U.S. patent application number 14/832704 was filed with the patent office on 2016-02-25 for vascular conduit device and system for implanting.
The applicant listed for this patent is EMORY UNIVERSITY. Invention is credited to Jorge Hernan Jimenez, Thomas A. Vassiliades, Ajit Yoganathan.
Application Number | 20160051800 14/832704 |
Document ID | / |
Family ID | 37670864 |
Filed Date | 2016-02-25 |
United States Patent
Application |
20160051800 |
Kind Code |
A1 |
Vassiliades; Thomas A. ; et
al. |
February 25, 2016 |
VASCULAR CONDUIT DEVICE AND SYSTEM FOR IMPLANTING
Abstract
The present invention provides a vascular conduit device
including a deformable flange and complementary securing ring in
cooperation for securing the device within an aperture defined in a
tissue wall. The present invention further provides a system for
implanting such a vascular conduit device in a tissue wall. More
specifically, the present invention provides a system including a
coring device for defining an aperture in a tissue wall (such as a
ventricle and/or a blood vessel) and securely implanting a vascular
conduit device therein so as to provide fluid communication between
a first and second surface of the tissue wall via the vascular
conduit device.
Inventors: |
Vassiliades; Thomas A.;
(Atlanta, GA) ; Yoganathan; Ajit; (Tucker, GA)
; Jimenez; Jorge Hernan; (Atlanta, GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
EMORY UNIVERSITY |
ATLANTA |
GA |
US |
|
|
Family ID: |
37670864 |
Appl. No.: |
14/832704 |
Filed: |
August 21, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11251100 |
Oct 14, 2005 |
9138228 |
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14832704 |
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10915691 |
Aug 11, 2004 |
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11251100 |
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Current U.S.
Class: |
604/8 |
Current CPC
Class: |
A61B 2017/00243
20130101; A61B 2017/1135 20130101; A61B 2017/1107 20130101; A61B
2017/00252 20130101; A61F 2/06 20130101; A61F 2/064 20130101; A61B
17/11 20130101; A61M 27/002 20130101; A61F 2/2493 20130101 |
International
Class: |
A61M 27/00 20060101
A61M027/00; A61F 2/06 20060101 A61F002/06 |
Claims
1-24. (canceled)
25. A system comprising: a conduit device configured for providing
fluid communication between a first surface and a second surface of
a tissue wall, the conduit device comprising: a tube defining a
lumen extending along an axis defined by the tube from a proximal
end to a distal end of the tube, the tube configured for insertion
within an aperture of the tissue wall extending from the first
surface to the second surface of the tissue wall; a flange attached
to the tube and extending outward from an outer surface of the
tube, the flange configured for engaging the first surface of the
tissue wall; and a ring attached to the tube and extending outward
from the outer surface of the tube, the ring configured for
engaging the second surface of the tissue wall; and a cap
configured for selectively engaging the tube such that the cap
seals the proximal end of the tube.
26. The system of claim 25, wherein the cap comprises a pawl member
configured for selectively engaging ridges of the tube.
27. The system of claim 25, wherein the cap comprises threads
configured for selectively engaging mating threads of the tube.
28. The system of claim 25, wherein the flange is disposed at or
near the distal end of the tube.
29. The system of claim 25, wherein the flange is integrally formed
with the tube.
30. The system of claim 25, wherein the flange is flexible to
facilitate insertion of the flange through the aperture of the
tissue wall.
31. The system of claim 25, wherein the ring is removably attached
to the tube.
32. The system of claim 31, wherein the ring comprises a pawl
member configured for selectively engaging ridges of the tube.
33. The system of claim 31, wherein the ring comprises threads
configured for selectively engaging mating threads of the tube.
34. The system of claim 25, wherein the conduit device is
configured for attaching a ventricular assist device to the tissue
wall.
35. A method comprising: inserting a tube of a conduit device
within an aperture of a tissue wall extending from a first surface
to a second surface of the tissue wall, the tube defining a lumen
extending along an axis defined by the tube from a proximal end to
a distal end of the tube; engaging the first surface of the tissue
wall with a flange of the conduit device, the flange attached to
the tube and extending outward from an outer surface of the tube;
engaging the second surface of the tissue wall with a ring of the
conduit device, the ring attached to the tube and extending outward
from the outer surface of the tube; and engaging the tube with a
cap such that the cap seals the proximal end of the tube.
36. The method of claim 35, wherein inserting the tube within the
aperture of the tissue wall comprises passing the distal end of the
tube through the aperture in the tissue wall.
37. The method of claim 35, wherein inserting the tube within the
aperture of the tissue wall comprises passing the flange through
the aperture of the tissue wall.
38. The method of claim 37, wherein passing the flange through the
aperture of the tissue wall comprises deforming the flange and
allowing the flange to return to an original shape.
39. The method of claim 35, wherein the flange is disposed at or
near the distal end of the tube.
40. The method of claim 35, wherein the flange is integrally formed
with the tube.
41. The method of claim 35, wherein the ring is removably attached
to the tube.
42. The method of claim 35, wherein engaging the tube with the cap
comprises selectively engaging ridges of the tube with a pawl
member of the cap.
43. The method of claim 35, wherein engaging the tube with the cap
comprises selectively engaging threads of the tube with mating
threads of the cap.
44. The method of claim 35, further comprising disengaging the cap
from the tube such that the conduit device provides fluid
communication between the first surface and the second surface.
45. A system comprising: a conduit device configured for providing
fluid communication between a first surface and a second surface of
a tissue wall, the conduit device comprising: a tube defining a
lumen extending along an axis defined by the tube from a proximal
end to a distal end of the tube, the tube configured for insertion
within an aperture of the tissue wall extending from the first
surface to the second surface of the tissue wall; and a ring
defining an opening extending along an axis defined by the ring
from a proximal end to a distal end of the ring and configured for
removably receiving the tube therethrough, the ring configured for
engaging the second surface of the tissue wall; and a cap
configured for selectively engaging the tube such that the cap
seals the proximal end of the tube.
46. The system of claim 45, wherein the cap comprises a pawl member
configured for selectively engaging ridges of the tube.
47. The system of claim 45, wherein the cap comprises threads
configured for selectively engaging mating threads of the tube.
48. The system of claim 45, wherein the ring is configured for
selectively engaging the tube via a pawl member and a ridge.
49. The system of claim 48, wherein the ring comprises the pawl
member, and wherein the tube comprises the ridge.
50. The system of claim 45, wherein the ring comprises threads
configured for selectively engaging mating threads of the tube.
51. The system of claim 45, wherein the conduit device further
comprises a flange attached to the tube and extending outward from
an outer surface of the tube.
52. The system of claim 51, wherein the flange is integrally formed
with the tube.
53. The system of claim 51, wherein the flange is disposed at or
near the distal end of the tube and configured for engaging the
first surface of the tissue wall.
54. The system of claim 45, wherein the conduit device is
configured for attaching a ventricular assist device to the tissue
wall.
55. A method comprising: inserting a tube of a conduit device
within an aperture of a tissue wall extending from a first surface
to a second surface of the tissue wall, the tube defining a lumen
extending along an axis defined by the tube from a proximal end to
a distal end of the tube; engaging the tube with a ring of the
conduit device, the ring defining an opening extending along an
axis defined by the ring from a proximal end to a distal end of the
ring and configured for removably receiving the tube therethrough;
engaging the second surface of the tissue wall with the ring; and
engaging the tube with a cap such that the cap seals the proximal
end of the tube.
56. The method of claim 55, wherein inserting the tube within the
aperture of the tissue wall comprises passing the distal end of the
tube through the aperture in the tissue wall.
57. The method of claim 55, wherein engaging the tube with the ring
comprises selectively engaging the tube with the ring via a pawl
member and a ridge.
58. The method of claim 57, wherein the ring comprises the pawl
member, and wherein the tube comprises the ridge.
59. The method of claim 55, wherein engaging the tube with the ring
comprises selectively engaging threads of the ring with mating
threads of the tube.
60. The method of claim 55, wherein the conduit device further
comprises a flange attached to the tube and extending outward from
an outer surface of the tube, and wherein engaging the tube with
the ring comprises engaging the tube with the ring such that the
ring is spaced apart from the flange.
61. The method of claim 60, wherein the flange is integrally formed
with the tube.
62. The method of claim 55, wherein engaging the tube with the cap
comprises selectively engaging ridges of the tube with a pawl
member of the cap.
63. The method of claim 55, wherein engaging the tube with the cap
comprises selectively engaging threads of the tube with mating
threads of the cap.
64. The method of claim 55, further comprising disengaging the cap
from the tube such that the conduit device provides fluid
communication between the first surface and the second surface.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of copending U.S. patent
application Ser. No. 11/251,100, filed on Oct. 14, 2005, which is a
continuation-in-part of U.S. patent application Ser. No.
10/915,691, filed on Aug. 11, 2004, each of which is hereby
incorporated herein in its entirety by reference.
FIELD OF INVENTION
[0002] This invention relates to devices and methods for creating
and maintaining a fluid conduit in a tissue wall. For example, some
embodiments of the present invention may provide an alternative
conduit between the left ventricle and the aorta to create a
double-outlet left ventricle.
BACKGROUND OF THE INVENTION
[0003] Construction of an alternative conduit between the left
ventricle and the aorta (an apicoaortic conduit, or AAC) to create
a double-outlet left ventricle (LV) has been successfully employed
to treat a variety of complex congenital LV outflow obstruction
(fibrous tunnel obstruction, aortic annular hypoplasia, tubular
hypoplasia of the ascending aorta, and patients with diffuse septal
thickening, severe LV hypertrophy and a small LV cavity) as well as
adult-onset aortic stenosis in patients with complicating
preoperative conditions (previous failed annular augmentation
procedures, previous infection, previous CABG with patent anterior
internal mammary artery grafts, and a porcelain ascending
aorta).
[0004] However, the AAC insertion procedure has been poorly
accepted, primarily because of early valve failures using
first-generation bioprostheses as well as the success of direct
LVOTO repair and aortic valve replacement. In the United States,
despite an aging population, the unadjusted mortality for isolated
aortic valve operations in 2001 remained under 4%. Further, the AAC
insertion operation, with or without cardiopulmonary bypass, has
not been as technically straightforward as direct aortic valve
replacement. For most surgeons, AAC insertion is not a familiar
operation and is of historical interest only.
[0005] Nonetheless, several studies have demonstrated that AAC
insertion successfully lessens the LV-aortic pressure gradient,
preserves or improves ventricular function and maintains normally
distributed blood flow through the systemic and coronary
circulation. While there have been several techniques described,
the most commonly employed method is the lateral thoracotomy
approach with placement of the AAC to the descending aorta. Other
techniques include a median sternotomy approach with insertion of
the distal limb of the AAC to the ascending aorta, to the
transverse part of the aortic arch, or to the intra-abdominal
supraceliac aorta.
[0006] In general, the thoracic aorta and the left ventricle apex
are exposed through a left lateral thoracotomy, and a needle is
passed through the apex and into the left ventricle. While the
connector is still spaced apart from the apex, the sutures that
will fix the connector to the apex are threaded through a cuff on
the connector and through the apex in a matching pattern. The cuff
is set back from the end of the connector by 1-2 centimeters to
allow the end of the connector to extend through the heart muscle
and into the left ventricle. Once the sutures are in place, a
ventricular coring device is used to remove a core of ventricular
muscle, and the pre-threaded sutures are then pulled to draw the
connector into the opening until the cuff comes to rest: on the
apex. The sutures are tied off, and additional sutures may be
added. Either before or after this procedure, the opposite end of
the connector is attached to a valved conduit which terminates at
the aorta.
[0007] The current techniques and technology available to perform
AAC insertion were originally designed to be performed on-pump;
either with an arrested or fibrillating heart. While off--pump
cases have been described, they can be technically difficult due to
the shortcomings of presently available vascular conduits and
systems for installing such conduits. For example, because existing
conduits require the use of sutures to reliably secure the
connector in place, it is often difficult for surgeons or other
clinicians to insert such sutures reliably in active cardiac and/or
vascular tissue.
SUMMARY OF THE INVENTION
[0008] This invention describes an improved system and method for
the insertion of a vascular conduit (such as an AAC) that will
significantly improve and simplify the in vivo insertion of a graft
into the beating cardiac apex or other tissue walls (such as other
areas of the heart including the anterior, lateral, posterior walls
of the left or right ventricle, the left or right atrium, the
aortic wall, ascending, transverse, or descending, or other blood
vessel walls), such that vascular conduit insertions (including AAC
procedures) may be rendered far more attractive to clinicians.
Because vascular conduits and systems of the present invention may
be used to create alternate outflow tracts in "off-pump"
procedures, the embodiments of the present invention may
effectively reduce and/or negate the detrimental effects of both
cardio-pulmonary by-pass (CPB) and global cardiac ischemia.
Additionally, because some conduit embodiments of the present
invention (for AAC procedures, for example) may be inserted into a
ventricular or atrial free wall or cardiac apex, the conduction
system of the heart may be avoided, along with the native coronary
arteries and grafts from previous surgical revascularization. In
some embodiments of the present invention, wherein the system is
used to implant an AAC, a small size valve (19 to 21 mm for typical
adult body surface areas) is usually adequate; as the effective
postoperative orifice is the sum of the native and prosthetic
aortic valves. Further, the present invention provides vascular
conduits that may be compatible with newer generation biologic
valves, such that valved conduit failure is far less likely.
[0009] In one embodiment, the present invention provides a system
for implanting a vascular conduit device (such as an AAC
component). According to some embodiments, the system comprises a
coring device for defining an aperture in a tissue wall (such as a
cardiac free wall or apex and/or the aorta) having a first tissue
surface and a second tissue surface. The coring device may define a
lumen adapted to be capable of receiving a guide wire for directing
the coring device to the first or second tissue surface, depending
upon whether the approach is intra- or extra-vascular,
respectively. The system may also comprise a conduit device for
lining the aperture defined in the tissue wall and maintaining
fluid communication between the first and second tissue surfaces of
the tissue wall. The conduit device may be adapted to be capable of
being advanced over the guide wire and/or the coring device so as
to be guided to the aperture defined by the coring device. The
conduit device may comprise, in some embodiments: a tube having
proximal and distal ends, and inside and outside surfaces; a
flexible flange disposed at or near the distal end, wherein the
flexible flange is adapted to be capable of operably engaging the
first tissue surface; and a securing ring adapted to fit over the
tube and adapted to be capable of operably engaging the second
tissue surface and cooperating with the flexible flange so as to
secure the conduit device within the aperture.
[0010] According to some embodiments of the present invention, the
system may also comprise a hemostatic device for selectively
deploying so as to temporarily occlude the aperture (so as to
prevent the passage of blood through the aperture and into an
adjacent body cavity, for example). The hemostatic device may also
be adapted to be capable of being advanced over the guide wire
and/or within the lumen of the coring device such that the
hemostatic device may be accurately guided to the site of the
newly-formed aperture created by the coring device. The hemostatic
device may comprise at least one of an "umbrella" occlusion device,
a dilation balloon, and/or combinations of such devices.
Furthermore, according to various system embodiments of the present
invention, the coring device may comprise at least one of: a pulsed
laser scalpel; a continuous wave laser scalpel; a mechanical coring
device; a device employing ultrasonic energy (such as
high-frequency focused ultra-sound); and/or combinations of such
coring devices. Some embodiments of the present invention may also
provide a specialized delivery device for enclosing the conduit
device and selectively implanting the conduit device within the
aperture. The delivery device may be operably engaged with an outer
surface of the coring device and may comprise one or more
retracting arms for dilating the aperture prior to and/or
simultaneously with the implantation of the conduit device.
[0011] Some additional system embodiments of the present invention
may also comprise a guiding catheter defining a guiding lumen for
receiving and directing the coring device and the conduit device to
the tissue wall via an endovascular pathway. Thus, according to
various system embodiments of the present invention, the system may
be used to implant the conduit device via an endovascular pathway
such that the conduit may be implanted from inside the left
ventricle and/or inside another blood vessel.
[0012] Other embodiments of the present invention provide a
vascular conduit device for lining an aperture defined in a tissue
wall (such as the cardiac wall, apex and/or a blood vessel wall)
and maintaining fluid communication between a first tissue surface
and a second tissue surface of the tissue wall. According to some
embodiments, the vascular conduit device may comprise a tube having
proximal and distal ends, and inside and outside surfaces, wherein
the outside surface of the tube defines a plurality of ridges. The
vascular conduit device may further comprise a flexible flange
disposed at or near the distal end for operably engaging the first
tissue surface and a securing ring adapted to fit over the tube for
operably engaging the second tissue surface. The securing ring may
also comprise at least one deformable pawl member for releasably
engaging the plurality of ridges defined by the outer surface of
the tube such that the securing ring cooperates with the flexible
flange so as to secure the vascular conduit device within the
aperture.
[0013] According to some embodiments, the flexible flange and/or
securing ring may define complementary concave and/or convex
profiles so as to conform more completely to the first and second
tissue surfaces. Furthermore, the flexible flange may comprise a
frusto-conical assembly such that the flange may be more easily
inserted into the aperture. According to various other embodiments
of the present invention, the outside surface of the tube may
comprise threading on at least a portion of the outside surface of
the tube and corresponding threading on an inside diameter of the
securing ring such that the securing ring may be secured with
respect to the flange and the tissue wall held there between.
[0014] According to some embodiments of the present invention, the
flexible flange may be soft and thin enough to bend backwards so
that it can be pushed through the aperture defined in the tissue
wall, but rigid enough to flex back to its original position and
hold its shape once it emerges along a first tissue surface of the
tissue wall. The tube of the vascular conduit device may then be
drawn back so that the flexible flange presses against the first
tissue surface of the tissue wall. The securing ring may then be
deployed over the body of the connector and against the second
tissue surface of the tissue wall. Various vascular conduit device
embodiments are described herein to secure the position of the
second ring against a surface of the tissue wall such that no
sutures may be required. Such embodiments may include, but are not
limited to: the ridge and pawl mechanism described above, a
threaded surfaces disposed on the tube and an inner surface of the
securing ring, a biasing device for biasing the securing ring
toward the flange; and/or combinations of such securing
devices.
[0015] According to one embodiment for using the new system and/or
vascular conduit device of the present invention, a needle is
passed through a tissue wall (such as the wall of the cardiac apex)
to provide access to the first tissue surface (defining the
interior of the left ventricle, for example). A guide wire may then
be inserted into the opening and, following dilation of the
opening, an occlusion device may be threaded over the wire and into
a cavity defined by the tissue wall and deployed. A coring device
may then be threaded in-line over the guide wire such that a core
of tissue may be removed to form an aperture in the tissue wall.
While the occlusion device maintains hemostasis, the coring device
may be removed and the vascular conduit device of the present
invention may be mounted on a dilator and introduced over the guide
wire and occlusion device catheter. As the vascular conduit device
is introduced into the aperture, the flexible flange retracts.
Furthermore, as discussed above, as the vascular conduit device
enters the aperture, it may displace the occlusion device to allow
the flange to resume its normal shape. As discussed above, the
vascular conduit device may then be drawn tight against the first
tissue wall such that the securing ring may be deployed over the
body of the vascular conduit device to fit snugly against the
second tissue surface. Once the connector is firmly in place, the
occlusion device may be withdrawn and the vascular conduit device
may be clamped shut while its free end is connected to a vascular
graft or valved conduit that may terminate at another tissue wall
(such as a blood vessel wall, for example).
[0016] Use of this new vascular conduit device, system, and method
will significantly improve the ease and safety of vascular conduit
insertion (such as the implantation of AAC devices). As persons of
ordinary skill would readily appreciate, this method can also be,
used in a minimally invasive, endoscopically assisted approach.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The invention will be better understood by reference to the
Detailed Description of the
[0018] Invention when taken together with the attached drawings,
wherein:
[0019] FIG. 1 is a perspective view of a first embodiment of an LV
apical connector according to the invention;
[0020] FIG. 2 is a side view of the embodiment shown in Fig: 1;
[0021] FIG. 3 is a perspective view oft second embodiment of an LV
apical connector according to the invention;
[0022] FIG. 4 is a side view of the embodiment shown in FIG. 3;
[0023] FIG. 5 is aside view of a third embodiment of an LV apical
connector according to the invention.
[0024] FIG. 6 is a perspective view of a vascular conduit device,
including a tube, flexible flange, and securing ring, according to
one embodiment of the present invention.
[0025] FIG. 7 is a perspective view of a vascular conduit device,
including a tube, flexible flange, and securing ring, according to
one embodiment of the present invention, wherein the flexible
flange and securing rings define convex and concave profiles,
respectively.
[0026] FIG. 8A is a cross-sectional view of a tissue wall and
aperture defined therein in relation to one system embodiment of
the present invention including a coring device for defining an
aperture and a vascular conduit device for defining and maintaining
the aperture.
[0027] FIG. 8B is a cross-sectional view of a tissue wall and
aperture defined therein including a side view of a vascular
conduit device, according to one embodiment of the present
invention, implanted in the aperture.
[0028] FIG. 9A is a cross-sectional side view of a system according
to one embodiment of the present invention including a delivery
device for enclosing and selectively delivering the conduit
device.
[0029] FIG. 9B is a cross-sectional side view of a system according
to one embodiment of the present invention including a delivery
device comprising a pair of retracting arms for dilating the
aperture during implantation of the conduit device.
[0030] FIG. 10 is a cross-sectional side view of an exemplary
apico-aortic connection (AAC) constructed using some embodiments of
the present invention.
[0031] FIG. 11 is a side view of an exemplary embodiment of the
conduit device of the present invention including a notch and pin
arrangement for selectively engaging the conduit device with a
coring device.
[0032] FIG. 12 is a cross-sectional side view of an exemplary
apico-aortic connection (AAC) inserted via endovascular methods
using system embodiments of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0033] The present inventions now will be described more fully
hereinafter with reference to the accompanying drawings, in which
some, but not all embodiments of the inventions are shown. Indeed,
these inventions may be embodied in many different forms and should
not be construed as limited to the embodiments set forth herein;
rather, these embodiments are provided so that this disclosure will
satisfy applicable legal requirements. Like numbers refer to like
elements throughout. The singular forms "a," "an," and "the"
include plural referents unless the context clearly dictates
otherwise.
[0034] Although some embodiments of the invention described herein
are directed to a vascular conduit device 100 and a system for
implanting such a device to form an apico-aortic connector (AAC)
between the cardiac apex and the aorta, it will be appreciated by
one skilled in the art that the invention is not so limited. For
example, aspects of the vascular conduit device 100 and systems of
the present invention can also be used to establish and/or maintain
conduits in a variety of tissue structures using minimally-invasive
and/or invasive delivery techniques. Furthermore, while the
embodiments of the invention described herein are directed to the
thoracoscopic implantation of the vascular conduit device to form
at least one vascular port for establishing an AAC, it should be
understood that the system and/or vascular conduit device
embodiments of the present invention may be used to establish
valved and/or open conduits (including bypass conduits) to augment
native blood vessels in order to treat a variety of vascular
conditions including, but not limited to: aortic valvular disease,
congestive heart failure, left ventricle outflow tract obstructions
(LVOTO), peripheral arterial obstructions, small vessel
obstructions, and/or other conditions. Furthermore, the vascular
conduit device and system of the present invention may also be used
to establish a port for inter-ventricular repairs such as, for
example, valve repair and/or replacement or ablation procedures.
Thus, the vascular conduit device 100 described in further detail
below may also comprise a threaded fluid-tight cap, and/or a cap
having at least one pawl member (for engaging corresponding ridges
defined on an outer surface of the vascular conduit device 100) for
selectively sealing the proximal end 7 of the vascular conduit
device 100 such that the tube 1 may serve as a re-usable port for
repairing and/or treating diseased portions of the cardiac anatomy.
Furthermore, the vascular conduit device 100 and system embodiments
of the present invention may also be used to implant a conduit
and/or port for left ventricular assist devices.
[0035] Furthermore, (as shown generally in FIG. 12) some system
embodiments of the present invention may also be used "from the
inside out", such that the coring device 830 and conduit device 100
may be passed from through an intravascular space (percutaneously).
For example, in one possible embodiment, the system embodiments of
the present invention may be used to establish an apico-aortic
conduit (AAC) percutaneously (see FIG. 12). The system components
may be introduced (via methods that will be appreciated by one
skilled in the art) into the femoral vein, across the atrial
septum, through the mitral valve and out the ventricular free wall.
Therefore, the ventricular conduit device (see element 100a, FIG.
12) would be placed from inside the vasculature (via a guiding
catheter, for example). In similar fashion, the aortic conduit
device (see element 100b, FIG. 12) may be passed retrograde in the
femoral artery (via guide wire and/or guiding catheter) or other
blood vessel and implanted using the systems of the present
invention from the luminal side of the aorta. The two connectors
would then be joined with a valved conduit introduced from either
end of the system (see FIG. 12).
[0036] As shown in FIGS. 1 and 2, the vascular conduit device 100
according to one embodiment of the present invention includes tube
(or conduit) 1 having an axis 3, distal end 5, a proximal end 7, an
outer surface 9 and an inner surface 11. Distal end 5 is provided
with a flange 13 extending, from outer surface 9 in a direction
away from axis 3. Flange 13 may be integrally formed with tube 1,
or it maybe formed separately and permanently attached to distal
end 5 of tube 1 by known means. Tube 1 should be sufficiently rigid
to maintain its shape so as not to occlude the passage of blood
and/or other fluids therethrough during use (see generally, element
860, FIG. 8B). Flange 13 may be sufficiently flexible to allow
introduction of the distal end 5 of the vascular conduit device 100
into an aperture 800 (see FIG. 8A) having a diameter equal to or
slightly less than the diameter of outer surface 9, but have
sufficient stiffness and/or shape memory to flex back to its
original position once it has passed through the aperture 800
(which may be defined in a tissue wall 850, as shown generally in
FIGS. 8A-8B).
[0037] As shown generally in FIGS. 8A-8B, the vascular conduit
device 100 may maintain and/or provide a lining for an aperture 800
defined in a tissue wall 850 so as to maintain fluid communication
860 between a first tissue surface 853 and a second tissue surface
855 of the tissue wall 850. As described generally above, and as
shown in FIGS. 6 and 7, the vascular conduit device 100 may
comprise a tube 1 having proximal 7 and distal 5 ends, and inside
and outside surfaces, wherein the outside surface of the tube 1
defines a plurality of ridges 610. According to some embodiments,
the vascular conduit device 100 may also comprise a flexible flange
13 disposed at or near the distal end 5 for operably engaging the
first tissue surface 853 (see FIG. 8B). As shown in FIGS. 6 and 7,
the vascular conduit device 100 may also comprise a securing ring
17 adapted to fit over the tube 1 for operably engaging the second
tissue surface 855. The securing ring 17 may also comprise at least
one deformable pawl member 620 for releasably engaging the
plurality of ridges 610 defined by the outer surface of the tube 1
such that the securing ring 17 cooperates with the flexible flange
13 so as to secure the vascular conduit device 100 within the
aperture 850.
[0038] As shown generally in FIG. 8B, once the vascular conduit
device 100 is secured within the aperture 850 defined in the tissue
wall 800, the vascular conduit device 100 may define a pathway for
fluid communication (and/or a pathway for thoracoscopic instruments
or other surgical tools) between a first tissue surface 853 and a
second tissue surface 855. Furthermore, the proximal end 7 of the
vascular conduit device 100 may be configured to receive a number
of different valved and/or open conduits for creating, for example,
vascular bypasses or other alternate fluid pathways within a living
organism. For example, according apico-aortic conduit embodiments
of the present invention (see FIG. 10), a first vascular conduit
device 100a (shown generally in FIG. 6) may be implanted and/or
secured in the apex 850a of the left ventricle, and a second
vascular conduit device 100b (shown generally in FIG. 7) may be
implanted and/or secured within a wall 850b of the aorta. The two
devices may then be connected via a commercially-available valved
conduit device 1020 (including a one-way valve 1025) in order to
create an alternative valved pathway for blood in order to augment
a diminished flow of blood that may be passing through a diseased
and/or damaged aortic valve. Thus, according to some embodiments,
the proximal end 7 of the tube 1 defining the fluid pathway through
the vascular conduit device 100 may be formed so as to be
compatible with one or more existing valved conduit devices 1020.
Furthermore, according to some embodiments, the vascular conduit
device 100 may be fitted with an adapter sleeve (not shown) such
that the proximal end 7 of the tube may be connected in a
fluid-tight manner with one or more commercially-available conduit
devices 1020 for establishing a bypass and/or alternate pathway
between two body cavities or blood vessels. Furthermore, the
vascular conduit device 100 of the present invention may be used to
bypass and/or repair a variety of diseased and/or damaged blood
vessels. For example, some embodiments of the present invention may
be used to bypass an abdominal aortic aneurysm (AAA) by providing
two aortic vascular conduit devices 100b (see FIG. 7) for example
connected by a section of conduit 1020 spanning the diseased and/or
damaged portions of the abdominal aorta.
[0039] As discussed below, the flexible flange 13 and tube 1 of
various embodiments of the vascular conduit device 100 may be
altered so as to be compatible with various tissue walls 850. For
example, the vascular conduit device 100 shown in FIG. 7 may be
suited for use in defining and maintaining an aperture in a large
blood vessel having a curved tissue wall (such as the aorta).
Furthermore, the vascular conduit device 100 shown in FIG. 6 may be
suited for use in defining and maintaining an aperture in a body
cavity having a relatively thick and/or muscular tissue wall (such
as the cardiac muscle of the left ventricle).
[0040] Therefore, as shown in FIG. 7, the flexible flange 13 may
define, in some embodiments, a convex profile with respect to the
proximal end 7 of the tube 1 so as to be capable of conforming to a
curved first tissue surface 853 (such as a tissue surface defined
by the inner wall surface of a blood vessel (such as the aorta)).
Furthermore, in some embodiments, the securing ring 17 may also
define a corresponding concave profile such that the securing ring
17 may be capable of operably engaging a curved and/or contoured
second tissue surface 855 and be better capable of cooperating with
the flexible flange 13 so as to secure the vascular conduit device
100 within the aperture 850. Furthermore, as shown generally in
FIG. 6, the flexible flange 13 may also comprise a frusto-conical
assembly such that the insertion of the flexible flange 13 into a
relatively narrow tissue aperture 800 may be more easily
accomplished (see generally FIG. 8A). Furthermore, the
frusto-conical assembly of some flexible flange 13 embodiments of
the present invention may also prevent and/or minimize the
occurrence of the accidental removal of the vascular conduit device
100 from the second tissue surface 855 of the tissue wall 850. The
relative thicknesses of the materials used to form the flexible
flange 13 may also be varied so as to allow the flange 13 to be
optimized based on the expected type of tissue wall 850 it may be
used to engage. For example, a relatively thin and/or contoured
flexible flange 13 (as shown generally in FIG. 7) may be used to
secure vascular conduit devices 100 within more fragile and/or thin
blood vessels. Furthermore, the relatively thick and robust
frusta-conical flexible flange 13 (shown generally in FIG. 6) may
be used to secure vascular conduit devices 100 within more
substantial tissue walls (such as cardiac muscle).
[0041] Tube 1 and flange 13 may be made-of any suitable
biocompatible material. Alternatively, tube 1 and flange 13 may be
coated with a biocompatible material. According to one exemplary
embodiment, the tube 1 may comprise a first polymer material having
a first hardness and the flange 13 may comprise a second polymer
material having a second hardness, wherein the first hardness is
greater than the second hardness. Thus, according to some such
embodiments, the flange 13 may be easily deformable as it is
inserted into the aperture 800 defined in the tissue wall 850, but
the tube 1 may remain relatively rigid so as to maintain a path for
fluid communication (see element 860, FIG. 8B) between the surfaces
853, 855 of the tissue wall 850.
[0042] According to some other embodiments, at least a portion of
the outer surface 9 of tube 1 may be threaded. Threading 15 may
extend the entire length of tube 1, or extend over only a portion
thereof. According to one exemplary embodiment, threading 15 may be
absent from a length of the distal end 5 of the tube 1 that is
slightly less than the thickness of the tissue wall 850. This
alternative embodiment may serve to prevent over-tightening of the
vascular conduit device 100, which may, in some case lead to damage
and/or rupture of portions of the tissue wall 850 near the aperture
800 defined therein. According to another embodiment, threading 15
may not extend all the way to the proximal end 7 such that the tube
1 (and the resulting vascular conduit device 100) may be used to
provide a conduit through tissue walls having a variety of
thicknesses.
[0043] External ring 17 (or securing ring 17) may be provided with
an inner diameter 18 and an outer diameter 19. Inner diameter 18
may further define threads 23 to correspond to the threading 15 on
the outer surface 9 of tube 1. The outer diameter 19 of external
ring 17 may have any shape suitable to the designer, including
circular or hexagonal. According to one embodiment of the
invention, external ring 17 may be adapted to be engaged by a
tightening device (not shown) for tightening external ring 17 on
tube 1. As discussed above with respect to the tube 1, the external
ring 17 may be made of any suitable biocompatible material.
Alternatively, external ring 17 may be coated with a biocompatible
material.
[0044] For embodiments wherein the tube defines threading 15 and
wherein the complementary external ring 17 defines threads 23, the
tightening device may comprise a specialized wrench device for
rotating the external ring 17 relative to the tube 1. Furthermore,
in other embodiments (such as those shown generally in FIGS. 6 and
7) the tightening device may comprise a simple push tool capable of
encircling a coring device 830 (see discussion below of FIG. 8A)
and pushing the external ring 17 towards the distal end 5 of the
tube 1 such that the at least one pawl member 620 of the external
ring 17 may be engaged with the plurality of ridges 610 defined on
an outer surface of the tube 1. According to some embodiments of
the present invention, as shown generally in FIG. 11, the vascular
conduit device 100 may be selectively secured to the coring device
830 (or, in some embodiments, the delivery device 910, discussed
below) by a pin 831 and notch 101 arrangement. For example, as
shown in FIG. 11 a pin 831 may extend from an external surface of
the coring device 830 (or the delivery device 910) and be operably
engaged with a complementary notch 101 defined in the proximal end
of the vascular conduit device 100. Thus, a clinician may use the
coring device 830 (or the delivery device 910) to advance the
vascular conduit device 100 to the aperture 800 and into an
implanted position (see FIG. 8B, for example) and subsequently
apply counter-traction to the vascular conduit device 100 (via the
pin 831) such that the external ring 17 may be advanced and secured
relative to the vascular conduit device 100. In some embodiments,
the clinician may then rotate the coring device 830 (and/or the
delivery device 910) to release the pin 831 from the notch 101 and
retract the coring device 830, leaving the vascular conduit device
100 securely implanted (as shown generally in FIG. 8B).
Furthermore, in some embodiments, the hemostatic device 820 (see
FIG. 8A) may also be used to apply counter-traction force to hold
the tube 1 and flexible flange 13 in place within the aperture 800
as the external ring 17 is engaged with respect to the second
tissue surface 855 from a proximal position.
[0045] According to the embodiment shown in FIGS. 3 and 4, tube 1
of the vascular conduit device 100 may also be provided with an
external ring 17 that is biased toward flange 13 by a biasing
device 27 (such as a spring device), having proximal end 29 and
distal end 31. The biasing device 27 may be configured so as to
tend to force external ring 17 into contact with flange 13. As
shown in FIGS. 4-6, the biasing device 27 may be a spring in
compression. As one of ordinary skill in the art will appreciate,
any biasing device may be used, including one or more flexible
bands or rods. Furthermore, tube 1 may be provided with and/or
define an engagement feature 33, such as a ring, slot or bore, to
engage the proximal end 29 of the biasing device 27. Likewise,
external ring 17 may be provided with an engagement feature (not
shown) adapted to receive the distal end 31 of the biasing device
27.
[0046] According to some embodiments, release device 37 may also be
provided to releasably hold external ring 17 and biasing device 27
in pre-deployment configuration, with biasing device 27 in
compression, until such a time as the flange 13 has been placed in
the interior of a cavity defined by the tissue wall 850 (such as
the interior of the ventricle) and the external ring 17 is ready to
be deployed against the outer tissue surface 855 of the heart
muscle (see generally FIG. 8B, showing the vascular conduit device
100 secured within the aperture 800).
[0047] According to the embodiment shown in FIGS. 1 and 4, release
device 37 may include one or more hooks 39 extending from the
proximal surface 41 of the external ring 17 and adapted to
releasably engage an engagement feature 43; for example, a slot or
bore, defined in tube 1. Alternatively, as shown in FIG. 5, the
release device 37 may extend to and hook over the proximal end 7 of
tube 1.
[0048] In some additional embodiments, a portion of tube 1 may be
threaded and the inside diameter of external ring 17 threaded to
permit further tightening of external ring 17 on tube 1 after
deployment of the external ring 17 following removal of the release
device 37.
[0049] Some embodiments of the present invention, as shown
generally in FIG. 8A, further provide a system for implanting a
vascular conduit device 100, wherein the system comprises a coring
device 830 for defining an aperture 800 in a tissue wall 850 having
a first tissue surface 853 and a second tissue surface 855. The
various components of the system embodiments of the present
invention may be inserted into a patient (via, for example, a
thoracoscopic, endovascular, and/or percutaneous procedure) such
that a guide catheter (not shown) and/or guide wire 810 (see FIG.
8B) may be inserted into the thoracic cavity of a patient in order
to gain access to diseased vasculature and/or the heart.
Furthermore, according to some embodiments, the system of the
present invention may be used to implant a vascular conduit device
100 via more invasive surgical procedures that will be appreciated
by one skilled in the art. Furthermore, as shown generally in FIG.
12, the vascular conduit device 100 may also be delivered and
implanted endovascularly from the inside (and/or from a first
tissue surface 853) of the ventricle and/or aorta.
[0050] As shown in FIG. 8A, the coring device 830 may define a
lumen adapted to be capable of receiving a guide wire 810 for
directing the coring device 830 to the second tissue surface 855.
Furthermore, the system of the present invention may also comprise
a conduit device 100 (such as the vascular conduit device discussed
above) for lining the aperture 800 defined in the tissue wall 850
and maintaining fluid communication between the first 853 and
second tissue 855 surfaces of the tissue wall 850. The conduit
device 100 may be adapted to be capable of being advanced over the
guide wire 810 and coring device 830. As described above with
respect to FIGS. 1-5, the vascular conduit device 100 may comprise:
a tube 1 having proximal 7 and distal 5 ends, and inside and
outside surfaces; a flexible flange 13 disposed at or near the
distal end 5; and a securing ring 17 (or external ring 17) adapted
to fit over the tube 1 and adapted to be capable of operably
engaging the second tissue surface 855 and cooperating with the
flexible flange 13 so as to secure the conduit device 100 within a
tissue aperture 800.
[0051] According to various embodiments of the system of the
present invention, the coring device 830 may comprise at least one
of: a pulsed laser scalpel; a continuous wave laser scalpel; a
mechanical coring device (such as, for example, a rotoblator
catheter or other mechanical and/or catheter-based mechanical
cutting device); an ultrasonic coring device (such as
high-frequency focused ultra-sound); and combinations thereof. For
example, in one exemplary embodiment, the coring device 830 may
comprise a pulsed excimer laser device having a light pulse
duration that is less than the tissue wall's 850 time of thermal
diffusion (defining how quickly the laser's imparted heat spreads
to adjacent tissue) so as to provide a relatively "cool" cutting
method (i.e. less than about 50 degrees C.). Furthermore, the
pulsed laser may be provided with a relatively shallow cutting
depth (i.e. less than about 50 .mu.m) such that the coring device
830 may be precisely controlled. The use of a pulsed laser scalpel
as the coring device 830 may thus result in minimal damage to
tissue adjacent the targeted aperture 800 area, which may be
especially advantageous in embodiments wherein the system is used
to implant a vascular conduit device 100 in the ventricular apex,
as the cardiac tissue of the left ventricle contains tissues that
are vital for maintaining the electrical pacing of the heart.
[0052] Some system embodiments of the present invention (as shown
generally in FIG. 8A) may further comprise a hemostatic device 820
for selectively deploying so as to temporarily occlude the aperture
800. As one skilled in the art will appreciate, the hemostatic
device 820 may be adapted to be capable of being advanced over the
guide wire 810 within the lumen of the coring device 830.
Furthermore, according to some embodiments, the hemostatic device
820 may be delivered via a delivery catheter defining a lumen for
receiving the guide wire 810 and having a sufficiently small outer
diameter to be guided within the lumen defined by the coring device
830. According to various embodiments of the present invention, the
hemostatic device 830 may comprise at least one of: an "umbrella"
occlusion device; a dilation balloon; and/or combinations thereof.
According to some embodiments, the hemostatic device 820 (as shown
in FIG. 8A) may be used to maintain "traction" for the advance of
the coring device 830 (which, in pulsed excimer laser embodiments,
may comprise a circular array 835 of lasers that must be advanced
into the tissue wall 850 in order to core the wall and define an
aperture 800 therein). Thus, in some embodiments, a clinician may
deploy the hemostatic device 820 proximal to the first tissue
surface 853 of the tissue wall 850 and exert a force (using the
deployed hemostatic device) against the first tissue surface 853
such that the laser array 835 of the coring device 830 may be
advanced to define the aperture 800 in the tissue wall 850. The
exertion of such "traction" forces using the hemostatic device 820
may be useful in instances wherein the tissue wall 850 is in motion
(such as is the case with the cardiac muscle defining the walls of
the left ventricle). Thus, embodiments of the present invention may
be successfully employed in "off-pump" procedures wherein the heart
is left beating during the course of the procedure for implanting
the vascular conduit device 100.
[0053] Following the coring process, the vascular conduit device
100 (as described in its various embodiments above) may be advanced
along the outer surface of the coring device 830 and into position
within the aperture (as shown generally in FIG. 8B) so as to define
a pathway for fluid flow 860 through the tissue wall 850. According
to some embodiments, a dilator device (not shown) may be introduced
(over the guide wire 810, for example) for dilating the initial
aperture 800 defined by the coring device 830. The dilator device
may also be used to advance the vascular conduit device 100 into
its final implanted position (see FIG. 8B) by at least partially
expanding the dilator device within the inner surface 11 of the
tube 1 so as to carry the vascular conduit device 100 with the
partially-expanded portion of the dilator device. The dilator
device may comprise, in various embodiments, a dilation balloon, a
multi-arm endoscopic and/or thoracoscopic retractor device, and/or
other types of dilator devices that will be appreciated by one
skilled in the art.
[0054] For example, as shown generally in FIGS. 9A and 9B, some
embodiments of the present invention may comprise a dilator device
that may serve as a delivery device 910 for dilating the aperture
800 formed by the coring device 830 and for percutaneously and/or
thoracoscopically delivering the vascular conduit device 100 to a
secured position (see FIG. 8A, for example) relative to the
aperture 800 defined in the tissue wall 850. The delivery device
910 may be operably engaged with an outer surface of the coring
device 830 and may comprise two or more retractor arms 912 that may
be opened as the vascular conduit device 100 is pushed out from the
delivery device 810 by applying an opening force to a plunger 915.
Thus, as shown in FIG. 9B, the delivery device 910 may be
configured to simultaneously dilate the aperture 800 (using the
retractor arms 912) and deliver the vascular conduit device 100. As
shown in FIG. 9B the flexible flange 13 of the vascular conduit
device 100 may urge the retractor arms 912 to an open position as
the plunger 915 pushes the vascular conduit device 100 outward and
into the aperture 800. The retractor anus 912, when deployed as
shown in FIG. 9B may also serve to provide "counter-traction" such
that the clinician may apply a distally-acting force on the plunger
915, a clinician may deploy the securing ring 17 relative to the
tube 1 of the vascular conduit device 100 in order to secure the
vascular conduit device 100 within the aperture 800 (as shown in
FIG. 8B, for example).
[0055] As described above (see FIG. 8A, for example) the hemostatic
device 820 may also be deployed in order to provide additional
"counter-traction" such that the distal end 5 of the vascular
conduit device 100 (once implanted in the aperture 800) may contact
the expanded hemostatic device 820. Thus, by applying a
distally-acting force on the plunger 915, a clinician may deploy
the securing ring 17 relative to the tube 1 of the vascular conduit
device 100 in order to secure the vascular conduit device 100
within the aperture 800 (as shown in FIG. 8B, for example).
[0056] According to one exemplary embodiment, the system of the
present invention (shown generally in FIGS. 8B and 10) may be used
to implant vascular conduit devices 100a, 100b to serve as the
terminal points for an apico-aortic conduit. According to such
embodiments, a thoracoscopic procedure may be used to insert a
needle through the apex and into the left ventricle 850a. A guide
wire 810 may then inserted into the opening and, following dilation
of the opening (using a dilation device, for example), an
hemostatic device 820 may be threaded over the wire 810 and into
the left ventricle and deployed proximal to an first tissue surface
853 thereof. The hemostatic device 820 may comprise, for example,
known occlusion devices such as an occlusion balloon, the Guidant
Heartstring.TM. disclosed generally at
http://www.guidant.com/products, or the Baladi inverter, disclosed
in U.S. Pat. Nos. 5,944,730 and 6,409,739. As described above, and
as shown generally in FIG. 12, the vascular conduit devices 100a,
100b may also be implanted endovascularly (i.e. from the inside of
the left ventricle and/or the aorta) by introducing the system
embodiments of the present invention through the vasculature via
guidewire and/or guiding catheter. For example, the aortic conduit
100b may be introduced via the system embodiments of the present
invention (including a guiding catheter) inserted in the femoral
artery. In addition, the ventricular conduit 100a may be introduced
via the systems of the present invention (including a guiding
catheter) inserted into the femoral vein, across the atrial septum,
through the mitral valve and out the ventricular free wall. A
ventricular coring device 830 may then be threaded in-line over the
hemostatic device 820 and a core of ventricular muscle is removed
from the tissue wall 850 of the apex in order to form an aperture
800. In addition to known coring techniques, an annular contact
laser (and in some embodiments a "cool" cutting pulsed excimer
laser, having elements arranged in a circular array 835) may be
used to vaporize the tissue along the perimeter of the core. The
cored tissue may then be removed according to known methods.
According to a further alternative embodiment, a contact laser may
be used to vaporize the entire area of the core, eliminating the
need to remove cored tissue. In yet another embodiment, a
mechanical coring device (such as a catheter-based rotoblator
device) or an ultrasonic coring device, may be used to form the
aperture 800. No matter the method of coring, once coring has
been-completed, the coring device 830 may be removed while the
occlusion device maintains hemostasis, and the vascular conduit
device 100 of the present invention may be mounted on a dilator
and-introduced over the guide wire 810 and hemostatic device 820.
As the vascular conduit device 100 is introduced into the aperture
800 in the apex, the flexible flange 13 may deform and/or retract.
As the vascular conduit device 100 enters the-left ventricle, it
may displace the hemostatic device 820 to allow the flexible flange
13 to resume its normal shape. As discussed above the vascular
conduit device 100 may then be drawn tight against the first tissue
surface 853 of the wall 850 of the left ventricle. According to a
first embodiment, external ring 17 is threaded onto the tube 1 and
tightened until it is snug against the second tissue surface 855 of
the ventricular apex.
[0057] According to it second embodiment, once the flexible flange
13 has been introduced into the ventricle and pulled back to engage
the first tissue surface 853, release-device 37 is released,
allowing biasing device 27 to force the external ring 17 against
the second tissue surface 855 of the ventricular apex. According to
a further aspect of this embodiment of the invention, threads on
the inside diameter of external ring 17 may be made to engage
threads on the outer surface of the tube 1 to further secure
external ring 17 against the tissue wall 850 of the ventricular
apex.
[0058] Once the vascular conduit device 100 is firmly in place (see
generally FIG. 8B), the occlusion device 820 may be retracted and
withdrawn. The vascular conduit device 100 may then be clamped shut
and/or capped while its free end (defined by the proximal end 7 of
the tube 1) is connected to a valved conduit and/or graft which may
terminate at a complementary vascular conduit device 100 implanted
in the aorta (see FIG. 7 showing an exemplary embodiment of a
vascular conduit device 100 suited for implantation in the tissue
wall 850 of the aorta).
[0059] Many modifications and other embodiments of the inventions
set forth herein will come to mind to one skilled in the art to
which these inventions pertain having the benefit of the teachings
presented in the foregoing descriptions and the associated
drawings. Therefore, it is to be understood that the inventions are
not to be limited to the specific embodiments disclosed and that
modifications and other embodiments are intended to be included
within the scope of the appended claims. Although specific terms
are employed herein, they are used in a generic and descriptive
sense only and not for purposes of limitation.
* * * * *
References