U.S. patent application number 15/233390 was filed with the patent office on 2016-12-01 for method for vessel access closure.
The applicant listed for this patent is PROMED, INC.. Invention is credited to Robert Elliott DeCou, Nicanor Domingo, Richard S. Ginn, Hans F. Valencia, Scott Yerby.
Application Number | 20160345945 15/233390 |
Document ID | / |
Family ID | 44505699 |
Filed Date | 2016-12-01 |
United States Patent
Application |
20160345945 |
Kind Code |
A1 |
Ginn; Richard S. ; et
al. |
December 1, 2016 |
METHOD FOR VESSEL ACCESS CLOSURE
Abstract
Assemblies for closing vascular access ports, such as
arteriotomies, which comprise a closure device deployment assembly
comprising an elongate foot member having a relatively short distal
portion which is bendably coupled to a relatively long proximal
portion and an expandable closure device removably coupled to the
distal portion of the foot member.
Inventors: |
Ginn; Richard S.; (Gilroy,
CA) ; Domingo; Nicanor; (Santa Clara, CA) ;
Valencia; Hans F.; (San Jose, CA) ; DeCou; Robert
Elliott; (San Carlos, CA) ; Yerby; Scott;
(Montara, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PROMED, INC. |
Santa Clara |
CA |
US |
|
|
Family ID: |
44505699 |
Appl. No.: |
15/233390 |
Filed: |
August 10, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12841083 |
Jul 21, 2010 |
9445796 |
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15233390 |
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61308859 |
Feb 26, 2010 |
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61353561 |
Jun 10, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2002/823 20130101;
A61B 17/0057 20130101; A61B 2017/0061 20130101; A61B 2017/00663
20130101; A61B 2017/00867 20130101; A61B 2017/00672 20130101; A61F
2/954 20130101; A61F 2/82 20130101; A61F 2002/9534 20130101; A61F
2/966 20130101; A61B 2017/00659 20130101; A61B 2017/00592 20130101;
A61B 2017/00597 20130101; A61F 2/95 20130101; A61B 2017/00942
20130101 |
International
Class: |
A61B 17/00 20060101
A61B017/00; A61F 2/954 20060101 A61F002/954; A61F 2/966 20060101
A61F002/966; A61F 2/82 20060101 A61F002/82 |
Claims
1. An assembly for closing a hole in a blood vessel having a lumen
therein comprising: (a) a closure device deployment assembly
comprising: (i) an elongate foot member comprising a relatively
short distal region which is bendably coupled to a relatively long
proximal region, and (ii) an expandable closure device removably
coupled to said distal region of said foot member, (b) said distal
region of said foot member and said closure device being capable of
being advanced out of the distal end of said closure device
deployment assembly and into the lumen of a blood vessel with at
least some of the proximal portion of said foot member remaining in
said delivery sheath to reorient said closure device by causing
said distal region of said foot member to bend with relation to
said proximal region of said foot member whereby said closure
device is more difficult to withdraw from said blood vessel, and
(c) said closure device being capable of being decoupled from said
foot member whereby it expands.
2. The assembly of claim 1 wherein the bend in said foot member is
at a predetermined bending axis.
3. The assembly of claim 2 wherein said foot member is pre-biased
to bend when constraint is removed by advancing the distal region
of said foot member out of a constraining structure.
4. The assembly of claim 3 wherein said constraining structure is
said deployment sheath.
5. The assembly of claim 1 wherein said delivery assembly comprises
a deployment tension member and said distal region of said foot
member is caused to bend by exerting tension on said deployment
tension member.
6. The assembly of claim 1 wherein said delivery assembly comprises
an attachment tension member which is connected to said closure
device and an elongate deployment member configured to exert
compressive force on said closure device and said distal portion of
said foot member is caused to bend by pushing on said elongate
deployment device.
7. An assembly for closing a hole in a blood vessel having a lumen
comprising: (a) a delivery sheath having a distal portion and a
proximal portion, the distal portion of a closure device deployment
assembly being housed in said delivery sheath, said closure device
deployment assembly comprising: (i) an elongate foot member
comprising a relatively short distal region and a relatively long
proximal region, said distal region being hingedly coupled to said
proximal region, and (ii) an expandable closure device removably
coupled to said distal region of said foot member, (b) said distal
region of said foot member being capable of being advanced out of
the distal end of said closure device deployment assembly to move
said closure device into the lumen of a blood vessel with at least
some of the proximal region of said foot member remaining in said
delivery sheath to reorient said closure device such that it is at
an angle with the proximal region of said foot member and more
difficult to withdraw from said blood vessel by causing said distal
region of said foot member to bend at the location where it is
hingedly coupled to the proximal region of said foot member, and
(c) said closure device being capable of being decoupled from said
foot member whereby it expands.
8. The assembly of claim 1 wherein the closure device is coupled to
said foot member with a removable tether.
9. The assembly of claim 7 wherein said closure device is coupled
to said foot member with a removable tether.
10. The assembly of claim 8 wherein said removable tether
constrains the expandable closure device from expanding prior to
removal of the tether.
11. The assembly of claim 9 wherein said removable tether
constrains the expandable closure device from expanding prior to
removal of the tether.
12. The assembly of claim 7 wherein the bend in said foot member is
at a predetermined bending axis.
13. The assembly of claim 7 wherein said foot member is pre-biased
to bend when constraint is removed by advancing the distal region
of said foot member out of a constraining structure.
14. The assembly of claim 13 wherein said constraining structure is
said deployment sheath.
15. The assembly of claim 7 wherein said delivery assembly
comprises a deployment tension member and said distal region of
said foot member is caused to bend by exerting tension on said
deployment tension member.
16. The assembly of claim 7 wherein said delivery assembly
comprises an attachment tension member which is connected to said
closure device and an elongate deployment member configured to
exert compressive force on said closure device and said distal
portion of said foot member is caused to bend by pushing on said
elongate deployment device.
17. An assembly for closing a hole in a blood vessel having a lumen
therein comprising: (a) a delivery sheath having a proximal portion
and a distal portion of a delivery sheath housing a closure device
deployment assembly comprising: (i) an elongate foot member
comprising a relatively short distal region which is bendably
coupled to a relatively long proximal region, (ii) an expandable
closure device removably coupled to said distal region of said foot
member, and (iii) a deployment tension member comprising a tether
which passes through said distal region of said foot member and is
releasably coupled to said closure device, (b) said distal region
of said foot member and said closure device being capable of being
advanced out of the distal end of said closure device deployment
assembly into the lumen of a blood vessel with at least some of the
proximal portion of said foot member remaining in said delivery
sheath and causing said distal region of said foot member to bend
with relation to said proximal region of said foot member by
exerting tension on said deployment tension member to reorient said
closure device whereby said closure device is more difficult to
withdraw from said blood vessel, and (c) said closure device being
capable of being decoupled from said foot member whereby it
expands.
18. An assembly for closing a hole in a blood vessel having a lumen
comprising: (a) a delivery sheath having a proximal portion and a
distal portion and a closure device deployment assembly housed in
said delivery sheath, said closure device deployment assembly
comprising: (i) an elongate foot member comprising a relatively
short distal region and a relatively long proximal region, said
distal region being hingedly coupled to said proximal region, ( ii)
an expandable closure device removably coupled to said distal
region of said foot member, and (iii) a deployment tension member
comprising a tether which passes through said distal region of said
foot member and is releasably coupled to said closure device, (b)
said distal region of said foot member and said distal end of said
closure device deployment assembly being capable of being advanced
out of said delivery sheath to move said closure device into the
lumen of a blood vessel with at least some of the proximal region
of said foot member remaining in said delivery sheath and causing
said distal region of said foot member to bend at the location
where it is hingedly coupled to the proximal region of said foot
member by exerting tension on said deployment tension member
whereby said closure device is reoriented such that it is at an
angle with said proximal region of said foot member and more
difficult to withdraw from said blood vessel, and (c) said closure
device being capable of being decoupled from said foot member.
Description
RELATED APPLICATION DATA
[0001] The present application is a continuation of U.S. patent
application Ser. No. 12/841,083, filed Jul. 21, 2010, which claims
the benefit under 35 U.S.C. .sctn.119 to U.S. provisional patent
applications Ser. No. 61/308,859 filed Feb. 26, 2010, and
61/353,561 filed Jun. 10, 2010. The foregoing applications are
hereby incorporated by reference into the present application in
their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to closure of
surgically created vascular access ports or holes, such as
arteriotomies, and more specifically to closure technologies
pertinent to relatively large surgically-created access
defects.
BACKGROUND
[0003] Minimally invasive diagnostic and interventional procedure
prevalence in US and foreign hospitals continues to increase, as
does the demand for certain procedures which involve placement of
relatively large devices into targeted locations that are initially
accessed through the vasculature. For example, percutaneous
prosthetic heart valve placement and ascending aortic aneurysm
stent graft procedures that are not accomplished using one or more
trans-thoracic or trans-abdominal access ports generally involve
one or more femoral arteriotomies which may be large in size
relative to conventional femoral arteriotomies, due, at least in
part, to the size of devices utilized for such procedures.
Subsequent to completion of the diagnostic or interventional
aspects of such treatments, any associated arteriotomies generally
must be closed. While there are existing technologies for closing
defects created in veins and arteries due to diagnostic and/or
interventional tool access, such as those available from St. Jude
Medical, Inc., Abbott Laboratories, Inc., and Access Closure, Inc.
under the tradenames Angio-Seal(.RTM.), StarClose(.RTM.), and
Mynx(.RTM.), respectively, none of these are well suited for
closing relatively large defects--particularly not in the arterial
environment wherein relatively high flow rate and pressure are
complicating factors.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] FIGS. 1A-1E illustrate aspects of an access closure device
deployment wherein a collapsed device is passed through an
introducer lumen to a targeted intravascular deployment position
before it is deployed.
[0005] FIGS. 1F and 1G illustrate cross-sectional views of two
different embodiments of deployed closure device
configurations.
[0006] FIGS. 1H-1J illustrate orthogonal views of two different
embodiments of deployed closure device configurations.
[0007] FIGS. 1K and 1L illustrate cross-sectional views of two
different embodiments of deployed closure device
configurations.
[0008] FIGS. 2A-2F illustrate aspects of an access closure device
deployment wherein a two-portion collapsed device is passed through
an introducer lumen to a targeted intravascular deployment position
before expansion.
[0009] FIGS. 2G-21 illustrate side views and an orthogonal view,
respectively, of a suitable device frame configuration.
[0010] FIGS. 3A-3D illustrate orthogonal views of a device
embodiment that may be rolled up into a collapsed shape, and
unrolled or unfurled to an expanded shape.
[0011] FIG. 4 illustrates one embodiment of a manual operational
interface configuration.
[0012] FIG. 5 illustrates various aspects of an arteriotomy closure
method in accordance with the present invention.
[0013] FIGS. 6A-6X illustrate various aspects of arteriotomy
closure configurations wherein a collapsed closure device may be
controllably rotated relative to an elongate deployment member to
prevent withdrawal of the closure device through the
arteriotomy.
[0014] FIGS. 7A-7F illustrate various aspects of an arteriotomy
closure device deployment wherein a collapsed closure device may be
controllably rotated relative to an elongate deployment member to
prevent withdrawal of the closure device through the
arteriotomy.
[0015] FIG. 8A illustrates aspects of deployment steps using a
configuration such as that illustrated in FIGS. 6A-6X, wherein a
foot is pre-biased to flex once released from a restraining
sheath.
[0016] FIG. 8B illustrates aspects of deployment steps using a
configuration such as that illustrated in FIGS. 6A-6X, wherein a
foot is flexed after release from a restraining sheath, subsequent
to application of a flexing load.
[0017] FIGS. 9A-9E illustrate various aspects of arteriotomy
closure configurations wherein a collapsed closure device may be
controllably rotated relative to an elongate deployment member to
prevent withdrawal of the closure device through the
arteriotomy.
[0018] FIG. 10 illustrates aspects of deployment steps using a
configuration such as that illustrated in FIGS. 9A-9E, wherein a
foot is pre-biased to flex once released from a restraining
sheath.
[0019] FIG. 11 illustrates aspects of a deployment sheath
configured to assist an operator with positioning of related
instrumentation adjacent an arteriotomy location.
[0020] FIGS. 12A-12D illustrate aspects of a proximal deployment
interface which may be utilized with closure device deployment
configurations such as those depicted in FIGS. 9A-9E.
SUMMARY
[0021] One embodiment is directed to a method for closing an
opening in a blood vessel, comprising providing a closure device
removably coupled to a delivery member; passing the closure device
through the opening; controllably expanding the closure device from
a collapsed state to an expanded state, wherein the closure device
is configured to restrict fluids from exiting the opening; and
decoupling the closure device from the delivery member. The closure
device may be a self-expanding structure configured to expand
itself from the collapsed state to the expanded state when not
restrained in the collapsed state. Controllably expanding may
comprise moving a portion of a deployment tensile element relative
to the self-expanding structure to allow the self-expanding
structure to expand itself to the expanded state. The closure
device expanded state may form a substantially cylindrical shape
defining a lumen there-through. The method may further comprise
controllably moving the collapsed closure device relative to the
deployment member to place the closure device into a geometric
configuration selected to prevent withdrawal of the closure device
back out of the hole. Controllably moving may comprise rotating the
collapsed closure device relative to the deployment member to place
the closure device into a rotated orientation selected to prevent
withdrawal of the closure device back out of the hole. Controllably
moving may comprise translating the collapsed closure device
relative to the deployment member. Translating may cause the
collapsed closure device to controllably rotate to a rotated
orientation selected to prevent withdrawal of the closure device
back out of the hole. The method may further comprise applying a
tensile load to at least a portion of the closure device using a
tensile element positioned through the opening in the blood vessel.
Passing the closure device through the opening may comprise
advancing an introducer sheath defining a lumen in which the
closure device is temporarily housed.
[0022] Another embodiment is directed to a method for closing an
opening in a blood vessel, the blood vessel having an inner surface
that defines a lumen having a longitudinal axis, comprising passing
a closure device through the opening; and controllably expanding
the closure device from a collapsed state to an expanded state,
wherein the closure device is configured to contact at least 90
degrees of an inner surface of the vessel adjacent the opening
relative to the longitudinal axis and restrict fluids from exiting
the opening. The closure device may be a self-expanding structure
configured to expand itself from the collapsed state to the
expanded state when not restrained in the collapsed state.
Controllably expanding may comprise moving a portion of a
deployment tensile element relative to the self-expanding structure
to allow the self-expanding structure to expand itself to the
expanded state. The closure device expanded state may form a
substantially cylindrical shape defining a lumen there-through. The
method may further comprise controllably moving the collapsed
closure device relative to the deployment member to place the
closure device into a geometric configuration selected to prevent
withdrawal of the closure device back out of the hole. Controllably
moving may comprise rotating the collapsed closure device relative
to the deployment member to place the closure device into a rotated
orientation selected to prevent withdrawal of the closure device
back out of the hole. Controllably moving may comprise translating
the collapsed closure device relative to the deployment member.
Translating may cause the collapsed closure device to controllably
rotate to a rotated orientation selected to prevent withdrawal of
the closure device back out of the hole. The method may further
comprise applying a tensile load to at least a portion of the
closure device using a tensile element positioned through the
opening in the blood vessel. Passing the closure device through the
opening may comprise advancing an introducer sheath defining a
lumen in which the closure device is temporarily housed.
DETAILED DESCRIPTION
[0023] Referring again to FIG. 1A, an introducer catheter (2) is
shown with its distal tip (6) inserted across a hole formed in a
blood vessel, such as an arteriotomy (28), which has been created
in a blood vessel such as the femoral artery (22) to provide
transvascular access for a procedure such as a percutaneous heart
valve installation. The hole or arteriotomy (28) may have a
diameter as large as 18 French or larger. In FIG. 1A, the valve
deployment related tooling has been removed, and hemostasis through
the lumen (4) defined through the introducer (2) may be controlled,
for example, with valves integrated into the introducer or positive
flush from an associated flush assembly (8). The embodiment
depicted in FIG. 1A shows a closure device assembly being inserted
through the introducer to facilitate execution of a controlled
arteriotomy closure, the device assembly generally comprising a
collapsed closure device (14), an elongate deployment member (10)
having a distal portion (12) configured to removably accommodate
the collapsed device (14), an insertion/retraction member (16)
removably coupled with the device (14), a deployment tension member
(18) configured to cause the collapsed device (14) be expandable to
a deployed or expanded shape, and an attachment tension member (20)
configured to pull the device proximally toward the operator of the
assembly. In one embodiment the closure device (14) may be selected
to span and close an arteriotomy having a diameter as large as 18
French or larger. The elongate deployment member preferably
comprises a flexible material construct, such as a polymer
extrusion. The deployment and attachment tension members preferably
comprise relatively small diameter sutures, wires, or tensile load
bearing lines made from polymers and/or metals, such as
polyethylene, polyethylene terepthalate, stainless steel, titanium,
nitinol, and the like. An insertion/retraction member (16)
preferably is capable of not only withstanding tensile loads, but
also relatively low-level compressive loads, as in a scenario
wherein such structure is utilized to push a device (14) distally.
Suitable materials for an insertion/retraction member (16) include
the polymers and metals mentioned above in reference to the tension
members (18, 20) in construction, given the desirable compressive
functionality in addition to tensile, the insertion/retraction
member generally will be stiffer, and potentially larger in
diameter, as compared with such tension members (18, 20). The
collapsed closure device (14) may comprise a plurality of flexible
structural frame elements coupled together to form a collapsible
and expandable member having an outer shape that is substantially
cylindrical in both collapsed form and expanded form, and defining
a lumen through the cylindrical expanded form, with generally no
lumen defined through the generally cylindrical collapsed form.
Further description of suitable closure device (14) details is
featured below.
[0024] Referring to FIG. 1B, the delivery member (10) has been
inserted farther through the introducer (2), and the distal portion
(12) of the delivery member (10), with the collapsed device (14)
confined therein, is being positioned past the distal tip of the
introducer (6) and into the blood vessel (22).
[0025] Referring to FIG. 1C, with insertion of the
insertion/retraction member (16) relative to the delivery member
(10), the collapsed device (14) may be pushed out of the confining
distal portion (12) of the delivery member (10) and into the free
bloodstream space of the vessel (22). The attachment tension member
(20) may then be tensioned to maintain the collapsed device in a
position adjacent to the distal tip (6) of the introducer (2) as
the delivery member (10) is retracted relative to the introducer
(2), as shown in FIG. 1C.
[0026] Referring to FIG. 1D, with tensioning of the deployment
tension member (element 18 in FIGS. 1A-1C), the device may be
allowed to expand to an expanded shape (element 24 refers to the
expanded form of the previously collapsed closure device, element
14) preferably substantially occupying the entire cross-section of
the blood vessel (22) and spanning well beyond the diameter of the
arteriotomy (28) with space on either side to prevent exit of the
closure device (24) through the arteriotomy (28). The deployment
tension member (18) may comprise an elongate cable, suture, string,
or the like configured to occupy very little cross-sectional space,
and to be able to withstand tensile loading sufficient, for
example, to untie a knot configured to maintain the device in a
collapsed configuration. One suitable tying or knot configuration
comprises what is known as a "highwayman's hitch" tied around the
collapsed device (element 14 in FIGS. 1A-1C); with such a
configuration, a controlled tensile pull on the deployment tension
member from an operator at the proximal end of the instrument
assembly causes the highwayman's hitch to untie, allowing the
device to expand. Expansion from a collapsed state to an expanded
state may be accomplished using a self-expanding device structure
configured to expand itself to a final expanded shape, or an
expandable shape configured to be expanded from a collapsed state
to an expanded shape with the assistance of a balloon or other
expansion device which may be placed through the device. In another
embodiment, an expansion device comprising an expandable balloon or
other expandable member configured to controllably expand based at
least in part upon thermal energy, electric energy, shape memory,
and/or hydrophilic expansion may be utilized to complete expansion
of a device configuration which at least partially expands on its
own, but which may require assistance to expand fully. As shown in
FIG. 1D, the expanded closure device (24) remains coupled to the
attachment tension member (20), and the introducer remains located
adjacent to the expanded device (24), holding the arteriotomy (28)
open and providing a conduit for the attachment tension member to
be used to make small adjustments in the positioning of the
expanded device (24) relative to the blood vessel (22)
structure.
[0027] Referring to FIG. 1E, with the expanded device (24) in a
desirable position, the introducer catheter (2) has been removed,
allowing the arteriotomy (28) to close to a greater degree as it
still surrounds the attachment tension member (20) which continues
to be coupled to the expanded device (24). The attachment tension
member (20) may then be released or uncoupled from the deployed
device (24) with a cutting tool (26), or controlled detachment
configuration, such as a small mechanical latch or fitting, or a
controlled release link configuration described, for example, in
U.S. Pat. No. 5,122,136, which is incorporated by reference herein
in its entirety. Uncoupling of the attachment tension member (20)
from the device (24) allows for the arteriotomy (28) to completely
close, leaving behind an access closure supported at least in part
by the expanded device.
[0028] FIG. 1F depicts a cross-sectional view of the configuration
illustrated in FIG. 1E. Referring to FIG. 1F, the attachment
tension member (20) is shown coupled to the expanded closure device
(24) and leading out of the collapsing/closing arteriotomy (28).
Subsequent to decoupling of the attachment tension member (20) from
the device (24), complete hemostasis of the arteriotomy may be
accomplished based upon one or more of several factors: 1) the
device may be configured to bias the arteriotomy closed; 2) the
vessel wall tissue defining the arteriotomy there-through generally
is self- biased to close (with a somewhat spring-like state of
tissue mechanics in a vessel wall, the wall is generally biased to
close when mechanically allowed to do so); 3) the device (24) may
comprise a structure or materials which are specifically configured
to prevent the flow of blood through the wall at the location of
the arteriotomy. Many suitable construction variations may be
utilized for the closure device (14, 24); for example, the device
embodiment depicted in FIG. 1F, comprises a frame comprised of
frame elements or structural members (30) which are coupled to a
thin, sheet-like connecting material (34) configured to be
substantially impermeable to blood, and therefore a blocking
element is pressed adjacent the arteriotomy (28) location to
facilitate hemostatis across the arteriotomy (28) until it has
healed shut. The outer surface of the structural member
(30)/connecting material (34) assembly may be coupled to cover
structure (32), and may be relatively thick (in one embodiment
having a substantially uniform thickness of about 0.015 inches) as
compared with the connecting material (34), which may be further
selected for its ability to facilitate hemostatis of the
arteriotomy (28). Suitable materials for connecting material (34)
and cover structures (32) include polytetrafluoroethylene ("PTFE"),
expanded polytetrafluoroethylene ("ePTFE"), polyethylene
terepthalate ("PET"), polyester, polylactic acid ("PLA"), poly
glycolic acid ("PGA"), poly-lactic-co-glycolic acid, fluorinated
ethylene-propylene, silicone, polyethylene, polyurethane,
copolymers of any of the above, other polymers, as well as porcine
or equine submucosa. The structural members (30) may comprise
metals, such as nitinol, or polymers, such as resorbable polymers,
as described below in reference to the construction of the
collapsed (14) or expanded (24) forms of suitable closure
devices.
[0029] In one embodiment, a cover structure may be biased to
maintain a substantially cylindrical outer surface shape, and to
assist in spreading loads from the structural members (30)
substantially uniformly to surrounding tissue via such
substantially cylindrical outer surface shape. The closure device
embodiment depicted in FIG. 1F, when in the expanded configuration
as shown, forms a substantially cylindrical outer shape defining a
lumen there-through; the substantially cylindrical outer shape
interfaces with substantially all (i.e., approximately 360 degrees
of the circumferential inner surface 238 of the vessel 22 which
defines the vessel lumen 236) of the interior surface (238) of the
blood vessel (22) in the region of the arteriotomy (28), including
in this embodiment, the portions of this inner surface (238) which
extend along the longitudinal axis of the vessel on either side of
the arteriotomy (28) for a given distance each way. In other words,
if an arteriotomy is created at a position approximately midway
along a two-inch-long, generally cylindrical vessel portion of
interest, in one embodiment, a portion of the expanded closure
device may be configured to interface with substantially all of the
two-inch-long, generally cylindrical, inner surface (238). In other
embodiments, an expanded closure device may be configured to
interface with less than substantially all 360 degrees of this
circumferential surface. For example, referring to FIG. 1K, an
embodiment is depicted that is similar to that depicted in FIG. 1F,
with the exception that an expanded closure device (240) directly
interfaces with approximately 90 degrees (244) of the
circumferential inner surface (238) of the vessel (22). FIG. 1L
depicts an embodiment wherein an expanded closure device (242)
directly interfaces with approximately 135 degrees (246) of the
circumferential inner surface (238) of the vessel (22). The
embodiment depicted in FIG. 1G varies from that of FIG. 1F in that
the cover structure (32) of FIG. 1F is configured to cover
substantially the entire approximately cylindrical outer surface of
the structural member (30)/connecting material (34) assembly, while
the cover structure (32) of FIG. 1G is configured to cover the
approximately 2/3 of the approximately cylindrical outer surface of
the structural member 30)/connecting material (34) assembly closest
to the arteriotomy location.
[0030] Many closure device (14) variations are suitable, with
general preferred characteristics being that the device be
deployable through the arteriotomy in a collapsed state, and
expandable once in the targeted vessel to an expanded state which
promotes closure of the hole or arteriotomy through which it was
delivered. For example, in one embodiment shown in orthogonal view
in FIG. 1H, the closure device may comprise a simple scaffold or
frame constructed of bent and straight portions of elongate
structural members (30) in a coiled, meshed, zig-zag, or other
pattern coupled to a cover structure (32) positioned to promote
hemostasis of the arteriotomy (28). Such structural members (30)
may, for example, comprise highly flexible metallic alloys or
polymeric materials, such as bioresorbable polymers. Suitable
metallic alloys include nickel titanium alloys, such as the
superalloy known as nitinol; other suitable materials include
stainless steel, cobalt chrome, titanium, nickel, gold, tantalum,
and alloys thereof Suitable polymeric materials include those
comprising poly lactic acid, poly glycolic acid,
poly(lactic-co-glycolic acid), silicone, polyethylene,
polyurethane, polyester, and copolymers thereof.
[0031] In another embodiment, such as that shown in FIGS. 1I and
1J, a suitable closure device (14) may comprise merely a scaffold
or frame comprising bent and/or straight portions of elongate
structural member (30) material in a configuration that tends to
bias an arteriotomy (28) closed when in a deployed/expanded
configuration by urging adjacent vessel (22) wall tissue portions
(36, 38) toward each other by means of small hooks, or
high-friction or protein binding materials that are configured to
attach or adhere to the inside of the vessel wall.
[0032] In another embodiment, a closure device (14) may comprise an
expandable scaffold or frame such as an intraluminal stent or
stentlike structure. The stent may be self-expanding or
balloon-expandable and may be a stent configured for any blood
vessel including coronary arteries and peripheral arteries (e.g.,
renal, Superficial Femoral, Carotid, and the like), a urethral
stent, a biliary stent, a tracheal stent, a gastrointestinal stent,
or an esophageal stent, for example. More specifically, the stent
may be, for example, a stent available commercially as a Wallstent,
Palmaz-Shatz, Wiktor, Strecker, Cordis, AVE Micro Stent,
Igaki-Tamai, Millenium Stent (Sahajanand Medical Technologies),
Steeplechaser stent (Johnson & Johnson), Cypher (Johnson &
Johnson), Sonic (Johnson & Johnson), BX Velocity (Johnson &
Johnson), Flexmaster (JOMED), JoStent (JOMED), S7 Driver
(Medtronic), R-Stent (Orbus), Tecnic stent (Sorin Biomedica),
BiodivYsio (Biocompatibles Cardiovascular), Trimaxx (Abbott),
DuraFlex (Avantec Vascular), NIR stent (Boston Scientific), Express
2 stent (Boston Scientific), Liberte stent (Boston Scientific),
Achieve (Cook/Guidant), S-Stent (Guidant), Vision (Guidant),
Multi-Link Tetra (Guidant), Multi-Link Penta (Guidant), Multi-Link
Vision (Guidant), Gianturco-Roubin FLEX-STENT..RTM.., GRII..TM..,
SUPRA-G, or V FLEX coronary stents from Cook Inc. (Bloomington,
Ind.) Some exemplary stents are also disclosed in U.S. Pat. No.
5,292,331 to Boneau, U.S. Pat. No. 6,090,127 to Globerman, U.S.
Pat. No. 5,133,732 to Wiktor, U.S. Pat. No. 4,739,762 to Palmaz,
and U.S. Pat. No. 5,421,955 to Lau, each of which is incorporated
by reference herein in its entirety. Suitable expandable stentlike
structures are also disclosed in percutaneous valve configuration
disclosures. For example, the configuration disclosed in U.S. Pat.
No. 7,445,631 to Sadra Medical, Inc., absent the valve leaflets,
may be suitably used in the subject application; U.S. publication
2009/0210052 to
[0033] Forster et al discloses (for example, FIGS. 2A-2C) a
tri-star collapsible frame configuration which may be utilized
absent the valve leaflets in the subject application; each of these
references is incorporated by reference herein in its entirety.
[0034] Any of the above devices, scaffolds, frames, stents, or
stentlike structures may be combined with strips, sheets, or
sheet-like portions of connecting material, such as PTFE or ePTFE,
to form what may be referred to as a variant of a stent graft. A
suitable stent graft is described, for example, in PCT Publication
WO 1997-021403 to Prograft Medical, and is incorporated by
reference herein in its entirety. Further, any of the
aforementioned frames may be coupled to a cover structure (with or
without connecting material as well) comprising a metal or polymer
material positioned to assist in maintaining hemostasis of the
arteriotomy, as depicted in FIGS. 1F-1H.
[0035] Referring to FIGS. 2A-2I, another embodiment is depicted
wherein a closure device (40) has two end portions coupled by a
highly bendable midportion. Referring to FIG. 2A, a distal tip (6)
of an introducer catheter (2) is positioned through an arteriotomy
(28) formed in a blood vessel (22). In one embodiment, the
arteriotomy may be as large as 18 French or larger in diameter. An
access closure device deployment assembly is shown being advanced
toward the introducer (2) in FIG. 2B, the assembly comprising an
expandable device (40) removably coupled to a deployment tension
member (19) and an attachment tension member (21), each of which
are movably coupled through a device insertion/retraction member
(16) to a proximal location where they may be manipulated or
controlled by an operator.
[0036] Referring to FIG. 2C, the insertion/retraction member (16)
is withdrawn relative to a delivery member (10), causing the
collapsed device (40) to become disposed within the distal portion
(12) of the delivery member (10). Such a configuration may be
inserted into the introducer catheter (2), as shown in FIG. 2D, to
dispose the collapsed device (40) past the distal tip (6) of the
introducer (2). Referring to FIG. 2E, the introducer (2) may be
withdrawn to urge the collapsed device (40) into a position wherein
it is approximately centered adjacent the arteriotomy (28) to
provide a temporary hemostasis through the arteriotomy (28).
Referring to FIG. 2F, having placed the non-expanded device (40) in
a desirable position as in FIG. 2E, the deployment tension member
(19) may be proximally tensioned to allow the device to expand,
such as by using a highwayman's hitch as described above, and the
attachment tension member (21) may be subsequently uncoupled from
the expanded device (42) to allow for the arteriotomy (28) to close
and for the delivery instrumentation to be removed. As shown in
FIG. 2F, for example, the deployed device (42) spans across the
longitudinal length of the arteriotomy (28) with extra length on
both sides to provide stability and leak prevention. Referring to
FIGS. 2G-2I, three views of a suitable structural member frame for
the deployment paradigm illustrated in FIGS. 2A-2F are depicted to
show that two substantially cylindrical end portions (44, 46) are
coupled by a highly flexible mid portion (48) in this embodiment,
the midportion (48) preferably being positioned directly adjacent
the arteriotomy location to provide support for the closure (i.e.,
by urging a related cover member directly against the arteriotomy
location); such preferred position/orientation of the flexible mid
portion (48) may be accomplished, at least in part, by interfacing
a tensile member (not shown) directly with the midportion (48), for
example by tying with a knot to one of the small apertures shown in
the midportion (48) embodiments of FIGS. 2G-21. Tension on such a
tensile member is likely to assist with the orientation/position
selection described herein, either before or after allowing the
device to reach its expanded state. Such structural members may
comprise materials similar to the structural members (30) described
in reference to FIGS. 1A-1J, and may be coupled to sheet-like
members and/or cover members to form a substantially cylindrical
expanded device surface shape (as in the embodiment shown in FIG.
2F wherein a cover member 30 extends around each of, and between
(i.e., across the midportion 48 span), the two zig zag cylindrical
frame sub-portions 44, 46, to span the arteriotomy 28 and play a
key role in effecting the closure thereof), which also may be
similar to those (34, 32) described above in reference to FIGS.
1A-1J. In other words, the embodiment shown in FIGS. 2A-2F, while
delivered in a two-lobed collapsed form, may be expanded to form a
substantially cylindrical shape due to a sheet-like member coupled
across the frame, and/or a cover member extended across the outer
surfaces of the frame.
[0037] Referring to FIGS. 3A-3D, a roll-up type expandable device
(5) configuration is depicted to illustrate that suitable
prostheses need not be conventionally radially expandable--they may
be expanded by allowing, or mechanically facilitating (i.e., with
an assisting device such as a balloon or unrolling torque tool),
the unrolling or unfurling of a device that has been rolled into a
smaller radial configuration, as illustrated in FIG. 3C.
[0038] Referring to FIG. 4, one embodiment of a handle is depicted
for deploying and actuating configurations such as those described
in reference to FIGS. 1A-1J and 2A-2I. As shown in FIG. 4, an
actuator handle body (56) is movably coupled to a delivery member
(16) insertion/retraction actuator slide button (54) and a
deployment tension member (18, 19) tension actuation pull feature
(52). Such a configuration allows for an operator to hold the
handle body (56) in one hand and easily control insertion and
retraction of the insertion/retraction member (16) with a thumb or
finger of the same hand, while also allowing for the operator to
use fingers of the other hand to pull the deployment tension member
(18, 19) tension actuation pull feature (52) and allow a related
device to expand or be expanded.
[0039] Referring to FIG. 5, a method is illustrated wherein an
arteriotomy is created, an introducer inserted, and a diagnostic or
interventional tool inserted through the introducer (58) to conduct
a cardiovascular procedure (60) such as a percutaneous valve
replacement. After the diagnostic and/or interventional tool or
tools have been retracted back through the introducer (62), it may
be desirable to close the arteriotomy. A distal tip or portion of
the introducer may be retracted to a position close to the
arteriotomy (64) but still within the vessel, and a closure
assembly comprising an expandable device configured to facilitate
hemostatis of the arteriotomy may be inserted through the
introducer toward the arteriotomy (66). The closure assembly distal
portion may be inserted past the arteriotomy and into the vascular
lumen (68), after which the device may be positioned and/or
repositioned to a desired location relative to the arteriotomy and
surrounding anatomy (70). The device may then be allowed to expand,
or may be expanded, to cause hemostasis at the arteriotomy (72),
and the closure assembly and introducer may be withdrawn away from
and detached from the expanded device, leaving a closed arteriotomy
(74).
[0040] Referring to FIGS. 6A-6X, various aspects of another
embodiment of a closure assembly are depicted, wherein a collapsed
closure device may be controllably repositioned and/or reoriented
during a deployment process in a manner that geometrically prevents
such device from escaping the arteriotomy as other delivery tools
subsequently are removed, and also limits or reduces blood or other
fluids from escaping the arteriotomy once the device has been
expanded into a final configuration, thereby effectively closing
the arteriotomy. Referring to FIG. 6A, a delivery assembly is
depicted comprising an outer introducer sheath (2), a delivery
sheath (76) placed through the working lumen of the introducer
sheath (2), and a arteriotomy closure device deployment assembly
threaded through the working lumen of the delivery sheath (76), the
assembly being depicted in FIG. 6B without the sheaths and
featuring a collapsed closure device (86) coupled to both an
elongate deployment member (90) and a foot member (92), the foot
member being threaded through a working lumen defined by a portion
of the deployment member (90). The closure device (86) may comprise
an expandable frame, scaffold, or prosthesis with or without
associated sheet-like members and/or cover members, and may be
similar to those described above in reference to FIGS. 1A-3D, or
below in reference to FIGS. 6K-6V. A deployment tension member
(82), such as a suture or wire, is threaded through another working
lumen defined by a portion of the deployment member (90) and looped
around the collapsed closure device (86) as well as a portion of
the foot member (92) to maintain the collapsed configuration of the
closure device until the deployment tension member is tensioned,
causing a releasable knot (83), such as a highwayman's hitch, to
release and allow the collapsed closure device to expand or be
expanded. An attachment tension member (84), such as a suture or
wire that may be resorbable, akin to the attachment tension members
(20, 21) described above, is threaded through a lumen or channel
defined by the foot member (92) and tied to the closure device
(84).
[0041] Referring to FIGS. 6C-6E, one configuration for controllably
repositioning and/or reorienting a collapsed closure device (86)
during deployment is configured. As shown in FIG. 6C, application
of a load (100) to the elongate deployment member (90) initially
will result in a compressive load at the interface (94) between the
elongate deployment member (90) and the collapsed closure device
(86). This compressive loading may result in translational
repositioning of the closure device (86) initially until there is
no more slack in the attachment tension member (84), after which a
moment will be effectively applied to the closure device (86),
causing it to rotate (98), or rotationally reorient, relative to
the elongate deployment member, as depicted in FIGS. 6D and 6E.
FIG. 6E, in particular, diagrammatically illustrates that a
compressive interfacial load (94) applied along with a tensile load
(96) through the attachment tension member (84) attached at a
different location from the interfacial load application results in
a rotation actuation. In one embodiment, rotational actuation may
be accomplished by both actively tensioning the attachment tension
member (84) and actively pushing the elongate delivery member (90).
In other embodiments, only one of such members (84, 90) may be
actively loaded, with the other kept relatively stationary. For
example, referring to FIG. 6D, the attachment tension member (84)
is shown grounded or anchored at a proximal location, so that
rotation of the collapsed closure device (86) may be induced merely
with compression or pushing upon the elongate deployment member
(90) after slack in the attachment tension member (84) has been
eliminated. Such rotation causes bending or hinging of a distal
portion of the foot member at a predetermined hinge or bending axis
(102), and the amount of rotational reorientation may be physically
limited by the positions of distal portions of the elongate
delivery member (90).
[0042] Referring to FIGS. 6F-6H, components of the above-described
delivery assembly are shown disassembled to some degree. FIG. 6F
depicts a foot member (92) coupled to a collapsed closure device
(86) with a deployment tension member (82) and attachment tension
member (84). FIG. 6G illustrates an elongate deployment member
comprising a first guide tube (104) coupled to a second guide tube
(106) with a deployment member outer layer (108), as shown in the
orthogonal view of FIG. 6H. Both guide tubes (104, 106) define
working lumens there-through (150, 152, respectively). In the
assembly of FIG. 6C, for example, a deployment tension member (82)
may be passed through the first guide tube lumen (150), and a foot
member (92), which itself defines a lumen through which an
attachment tension member (84) may be passed, may be placed through
the second guide tube lumen (152).
[0043] Referring to FIGS. 61 and 6J, orthogonal side views of a
foot member (92) embodiment are depicted. In the depicted
embodiment, the proximal portion (142) of the foot member may
comprise a flexible tube comprising a polymer such as fluorinated
ethylene-propylene, and the distal portion (110) may comprise a
mechanically flattened continuation of such tubing configured with
holes (112) to accommodate knots and fastening of a deployment
tension member (element 82 in FIG. 6C, for example) and/or
attachment tension member (element 84 in FIG. 6C, for example) . A
crease is provided to create a preferred bending or hinging axis
(102) between the proximal (142) and distal (110) portions of the
foot member. In another embodiment, the proximal portion (142) of
the foot member may comprise a reinforcing material or member, such
as a piece of metal hypotube, to increase the structural modulus of
such portion and facilitate precise positioning and loading of such
portion to maneuver the delivery assembly or portions thereof
[0044] Referring to FIGS. 6K-6M, as described above, the closure
device may be an expandable or self-expanding device that is
configured to be transformable from a collapsed state to an
expanded state when unrestrained, in the case of a self-expanding
configuration, or unrestrained and actively expanded (for example,
with an expansion balloon), in the case of an actively expandable
configuration. Expansion of one embodiment is depicted in the
transformation between FIG. 6K and FIG. 6L, wherein the collapsed
closure device (86) is freed from the constraints of one or more
restraining members, such as a lumen or lumens of one or more
sheaths, or one or more deployment attachment members which may be
looped around the collapsed configuration. FIG. 6M illustrates an
orthogonal view of the expanded configuration of FIG. 6L. The
expanded configuration of the depicted embodiment, illustrated in
FIGS. 6L and 6M, comprises an expanded form of an expandable
closure device (114) featuring a cylindrical pattern of nitinol
frame elements or structural members (30), coupled to a cover
structure (32), similar to those described above in reference to
FIGS. 1A-1J and 2A-2I. A sheet-like member may also be coupled to
the frame elements to assist with arteriotomy closure, as described
above. As described above, preferably the cover (32) is sized to
not only contain substantially the entire structure when in a
collapsed configuration, but also to provide an additional layer of
arteriotomy closure and leak prevention when the device has been
expanded and the cover (32) has been oriented directly adjacent the
location of the arteriotomy. Also as described above, the cover
(32) may comprise a bioresorbable material, and in other
embodiments, elements of the closure device (14, 24) structure may
comprise a polymeric material which also may be bioresorbable. The
cover (32) may be coupled to the closure device (114) using a clip,
wire, or suture which may be looped around one of the frame
elements (30) and through the material comprising the cover (32).
Geometric features may be created in the closure device to assist
with such coupling, and may be configured to allow for coupling of
the cover and closure device without a clip, wire, or suture.
[0045] Referring to FIGS. 6N-60, three different views of a closure
device frame or scaffold (116) configuration comprising two crowns
coupled together, using a weld or adhesive junction, for example,
are illustrated. A clip, wire, or suture around one of the crown
junctions may be utilized to couple a cover to such device.
[0046] Referring to FIGS. 6Q and 6R, two different views of a
closure device frame or scaffold embodiment (118) are shown wherein
a small loop feature (119) has been formed to assist with the
coupling of such scaffold and a cover. FIG. 6S depicts a similar
embodiment (120) having a larger loop feature (121). FIG. 6T
depicts an embodiment (124) wherein a loop feature (125) is formed
with an end to end structural member junction that may comprise
welds or adhesive junctions; FIG. 6U depicts a similar embodiment
(126) with a larger loop feature (127). FIG. 6V depicts an
embodiment (128) having several features of interest, including an
end to end crimp tube junction (131), a small bend feature (130)
which may be positioned to contain or assist with coupling an
associated cover member, and two pinch coil features (129)
configured to retain a portion of a cover member with a pinch
friction/load fit, somewhat akin to that provided to a piece of
paper with a paper clip. In other embodiments, pinch coil features
(129) may be created at various locations about the closure device
frame or scaffold structure, in addition to the end apex locations
as shown in the variation of FIG. 6V.
[0047] FIG. 6W illustrates a side view of a delivery sheath (76),
which may comprise a generally cylindrical polymeric tube with
sequentially stepped down outer diameter shaping (to provide
greater flexural modulus performance and shaping distally) and an
atraumatic tip (79) similar to that shown in FIG. 6A (element 78 of
FIG. 6A) comprising a partially hemispheric or capsular arcuate
geometry with notches (80) to allow for passage of closely fit
objects (i.e., by bending forward/distally one or more of the
plurality of atraumatic tip flaps formed by the notches 80 and
capsular shape of the atraumatic tip 79) through a working lumen
which preferably is formed and defined through the sheath (76). As
described above, the introducer illustrated in FIG. 6A, for
example, has similar atraumatic tip features, including a notched
(80) partially hemispheric or capsular arcuate geometry (element 78
of FIG. 6A) configured to accommodate the passage of relatively
closely fit objects (i.e., by bending forward/distally one or more
of the plurality of atraumatic tip 25 flaps formed by the notches
80 and capsular shape of the atraumatic tip, element 78 of FIG. 6A)
.
[0048] FIG. 6X illustrates aspects of the proximal portions of a
delivery assembly which may be utilized with a distal deployment
configuration such as that illustrated in FIG. 6A. Referring to
FIG. 6X, the outermost layer of the distal aspects of the depicted
configuration comprises the delivery sheath (76), which terminates
proximally with a delivery sheath hub (77) configured to be
manipulated by an operator. Within the lumen defined by the
delivery sheath is a delivery assembly comprising an elongate
deployment member (90) movably coupled to a foot member proximal
portion (142). The elongate deployment member (90) terminates
proximally with an elongate deployment member hub (91) configured
to be manually manipulated by an operator. This hub (91) features a
releasable termination screw to fix one end or one portion of a
deployment tension member (82), the other portion or end of which
may be coupled to a pull tab (132) configured for tension
manipulation by an operator--to, for example, untie a highwayman's
hitch knot configured to releasably contain a closure device in a
collapsed configuration. The elongate deployment member hub (91)
also features a screw (144) adjustable compression spring (146).
The proximal portion of the foot member (142) terminates proximally
in a foot hub (140) configured to be manually manipulated by an
operator. A set screw (138) may be utilized to fasten the hub (140)
to the foot member proximal portion (142). The attachment tension
member (84) is proximally routed through the proximal portion of
the foot member (142) to a releasable fixation screw (136) proximal
portion of the foot member (142), which, as described above, may be
reinforced by, or may comprise, a relatively stiff material or
construct, such as a metal hypotube. In operation, when an operator
wants to induce rotation and/or translation of a collapsed closure
device, as described, for example, in reference to FIGS. 6C- 6E, he
may longitudinally reposition the elongate deployment member hub
(91), foot member hub (140), and attachment tension member (84)
tensioning to create such rotation and/or translation of the distal
foot portion and collapsed closure device. A compression spring
seat (148) coupled to the proximal portion of the foot member (142)
applies loads to the proximal portion of the foot member (142) as
the foot member hub (140) is pushed toward the elongate deployment
member hub (91). A shoulder bolt (134) maintains the orientation of
the foot member rotationally to allow the operator to understand
the direction of flexion of the foot member upon desired rotation
and/or translation. The compression spring adjustment screw may be
tightened to pre-bias the distal foot portion to flex when released
from constraining members, such as one or more sheaths which may
temporarily surround and mechanically constrain the distal foot
portion (i.e., thereby urging the distal foot straight as opposed
to flexed). Alternatively, the spring may be left relatively
unloaded to allow for release from constraining members without
pre-biased flexion actuation, followed by controlled flexion
actuation using the various hubs and attachment tension element.
Aspects of embodiments of such operation are described in reference
to FIGS. 7A-7F, and 8A-8B.
[0049] Referring to FIG. 7A, an assembly has been inserted through
an arteriotomy (28) and advanced forward to place a collapsed
closure device (86), such as those described above in reference to
FIGS. 1A-1J, 2A-2I, 3A-3D, or 6L-6V, within a blood vessel (22) and
surrounded by one or more sheaths (76, 2). In some embodiments, the
arteriotomy (28) may have a diameter as large as 18 French or
greater. Referring to FIG. 7B, to begin deployment of the closure
device (86), the introducer sheath (2) may be withdrawn proximally
using an introducer manipulation hub (3), and/or the elongate
deployment member (90) and foot member (142) may be advanced
distally, to further expose the collapsed closure device (86).
Referring to FIG. 7C, the delivery sheath (76) and collapsed
closure device (86) may be moved relative to each other to further
expose the collapsed closure device (86). Referring to FIG. 7D, the
exposed collapsed closure device (86) may be controllably
translated and/or rotated to cause rotational reorientation to a
toggled position. Referring to FIG. 7E, the closure device (86) is
intentionally dimensioned to not be easily passable through the
arteriotomy when in the toggled position. In one embodiment, the
closure device (86) may have a proximal portion, centerpoint, and
distal portion along an axis parallel to a longitudinal axis of the
closure device when collapsed or expanded. Preferably the total
length of the device along this axis is greater than the largest
dimension of the arteriotomy, and preferably the distal portion and
proximal portion are long enough to prevent additional rotation of
the device relative to the vessel. In one embodiment, the
attachment tension member (84) may be tensioned to place the
collapsed closure device (86) against the arteriotomy with the
central point (154), adjacent to which the attachment tension
member preferably is terminated upon the device, aligned with the
center of the arteriotomy (28), and the proximal (156) and distal
(158) portions of the device extending away from the arteriotomy
(28). In other words, upon controlled repositioning and/or
reorientation of the collapsed closure device to the toggled or
rotated position, further withdrawal of the closure device out of
the arteriotomy is prevented by virtue of the geometry of the
arteriotomy and closure device, the device in the depicted
embodiment (86 collapsed; 88 expanded) spanning across the diameter
of the previous arteriotomy location with extra length to spare on
either side of this previous arteriotomy location. Referring to
FIG. 7F, the deployment tension member (not shown) has been
tensioned to allow the closure device to take its expanded shape
(88), preferably urging the associated cover against the inside of
the arteriotomy, which shrinks to a closed configuration (27) when
all of the hardware has been withdrawn with the exception of the
attachment tension member (84), which is configured to remain
attached to the expanded device (88), and is preferably configured
to subsequently biologically erode after being clipped most
proximally and allowed to stay inside of the body after
transcutaneous wound closure.
[0050] Referring to FIG. 8A, a deployment process is outlined,
wherein subsequent to transcutaneous access and arteriotomy
creation (160), an introducer and associated hardware may be
inserted through the arteriotomy and advanced through a portion of
the artery (162). A deployment assembly may be advanced (164) with
the introducer, or subsequently advanced, and may be exposed by
moving the introducer longitudinally relative to the deployment
assembly. In one embodiment wherein the foot member is pre-biased
to reorient by a proximal loading configuration such as a
compressed compression spring, when the distal portion of the foot
member is cleared of mechanical confinement by a delivery sheath or
introducer sheath, it flexes at the foot hinge or bend axis to
reorient the collapsed closure device. In preparation for such
reorientation, the introducer may be moved proximally relative to
the closure device (166). In the depicted embodiment wherein the
foot member is pre-biased to flex when not constrained, the last
anti-flexion constraint, the delivery sheath, is withdrawn relative
to the foot member, closure device, and elongate delivery member,
and the closure device and distal portion of the foot become
reoriented (168). Subsequently, the introducer, delivery sheath,
and foot member/elongate delivery member assembly may be withdrawn
to allow the closure device to be urged against the arteriotomy
with tension in the attachment tensile member (170). Subsequently,
the deployment tension member may be controllably tensioned to
allow the closure device to expand in position against the
arteriotomy, preferably with a cover portion of the closure device
positioned immediately adjacent the arteriotomy location (172). The
deployment and access tools may be withdrawn, leaving behind only
the expanded closure device and the attachment tension member, or
"tether line" (176), which may subsequently be shortened prior to
transcutaneous access closure (176).
[0051] Referring to FIG. 8B, another embodiment is depicted,
differing from that of FIG. 8A in that the foot member is not
pre-biased to flex upon release from constraining members such as
an introducer sheath or delivery sheath. In the embodiment of FIG.
8B, the collapsed closure device may be exposed to the bloodstream
while the foot remains in an un-flexed configuration, and when the
operator desires, may be controllably rotated and/or translated
into the rotated configuration with a flexion inducing load applied
deliberately (169).
[0052] Referring to FIGS. 9A-9E, another closure device deployment
embodiment is depicted, wherein an elongate bending spring member
is built into the foot member to pre-bias the foot to flex when not
constrained by a constraining structure such as a delivery or
introducer sheath. Referring to FIG. 9A, an assembly somewhat
similar to that depicted in FIG. 6A is depicted, with the exception
that the foot member (93) comprises an elongate bending spring
member (178) extending through the distal portion of the foot
member, and also through some of the distal end of the proximal
portion of the foot member. Preferably the elongate bending spring
member (178) comprises a pre-bent metallic or polymeric member and
is configured to assume a foot flexion position, as depicted in
FIG. 9B, for example, when not otherwise constrained by a sheath or
other contraining member to assume a straight position, as shown in
FIG. 9A. In one embodiment the elongate spring member comprises
nitinol superalloy wire in a "V" shape as in FIG. 9D, and is
coupled to proximal and distal foot member structures using
interference fitting and a discrete adhesive coupling at the distal
tip of the "V" shape. In other embodiments, the elongate spring
member may comprise other biocompatible metals, such as stainless
steel, cobalt chrome, titanium, nickel, gold, tantalum and/or
alloys thereof, as well as biocompatible polymeric materials such
as polytetrafluoroethylene, expanded polytetrafluoroethylene,
polyethylene terepthalate, polyester, polylactic acid, poly
glycolic acid, poly-lactic-co-glycolic acid, fluorinated
ethylene-propylene, silicone, polyethylene, polyurethane, and/or
copolymers of any of the above. Further details of an elongate
spring foot member are depicted in FIGS. 9C-9E. Referring to FIG.
9C, the elongate bending spring member (178) extends nearly the
entire length of the distal portion (184) of the foot member (93),
and a relative small length of the distal end of the proximal
portion (182) of the foot member (93). When allowed to rotate
(i.e., without a sheath or other constraint holding it straight),
as in FIG. 9E, the foot member distal portion (184) is configured
to rotate to a preselected angle (186) in accordance with the
pre-shaped configuration of the elongate spring member, about an
axis of rotation, or bending or hinge point, (180) that divides the
proximal portion (182) from the distal portion (184). Referring to
FIG. 9D, an orthogonal view illustrates the placement of a
collapsed closure device (86) relative to the distal portion (184)
of the foot member, such distal portion (184) being in an unfolded
configuration in FIG. 9D, to accommodate interfacing and coupling
with a collapsed closure device (86). Four holes in the distal
portion (184) of the foot are configured to assist with releasable
fastening of a deployment tension member (element 82 in FIG. 9A)
using a releasable knot, such as a highwayman's hitch. The distal
portion (184) of the foot member may be created by crushing flat a
substantially cylindrical piece of tubing comprising the proximal
portion (182) of the foot member, and creating an "H"-shaped slice
in such flattened portion to create the wings (232, 234)
configuration depicted in FIG. 9D. Each of the wings (232, 234) is
configured to be wrapped around the exterior of a collapsed closure
device (86) to form a stable saddle-like interface. Two additional
holes (204, 206) are formed through the foot member (93), one (204)
to accommodate a deployment tension member (element 82 in FIG. 9A),
and the other (206) to accommodate an attachment tension member
(element 84 in FIG. 9A). Some sample dimensions for one particular
embodiment include a collapsed closure device length dimension
(188) of about 0.5'', a bending axis to proximal end of collapsed
closure device dimension (190) of about 0.125'', a distal tip of
foot member to distal end of collapsed closure device dimension
(192) of about 0.25'', a distal end of collapsed closure device to
distal wing edge dimension (194) of about 1/16'', a distal end of
foot member to distal wing edge dimension (196) of about 5/16'', a
deployment member hole to proximal wing edge dimension (198) of
about 1/16'', and a wing length dimension (200) of about
0.25''.
[0053] Referring to FIG. 10, a process for utilizing an arteriotomy
closure system such as that described in reference to FIGS. 9A-9E
is depicted, with steps similar to those described in reference to
FIG. 8A, with the exception of inserting a deployment assembly
wherein the associated foot member comprises a pre-formed nitinol
("NiTi" or nickel titanium alloy) member biased to flex the distal
foot portion at the rotational (or hinge or bending) axis when
freed of confinement by a confining structure such as a delivery or
introducer sheath (208).
[0054] Referring to FIG. 11, a particular embodiment of a
deployment sheath (76) is depicted, wherein a blood channel (210)
is formed within the exterior surface of the sheath (76) to allow
pressurized blood, when present at the distal tip of the sheath
(76), to flow from the distal end of the sheath, proximally through
the channel (with an introducer sheath in place over the deployment
sheath, the channel would be confined at the outer surface by the
inside surface of the introducer lumen, but would remain free to
flow through the channel proximally), to a lumen inlet (212), the
associated lumen (214) being fluidly connected with a simple
indicator fitting (216) configured to effectively ooze or squirt
blood when appropriate blood pressure is present at the distal end
of the channel (210). Such a configuration may be utilized in the
relatively high-pressure (relative to venous) arterial system where
arteriotomies are created, to provide an indication to an operator
that the distal portion of the subject sheath (79) is exposed to
arterial flow. In one embodiment, such an indication may be
utilized to position the distal portion of such sheath (79) just at
the transition out of the arteriotomy and into non-pressurized
space, when conducting a closure device deployment, as described
above.
[0055] Referring to FIGS. 12A-12D, various aspects of a manual
interface or control handle assembly for operating a closure device
deployment system, such as those described in reference to FIGS.
6A-6X and 9A-9E, are illustrated. Referring to FIG. 12A, in one
embodiment the control handle assembly (220) comprising a
manipulable handle housing (218) and two manually movable elements
(222, 224) configured to assist with various aspects of the
deployment, is coupled to an elongate deployment member (90).
Referring to the partial cutaway view of FIG. 12B, a foot member
(93) extends distally through the elongate deployment member (90)
and proximally is coupled to the first manually movable element
(222), which is slidably coupled to the handle housing (218) to
facilitate convenient thumb or finger insertion/retraction of the
foot member (93) relative to the elongate deployment member (90).
Extending proximally from the foot member (93), an attachment
tension member (84) is coupled to a second manually movable element
(224) by way of a spring-loaded mechanical fitting (226) configured
to provide the operator with a tactile bump in tensile pull (using,
for example, a small enlargement in the tension member that passes
a fitting within the spring-loaded mechanical fitting) when he is
about to release the attachment tension member from the housing,
such that it may be left in situ. In operation, when the second
movable element (224) is pulled proximally by a small amount (228)
as in FIG. 12C, the movable element (224) detaches from the
housing. Additional proximal pulling (230) takes the attachment
tension member (84) past the detent, bump, or pull limit tactile
feedback mechanism, to provide the operator with an understanding
that pulling past such point permanently releases the attachment
tension member (84) from the housing (84) and the control handle
assembly (220) in general.
[0056] Various exemplary embodiments of the invention are described
herein. Reference is made to these examples in a non-limiting
sense. They are provided to illustrate more broadly applicable
aspects of the invention. Various changes may be made to the
invention described and equivalents may be substituted without
departing from the true spirit and scope of the invention. In
addition, many modifications may be made to adapt a particular
situation, material, composition of matter, process, process act(s)
or step(s) to the objective(s), spirit or scope of the present
invention. Further, as will be appreciated by those with skill in
the art that each of the individual variations described and
illustrated herein has discrete components and features which may
be readily separated from or combined with the features of any of
the other several embodiments without departing from the scope or
spirit of the present inventions. All such modifications are
intended to be within the scope of claims associated with this
disclosure.
[0057] Any of the devices described for carrying out the subject
interventions may be provided in packaged combination for use in
executing such interventions. These supply "kits" further may
include instructions for use and be packaged in sterile trays or
containers as commonly employed for such purposes.
[0058] The invention includes methods that may be performed using
the subject devices. The methods may comprise the act of providing
such a suitable device. Such provision may be performed by the end
user. In other words, the "providing" act merely requires the end
user obtain, access, approach, position, set-up, activate, power-up
or otherwise act to provide the requisite device in the subject
method. Methods recited herein may be carried out in any order of
the recited events which is logically possible, as well as in the
recited order of events.
[0059] Exemplary aspects of the invention, together with details
regarding material selection and manufacture have been set forth
above. As for other details of the present invention, these may be
appreciated in connection with the above-referenced patents and
publications as well as generally known or appreciated by those
with skill in the art. For example, one with skill in the art will
appreciate that one or more lubricious coatings (e.g., hydrophilic
polymers such as polyvinylpyrrolidone-based compositions,
fluoropolymers such as tetrafluoroethylene, hydrophilic gel or
silicones) may be used in connection with various portions of the
devices, such as relatively large interfacial surfaces of movably
coupled parts, if desired, for example, to facilitate low friction
manipulation or advancement of such objects relative to other
portions of the instrumentation or nearby tissue structures. The
same may hold true with respect to method-based aspects of the
invention in terms of additional acts as commonly or logically
employed.
[0060] In addition, though the invention has been described in
reference to several examples optionally incorporating various
features, the invention is not to be limited to that which is
described or indicated as contemplated with respect to each
variation of the invention. Various changes may be made to the
invention described and equivalents (whether recited herein or not
included for the sake of some brevity) may be substituted without
departing from the true spirit and scope of the invention. In
addition, where a range of values is provided, it is understood
that every intervening value, between the upper and lower limit of
that range and any other stated or intervening value in that stated
range, is encompassed within the invention.
[0061] Also, it is contemplated that any optional feature of the
inventive variations described may be set forth and claimed
independently, or in combination with any one or more of the
features described herein. Reference to a singular item, includes
the possibility that there are plural of the same items present.
More specifically, as used herein and in claims associated hereto,
the singular forms "a," "an," "said," and "the" include plural
referents unless the specifically stated otherwise. In other words,
use of the articles allow for "at least one" of the subject item in
the description above as well as claims associated with this
disclosure. It is further noted that such claims may be drafted to
exclude any optional element. As such, this statement is intended
to serve as antecedent basis for use of such exclusive terminology
as "solely," "only" and the like in connection with the recitation
of claim elements, or use of a "negative" limitation.
[0062] Without the use of such exclusive terminology, the term
"comprising" in claims associated with this disclosure shall allow
for the inclusion of any additional element--irrespective of
whether a given number of elements are enumerated in such claims,
or the addition of a feature could be regarded as transforming the
nature of an element set forth in such claims. Except as
specifically defined herein, all technical and scientific terms
used herein are to be given as broad a commonly understood meaning
as possible while maintaining claim validity.
[0063] The breadth of the present invention is not to be limited to
the examples provided and/or the subject specification, but rather
only by the scope of claim language associated with this
disclosure.
* * * * *