U.S. patent application number 16/435687 was filed with the patent office on 2020-03-26 for side-delivered transcatheter heart valve replacement.
The applicant listed for this patent is VDYNE, LLC. Invention is credited to MARK CHRISTIANSON, NEELAKANTAN SAIKRISHNAN, ROBERT VIDLUND.
Application Number | 20200093589 16/435687 |
Document ID | / |
Family ID | 69885698 |
Filed Date | 2020-03-26 |
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United States Patent
Application |
20200093589 |
Kind Code |
A1 |
CHRISTIANSON; MARK ; et
al. |
March 26, 2020 |
SIDE-DELIVERED TRANSCATHETER HEART VALVE REPLACEMENT
Abstract
The invention relates to a transcatheter heart valve replacement
(A61F2/2412), and in particular to a side delivered large diameter,
low profile transcatheter prosthetic valve having a compressible
tubular frame having a side wall and a central axial lumen, said
tubular frame having a height of 8-20 mm and a diameter of 40-80
mm, an atrial sealing cuff, a subannular anchoring component, and
aa flow control component comprising a leaflet structure, wherein
the valve is side-delivered longitudinally to a mitral valve
annulus or tricuspid valve annulus of a patient using a 22-34 Fr
delivery catheter.
Inventors: |
CHRISTIANSON; MARK;
(PLYMOUTH, MN) ; VIDLUND; ROBERT; (FOREST LAKE,
MN) ; SAIKRISHNAN; NEELAKANTAN; (PLYMOUTH,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
VDYNE, LLC |
MAPLE GROVE |
MN |
US |
|
|
Family ID: |
69885698 |
Appl. No.: |
16/435687 |
Filed: |
June 10, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62766611 |
Sep 20, 2018 |
|
|
|
62737343 |
Sep 27, 2018 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2210/0014 20130101;
A61L 31/14 20130101; A61F 2/91 20130101; A61F 2/2418 20130101; A61F
2230/0013 20130101; A61L 27/3625 20130101; A61F 2/2436 20130101;
A61L 31/129 20130101; A61F 2230/0067 20130101; A61F 2/2409
20130101; A61F 2220/0008 20130101; A61F 2002/068 20130101; A61L
31/022 20130101; A61L 31/005 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61L 27/36 20060101 A61L027/36; A61L 31/02 20060101
A61L031/02; A61L 31/12 20060101 A61L031/12; A61L 31/14 20060101
A61L031/14; A61F 2/91 20060101 A61F002/91; A61L 31/00 20060101
A61L031/00 |
Claims
1. A side-delivered transcatheter prosthetic valve comprising: a
compressible tubular frame having a side wall and a central axial
lumen, said tubular frame having a height of 8-20 mm and a diameter
of 40-80 mm, an atrial sealing cuff attached to a top edge of the
side wall, a subannular anchoring component attached to the tubular
frame, said subannular anchoring component selected from one or
more of the group consisting of a lower tension arm extending from
a distal side of the tubular frame, a proximal anchoring tab
extending from a proximal side of the tubular frame, a ventricular
sealing collar attached to a bottom edge of the side wall, and at
least one tissue anchor to connect the tubular frame to native
tissue, and a flow control component comprising a leaflet structure
having three leaflets of pericardial material sewn to a leaflet
frame to form a rounded cylinder mounted within the lumen of the
tubular 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, wherein the valve is compressible to a
compressed configuration for introduction into the body using a
delivery catheter for implanting at a mitral valve annulus or
tricuspid valve annulus of a patient, said delivery catheter having
an internal diameter from 22 Fr (7.33 mm) to 34 Fr (11.33 mm), said
compressed configuration having a long-axis that is substantially
parallel to a length-wise cylindrical axis of the delivery
catheter, and substantially orthogonal to the blood flow through
the flow control component mounted in the central axial lumen, said
compressed configuration having a height and a width to fit within
the delivery catheter, the height and width of the compressed
configuration compressed by longitudinal/length-wise rolling or
folding, wherein the valve is expandable to an expanded
configuration having a long-axis substantially orthogonal to the
blood flow through the flow control component mounted in the
central axial lumen, said tubular frame and said atrial sealing
cuff having a polyester cover, and said tubular frame and said
atrial sealing cuff made from superelastic shape-memory material
selected from Ni-Ti alloy, Cu-Zn-Al-Ni alloys, Cu-Al-Ni alloys, a
polymer composite, a composite containing one or more of carbon
nanotubes, carbon fibers, metal fibers, glass fibers, and polymer
fibers, a stainless steel, a cobalt chromium material, and a
titanium material.
2. The valve of claim 1, wherein the at least one tissue anchor to
connect the tubular frame to native tissue is an anterior leaflet
clip or anchor, a posterior leaflet clip or anchor, or a septal
leaflet clip or anchor.
3. The valve of claim 1, wherein said tubular frame is comprised of
a braided, wire, or laser-cut wire frame, and said tubular frame is
covered with a biocompatible material.
4. The valve of claim 1, wherein the tubular 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 8-20 mm.
5. The valve of claim 1, wherein the tubular frame has an inner
surface and an outer surface, said inner surface and said outer
surface covered with pericardial tissue.
6. The valve of claim 1, wherein the tubular 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 8-20 mm.
7. The valve of claim 1, wherein the flow control component has an
internal diameter of 20-60 mm and a height of 8-20 mm.
8. 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.
9. The valve of claim 1, wherein the lower tension arm extending
from the distal side of the tubular frame is comprised of wire loop
or wire frame, integrated frame section, or stent, and extends from
about 10-40 mm away from the tubular frame.
10. The valve of claim 1, comprising (i) an upper tension arm
attached to a distal upper edge of the tubular frame, the upper
tension arm comprised of wire loop or wire frame extending from
about 2-20 mm away from the tubular frame, and (ii) the lower
tension arm extending from the distal side of the tubular frame is
comprised of wire loop or wire frame, integrated frame section, or
stent, and extends from about 10-40 mm away from the tubular
frame.
11. A method for side delivery of implantable prosthetic valve
between a ventricle and an atrium of a heart, the method comprising
the steps: advancing a delivery catheter containing the valve of
claim 1 in a compressed configuration to the atrium of the heart,
and partially releasing the valve from the delivery catheter to
position a distal side wall of the tubular frame at an oblique
angle against a distal portion of the native annulus and allowing
blood to flow from the atrium to the ventricle both through the
native valve and through the prosthetic valve, releasing the
remainder of the prosthetic valve from the delivery catheter to an
expanded configuration to assess valve function at the oblique
angle before seating the valve completely into the native annulus,
pushing a proximal side wall of the tubular frame into the native
annulus to complete seating of the valve in the native annulus,
wherein said atrial sealing cuff is disposed on the atrial floor
and the tubular frame is seated within the native annulus, and
anchoring the subannular anchoring component of the valve to native
annular or subannular tissue, wherein the native valve is a
tricuspid valve or a mitral valve.
12. The method of claim 11, 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 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.
13. The method of claim 11, comprising the additional step of
anchoring one or more secondary tissue anchors attached to the
valve into native tissue.
14. The method of claim 11, wherein the subannular anchoring
component is a lower tension arm extending from a distal side of
the tubular frame.
15. The method of claim 11, 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, wherein
an upper tension arm mounted on the valve is conformationally
pressure locked against supra-annular tissue, and wherein the lower
tension arm mounted on the valve is conformationally pressure
locked against sub-annular tissue.
16. A transcatheter heart valve replacement, comprising a side
delivered large diameter, low profile transcatheter prosthetic
valve having a compressible tubular frame having a side wall and a
central axial lumen, said tubular frame having a height of 8-20 mm
and a diameter of 40-80 mm, an atrial sealing cuff and a subannular
anchoring component attached to the tubular frame, and a flow
control component disposed within the tubular frame comprising a
leaflet structure, wherein the valve is side-delivered in a
compressed configuration longitudinally to a mitral valve annulus
or tricuspid valve annulus of a patient using a 22-34 Fr delivery
catheter.
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 a transcatheter heart valve
replacement (A61F2/2412).
Description of the Related Art
[0007] In 1952 surgeons implanted the first mechanical heart valve.
This first valve was a ball valve and it was designed by Dr.
Charles Hufnagel. The recipient of this valve was a 30-year-old
woman who could lead a normal life after the surgery. However, one
downside of this design was that it 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 disc 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] Accordingly, the present invention is directed to a side
delivered transcatheter prosthetic valve comprising:
[0014] a compressible tubular frame having a side wall and a
central axial lumen, said tubular frame having a height of 8-20 mm
and a diameter of 40-80 mm,
[0015] an atrial sealing cuff attached to a top edge of the side
wall,
[0016] a subannular anchoring component attached to the tubular
frame, said subannular anchoring component selected from one or
more of the group consisting of a lower tension arm extending from
a distal side of the tubular frame, a proximal anchoring tab
extending from a proximal side of the tubular frame, a ventricular
sealing collar attached to a bottom edge of the side wall, and at
least one tissue anchor to connect the tubular frame to native
tissue, and
[0017] a flow control component comprising a leaflet structure
having three leaflets of pericardial material sewn to a leaflet
frame to form a rounded cylinder mounted within the lumen of the
tubular 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,
[0018] wherein the valve is compressible to a compressed
configuration for introduction into the body using a delivery
catheter for implanting at a mitral valve annulus or tricuspid
valve annulus of a patient, said delivery catheter having an
internal diameter from 22 Fr (7.33 mm) to 34 Fr (11.33 mm),
[0019] said compressed configuration having a long-axis that is
substantially parallel to a length-wise cylindrical axis of the
delivery catheter, and substantially orthogonal to the blood flow
through the flow control component mounted in the central axial
lumen,
[0020] said compressed configuration having a height and a width to
fit within the delivery catheter, the height and width of the
compressed configuration compressed by longitudinal/length-wise
rolling or folding,
[0021] wherein the valve is expandable to an expanded configuration
having a long-axis substantially orthogonal to the blood flow
through the flow control component mounted in the central axial
lumen,
[0022] said tubular frame and said atrial sealing cuff having a
polyester cover, and said tubular frame and said atrial sealing
cuff made from superelastic shape-memory material selected from
Ni-Ti alloy, Cu-Zn-Al-Ni alloys, Cu-Al-Ni alloys, a polymer
composite, a composite containing one or more of carbon nanotubes,
carbon fibers, metal fibers, glass fibers, and polymer fibers, a
stainless steel, a cobalt chromium material, and a titanium
material.
[0023] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the at least one
tissue anchor to connect the tubular frame to native tissue is an
anterior leaflet clip or anchor, a posterior leaflet clip or
anchor, or a septal leaflet clip or anchor.
[0024] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein said tubular frame
is comprised of a braided, wire, or laser-cut wire frame, and said
tubular frame is covered with a biocompatible material.
[0025] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the tubular 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 8-20 mm.
[0026] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the tubular frame
has an inner surface and an outer surface, said inner surface and
said outer surface covered with pericardial tissue.
[0027] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the tubular 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 8-20 mm.
[0028] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the flow control
component has an internal diameter of 20-60 mm and a height of 8-20
mm.
[0029] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve 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.
[0030] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the tension arm
extending from the distal side of the tubular frame is comprised of
wire loop or wire frame, integrated frame section, or stent, and
extend from about 10-40 mm away from the tubular frame.
[0031] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the valve also
comprises (i) an upper tension arm attached to a distal upper edge
of the tubular frame, the upper tension arm comprised of wire loop
or wire frame extending from about 2-20 mm away from the tubular
frame, and (ii) the lower tension arm extending from the distal
side of the tubular frame is comprised of wire loop or wire frame,
integrated frame section, or stent, and extends from about 10-40 mm
away from the tubular frame.
[0032] The present invention is also directed to a method for side
delivery of implantable prosthetic valve between a ventricle and an
atrium of a heart, the method comprising the steps: [0033]
advancing a delivery catheter containing the valve described and
claimed herein in a compressed configuration to the atrium of the
heart, [0034] and [0035] partially releasing the valve from the
delivery catheter to position the distal side wall of the tubular
frame at an oblique angle against a distal portion of the native
annulus and allowing blood to flow from the atrium to the ventricle
both through the native valve and through the prosthetic valve,
[0036] releasing the remainder of the prosthetic valve from the
delivery catheter to an expanded configuration to assess valve
function at the oblique angle before seating the valve completely
into the native annulus,
[0037] pushing a proximal side wall of the tubular frame into the
native annulus to complete seating of the valve in the native
annulus, wherein said atrial sealing cuff is disposed on the atrial
floor and the tubular frame is seated within the native annulus,
and
[0038] anchoring the subannular anchoring component of the valve to
native annular or subannular tissue, [0039] wherein the native
valve is a tricuspid valve or a mitral valve.
[0040] In another preferred embodiment, there is provided a method
for side delivery of implantable prosthetic valve between a
ventricle and an atrium of a heart 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 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.
[0041] In another preferred embodiment, there is provided a method
for side delivery of implantable prosthetic valve between a
ventricle and an atrium of a heart comprising the additional step
of anchoring one or more tissue anchors attached to the valve into
native tissue.
[0042] In another preferred embodiment, there is provided a method
for side delivery of implantable prosthetic valve between a
ventricle and an atrium of a heart wherein the subannular anchoring
component is a lower tension arm extending from a distal side of
the tubular frame.
[0043] In another preferred embodiment, there is provided a method
for side delivery of implantable prosthetic valve between a
ventricle and an atrium of a heart 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, 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.
[0044] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve comprising: (i) a tubular
frame having a flow control component mounted within the tubular
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, wherein the valve is compressible to a compressed
configuration for introduction into the body using a delivery
catheter, and expandable to an expanded configuration for
implanting at a desired location in the body, wherein the valve is
compressible and expandable along a long-axis substantially
parallel to a cylindrical axis of the delivery catheter, and
wherein the valve has a height of about 5-60 mm and a diameter of
about 25-80 mm.
[0045] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the tubular frame
forms a two part framework, a first part comprises a flared atrial
cuff joined to a second part that comprises cylindrical member,
wherein the cuff is joined to the cylindrical member around the
circumference of a top edge of the cylindrical member.
[0046] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein said tubular frame
is comprised of a braid, wire, or laser-cut wire frame, and said
tubular frame is covered with a biocompatible material.
[0047] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the tubular frame
has a side profile of a flat cone shape having a diameter R of
40-80 mm, a diameter r of 20-40 mm, and a height of 10-20 mm.
[0048] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the tubular frame
has an inner surface and an outer surface, said inner surface
covered with a biocompatible material comprising pericardial
tissue, and said outer surface covered with a biocompatible
material comprising a woven synthetic polyester material.
[0049] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the tubular frame
has a side profile of an hourglass flat conical shape having a top
diameter R1 of 40-80 mm, a bottom diameter R2 of 50-70 mm, an
internal diameter r of 20-30 mm, and a height of 5-60 mm.
[0050] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the valve in an
expanded configuration has a central tube axis that is
substantially parallel to the first direction.
[0051] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve wherein the flow control
component has an internal diameter of 20-30 mm and a height of
20-40 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.
[0052] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve 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
ribs, rigid or semi-rigid battons, rigid or semi-rigid panels, and
combination thereof.
[0053] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve comprising a tension arm
extending from a distal side of the tubular frame, the tension arm
comprised of wire loop or wire frame extending from about 10-40 mm
away from the tubular frame.
[0054] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve comprising (i) an upper
tension arm attached to a distal upper edge of the tubular frame,
the upper tension arm comprised of wire loop or wire frame
extending from about 2-20 mm away from the tubular frame, and (ii)
a lower tension arm extending from a distal side of the tubular
frame, the lower tension arm comprised of wire loop or wire frame
extending from about 10-40 mm away from the tubular frame.
[0055] In another preferred embodiment, there is provided a side
delivered transcatheter prosthetic valve comprising at least one
tissue anchor connected to the tubular frame for engaging annular
tissue.
[0056] In another preferred embodiment, there is provided a method
for side delivery of implantable prosthetic valve to a desired
location in the body, the method comprising the steps: (i)
advancing a delivery catheter to the desired location in the body
and delivering an expandable prosthetic valve to the desired
location in the body by releasing the valve from the delivery
catheter, wherein the valve comprises a tubular frame having a flow
control component mounted within the tubular 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, wherein the
valve is compressible to a compressed configuration for
introduction into the body using a delivery catheter, and
expandable to an expanded configuration for implanting at a desired
location in the body, wherein the valve is compressible and
expandable along a long-axis substantially parallel to a
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.
[0057] In another preferred embodiment, there is provided a method
for side delivery of implantable prosthetic valve wherein releasing
the valve from the delivery catheter comprises pulling the valve
out of the delivery catheter using a rigid elongated pushing rod
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.
[0058] In another preferred embodiment, there is provided a method
for side delivery of implantable prosthetic valve comprising the
additional step of anchoring one or more tissue anchors attached to
the valve into annular tissue.
[0059] In another preferred embodiment, there is provided a method
for side delivery of implantable prosthetic valve comprising the
additional step of positioning a tension arm of the heart valve
prosthesis into the right ventricular outflow tract of the right
ventricle.
[0060] In another preferred embodiment, there is provided a method
for side delivery of implantable prosthetic valve comprising the
additional steps of positioning a lower tension arm of the heart
valve prosthesis into the right ventricular outflow tract of the
right ventricle, and positioning an upper tension arm into a
supra-annular position, the upper tension arm connected to the
lower tension arm, and the upper tension arm providing a
supra-annular downward force in the direction of the ventricle and
lower tension arm providing a sub-annular upward force in the
direction of the atrium.
[0061] In another preferred embodiment, there is provided a method
for side delivery of implantable prosthetic valve comprising the
the additional step of rotating the heart valve prosthesis using a
steerable catheter 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.
[0062] In another preferred embodiment, there is provided a method
for loading an implantable prosthetic valve into a delivery
catheter, the method comprising the steps: (i) attaching a pulling
wire to a sidewall of an implantable prosthetic valve and pulling
the valve into a tapering fixture or funnel, wherein the valve
comprises a tubular frame having a flow control component mounted
within the tubular 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, wherein pulling the valve into a
tapering fixture or funnel compresses the valve to a compressed
configuration for loading into a delivery catheter, wherein the
valve is compressible and expandable along a long-axis
substantially parallel to a 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.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF DRAWINGS
[0063] FIG. 1 is an illustration of a plan view of a heart valve
prosthesis according to the present invention with a valve frame
having a distal upper and lower tension arm mounted on, and
anchored to, the anterior leaflet side of the native annulus, and
having a mechanical anchor element, e.g. surgical tissue screw,
anchored on a posterior or septal side of the native annulus.
[0064] FIG. 2 is an illustration of a plan view of a heart valve
prosthesis according to the present invention with a valve frame
having a distal upper and lower tension arm mounted on, and
anchored to, the anterior leaflet side of the native annulus, and
having a mechanical anchor element, e.g. proximal sealing cuff, for
anchoring on the posterior and septal side of the native
annulus.
[0065] FIG. 3 is an illustration of a plan view of a heart valve
prosthesis according to the present invention with a valve frame
having a distal upper and lower tension arm mounted on, and
anchored to, the anterior leaflet side of the native annulus, and
having a mechanical anchor element, e.g. hourglass annular seal,
for anchoring on the posterior and/or septal side of the native
annulus.
[0066] FIG. 4 is an illustration of a PLAN view of a low-profile,
e.g. 10 mm in height, wire loop embodiment of the heart valve
prosthesis having an annulus support loop and an upper and lower
tension arm formed as a unitary or integral part, and covered with
a biocompatible material.
[0067] FIG. 5 is an illustration of a TOP view of a low-profile,
e.g. 10 mm in height, wire loop embodiment of the heart valve
prosthesis having an annulus support loop, an upper and lower
tension arm formed as a unitary or integral part, an inner
two-panel conical valve sleeve, and covered with a biocompatible
material.
[0068] FIG. 6 is an illustration of a BOTTOM view of a low-profile,
e.g. 10 mm in height, wire loop embodiment of the heart valve
prosthesis having an annulus support loop, an upper and lower
tension arm formed as a unitary or integral part, an inner
two-panel conical valve sleeve, and covered with a biocompatible
material.
[0069] FIG. 7 is an illustration of a compressed and elongated wire
loop embodiment of the heart valve prosthesis disposed within a
delivery catheter and having an annulus support loop and an upper
and lower tension arm formed as a unitary or integral part.
[0070] FIG. 8 is an illustration of a compressed and elongated wire
loop embodiment of the heart valve prosthesis partially ejected,
and partially disposed within, a delivery catheter and having an
annulus support loop and an upper and lower tension arm formed as a
unitary or integral part.
[0071] FIG. 9 is an illustration of a plan view of a heart valve
prosthesis partially mounted within the valve annulus.
[0072] FIG. 10 is an illustration of a plan view of a heart valve
prosthesis completely seated within the valve annulus.
[0073] FIG. 11 is an illustration of a plan view of a native right
atrium of a human heart, and shows the superior vena cava (SVC),
the inferior vena cava (IVC), the right atrium (RA), the tricuspid
valve and annulus (TCV), the anterior leaflet (A), the posterior
leaflet (P), the septal leaflet (S), the right ventricle (RV), and
the right ventricular outflow tract (RVOT).
[0074] FIG. 12 is an illustration of a heart valve prosthesis
having a wire-frame according to the present invention being
delivered to tricuspid valve annulus.
[0075] FIG. 13 is an illustration of a heart valve prosthesis
having a wire-frame according to the present invention being
delivered to tricuspid valve annulus.
[0076] FIG. 14 is an illustration of a heart valve prosthesis
having a wire-frame according to the present invention that has
been delivered to tricuspid valve annulus.
[0077] FIG. 15 is an illustration of a heart valve prosthesis
having a braided/laser cut-frame according to the present invention
being delivered to tricuspid valve annulus.
[0078] FIG. 16 is an illustration of a heart valve prosthesis
having a braided/laser cut-frame according to the present invention
being delivered to tricuspid valve annulus.
[0079] FIG. 17 is an illustration of a heart valve prosthesis
having a braided/laser cut-frame according to the present invention
that has been delivered to tricuspid valve annulus.
[0080] FIG. 18 is an illustration of a heart valve prosthesis
according to the present invention being delivered to tricuspid
valve annulus and shows step 1 in a valve assessment process.
[0081] FIG. 19 is an illustration of a heart valve prosthesis
according to the present invention being delivered to tricuspid
valve annulus, and shows Step 2 in a valve assessment process.
[0082] FIG. 20 is an illustration of a heart valve prosthesis
according to the present invention that has been delivered to
tricuspid valve annulus, and shows Step 3 in a valve assessment
process.
[0083] FIG. 21 is an illustration of a wire-frame embodiment of a
heart valve prosthesis according to the present invention in a
compressed, intra-catheter phase.
[0084] FIG. 22 is an illustration of a profile, or plan, view of a
wire-frame embodiment of the heart valve prosthesis according to
the present invention in a un-compressed, post-catheter-ejection
phase.
[0085] FIG. 23 is an illustration of a profile, or plan, view of a
braided or laser-cut frame embodiment of the heart valve prosthesis
according to the present invention in a un-compressed,
post-catheter-ejection phase.
[0086] FIG. 24 is an illustration of a TOP view of a heart valve
prosthesis according to the present invention having covered wire
loops for the upper tension arm(s).
[0087] FIG. 25 is an illustration of a PLAN view of a heart valve
prosthesis according to the present invention having a wire loop
construction for the upper and lower tension arms.
[0088] FIG. 26 is an illustration of a CUT-AWAY PLAN view of a
heart valve prosthesis according to the present invention, and
shows the inner panel valve sleeve mounted within the inner space
defined by the tubular frame.
[0089] FIG. 27 is an illustration of a BOTTOM view of a heart valve
prosthesis according to the present invention having covered wire
loops for the lower tension arm.
[0090] FIG. 28 is an illustration of a TOP view of a heart valve
prosthesis according to the present invention having braid or
laser-cut wire frame for the upper tension arm(s).
[0091] FIG. 29 is an illustration of a PLAN view of a heart valve
prosthesis according to the present invention having braid or
laser-cut wire frame construction for the upper and lower tension
arms.
[0092] FIG. 30 is an illustration of a CUT-AWAY PLAN view of a
braid or laser-cut embodiment of the heart valve prosthesis
according to the present invention, and shows the inner panel valve
sleeve mounted within the inner space defined by the tubular
frame.
[0093] FIG. 31 is an illustration of a BOTTOM view of a heart valve
prosthesis according to the present invention having braid or
laser-cut wire frame for the lower tension arm.
[0094] FIG. 32 is an illustration of a heart valve prosthesis
according to the present invention having a wire loop construction
for the tubular frame, with two vertical support posts extending
down the edge on opposing sides of the valve sleeve. During
compression into the delivery catheter, the posts are engineered to
fold horizontally during compression, and to elastically unfold
during ejection to deploy the valve sleeve.
[0095] FIG. 33 is an illustration of a CUT-AWAY PLAN view of a
heart valve prosthesis according to the present invention, and
shows a two-post embodiment of the inner panel valve sleeve mounted
within the inner space defined by the tubular frame.
[0096] FIG. 34 is an illustration of a CUT-AWAY PLAN view of a
heart valve prosthesis according to the present invention, and
shows a three-panel, three-post embodiment of the inner panel valve
sleeve mounted within the inner space defined by the tubular
frame.
[0097] FIG. 35 is an illustration of a heart valve prosthesis
according to the present invention having a braid or laser-cut
construction for the tubular frame, with a valve sleeve that
extends beyond the bottom of the tubular frame.
[0098] FIG. 36 is an illustration of a heart valve prosthesis
having a braid or laser-cut tubular frame and extended valve sleeve
compressed within a delivery catheter.
[0099] FIG. 37 is an illustration of a heart valve prosthesis
having a braid or laser-cut tubular frame and extended valve sleeve
shown partially compressed within a delivery catheter, and
partially ejected from the delivery catheter.
[0100] FIG. 38 is an illustration of a heart valve prosthesis
having a braid or laser-cut tubular frame and extended valve sleeve
engaging the tissue on the anterior side of the native annulus with
the curved distal side-wall of the tubular frame sealing around the
native annulus.
[0101] FIG. 39 is an illustration of a heart valve prosthesis
having a braid or laser-cut tubular frame and extended valve sleeve
engaging the tissue on the anterior side of the native annulus with
the curved distal side-wall of the tubular frame sealing around the
native annulus, and with the proximal side-wall tension-mounted
into the posterior side of the native annulus.
[0102] FIG. 40 is an illustration of a TOP view of a heart valve
prosthesis according to the present invention having braid or
laser-cut wire frame and shown mounted within a cross-sectional
view of the atrial floor at the annulus.
[0103] FIG. 41 is an illustration of a BOTTOM view of a heart valve
prosthesis according to the present invention having braid or
laser-cut wire frame for a lower tension arm and shown mounted
within a cross-sectional view of the ventricular ceiling at the
annulus.
[0104] FIG. 42 is an illustration of a PLAN view of an embodiment
of the prosthetic valve shown in a compressed configuration within
a delivery catheter.
[0105] FIG. 43 is an illustration of a cross-sectional view of one
embodiment of a compressed valve within a delivery catheter.
[0106] FIG. 44 is an illustration of a cross-sectional view of
another embodiment of a compressed valve within a delivery
catheter.
[0107] FIG. 45 is an illustration of a cross-sectional view of one
embodiment of the prosthetic valve.
[0108] FIG. 46 (a)-(b)-(c) is an illustration of a sequence of a
low-profile valve being rolled into a configuration for placement
within a delivery catheter.
[0109] FIG. 47 is an illustration of an END-VIEW of a low-profile
valve that has been longitudinally rolled and loaded within a
delivery catheter.
[0110] FIG. 48 is an illustration of a rotational lock embodiment
of the present invention where the prosthetic valve is delivered to
the native annulus with an off-set sub-annular tension arm/tab
positioned below the native annulus, and an off-set supra-annular
tension arm/tab positioned above the native annulus, while the
tubular frame is partially rolled off-set from the annular plane
along a longitudinal axis.
[0111] FIG. 49 is an illustration of a rotational lock embodiment
of the present invention where the prosthetic valve is delivered to
the native annulus with an off-set sub-annular tension arm/tab
positioned below the native annulus, and an off-set supra-annular
tension arm/tab positioned above the native annulus, while the
tubular frame is rolled into functional position parallel to the
annular plane.
[0112] FIG. 50 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic valve shown deployed into the native
annulus.
[0113] FIG. 51 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic valve shown compressed or housed within
the delivery catheter.
[0114] FIG. 52 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic valve shown ejected from the delivery
catheter and positioned against the anterior side of the native
annulus.
[0115] FIG. 53 is an illustration of a open cross-section view of a
low-profile, side-delivered prosthetic valve and shows the inner
valve sleeve.
[0116] FIG. 54 is an illustration of a two-panel embodiment of an
inner valve sleeve.
[0117] FIG. 55 is an illustration of one embodiment of an inner
valve sleeve having two rigid support posts.
[0118] FIG. 56 is an illustration of a three-panel embodiment of an
inner valve sleeve.
[0119] FIG. 57 is an illustration of a three-panel embodiment of an
inner valve sleeve having three rigid support posts.
[0120] FIG. 58 is a flowchart describing one set of method steps
for delivery of a low-profile, side-delivered prosthetic valve.
[0121] FIG. 59 a-b-c is a series of illustrations of a plan view of
a tissue anchor having a floating radio-opaque marker. 59a shows
the tissue anchor accessing the annular tissue with the
radio-opaque marker at the distal end of the anchor and in contact
with the atrial surface of the annular tissue. 59b shows the tissue
anchor advancing into the annular tissue with the radio-opaque
marker threaded onto the tissue anchor and maintaining position on
the atrial surface of the annular tissue. 59c shows the tissue
anchor completely advanced into the annular tissue such that the
tissue anchor and the threaded floating marker are now adjacent,
indicating the desired depth, tension, and/or plication of the
tissue anchor with respect to the annular tissue.
[0122] FIG. 60 is an illustration of a plan view of of a tissue
anchor having a straight thread and a constant pitch.
[0123] FIG. 61 is an illustration of a plan view of of a tissue
anchor having a straight thread and a variable pitch.
[0124] FIG. 62 is an illustration of a plan view of of a tissue
anchor having a tapered thread and a constant pitch.
[0125] FIG. 63 is an illustration of a plan view of of a tissue
anchor having a sunken taper thread and a variable pitch.
[0126] FIG. 64 is an illustration of Step 1 of a 4 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 64 shows a low profile valve being
inserted into the valve annulus and low profile valve having an
integral anchor delivery conduit or channel with an anchor disposed
in the lumen of the channel and an anchor delivery catheter
attached to the anchor.
[0127] FIG. 65 is an illustration of Step 2 of a 4 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 65 shows a low profile valve completely
deployed within the valve annulus and an integral anchor delivery
conduit or channel with an anchor disposed in the lumen of the
channel and an anchor delivery catheter attached to the anchor.
[0128] FIG. 66 is an illustration of Step 3 of a 4 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 66 shows the anchor being pushed out of
the lumen of the delivery conduit or channel and into the annular
tissue.
[0129] FIG. 67 is an illustration of Step 4 of a 4 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 67 shows the anchor in a locked position
after being pushed out of the lumen of the delivery conduit or
channel and into the annular tissue, thus anchoring the proximal
side of the low profile valve.
[0130] FIG. 68 is an illustration of Step 1 of a 5 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 68 shows catheter delivery of an
attachment wire with the clip housed within the lumen of the clip
delivery catheter.
[0131] FIG. 69 is an illustration of Step 2 of a 5 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 69 shows the clip delivery catheter
inserted into an intra-annular space and shows an attachment wire
and shows the clip housed within the lumen of the clip delivery
catheter.
[0132] FIG. 70 is an illustration of Step 3 of a 5 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 70 shows a receiver element ejected from
the delivery catheter and positioned behind tissue to be
captured.
[0133] FIG. 71 is an illustration of Step 4 of a 5 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 71 shows an anchor element piercing the
annular tissue and inserting into a receiver element.
[0134] FIG. 72 is an illustration of Step 5 of a 5 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 72 shows that the clip delivery catheter
is withdrawn and the anchor element and receiver element are
connected to the annular tissue and a also connected by connector
wire to the low profile valve.
[0135] FIG. 73 is an illustration of one embodiment of a partial
cut-away interior view of a tri-leaflet embodiment of a
low-profile, e.g. 8-20 mm, side-delivered prosthetic valve.
[0136] FIG. 74 is an illustration of another embodiment of a
partial cut-away interior view of a tri-leaflet embodiment of a
low-profile, e.g. 8-20 mm, side-delivered prosthetic valve.
[0137] FIG. 75 is an illustration of a top view of a tri-leaflet
embodiment of a low-profile, e.g. 8-20 mm, side-delivered
prosthetic valve.
[0138] FIG. 76 is an illustration of the trans-septal (femoral-IVC)
delivery of a low-profile, e.g. 8-20 mm, side-delivered prosthetic
MITRAL valve shown partially housed within the delivery catheter,
and partially ejected for deployment into the native mitral
annulus.
[0139] FIG. 77 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic MITRAL valve shown housed within the
delivery catheter.
[0140] FIG. 78 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic MITRAL valve shown partially housed
within a delivery catheter and partially latterally ejected from
the delivery catheter and positioned for deployment against the
anterior side of the native mitral annulus.
[0141] FIG. 79 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic MITRAL valve shown ejected from the
delivery catheter and positioned against the anterior side of the
native mitral annulus.
[0142] FIG. 80 is an illustration of a side or plan view of a
low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown
deployed into the native MITRAL annulus.
DETAILED DESCRIPTION OF THE INVENTION
[0143] The invention is directed to a transcatheter heart valve
replacement that is a low profile, orthogonally delivered (side
delivered) implantable prosthetic valve having an ring-shaped
tubular frame, an inner 2- or 3-panel sleeve, an elongated
sub-annular tension arm extending into the right ventricular
outflow tract, and one or more anchor elements.
[0144] 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.
[0145] 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.
[0146] 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.
[0147] 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."
[0148] 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.
[0149] 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.
[0150] 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."
[0151] 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.
[0152] 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
Orthogonal or Side-Delivery
[0153] In the description and claims herein, the term "orthogonal"
or "side-delivered" or "side-delivery" is 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. 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 in a manner akin to
pushing a closed umbrella out of a sleeve. The valves of the
present invention are compressed and delivered in a sideways
manner. 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. 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 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.
Transcatheter
[0154] 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.
Tubular Frame
[0155] In the description and claims herein, the term "tubular
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.
Tubular Frame Structure
[0156] The tubular 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 tubular frame is formed by
manufacturing the structural material as a braided wire frame, a
laser-cut wire frame, or a wire loop. The tubular 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 tubular 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 tubular frame used in the prosthetic
valve deployed in the tricuspid annulus may have a complex shape
determined by the anatomical structures where the valve is being
mounted. For example, in the tricuspid annulus, the circumference
of the tricuspid valve may be a rounded ellipse, the septal wall is
known to be substantially vertical, and the tricuspid is known to
enlarge in disease states along the anterior-posterior line.
Accordingly, a prosthetic 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
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.
Tubular Frame Covering
[0157] The tubular frame is optionally internally or externally
covered, partially or completely, with a biocompatible material
such as pericardium. The tubular frame may also be optionally
externally covered, partially or completely, with a second
biocompatible material such as polyester or Dacron (R).
Tubular Frame Purpose
[0158] The tubular frame has a central axial lumen where a
prosthetic valve or flow-control structure, such as a reciprocating
compressible sleeve, is mounted across the diameter of the lumen.
The tubular frame is also tensioned against the inner aspect of the
native annulus and provides structural patency to a weakened
annular ring.
Tubular Frame Optional Collars
[0159] The tubular 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 tubular frame. The tubular 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.
Tubular Frame Delivery
[0160] The tubular 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 valves having either a single atrial collar, a
single ventricular collar, or having no additional collar
structure.
Flow Control Component
[0161] 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
tubular frame, to function as a prosthetic 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".
Tissue Anchor
[0162] 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.
Support Post
[0163] 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.
[0164] 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.
[0165] The term "lumen" refers to the inside of a cylinder tube.
The term "bore" refers to the inner diameter.
[0166] Displacement--The volume of fluid displaced by one complete
stroke or revolution
[0167] 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)
[0168] 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.
[0169] Force--A push or pull acting upon a body. In a hydraulic
cylinder, it is the product of the pressure on the fluid,
multiplied by the effective area of the cylinder piston.
Prosthetic Valve
[0170] 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
valves), as well as homograft and autograft valves. For
bioprosthetic pericardial valves, it is contemplated to use
bioprosthetic aortic valves, bioprosthetic mitral valves,
bioprosthetic tricuspid valves, and bioprosthetic pulmonary
valves.
Frame Material
[0171] Preferably, the frame is made from superelastic metal wire,
such as Nitinol (TM) wire or other similarly functioning material.
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 such as Cu--Zn--Al--Ni
alloys, Cu--Al--Ni 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 wire
frame. Such materials are available from any number of commercial
manufacturers, such as Pulse Systems. Laser cut wire frames are
preferably made from Nickel-Titanium (Nitinol (TM)), but also
without limitation made from stainless steel, cobalt chromium,
titanium, and other functionally equivalent metals and alloys, or
Pulse Systems braided frame that is shape-set by heat treating on a
fixture or mandrel.
[0172] One key aspect of the frame design is that it be
compressible and when released have the stated property that it
return 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
compression features.
Laser Cut
[0173] 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.
[0174] Secondarily the tube is placed on a mold of the desired
shape, heated to the Martensitic temperature and quenched. 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 at the calibrated temperature.
Braided Wire
[0175] A frame can be constructed utilizing simple braiding
techniques. Using a Nitinol wire--for example a 0.012'' wire--and a
simple braiding fixture, the wire is wound on the braiding fixture
in a simple over/under braiding pattern until an isodiametric tube
is formed from a single wire. The two loose ends of the wire are
coupled using a stainless steel or Nitinol coupling tube into which
the loose ends are placed and crimped. Angular braids of
approximately 60 degrees have been found to be particularly useful.
Secondarily, the braided wire frame is placed on a shaping fixture
and placed in a muffle furnace at a specified temperature to set
the wire frame to the desired shape and to develop the martensitic
or super elastic properties desired.
[0176] Tethers--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.
Tines-Anchors-Tines/Barbs
[0177] 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, 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.
[0178] In one embodiment, where a prosthetic 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.
Tube and/or Cover Material--Biological Tissue--
[0179] 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 valve for implantation, and U.S. Pat. No. 5,336,616
to LifeCell Corporation discloses acellular collagen-based tissue
matrix for transplantation.
Polymers
[0180] In one preferred embodiment, the conduit may optionally be
made from a synthetic material such a polyurethane or
polytetrafluoroethylene.
[0181] 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 polyamides,
polyolefins, polyesters, 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.
Polyamides (PA)
[0182] 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.
Polyolefin
[0183] 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.
Polyesters
[0184] 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.
Polytetrafluoroethylene
[0185] 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.
Polyurethanes
[0186] 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.
Covered Wire Frame Materials
[0187] 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.
[0188] 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
polybutyl 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.
[0189] Examples of preferred embodiments of the reciprocating
pressure conduit valve include the following details and
features.
Example
[0190] One preferred embodiment of a side delivered transcatheter
prosthetic valve has a tubular frame with a flow control component
mounted within the tubular 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, 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 having a
long-axis oriented at an intersecting angle of between 45-135
degrees to the first direction, and expandable to an expanded
configuration having a long-axis oriented at an intersecting angle
of between 45-135 degrees to the first direction, wherein the
long-axis of the compressed configuration of the valve is
substantially parallel to a length-wise cylindrical axis of the
delivery catheter,
[0191] wherein the valve has a height of about 5-60 mm and a
diameter of about 25-80 mm. Importantly, this heart valve
substitute does not have a traditional valve configuration, can be
delivered to the heart using the inferior vena cava (IVC/femoral
transcatheter delivery pathway compressed within a catheter, and
expelled from the catheter to be deployed without open heart
surgery.
Example
[0192] In another preferred embodiment of a transcatheter valve,
comprises: a cylindrical tubular frame having a height of about
5-60 mm and an outer diameter of about 25-80 mm, said tubular frame
comprised of a braid, wire, or laser-cut wire frame having a
substantially circular central aperture, said tubular frame
partially covered with a biocompatible material; a collapsible flow
control component disposed within the central aperture, said sleeve
having a height of about 5-60 mm and comprised of at least two
opposing leaflets that provide a reciprocating closable channel
from a heart atrium to a heart ventricle; an upper tension arm
attached to a distal upper edge of the tubular frame, the upper
tension arm comprised of stent, segment of tubular frame, wire loop
or wire frame extending from about 10-30 mm away from the tubular
frame; a lower tension arm extending from a distal side of the
tubular frame, the lower tension arm comprised of stent, segment of
tubular frame, wire loop or wire frame extending from about 10-40
mm away from the tubular frame; and at least one tissue anchor to
connect the tubular frame to native tissue.
Example
[0193] In another preferred embodiment of a transcatheter valve,
there is provided a feature wherein the sleeve is shaped as a conic
cylinder, said top end having a diameter of 30-35 mm and said
bottom end having a diameter of 8-20 mm.
Example
[0194] In another preferred embodiment of a transcatheter valve,
there is provided a feature wherein the cover is comprised of
polyester, polyethylene terephthalate, decellularized pericardium,
or a layered combination thereof.
Example
[0195] In a preferred embodiment of the invention, there is also
provided a method for side delivery of implantable prosthetic valve
to a desired location in the body, the method comprising the steps:
(i) advancing a delivery catheter to the desired location in the
body and delivering an expandable prosthetic valve to the desired
location in the body by releasing the valve from the delivery
catheter, wherein the valve comprises a tubular frame having a flow
control component mounted within the tubular 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, 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
having a long-axis oriented at an intersecting angle of between
45-135 degrees to the first direction, and expandable to an
expanded configuration having a long-axis oriented at an
intersecting angle of between 45-135 degrees to the first
direction, wherein the long-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.
Example
[0196] In a preferred embodiment of the invention, there is also
provided a method for loading an implantable prosthetic valve into
a delivery catheter, the method comprising the steps: loading an
implantable prosthetic valve sideways into a tapering fixture or
funnel attached to a delivery catheter, wherein the valve comprises
a tubular frame having a flow control component mounted within the
tubular 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, 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 having a long-axis oriented at an
intersecting angle of between 45-135 degrees to the first
direction, and expandable to an expanded configuration having a
long-axis oriented at an intersecting angle of between 45-135
degrees to the first direction, wherein the long-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.
Example
[0197] In a preferred embodiment of the invention, there is also
provided a method for loading an implantable prosthetic valve into
a delivery catheter, the method comprising the steps: (i) loading
an implantable prosthetic valve into a tapering fixture or funnel
attached to a delivery catheter, wherein the valve comprises a
tubular frame having a flow control component mounted within the
tubular 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, wherein said loading is perpendicular or
substantially orthogonal to the first direction, 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 having a
long-axis oriented at an intersecting angle of between 45-135
degrees to the first direction, and expandable to an expanded
configuration having a long-axis oriented at an intersecting angle
of between 45-135 degrees to the first direction, wherein the
long-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.
Example
[0198] 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. 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, and 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 used in biomedical implants.
[0199] 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.
[0200] 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 tricuspid 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 tricuspid valve.
Drawings
[0201] Referring now to the drawings, FIG. 1 is an illustration of
a plan view of a heart valve prosthesis 100 according to the
present invention with a valve frame 102 having upper tension arm
128 and lower tension arm 126 mounted on and anchoring to the
annulus. FIG. 1 shows lower tension arm/tab 126 extending into the
Right Ventricular Outflow Tract (RVOT). The lateral, or
side-delivered, delivery of the valve 100 through the inferior vena
cava, provides for direct access to the valve annulus without the
need to delivery a compressed valve around a right angle turn, as
is required for IVC delivery of axially, or vertically loaded,
traditional transcatheter valves. FIG. 1 shows one embodiment where
a screw or other anchor device 138 is used in conjunction with the
tension-mounting method described herein where upper and lower
tension arms on the anterior leaflet side anchor the valve in
place, and a secondary anchor element completes the securement of
the valve in the annular site.
[0202] FIG. 1 shows polyester mesh covering 108 a valve tubular
frame 102 encircling a collapsible flow control sleeve 110. FIG. 1
also shows the frame 102 having Nitinol wire frame in diamond
shapes with a biocompatible covering. In one embodiment, the frame
may have a pericardial material on top and a polyester material,
e.g. surgical Dacron(R), underneath to be in contact with the
native annulus and promote ingrowth.
[0203] FIG. 2 is an illustration of a plan view of another
embodiment of a heart valve prosthesis according to the present
invention with a valve frame 102 having a distal upper tension arm
128 and lower tension arm 126 mounted on, and anchored to, the
anterior leaflet side of the native annulus, and having a
mechanical anchor element, e.g. proximal sealing cuff, 130 for
anchoring on the posterior and septal side of the native annulus.
The sealing cuff 130 may be a short tab on the posterior side of
the valve or may be a semi-circular or circular collar or cuff that
engages the atrial floor to seal the annulus from perivalvular
leaks.
[0204] FIG. 3 is an illustration of a plan view of another
embodiment of a heart valve prosthesis according to the present
invention with a valve frame having a distal upper and lower
tension arm mounted on, and anchored to, the anterior leaflet side
of the native annulus, and having a mechanical anchor element, e.g.
hourglass annular seal, 132 for anchoring on the posterior and/or
septal side of the native annulus. The hourglass, or concave,
sealing cuff 132 may be only a short segment on the posterior side
of the valve or may be a semi-circular or circular combined upper
and lower collar or cuff that engages the atrial floor and the
ventricular ceiling to seal the annulus from perivalvular leaks.
This embodiment may also include embodiments having a partial
collar. This embodiment may be used in conjunction with other
anchoring elements described herein.
[0205] FIG. 4 is an illustration of a PLAN view of a low-profile,
e.g. 10 mm in height, wire loop embodiment of the heart valve
prosthesis having an annulus support loop 140 and an upper and
lower tension arm 142, 144 formed as a unitary or integral part,
and covered with a biocompatible material. This embodiment shows
how a low profile, side-delivered valve can having a very large
diameter, 40-80 mm, with requiring an excessively large delivery
catheter, as would be required by a large diameter valve that is
delivered using the traditional, vertical or axial,
orientation.
[0206] FIG. 5 is an illustration of a TOP view of a low-profile,
e.g. 10 mm in height, wire loop embodiment of the heart valve
prosthesis having an annulus support loop 140, an upper and lower
tension arm 142, 144 formed as a unitary or integral part, an inner
two-panel conical valve sleeve 110, and covered with a
biocompatible material. FIG. 5 shows the inner two-panel sleeve and
the reciprocating collapsible aperture at the lower end for
delivering blood to the ventricle.
[0207] FIG. 6 is an illustration of a BOTTOM view of a low-profile,
e.g. 10 mm in height, wire loop embodiment of the heart valve
prosthesis having an annulus support loop, an upper and lower
tension arm formed as a unitary or integral part, an inner
two-panel conical valve sleeve, and covered with a biocompatible
material. FIG. 6 shows a PLAN view of the inner two-panel sleeve
110 and the collapsible terminal aperture 156 at the ventricular
side.
[0208] FIG. 7 is an illustration of a compressed and elongated wire
loop embodiment of the heart valve prosthesis disposed within a
delivery catheter 118 and having an ring shaped tubular frame 102
with braid/laser-cut 104 and an upper and lower tension arm 142,
144 formed as a unitary or integral part. FIG. 7 illustrates how a
large diameter valve, using side-loading, can be delivered.
[0209] FIG. 8 is an illustration of a compressed and elongated wire
loop embodiment of the heart valve prosthesis partially ejected,
and partially disposed within, a delivery catheter and having an
annulus support loop and an upper and lower tension arm formed as a
unitary or integral part. FIG. 8 shows how a valve can be partially
delivered for positioning in the annulus. The lower tension arm 144
can be used to navigate through the tricupid leaflets and chordae
tendinae while the valve body, the tubular frame, 102 is still
within the steerable IVC delivery catheter 118.
[0210] FIG. 9 is an illustration of a plan view of a heart valve
prosthesis partially mounted within the valve annulus. By using the
side-delivered valve of the present invention, the distal side of
the prosthesis 142, 144 can be mounted against the anterior aspect
of the native annulus, and valve function can be assessed. By
allowing two pathways for blood flow, the first through the native
valve near the posterior leaflet, and the second through the
central aperture of the prosthetic valve, a practitioner can
determine if the heart is decompensating or if valve function is
less than optimal.
[0211] FIG. 10 is an illustration of a plan view of a heart valve
prosthesis completely seated within the valve annulus. FIG. 19
shows that the valve can be secured in place once the valve
function assessment shows that the deployment is successful.
Importantly, since the valve is a low-profile valve, and fits
easily within a standard, e.g. 8-12 mm, delivery catheter without
requiring the forceful loading of typical transcatheter valves, the
side-loading valve can be easily retrieved using the same delivery
catheter that is used to deploy the valve.
[0212] FIG. 11 is an illustration of a plan view of a native right
atrium of a human heart, and shows the superior vena cava (SVC),
the inferior vena cava (IVC), the right atrium (RA), the tricuspid
valve and annulus (TCV), the anterior leaflet (A), the posterior
leaflet (P), the septal leaflet (S), the right ventricle (RV), and
the right ventricular outflow tract (RVOT).
[0213] FIG. 12 is an illustration of a heart valve prosthesis
according to the present invention being delivered to tricuspid
valve annulus. FIG. 12 shows wire-frame lower tension arm 144
ejected from the delivery catheter 118 and being directed through
the annulus and towards the right ventricular outflow tract. FIG.
12 shows an embodiment of an accordion-compressed low-profile valve
122 and shows the lower tension arm directed towards the anterior
leaflet for placement into the RVOT.
[0214] FIG. 13 is an illustration of a heart valve prosthesis
according to the present invention being delivered to tricuspid
valve annulus. FIG. 13 shows wire-frame lower tension arm 144 and
upper tension arm 142 ejected from the delivery catheter 118, the
lower tension arm directed through the annulus and into the right
ventricular outflow tract, and the upper tension arm staying in a
supra-annular position, and causing a passive, structural anchoring
of the distal side of the valve about the annulus. FIG. 13 also
shows steerable anchoring catheter 150 attached to a proximal
anchoring tab 152. While the valve is held in a pre-seating
position, the valve can be assessed, and once valve function and
patient conditions are correct, the steerable anchoring catheter
can push the proximal side of the valve from its oblique angle,
down into the annulus. The steerable anchoring catheter can then
install one or more anchoring elements 152.
[0215] FIG. 14 is an illustration of a heart valve prosthesis
according to the present invention being delivered to tricuspid
valve annulus. FIG. 14 shows the entire valve ejected from the
delivery catheter, the wire-frame lower tension arm directed
through the annulus and into the right ventricular outflow tract,
and the upper wire-frame tension arm staying in a supra-annular
position, and causing a passive, structural anchoring of the distal
side of the valve about the annulus, and at least one tissue anchor
anchoring the proximal side of the prosthesis into the annulus
tissue.
[0216] FIG. 15 is an illustration of a heart valve prosthesis
according to the present invention being delivered to tricuspid
valve annulus. FIG. 15 shows braided/laser cut-frame lower tension
arm 126 ejected from the delivery catheter 118 and being directed
through the annulus and towards the right ventricular outflow
tract.
[0217] FIG. 16 is an illustration of a heart valve prosthesis
according to the present invention being delivered to tricuspid
valve annulus. FIG. 16 shows braided/laser cut-frame lower tension
arm 126 and upper tension arm 128 ejected from the delivery
catheter 118, the lower tension arm directed through the annulus
and into the right ventricular outflow tract, and the upper tension
arm staying in a supra-annular position, and causing a passive,
structural anchoring of the distal side of the valve about the
annulus.
[0218] FIG. 17 is an illustration of a heart valve prosthesis
according to the present invention being delivered to tricuspid
valve annulus. FIG. 17 shows the entire braided/laser cut-frame
valve 102 ejected from the delivery catheter 118, the lower tension
arm directed through the annulus and into the right ventricular
outflow tract, and the upper tension arm staying in a supra-annular
position, and causing a passive, structural anchoring of the distal
side of the valve about the annulus, and at least one tissue anchor
anchoring the proximal side of the prosthesis into the annulus
tissue.
[0219] FIG. 18 is an illustration of a heart valve prosthesis
according to the present invention being delivered to tricuspid
valve annulus and shows step 1 in a valve assessment process. FIG.
18 shows braided/laser cut-frame lower tension arm ejected from the
delivery catheter and being directed through the annulus and
towards the right ventricular outflow tract.
[0220] FIG. 19 is an illustration of a heart valve prosthesis
according to the present invention being delivered to tricuspid
valve annulus, and shows Step 2 in a valve assessment process. FIG.
19 shows braided/laser cut-frame lower tension arm and upper
tension arm ejected from the delivery catheter, the lower tension
arm directed through the annulus and into the right ventricular
outflow tract, and the upper tension arm staying in a supra-annular
position, and causing a passive, structural anchoring of the distal
side of the valve about the annulus. FIG. 28 shows that a steerable
anchoring catheter can hold the valve at an oblique angle in a
pre-attachment position, so that the valve can be assessed, and
once valve function and patient conditions are correct, the
steerable anchoring catheter can push the proximal side of the
valve from its oblique angle, down into the annulus. The steerable
anchoring catheter can then install one or more anchoring
elements.
[0221] FIG. 20 is an illustration of a heart valve prosthesis
according to the present invention that has been delivered to
tricuspid valve annulus, and shows Step 3 in a valve assessment
process. FIG. 20 shows the entire braided/laser cut-frame valve
ejected from the delivery catheter, the lower tension arm directed
through the annulus and into the right ventricular outflow tract,
and the upper tension arm staying in a supra-annular position, and
causing a passive, structural anchoring of the distal side of the
valve about the annulus, and at least one tissue anchor anchoring
the proximal side of the prosthesis into the annulus tissue.
[0222] FIG. 21 is an illustration of a heart valve prosthesis
according to the present invention in a compressed, intra-catheter
phase. The lower and upper tension arms 144, 142 are elongated to
the right, and the prosthetic valve 102 is shown laterally
compressed in the delivery catheter 118. The lateral compression is
a function of the use of minimal structural materials, e.g. a
minimal inner valve sleeve 110, and the relatively short height of
the outer cylindrical frame 102. This lateral delivery provides for
very large, e.g. up to 80 mm or more, valve prosthesis' to be
delivered. The lateral delivery also avoids the need to perform a
90 degree right turn when delivering a valve using the IVC femoral
route. This sharp delivery angle has also limited the size and make
up of prior valve prosthesis', but is not a problem for the
inventive valve herein.
[0223] FIG. 22 is an illustration of a profile, or plan, view of a
wire-frame embodiment of the heart valve prosthesis according to
the present invention in a un-compressed, post-catheter-ejection
phase. FIG. 22 shows an embodiment where the upper wire-frame
tension arm 142 is attached to the tubular frame 102, but the lower
tension arm 144 is shaped in an S-shape and connects only to the
upper tension arm 142.
[0224] FIG. 23 is an illustration of a profile, or plan, view of a
braid or laser-cut frame embodiment of the heart valve prosthesis
according to the present invention in a un-compressed,
post-catheter-ejection phase. FIG. 23 shows an embodiment where the
upper braid or laser-cut tension arm 128 is attached to the upper
edge of the tubular frame 102, and the lower tension arm 126 is
attached to the lower edge of the tubular frame 102.
[0225] FIG. 24 is an illustration of a TOP view of a heart valve
prosthesis according to the present invention having covered wire
loop for the upper tension arm(s). FIG. 24 shows the tubular frame
102 having an inner sleeve 110 sewn into the central aperture 106,
with the two (2) panels extending downward (into the page) in a
ventricular direction. FIG. 24 shows the upper tension arms 142
oriented towards the anterior leaflet side of the atrial floor,
shown in dashed outline.
[0226] FIG. 25 is an illustration of a PLAN view of a heart valve
prosthesis according to the present invention having a wire loop
construction for the upper 142 and lower 144 tension arms.
[0227] FIG. 26 is an illustration of a CUT-AWAY PLAN view of a
heart valve prosthesis according to the present invention, and
shows the inner panel valve sleeve 110 mounted within the inner
space defined by the tubular frame.
[0228] FIG. 27 is an illustration of a BOTTOM view of a heart valve
prosthesis according to the present invention having a covered wire
loop for the lower tension arm 144. FIG. 27 shows the tubular frame
102 having an inner sleeve 110 sewn into the central aperture, with
the two (2) panels extending upward (out of the page) in a
ventricular direction. FIG. 27 shows the lower tension arm 144
oriented towards the anterior leaflet side of the ventricular
ceiling, shown in dashed outline.
[0229] FIG. 28 is an illustration of a TOP view of a heart valve
prosthesis according to the present invention having covered braid
or laser-cut frame 102 for the upper tension arm 128. FIG. 28 shows
the tubular frame 102 having an inner sleeve 110 sewn into the
central aperture, with the two (2) panels extending downward (into
the page) in a ventricular direction. FIG. 28 shows the upper
tension arm 128 oriented towards the anterior leaflet side of the
atrial floor, shown in dashed outline.
[0230] FIG. 29 is an illustration of a PLAN view of a heart valve
prosthesis according to the present invention having a braid or
laser-cut frame construction 102 for the upper and lower tension
arms 128, 126.
[0231] FIG. 30 is an illustration of a CUT-AWAY PLAN view of a
heart valve prosthesis according to the present invention, and
shows the inner panel valve sleeve 110 mounted within the inner
space defined by the tubular frame 102.
[0232] FIG. 31 is an illustration of a BOTTOM view of a heart valve
prosthesis according to the present invention having a covered
braid or laser-cut frame for the lower tension arm. FIG. 31 shows
the tubular frame 102 having an inner sleeve 110 sewn into the
central aperture, with the two (2) panels extending upward (out of
the page) in a ventricular direction. FIG. 31 shows the lower
tension arm 126 oriented towards the anterior leaflet side of the
ventricular ceiling, shown in dashed outline.
[0233] FIG. 32 is an illustration of a heart valve prosthesis
according to the present invention having a wire loop construction
for the tubular frame 102, with two vertical support posts 154
extending down the edge on opposing sides of the sleeve 110. During
compression into the delivery catheter 118 (not shown), the posts
154 are engineered to fold horizontally during compression, and to
elastically unfold during ejection to deploy the valve sleeve
110.
[0234] FIG. 33 is an illustration of a CUT-AWAY PLAN view of a
heart valve prosthesis according to the present invention, and
shows a two-post embodiment 154 of the inner panel valve sleeve 110
mounted within the inner space defined by the tubular frame
102.
[0235] FIG. 34 is an illustration of a CUT-AWAY PLAN view of a
heart valve prosthesis according to the present invention, and
shows a three-panel, three-post embodiment of the inner panel valve
sleeve mounted within the inner space defined by the tubular
frame.
[0236] FIG. 35 is an illustration of a low-profile, side-delivered
heart valve prosthesis according to the present invention having a
braid or laser-cut construction for the tubular frame 102, with a
valve sleeve 110 that extends beyond the bottom of the tubular
frame. FIG. 35 shows a longer lower tension arm 126 for extending
sub-annularly towards the RVOT, and a shorter upper tension arm 128
for extending over the atrial floor. FIG. 35 shows an elongated two
(2) panel valve sleeve 110 that extends into the sub-annular
leaflet space. The tubular frame 102 shown in FIG. 35 is about 10
mm in height and the valve sleeve 110 extends about 10 mm below the
bottom of the tubular frame, resulting in a valve 20 mm in total
height.
[0237] FIG. 36 is an illustration of a low-profile, side-delivered
heart valve prosthesis having a braid or laser-cut tubular frame
and extended valve sleeve compressed within a delivery catheter
118. FIG. 36 shows the valve attached to a secondary steerable
catheter 150 for ejecting, positioning, and anchoring the valve.
The secondary catheter 150 can also be used to retrieve a failed
deployment of a valve.
[0238] FIG. 37 is an illustration of a heart valve prosthesis
having a braid or laser-cut tubular frame and extended valve sleeve
shown partially compressed within a delivery catheter, and
partially ejected from the delivery catheter. FIG. 37 shows that
while the valve is still compressed the lower tension arm can be
manipulated through the leaflets and chordae tendinae to find a
stable anterior-side lodgment for the distal side of the valve.
[0239] FIG. 38 is an illustration of a heart valve prosthesis
having a braid or laser-cut tubular frame and extended valve sleeve
engaging the tissue on the anterior side of the native annulus with
the curved distal side-wall of the tubular frame sealing around the
native annulus. FIG. 38 shows the valve held by the steerable
secondary catheter at an oblique angle while valve function is
assessed.
[0240] FIG. 39 is an illustration of a heart valve prosthesis
having a braid or laser-cut tubular frame and extended valve sleeve
fully deployed into the tricuspid annulus. The distal side of the
valve is shown engaging the tissue on the anterior side of the
native annulus with the curved distal side-wall of the tubular
frame sealing around the native annulus, and with the proximal
side-wall tension-mounted into the posterior side of the native
annulus.
[0241] FIG. 40 is an illustration of a TOP view of a heart valve
prosthesis according to the present invention having braid or
laser-cut wire frame 102 and shown mounted within a cross-sectional
view of the atrial floor at the annulus.
[0242] FIG. 41 is an illustration of a BOTTOM view of a heart valve
prosthesis according to the present invention having braid or
laser-cut wire frame 102 for a lower tension arm 126 and shown
mounted within a cross-sectional view of the ventricular ceiling at
the annulus. FIG. 41 shows the two panel valve sleeve 110 in an
open position 106, e.g. atrial systole and ventricular diastole.
FIG. 41 shows RVOT as a darkened circle.
[0243] FIG. 42 is an illustration of a PLAN view of an embodiment
of the prosthetic valve shown in a compressed configuration within
a delivery catheter. FIG. 42 shows the tubular frame wall
rolled-over, outwardly, resulting in a 50% reduction in height of
the catheter-housed valve. The low profile, side-delivered valves
of the present invention do not require the aggressive,
strut-breaking, tissue-tearing, stitch-pulling forces that
traditional transcatheter valves are engineered to mitigate.
[0244] FIG. 43 is an illustration of a cross-sectional view of one
embodiment of a compressed valve within a delivery catheter 118.
This cross-sectional end view shows one embodiment of a single-fold
compression configuration where the tubular frame wall 102 and
attached two-panel sleeve 110 are rolled-over, outwardly, resulting
in a 50% reduction in height, and providing the ability to fit
within the inner diameter of a 1 cm (10 mm) delivery catheter.
[0245] FIG. 44 is an illustration of a cross-sectional view of
another embodiment of a compressed valve within a delivery
catheter. This cross-sectional end view shows another embodiment of
a single-fold compression configuration where the tubular frame
wall and attached two-panel sleeve are folded-over, outwardly,
resulting in a 50% reduction in height, and providing the ability
to fit within the inner diameter of a 1 cm (10 mm) delivery
catheter.
[0246] FIG. 45 is an illustration of a cross-sectional view of an
embodiment of the prosthetic valve to further illustrate how the
folding and rolling configurations can be effectuated due to the
minimal material requirement of the low-profile, side-delivered
valve 102, 110.
[0247] FIG. 46 (a)-(b)-(c) is an illustration of a sequence of a
low-profile valve being rolled into a configuration for placement
within a delivery catheter. Tubular frame 102 having aperture 106
supports sleeve 110.
[0248] FIG. 47 is an illustration of an END-VIEW of a low-profile
valve that has been longitudinally rolled and loaded within a
delivery catheter 118, and show frame 102 and sleeve 110.
[0249] FIG. 48 is an illustration of a rotational lock embodiment
of the present invention where the prosthetic valve is delivered to
the native annulus with an off-set sub-annular tension arm/tab 126
positioned below the native annulus, and an off-set supra-annular
tension arm/tab 128 positioned above the native annulus, while the
tubular frame 102 is partially rolled off-set from the annular
plane along a longitudinal axis.
[0250] FIG. 49 is an illustration of a rotational lock embodiment
of the present invention where the prosthetic valve is delivered to
the native annulus with an off-set sub-annular tension arm/tab 126
positioned below the native annulus, and an off-set supra-annular
tension arm/tab 128 positioned above the native annulus, while the
tubular frame 102 is rolled into functional position parallel to
the annular plane. Once the valve is rolled into position, and the
tension arms are locked against the sub-annular and supra-annular
tissues, the valve can also be further anchored using traditional
anchoring elements as disclosed herein.
[0251] FIG. 50 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic valve 100 shown deployed into the native
annulus. FIG. 50 shows that low-profile, side-delivered valves can
be delivered and traditionally anchored with or without the need
for shaped, tension arms.
[0252] FIG. 51 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic valve having frame 102 and sleeve 110
shown compressed or housed within the delivery catheter 118.
[0253] FIG. 52 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic valve shown ejected from the delivery
catheter 118 and positioned against the anterior side of the native
annulus. While the valve is held at this oblique angle by secondary
catheter 150, valve function and patient condition are assessed,
and if appropriate the valve is completely deployed within the
native annulus, and anchored using traditional anchoring
elements.
[0254] FIG. 53 is an illustration of an open cross-section view of
a low-profile, side-delivered prosthetic valve and shows the inner
valve sleeve 110 and frame 102.
[0255] FIG. 54 is an illustration of a two-panel embodiment of an
inner valve sleeve 110.
[0256] FIG. 55 is an illustration of one embodiment of an inner
valve sleeve 110 having two rigid support posts 154.
[0257] FIG. 56 is an illustration of a three-panel embodiment of an
inner valve sleeve 110.
[0258] FIG. 57 is an illustration of a three-panel embodiment of an
inner valve sleeve 110 having three rigid support posts 154.
[0259] FIG. 58 is a flowchart describing one set of method steps
for delivery of a low-profile, side-delivered prosthetic valve.
[0260] STEP 1: Provide low profile, side-loading prosthetic
valve;
[0261] STEP 2: compress valve into a delivery catheter, where the
valve is compressed along a horizontal axis that is parallel to the
length-wise axis of the delivery catheter;
[0262] STEP 3: advance the delivery catheter containing the
side-loaded valve to the right atrium via the inferior vena
cava;
[0263] STEP 4: expel the side-loaded valve from the delivery
catheter, and using a steerable secondary catheter, seat the valve
into the native annulus;
[0264] STEP 5: optionally, before fully seating the valve into the
native annulus, hold the valve at an oblique angle to assess valve
function, and then after assessing valve function, fully seat the
valve into the native annulus.
[0265] FIG. 59 is an illustration of a plan view of a tissue anchor
having a floating radio-opaque marker. This figure shows the tissue
anchor accessing the annular tissue withe the radio-opaque marker
at the distal end of the anchor and in contact with the atrial
surface of the annular tissue. This figure shows the tissue anchor
advancing into the annular tissue with the radio-opaque marker
threaded onto the tissue anchor and maintaining position on the
atrial surface of the annular tissue. This figure shows the tissue
anchor completely advanced into the annular tissue such that the
tissue anchor and the threaded floating marker are now adjacent,
indicating the desired depth, tension, and/or plication of the
tissue anchor with respect to the annular tissue.
[0266] FIG. 60 is an illustration of a plan view of of a tissue
anchor having a straight thread and a constant pitch.
[0267] FIG. 61 is an illustration of a plan view of of a tissue
anchor having a straight thread and a variable pitch.
[0268] FIG. 62 is an illustration of a plan view of of a tissue
anchor having a tapered thread and a constant pitch.
[0269] FIG. 63 is an illustration of a plan view of of a tissue
anchor having a sunken taper thread and a variable pitch.
[0270] FIG. 64 is an illustration of Step 1 of a 4 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 64 shows a low profile valve being
inserted into the valve annulus and low profile valve having an
integral anchor delivery conduit or channel with an anchor disposed
in the lumen of the channel and an anchor delivery catheter
attached to the anchor.
[0271] FIG. 65 is an illustration of Step 2 of a 4 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 65 shows a low profile valve completely
deployed within the valve annulus and an integral anchor delivery
conduit or channel with an anchor disposed in the lumen of the
channel and an anchor delivery catheter attached to the anchor.
[0272] FIG. 66 is an illustration of Step 3 of a 4 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 66 shows the anchor being pushed out of
the lumen of the delivery conduit or channel and into the annular
tissue.
[0273] FIG. 67 is an illustration of Step 4 of a 4 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 67 shows the anchor in a locked position
after being pushed out of the lumen of the delivery conduit or
channel and into the annular tissue, thus anchoring the proximal
side of the low profile valve.
[0274] FIG. 68 is an illustration of Step 1 of a 5 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 68 shows catheter delivery of an
attachment wire with the clip housed within the lumen of the clip
delivery catheter.
[0275] FIG. 69 is an illustration of Step 2 of a 5 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 69 shows the clip delivery catheter
inserted into an intra-annular space and shows an attachment wire
and shows the clip housed within the lumen of the clip delivery
catheter.
[0276] FIG. 70 is an illustration of Step 3 of a 5 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 70 shows a receiver element ejected from
the delivery catheter and positioned behind tissue to be
captured.
[0277] FIG. 71 is an illustration of Step 4 of a 5 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 71 shows an anchor element piercing the
annular tissue and inserting into a receiver element.
[0278] FIG. 72 is an illustration of Step 5 of a 5 step process for
clipping a low profile valve to annular tissue, as shown here in a
non-limiting example of clipping to a proximal or anterior side of
the native annulus. FIG. 72 shows that the clip delivery catheter
is withdrawn and the anchor element and receiver element are
connected to the annular tissue and a also connected by connector
wire to the low profile valve.
[0279] FIG. 73 is an illustration of one embodiment of a partial
cut-away interior view of a tri-leaflet embodiment of a
low-profile, e.g. 8-20 mm, side-delivered prosthetic valve.
[0280] FIG. 74 is an illustration of another embodiment of a
partial cut-away interior view of a tri-leaflet embodiment of a
low-profile, e.g. 8-20 mm, side-delivered prosthetic valve.
[0281] FIG. 75 is an illustration of a top view of a tri-leaflet
embodiment of a low-profile, e.g. 8-20 mm, side-delivered
prosthetic valve.
[0282] FIG. 76 is an illustration of the trans-septal (femoral-IVC)
delivery of a low-profile, e.g. 8-20 mm, side-delivered prosthetic
MITRAL valve shown partially housed within the delivery catheter,
and partially ejected for deployment into the native mitral
annulus.
[0283] FIG. 77 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic MITRAL valve shown housed within the
delivery catheter.
[0284] FIG. 78 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic MITRAL valve shown partially housed
within a delivery catheter and partially laterally ejected from the
delivery catheter and positioned for deployment against the
anterior side of the native mitral annulus.
[0285] FIG. 79 is an illustration of a low-profile, e.g. 8-20 mm,
side-delivered prosthetic MITRAL valve shown ejected from the
delivery catheter and positioned against the anterior side of the
native mitral annulus.
[0286] FIG. 80 is an illustration of a side or plan view of a
low-profile, e.g. 8-20 mm, side-delivered prosthetic valve shown
deployed into the native MITRAL annulus.
PARTS LIST
[0287] 100 side-loading transcatheter heart valve replacement
[0288] 102 a ring-shaped tubular frame
[0289] 104 a braid, wire, or laser-cut wire frame
[0290] 106 substantially circular central aperture,
[0291] 108 biocompatible material cover for frame;
[0292] 110 valve sleeve, aka a collapsible flow control sleeve
[0293] 112,114 valve sleeve panels
[0294] 116 a reciprocating closable channel from a heart atrium to
a heart ventricle;
[0295] 118 a transcatheter implantation (delivery) catheter
[0296] 120 an internal diameter from 22 Fr (7.33 mm) to 34 Fr
(11.33 mm),
[0297] 122 compressed tubular frame oriented parallel to
length-wise axis delivery catheter
[0298] 124 length-wise axis of a delivery catheter.
[0299] 126 lower tension arm/tab, braid/laser
[0300] 128 upper tension arm/tab, braid/laser
[0301] 130 proximal sealing cuff
[0302] 132 hourglass annular seal
[0303] 134 upper proximal tab
[0304] 136 lower proximal tab
[0305] 138 screw anchor
[0306] 140 wire tubular frame
[0307] 142 upper tension arm/tab, wire
[0308] 144 lower tension arm/tab, wire
[0309] 146 substantially circular central aperture
[0310] 148 upper proximal tab, wire
[0311] 150 steerable anchoring/deployment catheter
[0312] 152 screw/anchor tab
[0313] 154 valve sleeve support posts
[0314] 156 sleeve terminus aperture
[0315] 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.
[0316] 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.
* * * * *