U.S. patent application number 12/439681 was filed with the patent office on 2010-03-04 for blood vessel prosthesis and delivery apparatus.
This patent application is currently assigned to BARTS AND THE LONDON NHS TRUST. Invention is credited to Martin Terry Rothman.
Application Number | 20100057181 12/439681 |
Document ID | / |
Family ID | 37137157 |
Filed Date | 2010-03-04 |
United States Patent
Application |
20100057181 |
Kind Code |
A1 |
Rothman; Martin Terry |
March 4, 2010 |
BLOOD VESSEL PROSTHESIS AND DELIVERY APPARATUS
Abstract
A prosthesis delivery apparatus, a method of delivering a
prosthesis, and a prosthesis are provided. The prosthesis (3) is
for delivering to the branch region of the ascending aorta (1) and
the right and left coronary arteries (12, 13), and it comprises a
main conduit (33) and first and second branch conduits (31, 32).
The branch conduits (31, 32) are or locating in the right and left
coronary arteries (12, 13) respectively upon moving from a first
position in which they are located in the main conduit (33) to a
second position in which they project out from the main conduit
(33). The branch conduits (31, 32) turn inside out as the move from
the first position to the second position.
Inventors: |
Rothman; Martin Terry;
(London, GB) |
Correspondence
Address: |
STEPTOE & JOHNSON LLP
2121 AVENUE OF THE STARS, SUITE 2800
LOS ANGELES
CA
90067
US
|
Assignee: |
BARTS AND THE LONDON NHS
TRUST
Whitechapel, London
GB
|
Family ID: |
37137157 |
Appl. No.: |
12/439681 |
Filed: |
August 30, 2007 |
PCT Filed: |
August 30, 2007 |
PCT NO: |
PCT/GB07/03274 |
371 Date: |
August 3, 2009 |
Current U.S.
Class: |
623/1.11 ;
606/108 |
Current CPC
Class: |
A61F 2/07 20130101; A61F
2/954 20130101; A61F 2002/061 20130101; A61F 2002/065 20130101 |
Class at
Publication: |
623/1.11 ;
606/108 |
International
Class: |
A61F 2/06 20060101
A61F002/06; A61F 11/00 20060101 A61F011/00 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 31, 2006 |
GB |
06172191.1 |
Claims
1. Prosthesis delivery apparatus for delivering a prosthesis to the
branch region of the ascending aorta and the right and left
coronary arteries, the apparatus comprising: a prosthesis
comprising a main conduit and first and second branch conduits, a
first guide wire for inserting in the ascending aorta such that it
extends through the ascending aorta into the right coronary artery;
and a second guide wire for inserting in the ascending aorta such
that it extends through the ascending aorta into the left coronary
artery; wherein the prosthesis is arranged such that: the first and
second branch conduits are movable along the first and second guide
wires to the branch region, and the first branch conduit is movable
from a first position in which it projects inside the main conduit,
to a second position in which it projects out from the main conduit
for location in the right coronary artery, the first branch conduit
being arranged to turn inside out as it moves from the first
position to the second position, and the second branch conduit is
movable from a first position in which it projects inside the main
conduit to a second position in which it projects out from the main
conduit for location in the left coronary artery, the second branch
conduit being arranged to turn inside out as it moves from the
first position to the second position.
2. The delivery apparatus of claim 1, comprising one or more
actuators for moving the first and second branch conduits from the
first to the second position.
3. The delivery apparatus of claim 2, comprising one or more
actuators for moving the first branch and second branch conduits
along the first and second guide wires to the branch region.
4. The delivery apparatus of claim 3, wherein the same actuators
are used to move the first branch and second branch conduits along
the first and second guide wires to the branch region and to move
the first and second branch conduits from the first to the second
position.
5. The delivery apparatus of claim 2, wherein the actuators are
push rods.
6. The delivery apparatus of claim 5, wherein the push rods are
slidably mounted on the guide wires.
7. The delivery apparatus of claim 1, wherein the first and/or
second guide wire comprises an identifying mark or shape.
8. The delivery apparatus of claim 1, wherein the first and/or
second guide wire is configured for insertion into the ascending
aorta percutaneously.
9. The delivery apparatus of claim 1, wherein the prosthesis is
configured for insertion into the ascending aorta
percutaneously.
10. The delivery apparatus of claim 1, wherein the prosthesis is
expandable from a collapsed state to an expanded state.
11. The delivery apparatus of claim 10, comprising a delivery
casing for holding the prosthesis in a collapsed state during
delivery of the prosthesis to the branch region.
12. The delivery apparatus of claim 11, wherein the prosthesis is
arranged to expand automatically upon removal of the delivery
casing.
13. The delivery apparatus of claim 1, further comprising one or
more stents for securing the prosthesis in place at the branch
region.
14. A prosthesis for locating at the branch region of the ascending
aorta and the right and left coronary arteries, the prosthesis
comprising a main conduit and first and second branch conduits, the
first branch conduit being for locating in the right coronary
artery and the second branch conduit being for locating in the left
coronary artery, wherein: the first branch conduit is movable from
a first position in which it projects inside the main conduit to a
second position in which projects out from the main conduit in
order for it to locate in the right coronary artery, the first
branch conduit being arranged to turn inside out as it moves from
the first position to the second position, and the second branch
conduit is movable from a first position in which it projects
inside the main conduit to a second position in which projects out
from the main conduit in order for it to locate in the left
coronary artery, the second branch conduit being arranged to turn
inside out as it moves from the first position to the second
position.
15. The prosthesis of claim 14, wherein the main conduit comprises
a first end which defines an opening, a second end which defines an
opening and a side wall extending between the first and second ends
of the main conduit, the first and second branch conduits being
mounted to the side wall of the main conduit.
16. The prosthesis of claim 15, wherein the first and/or second
branch conduits are configured to be movable along respective first
and second guide wires.
17. The prosthesis of claim 14, wherein the first and/or second
branch conduits have an engagement surface at one end for engaging
one or more actuators for moving the branch conduits from the first
to the second position.
18. The prosthesis of claim 14, wherein the prosthesis is
expandable from a collapsed state to an expanded state.
19. The prosthesis of claim 18, further comprising a removable
delivery casing for holding the prosthesis in the collapsed
state.
20. The prosthesis of claim 14, wherein the first and second branch
conduits are mounted to opposing flanks of the sidewall of the main
conduit.
21. The prosthesis of claim 14, wherein the main conduit, and first
and second branch conduits are one-piece.
22. The prosthesis of claim 14, wherein the first and/or second
branch conduit comprises a fixing means for fixing the branch
conduit in the coronary artery.
23. The prosthesis of claim 22, wherein the fixing means for fixing
the first and/or second branch conduit is a stent.
24. The prosthesis of claim 14, wherein the main conduit comprises
one or more fixing means for fixing the first and/or second end of
the main conduit to the wall of the ascending aorta.
25. The prosthesis of claim 24, wherein the fixing means for fixing
the first and/or second end of the main conduit is a stent.
26. (canceled)
27. (canceled)
28. A method for delivering a prosthesis to the branch region of
the ascending aorta and the right and left coronary arteries, the
prosthesis comprising a main conduit and first and second branch
conduits, the method comprising the steps of: inserting a first
guide wire in the ascending aorta such that it extends through the
ascending aorta into the right coronary artery; inserting a second
guide wire in the ascending aorta such that it extends through the
ascending aorta into the left coronary artery. moving the
prosthesis to the branch region by moving the first branch conduit
along the first guide wire and the second branch conduit along the
second guide wire; and moving the first branch conduit along the
first guide wire from a first position in which it projects inside
the main conduit to a second position in which it projects out from
the main conduit, to locate the first branch conduit in the right
coronary artery, the first branch conduit turning inside out as it
moves from the first position to the second position; moving the
second branch conduit along the second guide wire from a first
position in which it projects inside the main conduit to a second
position in which it projects out from the main conduit, to locate
the second branch conduit in the left coronary artery, the second
branch conduit turning inside out as it moves from the first
position to the second position.
29. The method of claim 28, wherein one or more actuators are used
for moving the first branch and second branch conduits along the
first and second guide wires to the branch region.
30. The method of claim 29, wherein one or more actuators are used
for moving the first and second branch conduits from the first to
the second position.
31. The method of claim 29, wherein the same actuators are used to
move the first branch and second branch conduits along the first
and second guide wires toward the branch region and to move the
first and second branch conduits from the first to the second
position.
32. The method of claim 29, wherein the actuators are push
rods.
33. The method of claim 32, wherein the push rods are slidably
mounted on the guide wires.
34. The method of claim 28, wherein the first and/or second guide
wire comprises an identifying mark or shape.
35. The method of claim 28, wherein the first and/or second guide
wire is inserted into the ascending aorta percutaneously.
36. The method of claim 28, wherein the prosthesis is inserted into
the ascending aorta percutaneously.
37. The method of claim 28, wherein the prosthesis is expanded from
a collapsed state to an expanded state at the branch region.
38. The method of claim 37, wherein a delivery casing is provided
for holding the prosthesis in a collapsed state during delivery of
the prosthesis to the branch region.
39. The method of claim 38, wherein the prosthesis expands
automatically upon removal of the delivery casing.
40. The method of claim 28, wherein one or more stents are used to
secure the prosthesis at the branch region.
Description
[0001] The invention relates to a prosthesis for a blood vessel,
and a delivery apparatus for delivering the prosthesis to the blood
vessel, particularly, but not necessarily exclusively, for use in
the treatment of aneurysms or dissections of the blood vessel.
[0002] Aneurysms are permanent distensions of the wall of a blood
vessel, e.g. an artery, which disrupt the haemodynamics of the
blood vessel. The aneurysm may halt the flow of blood at certain
regions of the blood vessel, increasing the risk of clot formation,
which may in turn cause cerebral embolism. Furthermore, a reduction
in the structural wall integrity of the blood vessel may occur,
which can cause a reduction in the effectiveness of the blood
vessel and put a higher strain on the heart muscle, increasing the
risk of heart failure or vessel rupture.
[0003] Dissections are tears in the blood vessel's intima or
delaminations of the collagen/elastin wall architecture of the
blood vessel. Dissections can result in a false lumen, i.e. inner
cavity, within the blood vessel. The false lumen may provide areas
in which blood can pool, increasing the risk of clot formation and
subsequent cerebral embolism. Severe dissection may even result in
a breach of the blood vessel integrity and possible bleeding from
the blood vessel e.g. into the thoracic cavity, which may cause
death in a short period of time.
[0004] Traditional treatment for dissections and aneurysms include
surgical resection, removing the offending tissue (depending on the
extent of the damage to the blood vessel), or the insertion of a
tubular prosthesis or stent grant within the lumen of the blood
vessel to remove the mechanical loading on the damaged blood vessel
wall and to provide a haemodynamically compatible conduit for the
transport of blood. Prostheses are traditionally made from
Dacron.RTM. or high density Polytetrafluoroethylene (PTFE).
[0005] More recently, endovascular methods of prosthesis
introduction have reduced health risks to the patient by allowing
percutaneous introduction of the prosthesis via the femoral artery.
Operations can therefore be conducted under local anaesthetic, and
cardiac arrest and/or cardiac bypass procedures may be eliminated,
reducing the overall cost of the treatment.
[0006] Prostheses and stent grafts have been designed for
positioning at bifurcation regions of blood vessels, i.e. regions
in which the blood vessel branches. For example, PCT Application
nos. WO00042948, WO03082153 and WO05122957 and U.S. Pat. No.
5,984,955 disclose bifurcated prostheses/stent grafts for
positioning primarily at the iliac bifurcation of the aorta. The
prostheses comprise a main conduit, a first branch conduit
extending therefrom, and a removable or retractable second branch
conduit. The main conduit is designed to locate within the aorta
and the first and second branch conduits are designed to locate
within respective iliac arteries.
[0007] Journal article: K. Inoue et al., Aortic Arch Reconstruction
by Transluminally Placed Endovascular Branched Stent Graft",
Circulation. 1999; 100 describes a stent graft which includes
conduits for aortic branches and a method of introduction.
[0008] The prostheses/stent grafts described above are generally
sited percutaneously using a catheter delivery system which allows
introduction to and guidance through the vasculature. Control of
the device is made through pushrods or hypotubes which can extract
the device from a casing and locate it in position.
[0009] Notably, none of these prostheses and stent grafts, or the
delivery systems thereof, are intended for, or are indeed
appropriate for, positioning at the branch region of the ascending
aorta where the aortic root meets the right and left coronary
arteries, which feed the heart muscle with oxygenated blood. The
anatomy of the aortic root and the coronary arteries is complex.
This location is particularly prone to aneurysms and
dissections.
[0010] According to a first aspect of the present invention, there
is provided [0011] a prosthesis delivery apparatus for delivering a
prosthesis to the branch region of the ascending aorta and the
right and left coronary arteries, the apparatus comprising: [0012]
a prosthesis comprising a main conduit and first and second branch
conduits, a first guide wire for inserting in the ascending aorta
such that it extends through the ascending aorta into the right
coronary artery; and [0013] a second guide wire for inserting in
the ascending aorta such that it extends through the ascending
aorta into the left coronary artery; [0014] wherein the prosthesis
is arranged such that: [0015] the first and second branch conduits
are movable along the first and second guide wires to the branch
region, and [0016] the first branch conduit is movable from a first
position in which it projects inside the main conduit, to a second
position in which it projects out from the main conduit for
location in the right coronary artery, the first branch conduit
being arranged to turn inside out as it moves from the first
position to the second position, and [0017] the second branch
conduit is movable from a first position in which it projects
inside the main conduit to a second position in which it projects
out from the main conduit for location in the left coronary artery,
the second branch conduit being arranged to turn inside out as it
moves from the first position to the second position.
[0018] According to a second aspect of the present invention, there
is provided: [0019] a method for delivering a prosthesis to the
branch region of the ascending aorta and the right and left
coronary arteries, the prosthesis comprising a main conduit and
first and second branch conduits, the method comprising the steps
of: [0020] inserting a first guide wire in the ascending aorta such
that it extends through the ascending aorta into the right coronary
artery; [0021] inserting a second guide wire in the ascending aorta
such that it extends through the ascending aorta into the left
coronary artery. [0022] moving the prosthesis to the branch region
by moving the first branch conduit along the first guide wire and
the second branch conduit along the second guide wire; and [0023]
moving the first branch conduit along the first guide wire from a
first position in which it projects inside the main conduit to a
second position in which it projects out from the main conduit, to
locate the first branch conduit in the right coronary artery, the
first branch conduit turning inside out as it moves from the first
position to the second position; [0024] moving the second branch
conduit along the second guide wire from a first position in which
it projects inside the main conduit to a second position in which
it projects out from the main conduit, to locate the second branch
conduit in the left coronary artery, the second branch conduit
turning inside out as it moves from the first position to the
second position.
[0025] Preferably, the prosthesis is mounted on the first and
second guide wires, by inserting the first and second guide wires
through the first and second branch conduits respectively, prior to
moving the branch conduits toward the branch region.
[0026] According to a third aspect of the present invention, there
is provided: [0027] a prosthesis for locating at the branch region
of the ascending aorta and the right and left coronary arteries,
the prosthesis comprising a main conduit and first and second
branch conduits, the first branch conduit being for locating in the
right coronary artery and the second branch conduit being for
locating in the left coronary artery, wherein: [0028] the first
branch conduit is movable from a first position in which it
projects inside the main conduit to a second position in which
projects out from the main conduit in order for it to locate in the
right coronary artery, the first branch conduit being arranged to
turn inside out as it moves from the first position to the second
position, and [0029] the second branch conduit is movable from a
first position in which it projects inside the main conduit to a
second position in which projects out from the main conduit in
order for it to locate in the left coronary artery, the second
branch conduit being arranged to turn inside out as it moves from
the first position to the second position.
[0030] This arrangement of the branch conduits described above
permits the prosthesis to take a compact shape during delivery to
the branch region of the blood vessel. Thus, the possibility of
obstruction of the prosthesis during delivery is reduced.
Furthermore, by arranging the branch conduits to turn inside out,
moving the branch conduit from the first to the second position may
be straightforward, and construction of the branch conduits may be
uncomplicated. The prosthesis may be manufactured in one-piece.
[0031] Preferably, the prosthesis used in the delivery apparatus
according to the first aspect of the present invention and/or of
the prosthesis used in the method according to the second aspect of
the present invention, is a prosthesis according to the third
aspect of the invention.
[0032] The prosthesis may be used to treat aneurysms or dissections
of the ascending aorta proximal to the aortic valve and the left
ventricle of the heart.
[0033] According to a fourth aspect of the present invention, there
is provided: [0034] a prosthesis delivery apparatus for delivering
a prosthesis to a branch region of a blood vessel, the branch
region having first and second blood vessel branches, the apparatus
comprising: [0035] a prosthesis comprising a main conduit and first
and second branch conduits, [0036] a first guide wire for inserting
in the blood vessel such that it extends through the blood vessel
into the first blood vessel branch; and [0037] a second guide wire
for inserting in the blood vessel such that it extends through the
blood vessel into the second blood vessel branch; [0038] wherein
the prosthesis is arranged such that the first branch conduit is
movable along the first guide wire toward the first blood vessel
branch for location in the first blood vessel branch and the second
branch conduit is movable along the second guide wire toward the
second blood vessel branch for location in the second blood vessel
branch.
[0039] According to a fifth aspect of the present invention, there
is provided: [0040] a method for delivering a prosthesis to a
branch region of a blood vessel, the branch region having first and
second blood vessel branches, the prosthesis comprising a main
conduit and first and second branch conduits, the method comprising
the steps of: [0041] inserting a first guide wire in the blood
vessel such that it extends through the blood vessel into the first
blood vessel branch; [0042] inserting a second guide wire in the
blood vessel such that it extends through the blood vessel into the
second blood vessel branch; [0043] moving the first branch conduit
along the first guide wire toward the first blood vessel branch for
location in the first blood vessel branch and moving the second
branch conduit along the second guide wire toward the second blood
vessel branch for location in the second blood vessel branch.
[0044] Preferably, in the fourth and fifth aspects of the present
invention, the prosthesis is mounted on the first and second guide
wires by inserting the first and second guide wires through the
first and second branch conduits respectively, prior to moving the
branch conduits toward the first and second blood vessel
branches.
[0045] According to a sixth aspect of the present invention, there
is provided: [0046] a prosthesis for locating at a branch region of
a blood vessel, the branch region having a first blood vessel
branch, the prosthesis comprising a main conduit and a first branch
conduit, the first branch conduit being for locating in the first
blood vessel branch, wherein the first branch conduit is movable
from a first position in which it projects inside the main conduit
to a second position in which projects out from the main conduit in
order for it to locate in the first blood vessel branch, the first
branch conduit being arranged to turn inside out as it moves from
the first position to the second position.
[0047] Preferably, in the sixth aspect of the present invention,
the prosthesis comprises a second branch conduit, the second branch
conduit being for locating in a second blood vessel branch of the
branch region.
[0048] Preferably, the second branch conduit is movable from a
first position in which it projects inside the main conduit to a
second position in which it projects out from the main conduit in
order for it to locate in the second blood vessel branch, the
second branch conduit being arranged to turn inside out as it moves
from the first position to the second position.
[0049] This arrangement of the branch conduit(s) permits the
prosthesis to take a compact shape during delivery to the branch
region of the blood vessel. Thus, the possibility of obstruction of
the prosthesis during delivery is reduced. Furthermore, by
arranging the branch conduit(s) to turn inside out, moving the
branch conduit(s) from the first to the second position may be
straightforward, and construction of the branch conduit(s) may be
uncomplicated. The prosthesis may be manufactured in one-piece, for
example.
[0050] In the various aspects of the invention, preferably, the
main conduit comprises a first end which defines an opening, a
second end which defines an opening, and a sidewall extending
between the first and second ends. Preferably, the first and second
branch conduits are mounted to opposing flanks of the sidewall of
the main conduit. Preferably, the first and second branch conduits
and the main conduit are one-piece.
[0051] The main conduit may be substantially cylindrical. The
cross-section of the main conduit, in a plane substantially
perpendicular to the longitudinal axis of the main conduit, may
therefore be substantially circular. In this description, the term
`mounted to opposing flanks` is intended to mean that the first and
second branch conduits are mounted to the sidewall at positions
which are more than 90 degrees apart, preferably more than 150
degrees apart, about the circumference of the circle or other
cross-sectional shape. The first and second branch conduits may be
mounted at positions of the sidewall that are offset in a direction
parallel to the longitudinal axis of the main conduit.
[0052] According to a seventh aspect of the present invention,
there is provided: [0053] a prosthesis for locating at a branch
region of a blood vessel, the branch region having first and second
blood vessel branches, the prosthesis comprising: [0054] a main
conduit and first branch and second branch conduits, the main
conduit having a first end which defines an opening, a second end
which defines an opening, and a side wall extending between the
first and second ends, the first and second branch conduits being
for locating in the first and second blood vessel branches
respectively, [0055] wherein the first and second branch conduits
are mounted to opposing flanks of the sidewall of the main conduit,
and [0056] the main conduit and first and second branch conduits
are one-piece.
[0057] Preferably, the prosthesis used in the delivery apparatus
according to the fourth aspect of the present invention, and/or the
prosthesis used in the method according to the fifth aspect of the
present invention, is a prosthesis according to the sixth or
seventh aspect of the invention.
[0058] In the fourth, fifth, sixth and seventh aspects of the
present invention, preferably, the blood vessel is an artery,
preferably the aorta, most preferably the ascending aorta.
Preferably, the first and second blood vessel branches are the left
and right coronary arteries. Thus, the prosthesis may be used to
treat aneurysms or dissections of the ascending aorta proximal to
the aortic valve and the left ventricle of the heart.
[0059] In the various aspects of the invention, preferably, one or
more first actuators are provided to move the first and second
branch conduits from the first to the second position. Preferably,
the first actuators are push rods. The push rods may be slidably
mounted on the guide wires. Thus, since the guide wires are located
in the blood vessel branches, the push rods may push the branch
conduits in the appropriate directions for location in the blood
vessel branches (e.g. the left and right coronary arteries), simply
by sliding along the guide wires.
[0060] Preferably, first and second push rods are provided as first
actuators, the first push rod being arranged to push the first
branch conduit and the second push rod being arranged to push the
second branch conduit. Preferably, the first and second push rods
are slidably mounted on the first and second guide wires
respectively. The first and second guide wires may extend through a
portion of, or all of, the first and second push rods respectively.
For example, the guide wires may extend through the first and
second push rods at positions within the prosthesis, but be
separated from the push rods at positions outside the prosthesis.
The guide wires may extend out of the push rods via one or more
side holes.
[0061] Preferably, one or more second actuators are provided to
push the prosthesis, e.g. the main conduit of the prosthesis,
toward the branch region of the blood vessel, which in turn causes
the first and second branch conduits to move along the first and
second guide wires respectively. Preferably, the second actuator
can also move the prosthesis in the opposite direction, i.e. in a
direction away from the branch region. Thus, the first and second
actuators may work against each other, e.g. so that the main
conduit of the prosthesis can be held stationary whilst the branch
conduits are moved from the first position to the second position.
The second actuators may be one or more push rods. The first
actuator push rods may be arranged to extend through one or more
conduits provided by the second actuator push rods.
[0062] Preferably, the first and/or second guide wire comprises an
identifying mark or shape. Thus, the appropriate guide wire can be
chosen for each blood vessel branch.
[0063] Preferably, the prosthesis is expandable from a contracted
state to an expanded state. Accordingly, the prosthesis may be
placed in a contracted position during delivery to the branch
region, so that it is less likely to be obstructed during delivery.
Then, once positioned at the branch region, it may be expanded to a
desired size for use.
[0064] Preferably, a delivery casing is provided for holding the
prosthesis in a contracted state during delivery of the prosthesis
to the branch region. Preferably, the prosthesis is arranged to
expand automatically upon removal of the delivery casing. The
delivery casing may be a sleeve that surrounds the prosthesis to
maintain it in a contracted state. The delivery casing may be
elongated and may act as the second actuator for pushing the
prosthesis to the branch region of the blood vessel.
[0065] The prosthesis may be resiliently biased when positioned in
the contracted state such that, upon removal of the delivery
casing, the prosthesis expands automatically. The prosthesis may be
formed of PTFE, or Nylon etc. The prosthesis may be resiliently
biased by e.g. shape memory alloy elements, e.g. formed of Nitinol,
embedded therein.
[0066] By locating in the blood vessel branches (e.g., the right
and left coronary arteries), the first and second branch conduits
may be used to anchor the prosthesis in position; prevent occlusion
of the opening between the blood vessel branches, into which they
locate, and the blood vessel (e.g., the ascending aorta); and/or
help maintain the main conduit in the expanded state.
[0067] A fixing means may be provided for fixing the first and
second branch conduits in position in the respective first and
second blood vessel branches. The fixing means may be integral with
the branch conduits. For example, the fixing means may be one or
more stents attached to e.g. an end of the branch conduits.
Balloons may be provided on the first actuators, e.g. push rods, to
expand the stents in order to fix the branch conduits in position.
The first actuators, e.g. push rods, may be used to hold the branch
conduits in position prior to fixing, to prevent e.g. retraction of
the branch conduits from the blood vessel branches. Alternatively,
separate fixing means may be provided to fix the branch conduits in
position, e.g. after the push rods have been retracted. For
example, independent stents or endovascular staples may be
used.
[0068] A fixing means may be provided at one or both ends of the
main conduit. The fixing means may be used to anchor the respective
ends of the main conduit against the blood vessel wall in order to
prevent blood ingress between the main conduit and the blood vessel
wall. The fixing means may be integral with the respective ends of
the main conduit. For example, the fixing means may be one or more
stents attached to the ends, the stents being expandable e.g. by
balloons. Alternatively, separate fixing means may be provided to
fix the main conduit in position, e.g. after the first actuator
push rods have been retracted. For example, independent stents, or
endovascular staples may be used.
[0069] Preferably, the prosthesis and/or the guide wires are
configured for insertion into the blood vessel percutaneously.
Thus, an endovascular method of prosthesis delivery may be
provided.
[0070] By having open first and second ends of the main conduit,
blood may flow between the blood vessel and the main conduit. The
guide wires and/or actuators (e.g. push rods) may extend through
the main conduit via the opening of the first end. Preferably, the
second end of the main conduit is for locating adjacent the aortic
valve. The second end of the main conduit may comprise an
artificial aortic valve.
[0071] Preferably, the first and second branch conduits are
connected to the side wall of the main conduit such that blood may
flow between the first and second branch conduits and the main
conduit. By connecting the branch conduits to the side wall, rather
than the second end for example, an appropriate configuration may
be achieved for positioning the prosthesis e.g. at the branching of
the aortic root and the right and left coronary arteries. In
particular, this arrangement may permit the branch conduits to
project in directions substantially opposite from each other, and
substantially perpendicular to the longitudinal axis of the main
conduit. Thus, the prosthesis may conform to the complex anatomy of
the bifurcation of the aortic root and the right and left coronary
arteries.
[0072] An example embodying the present invention is now described
with reference to the accompanying drawings, in which: [0073] FIG.
1a shows guide wires of a delivery apparatus according to a first
embodiment of the present invention extending through a blood
vessel to a branch region of the blood vessel; [0074] FIGS. 1b and
1c show a prosthesis according to the present invention mounted on
the guide wires of FIG. 1a and moved towards the branch region of
the blood vessel; [0075] FIGS. 2a to 2d show successive steps
performed during the location of branch conduits of the prosthesis
of FIGS. 1b and 1c into blood vessel branches of the branch region
of the blood vessel; [0076] FIG. 3 shows a delivery apparatus
according to a second embodiment of the present invention; and
[0077] FIGS. 4a to 4e show a branch conduit of a prosthesis
according to a third embodiment of the present invention.
[0078] A first embodiment of a delivery apparatus according to the
present invention, for delivering a prosthesis to a branch region
of a blood vessel, is shown in FIGS. 1a to 1c and FIGS. 2a to 2d.
In this embodiment, the blood vessel is the ascending aorta 1 of a
human, and the branch region is the region at the aortic root 11,
where the right and left coronary arteries 12, 13 connect to the
aorta 1, adjacent to the aortic valve 15.
[0079] The delivery apparatus comprises first and second guide
wires 21, 22, a prosthesis 3, a prosthesis delivery casing 4, and
first and second push rods 51, 52. The prosthesis 3 is formed from
haemodynamically compatible material and comprises a main conduit
33 having a first end 331, a second end 332 and side wall 34
extending between the first and second ends 331, 332. The first and
second ends 331, 332 are open. The prosthesis 3 comprises first and
second branch conduits 31, 32, which are connected at respective
first ends 311, 321 to opposite flanks of the side wall 34. The
first ends 311, 321 of the branch conduits 31, 32 are open to
permit blood flow between the branch conduits 31, 32 and the main
conduit 33. The second ends 312, 322 of the branch conduits 31, 32
are also open, to permit blood flow between the branch conduits 31,
32 and the coronary arteries 12, 13.
[0080] The steps undertaken to deploy the prosthesis 3, using the
delivery apparatus, are described below.
[0081] Firstly, with reference to FIGS. 1a to 1c, the first guide
wire 21 is percutaneously inserted into the aorta 1 such that it
extends through the aorta 1 and a first end 212 of the first guide
wire 21 is positioned in the right coronary artery 12. The first
guide wire 21 may be placed in this position using a catheter (not
shown), which is subsequently removed.
[0082] Next, the second guide wire 22 is percutaneously inserted
into the aorta 1 such that it extends through the aorta 1 and a
first end 222 of the second guide wire 22 is positioned in the left
coronary artery 13. The second guide wire 22 may also be placed in
this position using a catheter (not shown), which is subsequently
removed.
[0083] Next, the prosthesis 3, surrounded by the delivery casing 4,
is mounted on the first and second guide wires 21, 22 and pushed by
a push rod 53 along the guide wires 21, 22, past the aortic branch
arteries 14, toward the aortic root 11, as shown in FIGS. 1b and
1c.
[0084] As can be seen in FIG. 2a, which shows a cross-section of
the prosthesis 3 mounted on the first and second guide wires 21,
22, during delivery to the aortic root region 11, the first and
second branch conduits 31, 32 are in a first position in which they
project into the interior of the main conduit 33. Furthermore, the
main conduit 33 is held in a contracted state by the delivery
casing 4. The delivery casing 4 is a removable sleeve that
surrounds and compresses the main conduit 33. Accordingly, the
prosthesis 3 may take a compact shape during delivery to the aortic
root region 11, reducing the chance of the prosthesis 3 being
obstructed on the way.
[0085] In the first position, the first and second branch conduits
31, 32 are inclined from the sidewall 34. The first and second
branch conduits 31, 32 project toward the first end opening 333 of
the main conduit 3. As shown in FIG. 2a, the first and second guide
wires 21, 22 extend into the main conduit 33 via the first end
opening 333 of the main conduit 33, and through the first and
second branch conduits 31, 32 via the open second ends 312, 322 of
the first and second branch conduits 31, 32. The first and second
guide wires 21, 22 then project from the prosthesis 3 via the first
ends 311, 321 of the first and second branch conduits 31, 32,
whereupon they extend between the sidewall 34 and the delivery
casing 4, and then through an opening 42 of the delivery casing
4.
[0086] Once the prosthesis 3 has reached the aortic root region 11,
deployment of the prosthesis 3 takes place as described below with
respect to FIGS. 2b to 2d.
[0087] Firstly, the delivery casing 4 is partially removed from the
prosthesis 3, so that the first ends 311, 321 of the first and
second branch conduits 31, 32 are exposed, as shown in FIG. 2b. The
main conduit 33 of the prosthesis 3 comprises shape memory alloy
elements, such that, upon removal of the delivery casing 4, the
main conduit 33 expands automatically. Once the first ends 311, 321
of the first and second branch conduits 31, 32 are exposed, first
and second push rods 51, 52, which have engagement surfaces 511,
521, that abut the second ends 312, 322 of the first and second
branch conduits 31, 32, are manually controlled to push the second
ends 312, 322 of the branch conduits through the open first ends
311, 321 of the first and second branch conduits 31, 32. This
causes the branch conduits 31, 32 to evert, i.e. turn inside out,
whereupon they are placed in a second position, as shown in FIG.
2c, in which they project outward from the main conduit 33 of the
prosthesis 3. In the second position, the branch conduits 31, 32
project in a direction substantially perpendicular to the
longitudinal axis of the main conduit 33, indicated generally by
line A
[0088] As the first and second branch conduits 31, 32 are moved
from the first position to the second position, by the push rods
51, 52, they are forced into the right and left coronary arteries
respectively. This helps anchor the prosthesis 3 in position,
ensures that the fluid path between the aorta 1 and the coronary
arteries 12, 13 is kept open, and helps maintain the main conduit
33 in the expanded state.
[0089] Next, the delivery casing is removed fully from the
prosthesis, such that the entire main conduit 33 can expand to
substantially the size of the inner wall diameter of the aorta 1.
The push rods 51, 52 are also retracted. To secure the prosthesis 3
in position, a stents (not shown) can be used.
[0090] Thus, the prosthesis 3 may reduce mechanical loading on the
aorta 1 at the aortic root region 11, and may provide a
haemodynamically compatible conduit for the transport of blood
between the aorta and the right and left coronary arteries.
[0091] Subsequently, the first and second guide wires 21, 22 can be
removed.
[0092] In FIG. 2a, it can be seen that the first and second branch
conduits 31, 32 are mounted to opposite flanks of the sidewall 34
at points level with one another, i.e. the mounting points are
generally aligned in a direction parallel to the longitudinal axis
A of the main conduit 33. However, the mounting points may be
offset in a direction parallel to the longitudinal axis A of the
main conduit 33. This may be particularly useful to enable compact
packing of the prosthesis 4; it may mean that the branch conduits
31, 32 do not obstruct each other if the prosthesis 4 is
compressed.
[0093] FIG. 3 shows a delivery apparatus according to a second
embodiment of the present invention. The delivery apparatus is
similar to and functions in generally the same way as the apparatus
of the first embodiment of the invention, except that the
prosthesis in this second embodiment comprises two guide tubes 35,
36. The guide tubes 35, 36 are provided to make mounting of the
prosthesis, on the guide wires 21, 22, simpler. The same numbering
is used to indicate features common to FIG. 3 and FIGS. 1a to
2d.
[0094] As shown in FIG. 3, the guide tubes 35, 36 each fit into the
first and second branch conduits 31, 32 respectively, when the
branch conduits 31, 32 are in their first positions.
[0095] The guide tubes 35, 36 extend through the branch conduits
31, 32 and through the first ends 311, 321 of each branch conduit
31, 32, whereupon they extend between the sidewall 34 and the
delivery casing 4 and through the opening 42 of the delivery casing
4, and then project from the prosthesis 4.
[0096] Since the guide tubes 35, 36 project from the prosthesis 4,
the guide wires 21, 22 can easily be inserted into the guide tubes
35, 36, whereupon the guide tubes 35, 36 serve to channel the guide
wires 21, 22 between the delivery casing 4 and the sidewall 34,
through the branch conduits 31, 32 and through the main conduit 33
of the prosthesis. Thus, mounting of the prosthesis on the guide
wires, is made easier.
[0097] The guide tubes 35, 36 are connected to the prosthesis 4;
however, alternatively, the guide tubes 35, 36 can be connected to
the push rods 51, 52.
[0098] FIGS. 4a to 4e show a branch conduit 32' a push rod 52' of a
delivery apparatus according to a third embodiment of the present
invention. The branch conduit 32' is similar to the branch conduits
31, 32 of the previous embodiments of the invention, and it
functions in generally the same way, except that it comprises an
integral stent 61, located at its second end 322'. The branch
conduit 32' can be used as an alternative to the branch conduits
31, 32 of the previous embodiments. The stent 61 is provided as a
fixing means, to fix the branch conduit 32' in position once it is
located in the appropriate blood vessel branch. The push rod 52' is
similar to the push rods 51, 52 of the previous embodiments of the
invention, and functions in generally the same way as in these
previous embodiments, except that it comprises an inflatable
balloon 62. The balloon 62 is provided to expand the stent 61.
[0099] The steps taken to deploy the branch conduit 32' can be seen
in FIGS. 4a to 4e. In FIG. 4a, the branch conduit 32' is located in
its first position, i.e. in a position in which it is located
inside the main conduit of the prosthesis. From the position shown
in FIG. 4a, the branch conduit 32' is forced along the guide wire
22 to its second position, as shown in FIG. 4b, by the push rod
52'. The branch conduit 32' everts as it moves from the first to
the second position, but the stent 61 does not evert. Once the
branch conduit 32' in the second position, the balloon 62 is
inflated, which forces the stent 61 to expand, as shown in FIG. 4c.
This causes the stent 61 to press the branch conduit 32 against the
side walls of the blood vessel, fixing the branch conduit 32' in
position. Once the branch conduit 32' is fixed in position, the
balloon 62 is deflated as shown in FIG. 4d. Then, the push rod 52',
including the balloon 62, is retracted, as shown in FIG. 4e.
* * * * *