling
the same range being broken down into at least equal subparts. As
will be understood by one skilled in the art, a range includes each
individual member.
Definitions
[0105] Side-Delivery or Orthogonal Delivery
[0106] In the description and claims herein, the terms
"side-delivered", "side-delivery", "orthogonal", "orthogonally
delivered" and so forth are used to describe that the valves of the
present invention are compressed and delivered at a roughly 90
degree angle compared to traditional transcatheter heart valves.
Orthogonal delivery is a transverse delivery where a perimeter
distal sidewall exits the delivery catheter first, followed by the
central aperture, followed by the proximal sidewall.
[0107] Traditional valves have a central cylinder axis that is
parallel to the length-wise axis of the delivery catheter and are
deployed from the end of the delivery catheter and expanded
radially outward from the central annular axis, in a manner akin to
pushing a closed spring-loaded umbrella out of a sleeve to make it
spring open. However, the valves of the present invention are
compressed and delivered in a sideways manner. To begin with the
shape of the expanded valve is that of a large diameter shortened
cylinder with an extended collar or cuff. The valves are
compressed, in one preferred embodiment, where the central axis of
the valve is roughly perpendicular to (orthogonal to) the
length-wise axis of the delivery catheter. In one preferred
embodiment, the valves are compressed vertically, similar to
collapsing the height of a cylinder accordion-style from taller to
shorter, and the valves are also compressed by folding a front
panel against a back panel. In another preferred embodiment, the
valves may be compressed by rolling.
[0108] Traditional valves can only be expanded as large as what the
internal diameter of the delivery catheter will allow. Efforts to
increase the expanded diameter of traditional valves have run into
the problems of trying to compress too much material and structure
into too little space.
[0109] Mathematically, the term orthogonal refers to an
intersecting angle of 90 degrees between two lines or planes. As
used, herein the term "substantially orthogonal" refers to an
intersecting angle ranging from 75 to 105 degrees. The intersecting
angle or orthogonal angle refers to both (i) the relationship
between the length-wise cylindrical axis of the delivery catheter
and the long-axis of the compressed valve of the invention, where
the long-axis is perpendicular to the central cylinder axis of
traditional valves, and (ii) the relationship between the long-axis
of the compressed or expanded valve of the invention and the axis
defined by the blood flow through the prosthetic heart valve where
the blood is flowing, eg. from one part of the body or chamber of
the heart to another downstream part of the body or chamber of the
heart, such as from an atrium to a ventricle through a native
annulus.
[0110] Transcatheter
[0111] In the description and claims herein, the term
"transcatheter" is used to define the process of accessing,
controlling, and delivering a medical device or instrument within
the lumen of a catheter that is deployed into a heart chamber, as
well as an item that has been delivered or controlled by such as
process. Transcatheter access is known to include via femoral
artery and femoral vein, via brachial artery and vein, via carotid
and jugular, via intercostal (rib) space, and via sub-xyphoid.
Transcatheter can be synonymous with transluminal and is
functionally related to the term "percutaneous" as it relates to
delivery of heart valves.
[0112] In preferred embodiments of the invention, the transcatheter
approach includes (i) advancing to the mitral valve or pulmonary
artery of the heart through the inferior vena cava via the femoral
vein, (ii) advancing to the mitral valve or pulmonary artery of the
heart through the superior vena cava via the jugular vein, (iii)
advancing to the mitral valve of the heart through a trans-atrial
approach, e.g. fossa ovalis or lower, via the IVC-femoral or the
SVC-jugular approach.
[0113] Annular Support Frame
[0114] In the description and claims herein, the term "annular
support frame", and also "wire frame" or "flange or "collar" refers
to a three-dimensional structural component that is seated within a
native valve annulus and is used as a mounting element for a
leaflet structure, a flow control component, or a flexible
reciprocating sleeve or sleeve-valve.
[0115] In a preferred embodiment, the annular support frame is a
self-expanding annular support frame, having a central channel and
an outer perimeter wall circumscribing a central vertical axis in
an expanded configuration. The perimeter wall encompasses both the
collar and the lower body portions.
[0116] The perimeter wall can be further defined as having a front
wall portion and a back wall portion, which are connected along a
near side (to the IVC) or proximal side to a proximal fold area,
and connected along a far or distal side to a distal fold area.
[0117] This front wall portion can be further defined as having a
front upper collar portion and a front lower body portion, and the
the back wall portion can be further defined as having a back upper
collar portion and a back lower body portion.
[0118] The annular (outer) support frame has a flow control
component mounted within the annular support frame and configured
to permit blood flow in a first direction through an inflow end of
the valve and block blood flow in a second direction, opposite the
first direction, through an outflow end of the valve.
[0119] Since the outer frame is preferably made of superelastic
metal or alloy such as Nitinol, the frame is compressible.
Preferably, the outer frame is constructed of a plurality of
compressible wire cells having a orientation and cell geometry
substantially orthogonal to the central vertical axis to minimize
wire cell strain when the annular support frame when configured in
a vertical compressed configuration, a rolled compressed
configuration, or a folded compressed configuration.
[0120] Annular Support Frame Structure
[0121] The annular support frame can be a ring, or cylindrical or
conical tube, made from a durable, biocompatible structural
material such as Nitinol or similar alloy, wherein the annular
support frame is formed by manufacturing the structural material as
a braided wire frame, a laser-cut wire frame, or a wire loop. The
annular support frame is about 5-60 mm in height, has an outer
diameter dimension, R, of 30-80 mm, and an inner diameter dimension
of 31-79 mm, accounting for the thickness of the wire material
itself. As stated, the annular support frame can have a
side-profile of a ring shape, cylinder shape, conical tube shape,
but may also have a side profile of a flat-cone shape, an inverted
flat-cone shape (narrower at top, wider at bottom), a concave
cylinder (walls bent in), a convex cylinder (walls bulging out), an
angular hourglass, a curved, graduated hourglass, a ring or
cylinder having a flared top, flared bottom, or both. In one
preferred embodiment, the annular support frame used in the
prosthetic heart valve deployed in the mitral annulus may have a
complex shape determined by the anatomical structures where the
valve is being mounted. For example, in the mitral annulus, the
circumference of the mitral valve may be a rounded ellipse, the
septal wall is known to be substantially vertical, and the mitral
is known to enlarge in disease states. Accordingly, a prosthetic
heart valve may start in a roughly tubular configuration, and be
heat-shaped to provide an upper atrial cuff or flange for atrial
sealing and a lower trans-annular tubular or cylindrical section
having an hourglass cross-section for about 60-80% of the
circumference to conform to the native annulus along the posterior
and anterior annular segments while remaining substantially
vertically flat along 20-40% of the annular circumference to
conform to the septal annular segment.
[0122] Annular Support Frame Covering
[0123] The annular support frame is optionally internally or
externally covered, partially or completely, with a biocompatible
material such as pericardium. The annular support frame may also be
optionally externally covered, partially or completely, with a
second biocompatible material such as polyester or Dacron.RTM..
[0124] Annular Support Frame Purpose
[0125] The annular support frame has a central axial lumen where a
prosthetic heart valve or flow-control structure, such as a
reciprocating compressible sleeve, is mounted across the diameter
of the lumen. The annular support frame is also tensioned against
the inner aspect of the native annulus and provides structural
patency to a weakened annular ring.
[0126] Annular Support Frame Optional Collars
[0127] The annular support frame may optionally have a separate
atrial collar attached to the upper (atrial) edge of the frame, for
deploying on the atrial floor, that is used to direct blood from
the atrium into the sleeve and to seal against blood leakage around
the annular support frame. The annular support frame may also
optionally have a separate ventricular collar attached to the lower
(ventricular) edge of the frame, for deploying in the ventricle
immediately below the native annulus that is used to prevent
regurgitant leakage during systole, to prevent dislodging of the
device during systole, to sandwich or compress the native annulus
or adjacent tissue against the atrial collar, and optionally to
attach to and support the sleeve/conduit.
[0128] Annular Support Frame Delivery
[0129] The annular support frame may be compressed for
transcatheter delivery and may be expandable as a self-expandable
shape-memory element or using a transcatheter expansion balloon.
Some embodiments may have both an atrial collar and a ventricular
collar, whereas other embodiments within the scope of the invention
include prosthetic heart valves having either a single atrial
collar, a single ventricular collar, or having no additional collar
structure.
[0130] Frame Material
[0131] Preferably, the frame is made from a superelastic metal
component, such as laser-cut Nitinol tube, or flat sheet or other
similarly functioning material such as braided wire. The material
may be used for the frame/stent, for the collar, and/or for
anchors. It is contemplated as within the scope of the invention to
use other shape memory alloys, as well as polymer composites
including composites containing carbon nanotubes, carbon fibers,
metal fibers, glass fibers, and polymer fibers. It is contemplated
that the frame may be constructed as a braid, wire, or laser cut
frame. Laser cut frames are preferably made from Nitinol, but also
without limitation made from stainless steel, cobalt chromium,
titanium, and other functionally equivalent metals and alloys.
[0132] One key aspect of the frame design is that it be
compressible and when released have the stated property that it
returns to its original (uncompressed) shape. This requirement
limits the potential material selections to metals and plastics
that have shape memory properties. With regards to metals, Nitinol
has been found to be especially useful since it can be processed to
be austenitic, martensitic or super elastic. Martensitic and super
elastic alloys can be processed to demonstrate the required
mechanical behavior.
[0133] Laser Cut
[0134] One possible construction of the wire frame envisions the
laser cutting of a thin, isodiametric Nitinol tube. The laser cuts
form regular cutouts in the thin Nitinol tube. In one preferred
embodiment, the Nitinol tube expands to form a three-dimensional
structure formed from diamond-shaped cells. The structure may also
have additional functional elements, e.g. loops, anchors, etc. for
attaching accessory components such as biocompatible covers, tissue
anchors, releasable deployment and retrieval control guides, knobs,
attachments, rigging, and so forth.
[0135] Secondarily the tube is thermo-mechanically processed using
industry standard Nitinol shape forming methods. The treatment of
the wire frame in this manner will form a device that has shape
memory properties and will readily revert to the memory shape once
deployed.
[0136] Braided Wire
[0137] Another possible construction of the wire frame envisions
utilizing simple braiding techniques using a Nitinol wire and a
simple braiding fixture. The wire is wound on the braiding fixture
in a pattern until an isodiametric tube is formed. Secondarily, the
braided wire frame is placed on a shaping fixture and processed
using industry standard
[0138] Nitinol Shape Forming Methods.
[0139] Flow Control Component
[0140] In the description and claims herein, the term "flow control
component" refers in a non-limiting sense to a leaflet structure
having 2-, 3-, 4-leaflets of flexible biocompatible material such a
treated or untreated pericardium that is sewn or joined to a
annular support frame, to function as a prosthetic heart valve.
Such a valve can be a heart valve, such as a tricuspid, mitral,
aortic, or pulmonary, that is open to blood flowing during diastole
from atrium to ventricle, and that closes from systolic ventricular
pressure applied to the outer surface. Repeated opening and closing
in sequence can be described as "reciprocating".
[0141] Tissue Anchor
[0142] In the description and claims herein, the term "tissue
anchor" or "plication tissue anchor" or "secondary tissue anchor",
or "dart" or "pin" refers to a fastening device that connects the
upper atrial frame to the the native annular tissue, usually at or
near the periphery of the collar. The anchor may be positioned to
avoid piercing tissue and just rely on the compressive force of the
two plate-like collars on the captured tissue, or the anchor,
itself or with an integrated securement wire, may pierce through
native tissue to provide anchoring, or a combination of both. The
anchor may have a specialized securement mechanism, such as a
pointed tip with a groove and flanged shoulder that is inserted or
popped into a mated aperture or an array of mated apertures that
allow the anchor to attach, but prevent detachment when the
aperture periphery locks into the groove near the flanged shoulder.
The securement wire may be attached or anchored to the collar
opposite the pin by any attachment or anchoring mechanisms,
including a knot, a suture, a wire crimp, a wire lock having a cam
mechanism, or combinations.
[0143] Support Post
[0144] The term "support post" refers to a rigid or semi-rigid
length of material such as Nitinol or PEEK, that may be mounted on
a spoked frame and that runs axially, or down the center of, or
within a sewn seam of--, the flexible sleeve. The sleeve may be
unattached to the support post, or the sleeve may be directly or
indirectly attached to the support post.
[0145] In the description that follows, the term "body channel" is
used to define a blood conduit or vessel within the body. Of
course, the particular application of the prosthetic heart valve
determines the body channel at issue. An aortic valve replacement,
for example, would be implanted in, or adjacent to, the aortic
annulus. Likewise, a tricuspid or mitral valve replacement will be
implanted at the tricuspid or mitral annulus. Certain features of
the present invention are particularly advantageous for one
implantation site or the other. However, unless the combination is
structurally impossible, or excluded by claim language, any of the
heart valve embodiments described herein could be implanted in any
body channel.
[0146] The term "lumen" refers to the inside of the cylinder tube.
The term "bore" refers to the inner diameter.
[0147] Displacement--The volume of fluid displaced by one complete
stroke or revolution.
[0148] Ejection fraction is a measurement of the percentage of
blood leaving your heart each time it contracts. During each
heartbeat pumping cycle, the heart contracts and relaxes. When your
heart contracts, it ejects blood from the two pumping chambers
(ventricles).
[0149] As a point of further definition, the term "expandable" is
used herein to refer to a component of the heart valve capable of
expanding from a first, delivery diameter to a second, implantation
diameter. An expandable structure, therefore, does not mean one
that might undergo slight expansion from a rise in temperature, or
other such incidental cause. Conversely, "non-expandable" should
not be interpreted to mean completely rigid or a dimensionally
stable, as some slight expansion of conventional "non-expandable"
heart valves, for example, may be observed.
[0150] Prosthetic Heart Valve
[0151] The term prosthesis or prosthetic encompasses both complete
replacement of an anatomical part, e.g. a new mechanical valve
replaces a native valve, as well as medical devices that take the
place of and/or assist, repair, or improve existing anatomical
parts, e.g. native valve is left in place. For mounting within a
passive assist cage, the invention contemplates a wide variety of
(bio)prosthetic artificial heart valves. Contemplated as within the
scope of the invention are ball valves (e.g. Starr-Edwards),
bileaflet valves (St. Jude), tilting disc valves (e.g.
Bjork-Shiley), stented pericardium heart-valve prosthesis' (bovine,
porcine, ovine) (Edwards line of bioprostheses, St. Jude prosthetic
heart valves), as well as homograft and autograft valves. For
bioprosthetic pericardial valves, it is contemplated to use
bioprosthetic aortic valves, bioprosthetic mitral valves,
bioprosthetic mitral valves, and bioprosthetic pulmonary
valves.
[0152] Tethers--
[0153] The tethers are made from surgical-grade materials such as
biocompatible polymer suture material. Non-limiting examples of
such material include ultra high-molecular weight polyethylene
(UHMWPE), 2-0 exPFTE(polytetrafluoroethylene) or 2-0 polypropylene.
In one embodiment the tethers are inelastic. It is also
contemplated that one or more of the tethers may optionally be
elastic to provide an even further degree of compliance of the
valve during the cardiac cycle.
[0154] Tines--Anchors--Tines/Barbs
[0155] The device can be seated within the valvular annulus through
the use of tines or barbs. These may be used in conjunction with,
or in place of one or more tethers. The tines or barbs are located
to provide attachment to adjacent tissue. Tines are forced into the
annular tissue by mechanical means such as using a balloon
catheter. In one non-limiting embodiment, the tines may optionally
be semi-circular hooks that upon expansion of the wire frame body,
pierce, rotate into, and hold annular tissue securely. Anchors are
deployed by over-wire delivery of an anchor or anchors through a
delivery catheter. The catheter may have multiple axial lumens for
delivery of a variety of anchoring tools, including anchor setting
tools, force application tools, hooks, snaring tools, cutting
tools, radio-frequency and radiological visualization tools and
markers, and suture/thread manipulation tools. Once the anchor(s)
are attached to the moderator band, tensioning tools may be used to
adjust the length of tethers that connect to an implanted valve to
adjust and secure the implant as necessary for proper functioning.
It is also contemplated that anchors may be spring-loaded and may
have tether-attachment or tether-capture mechanisms built into the
tethering face of the anchor(s). Anchors may also have in-growth
material, such as polyester fibers, to promote in-growth of the
anchors into the myocardium.
[0156] In one embodiment, where a prosthetic heart valve may or may
not include a ventricular collar, the anchor or dart is not
attached to a lower ventricular collar, but is attached directly
into annular tissue or other tissue useful for anchoring.
[0157] Tube and/or Cover Material--Biological Tissue--
[0158] The tissue used herein is a biological tissue that is a
chemically stabilized pericardial tissue of an animal, such as a
cow (bovine pericardium) or sheep (ovine pericardium) or pig
(porcine pericardium) or horse (equine pericardium). Preferably,
the tissue is bovine pericardial tissue. Examples of suitable
tissue include that used in the products Duraguard.RTM.,
Peri-Guard.RTM., and Vascu-Guard.RTM., all products currently used
in surgical procedures, and which are marketed as being harvested
generally from cattle less than 30 months old. Other patents and
publications disclose the surgical use of harvested, biocompatible
animal thin tissues suitable herein as biocompatible "jackets" or
sleeves for implantable stents, including for example, U.S. Pat.
No. 5,554,185 to Block, U.S. Pat. No. 7,108,717 to Design &
Performance-Cyprus Limited disclosing a covered stent assembly,
U.S. Pat. No. 6,440,164 to Scimed Life Systems, Inc. disclosing a
bioprosthetic heart valve for implantation, and U.S. Pat. No.
5,336,616 to LifeCell Corporation discloses acellular
collagen-based tissue matrix for transplantation.
[0159] Polymers
[0160] In one preferred embodiment, the conduit may optionally be
made from a synthetic material such a polyurethane or
polytetrafluoroethylene.
[0161] Where a thin, durable synthetic material is contemplated,
e.g. for a covering, synthetic polymer materials such expanded
polytetrafluoroethylene or polyester may optionally be used. Other
suitable materials may optionally include thermoplastic
polycarbonate urethane, polyether urethane, segmented polyether
urethane, silicone polyether urethane, silicone-polycarbonate
urethane, and ultra-high molecular weight polyethylene. Additional
biocompatible polymers may optionally include polyolefins,
elastomers, polyethylene-glycols, polyethersulphones,
polysulphones, polyvinylpyrrolidones, polyvinylchlorides, other
fluoropolymers, silicone polyesters, siloxane polymers and/or
oligomers, and/or polylactones, and block co-polymers using the
same.
[0162] Polyamides (PA)
[0163] PA is an early engineering thermoplastic invented that
consists of a "super polyester" fiber with molecular weight greater
than 10,000. It is commonly called Nylon. Application of polyamides
includes transparent tubing's for cardiovascular applications,
hemodialysis membranes, and also production of percutaneous
transluminal coronary angioplasty (PTCA) catheters.
[0164] Polyolefin
[0165] Polyolefins include polyethylene and polypropylene are the
two important polymers of polyolefins and have better
biocompatibility and chemical resistance. In cardiovascular uses,
both low-density polyethylene and high-density polyethylene are
utilized in making tubing and housings. Polypropylene is used for
making heart valve structures
[0166] Polyesters
[0167] Polyesters includes polyethylene-terephthalate (PET), using
the name Dacron. It is typically used as knitted or woven fabric
for vascular grafts. Woven PET has smaller pores which reduces
blood leakage and better efficiency as vascular grafts compared
with the knitted one. PET grafts are also available with a protein
coating (collagen or albumin) for reducing blood loss and better
biocompatibility [39]. PET vascular grafts with endothelial cells
have been searched as a means for improving patency rates.
Moreover, polyesters are widely preferred material for the
manufacturing of bioabsorbable stents. Poly-L-lactic acids (PLLA),
polyglycolic acid (PGA), and poly(D, L-lactide/glycolide) copolymer
(PDLA) are some of the commonly used bioabsorbable polymers.
[0168] Polytetrafluoroethylene
[0169] Polytetrafluoroethylene (PTFE) is synthetic fluorocarbon
polymer with the common commercial name of Teflon by Dupont Co.
Common applications of PTFE in cardiovascular engineering include
vascular grafts and heart valves. PTFE sutures are used in the
repair of mitral valve for myxomatous disease and also in surgery
for prolapse of the anterior or posterior leaflets of mitral
valves. PTFE is particularly used in implantable prosthetic heart
valve rings. It has been successfully used as vascular grafts when
the devices are implanted in high-flow, large-diameter arteries
such as the aorta. Problem occurs when it is implanted below aortic
bifurcations and another form of PTFE called elongated-PTFE
(e-PTFE) was explored. Expanded PTFE is formed by compression of
PTFE in the presence of career medium and finally extruding the
mixture. Extrudate formed by this process is then heated to near
its glass transition temperature and stretched to obtain
microscopically porous PTFE known as e-PTFE. This form of PTFE was
indicated for use in smaller arteries with lower flow rates
promoting low thrombogenicity, lower rates of restenosis and
hemostasis, less calcification, and biochemically inert
properties.
[0170] Polyurethanes
[0171] Polyurethane has good physiochemical and mechanical
properties and is highly biocompatible which allows unrestricted
usage in blood contacting devices. It has high shear strength,
elasticity, and transparency. Moreover, the surface of polyurethane
has good resistance for microbes and the thrombosis formation by PU
is almost similar to the versatile cardiovascular biomaterial like
PTFE. Conventionally, segmented polyurethanes (SPUs) have been used
for various cardiovascular applications such as valve structures,
pacemaker leads and ventricular assisting device.
[0172] Covered Wire Frame Materials
[0173] Drug-eluting wire frames are contemplated for use herein.
DES basically consist of three parts: wire frame platform, coating,
and drug. Some of the examples for polymer free DES are Amazon Pax
(MINVASYS) using Amazonia CroCo (L605) cobalt chromium (Co--Cr)
wire frame with Paclitaxel as an antiproliferative agent and
abluminal coating have been utilized as the carrier of the drug.
BioFreedom (Biosensors Inc.) using stainless steel as base with
modified abluminal coating as carrier surface for the
antiproliferative drug Biolimus A9. Optima (CID S.r.I.) using 316 L
stainless steel wire frame as base for the drug Tacrolimus and
utilizing integrated turbostratic carbofilm as the drug carrier.
VESTA sync (MIV Therapeutics) using GenX stainless steel (316 L) as
base utilizing microporous hydroxyapatite coating as carrier for
the drug Sirolimus. YUKON choice (Translumina) used 316 L stainless
steel as base for the drugs Sirolimus in combination with
Probucol.
[0174] Biosorbable polymers may also be used herein as a carrier
matrix for drugs. Cypher, Taxus, and Endeavour are the three basic
type of bioabsorbable DES. Cypher (J&J, Cordis) uses a 316 L
stainless steel coated with polyethylene vinyl acetate (PEVA) and
poly-butyl methacrylate (PBMA) for carrying the drug Sirolimus.
Taxus (Boston Scientific) utilizes 316 L stainless steel wire
frames coated with translute Styrene Isoprene Butadiene (SIBS)
copolymer for carrying Paclitaxel which elutes over a period of
about 90 days. Endeavour (Medtronic) uses a cobalt chrome driver
wire frame for carrying zotarolimus with phosphorylcholine as drug
carrier. BioMatrix employing S-Wire frame (316 L) stainless steel
as base with polylactic acid surface for carrying the
antiproliferative drug Biolimus. ELIXIR-DES program (Elixir Medical
Corp) consisting both polyester and polylactide coated wire frames
for carrying the drug novolimus with cobalt-chromium (Co--Cr) as
base. JACTAX (Boston Scientific Corp.) utilized D-lactic polylactic
acid (DLPLA) coated (316 L) stainless steel wire frames for
carrying Paclitaxel. NEVO (Cordis Corporation, Johnson &
Johnson) used cobalt chromium (Co--Cr) wire frame coated with
polylactic-co-glycolic acid (PLGA) for carrying the drug
Sirolimus.
[0175] Examples of preferred embodiments of the valve include the
following details and features.
Example
[0176] The transcatheter prosthetic heart valve may be
percutaneously delivered using a transcatheter process via the
femoral through the IVC, carotid, sub-xyphoid, intercostal access
across the chest wall, and trans-septal to the mitral annulus
through the fossa ovalis.
[0177] The device is delivered via catheter to the right or left
atrium and is expanded from a compressed shape that fits with the
internal diameter of the catheter lumen. The compressed valve is
loaded external to the patient into the delivery catheter, and is
then pushed out of the catheter when the capsule arrives to the
atrium. The cardiac treatment technician visualizes this delivery
using available imaging techniques such as fluoroscopy or
ultrasound.
[0178] In a preferred embodiment the valve self-expands upon
release from the catheter since it is constructed in part from
shape-memory material, such as Nitinol.RTM., a nickel-titanium
alloy, or a cobalt-chromium alloy, alloys used in biomedical
implants.
[0179] In another embodiment, the valve may be constructed of
materials that requires balloon-expansion after the capsule has
been ejected from the catheter into the atrium.
[0180] The atrial collar/frame and the flow control component are
expanded to their functional diameter, as they are deployed into
the native annulus, providing a radial tensioning force to secure
the valve. Once the frame is deployed about the mitral annulus,
fasteners secure the device about the native annulus. Additional
fastening of the device to native structures may be performed, and
the deployment is complete. Further adjustments using hemodynamic
imaging techniques are contemplated as within the scope of the
invention in order to ensure the device is secure, is located and
oriented as planned, and is functioning as a substitute or
successor to the native mitral valve.
Example--Manufacturing Process
[0181] In a preferred embodiment the invention includes a process
for manufacturing a side-delivered transcatheter prosthetic heart
valve frame, comprising: [0182] (i) using additive or subtractive
metal or metal-alloy manufacturing to produce [0183] a
self-expanding annular support frame, [0184] wherein the additive
metal or metal-alloy manufacturing is 3D printing or direct metal
laser sintering (powder melt), and [0185] wherein the subtractive
metal or metal-alloy manufacturing is photolithography, laser
sintering/cutting, CNC machining, electrical discharge
machining.
[0186] In another preferred embodiment, there is provided a process
for manufacturing a side-delivered transcatheter prosthetic heart
valve frame, further comprising the steps of: (ii) mounting a flow
control component within the valve frame, said flow control
component configured to permit blood flow along the central
vertical axis through an inflow end of the flow control component
and block blood flow through an outflow end of the valve, (iii)
covering an outer surface of the valve frame with a pericardium
material or similar biocompatible material.
Example--Compression Methods
[0187] In another preferred embodiment, there is provided a method
of compressing, wherein the implantable prosthetic heart valve is
rolled or folded into a compressed configuration using a step
selected from the group consisting of:
[0188] (i) unilaterally rolling into a compressed configuration
from one side of the annular support frame;
[0189] (ii) bilaterally rolling into a compressed configuration
from two opposing sides of the annular support frame;
[0190] (iii) flattening the annular support frame into two parallel
panels that are substantially parallel to the long-axis, and then
rolling the flattened annular support frame into a compressed
configuration; and
[0191] (iv) flattening the annular support frame along a vertical
axis to reduce a vertical dimension of the valve from top to
bottom.
[0192] Drawings
[0193] Referring now to the drawings, FIG. 1 is an illustration of
a SIDE PERSPECTIVE view of a side-delivered (orthogonally
deliverable) transcatheter heart valve 100 with an A2 clip 111 and
an extendable self-contracting distal anchoring tab 269. A2 clip
111 is vertically extended subannularly during deployment of the
valve to capture native leaflet, e.g. A2, tissue, when the A2 clip
111 is retracted. The A2 clip is actuated using a steerable
catheter and/or guidewire system to deliver an external A2 clip 111
or to extend a pre-existing sheathed A2 clip from a mesh pocket on
the sidewall of the valve body. When an external A2 clip 111 is
delivered, imaging markers on or around the sleeve/pocket/sheath
113 help guide the steerable catheter to the A2 clip
sleeve/pocket/sheath 113, where the A2 clip 111 is pushed to a
subannular position, then a catheter sheath is withdrawn to expose
a distal portion of the A2 clip and expand the distal portion to a
shape-memory (spring-effect) configuration. When the expanded
distal portion of the A2 clip 111 is pulled up atrially in the
direction of the underside of the native annulus, the expanded
distal portion captures the native leaflet (A2 or other desired
leaflet) and secures it against the underside of the annulus and/or
valve body.
[0194] Distal anchoring tab 269 tracks on a guide wire inserted
near the A1 leaflet/commissure of the mitral valve. The guide wire
is pre-positioned around the native mitral leaflets and/or chordae,
especially the mitral P2 leaflet, to facilitate the over-wire
placement of the distal anchoring tab 269 around the "back side" of
the P2 leaflet to clamp the native P2 leaflet against the frame
102.
[0195] The use of an A2 clip on one side (A2) and a wrap-around
distal tab 269 on an opposite side (P2) provides oppositional
anchoring and securement and can reduce micro-motion and encourage
in-growth success of the valve.
[0196] FIG. 1 also shows collapsible flow control component 130
mounted within the annular outer support frame 102, the collapsible
(inner) flow control component 130 having leaflet frame 231 with
2-4 flexible leaflets 258 mounted thereon, the leaflet frame 231
foldable on an z-axis (front-to-back) 109 from a cylindrical
configuration to a flattened cylinder configuration and
compressible along a vertical axis 108 (y-axis) to a shortened
configuration, according to the invention. FIGS. 33-35 provide one
exemplary illustration.
[0197] Like the inner leaflet frame, the annular outer support
frame 102, 103 is made from a shape-memory material such as
Nickel-Titanium alloy, for example NiTiNOL, and is therefore a
self-expanding structure starting from a compressed configuration.
The annular (outer) support frame 102, 103 has a central (interior)
channel and an outer perimeter wall circumscribing a central
vertical axis 108, when in an expanded configuration, and said
annular outer support frame 102 having a distal side 118 and a
proximal side 114.
[0198] The flow control component 130 is mounted within the annular
outer support frame 102 and is configured to permit blood flow in a
first direction, e.g. atrial to ventricular, through an inflow end
132 of the valve 100 and block blood flow in a second direction,
opposite the first direction, through an outflow end 134 of the
valve 100.
[0199] The inner flow control component 130, like the outer annular
frame 102, is foldable and compressible. The inner flow control
component 130 comprises leaflet frame 231 with 2-4 flexible
leaflets 258 mounted on the leaflet frame 231.
[0200] The flow control component 130, and thereby the leaflet
frame 231, like the outer frame 102, is foldable along a z-axis
(front to back) from a cylindrical configuration to a flattened
cylinder configuration, where the fold lines are located on a
distal side and on a proximal side, taking the leaflet frame 231
from a ring or cylinder shape, and flattening it from a ring to a
two-layer band i.e. folded over on itself, or like a cylinder
flattened into a rectangle or square joined along two opposing
sides. This allows the outer frame 102 and the flow control
component 130 to reduce the radius along z-axis until the side
walls are in contact or nearly so. This also allows the outer frame
102 and the flow control component 130 to maintain the radius along
the horizontal axis, the y-axis, to minimize the number of wire
cells, which make up the outer and the inner, that are damaged by
forces applied during folding and/or compression necessary for
loading into the delivery catheter.
[0201] The flow control component 130, leaflet frame 231, and the
outer frame 102 are also vertically (y-axis) compressible, reducing
the height of the entire valve structure to fit within the inner
diameter of a 24-36 Fr (8-12 mm inner diameter) delivery catheter
138 (not shown in this Figure). By folding and compressing in the
z-axis and vertically compressing in the y-axis, the valve
structure is permitted to maintain a very large dimension, for
example, 40-80 mm along the horizontal, or x-axis. For example, a
60 mm or larger diameter valve can be delivered via transcatheter
techniques. The length of the long axis of a valve, e.g. 60 mm,
since it runs parallel to the central axis of the delivery
catheter, is not limited by the large amount of wire frame and
cover material necessary for such a large valve. This is not
possible with existing center-axis delivery (axial) transcatheter
valves. The use of a folded, compressed valve that is orthogonal to
the traditional axial-delivery valves permits treatment options not
available previously.
[0202] FIG. 1 also shows extendable self-contracting distal
anchoring tab 269 mounted on the distal side 118 of the annular
outer support frame 102.
[0203] In a preferred embodiment, the horizontal x-axis of the
valve is orthogonal to (90 degrees), or substantially orthogonal to
(75-105 degrees), or substantially oblique to (45-135 degrees) to
the central vertical y-axis when in an expanded configuration.
[0204] In a preferred embodiment, the horizontal x-axis of the
compressed configuration of the valve is substantially parallel to
a length-wise cylindrical axis of the delivery catheter.
[0205] In another preferred embodiment, the valve has a compressed
height (y-axis) and width (z-axis) of 6-15 mm, preferably 8-12 mm,
and more preferably 9-10 mm, and an expanded deployed height of
about 5-60 mm, preferably about 5-30 mm, and more preferably about
5-20 mm or even 8-12 mm or 8-10 mm. It is contemplated in preferred
embodiments that the length of the valve, x-axis, does not require
compression since it can extend along the length of the central
cylindrical axis of the delivery catheter.
[0206] In a preferred embodiment, the valve has an expanded
diameter length and width of 25-80 mm, preferably 40-80 mm, and in
certain embodiments length and/or width may vary and include
lengths of 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm,
65 mm, 70 mm, 75 mm, and 80 mm, in combination with widths that are
the same or different as the length.
[0207] In certain preferred embodiments, the valve is centric, or
radially symmetrical. In other preferred embodiments, the valve is
eccentric, or radially (y-axis) asymmetrical. In some eccentric
embodiments, the frame 102 may have a D-shape in cross-section so
the flat portion can be matched to the mitral annulus near the
anterior leaflet.
[0208] In certain preferred embodiments, the inner frame 231 is
25-29 mm in diameter, the outer frame 102 is 50-70 mm in diameter,
and the collar structure 103 extends beyond the top edge of the
outer frame by 10-30 mm to provide a seal on the atrial floor
against perivalvular leaks (PVLs).
[0209] Atrial collar 103 is shaped to conform to the native
deployment location. In a mitral replacement, the atrial collar
will be configured with varying portions to conform to the native
valve. In one preferred embodiment, the collar will have a distal
and proximal upper collar portion. The distal collar portion can be
larger than the proximal upper collar portion to account for
annular or subannular geometries.
[0210] FIG. 2 is an illustration of a top view of a native mitral
valve showing approximate locations of leaflet areas A1-A2-A3 and
P1-P2-P3.
[0211] FIG. 3 is an illustration of a side perspective view of a
valve having an A2 clip 111 in the folded position. Steerable
catheter/guidewire 115 is shown deploying this shape-memory
pre-installed "wire-W" embodiment of the A2 clip 111. A2 clip
attachment points 119 secure a proximal portion of the A2 clip so
that extendable hook portion 123 can be extended and retracted.
[0212] FIG. 4 is an illustration of a side perspective view of a
valve having an A2 clip 111 in the extended position. Steerable
catheter/guidewire 115 is shown deploying this shape-memory
pre-installed "wire-W" embodiment of the A2 clip 111 to a
sub-annular position to capture leaflet tissue. A2 clip attachment
points 119 secure a proximal portion of the A2 clip so that when
extendable hook portion 123 is extended, it generates a spring-back
force to capture the tissue caught between the A2 clip and the
annulus and/or valve body.
[0213] FIG. 5 is an illustration of a side perspective view of a
valve having an A2 clip 111 in the re-folded position after
capturing anterior leaflet and/or chordae tissue, especially the A2
leaflet.
[0214] FIG. 6 (a)-(d) is an illustration of an A2 clip in a pocket
or sleeve 113 that would be mounted on the perimeter wall of the
outer frame. FIG. 6(a) shows an A2 clip, post-hook embodiment 223,
stowed in the pocket 113 before deployment. Clip attachment 119 is
shown adjacent the clip 223 with upper portion of the clip 225 in a
compressed, folded configuration.
[0215] FIG. 6(b) shows an A2 clip extended in a ventricular
direction along the central (y) axis. FIG. 6(b) shows attachment
points 119 positioned above the upper proximal portion 225 of the
clip. Post-type hook 223 is shown folded and unextended in a
sub-annular position.
[0216] FIG. 6(c) shows an A2 clip completely unfolded for capturing
anterior tissue. FIG. 6(c) shows extended configuration with
attachment points 119 positioned above the upper proximal portion
225 of the clip. Post-type hook 223 is shown unfolded and extended
in a sub-annular position to capture native tissue.
[0217] FIG. 6(d) shows a retracted, re-folded A2 clip in a position
after capture of tissue where the tissue (not shown) is pinned
against the perimeter wall of the outer frame. In a retracted
position, FIG. 6(d) shows attachment points 119 positioned again
below the upper proximal portion 225 of the clip, while post-type
hook 223 is shown unfolded and extended in a capturing
configuration.
[0218] FIG. 7(a)-(h) is an illustration of a variety of anchor loop
configurations contemplated for use as a distal portion of the A2
clip. FIG. 7(a) shows a post-type hook 223. FIG. 7(b) shows a
loop-type hook 323. FIG. 7(c) shows a paddle-type hook 423. FIG.
7(d) shows a double loop-type hook 523. FIG. 7(e) shows a
footer-type hook 623. FIG. 7(f) shows a fish trap-type hook 723.
FIG. 7(g) shows a bent loop-type hook 823. FIGS. 7(g) and 7(h) also
show use of an optional locking nut 127 for an A2 clip.
[0219] FIG. 8 is an illustration of a TOP view of a mitral valve
and shows guide wire 434 directing the replacement valve 100 to the
A1 leaflet with the valve 100 in a compressed intra-catheter
configuration, according to the invention. Distal tab 268 is shown
with guide wire 434 threaded through the end of the distal tab 268,
to guide the distal tab 268 is over the guide wire 434, and lead
the valve 100 into the correct deployment location.
[0220] FIG. 9 is an illustration of a TOP view of a mitral valve
and prosthetic valve 100 with distal tab 268 attached to the outer
frame 102 and guide wire 434 threaded through the end of the distal
tab 268, such that when the guide wire 434 is pre-positioned into
the A1 location, the distal tab 268 is fed over the guide wire 434
leading the valve 100 into the correct deployment location. The
valve 100 is in a partial deployment stage being partially expelled
from delivery catheter 138, according to the invention.
[0221] FIG. 10 is an illustration of a TOP PERSPECTIVE view of a
prosthetic valve 100 having collar 103, outer frame 102, inner
frame 231, and spacer component 137. Distal tab 268 is attached to
the outer frame 102 and guide wire 434 is threaded through the end
of the distal tab 268, such that when the guide wire 434 is
pre-positioned into the A1 location, the distal tab 268 is fed over
the guide wire 434 leading the valve 100 into the correct
deployment location. FIG. 80 shows the valve 100 fully expelled
from delivery catheter 138 and positioned temporarily at an upwards
angle with a distal anchoring tab 268 in the A1 area. This angled
positioning avoids a pop-off effect and allows for the new
prosthetic valve 100 to engage the blood flow while the native
mitral valve continues to operate, just prior to the proximal side
being shoe-horned into place for a non-traumatic transition from
native valve to prosthetic valve 100, according to the
invention.
[0222] FIG. 11 is an illustration of a TOP view of a prosthetic
valve deployed in the native annulus (not visible--in dashed line),
according to the invention.
[0223] FIG. 12 is an illustration of a SIDE PERSPECTIVE view of a
prosthetic valve with an extended integrated A2 clip 111, deployed
in the native annulus (not visible), according to the
invention.
[0224] FIG. 13 is an illustration of a SIDE PERSPECTIVE view of an
embodiment of a prosthetic valve having a retracted A2 clip 111
integrated into the sidewall 110 of the A2 facing side of the outer
frame 102 of the valve, according to the invention.
[0225] FIG. 14(a)-(d) is a series of illustration showing capture
of the native tissue by the extendable self-contracting tab 269.
FIG. 14(a) shows part 1 of a sequence of a distal tab 269 tracking
over the guide wire 311. FIG. 14(b) shows part 2 of a sequence
showing withdrawal of the guide wire 311 and self-contracting
curvature of the shape-memory distal tab 269. FIG. 14(c) shows the
distal tab 269 pulling the native tissue against the outer wall 102
of the prosthetic valve. FIG. 14(d) shows completed capture of the
native tissue by tab 269 against side wall 102 and anchoring of the
valve. The tab 269 resumes a pre-curved configuration as guide wire
311 is withdrawn.
[0226] FIG. 15 is an illustration of a TOP view of an orthogonal
valve having the distal tab/securement arm 269, and additional
anchoring elements 278. Catheter 310 has guidewire 311 disposed
within the lumen of the catheter. Proximal tab 270 is used to
anchor the valve into or against native tissue on the proximal
side. Flow control component 130 is shown with three (3) leaflets
and is centrally positioned within the outer frame of a D-shaped
271 valve.
[0227] FIG. 16 is an illustration of a SIDE PERSPECTIVE view of an
exploded view of an embodiment having three leaflet cusp or pockets
258 mounted within a foldable and compressible inner wire frame
231, the inner 231 is mounted within an outer wire frame 102 having
a spacer panel 287. Outer frame 102 has a collar component 103
attached circumferentially at a top edge 107 of the outer wire
frame 102. Covered spacer 287 can be pierced to provide planned
regurgitation and/or can be used to provide a conduit for pacer
wires. Integrated anchoring A2 clip 111, and a distal anchoring tab
component 269 provide subannular valve securement to provide an
upward force against the underside of the native annulus, which
opposes the downward force against the atrial floor and top of the
native annulus that is provided by the collar component 103. Mesh
component 226 provides a biocompatible covering (e.g. polyester) to
facilitate and encourage in-growth, according to the invention.
[0228] Atrial collar 103 is shaped to conform to the native
deployment location. In a mitral replacement, the atrial collar
will have a tall back wall portion to conform to the septal area of
the native valve, and will have a distal and proximal upper collar
portion. The distal collar portion can be larger than the proximal
upper collar portion to account for the larger flat space above
(atrial) the left ventricular outflow tract (LVOT) subannular
area.
[0229] Integrated tabs are unitary construction with the body of
the outer frame. The tabs may vary in size and shape. In a
preferred embodiment, the distal tab, e.g. 269 may be longer to
reach posterior leaflet tissue and chordae. In above preferred
embodiment, the shapes of the tabs are configured to conform to the
A1 and A3 commissural areas of the mitral valve.
[0230] FIG. 17 is an illustration of a SIDE PERSPECTIVE view of a
side deliverable transcatheter heart valve 100 with an integrated
A2 clip 111 in a folded configuration along the z-axis (front to
back when viewed from the broader side) according to the invention.
FIG. 5 shows folded (flattened) outer frame 102 with
folded/flattened collar 103, hinge points 116, 120. FIG. 5 also
shows folded/flattened spacer 137, and leaflets 258 mounted within
folded/flattened inner frame 231.
[0231] FIG. 18 is an illustration of a SIDE PERSPECTIVE view of a
side deliverable transcatheter heart valve 100 with an integrated
A2 clip in a vertically compressed configuration according to the
invention. FIG. 6 shows outer frame 102 folded (z-axis) and
compressed vertically (y-axis) with collar 103 folded (z-axis) and
compressed (y-axis), along fold line between hinge points 116, 12o.
FIG. 6 also shows spacer 137, and leaflets 258 mounted within inner
frame
[0232] FIG. 19 is an illustration of a SIDE PERSPECTIVE view of a
side deliverable transcatheter heart valve 100 with an integrated
A2 clip 111 partially loaded into a delivery catheter 138,
according to the invention. FIG. 7 shows outer frame 102, A2 clip,
folded collar 103, and flow control component 130 having leaflets
258 and an inner frame 231.
[0233] FIG. 20 is an illustration of an END view of a delivery
catheter 138 showing the loaded valve 100 with outer frame 102 and
collar 103 visible, according to the invention.
[0234] FIG. 21 is an illustration of a TOP view of the folded,
compressed valve being expelled from the delivery catheter 138, in
a partial position to allow expansion of the leaflets 258, collar
103, and the inner frame 231 prior to seating in the native
annulus.
[0235] FIG. 22 is an illustration of a TOP PERSPECTIVE view of an
inner leaflet frame 231 in a cylinder configuration, shown at the
beginning of a process permitting folding and compression of the
inner frame, according to the invention.
[0236] FIG. 23 is an illustration of a TOP PERSPECTIVE view of an
inner leaflet frame 231 in a partially folded configuration with
the wireframe sidewalls rotating or hinging at their lateral
connection points 116, 120, shown as a partial first step in a
process permitting folding and compression of the inner frame,
according to the invention.
[0237] FIG. 24 is an illustration of a SIDE view of an inner
leaflet frame 231 in a completely folded configuration 208 with the
wireframe sidewalls rotated or hinged at their lateral connection
points, shown as a completed first step in a process permitting
folding and compression of the inner frame 231, according to the
invention.
[0238] FIG. 25 is an illustration of a SIDE view of an inner
leaflet frame 231 in a folded and vertically compressed
configuration 210 with the wireframe sidewalls vertically
compressed in a pleated or accordion configuration, shown as a
second step in a process permitting folding and compression of the
inner frame, according to the invention.
[0239] FIG. 26 is an illustration of a SIDE view of an inner
leaflet frame 231 as a linear wireframe sheet 202 before further
assembly into a cylinder structure, according to the invention.
[0240] FIG. 27 is an illustration of a SIDE PERSPECTIVE view of an
inner leaflet frame 231 in a cylinder or cylinder-like (conical,
etc) configuration, according to the invention.
[0241] FIG. 28 is an illustration of a SIDE PERSPECTIVE view of a
band of percardial tissue 257 that is configured in a cylinder
shape with leaflet pockets 258 sewn into a structural band 257,
according to the invention.
[0242] FIG. 29 is an illustration of a SIDE view of a band of
percardial tissue 257 with leaflet pockets sewn into a structural
band 257, before assembly into a cylindrical leaflet component and
mounting on an inner frame to form a collapsible (foldable,
compressible) flow control component, according to the
invention.
[0243] FIG. 30 is an illustration of a BOTTOM view of a band of
percardial tissue 257 with leaflet pockets 258 sewn into a
structural band 257, before assembly into a cylindrical leaflet
component and mounting on an inner frame to form a collapsible
(foldable, compressible) flow control component, according to the
invention.
[0244] FIG. 31 is an illustration of a SIDE PERSPECTIVE view of
part of a band of percardial tissue with a single leaflet pocket
sewn into a structural band, showing partial coaptation of a
leaflet pocket 258 with open edge 261 extending out and sewn edge
259 as closed top parabolic edge providing attachment, according to
the invention.
[0245] FIG. 32 is an illustration of a BOTTOM view of a cylindrical
leaflet component 258 showing complete coaptation, to form a closed
fluid-seal, according to the invention.
[0246] FIG. 33 is an illustration of a TOP PERSPECTIVE view of a
partially folded configuration of the outer wireframe 102 with an
integrated A2 clip 111, with sidewalls rotating or hinging at their
lateral connection points 116, 120, shown as a partial first step
in a process permitting folding and compression of the outer frame
102, according to the invention.
[0247] FIG. 34 is an illustration of a SIDE view of an outer frame
102 with an integrated A2 clip in a completely folded flat
configuration 208 with the wireframe sidewalls rotated or hinged at
their lateral connection points 116, 120, shown as a completed
first step in a process permitting folding and compression of the
outer frame 102, according to the invention.
[0248] FIG. 35 is an illustration of a SIDE view of an outer frame
102 with an integrated A2 clip in a folded and vertically
compressed configuration 210 with the wireframe sidewalls
vertically compressed in a pleated or accordion configuration,
shown as a second step in a process permitting folding and
compression of the outer frame 102, according to the invention.
[0249] FIG. 36 is an illustration of a TOP view of a valve
partially expelled from a delivery catheter 138, with a distal tab
268 leading the valve (along guide wire not shown) to the
deployment location, with distal flow control component 130
beginning to open and showing two of three leaflets 258 opening
from a folded, lie-flat configuration with the third leaflet
opening from a folded configuration where it is folded back on
itself when in the delivery catheter 138.
[0250] FIG. 37 is an illustration of a TOP view of a valve
compressed 136 (side loaded) within a delivery catheter 138 with an
outer frame 102 having a first tab 268 extending forward along a
x-axis and a second trailing tab 270 extending backwards along the
x-axis.
[0251] FIG. 38 is an illustration of an embodiment having multiple
extendable anterior leaflet and/or chordae anchoring clips 111.
[0252] FIG. 39 is an illustration showing a process of using a
distal tab to capture native tissue, according to the invention.
FIG. 39 shows P2 capture via orthogonal delivery, followed by A2
capture. Steps include (1) providing a foldable, compressible
orthogonal prosthetic mitral valve, (2) loading the valve sideways
into a delivery catheter, (3) and advancing the valve to the heart
via the IVC or SVC over a pre-placed guidewire that is threaded
onto a subannuluar distal tab. The process then continues with (4)
partially expelling the guide-wire tracking/straightened distal tab
portion of the valve, (5) capturing the P2 leaflet and/or chordae
by partially withdrawing guide wire to contract distal tab into its
pre-curved configuration, (6) partially expelling the valve body to
allow the leaflets to begin functioning and check for PVLs, (7)
positioning valve body in annulus and completing deployment of the
valve into the native annulus, and (8) actuating the A2 clip to
capture anterior leaflet tissue.
ADDITIONAL DEFINITIONS AND PARTS LIST
[0253] Below is provide a parts list in relation to claimed
elements. Part numbering may refer to functional components and may
be re-used across differing preferred embodiments to aid in
uniformly understanding structure-function relationships. To avoid
cluttering in drawing sheets, not every number may be added to the
drawing sheets. [0254] 100 A side delivered transcatheter
prosthetic heart valve. [0255] 102 a self-expanding annular (outer)
support frame. [0256] 103 Collar structure. [0257] 104 Central
channel. [0258] 106 Outer perimeter wall. [0259] 107 Top edge of
outer support frame. [0260] 108 Central vertical axis. [0261] 109
Z-axis, front to back, fold line axis. [0262] 110 Front wall
portion of perimeter wall. [0263] 111 A2 clip [0264] 112 Back wall
portion of perimeter wall. [0265] 113 A2 clip sleeve/pocket/sheath
[0266] 114 Proximal side. [0267] 115 A2 clip steerable
catheter/guidewire [0268] 116 Proximal fold area. [0269] 117
Secondary proximal fold areas. [0270] 118 Distal side. [0271] 119
A2 clip valve body attachment points [0272] 120 Distal fold area.
[0273] 121 secondary distal fold areas. [0274] 122 Front upper
collar portion. [0275] 123 A2 clip extendable hook portion, wire-W
[0276] 223 post hook [0277] 323 loop hook [0278] 423 paddle hook
[0279] 523 double loop hook [0280] 623 footer hook [0281] 723 fish
trap hook [0282] 823 bent loop hook [0283] 124 Front lower body
portion of outer frame. [0284] 125 A2 clip proximal portion [0285]
126 Back upper collar portion. [0286] 127 A2 clip locking
(slidable) nut [0287] 128 Back lower body portion. [0288] 129 Sewn
attachment points for inner to outer. [0289] 130 Flow control
component, made of an inner frame having tissue leaflets mounted
therein, collapsible (foldable and compressible), the inner mounted
within the annular outer support frame and configured to permit
blood flow in a first direction through an inflow end and block
blood flow in the opposite, second direction, through the outflow
end. [0290] 132 Inflow end. [0291] 134 Outflow end. [0292] 136 a
compressed configuration [0293] 138 Delivery catheter. [0294] 140
X-axis, a horizontal axis, parallel to delivery. catheter central
axis [0295] 142 Intersecting angle 45-135 degrees, X-axis to
Y-axis. [0296] 143 Inner frame cover, top cover, mesh. [0297] 144
Expanded configuration. [0298] 146 Length-wise cylindrical axis of
delivery catheter. [0299] 148 Height of about 5-60 mm. [0300] 150
Diameter of about 25-80 mm. [0301] 202 Plurality of compressible
wire cells--outer frame. [0302] 204 Orientation and cell geometry
substantially orthogonal to the central vertical axis to minimize
wire cell strain when the annular support frame is compressed.
[0303] 206 Vertical compressed configuration. [0304] 208 Folded
configuration. [0305] 210 Folded and compressed configuration.
[0306] 211 second A2 clip [0307] 212 Inner frame or outer frame
shape selected from a funnel, cylinder, flat cone, or circular
hyperboloid. [0308] 220 Braided matrix. [0309] 222 Wire frame
matrix. [0310] 224 Laser-cut wire frame. [0311] 226 Biocompatible
material. [0312] 227 Flared cuff on INNER frame. [0313] 228 Side
profile of inner frame as a flat cone shape. [0314] 229
Non-cylindrical inner frame, e.g. elliptical section. [0315] 230
Diameter R of 40-80 mm. [0316] 231 INNER frame, for mounting
leaflets. [0317] 232 Diameter r of 20-60 mm. [0318] 233 Set of
uniform wire frame cells of INNER [0319] 234 Height of 5-60 mm.
[0320] 235 Non-uniform variable height cells of INNER. [0321] 236
Interior surface of annular outer support frame. [0322] 237
Non-uniform cell geometries, sizes in wire frame. [0323] 238
Exterior surface of annular outer support frame. [0324] 239.
Compressed INNER. [0325] 240 Pericardial tissue for covering valve
surfaces. [0326] 241 Diamond or eye-shaped wire cells. [0327] 242
Woven synthetic polyester material. [0328] 243 Eyelets on inner
wire frame, consistent commissure attachment. [0329] 244 Outer
support frame with an hourglass shape. [0330] 245 Laser cut
attachment feature on inner frame. [0331] 246 Top diameter R1 of
40-80 mm. [0332] 248 Bottom diameter R2 of 50-70 mm. [0333] 250
Internal diameter r of 20-60 mm. [0334] 252 Height of 5-60 mm.
[0335] 254 Internal diameter of 20-60 mm. [0336] 256 Height of
10-40 mm. [0337] 257 Leaflet band, mounting band for leaflet
pockets. [0338] 258 LEAFLETS, plurality of leaflets, pericardial
material. [0339] 259 Sewn edge of leaflet. [0340] 260 Rounded
cylinder at an inflow end. [0341] 261 Open edge of leaflet [0342]
262 Flat closable aperture at an outflow end. [0343] 264
Longitudinal supports in/on flow control component, selected from
rigid or semi-rigid posts, rigid or semi-rigid ribs, rigid or
semi-rigid battons, rigid or semi-rigid panels, and combinations.
[0344] 266 (any) Tab or tension arm extending from a distal side of
the annular support frame. [0345] 268 DISTAL SUB-ANNULAR ANCHORING
TAB, can be LVOT or other, comprised of wire loop or wire frame,
integrated frame section, or stent, extending from about 10-40 mm
away from the annular support frame. [0346] 269 Independent Distal
tab. [0347] 270 PROXIMAL anchoring tab [0348] 271 D-shape [0349]
272 Distal upper edge of the annular support frame. [0350] 273
Upper atrial tension arm, comprised of wire loop or wire frame
extending from about 2-20 mm away from the annular support frame.
[0351] 274 Lower tension arm comprised of wire loop or wire frame,
integrated frame section, or stent, extending from about 10-40 mm
away from the annular support frame. [0352] 276 Distal side of the
annular support frame. [0353] 278 Tissue anchors connected to the
annular support frame for engaging native tissue. [0354] 280 Front
wall portion of frame is a first flat panel. [0355] 282 Back wall
portion of frame is a second flat panel. [0356] 284 Sewn seam.
[0357] 285 Hinge. [0358] 286 Flexible fabric span without any wire
cells. [0359] 287 Fabric panel. [0360] 288 Braided-wire cells.
[0361] 289 Commissure attachment--leaflet to frame. [0362] 290
Laser-cut wire cells. [0363] 302 Rolling into a compressed
configuration. [0364] 304 Bilaterally rolling into a compressed
configuration. [0365] 306 Flattening the annular support frame into
two parallel panels that are substantially parallel to the
long-axis. [0366] 308 Compressing the annular support frame along a
vertical axis to reduce a vertical dimension of the valve from top
to bottom. [0367] 310 Rigid elongated pushing rod/draw wire that is
releasably connected to the distal side of the valve, wherein
advancing the pushing rod away from the delivery catheter pulls the
compressed valve out of the delivery catheter, or (ii) pushing the
valve out of the delivery catheter using a rigid elongated pushing
rod that is releasably connected to the proximal side of the valve,
wherein advancing the pushing rod out of from the delivery catheter
pushes the compressed valve out of the delivery catheter. [0368]
311 Guide wire. [0369] 312 Steerable catheter for rotating the
heart valve prosthesis along an axis parallel to the plane of the
valve annulus, wherein an upper tension arm mounted on the valve is
conformationally pressure locked against supra-annular tissue, and
wherein a lower tension arm mounted on the valve is
conformationally pressure locked against sub-annular tissue. [0370]
314 A2 Clip for attachment to mitral A2 leaflet [0371] 316 A2 Clip
Deployment Tool [0372] 434 Guide wire
[0373] Various of the above-disclosed and other features and
functions, or alternatives thereof, may be combined into many other
different systems or applications. Various presently unforeseen or
unanticipated alternatives, modifications, variations or
improvements therein may be subsequently made by those skilled in
the art, each of which is also intended to be encompassed by the
disclosed embodiments.
[0374] Having described embodiments for the invention herein, it is
noted that modifications and variations can be made by persons
skilled in the art in light of the above teachings. It is therefore
to be understood that changes may be made in the particular
embodiments of the invention disclosed which are within the scope
and spirit of the invention as defined by the appended claims.
Having thus described the invention with the details and
particularity required by the patent laws, what is claimed and
desired protected by Letters Patent is set forth in the appended
claims.
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