U.S. patent application number 14/562467 was filed with the patent office on 2015-07-09 for methods and apparatus for locating a surface of a body lumen.
The applicant listed for this patent is Abbott Laboratories. Invention is credited to Brian A. Ellingwood, Arkady Kokish.
Application Number | 20150190071 14/562467 |
Document ID | / |
Family ID | 42631569 |
Filed Date | 2015-07-09 |
United States Patent
Application |
20150190071 |
Kind Code |
A1 |
Ellingwood; Brian A. ; et
al. |
July 9, 2015 |
METHODS AND APPARATUS FOR LOCATING A SURFACE OF A BODY LUMEN
Abstract
An embodiment of an apparatus for locating a surface of a body
lumen is disclosed. The apparatus includes a locator assembly that
has a distal end region configured to extend into an opening of the
body lumen and to selectably engage at least a portion of the body
lumen adjacent to the opening. The distal end region includes at
least one surface engaging element that is configured to engage the
surface of the body lumen. The apparatus includes a measuring
device that is in electrical communication with the surface
engaging element. The measuring device is configured to determine
changes in measurable characteristics of the surface engaging
element. Methods and apparatus for locating a surface of a body
lumen are also disclosed.
Inventors: |
Ellingwood; Brian A.;
(Sunnyvale, CA) ; Kokish; Arkady; (Los Gatos,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Abbott Laboratories |
Abbott Park |
IL |
US |
|
|
Family ID: |
42631569 |
Appl. No.: |
14/562467 |
Filed: |
December 5, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12393877 |
Feb 26, 2009 |
8905937 |
|
|
14562467 |
|
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|
Current U.S.
Class: |
600/587 |
Current CPC
Class: |
A61B 2017/12018
20130101; A61B 2017/00292 20130101; A61B 2017/00022 20130101; A61B
2017/00106 20130101; A61B 2017/00672 20130101; A61B 2562/12
20130101; A61B 5/053 20130101; A61B 2090/065 20160201; A61B 5/6885
20130101; A61B 5/1076 20130101; A61B 2560/0266 20130101; A61B
2017/0003 20130101; A61B 17/0057 20130101; A61B 2017/00243
20130101; A61B 2017/00575 20130101; A61B 5/0538 20130101; A61B
2017/00668 20130101; A61B 5/6862 20130101; A61B 17/00234 20130101;
A61B 5/6876 20130101 |
International
Class: |
A61B 5/107 20060101
A61B005/107; A61B 17/00 20060101 A61B017/00; A61B 5/00 20060101
A61B005/00 |
Claims
1. An apparatus for locating a surface of a body lumen, comprising:
a locator assembly including a distal end region configured to
extend into an opening of the body lumen and to selectably engage
at least a portion of the body lumen adjacent to the opening, said
distal end region including at least one surface engaging element
configured to engage the surface of the body lumen; and a measuring
device in electrical communication with said surface engaging
element, said measuring device configured to determine changes in
measurable characteristics of said surface engaging element.
2. The apparatus of claim 1, said locator assembly further
comprising a control member and said control member being in
electrical communication with said measuring device and a distal
end of said surface engaging element.
3. The apparatus of claim 2, said locator assembly further
comprising a tubular body and wherein said tubular body is in
electrical communication with said measuring device and a proximal
end of said surface engaging element and said tubular body being in
indirect electrical communication with said control member.
4. The apparatus of claim 2, further comprising a cover member,
wherein said cover member is in electrical communication with said
measuring device, said cover member being selectively electrically
isolated from said tubular body.
5. The apparatus of claim 1, said locator assembly further
comprising a plurality of engaging members configured to engage the
surface of the body lumen.
6. The apparatus of claim 5, a first engaging member being
selectively electrically isolated from a second engaging
member.
7. The apparatus of claim 5, said distal end region being
selectably controllable between an unexpanded state and an expanded
state for engaging the body lumen.
8. The apparatus of claim 7, said plurality of engaging members
being configured to expand substantially transversely with respect
to a longitudinal axis of said locator assembly.
9. The apparatus of claim 6, said first engaging member being in
electrical communication with a third engaging member that is
selectively electrically isolated from said second engaging
member.
10. The apparatus of claim 1, said measurable characteristics of
said surface engaging element that change are selected from the
group consisting of an impedance of said surface engaging element,
a pressure on said surface engaging element, changes ultrasonic
data near said surface engaging element, and combinations
thereof.
11. A method for locating a surface of a body lumen, comprising:
inserting a locator assembly through an opening of the body lumen,
said locator assembly comprising a distal end region including a
surface engaging element configured to selectively engage the
surface of the body lumen; positioning said locator assembly in
close proximity to the opening of the body lumen; measuring a
measurable characteristic of said surface engaging element within
the body lumen; and determining whether said measurable
characteristic of said surface engaging element indicates that said
surface engaging element has engaged the surface of the body
lumen.
12. The method of claim 11, said measurable characteristic
including an opening electrical characteristic and the method
further comprising after positioning said locator assembly within
the body lumen, measuring an initial electrical characteristic of
said surface engaging element.
13. The method of claim 12, wherein determining whether said
measurable characteristic of said surface engaging element
indicates that said surface engaging element has engaged the
surface of the body lumen further comprises comparing said measured
initial electrical characteristic of said surface engaging element
with said measured opening electrical characteristic of said
surface engaging element.
14. The method of claim 11, said locator assembly further
comprising a control member and said control member being in
electrical communication with said measuring device and a distal
end of said surface engaging element.
15. The method of claim 14, said locator assembly further
comprising a cover member, said cover member being in electrical
communication with said measuring device, and said cover member
being selectively electrically isolated from said control
member.
16. The method of claim 15, wherein determining whether said
opening electrical characteristic of said surface engaging element
indicates that said surface engaging element has engaged the
surface of the body lumen further comprises determining whether
said cover member and said control member are in electrical
communication.
17. A surface engaging element comprising: a proximal end portion
including at least one retaining portion; a distal end portion
including at least one retaining portion; and at least one engaging
member extending toward said proximal end portion and extending
toward said distal end portion, said at least one engaging member
configured to engage a surface of a body lumen.
18. The surface engaging element of claim 17, said surface engaging
element being formed from a unitary base material.
19. The surface engaging element of claim 18, said surface engaging
element being formed by a laser cutting process from said unitary
base material.
20. The surface engaging element of claim 18, said unitary base
material including nickel-titanium.
21-24. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 12/393,877, filed Feb. 26, 2009, which is
incorporated by reference in its entirety.
[0002] This application also incorporates U.S. Pat. Nos. 6,197,042
and 6,623,510, and U.S. patent application Ser. Nos. 09/546,998,
09/610,238, 09/680,837, 09/732,835, 10/081,723, and 10/081,726 by
reference each in their entirety.
BACKGROUND OF THE INVENTION
[0003] 1. The Field of the Invention
[0004] The present invention relates generally to medical devices,
and more particular to methods and apparatuses for locating a
surface of a body lumen.
[0005] 2. The Related Technology
[0006] Catheterization and interventional procedures, such as
angioplasty or stenting, generally are performed by inserting a
hollow needle through a patient's skin and tissue into the vascular
system. A guide wire may be advanced through the needle and into
the patients blood vessel accessed by the needle. The needle is
then removed, enabling an introducer sheath to be advanced over the
guide wire into the vessel, e.g., in conjunction with or subsequent
to a dilator.
[0007] A catheter or other device may then be advanced through a
lumen of the introducer sheath and over the guide wire into a
position for performing a medical procedure. Thus, the introducer
sheath may facilitate introducing various devices into the vessel,
while minimizing trauma to the vessel wall and/or minimizing blood
loss during a procedure.
[0008] Upon completing the procedure, the devices and introducer
sheath would be removed, leaving a puncture site in the vessel
wall. Traditionally, external pressure would be applied to the
puncture site until clotting and wound sealing occur; however, the
patient must remain bedridden for a substantial period of time
after clotting to ensure closure of the wound. This procedure,
however, may be time consuming and expensive, requiring as much as
an hour of a physician's or nurse's time. It is also uncomfortable
for the patient, and requires that the patient remain immobilized
in the operating room, catheter lab, or holding area. In addition,
a risk of hematoma exists from bleeding before hemostasis
occurs.
[0009] Various apparatus have been suggested for percutaneously
sealing a vascular puncture by occluding the puncture site. For
example, U.S. Pat. Nos. 5,192,302 and 5,222,974, issued to Kensey
et al., describe the use of a biodegradable plug that may be
delivered through an introducer sheath into a puncture site.
Another technique has been suggested that involves percutaneously
suturing the puncture site, such as that disclosed in U.S. Pat. No.
5,304,184, issued to Hathaway et al.
[0010] To facilitate positioning devices that are percutaneously
inserted into a blood vessel, "bleed back" indicators have been
suggested. For example, U.S. Pat. No. 5,676,689, issued to Kensey
et al., discloses a bleed back lumen intended to facilitate
positioning of a biodegradable plug within a puncture site.
[0011] Alternatively, U.S. Pat. No. 5,674,231, issued to Green et
al., discloses a deployable loop that may be advanced through a
sheath into a vessel. The loop is intended to resiliently expand to
engage the inner wall of the vessel, thereby facilitating holding
the sheath in a desired location with respect to the vessel.
[0012] Accordingly, apparatus and methods for locating a surface of
a body lumen would be useful.
BRIEF SUMMARY OF THE INVENTION
[0013] An embodiment of an apparatus for locating a surface of a
body lumen is disclosed. The apparatus includes a locator assembly
that has a distal end region configured to extend into an opening
of the body lumen and to selectably engage at least a portion of
the body lumen adjacent to the opening. The distal end region
includes at least one surface engaging element that is configured
to engage the surface of the body lumen. The apparatus includes a
measuring device that is in electrical communication with the
surface engaging element. The measuring device is configured to
determine changes in measurable characteristics of the surface
engaging element.
[0014] An embodiment of method for locating a surface of a body
lumen is disclosed. The method includes inserting a locator
assembly through an opening of the body lumen. The locator assembly
includes a distal end region having a surface engaging element
configured to selectively engage the surface of the body lumen. The
locator assembly is positioned in close proximity to the opening of
the body lumen. A measurable characteristic of the surface engaging
element is measured within the body lumen. It is determined whether
the measurable characteristic of the surface engaging element
indicates that the surface engaging element has engaged the surface
of the body lumen.
[0015] An embodiment of a surface engaging element is disclosed.
The surface engaging element includes a proximal end portion that
has at least one retaining portion. The surface engaging element
includes a distal end portion that has at least one retaining
portion. The surface engaging element includes at least one
engaging member that extends toward the proximal end portion and
extends toward the distal end portion. The at least one engaging
member is configured to engage a surface of a body lumen.
[0016] Additional features and advantages of the invention will be
set forth in the description which follows, and in part will be
obvious from the description, or may be learned by the practice of
the invention. The features and advantages of the invention may be
realized and obtained by means of the instruments and combinations
particularly pointed out in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] In order that the manner in which the above-recited and
other advantages and features of the invention are obtained, a more
particular description of the invention briefly described above
will be rendered by reference to specific embodiments thereof which
are illustrated in the appended drawings. Understanding that these
drawings depict only typical embodiments of the invention and are
not therefore to be considered limiting of its scope, the invention
will be described and explained with additional specificity and
detail through the use of the accompanying drawings in which:
[0018] FIG. 1 provides a general illustration of an apparatus for
closing openings formed in blood vessel walls in accordance with
the present invention.
[0019] FIG. 2A illustrates one embodiment of a locator assembly for
the apparatus of FIG. 1.
[0020] FIG. 2B illustrates one embodiment of a distal end region of
the locator assembly of FIG. 2A when the distal end region is in an
unexpanded state.
[0021] FIG. 2C illustrates the distal end region of the locator
assembly of FIG. 2B when the distal end region is in an expanded
state.
[0022] FIGS. 2B' and 2C' illustrate an alternative embodiment of a
locator assembly for locating a surface of a body lumen, in
accordance with the present invention.
[0023] FIGS. 2B'' and 2C'' illustrate a further embodiment of a
locator assembly for locating a surface of a body lumen, in
accordance with the present invention.
[0024] FIGS. 2B''' and 2C''' illustrate a still further embodiment
of a locator assembly for locating a surface of a body lumen, in
accordance with the present invention.
[0025] FIG. 2D illustrates one embodiment of a proximal end region
of the locator assembly of FIG. 2A.
[0026] FIG. 3A illustrates one embodiment of a carrier assembly for
the apparatus of FIG. 1.
[0027] FIG. 3B illustrates one embodiment of a carrier member for
the carrier assembly of FIG. 3A.
[0028] FIG. 3C illustrates one embodiment of a pusher member for
the carrier assembly of FIG. 3A.
[0029] FIG. 3D illustrates one embodiment of a cover member for the
carrier assembly of FIG. 3A.
[0030] FIG. 3E illustrates one embodiment of a support member for
the carrier assembly of FIG. 3A.
[0031] FIG. 4A illustrates a cross-sectional side view of one
embodiment of a triggering system for the carrier assembly of FIG.
3A.
[0032] FIG. 4B illustrates a first detailed cross-sectional side
view of the triggering system of FIG. 4A.
[0033] FIG. 4C illustrates a detailed view of the triggering system
of FIG. 4B.
[0034] FIG. 4D illustrates a second detailed cross-sectional side
view of the triggering system of FIG. 4A.
[0035] FIG. 5A illustrates the carrier control system of FIGS. 4A-D
as the carrier assembly of FIG. 3A moves distally from an initial
predetermined position.
[0036] FIG. 5B illustrates the carrier control system of FIGS. 4A-D
as the carrier assembly of FIG. 3A reaches a first predetermined
position.
[0037] FIG. 5C illustrates the carrier control system of FIGS. 4A-D
as the carrier assembly of FIG. 3A reaches a second predetermined
position.
[0038] FIG. 6A illustrates a top view of one embodiment of a
closure element in a natural, planar configuration and with a
natural cross-section for use with the apparatus of FIG. 1.
[0039] FIG. 6B illustrates a side view of the closure element of
FIG. 6A.
[0040] FIG. 6C illustrates a top view of the closure element of
FIGS. 6A-B after a natural cross-section of the closure element has
been reduced.
[0041] FIG. 6D illustrates a side view of the reduced closure
element of FIG. 6C.
[0042] FIG. 6E illustrates a side view of the reduced closure
element of FIGS. 6C-D as the reduced closure element transitions
from the natural, planar configuration to a tubular
configuration.
[0043] FIG. 6F illustrates a top view of the closure element of
FIGS. 6C-D upon completing the transition from the natural, planar
configuration to a substantially tubular configuration.
[0044] FIG. 6G illustrates a side view of the closure element of
FIG. 6F.
[0045] FIG. 7A illustrates the closure element of FIGS. 6A-G prior
to being disposed upon the carrier member of FIG. 3B.
[0046] FIG. 7B illustrates the closure element of FIGS. 6A-G upon
being disposed upon the carrier member of FIG. 3B.
[0047] FIG. 7C illustrates the closure element of FIGS. 6A-G as the
cover member of FIG. 3D receives the carrier member of FIG. 3B.
[0048] FIG. 7D illustrates the closure element of FIGS. 6A-G being
retained substantially within the carrier assembly of FIG. 3A when
the carrier member of FIG. 3B is disposed substantially within the
cover member of FIG. 3D.
[0049] FIG. 8A illustrates a sheath that is positioned through
tissue and into an opening formed in a wall of a blood vessel.
[0050] FIG. 8B illustrates the apparatus of FIG. 1 as prepared to
be received by the sheath of FIG. 8A.
[0051] FIG. 8C illustrates a locator assembly of the apparatus of
FIG. 8B being advanced distally into the blood vessel.
[0052] FIG. 8D illustrates a distal end region of the locator
assembly of FIG. 8C extending into the blood vessel and being
transitioned into an expanded state.
[0053] FIG. 8E illustrates the distal end region of FIG. 8D being
retracted proximally to engage an inner surface of the blood vessel
wall.
[0054] FIG. 8F illustrates a carrier assembly of the apparatus of
FIG. 8B being advanced distally into the sheath of FIG. 8A once the
distal end region of FIG. 8D has engaged the inner surface of the
blood vessel wall.
[0055] FIG. 8G illustrates relative positions of a tube set of the
carrier assembly of FIG. 8F upon reaching a first predetermined
position.
[0056] FIG. 8H illustrates the relative positions of the tube set
of FIG. 8G upon reaching a second predetermined position.
[0057] FIG. 8I illustrates a position of a pusher member of the
tube set of FIG. 8H moving distally from the second predetermined
position and beginning to distally deploy a closure element.
[0058] FIG. 8J illustrates the closure element of FIG. 8I upon
being deployed and engaging tissue adjacent to the opening in the
blood vessel wall.
[0059] FIG. 8K illustrates the closure element of FIG. 8J
transitioning from the substantially tubular configuration to the
natural, planar configuration while engaging the engaged
tissue.
[0060] FIG. 8L illustrates the closure element of FIG. 8K drawing
the engaged tissue substantially closed and/or sealed
[0061] FIG. 9 illustrates one embodiment of an introducer sheath
for the apparatus of FIG. 1.
[0062] FIG. 10A illustrates an assembly view of the components
included in an alternative embodiment of the apparatus for closing
openings formed in blood vessel walls.
[0063] FIG. 10B illustrates an assembly view of the components
shown in FIG. 10A, showing the reverse view of that shown in FIG.
10A.
[0064] FIG. 11A illustrates the assembled carrier assembly and
triggering assembly of the alternative embodiment of the apparatus
shown in FIG. 10A.
[0065] FIG. 11B illustrates a close-up view of the proximal end of
the apparatus shown in FIG. 11A.
[0066] FIG. 12 illustrates the apparatus of FIG. 11A after
advancement of the locator assembly block.
[0067] FIG. 13A illustrates the apparatus of FIG. 12 after distal
advancement of the triggering system and carrier assembly. FIG. 13B
illustrates a close-up view of the distal end of the housing and
internal components of the apparatus shown in FIG. 13A.
[0068] FIG. 14A illustrates the apparatus of FIG. 13 after further
distal advancement of the triggering system and carrier
assembly.
[0069] FIG. 14B illustrates a close-up view of the distal end of
the housing and internal components of the apparatus shown in FIG.
14A.
[0070] FIG. 15 illustrates a reverse view of the apparatus of FIGS.
11-14, showing the locator release system.
[0071] FIG. 16 illustrates a side view of another alternative
embodiment of an apparatus for closing openings formed in blood
vessel walls.
[0072] FIG. 16A illustrates a close-up view of the distal end of
the device shown in FIG. 16.
[0073] FIG. 17 illustrates a perspective view of the proximal end
of the device shown in FIG. 16.
[0074] FIG. 17A illustrates a close-up view of the proximal end of
the device shown in FIG. 17.
[0075] FIG. 18 illustrates a cross-sectional view of the device
shown in FIG. 16.
[0076] FIG. 18A illustrates a close-up cross-sectional view of a
portion of the device shown in FIG. 18.
[0077] FIG. 18B illustrates a close-up cross-sectional view of a
portion of the device shown in FIG. 18.
[0078] FIG. 19 illustrates a close-up cross-sectional view of the
proximal end of the device shown in FIG. 16.
[0079] FIG. 20A is a cross-sectional side view illustrating an
opening formed in a vessel, wherein a guidewire is shown disposed
within the opening.
[0080] FIGS. 20B-20F are partial cross-sectional views illustrating
the alternative embodiment of the closure device in accordance with
the present invention wherein the device is illustrated being
disposed over a guidewire.
[0081] FIG. 20G is a partial cross-sectional view illustrating the
placement of a closure element in accordance with the device
illustrated in FIGS. 20B-20F.
[0082] It should be noted that the figures are not drawn to scale
and that elements of similar structures or functions are generally
represented by like reference numerals for illustrative purposes
throughout the figures. It also should be noted that the figures
are only intended to facilitate the description of embodiments of
the present invention.
DETAILED DESCRIPTION
[0083] The embodiments described herein extend to methods, systems,
and apparatus for managing access through tissue. Some of the
apparatuses of the present invention are configured to deliver a
device for managing access through tissue into an opening formed in
and/or adjacent to tissue.
[0084] Medical devices may be used in a variety of spaces. It may
be desirable to generally reduce the size of medical devices. For
example, stents may be inserted into smaller and smaller
vasculature, thus making it generally desirable to reduce the
pre-deployment size of a stent. In another example, a closure
device may be used to close tissue in, for example, a body lumen.
In order to reach the desired body lumen, typically a delivery
device may be used to reach an access point in the body lumen. To
minimize the effects of a procedure on a patient, the reduction in
size of the access point may be desirable.
[0085] When engaging tissue and/or closing openings in tissue, it
may be desirable to use a locator assembly to selectably contact a
portion of the tissue. In some cases, the locator assembly may not
contact a portion of the desired tissue. For example, the locator
assembly may be positioned within a body lumen but away from an
inside surface of the body lumen. In these instances, engagement of
a portion of the desired tissue may be less likely and/or
favorable. It may be desirable to verify contact with a portion of
the desired tissue during a medical procedure.
[0086] In one embodiment, a locator assembly may include engagement
members configured to engage a portion of the desired tissue. The
locator assembly may include a device to take measurements of a
desired measurable characteristic. The measurable characteristic
may include, for example, impedance. Measurements may be taken when
a portion of the locator assembly is within a body lumen and when
the locator assembly is believed to be in contact with tissue.
Comparing the measurements taken when within the body lumen and
when the locator assembly is believed to be in contact with tissue
may indicate that the locator assembly has contacted a portion of
the desired tissue. For example, an impedance measurement taken
when within the body lumen may be higher than an impedance
measurement taken when the locator assembly is in contact with
tissue.
[0087] In a further embodiment, a surface engaging element can be
provided. The surface engaging element may include a flexible body
that may actuate between an expanded and relaxed configuration.
[0088] In some embodiments, an engagement portion of the surface
engaging element may include substantially uniform dimensions. In
other embodiments, the engagement portion of the surface engaging
element may include at least one non-uniform dimension. For
example, the engagement portion may have a dimension that is larger
than a support portion of the surface engaging element.
[0089] In further embodiments, the surface engaging element may be
assembled using a retaining portion. For example, an engagement
portion may be connected to a proximal, distal, and/or other
portion of the surface engaging element by a retaining portion,
such as a detent.
[0090] These results, whether individually or collectively, can be
achieved, according to one embodiment of the present invention, by
employing methods, systems, and/or apparatus as shown in the
figures and described in detail below.
[0091] Since current apparatuses for sealing openings formed in
blood vessel walls can snag tissue adjacent to the openings during
positioning and may not provide an adequate seal, an apparatus that
is configured to prevent inadvertent tissue contact during
positioning and to engage a substantial of amount of tissue
adjacent to the opening can prove much more desirable and provide a
basis for a wide range of medical applications, such as diagnostic
and/or therapeutic procedures involving blood vessels or other body
lumens of any size. This result can be achieved, according to one
embodiment of the present invention, by employing an apparatus 100
as shown in FIG. 1.
[0092] As will be discussed in more detail below, the apparatus 100
can deliver a closure element 500 (shown in FIGS. 6A-B) through
tissue 630 (shown in FIG. 8A) and into an opening 610 (shown in
FIG. 8A) formed in and/or adjacent to a wall 620 (shown in FIG. 8A)
of a blood vessel 600 (shown in FIG. 8A) or other body lumen. The
closure element (or clip) 500 preferably has a generally
annular-shape body 510 (shown in FIGS. 6A-B) defining a channel 540
and one or more barbs and/or tines 520 (shown in FIGS. 6A-B) for
receiving and engaging the blood vessel wall 620 and/or the tissue
630 around the opening 610. Although the closure element 500 has a
natural shape and size, the closure element 500 can be deformed
into other shapes and sizes, as desired, and is configured to
return to the natural shape and size when released. For example,
the closure element 500 can have a natural, planar configuration
with opposing tines 520 and a natural cross-section 530 as shown in
FIGS. 6A-B. The natural cross-section 530 of the closure element
500 can be reduced to form a reduced closure element 500' that has
a natural, planar configuration with opposing tines 520 and a
reduced cross-section 530' as shown in FIGS. 6C-D. By rotating the
opposing tines 520 axially as shown in FIG. 6E, the reduced closure
element 500' can be further deformed to form a substantially
tubular closure element 500'' (shown in FIG. 6F) having the reduced
cross-section 530' as well as being in a substantially tubular
configuration with the tines 520 in an axial configuration.
[0093] Being configured to draw the blood vessel wall 620 and/or
the tissue 630 adjacent to the opening 610 substantially closed
and/or to enhance hemostasis within the opening 610, the closure
element 500 can be formed from any suitable material, including any
biodegradable material, any shape memory alloy, such as alloys of
nickel-titanium, or any combination thereof. Additionally, it is
contemplated that the closure element may be coated with a
beneficial agent or be constructed as a composite, wherein one
component of the composite would be a beneficial agent. As desired,
the closure element 500 may further include radiopaque markers (not
shown) or may be wholly or partially formed from a radiopaque
material to facilitate observation of the closure element 500 using
fluoroscopy or other imaging systems. Exemplary embodiments of a
closure element are disclosed in U.S. Pat. Nos. 6,197,042, and
6,623,510, and in co-pending application Ser. Nos. 09/546,998,
09/610,238, and 10/081,726. The disclosures of these references and
any others cited therein are expressly incorporated herein by
reference.
[0094] The apparatus 100 is configured to receive and retain the
closure element 500 such that the closure element 500 is disposed
substantially within the apparatus 100. Thereby, if the apparatus
100 is introduced via an introducer sheath 640 (shown in FIG. 8A),
for example, the closure element 500 can be disposed within, and
delivered by way of, a lumen 644 (shown in FIG. 8A) of the
introducer sheath 640. The apparatus 100 also is configured to
engage the blood vessel wall 620 adjacent to the opening 610. Being
disposed substantially within the apparatus 100, the closure
element 500 can deeply penetrate, without inadvertently contacting,
tissue 630 adjacent to the opening 610 such that the apparatus 100
can position the closure element 500 substantially adjacent to an
outer surface 620a (shown in FIG. 8A) of the blood vessel wall 620
adjacent to the opening 610.
[0095] When properly positioned, the apparatus 100 can be activated
to deploy the closure element 500. Although preferably configured
to substantially uniformly expand the closure element 500 beyond
the natural cross-section 530 of the closure element 500 during
deployment, the apparatus 100, as desired, can deploy the closure
element 500 without expanding the closure element 500. The closure
element 500, when deployed, is configured to engage a significant
amount of the blood vessel wall 620 and/or tissue 630 adjacent to
the opening 610. Engaging the blood vessel wall 620 and/or tissue
630, the closure element 500 is further configured to return to the
natural cross-section 530. Thus, the engaged blood vessel wall 620
and/or tissue 630 are drawn substantially closed and/or sealed,
such that, for example, hemostasis within the opening 610 is
enhanced.
[0096] The apparatus 100 can be provided as one or more integrated
components and/or discrete components. As shown in FIG. 1, for
example, the apparatus 100 can comprise a locator (or obturator)
assembly 200 and a carrier assembly 300. For purposes of
illustration, the locator assembly 200 and the carrier assembly 300
are shown in FIG. 1 as comprising substantially separate
assemblies. As desired, however, the locator assembly 200 and the
carrier assembly 300 each can be provided, in whole or in part, as
one or more integrated assemblies.
[0097] Being configured to extend into the opening 610, the locator
assembly 200 can selectably contact the inner surface 620b of the
blood vessel wall 620 adjacent the opening 610. Whereby, the
locator assembly 200 is configured to draw the blood vessel wall
620 taut and maintain the proper position of the apparatus 100 in
relation to the opening 610 as the blood vessel 600 pulsates. The
locator assembly 200 can be provided in the manner disclosed in
co-pending application Ser. Nos. 09/732,835 and 10/081,723, the
disclosures of which are expressly incorporated herein by
reference. The locator assembly 200 preferably includes a flexible
or semi-rigid tubular body 210. As illustrated in FIG. 2A, the
tubular body 210 has a proximal end region 210a and a distal end
region 210b and includes a predetermined length 218a and a
predetermined outer cross-section 218b, both of which can be of any
suitable dimension. The distal end region 210b of the locator
assembly 200 preferably includes a substantially rounded, soft,
and/or flexible distal end or tip 220 to facilitate atraumatic
advancement and/or retraction of the distal end region 210b into
the blood vessel 600. As desired, a pigtail (not shown) may be
provided on the distal end 220 to further aid atraumatic
advancement of the distal end region 210b.
[0098] The distal end region 210b of the locator assembly 200
further is selectably controllable between an unexpanded state and
an expanded state. In the unexpanded state, the distal end region
210b has an unexpanded size; whereas, the distal end region 210b in
the expanded state has an expanded size, which is greater than the
unexpanded size of the distal end region 210b in the unexpanded
state. The distal end region 210b is configured to expand from the
unexpanded size to the expanded size and/or to contract from the
expanded size to the unexpanded size, and the expansion and
contraction of the distal end region 210b preferably is
substantially uniform about a longitudinal axis of the locator
assembly 200. For example, one or more expansion elements 230 can
be provided on the distal end region 210b and can be configured to
expand substantially transversely with respect to a longitudinal
axis of the locator assembly 200. Preferably being substantially
equally distributed about an outer periphery 212 of the distal end
region 210b, the expansion elements 230 may include radiopaque
markers (not shown) or may be wholly or partially formed from a
radiopaque material to facilitate observation of the expansion
elements 230 and/or the distal end region 210b using fluoroscopy or
other imaging systems.
[0099] At least one, and preferably all of the expansion elements
230 can comprise a substantially flexible member 230' with a
substantially fixed end region 230a', an intermediate region 230b',
and a movable end region 230c' as shown in FIGS. 2B-C. For each
substantially flexible member 230', the fixed end region 230a' is
fixedly coupled with the distal end region 210b; whereas, the
movable end region 230c' is movably coupled with the distal end
region 210b and configured to be axially movable relative to the
fixed end region 230a'. When each movable end region 230c' is
axially moved toward the relevant fixed end region 230a', the
intermediate regions 230b' buckle and/or expand transversely
outwardly, thereby transitioning the distal end region 210b of the
locator assembly 200 from the unexpanded state to the expanded
state. In contrast, the distal end region 210b transitions from the
expanded state to the unexpanded state as each of the movable end
regions 230c' are axially moved away from the relevant fixed end
region 230a'. Although the expansion elements 230 are shown as
comprising the flexible members 230' in FIGS. 2B-C for purposes of
illustration, it is understood that the expansion elements 230 can
comprise any type of expansion elements and are not limited to the
illustrated embodiments. It is further contemplated that the
expansion elements 230 may further include geometric features that
allow/enhance the ability of the expansion elements to bend or fold
from a retracted position to an expanded position. The expansion
elements may be constructed of a material such as steel, spring
steel, plastics or composites. In one embodiment, the expansion
elements are constructed of Nitinol.RTM..
[0100] FIGS. 2B' and 2C' illustrate an alternative embodiment of a
locator assembly 200'' for locating a surface of a body lumen, in
accordance with the present invention. The locator assembly 200''
of this embodiment may be functionally similar to that of the
locator assembly 200 previously described above and shown in FIGS.
2B and 2C in most respects, wherein certain features will not be
described in relation to this embodiment wherein those components
may function in the manner as described above and are hereby
incorporated into this alternative embodiment described below. Like
structures and/or components are given like reference numerals.
[0101] The locator assembly 200'' may be located proximal to a
distal end 210b'' of a tubular member 210'' and/or an apparatus
(such as apparatus 100 shown in FIG. 1). The locator assembly 200''
may include a surface engagement assembly 226''. The surface
engagement assembly 226'' may include a distal end portion 226a'',
a proximal end portion 226b'', and/or at least one surface
engagement element 230''. The surface engagement elements 230'' may
be configured to transition from a relaxed state to an expanded
state, similar to the substantially flexible member 230' described
above. For example, the surface engagement elements 230'' may be
moveably connected to and/or fixedly connected to a distal end
region 210b'' of the locator assembly 200''. In this example, a
distal end 230a'' of the surface engagement elements 230'' may be
moveably connected to and a proximal end 230c'' of the surface
engagement elements 230'' may be fixedly connected to the distal
end region 210b''. In other examples, other types of connections
may be contemplated.
[0102] The locator assembly 200'' may include two, three, four,
and/or other numbers of surface engaging elements 230''. At least
one of the surface engaging elements 230'' may be configured to
conduct a measurable characteristic of the surface engaging
elements 230'' to the locator assembly 200''. For instance, the
locator assembly 200'' may be in communication with a measuring
device 251. An example of a measuring device 251 may include an
impedance measuring device, a voltmeter, an amp meter, a pressure
transducer, piezoelectric crystals, other measuring devices, or
combinations thereof. The measuring device 251 may determine
changes in measurable characteristics of the locator assembly
200''. For instance, the measuring device 251 may measure changes
in the impedance of the locator assembly 200''. In another example,
the measuring device 251 may determine changes in pressure. Changes
in pressure may be determined by a pressure transducer or other
pressure measuring device. In a further example, the measuring
device 251 may retrieve ultrasonic data in and/or around the body
lumen. Ultrasonic data may be retrieved by piezoelectric crystal or
other ultrasonic data gathering device. Other measurable
characteristics may include electrical characteristics such as
voltage, current, other electrical characteristics, and/or other
measurable characteristics.
[0103] In embodiments where the measurable characteristic is an
electrical characteristic, the locator assembly 200'' may be in
electrical communication with at least one of the surface engaging
elements 230''. In the present embodiment, the locator assembly
200'' may include at least one distal conductive portion 204a''
and/or at least one proximal conductive portion 204b'' with which
at least one surface engaging element 230'' may be in electrical
communication. At least one of surface engaging elements 230'' may
be formed at least partially from an electrically conductive
material. In the present embodiment, at least one of surface
engaging elements 230'' may be formed at least partially from
Nitinol.RTM..
[0104] The distal conductive portions 204a'' and/or the proximal
conductive portions 204b'' may be in electrical communication with
the measuring device 251. For example, the at least one distal
conductive portion 204a'' may be in electrical communication with
the measuring device 251 through at least one distal conductor
connector 205a'' and/or the at least one proximal conductive
portion 204b'' may be in electrical communication with the
measuring device 251 through at least one proximal conductor
connector 205b''. The distal and/or proximal conductor connectors
205a'', 205b'' may extend toward the distal end 210b'' and/or
toward a proximal end 210a'' of the tubular member 210'' through at
least one lumen (not shown).
[0105] In the present embodiment, each of the surface engaging
elements 230'' may be in electrical communication with a different
distal conductive portion 204a'' and/or proximal conductive portion
204b''. Alternatively, more than one surface engaging element 230''
may be in electrical communication with the same distal conductive
portion 204a'' and/or proximal conductive portion 204b''. Other
combinations are also contemplated.
[0106] The surface engaging elements 230'' may be in electrical
communication with each other. For instance, two or more surface
engaging elements 230'' may be may be formed from the same piece of
material. In the present embodiment, each of the surface engaging
elements 230'' may be selectively electrically isolated from each
other. Isolation of the surface engaging elements 230'' may be
accomplished by insulators 206a'', 206b''. The insulators 206a'',
206b'' may include materials such as ceramics, polyethylene, and/or
other insulating materials.
[0107] FIGS. 2B'' and 2C'' illustrate a further embodiment of a
locator assembly 200''' for locating a surface of a body lumen, in
accordance with the present invention. The locator assembly 200'''
of this embodiment may be functionally similar to that of the
locator assemblies 200, 200'' previously described above and shown
in FIGS. 2B-2C and 2B'-2C' in most respects, wherein certain
features will not be described in relation to this embodiment
wherein those components may function in the manner as described
above and are hereby incorporated into this alternative embodiment
described below. Like structures and/or components are given like
reference numerals. For example, the locator assembly 200''' may be
configured to facilitate the determination of changes in measurable
characteristics of the locator assembly.
[0108] The locator assembly 200''' may be located proximal to a
distal end of a tubular member (such as 210b, 210b'' shown in FIGS.
2A, 2B, 2A', and 2B') and/or an apparatus (such as apparatus 100
shown in FIG. 1). The locator assembly 200''' may include a surface
engagement assembly 226'''.
[0109] The surface engagement assembly 226''' may include a distal
end portion 226a''', a proximal end portion 226b''', and/or at
least one surface engagement element 230'''. In the present
embodiment, the surface engagement assembly 226''' may include four
surface engagement elements 230''' that may be separated by a
distal and/or proximal engagement element support 231a''', 231b'''.
The distal and/or proximal engagement element supports 231a''',
231b''' may electrically insulate the surface engagement elements
230'''. In an alternative embodiment, the distal engagement element
supports 231a''', proximal engagement element supports 231b''',
and/or surface engagement elements 230''' may be formed as a
unitary piece and/or from the same material. For example, the
distal engagement element supports 231a''', proximal engagement
element supports 231b''', and/or surface engagement elements 230'''
may be laser cut from a Nitinol.RTM. tube.
[0110] The surface engagement elements 230''' may include a distal
and/or proximal retaining portion 229a''', 229b'''. The distal
and/or proximal retaining portions 229a''', 229b''' may include an
aperture and/or other retaining mechanism that may receive, for
example, a detent and/or other retaining mechanism. For instance, a
cover member (such as the cover member 220 shown in FIG. 2C) may
include a retaining mechanism (not shown) to limit motion between
the cover member and the surface engagement elements 230'''. The
cover member may be connected to a control member (such as control
member 250 shown in FIG. 2D) that is configured to transition the
surface engagement elements 230''' from a relaxed state to an
expanded state, similar to the substantially flexible member 230'
described above.
[0111] The surface engaging elements 230''' may include a measuring
component 253'''. The measuring component 253''' may facilitate the
determination of changes in measurable characteristics of the
locator assembly 200'''. For instance, the measuring component
253''' may facilitate the determination of changes in impedance,
pressure, ultrasonic data, or other measurable characteristics. The
measuring component 253''' may be in electrical communication with
a connector 205'''. The connector 205''' may be in electrical
communication with a measuring device (shown as 251 in FIG.
2B').
[0112] FIGS. 2B''' and 2C''' illustrate a further embodiment of a
locator assembly 200''' for locating a surface of a body lumen, in
accordance with the present invention. The locator assembly 200'''
of this embodiment may be functionally similar to that of the
locator assemblies 200, 200', 200'' previously described above and
shown in FIGS. 2B-2C, 2B'-2C', and 2B''-2C'' in most respects,
wherein certain features will not be described in relation to this
embodiment wherein those components may function in the manner as
described above and are hereby incorporated into this alternative
embodiment described below. Like structures and/or components are
given like reference numerals.
[0113] The locator assembly 200'''' may be located proximal to a
distal end of a tubular member (such as 210b, 210b'' shown in FIGS.
2A, 2B, 2A', and 2B') and/or an apparatus (such as apparatus 100
shown in FIG. 1). The locator assembly 200'''' may include a
surface engagement assembly 226'''', a cover member 220'''', and/or
a proximal end portion 226b''''.
[0114] The cover member 220'''' and/or proximal end portion
226b'''' may include a distal retaining portion 221a'''' and/or a
proximal retaining portion 221b'''', respectively. The surface
engagement assembly 226'''' may include at least one surface
engagement element 230''''. The surface engagement elements 230''''
may include a distal and/or proximal retaining portion 229a'''',
229b''''. The distal and/or proximal retaining portions 221a'''',
221b'''' on the cover member 220'''' and/or proximal end portion
226b'''' may include an aperture and/or other retaining mechanism
that may cooperate with corresponding distal and/or proximal
retaining portions 229a'''', 229b'''', such as a detent and/or
other retaining mechanism, on the surface engagement elements
230'''' to limit motion between the cover member 220'''', the
proximal end portion 226b'''', and/or the surface engagement
elements 230''''. The distal and/or proximal retaining portions
229a'''', 229b'''' may be located near a distal and/or proximal end
230a'''', 230c'''' of the surface engagement element 230'''',
respectively.
[0115] A control member 250'''' may be inserted through the
proximal end portion 226b'''' and/or may be connected to the cover
member 220''''. The control member 250'''' may be used to
transition the surface engagement elements 230'''' from a relaxed
state to an expanded state, similar to the substantially flexible
member 230' described above.
[0116] In the present embodiment, the control member 250'''' may be
a single piece, which may be elongate from the cover member 220''''
toward a proximal end (such as proximal end 210a'' shown in FIG.
2B') of the locator assembly 200''''. Alternatively, the control
member 250'''' may be in one or more pieces that may connected
together using various mechanisms, similar to the retaining
portions 221a'''', 221b'''', 229a'''', 229b'''' described
above.
[0117] The proximal end portion 226b'''' may include a tubular
member retaining portion 228''''. The tubular member retaining
portion 228'''' may be configured to engage a distal end (such as
distal end 210b, 210b'' shown in FIGS. 2B and 2B'). The tubular
member retaining portion 228'''', in the present embodiment, may
include a ramp and/or other retaining mechanism to limit the motion
of the tubular member in at least one direction.
[0118] The surface engagement elements 230'''' may include an
engagement member 232''''. The engagement member 232'''' may
include an engagement portion 234'''' and/or an engagement support
portion 237''''.
[0119] The engagement portion 234'''' may be configured to contact
and/or engage tissue. The engagement portion 234'''', in the
present embodiment, may be enlarged in an intermediate portion
235'''' in comparison to distal and/or proximal end 234a'''',
234b'''' of the engagement portion 234''''. An enlarged
intermediate portion 235'''' may facilitate contact and/or
engagement with tissue.
[0120] The engagement support portion 237'''' may support the
engagement portion 234'''' during, for example, transitioning from
a relaxed state to an expanded state. The engagement support
portion 237'''' may include an enlarged intermediate portion
238'''', similar to the enlarged intermediate portion 235'''' of
the engagement portion 234''''. Having an enlarged intermediate
portion 238'''' on the engagement support portion 237'''' may add
stability to the engagement portion 234'''' while in the expanded
state.
[0121] The intermediate portions 235'''', 238'''' of the engagement
portions 234'''' and/or the engagement support portions 237'''' may
be oval shaped. Alternatively, the intermediate portions 235'''',
238'''' may have the same shape, have differing shapes, and/or have
other combinations of shapes.
[0122] In the present embodiment, the proximal end 234b'''' of the
engagement portion 234'''' may be connected to a proximal support
portion 233''''. The proximal support portion 233'''' may be
connected to the proximal end portion 226b'''' and may separate the
engagement portion 234'''' from the proximal end portion 226b''''.
The distal end 234a'''' of the engagement portion 234'''' may be
connected to an intermediate support portion 236''''. The
intermediate support portion 236'''' may be connected to the
proximal end 237b'''' of the engagement support portion 237'''' and
may separate the engagement portion 234'''' from the engagement
support portion 237''''. The distal end 237a'''' of the engagement
support portion 237'''' may be connected to a distal support
portion 239''''. The distal support portion 239'''' may be
connected to the distal end (not shown) of the surface engagement
element 230'''' and may separate the engagement support portion
237'''' from the distal end portion 226a''''.
[0123] The surface engaging elements 230'''' may include a
measuring component 253''''. The measuring component 253'''' may
facilitate the determination of changes in measurable
characteristics of the locator assembly 200''''. For instance, the
measuring component 253'''' may facilitate the determination of
changes in impedance, pressure, ultrasonic data, or other
measurable characteristics. The measuring component 253'''' may be
in electrical communication with a connector 205''''. The connector
205'''' may be in electrical communication with a measuring device
(shown as 251 in FIG. 2B').
[0124] Referring now to FIG. 2D, the locator assembly 200 may
further include a locator control system associated with the
locator assembly. As shown in FIG. 2D, the locator control system
240 is associated with the proximal end region 210a of the locator
assembly 200 and is configured to selectively control the distal
end region 210b of the locator assembly 200 between the unexpanded
and expanded states. The locator control system 240 can selectively
control the distal end region 210b between the unexpanded and
expanded states, such as by being activated by a switching system
(not shown). For example, a control member 250, such as a rod,
wire, or other elongate member, can be moveably disposed within a
lumen (not shown) formed by the tubular body 210 and extending
substantially between the proximal end region 210a and the distal
end region 210b. The control member 250 has a proximal end region
250a that is coupled with the locator control system 240,
preferably via a control block 260 (shown in FIG. 4D), and a distal
end region (not shown) that is coupled with the distal end region
210b of the locator assembly 200, the expansion elements 230,
and/or the movable end regions 230c' of the substantially flexible
members 230'. The locator control system 240 can selectively
transition the distal end region 210b, the expansion elements 230,
and/or the substantially flexible members 230' between the
unexpanded and expanded states by moving the control member 250
axially relative to the tubular body 210.
[0125] The locator control system 240 further includes a locator
release system 490 for maintaining the unexpanded state and/or the
expanded state of the distal end region 210b, the expansion
elements 230, and/or the substantially flexible members 230'.
Preferably being configured to maintain the expanded state of the
distal end region 210b, the locator release system 490 can comprise
any type of locking system and can be engaged, for instance, by
activating the switching system. For example, once the
substantially flexible members 230' have entered the expanded
state, the locator release system 490 can secure the control member
250 to prevent axial movement relative to the tubular body 210,
thereby maintaining the substantially flexible members 230' in the
expanded state.
[0126] In the manner described in more detail below, the locator
control system 240 also can be configured to disengage the locator
release system 490, such that the distal end region 210b, the
expansion elements 230, and/or the substantially flexible members
230' can transition between the expanded and unexpanded states. The
locator release system 490 can be disengaged, for example, by
activating an emergency release system (not shown). As desired, the
locator control system 240 may further include a biasing system
(not shown), such as one or more springs or other resilient
members, to bias the distal end region 210b, the expansion elements
230, and/or the substantially flexible members 230' to enter and/or
maintain the unexpanded state when the locator release system 490
is disengaged.
[0127] Returning to FIG. 1, the carrier assembly 300 is coupled
with, and slidable relative to, the locator assembly 200. The
carrier assembly 300 is configured to receive and retain the
closure element 500 (shown in FIGS. 6A-B), which preferably is
disposed substantially within the carrier assembly 300. When the
locator assembly 200 engages the inner surface 620b (shown in FIG.
8A) of the blood vessel wall 620 (shown in FIG. 8A), the carrier
assembly 300 is further configured to position the closure element
500 substantially adjacent to the opening 610 (shown in FIG. 8A)
and to deploy the closure element 500. Upon being deployed, the
closure element 500 can maintain the reduced cross-section 530'
(shown in FIGS. 6C-D) but preferably can temporarily and
substantially uniformly expand beyond the natural cross-section 530
(shown in FIGS. 6A-B) of the closure element 500. In either case,
the closure element 500, when deployed, can engage a significant
amount of the blood vessel wall 620 and/or tissue 630 adjacent to
the opening 610. Thereafter, the closure element 500 is configured
to return to the natural cross-section 530, preferably
substantially uniformly, such that the blood vessel wall 620 and/or
tissue 630 is drawn substantially closed and/or sealed.
[0128] Turning to FIGS. 3A-D, the carrier assembly 300 can include
a tube set 305, comprising a carrier member 310, a pusher member
320, a support tube 340, and a cover member 330. The carrier member
310, the pusher member 320, the support tube 340, and the cover
member 330 can be provided as a plurality of nested, telescoping
members with a common longitudinal axis 350 as illustrated in FIG.
3A. The carrier member 310 is configured to receive and support the
closure element 500. While being disposed on the carrier member
310, the closure element 500 preferably is deformed from the
natural, planar configuration to form the substantially tubular
closure element 500'' (shown in FIGS. 6F-G) as will be discussed in
more detail below. Being disposed substantially about, and
supported by, an outer periphery 312b of the carrier member 310,
the substantially tubular closure element 500'' can be
substantially in axial alignment with the carrier member 310 with
the tines 520 pointed substantially distally.
[0129] Preferably being formed as a substantially rigid,
semi-rigid, or flexible tubular member, the carrier member 310 has
a proximal end region 310a and a distal end region 310b and
includes a predetermined length 318a and a predetermined
cross-section 318b, both of which can be of any suitable dimension.
The carrier member 310 also can define a lumen 314 that extends
substantially between the proximal end region 310a and the distal
end region 310b and that is configured to slidably receive at least
a portion of the tubular body 210 of the locator assembly 200.
Although the cross-section 318b of the carrier member 310 generally
is substantially uniform, the distal end region 310b of the carrier
member 310 preferably has a cross-section that increases distally,
as illustrated in FIGS. 3A-B, for substantially uniformly expanding
the substantially tubular closure element 500'' beyond the natural
cross-section 530 of the closure element 500 when the substantially
tubular closure element 500'' is deployed. To deploy the closure
element 500 without expanding the closure element 500, the distal
end region 310b can be formed with a cross-section (not shown) that
is substantially uniform. Although shown and described as having
the cross-section that increases distally for expanding the
substantially tubular closure element 500'', it will be understood
that the distal end region 310b of the carrier member 310 can be
provided with the substantially-uniform cross-section and that the
substantially tubular closure element 500'' can be deployed without
being expanded.
[0130] Being configured to distally deploy the substantially
tubular closure element 500'', the pusher member 320 has a proximal
end region 320a and a distal end region 320b and is coupled with,
and slidable relative to, the carrier member 310. The pusher member
320 includes a predetermined length 328a and a predetermined
cross-section 328b, both of which can be of any suitable dimension
and can be configured to slidably receive the carrier member 310
such that the distal end region 320b of the pusher member 320 is
offset proximally from the distal end region 310b of the carrier
member 310. As desired, the predetermined length 328a of the pusher
member 320 can be greater than or substantially equal to the
predetermined length 318a of the carrier member 310. The
predetermined length 328a of the pusher member 320 however is
preferably less than the predetermined length 318a of the carrier
member 310 such that the carrier member 310 and the pusher member
320 at least partially define a space 360 distal to the distal end
region 320b of the pusher member 320 and along the periphery 312b
of the carrier member 310.
[0131] Being formed from a substantially rigid, semi-rigid, or
flexible material, the pusher member 320 preferably is
substantially tubular and can define a lumen 324 that extends
substantially between the proximal end region 320a and the distal
end region 320b and that is configured to slidably receive at least
a portion of the carrier member 310. The cross-section 328b of the
pusher member 320 preferably is substantially uniform, and the
distal end region 320b of the pusher member 320 can comprise one or
more longitudinal extensions 325, which extend distally from the
pusher member 320 and along the periphery 312b of the carrier
member 310 as shown in FIG. 3C. The longitudinal extensions 325
preferably are biased such that the longitudinal extensions 325
extend generally in parallel with common longitudinal axis 350. The
longitudinal extensions 325 are sufficiently flexible to expand
radially, and yet sufficiently rigid to inhibit buckling, as the
distal end region 320b is directed distally along the carrier
member 310 and engage the distally-increasing cross-section of the
distal end region 310b of the carrier member 310 to deploy the
substantially tubular closure element 500''.
[0132] A cover member 330 is configured to retain the substantially
tubular closure element 500'' substantially within the carrier
assembly 300 prior to deployment as shown in FIG. 3D. Being coupled
with, and slidable relative to, the pusher member 320, the cover
member 330 has a proximal end region 330a and a distal end region
330b and includes a predetermined length 338a and a predetermined
cross-section 338b, both of which can be of any suitable dimension.
Preferably being formed as a substantially rigid, semi-rigid, or
flexible tubular member, the cover member 330 has an inner
periphery 332a and an outer periphery 332b and can define a lumen
334. The lumen 334 extends substantially between the proximal and
distal end regions 330a, 330b of the cover member 330 and can be
configured to slidably receive at least a portion of the pusher
member 320. When the cover member 330 is properly positioned within
the carrier assembly 300, the distal end region 330b is configured
to extend over the space 360, thereby defining an annular cavity
370 for receiving and retaining the substantially tubular closure
element 500''.
[0133] The cross-section 338b of the cover member 330 preferably is
substantially uniform, and the distal end region 330b of the cover
member 330 preferably comprises one or more longitudinal extensions
335, which extends distally from the cover member 330 and along an
outer periphery 322b of the pusher member 320 as shown in FIG. 3D.
Although the longitudinal extensions 335 can extend generally in
parallel with common longitudinal axis 350, the longitudinal
extensions 335 preferably are biased such that the plurality of
longitudinal extensions 335 extend substantially radially inwardly
as illustrated in FIGS. 3A and 3D. Thereby, the longitudinal
extensions 335 can at least partially close the lumen 334
substantially adjacent to the distal end region 330b of the cover
member 330. To permit the substantially tubular closure element
500'' to be deployed from the annular cavity 370, the longitudinal
extensions 335 preferably are sufficiently flexible to expand
radially to permit the distal end region 310b of the carrier member
310 to move distally past the cover member 330 to open the annular
cavity 370 such that the distal end region 330b no longer extends
over the space 360.
[0134] If the carrier assembly 300 is assembled as the plurality of
nested, telescoping members as shown in FIG. 3A, the carrier member
310 is at least partially disposed within, and slidable relative
to, the lumen 324 of the pusher member 320 as shown in FIG. 3C. The
pusher member 320, in turn, is at least partially disposed within,
and slidable relative to, the lumen 334 of the cover member 330. To
couple the carrier assembly 300 with the locator assembly 200, the
tubular body 210 of the locator assembly 200 is at least partially
disposed within, and slidable relative to, the lumen 314 of the
carrier member 310. The longitudinal axis of the locator assembly
200 is preferably substantially in axial alignment with the common
longitudinal axis 350 of the carrier member 310, the pusher member
320, the cover member 330, and the support tube 340.
[0135] It will be appreciated that the tube set 305 preferably also
includes a support member 340 as shown in FIGS. 3A and 3E. The
support member 340 is configured to slidably receive the tubular
body 210 of the locator assembly 200 and to provide radial support
for the distal end region 210b of the tubular body 210 when the
locator assembly 200 is coupled with the carrier assembly 300. The
carrier assembly 300 can advantageously include the support member
340, for example, if the tubular body 210 is not sufficiently rigid
or under other circumstances in which support for the tubular body
210 might be desirable. It also will be appreciated that the
support member 340 also can be configured to inhibit the plurality
of longitudinal extensions 335, which extend from the distal end
region 330b of the cover member 330, from expanding prematurely
prior to the closure element 500 being deployed.
[0136] The support member 340 is preferably formed as a
substantially rigid, semi-rigid, or flexible tubular member, having
a proximal end region 340a and a distal end region 340b. Wherein an
outer periphery 342b of the support member 340 can define a lumen
344 that extends substantially between the proximal end region 340a
and the distal end region 340b, the lumen is configured to slidably
receive and support at least a portion of the tubular body 210 of
the locator assembly 200. The support member 340, in turn, can be
at least partially slidably disposed within the lumen 314 of the
carrier member 310 such that the tubular body 210 of the locator
assembly 200 may be coupled with, and slidable relative to, the
carrier member 310 in the manner described in more detail above.
The support member 340 has a predetermined length 348a and a
predetermined cross-section 348b, both of which can be of any
suitable dimension, and the cross-section 348b preferably is
substantially uniform. Although shown and described as being
substantially separate for purposes of illustration, it will be
appreciated that the carrier member 310, the pusher member 320, the
cover member 330, and/or the support member 340 can be provided, in
whole or in part, as one or more integrated assemblies.
[0137] The carrier assembly 300 may further include a housing 380
as illustrated in FIG. 4A. Preferably being formed as an elongate
member with a longitudinal axis 386, the housing 380 has an outer
periphery 382b and includes a proximal end region 380a and a distal
end region 380b. Thereby, when the apparatus 100 is properly
assembled, the tubular body 210 of the locator assembly 200 at
least partially disposed within the tube set 305 such that the
distal end region 210b of the tubular body 210 extends beyond the
distal end regions 310b, 320b, 330b, and/or 340b. The tubular body
210, the carrier member 310, the pusher member 320, the cover
member 330, and, if provided, the support member 340 is at least
partially disposed within, and slidable relative to, the housing
380, and the respective distal end regions 210b, 310b, 320b, 330b,
and 340b extend from the distal end region 380b of the housing 380
such that the common longitudinal axis 350 (shown in FIG. 3A) of
the tube set 305 is substantially axially aligned with the
longitudinal axis 386 of the housing 380. Being configured to
slidably retain the respective proximal end regions 210a, 310a,
320a, 330a, and 340a, the housing 380 supports the tube set 305 and
can have one or more handles 390 to facilitate use of the apparatus
100. The handles 390 extend substantially radially from the outer
periphery 382b of the housing 380 and can be provided in the manner
known in the art.
[0138] When the apparatus 100 is properly assembled, the tubular
body 210 of the locator assembly 200 is at least partially disposed
within the tube set 305 of the carrier assembly 300 such that the
distal end region 210b of the tubular body 210 extends beyond the
distal end regions 310b, 320b, 330b, and/or 340b. Further, the
proximal end region 210a of the tubular body 210 and the proximal
end regions 310a, 320a, 330a, and/or 340a of the tube set 305 are
at least partially disposed within, and slidable relative to, the
housing 380. The switching system of the locator assembly 200 and a
switching system 450 of the triggering system 400 preferably are
accessible external to the housing 380 as shown in FIGS. 4A and
4C.
[0139] Turning to FIGS. 4B-D, a triggering system 400 can be
disposed substantially within the housing 380. The triggering
system 400 is configured to control the relative axial movement
and/or positioning of the respective distal end regions 310b, 320b,
330b, and 340b of the tube set 305 and/or the distal end region
210b of the locator assembly 200. Being coupled with the proximal
end regions 210a, 310a, 320a, 330a, and/or 340a, the triggering
system 400 can control the relative axial movement of the distal
end regions 210b, 310b, 320b, 330b, and/or 340b in any manner, such
as by being activated by the switching system 450. As desired, the
triggering system 400 can induce axial motion, such as distal
motion, with respect to one or more of the distal end regions 210b,
310b, 320b, 330b, and/or 340b. One or more of the distal end
regions 210b, 310b, 320b, 330b, and/or 340b can be axially moved.
Axial motion of one or more of the carrier member 310, the pusher
member 320, the cover member 330, and the support member 340 and/or
the tubular body 210 can be attained, for example, by applying an
axial force to the switching system 450. To facilitate monitoring
of the positioning of the carrier assembly 300 and/or the
substantially tubular closure element 500'', one or more of the
distal end regions 210b, 310b, 320b, 330b, and/or 340b may include
radiopaque markers (not shown) or may be wholly or partially formed
from a radiopaque material.
[0140] The triggering system 400 is configured to overcome internal
resistance such that the relative axial movement and/or positioning
of the respective distal end regions 310b, 320b, 330b, and 340b of
the tube set 305 and/or the distal end region 210b of the locator
assembly 200 are controlled in accordance with a predetermined
manner when the triggering system 400 is activated. Thereby,
movement and/or positioning of the distal end regions 310b, 320b,
330b, 340b, and/or 210b is initiated when at least a predetermined
quantity of force is applied to the switching system 450. Stated
somewhat differently, a force that is less than the predetermined
quantity generally is insufficient to activate the triggering
system 400; whereas, when the force increases to a level that is
greater than or substantially equal to the predetermined quantity,
the triggering system 400 is configured to activate, move and/or
position the distal end regions 310b, 320b, 330b, 340b, and/or 210b
in accordance with the predetermined manner. The triggering system
400, once activated, preferably continues to move and/or position
the distal end regions 310b, 320b, 330b, 340b, and/or 210b in
accordance with the predetermined manner until the closure element
500 is deployed.
[0141] The triggering system 400, for example, can comprise one or
more sets of cooperating detents for coupling the axial motion of
the distal end regions 310b, 320b, 330b, and 340b in accordance
with a predetermined manner when the triggering system 400 is
activated. The term "detents" refers to any combination of mating
elements, such as blocks, tabs, pockets, slots, ramps, locking
pins, cantilevered members, support pins, and the like, that may be
selectively or automatically engaged and/or disengaged to couple or
decouple the carrier member 310, the pusher member 320, the cover
member 330, and the support member 340 relative to one another. It
will be appreciated that the cooperating detents as illustrated and
described below are merely exemplary and not exhaustive. For
example, the cooperating detents can include a first set of
cooperating blocks and pockets for releasably coupling the support
member 340, the carrier member 310, the pusher member 320, and the
cover member 330. When the carrier assembly 300 reaches a first
predetermined distal position, the support member 340 can be
decoupled from the carrier member 310, the pusher member 320, and
the cover member 330 and preferably is substantially inhibited from
further axial movement. Thereby, the carrier member 310, the pusher
member 320, and the cover member 330 may continue to be directed
distally as the support member 340 remains substantially
stationary.
[0142] As shown in FIGS. 4B-C, the cooperating detents can comprise
a carrier block 410, a pusher block 420, a cover block 430, and a
support block 440, which can be configured to couple and decouple
in accordance with the predetermined manner. For example, the
carrier block 410 is disposed on the proximal end region 310a of
the carrier member 310 and includes a carrier pin 412c that extends
from the carrier block 410; whereas, the proximal end region 330a
of the cover member 330 and the proximal end region 340a the
support member 340 are respectively coupled with the cover block
430 and the support block 440. A cover pin 432b extends from the
cover block 430, and the support block 440 has a support pin 442a,
which extends from the support block 440. The support pin 442a, the
cover pin 432b, and the carrier pin 412c each preferably are formed
from a substantially rigid material, such as an alloy of
nickel-titanium.
[0143] The pusher block 420 is disposed on the proximal end region
320a of the pusher member 320 and forms a support slot 422a, a
cover slot 422b, and a carrier slot 422c. The support slot 422a is
configured to receive and releasable engage the support pin 442a by
which the support member 340 can be coupled with, and decoupled
from, the pusher member 320. The cover member 330 can be coupled
with, and decoupled from, the pusher member 320 via the cover slot
422b, which is configured to receive and releasable engage the
cover pin 432b. The carrier slot 422c is configured to receive and
releasable engage the carrier pin 412c such that the carrier member
310 can be coupled with, and decoupled from, the pusher member 320.
The carrier block 410, the pusher block 420, the cover block 430,
and the support block 440 preferably are respectively disposed
substantially on the outer peripheries 312b, 322b, 332b, and 342b
and can be configured to couple and decouple in accordance with the
predetermined manner.
[0144] The triggering system 400 further includes one or more stops
for engaging the pusher block 420, the cover block 430, and/or the
support block 440, respectively. As illustrated in FIG. 4B, a
support stop 460a, a cover stop 460b, and a carrier stop 460c each
are formed in the housing 380 and are configured to receive, and
substantially inhibit further movement of, the support block 440,
the cover block 430, and the carrier block 410, respectively, in
accordance with the predetermined manner. For example, when an
axial force is applied to the tube set 305 via the switching system
450, the cover block 430 moves distally within the housing 380, and
the cover block 430 approaches the cover stop 460b. Upon being
received by the cover stop 460b, the cover block 430 is
substantially locked in place, substantially preventing any further
motion of the cover block 430.
[0145] Resisting the axial force, the cover pin 432b provides a
static load while the axial force is less than the predetermined
quantity of force. As the axial force increases to a level that is
greater than or substantially equal to the predetermined quantity,
the cover pin 432b is displaced from the cover slot 422b,
decoupling the cover member 330 from the carrier member 310, the
pusher member 320, and the support member 340. Creating the
internal resistance to be overcome by the triggering system 400,
the static forces provided by the pins 442a, 432b, and 412c is
approximately proportional to a composition and cross-section of
the respective pins 442a, 432b, and 412c and/or a depth and a slope
of the respective slots 422a, 422b, and 422c. As desired, the pins
442a, 432b, and 412c can be configured to provide static loads that
are differing and/or substantially uniform.
[0146] Turning to FIG. 4D, the triggering system 400 may further
include a tube release system 470 for inhibiting inadvertent
advancement of the tube set 305. The tube release system 470 is
coupled with a tube release member 480, such as a rod, wire, or
other elongate member. The tube release member 480 has a proximal
end region 480a that is disposed substantially between the pusher
block 420 and the housing 380 (shown in FIG. 4A) and a distal end
region 480b that is coupled with the tube release system 470.
Preferably, a tab 485 is coupled with the proximal end region 480a
of the tube release member 480, and a pin (not shown) extends from
the pusher block 420 and is disposed substantially between the tab
485 and a groove (not shown) formed in the housing 380. The tube
release system 470 is configured to release the tube set 305 when
the tube release member 480 is moved proximally, freeing the pusher
block 420.
[0147] A locator release system 490 for permitting the distal end
region 210b, the expansion elements 230, and/or the substantially
flexible members 230' of the locator assembly 200 to transition
from the expanded state to the unexpanded state can be included
with the triggering system 400. The locator release system 490 can
comprise a rod, wire, or other elongate member and has a proximal
end region 490a and a distal end region 490b. The proximal end
region 490a of the locator release system 490 can be coupled with,
and configured to activate, the locator control system (shown in
FIG. 2D), and the distal end region 490b extends beyond the pusher
block 420. Thereby, when the pusher block 420 is advanced during
deployment of the closure element 500, the control block 260 is
disengaged such that the distal end region 210b, the expansion
elements 230, and/or the substantially flexible members 230' of the
locator assembly 200 to transition from the expanded state to the
unexpanded state.
[0148] The operation of the triggering system 400 in accordance
with one predetermined manner is illustrated in FIGS. 5A-C with the
closure element 500 (shown in FIGS. 6A-B) disposed substantially
within the apparatus 100. As shown in FIG. 5A, the distal end
region 210b of the locator assembly 200 has been positioned as
desired and has transitioned from the unexpanded state to the
expanded state. While the locator control system 240 (shown in FIG.
2D) maintains the distal end region 210b in the expanded state, a
distally-directed axial force is applied to the triggering system
400 via the switching system 450. Once the tube release member 480
(shown in FIG. 4D) has been moved proximally to free the pusher
block 420, the tube set 305 is substantially freely slidable within
the housing 380 and responds to the axial force by sliding distally
from an initial predetermined position to a first predetermined
position.
[0149] In the initial predetermined position, the carrier member
310, the pusher member 320, the cover member 330, and the support
member 340 are coupled via the slots 422c, 422b, and 422a (shown in
FIG. 4C) and the pins 412c, 432b, and 442a (shown in FIG. 4C).
Stated somewhat differently, the support pin 442a, the cover pin
432b, and the carrier pin 412c are respectively disposed within,
and engaged by, the support slot 422a, the cover slot 422b, and the
carrier slot 422c such that the carrier block 410, the pusher block
420, the cover block 430, and the support block 440 are coupled as
illustrated in FIG. 4C. Therefore, the carrier member 310, the
pusher member 320, the cover member 330, and the support member 340
each slide distally from the initial predetermined position to the
first predetermined position in response to the axial force.
[0150] FIG. 5B illustrates the positions of the carrier member 310,
the pusher member 320, the cover member 330, and the support member
340 upon reaching the first predetermined position. In the first
predetermined position, the support block 440 and the cover block
430 respectively engage the support stop 460a and the cover stop
460b. Thereby, the support stop 460a receives, and substantially
inhibits further movement of, the support block 440 and, therefore,
the support member 340; whereas, the cover stop 460b receives, and
substantially inhibits further movement of, the cover block 430
and, therefore, the cover member 330. Although the support block
440 and the cover block 430 preferably engage the support stop 460a
and the cover stop 460b in the first predetermined position, it
will be appreciated that the support block 440 can engage the
support stop 460a and the cover block 430 can engage the cover stop
460b in different predetermined positions. In other words, the
predetermined manner can comprise any number of predetermined
positions, each predetermined position being associated with any
number of the blocks 410, 420, 430, and 440 engaging any number of
relevant stops 460a, 460b, and 460c.
[0151] To continue distally from the first predetermined position,
the carrier member 310 and the pusher member 320 can be decoupled
from the cover member 330 and the support member 340 by disengaging
the support pin 442a and the cover pin 432b from the support slot
422a and the cover slot 422b, respectively. In the manner described
in more detail above with reference to FIGS. 4B-C, the support pin
442a and the cover pin 432b each resist the axial force. While the
axial force is less than the combined static force provided by the
support pin 442a and the cover pin 432b, the carrier member 310 and
the pusher member 320 remain coupled with the cover member 330 and
the support member 340. As the axial force increases to a level
that is greater than or substantially equal to the combined static
force, the support pin 442a and the cover pin 432b are respectively
displaced from the support slot 422a and the cover slot 422b,
decoupling the carrier member 310 and the pusher member 320 from
the cover member 330 and the support member 340. Thereby, the cover
member 330 and the support member 340 preferably are inhibited from
further distal movement and remain substantially stationary;
whereas, the carrier member 310 and the pusher member 320 proceed
distally toward a second predetermined position.
[0152] The pusher member 320 and the carrier member 310 continue
distally until the second predetermined position is reached as
shown in FIG. 5C. In the second predetermined position, the carrier
block 410 engages the carrier stop 460c. Whereby, the carrier stop
460c receives, and substantially inhibits further movement of, the
carrier block 410 and, therefore, the carrier member 310. To
continue distally from the second predetermined position, the
pusher member 320 can be decoupled from the carrier member 310 by
disengaging the carrier pin 412c from the carrier slot 422c. In the
manner described in more detail above with reference to FIGS. 4B-C,
the carrier pin 412c resists the axial force. While the axial force
is less than the static force provided by the carrier pin 412c, the
pusher member 320 remains coupled with the carrier member 310.
[0153] As the axial force increases to a level that is greater than
or substantially equal to the static force, the carrier pin 412c is
displaced from the carrier slot 422c, decoupling the pusher member
320 from the carrier member 310. Thereby, the carrier member 310
preferably is inhibited from further distal movement and remains
substantially stationary; whereas, the pusher member 320 proceeds
distally to deploy the closure element 500 and to activate the
locator release system 490 (shown in FIG. 4D) such that the distal
end region 210b, the expansion elements 230, and/or the
substantially flexible members 230' of the locator assembly 200
transition from the expanded state to the unexpanded state.
Preferably, the axial force that is applied to overcome the static
force associated with the first predetermined position is
sufficient to overcome the static forces associated with the
subsequent predetermined positions, to deploy the closure element
500, and to activate the locator release system 490 such that the
triggering system 400 operates in one substantially-continuous
motion.
[0154] It will be appreciated that the triggering system 400 can
include an energy storing element (not shown), which can be
disposed substantially between the housing 380 and the blocks 410,
420, 430, and 440 and which is configured to store potential energy
for moving the tube set 305 from the initial predetermined position
through the other predetermined positions, deploying the closure
element 500, and/or activating the locator release system 490. The
energy-storing element is configured store the potential energy
when the tube set 305 is in the initial predetermined position and
to release the potential energy, when activated, such that the tube
set 305 travels through the predetermined positions at a
substantially constant and continuous rate. For example, the
energy-storing element can comprise one or more springs (not
shown). Each of the springs can be in a compressed state when the
tube set 305 is in the initial predetermined position and released
from the compressed state when the switching system 450 of the
triggering system 400 is activated.
[0155] In use, the closure element 500 is disposed within the
carrier assembly and adjacent to the distal end of the pusher tube
320. As shown in FIGS. 7A-B, for example, the reduced closure
element 500' can be slidably received over the distally-increasing
cross-section 318b of the distal end region 310b of the carrier
member 310 and disposed about the periphery 312 of the carrier
member 310 adjacent to the space 360. Since the reduced
cross-section 530' of the reduced closure element 500' is less than
the cross-section 318b of the distally-increasing cross-section
318b, the reduced closure element 500' must be temporarily radially
deformed to be received over the distal end region 310b. Also, as
the reduced closure element 500' is received over the distal end
region 310b, the opposing tines 520 of the reduced closure element
500' engages the distal end region 310b. The reduced closure
element 500' thereby forms the substantially tubular closure
element 500'' in the manner described in more detail above with
reference to FIGS. 6E-G.
[0156] After being received over the distal end region 310b, the
substantially tubular closure element 500'' is disposed about the
space 360, and the tines 520 are directed substantially distally as
shown in FIG. 7B. As desired, one or more of the tines 520 can be
disposed proximally of the distally-increasing cross-section 318b
of the distal end region 310b, as illustrated in FIG. 7B, and/or
can be at least partially disposed upon, and contact, the
distally-increasing cross-section 318b of the distal end region
310b. To improve the engagement between the closure element 500
(shown in FIGS. 6A-B) and the blood vessel wall 620 and/or tissue
630 (collectively shown in FIG. 8A), the substantially tubular
closure element 500'' preferably is disposed on the carrier member
310 such that the tines 520 define a first plane that is
substantially perpendicular to a second plane defined by the
switching system 450 and/or the handles 390 (collectively shown in
FIG. 5A).
[0157] Once disposed about the space 360, the substantially tubular
closure element 500'' can be retained on the outer periphery 312b
of the carrier member 310 when distal end region 310b of the
carrier member 310 and the distal end region 320b of the pusher
member 320 are slidably received within the lumen 334 of the cover
member 330 as illustrated in FIGS. 7C-D. When the cover member 330
is properly positioned within the carrier assembly 300, the distal
end region 330b of the cover member 330 extends over the space 360
and defines the annular cavity 370 for retaining the substantially
tubular closure element 500''. As such, the substantially tubular
closure element 500'' is disposed substantially between the outer
periphery 312b of the carrier member 310 and the inner periphery
332a of the cover member 330 such that the substantially tubular
closure element 500'' maintains the substantially tubular
configuration with the tines 520 being directed substantially
distally. As desired, the cover member 330 may radially compress
the substantially tubular closure element 500'' such that the
substantially tubular closure element 500'' enters and maintains a
compressed tubular configuration. The body 510 of the substantially
tubular closure element 500'' can be disposed distally of the
distal end region 320b of the pusher member 320, as illustrated in
FIGS. 7C-D, or can engage the distal end region 320b, as
desired.
[0158] FIGS. 8A-8L illustrate an embodiment of a method for
accessing a body lumen and/or delivering a closure element. The
method may incorporate various components of the apparatuses
described herein. For example, various locator assemblies (such as
locator assembly 200, 200', 200'', 200''', 200'''' shown in FIGS.
2A, 2B, 2A', 2B', 2A'', 2B'', 2A''', and 2B''', respectively) may
be used with the present embodiment. For ease of description, the
method will be described with the locator assembly 200 shown in
FIGS. 2A and 2B. However, it will be understood that other locator
assembly embodiments may be used.
[0159] As shown in FIG. 8A, a sheath 640 may be inserted or
otherwise positioned through skin 650 and tissue 630 and within the
blood vessel 600 or other body lumen via the opening 610.
Comprising a substantially flexible or semi-rigid tubular member,
the sheath 640 has a proximal end region 640a and a distal end
region 640b and includes a predetermined length and a predetermined
cross-section, both of which can be of any suitable dimension. The
sheath 640 also forms a lumen 644 that extends along a longitudinal
axis of the sheath 640 and substantially between the proximal and
distal end regions 640a, 640b. The lumen 644 can have any suitable
internal cross-section 648b and is suitable for receiving one or
more devices (not shown), such as a catheter, a guide wire, or the
like. The lumen 644 is configured to slidably receive a tubular
body 210 of the locator assembly 200 and/or the tube set 305 of the
carrier assembly 300 (shown in FIG. 4A).
[0160] Since the internal cross-section 648b of the sheath 640
typically is less than or substantially equal to the predetermined
cross-section 338b of the cover member 330, the sheath 640 may be
configured to radially expand, such as by stretching, to receive
the tube set 305. Alternatively, or in addition, the sheath 640 can
be advantageously configured to split as the tube set 305 is
received by, and advances within, the lumen 644 of the sheath 640,
thereby permitting the apparatus 100 to access the blood vessel
wall 620. To facilitate the splitting, the sheath 640 can include
one or more splits 645, such as longitudinal splits, each split
being provided in the manner known in the art. Each split 645 is
configured to split the sheath 640 in accordance with a
predetermined pattern, such as in a spiral pattern. It will be
appreciated that, when the internal cross-section 648b of the
sheath 640 is greater than the predetermined cross-section 338b of
the cover member 330, it may not be necessary for the sheath 640 to
be configured to radially expand and/or split. In addition to, or
as an alternative to, the apparatus 100 may include a cutting means
that initiates a tear line or split in the sheath when the sheath
is engaged with the distal end of the apparatus 100.
[0161] The sheath 640 may be advanced over a guide wire or other
rail (not shown) which has been positioned through the opening 610
and into the blood vessel 600 using conventional procedures such as
those described above. Preferably, the blood vessel 600 is a
peripheral blood vessel, such as a femoral or carotid artery,
although other body lumens may be accessed using the sheath 640.
The opening 610, and consequently the sheath 640, may be oriented
with respect to the blood vessel 600 such as to facilitate the
introduction of devices through the lumen 644 of the sheath 640 and
into the blood vessel 600 with minimal risk of damage to the blood
vessel 600. One or more devices (not shown), such as a catheter, a
guide wire, or the like, may be inserted through the sheath 640 and
advanced to a preselected location within the patient's body. For
example, the devices may be used to perform a therapeutic or
diagnostic procedure, such as angioplasty, atherectomy, stent
implantation, and the like, within the patent's vasculature.
[0162] After the procedure is completed, the devices are removed
from the sheath 640, and the apparatus 100 is prepared to be
received by the lumen 644 of the sheath 640 as shown in FIG. 8B.
Being in the unexpanded state, the distal end region 210b of the
tubular body 210 of the locator assembly 200 is slidably received
by the lumen 644 and atraumatically advanced distally into the
blood vessel 600 as illustrated in FIGS. 8B-C. Once the distal end
region 210b of the tubular body 210 extends into the blood vessel
600, the distal end region 210b can transition from the unexpanded
state to the expanded state as shown in FIG. 8D by activating the
switching system of the locator assembly 200.
[0163] In some embodiments, the locator assembly 200 may be in
communication with a measuring device 251. In these embodiments, a
measurement of a measurable characteristic may be taken while the
locator assembly 200 is positioned within the body lumen (i.e.
blood vessel 600). For example, an impedance measurement may be
taken within the body lumen. The measurement may be taken with the
distal end 210b in the expanded state.
[0164] Turning to FIG. 8E, the apparatus 100 and the sheath 640
then are retracted proximally until the distal end region 210b is
substantially adjacent to an inner surface 620b of the blood vessel
wall 620. The distal end region 210b thereby draws the blood vessel
wall 620 taut and maintains the proper position of the apparatus
100 as the blood vessel 600 pulsates. Since the expanded
cross-section of the distal end region 210b is greater than or
substantially equal to the cross-section of the opening 610 and/or
the cross-section of the lumen 644, the distal end region 210b
remains in the blood vessel 600 and engages the inner surface 620b
of the blood vessel wall 620. The distal end region 210b can
frictionally engage the inner surface 620b of the blood vessel wall
620, thereby securing the apparatus 100 to the blood vessel 600.
The sheath 640 is retracted proximally such that the distal end
region 640b of the sheath 640 is substantially withdrawn from the
blood vessel 600, as shown in FIG. E, permitting the apparatus 100
to access the blood vessel wall 620.
[0165] A second measurement of a measurable characteristic may be
taken. The second measurement may be taken after proximally
retracting the apparatus 100. The first measurement and the second
measurement may be compared to determine whether the locator
assembly 200 has contacted tissue of the body lumen (i.e. the inner
surface 620b of the blood vessel wall 620). Alternatively, the
apparatus 100 may be retracted proximally until a measurable
characteristic is within a predetermined range of the first
measurement. For example, a predetermined range of impedance
differences may be used to determine whether the locator assembly
200 has contacted the tissue of the body lumen. The technician may
be notified that the measurable characteristic is within the
predetermined range of the first measurement by, for example, a
light, buzzer, and/or other notification method.
[0166] As the apparatus 100 is being retracted, the apparatus 100
preferably also is axially rotated such that the first plane
defined by the tines 520 of the substantially tubular closure
element 500'' is substantially parallel with a third plane defined
by the blood vessel 600. Thereby, the engagement between the
substantially tubular closure element 500'' and the blood vessel
wall 620 and/or tissue 630 can be improved because the tines 520
are configured to engage the blood vessel wall 620 and/or tissue
630 at opposite sides of the opening 610. If the substantially
tubular closure element 500'' is disposed on the carrier member 310
such that the first plane defined by the tines 520 is substantially
perpendicular to the second plane defined by the switching system
450 and/or the handles 390 (collectively shown in FIG. 5A), for
example, the apparatus 100 can be positioned such that the second
plane defined by the switching system 450 and/or the handles 390 is
substantially perpendicular to the third plane defined by the blood
vessel 600.
[0167] Once the distal end region 210b of the locator assembly 200
contacts the inner surface 620b of the blood vessel wall 620, the
tube set 305 can then be advanced distally and received within the
lumen 644 of the sheath 640 as illustrated in FIG. 8F. In the
manner described in more detail above with reference to FIG. 8A,
the sheath 640 can radially expand and/or split in accordance with
the predetermined pattern as the tube set 305 advances because the
internal cross-section 648b of the sheath 640 is less than or
substantially equal to the predetermined cross-section 338b of the
cover member 330. Being coupled, the carrier member 310, the pusher
member 320, the cover member 330, and the support member 340 each
advance distally and approach the first predetermined position as
illustrated in FIG. 8G.
[0168] Upon reaching the first predetermined position, the tube set
305 is disposed substantially adjacent to the outer surface 620a of
the blood vessel wall 620 adjacent to the opening 610 such that the
blood vessel wall 620 adjacent to the opening 610 is disposed
substantially between the expanded distal region 210b of the
locator assembly 200 and the tube set 305. The cover member 330 and
the support member 340 each decouple from the carrier member 310
and the pusher member 320 in the manner described in more detail
above with reference to FIGS. 5A-C when the tube set 305 is in the
first predetermined position. Thereby, the cover member 330 and the
support member 340 preferably are inhibited from further axial
movement and remain substantially stationary as the carrier member
310 and the pusher member 320 each remain coupled and axially
slidable.
[0169] As shown in FIG. 8H, the cover member 330 and the support
member 340 remaining substantially stationary while the carrier
member 310 and the pusher member 320 continue distally and approach
the second predetermined position. As the carrier member 310 and
the pusher member 320 distally advance toward the second
predetermined position, the annular cavity 370 moves distally
relative to the substantially-stationary cover member 330 such that
the distal end region 330b of the cover member 330 no longer
encloses the annular cavity 370.
[0170] Thereby, the substantially tubular closure element 500'' is
not completely enclosed by the annular cavity 370 formed by the
distal end regions 310b, 320b, and 330b of the carrier member 310,
the pusher member 320, and the cover member 330.
[0171] Although not completely enclosed by the annular cavity 370,
the substantially tubular closure element 500'' is advantageously
retained on the outer periphery 312b of the carrier member 310 by
the distal end region 330b of the cover member 330 as illustrated
in FIG. 8H. For example, by retaining the substantially tubular
closure element 500'' between the distal end region 330b of the
cover member 330 and the distal end region 310b the carrier member
310, the apparatus 100 is configured to provide better tissue
penetration. The timing between the deployment of the substantially
tubular closure element 500'' by the tube set 305 and the
retraction and transition to the unexpanded state by the locator
assembly 200 likewise is facilitated because the substantially
tubular closure element 500'' is retained between the distal end
region 330b and the distal end region 310b. Further, the carrier
member 310 and the cover member 330 operate to maintain the
substantially tubular closure element 500'' in the tubular
configuration.
[0172] When the tube set 305 is in the second predetermined
position, the carrier member 310 decouples from the pusher member
320 in the manner described in more detail above with reference to
FIGS. 5A-C. Therefore, the carrier member 310, the cover member
330, and the support member 340 preferably are inhibited from
further axial movement and remain substantially stationary;
whereas, the pusher member 320 remains axially slidable. As the
pusher member 320 continues distally, the distal end region 320b of
the pusher member 320 contacts the substantially tubular closure
element 500'' and displaces the substantially tubular closure
element 500'' from the space 360 as shown in FIG. 8I. Since the
space 360 is substantially radially exposed, the pusher member 320
directs the substantially tubular closure element 500'' over the
distally-increasing cross-section of the distal end region 310b of
the substantially-stationary carrier member 310 such that the
cross-section 530' (shown in FIGS. 6F-G) of the substantially
tubular closure element 500'' begins to radially expand, preferably
in a substantially uniform manner. As the substantially tubular
closure element 500'' traverses the distally-increasing
cross-section of the distal end region 310b, the cross-section 530'
of the substantially tubular closure element 500'' radially expands
beyond natural cross-section 530 (shown in FIGS. 6A-B) of the
closure element 500.
[0173] Upon being directed over the distally-increasing
cross-section of the distal end region 310b by the pusher member
320, the substantially tubular closure element 500'' is distally
deployed as illustrated in FIG. 8J. When the substantially tubular
closure element 500'' is deployed, the tines 520 can pierce and
otherwise engage significant amount of the blood vessel wall 620
and/or tissue 630 adjacent to the opening 610. For example, the
tines 520 can engage a significant amount of the blood vessel wall
620 and/or tissue 630 because the cross-section 530' of the
substantially tubular closure element 500'' is expanded beyond
natural cross-section 530 of the closure element 500 during
deployment.
[0174] As the closure element is being deployed from the space 360,
the locator assembly 200 also begins to retract proximally and the
locator release system 490 (shown in FIG. 4D) can be activated to
transition from the expanded state to the unexpanded state as the
substantially tubular closure element 500'' is deployed as shown in
FIG. 8J. Preferably, the distal end region 210b of the locator
assembly 200 retracts proximally and transitions from the expanded
state to the unexpanded state substantially simultaneously with the
deployment of the substantially tubular closure element 500''. As
desired, the distal end region 210b may be configured to draw the
blood vessel wall 620 and/or tissue 630 adjacent to the opening 610
proximally and into the channel 540 defined by the substantially
tubular closure element 500''. The tines 520 of the substantially
tubular closure element 500'' thereby can pierce and otherwise
engage the drawn blood vessel wall 620 and/or tissue 630. Since the
cross-section 530' of the substantially tubular closure element
500'' is expanded beyond natural cross-section 530 of the closure
element 500, a significant amount of the blood vessel wall 620
and/or tissue 630 can be drawn into the channel 540 and engaged by
the tines 520.
[0175] Turning to FIG. 8K, the substantially tubular closure
element 500', once deployed, begins to transition from the tubular
configuration, returning to the natural, planar configuration with
opposing tines 520 and a natural cross-section 530 of the closure
element 500. Preferably, the substantially tubular closure element
500'' substantially uniformly transitions from the tubular
configuration to the natural, planar configuration. Rotating
axially inwardly to form the opposing tines 520 of the closure
element 500, the tines 520 draw the tissue 630 into the channel 540
as the substantially tubular closure element 500'' forms the
closure element 500. Also, the tissue 630 is drawn substantially
closed and/or sealed as the cross-section 530' of the substantially
tubular closure element 500'' contracts to return to the natural
cross-section 530 of the closure element 500. Thereby, the opening
610 in the blood vessel wall 620 can be drawn substantially closed
and/or sealed via the closure element 500 as illustrated in FIG.
8L.
[0176] It will be appreciated that the closure element 500 may be
constructed of other materials, that it may comprise alternative
shapes, and that it may adopt alternative methods of operation such
that the closure element 500 achieves closure of openings in blood
vessel walls or other body tissue. In an additional non-limiting
example, the closure element 500 is constructed of materials that
use a magnetic force to couple a pair of securing elements in order
to close an opening in the lumen wall or tissue. In this
alternative embodiment, the closure element 500 may be of a unitary
or multi-component construction having a first securing element
positionable at a first position adjacent the opening, and a second
securing element positionable at a second position adjacent the
opening. The first and second securing elements are provided having
a magnetic force biasing the first and second securing elements
together, thereby closing the opening, or they are provided having
a magnetic force biasing both the first and second securing
elements toward a third securing element positioned in a manner to
cause closure of the opening. The magnetic closure element 500 may
be provided without tines 520, provided the magnetic force coupling
the closure elements is sufficient to close the opening.
Alternatively, the closure element 500 may be provided with a
combination of the magnetic securing elements and tines 520 to
provide a combination of coupling forces. Other and further
materials, methods, and combinations may be utilized to construct
the closure element 500 to achieve the objectives described and
implied herein.
[0177] It will be appreciated that the distal end region 380b of
the housing 380 can be configured to couple with an introducer
sheath 700 as shown in FIG. 9. Comprising a substantially flexible
or semi-rigid tubular member, the introducer sheath 700 has a
proximal end region 700a and a distal end region 700b and includes
a predetermined length and a predetermined cross-section, both of
which can be of any suitable dimension. The distal end region 700b
is configured to facilitate insertion of the introducer sheath 700
through tissue and/or into the opening 610 (shown in FIG. 8A)
formed in and/or adjacent to the wall 620 (shown in FIG. 8A) of the
blood vessel 600 (shown in FIG. 8A) or other body lumen. For
example, the distal end region 430b can have a tapered tip (not
shown) for facilitating substantially atraumatic introduction of
the introducer sheath 700 through a passage formed in the tissue
630 and/or at least partially into the blood vessel wall 620, which
is accessible via the passage. The introducer sheath 700 has an
external cross-section 708b. The external cross-section 708b of
introducer sheath 700 can be of any suitable dimension, and, as
desired can be sized such that the introducer sheath 700 can be
slidably received and advanced within the lumen 644 (shown in FIG.
8A) of the sheath 640.
[0178] The introducer sheath 700 also forms a lumen 704 that
extends along a longitudinal axis of the introducer sheath 700 and
substantially between the proximal and distal end regions 700a,
700b. The lumen 704 can have any suitable length 708a and internal
cross-section 708b and is configured to slidably receive the
tubular body 210 of the locator assembly 200 (shown in FIG. 4A)
and/or the tube set 305 of the carrier assembly 300 (shown in FIG.
4A). Since the internal cross-section 708b of the introducer sheath
700 typically is less than or substantially equal to the
predetermined cross-section 338b of the cover member 330, the
introducer sheath 700 may be configured to radially expand, such as
by stretching, to receive the tube set 305. Alternatively, or in
addition, the introducer sheath 700 can be advantageously
configured to split as the tube set 305 is received by, and
advances within, the lumen 704 of the introducer sheath 700 in the
manner described in more detail above with reference to the sheath
640 (shown in FIG. 8A). To facilitate the splitting, the introducer
sheath 700 can include one or more splits (not shown), such as
longitudinal splits, each split being provided in the manner known
in the art. Each split is configured to split the introducer sheath
700 in accordance with a predetermined pattern, such as in a spiral
pattern. It will be appreciated that, when the internal
cross-section 708b of the introducer sheath 700 is greater than the
predetermined cross-section 338b of the cover member 330, it may
not be necessary for the introducer sheath 700 to be configured to
radially expand and/or split.
[0179] The introducer sheath 700 can be coupled with the housing
380 via one or more cooperating connectors (not shown) such that
the lumen 704 is substantially axially aligned with the tubular
body 210 of the locator assembly 200 and/or the tube set 305 of the
carrier assembly 300 and, as desired, may be removably and/or
substantially permanently coupled with the housing 380. For
example, a hub assembly 710 can be provided on the distal end
region of the housing 380b and configured to couple with the
proximal end region 700a of the introducer sheath 700. The proximal
end region 430a of the introducer sheath 700 is coupled with, or
otherwise provided on, a distal end region 710b of the hub assembly
710, such as via an adhesive, one or more cooperating connectors,
and/or a thermo-mechanical joint.
[0180] The hub assembly 710 also includes a proximal end region
710a, which provides the one or more mating connectors for coupling
the introducer sheath 700 with the housing 380 and forms a lumen
(not shown), which extends substantially between the proximal end
region 710a and the distal end region 710b. The lumen of the hub
assembly 710 preferably has an internal cross-section or size that
is greater than the internal cross-section or size of the lumen 704
of the introducer sheath 700. When the proximal end region 710a of
the lumen 704 is properly connected with the hub assembly 710, the
lumen of the hub assembly 710 is configured to communicate with the
lumen 704 of the introducer sheath 700. As desired, the proximal
end region 700a of the introducer sheath 700 may be flared to
facilitate the connection between the introducer sheath 700 and the
hub assembly 710.
[0181] When properly assembled, the hub assembly 710 preferably is
substantially fluid tight such that the one or more devices can be
inserted into the lumen 704 of the introducer sheath 700 without
fluid passing proximally through the lumen 704. The hub assembly
710 can be made to be watertight, such as via one or more seals
(not shown) and/or valves (not shown), and/or other watertight
mechanisms. For example, the hub assembly 710 can include a thrust
washer and/or valve, a guide for directing the devices into the
lumen 704 of the introducer sheath 700, and/or a seal (collectively
not shown). The various seals and/or guides can be coupled with the
hub assembly 710 via, for example, one or more spacers and/or end
caps (also collectively not shown).
[0182] As desired, the hub assembly 710 further can include one or
more side ports 720. The side ports 720 can communicate with the
lumen of the hub assembly 710 and/or the lumen 704 of the
introducer sheath 700. At least one of the side ports 720 can be
configured to be connected with, and to communicate with, tubing
(not shown) to, for example, infuse fluids into the lumen 704 and
through the introducer sheath 700. Alternatively, or in addition,
at least one of the side ports 720 can provide a "bleed back"
indicator, such as in the manner disclosed in the co-pending
application Ser. No. 09/680,837. The disclosures of this reference
and any others cited therein are expressly incorporated herein by
reference.
[0183] An alternative embodiment of the apparatus is shown in FIGS.
10-15. The embodiment of FIGS. 10-15 has many identical or similar
structures that perform identical or similar functions to the
embodiment described above and in reference to the preceding
Figures. In the description of the alternative embodiment below,
and in FIGS. 10-15, components of the apparatus that are identical
or substantially correspond to those previously described will bear
the same reference numerals identified above with the addition of
the prime (') identifier.
[0184] Turning to FIGS. 10 and 11, the locator assembly 200' is
substantially similar to the structure described above in reference
to FIGS. 2A-D, including a flexible or semi-rigid tubular body 210'
(such as an elongate rail) with a longitudinal axis. The tubular
body 210' has a proximal end region 210a' and a distal end region
210b' and includes a predetermined length 218a' and a predetermined
outer cross-section, both of which can be of any suitable
dimension. The distal end region 210b' of the locator assembly 200'
preferably includes a substantially rounded, soft, and/or flexible
distal end or tip 220' to facilitate atraumatic advancement and/or
retraction of the distal end region 210b' into the blood vessel
600. As desired, a pigtail (not shown) may be provided on the
distal end 220' to further aid atraumatic advancement of the distal
end region 210b'.
[0185] The distal end region 210b' of the locator assembly 200'
further is selectably controllable between an unexpanded state and
an expanded state, in the manner described above in relation to
FIGS. 2A-D. In the alternative embodiment shown in FIGS. 10A-B, the
distal end region is shown in its expanded state, wherein the
substantially flexible members 230' of the expansion elements 230'
are flexed outward.
[0186] A control member 250', such as a rod, wire, or other
elongate member, can be moveably disposed within a lumen (not
shown) formed by the tubular body 210' and extending substantially
between the proximal end region 210a' and the distal end region
210b'. The control member 250' has a proximal end region 250a' that
is coupled with a control block 260', and a distal end region that
is coupled with the distal end region 210b' of the locator assembly
200', the expansion elements 230', and/or the movable end regions
230c' of the substantially flexible members 230'. The control block
260' is preferably of a tubular shape and formed of a metal or
rigid plastic, and is adapted to be retained in a control block
cavity 265' (see FIG. 10B) formed on the internal surface of the
housing bottom half 380d', to thereby maintain the control block
260' in a substantially fixed position relative to the housing
380'. The locator control system can selectively transition the
distal end region 210b', the expansion elements 230', and/or the
substantially flexible members 230' between the unexpanded and
expanded states by moving the tubular body 210' axially relative to
the control member 250'.
[0187] Formed on the proximal end 210a' of the tubular body 210' is
a tubular body block 270' having a proximal groove 271'. The
tubular body block 270' is formed of metal, rigid plastic, or other
substantially rigid material and is preferably formed integrally
with or attached securely to the tubular body 210'. The proximal
groove 271' and the proximal end of the tubular body block 270'
have a shape adapted to cooperate with a pair of tabs 281a'-b'
formed on a locator assembly block 280' whereby the tubular body
block 270' is maintained in a fixed axial relationship with the
locator assembly block 280'. In this way, the tubular body block
270' and tubular body 210' are advanced distally by distal
advancement of the locator assembly block 280'.
[0188] A locator assembly spring 290' is located coaxially with and
substantially surrounds a portion of the tubular body block 270'.
The locator assembly spring 290' is located between and contacts
the distal side of two of the tabs 281a formed on the locator
assembly block 280', and the proximal side of a locator assembly
spring stop 381' formed on the inner surface of the housing bottom
half 380d' (see FIG. 10B). The locator assembly spring 290' so
located provides a force biasing the locator assembly block 280' in
the proximal direction relative to the housing 380'.
[0189] The locator assembly block 280' is preferably formed of
metal, plastic, or other rigid material. A function of the locator
assembly block 280' is to allow the user to apply a force causing
distal movement of the tubular body 210' relative to the control
member 250' to cause the locator assembly 200' to transition from
the unexpanded state to the expanded state. The proximal end of the
locator assembly block 280' has a slot 281' formed therein, the
slot 281' preferably having a size sufficient to accommodate the
control block 260' and the control block cavity 265', and to allow
the locator assembly block 280' to travel axially relative to the
housing 380'. The distal end of the locator assembly block 280' has
a pair of distally extending forks 282a-b, with each of the forks
282a-b having a ramp 283a-b on its inward facing surface. Finally,
the locator assembly block 280' has a pair of distally extending
release tabs 284a-b, with each of the release tabs 284a-b having a
detent 285a-b.
[0190] As shown in FIGS. 11A-B, the locator assembly block 280' is
slidably received and retained within grooves formed in the
proximal end of the housing 380', with the proximal end of the
locator assembly block extending from the proximal end of the
housing. The control block 260' and control block cavity 265 are
located in the slot 281' formed in the proximal end of the locator
assembly block 280'.
[0191] The locator release system 490' performs the function of
releasing the locator assembly 200', thereby allowing the locator
assembly 200' to transition from its expanded state to its
unexpanded state. Turning to FIGS. 10A-B and FIG. 15, the locator
release system 490' of the alternative embodiment of the apparatus
includes a locator release rod 491' having a release tab spacer
block 492' formed on its proximal end. The locator release rod 491'
and release tab spacer block 492' are received and retained in a
groove formed on the interior surface of the housing bottom half
380d. The release tab spacer block 492' is preferably integrally
formed with or attached to the proximal end of the locator release
rod 491', and is formed of metal, plastic, or other rigid material.
As shown in FIG. 15, the release tab spacer block 492' has a shape
and size adapted to fit between the release tabs 284a-b formed on
the locator assembly block 280', thereby biasing the release tabs
284a-b outward and causing the outward facing detents 285a-b to
engage a pair of retaining grooves 286a-b formed on the interior of
the housing 380'. As long as the detents 285a-b are thus engaged
with the retaining grooves 286a-b of the housing 380', the locator
assembly block 280' is held in its axial position against the
spring force imparted in the proximal direction by the locator
assembly spring 290'. The distal end of the locator release rod
491' has an engagement member 493' that, in the preferred
embodiment, comprises an inward bend on the distal end of the
locator release rod. As described more fully below, the engagement
member 493' on the locator release rod 491' is preferably
positioned within the apparatus such that, when the closure element
500 is delivered, the engagement member 493' is engaged and caused
to move axially in the distal direction, thereby disengaging the
release tab spacer block 492' from the locator assembly block 280'
and causing the locator assembly simultaneously to transition from
its expanded state to the unexpanded state.
[0192] The alternative embodiment of the apparatus 100' includes a
carrier assembly 300' that is coupled with, and slidable relative
to, the locator assembly 200'. The carrier assembly 300' is
configured to receive and retain the closure element 500 (shown in
FIGS. 6A-B), which preferably is disposed substantially within the
carrier assembly 300'. When the locator assembly 200' engages the
inner surface 620b (shown in FIG. 8A) of the blood vessel wall 620
(shown in FIG. 8A), the carrier assembly 300' is further configured
to position the closure element 500 substantially adjacent to the
opening 610 and to deploy the closure element 500, as described
elsewhere herein.
[0193] Turning to FIGS. 10A-B, the carrier assembly 300' includes a
tube set comprising a carrier member 310', a pusher member 320', a
cover member 330', and a support member 340'. The carrier member
310', pusher member 320', cover member 330', and support member
340' are preferably provided as a plurality of nested, telescoping
members with a common longitudinal axis. The carrier member 310' is
configured to receive and support the closure element 500. While
being disposed on the carrier member 310', the closure element 500
preferably is deformed from the natural, planar configuration to
form the substantially tubular closure element 500'' (shown in
FIGS. 6F-G) as described herein.
[0194] The carrier member 310' includes a proximal end region 310a'
and a distal end region 310b'. The carrier member 310' can also
define a lumen 314' that extends substantially between the proximal
end region 310a' and the distal end region 310b' and that is
configured to slidably receive at least a portion of the tubular
body 210' of the locator assembly 200' and/or the support member
340'. Although the exterior cross-section of the carrier member
310' is substantially uniform, the distal end region 310b' of the
carrier member 310' preferably has a cross-section that increases
distally, as illustrated in FIGS. 10A-B, for substantially
uniformly expanding the substantially tubular closure element 500''
beyond the natural cross-section 530 of the closure element 500
when the substantially tubular closure element 500'' is deployed.
Alternatively, the distal end region 310b' may be formed with a
uniform cross-section to deploy the closure element 500 without
cross-sectional expansion.
[0195] The pusher member 320' has a proximal end region 320a' and a
distal end region 320b' and is coupled with, and slidable relative
to, the carrier member 310'. The pusher member 320' includes a
predetermined length and a predetermined cross-section, both of
which can be of any suitable dimension and can be configured to
slidably receive the carrier member 310' such that the distal end
region 320b' of the pusher member 320' is offset proximally from
the distal end region 310b' of the carrier member 310'. As desired,
the predetermined length of the pusher member 320' can be greater
than or substantially equal to the predetermined length of the
carrier member 310'. The predetermined length of the pusher member
320' preferably is less than the predetermined length of the
carrier member 310' such that the carrier member 310' and the
pusher member 320' at least partially define a space 360' distal to
the distal end region 320b' of the pusher member 320' and along the
periphery of the carrier member 310'.
[0196] The pusher member 320' preferably is substantially tubular
and can define a lumen 324' that extends substantially between the
proximal end region 320a' and the distal end region 320b' and that
is configured to slidably receive at least a portion of the carrier
member 310'. The cross-section of the pusher member 320' preferably
is substantially uniform, and the distal end region 320b' of the
pusher member 320' can comprise one or more longitudinal extensions
325', which extend distally from the pusher member 320' and along
the periphery of the carrier member 310'. The longitudinal
extensions 325' preferably are biased such that the longitudinal
extensions 325' extend generally in parallel with the common
longitudinal axis of the carrier assembly tube set. The
longitudinal extensions 325' are sufficiently flexible to expand
radially, and yet sufficiently rigid to inhibit buckling, as the
distal end region 320b' is directed distally along the carrier
member 310' and engage the distally-increasing cross-section of the
distal end region 310b' of the carrier member 310' to deploy the
substantially tubular closure element 500''.
[0197] The cover member 330' is configured to retain the
substantially tubular closure element 500'' substantially within
the carrier assembly 300' prior to deployment. Being coupled with,
and slidable relative to, the pusher member 320', the cover member
330' has a proximal end region 330a' and a distal end region 330b'
and includes a predetermined length and a predetermined
cross-section, both of which can be of any suitable dimension.
Preferably being formed as a substantially rigid, semi-rigid, or
flexible tubular member, the cover member 330' has an inner
periphery and an outer periphery and can define a lumen 334'. The
lumen 334' extends substantially between the proximal and distal
end regions 330a', 330b' of the cover member 330' and can be
configured to slidably receive at least a portion of the pusher
member 320'. When the cover member 330' is properly positioned
within the carrier assembly 300', the distal end region 330b' is
configured to extend over the space 360', thereby defining an
annular cavity 370' for receiving and retaining the substantially
tubular closure element 500''.
[0198] The cross-section of the cover member 330' preferably is
substantially uniform, and the distal end region 330b' of the cover
member 330' preferably comprises one or more longitudinal
extensions 335', which extend distally from the cover member 330'
and along an outer periphery of the pusher member 320' (see FIG.
3D). Although the longitudinal extensions 335' can extend generally
in parallel with common longitudinal axis 350', the longitudinal
extensions 335' preferably are biased such that the plurality of
longitudinal extensions 335' extend substantially radially inwardly
as illustrated in FIGS. 3A and 3D. Thereby, the longitudinal
extensions 335' can at least partially close the lumen 334'
substantially adjacent to the distal end region 330b' of the cover
member 330'. To permit the substantially tubular closure element
500'' to be deployed from the annular cavity 370', the longitudinal
extensions 335' preferably are sufficiently flexible to expand
radially to permit the distal end region 310b' of the carrier
member 310' to move distally past the cover member 330' to open the
annular cavity 370' such that the distal end region 330b' no longer
extends over the space 360'.
[0199] If the carrier assembly 300' is assembled as the plurality
of nested, telescoping members as shown in FIG. 3A, the carrier
member 310' is at least partially disposed within, and slidable
relative to, the lumen 324' of the pusher member 320'. The support
member 340' is slidable relative to the pusher member 310'. The
pusher member 320', in turn, is at least partially disposed within,
and slidable relative to, the lumen 334' of the cover member 330'.
To couple the carrier assembly 300' with the locator assembly 200',
the tubular body 210' of the locator assembly 200' is at least
partially disposed within, and slidable relative to, the lumen 314'
of the carrier member 310'. The longitudinal axis of the locator
assembly 200' preferably is substantially in axial alignment with
the common longitudinal axis of the carrier member 310', the pusher
member 320', and the cover member 330'.
[0200] The tube set 305 preferably also includes a support member
340' as shown in FIGS. 10A-B. The support member 340' is configured
to slidably receive the tubular body 210' of the locator assembly
200' and to provide radial support for the distal end region 210b'
of the tubular body 210' when the locator assembly 200' is coupled
with the carrier assembly 300'. The carrier assembly 300' can
advantageously include the support member 340', for example, if the
tubular body 210' is not sufficiently rigid or under other
circumstances in which support for the tubular body 210' might be
desirable. It also will be appreciated that the support member 340'
also can be configured to inhibit the plurality of longitudinal
extensions 335', which extend from the distal end region 330b' of
the cover member 330', from expanding prematurely when the closure
element 500 is deployed. If the longitudinal extensions 335' were
to expand prematurely, they may become hung up on the introducer
sheath 640 or other delivery member (in an introducer sheath or
delivery member is used), the tissue 630, or the wall 620 of the
blood vessel. This may interfere with the proper advancement or
other movement of the cover member 330' and the carrier assembly
300'.
[0201] Preferably being formed as a substantially rigid,
semi-rigid, or flexible tubular member, the support member 340'
includes a proximal end region 340a' and a distal end region 340b'.
Having an outer periphery, the support member 340' can define a
lumen 344' that extends substantially between the proximal end
region 340a' and the distal end region 340b' and that is configured
to slidably receive and support at least a portion of the tubular
body 210' of the locator assembly 200'. The support member 340', in
turn, can be at least partially slidably disposed within the lumen
314' of the carrier member 310' such that the tubular body 210' of
the locator assembly 200' is coupled with, and slidable relative
to, the carrier member 310' in the manner described in more detail
above. The support member 340' has a predetermined length and a
predetermined cross-section, both of which can be of any suitable
dimension, and the cross-section preferably is substantially
uniform. Although shown and described as being substantially
separate for purposes of illustration, it will be appreciated that
the carrier member 310', the pusher member 320', the cover member
330', and/or the support member 340' can be provided, in whole or
in part, as one or more integrated assemblies.
[0202] The carrier assembly 300' also can include a housing 380',
the top half 380c of which is illustrated in FIG. 10A, and the
bottom half 380d of which is shown in FIG. 10B. Preferably being
formed as an elongate member with a longitudinal axis, the housing
380' has an outer periphery and includes a proximal end region
380a' and a distal end region 380b'. Thereby, when the apparatus
100' is properly assembled, the tubular body 210' of the locator
assembly 200' is at least partially disposed within, and slidable
relative to, the tube set 305 such that the distal end region 210b'
of the tubular body 210' extends beyond the distal end regions
310b', 320b', 330b', and/or 340b'. The tubular body 210', the
carrier member 310', the pusher member 320', the cover member 330',
and, if provided, the support member 340' are at least partially
disposed within, and slidable relative to, the housing 380', and
the respective distal end regions 210b', 310b', 320b', 330b', and
340b' extend from the distal end region 380b' of the housing 380'
such that the common longitudinal axis 350' of the tube set 305 is
substantially axially aligned with the longitudinal axis 386' of
the housing 380'. Being configured to slidably retain the
respective proximal end regions 210a', 310a', 320a', 330a', and
340a', the housing 380' supports the tube set 305 and can have one
or more handles 391', 392' to facilitate use of the apparatus 100'.
The handles 391', 392' extend substantially radially from the outer
periphery of the housing 380' and can be provided in the manner
known in the art.
[0203] When the apparatus 100' is properly assembled, the tubular
body 210' of the locator assembly 200' is at least partially
disposed within, and slidable relative to, the tube set 305 of the
carrier assembly 300' such that the distal end region 210b' of the
tubular body 210' extends beyond the distal end regions 310b',
320b', 330b', and/or 340b'. Further, the proximal end region 210a'
of the tubular body 210' and the proximal end regions 310a', 320a',
330a', and/or 340a' of the tube set 305 are at least partially
disposed within, and slidable relative to, the housing 380'. The
switching system of the locator assembly 200' and a switching
system of the triggering system 400' preferably are accessible
external to the housing 380' as shown in FIGS. 11-15.
[0204] As shown in FIGS. 11-15, the triggering system 400' of the
alternative embodiment of the apparatus 100' can be disposed
substantially within the housing 380'. The triggering system 400'
is configured to control the relative axial movement and/or
positioning of the respective distal end regions 310b', 320b',
330b', and 340b' of the tube set 305 and/or the distal end region
210b' of the locator assembly 200'. Axial motion of one or more of
the carrier member 310', the pusher member 320', the cover member
330', and the support member 340' and/or the tubular body 210' can
be attained, for example, by applying an axial force to the
switching system 405''.
[0205] The triggering system 400' includes a set of block
members--a carrier block 410', a pusher block 420', a cover block
430', and a support block 440'--each of which is formed integrally
with or securely attached to its respective member of the carrier
assembly 300'. The block members are adapted to selectably couple
and decouple the carrier member 310', the pusher member 320', the
cover member 330', and the support member 340' relative to one
another in order to provide axial movement of those components in a
predetermined manner intended to deliver the closure element 500 in
the manner described herein. For example, when the carrier assembly
300' reaches a first predetermined distal position, the support
member 340' can be decoupled from the carrier member 310', the
pusher member 320', and the cover member 330' and is thereafter
substantially inhibited from further axial movement. Thereby, the
carrier member 310', the pusher member 320', and the cover member
330' may be directed distally as the support member 340' remain
substantially stationary. Subsequently, the carrier member 310' and
the cover member 330' can be decoupled from the pusher member 320'
and thereafter inhibited from further axial movement. Thereby, the
pusher member 320' may be directed distally as the support member
340', carrier member 310', and cover member 330' remain
substantially stationary, as described more fully herein.
[0206] The carrier block 410' is disposed on the proximal end
region 310a' of the carrier member 310' and includes a trigger
extension 405' that extends through a slot in the housing 380' to
the exterior of the housing 380' to be accessible to the user. The
carrier block 410' includes a pair of grooves 413a-b formed on a
peripheral surface of the carrier block 410', the grooves 413a-b
being adapted to receive and retain a pair of tabs 445a-b formed on
a pair of forks 444a-b extending distally from the support block
440', thereby selectably coupling the support block 440' to the
carrier block 410'. The carrier block 410' also includes a pair of
distal tabs 416a-b extending from the distal end of the carrier
block 410', and adapted to engage a pair of slots 423a-b formed on
the proximal end of the pusher block 420'.
[0207] The carrier block 410' also includes a pair of forks 414a-b
extending in the proximal direction from the proximal end of the
carrier block, each of the forks having an outward directed tab
415a-b at its proximal end. The tabs 415a-b are adapted to
selectably engage a pair of slots 387a-b (not shown) formed on the
interior surface of the housing 380' near its proximal end and,
when so engaged, to fix the axial position of the carrier block
410' and, with it, the carrier assembly 300' relative to the
housing 380'. The tabs 415a-b are disengaged from the slots in the
housing when the locator assembly block 280' is moved axially in
the distal direction in the following manner (see FIG. 11B). As the
locator assembly block 280' is advanced distally, the interior
surfaces of the ramps 283a-b on the locator assembly block forks
282a-b engage the exterior surfaces of the tabs 415a-b and cause
the carrier block forks 414a-b to flex inward, releasing the tabs
415a-b from the slots in the housing, thereby freeing the carrier
block 410' and the carrier assembly 300' to move axially. Thus,
axial movement of the carrier block 410' within the apparatus is
inhibited until the locator assembly block 280' is advanced to
transition the locator assembly 200' to the expanded condition,
simultaneously releasing the tabs 415a-b on the carrier block
410'.
[0208] The pusher block 420' is disposed on the proximal end region
320a' of the pusher member 320'. As described above, the pusher
block 420' includes a pair of slots 423a-b formed on its proximal
end that are adapted to selectably engage the pair of distal tabs
416a-b extending from the distal end of the carrier block 410'. The
pusher block 420' also includes a pair of grooves 424a-b formed on
its peripheral surface, the grooves 424a-b being adapted to engage
a pair of tabs 435a-b formed on a pair of forks 434a-b extending
from the proximal side of the cover block 430' to selectably couple
the cover block 430' to the pusher block 420'.
[0209] The cover block 430' is disposed on the proximal end region
330a' of the cover member 330'. As described above, the cover block
430' includes a pair of forks 424a-b extending from the proximal
end of the cover block 430', each of the forks having an inward
directed tab 435a-b that are adapted to engage the grooves 424a-b
on the peripheral surface of the pusher block 420' to selectably
couple the cover block 430' to the pusher block 420'.
[0210] The support block 440' is disposed on the proximal end
region 340a' of the support member 340'. As described above, the
support block includes a pair of forks 444a-b extending from the
distal end of the support block 440', each of the forks having an
inward directed tab 445a-b that are adapted to engage the grooves
413a-b formed on the surface of the carrier block 410' to
selectably couple the support block 440' to the carrier block
410'.
[0211] The carrier block 410', pusher block 420', cover block 430',
and support block 440' are shown in FIGS. 11-13 in their fully
coupled state, with the support block 440' coupled to the carrier
block 410', the pusher block 420' coupled to the carrier block
410', and the cover block 430' coupled to the pusher block 420'. In
this arrangement, the carrier assembly 300' comprises a coaxial set
of tubes (as shown, for example, in FIG. 3A), with the support
member 340' slidably retained substantially within the carrier
member 310', which is in turn slidably retained substantially
within the pusher member 320', which is in turn slidably retained
substantially within the cover member 330'.
[0212] The triggering system 400' of the alternative embodiment of
the apparatus includes an energy storing element that is used in
the final stage of the closure element 500 delivery process. The
energy storing element, preferably a spring such as the pusher
spring 425' shown in FIGS. 10A-B, is substantially retained in a
spring cavity 417' formed in the carrier block 410' and coaxially
surrounds a proximal portion 310a' of the carrier member 310'. The
pusher spring 425' is capable of expanding and contracting, storing
potential energy as it is contracted and releasing energy as it
expands. In its fully expanded state, the pusher spring 425' has a
length that is greater than the length of the spring cavity 417'.
The cross-sectional dimension of the pusher spring 425' is such
that it backs up against and contacts the proximal end of the
pusher block 420'. Thus, when the pusher spring 425' is in place
between the carrier block 410' and the pusher block 420', the
pusher spring 425' is capable of imparting a force biasing the
carrier block 410' away from the pusher block 420'.
[0213] Prior to delivery of the closure element 500, the distal end
of the carrier block 410' is in physical contact with the proximal
end of the pusher block 420'. In this pre-delivery condition, the
pusher spring 425' is in a contracted state and is maintained fully
within the spring cavity 417' formed in the carrier block 410'. A
catch member 418' serves the function of maintaining the carrier
block 410' and pusher block 420' in the pre-delivery condition
against the spring force of the pusher spring 425', the force of
which would otherwise force apart the carrier block 410' from the
pusher block 420'. The catch member 418' is a U-shaped piece of
metal, plastic, or other rigid material that engages a first groove
418a formed on the surface of the carrier block 410' and a second
groove 418b formed on the surface of the pusher block 420'. The
pusher block 420' includes a hole 426' extending through a portion
thereof, with one end of the hole 426' opening into the groove
418b. The hole 426' is adapted to receive a trip pin 427'. During
the closure element deployment process, the trip pin 427' is
advanced through the hole 426', where it encounters the catch
member 418' that is retained in the groove 418b. Further
advancement of the trip pin 427' causes the catch member 418' to
become disengaged from the groove 418b, thereby releasing the
restraining force on the pusher spring 425'.
[0214] The operation of the triggering system 400' of the
alternative embodiment of the apparatus 100' is illustrated in
FIGS. 11-14 with the closure element 500 (shown in FIGS. 6A-B)
disposed substantially within the apparatus 100'. As shown in FIGS.
11A-B, the apparatus has an initial position in which the locator
assembly block 280' is extended proximally and the triggering
system 400' is in its most proximal position. Accordingly, the
locator control system 200' is in its unexpanded state, as shown.
At a point in time that the distal end region 210b' of the locator
assembly 200' has been positioned as desired (for example, within
the blood vessel 600), the locator assembly block 280 is depressed
distally, as shown in FIG. 12, thereby transitioning the locator
assembly to the expanded state and, simultaneously, releasing the
triggering system 400' from the initial position (in the manner
described above) such that the triggering system can be advanced
distally within the housing 380'.
[0215] The triggering system 400' is then advanced distally within
the housing 380', thereby advancing the tube set 305 into position
adjacent the blood vessel. At a first predetermined position, shown
in FIG. 13, the support block 440' encounters a support stop (not
shown) on the interior surface of the housing bottom half 380d that
inhibits the support block 440' from advancing further distally. As
a result, an application of additional distal force to the
triggering system 400' causes the support block 440' to decouple
from the carrier block 410', as shown in FIG. 13. More
specifically, the tabs 445a-b on the forks 444a-b of the support
block 440' disengage from the grooves 413a-b on the carrier block
410'. Thus, the support block 440' remains in the position shown in
FIG. 13, while the carrier block 410' is able to advance further
distally upon application of force to the triggering system
400'.
[0216] Turning to FIGS. 14A-B, as the triggering system 400' is
advanced further distally, the cover block 430' engages a cover
stop on the interior surface near the distal end of the housing
380', thereby inhibiting additional distal advancement of the cover
block 430'. In addition, the trigger extension 405' engages the
handle 391' on the exterior of the apparatus, thereby inhibiting
additional distal advancement of the carrier block 410'. At this
point, the distal end of the tube set corresponds generally to the
state illustrated in FIG. 8G, prior to deployment of the closure
element 500.
[0217] The closure element 500 is next deployed by releasing the
pusher spring 425', which causes the pusher block 420' (and, thus,
the pusher member 320') to advance distally, deploying the closure
element in the manner described above. The pusher spring 425' is
released by disengaging the catch member 418' from the groove 418b
on the pusher block 420', thereby releasing the pusher spring 425'
to force the pusher block 420' and, thus, the pusher member
320'--distally relative to the carrier block 410'. This action
causes the pusher member 320' to deploy the closure element 500, as
shown, for example, in FIGS. 8H-L. The catch member 418' is
disengaged from the groove 418b by applying a force to the trigger
401', which, in the deployment position, is aligned with the trip
pin 427' retained in the pusher block 420'. A trigger spring 402'
biases the trigger outward relative to the housing 380'. The user
applies an inward directed force to the trigger 401' to counteract
the biasing force of the trigger spring 402' and force the trigger
401' against the trip pin 427'.
[0218] In addition to deploying the closure element 500, the distal
advancement of the pusher block 420' also causes the locator
release system 490' to activate, thereby transitioning the locator
control system 200' from the expanded state to the unexpanded
state. As the pusher block 420' advances distally to deploy the
closure element 500' in the manner described above, the pusher
block 420' also engages the engagement member 493' of the locator
release system 490' and advances the locator release rod 491'
distally. This action causes the release tab spacer block 492' to
disengage from the release tabs 284a-b on the locator assembly
block 280' (see FIG. 15), thereby releasing the locator assembly
block 280', which returns to its proximal position, causing the
locator assembly 200' to return to the unexpanded state. The
closure element 500 deployment and locator release actions occur
nearly simultaneously, as illustrated in FIGS. 8I-K.
[0219] As described previously, the apparatus 100 is preferably
brought into contact with the blood vessel 600 by inserting and
advancing the distal end of the apparatus through an introducer
sheath 640 to the blood vessel location. Although preferred, the
use of an introducer sheath 640 is not necessary, as the apparatus
can be used to deploy the closure element 500 without the use of an
introducer sheath 640. Furthermore, as describe above, when an
introducer sheath 640 is used, the locator assembly 200, 200' and
the carrier assembly 300, 300' may have cross-sectional dimensions
that allow them to be received within the introducer sheath 640
either without causing radial expansion or splitting of the sheath,
or with causing radial expansion or splitting of the sheath. If the
relative cross-sectional dimensions of the introducer sheath 640
and carrier assembly 300, 300' are such that the introducer sheath
640 is intended to be split during advancement of the carrier
assembly 300, 200', a sheath cutter 701' having a pointed tip 702'
may be utilized to initiate a split at the proximal end of the
introducer sheath 640. The sheath cutter 701' is advantageously
placed coaxially over the cover member 330' and is attached to the
distal end of the housing 380' (see FIGS. 11A-B), whereby it will
initiate a split in the introducer sheath 640. Distal advancement
of the carrier assembly 300, 300' causes the initial split at the
proximal end of the sheath to advance as the carrier assembly 300,
300' advances.
[0220] Another alternative embodiment of an apparatus for sealing
openings through tissue is shown in FIGS. 16-19. The embodiment of
FIGS. 16-19, as described below, has many identical or similar
structures that perform identical or similar functions to the
embodiments described above and in reference to the preceding
Figures. Accordingly, the description below should be considered in
view of the descriptions above of the preceding embodiments.
Furthermore, those of ordinary skill in the art will appreciate
that one or more of the components and/or features of the
embodiment shown in FIGS. 16-19 may also be incorporated in the
previously described embodiments, as those components and/or
features of the previously described embodiments may optionally be
incorporated in the embodiment described below and in reference to
FIGS. 16-19.
[0221] Turning to FIGS. 16 and 16A, the device 1001 is particularly
adapted for use in conjunction with a guidewire in an over the wire
deployment method described below. The device 1001 has a generally
elongated body that includes, beginning at its proximal end, an
actuator cap 1280, a generally cylindrical actuator housing 1800, a
generally cylindrical release barrel 1810, a generally cylindrical
main housing 1380, and a distal extension 1010. Several components
of a locator assembly, a carrier assembly, and a triggering system
are contained within the main housing 1380, as described more fully
below in relation to FIGS. 18 and 19. The distal extension 1010 of
the device includes an external protective sheath 1012 that covers
the distal portions of the locator assembly and carrier assembly.
The distal end region 1210b of the locator assembly extends out of
the distal end of the protective sheath 1012.
[0222] With particular reference to FIG. 16A, the distal end region
1210b of the locator assembly includes expansion elements 1230 that
include substantially flexible members 1230'. The substantially
flexible members 1230' are able to be selectively controllable
between and unexpanded state (as shown in FIG. 16A) and an expanded
state, generally in the manner described above in relation to FIGS.
2A-D. As shown in FIG. 16A, the locator assembly of the alternative
embodiment of the device 1001 is provided with a central lumen
1003, which is preferably of a diameter sufficient to accommodate a
standard guidewire or other structure, as appropriate. As described
below, the central lumen 1003 extends through the length of the
locator assembly and, thus, through the length of the device
1001.
[0223] Turning again to FIG. 16, the main housing 1380 includes a
pair of grips 1392a-b integrally formed on opposite sides of the
main housing 1380. The distal end of the main housing 1380 is
gradually tapered 1382, with the protective sheath 1012 extending
out of its distal end. A cylindrical counter spring 1386 is located
coaxially on the external surface of the main housing 1380 and
rests, at its distal end, against a shoulder 1384 formed in the
main housing just proximal to the section of the main housing upon
which the grips 1392 are formed. The proximal end of the counter
spring 1386 rests against the release barrel 1810, biasing the
release barrel 1810 proximally in relation to the shoulder 1384
formed on the main housing 1380. The release barrel 1810 is
generally cylindrical and coaxially surrounds the main housing
1380. A mechanical linkage 1812 connects the release barrel 1810 to
a release lever 1814 that cooperates with an actuator block 1282,
as described more fully below in reference to FIGS. 18 and 19. A
longitudinal slot 1388 is formed on each of the main housing 1380
and the release barrel 1810, through which extends a lever 1405
that, as described below, is used to advance the carrier assembly
in the distal direction to operate the device 1001.
[0224] A calibration set screw 1818 is located on the release
barrel 1810 near the distal end of the slot 1388. As the user
advances the lever 1405 distally to deploy the closure element 500
similar to that described above and shown in FIGS. 6a-6g, the lever
1405 will eventually engage the calibration set screw 1818. As
described below, further distal advancement of the lever 1405
causes the actuator block 1282 to release, thereby causing the
locator assembly to release the expansion elements 1230 and 1230'
from the expanded state to the unexpanded state. Thus, the setting
of the calibration set screw 1818 allows the user to fine tune the
synchronization of the release of the locator assembly with the
deployment of the closure element 500, as described below.
[0225] The actuator housing 1800 is attached by a screw 1802 to the
proximal end of the main housing 1380, and extends proximally from
the main housing 1380. A longitudinal slot 1804 is formed in the
actuator housing 1800 to accommodate the release lever 1814 and the
linkage 1812 (see FIGS. 18-19). The actuator cap 1280 extends out
from the proximal end of the actuator housing 1800. The actuator
cap 1280 is a generally cylindrical body that is coaxial with and
generally internal of the actuator housing 1800. The actuator cap
1280 includes a slide seal 1288 at its proximal end that is
slidable and that provides a fluid-tight seal, as described in more
detail below. Additional details concerning the actuator are
described below in reference to FIGS. 18 and 19.
[0226] Turning to FIGS. 17 and 17A, the proximal end of the device
is shown in more detail. As shown, the slide seal 1288 on the
actuator cap 1280 has been slid to an open position to expose the
interior of the actuator. The slide seal 1288 is provided with a
pair of tabs 1287 that cooperate with a pair of slots 1289 formed
on the proximal end of the actuator cap 1280 to allow the slide
seal 1288 to slide in relation to the actuator cap 1280. The
actuator cap 1280 includes a seal 1281, such as an o-ring, that
provides a fluid tight seal with the slide seal 1288.
[0227] As described above and as shown in FIGS. 17 and 17A, the
central lumen 1003 extends longitudinally through the center of the
device and is accessible at the proximal end of the actuator cap
1280 when the slide seal 1288 is in the open position. Additional
details concerning the central lumen 1003 are described below in
relation to the additional Figures.
[0228] FIG. 17 provides additional detail concerning the shape and
orientation of the grips 1392 formed on the main housing. As shown,
the grips 1392 extend radially outward on opposite sides of a point
near the distal end of the main housing 1380, and provide the user
with the ability to grip the housing with two fingers while
operating the lever 1405 with the user's thumb. Also shown in FIGS.
17 and 17A is the slot 1804 formed in the actuator housing 1800 to
accommodate the release lever 1814.
[0229] FIGS. 18, 18A, and 18B show a cross-section of the proximal
portion of the device 1001, including the previously described main
housing 1380, the release barrel 1810 located coaxially in a
slidable relation on the external surface of the main housing, the
counter spring 1386 that biases the release barrel proximally
relative to the shoulder 1384 formed on the main housing, the
actuator housing 1800 extending proximally from the proximal end of
the main housing, the linkage 1812 and release lever 1814 connected
to the release barrel 1810, and the actuator cap 1280 extending
proximally from the proximal end of the actuator housing 1800. The
actuator cap 1280 is attached to, or formed integrally with, an
actuator block 1282 that is generally cylindrical and that is
adapted to slide longitudinally within an actuator base 1284. The
actuator base 1284, in turn, is attached by the screw 1802 to the
proximal end of the main housing 1380 and the distal end of the
actuator housing 1800, as shown in FIG. 18.
[0230] The central lumen 1003 is shown extending through the length
of the device along its longitudinal axis. The central lumen 1003
is defined by the interior diameter of the tubular body 1210 of the
locator assembly 1200, which extends from the proximal end region
1210a to a distal end region 1210b (see FIG. 16A). The proximal end
region 1210a of the tubular body 1210 is attached or otherwise
connected to the actuator block 1282 such that when the actuator
block 1282 is advanced distally the tubular body 1210 is also
advanced distally, thereby causing the flexible members 1230' to
buckle and/or expand transversely outwardly, (in the manner
described above, for example, in relation to FIGS. 2A-D), thereby
transitioning the distal end region 1210b of the locator assembly
1200 from the unexpanded state to the expanded state. For example,
in FIG. 18, the actuator cap 1280 is shown in the extended
position, consistent with the locator assembly 1200 being in the
unexpanded state. In FIG. 19, the actuator cap 1280 is shown in the
depressed position, consistent with the locator assembly 1200 being
in the expanded state. An actuator spring 1286 is located in a
chamber 1285 formed within the interior of the device between the
distal end of the actuator block 1282 and the actuator base 1284
attached to the proximal end of the main housing 1380 and the
distal end of the actuator housing 1800. The actuator spring 1286
biases the actuator block 1282 in the proximal direction.
Depressing the actuator cap 1280 causes the actuator spring 1286 to
compress within the chamber 1285. Once the actuator cap is fully
depressed, the release lever 1814 is rotated inwardly such that a
catch 1816 formed on the release lever engages a slot 1283 formed
on the actuator block 1282, thereby holding the actuator block 1282
in place in the depressed position against the spring force of the
actuator spring 1286. The release lever 1814 may be disengaged,
thus transitioning the locator assembly 1200 from the expanded
state to the unexpanded state, either by manually releasing the
release lever 1814 from the actuator block 1282 and allowing the
actuator block to extend proximally, or by advancing the carrier
assembly lever 1405 distally to engage the calibration set screw
1818 on the release barrel 1810 and applying additional distal
force to the lever 1405 (and, thus, the release barrel 1810) to
cause the release lever 1814 to disengage from the actuator block
1282.
[0231] A tube set 1305 is located within the interior of the main
housing 1380, extending distally through the distal extension 1010.
The tube set 1305 shown in FIG. 18 includes a carrier tube 1310, a
pusher tube 1320, and a cover tube 1330, each located in a coaxial
orientation with each other and with the tubular body 1210 of the
locator assembly 1200. The tube set 1305 has a structure otherwise
substantially identical to that described above in relation to
FIGS. 3A-E. The cover tube 1330 is connected or otherwise attached
at its proximal end to a cover block 1430. The pusher tube 1320,
similarly, is connected or otherwise attached at its proximal end
to a pusher block 1420. Finally, the carrier tube 1310 is connected
or otherwise attached at its proximal end to a carrier block 1410.
The lever 1405 is attached to the pusher block 1420. Thus, any
movement of the lever 1405 will cause the pusher block 1420 to move
as well.
[0232] A leaf spring 1418 connects the carrier block 1410 to the
pusher block 1420, as shown in FIG. 18B. The leaf spring 1418 is
generally flat and extends longitudinally parallel to the central
axis of the device. A lip 1419 is formed on the distal end of the
leaf spring 1418, the lip 1419 oriented such that it engages the
distal end of the pusher block 1420, effectively locking the pusher
block 1420 to the carrier block 1410 until the leaf spring 1418 is
disengaged from the pusher block 1420, as described below. As long
as the pusher block 1420 is thereby locked to the carrier block
1410, advancement of the lever 1405 will cause advancement of the
combination of the carrier block 1410 and the pusher block
1420.
[0233] A guide pin 1900 is located and fixed on the interior of the
main housing 1380, and extends proximally from the distal wall of
the interior of the main housing. The guide pin 1900 is received
within a slot 1902 formed in the pusher block 1420 and cover block
1430, and prevents the pusher block 1420 and cover block 1430 from
rotating inside the main housing 1380.
[0234] A grooved pin 1910 is also located and fixed on the interior
of the main housing 1380, and extends proximally from the distal
wall of the interior of the main housing 1380. The grooved pin 1910
is preferably located on an opposite side of the interior of the
main housing from the guide pin 1900. The grooved pin 1910 has a
taper 1912 formed on its proximal end and a transverse groove 1914
formed just distally from the beginning of the taper 1912. The
location and orientation of the grooved pin 1910 are such that the
taper 1912 formed on the grooved pin 1910 engages and lifts the
leaf spring 1418 from its engagement with the pusher block 1420 as
the pusher block 1420 and carrier block 1410 are advanced distally
within the device. As the pusher block 1420 and carrier block 1410
are advanced still further, the lip 1419 formed on the leaf spring
1418 engages and locks in place in the transverse groove 1914
formed on the grooved pin 1910, thereby preventing the carrier
block 1410 (and, thus, the carrier tube 1310) from advancing any
further distally. This position of the device also corresponds to
the engagement of the lever 1405 with the calibration set screw
1818 (see FIG. 16). Any additional distal movement of the lever
1405 will cause the pusher block 1420 to move further distally
while the carrier block 1410 remains stationary, thus causing the
pusher tube 1320 to deploy the closure element 1500, in the manner
described above in relation to FIGS. 8A-L. This additional distal
movement of the lever 1405 also simultaneously causes the release
barrel 1810 to move distally and to disengage the release lever
1814 from the actuator block 1282, thereby releasing the actuator
block 1282 and causing the locator assembly 1200 to transition from
the expanded state to the unexpanded state.
[0235] Referring now to FIGS. 20A-L, methods of use of the device
1001 in accordance with the present invention will be described. As
previously described above and shown in FIGS. 16-19, the device
1001 is configured to deploy a closure element 500 over a wire,
wherein the over the wire deployment method utilizing the device
1001 described herein may for example include the following steps,
though methods of use associated with the apparatus should not be
limited to those described herein or shown in the appended
drawings.
[0236] Referring now to FIG. 20A, there is shown a vessel 620
disposed below a patient's tissue 630 and skin 650, wherein a
guidewire 1950 is shown disposed through an opening formed in the
vessel and tissue as described above. The guidewire 1950 may be
introduced into the blood vessel for the sole purpose of using the
device 1001 to deploy the closure element 500, or the guidewire may
have already been present from a previously completed
interventional procedure. If an introducer sheath is in place, it
should be removed prior to use of the apparatus 1001, thereby
leaving the guidewire 1950 in place extending into the blood
vessel.
[0237] As shown in FIG. 20B, the device 1001 is then threaded over
the guidewire 1950 by inserting the proximal end of the guidewire
1950 into the central lumen of the device 1001 at the distal end of
the device, the guidewire is disposed through the device and exits
at the proximal end of the device. The device 1001 is then advanced
along the guidewire until the distal end 210b of the locator
assembly is disposed through the opening formed in the blood vessel
as shown in FIG. 20C, whereby the correct position of the device is
confirmed by observing a slight flow of blood out of the proximal
end of the device, through the open slide seal 1288 on the actuator
cap 1280.
[0238] Once the correct position of the device is confirmed, the
actuator cap 1280 is depressed (i.e., the actuator block 1282 is
advanced distally) to deploy the flexible members on the distal end
210b of the locator assembly, i.e., to transition the locator
assembly from the unexpanded state to the expanded state. In the
expanded state, the flexible members are able to engage the inside
of the vessel wall at the location of the opening in the blood
vessel as shown in FIG. 20D. The correct position of the device at
this point may be confirmed by gently pulling on the device to feel
the resistance of the vessel wall against the flexible members in
the expanded state as shown in FIG. 20E. After verifying the
correct position in this manner, the guidewire may be removed from
the vessel and from the device by withdrawing the guidewire through
the proximal end of the device. Once the guidewire is removed, the
slide seal 1288 on the actuator cap 1280 may be closed to prevent
further flow of blood through the device.
[0239] Referring now to FIGS. 20F and 20G, the device 1001 is in
proper position to deploy the closure element 500. The closure
element 500'' is deployed by advancing the lever 1405, which
advances the carrier block 1410, pusher block 1420, and cover block
1430 until further distal advancement of the carrier block 1410 and
cover block 1430 are prevented by the interaction of the leaf
spring 1418 engaging and locking in place in the transverse groove
1914 formed on the grooved pin 1910, thereby preventing the carrier
block 1410 (and, thus, the carrier tube 1310) from advancing any
further distally. Further distal advancement of the lever 1405
thereafter causes advancement only of the pusher block 1420, which
causes deployment of the closure element 500 in the identical
manner described above, for example, in relation to FIGS. 8H-L. In
addition, further distal advancement of the lever 1405 causes the
lever 1405 simultaneously to engage the release barrel 1810, which
in turn pulls the release lever 1814 and frees the actuator block
1282 to spring back proximally, transitioning the locator assembly
1200 from the expanded state to the unexpanded state. The closure
element deployment and locator release actions occur nearly
simultaneously, as illustrated, for example, in FIGS. 8I-K.
[0240] As shown in FIG. 20G, the closure element 500 is shown in a
deployed position, wherein the closure element has been engaged
with the vessel wall to effectively close the opening formed
therein. As previously described and shown in FIGS. 20F and 20G,
the closure element 500 is expanded as it is deployed from the
device 1001, wherein by increasing the diameter of the closure
element 500, the closure element may engage tissue adjacent the
opening in the tissue. It is contemplated that the closure element
may be configured to penetrate the vessel wall to effect a closure,
or partially penetrate the vessel wall to effect closure.
[0241] The invention is susceptible to various modifications and
alternative forms, and specific examples thereof have been shown by
way of example in the drawings and are herein described in detail.
It should be understood, however, that the invention is not to be
limited to the particular forms or methods disclosed, but to the
contrary, the invention is to cover all modifications, equivalents,
and alternatives falling within the spirit and scope of the
claims.
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