U.S. patent application number 16/223765 was filed with the patent office on 2019-04-25 for apparatus and methods for engaging tissue.
The applicant listed for this patent is Abbott Laboratories. Invention is credited to Arkady Kokish.
Application Number | 20190117205 16/223765 |
Document ID | / |
Family ID | 41316871 |
Filed Date | 2019-04-25 |
View All Diagrams
United States Patent
Application |
20190117205 |
Kind Code |
A1 |
Kokish; Arkady |
April 25, 2019 |
APPARATUS AND METHODS FOR ENGAGING TISSUE
Abstract
A system includes a tissue engaging device and a delivery device
that cooperates with the tissue engaging device. The tissue
engaging device includes a distal tissue penetrating tip and two
locking portions at a proximal end. The two locking portions move
radially outwardly to transition the tissue engaging device from an
unlocked configuration to a locked configuration. The delivery
device includes a first elongate member being configured to
selective extend distally past the two locking portions. A member,
with a protruding portion disposed at a distal end of the delivery
device, extends radially inwardly and is configured to selectively
cooperate with the proximal end of the tissue engaging device to
prevent rotational movement of the tissue engaging device relative
to the delivery device.
Inventors: |
Kokish; Arkady; (Los Gatos,
CA) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Abbott Laboratories |
Abbott Park |
IL |
US |
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Family ID: |
41316871 |
Appl. No.: |
16/223765 |
Filed: |
December 18, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15069230 |
Mar 14, 2016 |
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16223765 |
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12122603 |
May 16, 2008 |
9282965 |
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15069230 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/00234 20130101;
A61B 2017/00663 20130101; A61B 17/10 20130101; A61B 2017/00584
20130101; A61B 2017/00672 20130101; A61B 17/3423 20130101; A61B
17/083 20130101; A61B 17/0057 20130101; A61B 17/08 20130101; A61B
2017/00004 20130101 |
International
Class: |
A61B 17/00 20060101
A61B017/00; A61B 17/10 20060101 A61B017/10; A61B 17/34 20060101
A61B017/34; A61B 17/08 20060101 A61B017/08 |
Claims
1. A system comprising: a tissue engaging device comprising: a
distal tissue penetrating tip; and two locking portions at a
proximal end, wherein the two locking portions move radially
outwardly to transition the tissue engaging device from an unlocked
configuration to a locked configuration; a delivery device
cooperating with the tissue engaging device, the delivery device
comprising: a first elongate member extending from a second
elongate member, the first elongate member being disposed within an
opening of the tissue engaging device that extends from the distal
end towards the proximal end, the first elongate member being
configured to selectively extend distally past the two locking
portions; and a member with a protruding portion disposed at a
distal end of the delivery device and extending radially inwardly,
the protruding portion selectively cooperating with the proximal
end of the tissue engaging device, the cooperation of the
protruding portion and the tissue engaging device preventing
rotational movement of the tissue engaging device relative to the
delivery device.
2. The system of claim 1, wherein the two locking portions
cooperate with two other locking portions to lock the tissue
engaging device in the locked configuration.
3. The system of claim 1, further comprising a locator extendable
through the elongate member.
4. The system of claim 1, wherein the tissue engaging device
comprises a first member and a second member that pivotally
cooperate.
5. The system of claim 1, further comprising a concave portion
formed in the second elongate member, the concave portion receiving
a portion of the tissue engaging device.
6. The system of claim 1, wherein the protruding member selective
cooperates with an opening formed in the proximal end of the tissue
engaging device.
7. The system of claim 1, wherein the tissue engaging device
comprise a bioabsorbable material, a biodegradable material, or
bioerodible material.
8. A system comprising: a tissue engaging device comprising: two
distal tissue penetrating tips; and two locking portions at a
proximal end, wherein the two locking portions move radially
outwardly to transition the tissue engaging device from an unlocked
configuration to a locked configuration, the two locking portions
are disposed on opposite sides of a longitudinal axis of the tissue
engaging device; a delivery device cooperating with the tissue
engaging device, the delivery device comprising: a first elongate
member extending from a second elongate member, the first elongate
member being disposed within an opening of the tissue engaging
device that extends from the distal end towards the proximal end,
the first elongate member being configured to extend distally past
the two locking portions with the two distal tissue penetrating
tips being in a tissue-capture open configuration; and a member
with a protruding portion disposed at a distal end of the delivery
device and extending radially inwardly, the protruding portion
selectively cooperating with the proximal end of the tissue
engaging device, the cooperation of the protruding portion and the
tissue engaging device preventing rotational movement of the tissue
engaging device relative to the delivery device.
9. The system of claim 8, wherein the two locking portions
cooperate with two other locking portions to lock the tissue
engaging device in the locked configuration.
10. The system of claim 8, wherein the tissue engaging device
comprises a first member and a second member.
11. The system of claim 10, wherein a distal end of each the first
member and the second member is formed with one of the two distal
tissue penetrating tips.
12. The system of claim 8, further comprising a concave portion
formed in the second elongate member, the concave portion receiving
a portion of the tissue engaging device.
13. The system of claim 8, wherein the protruding portion
selectively cooperates with an opening formed in the tissue
engaging device, the opening extending through the tissue engaging
device in a proximal to distal direction.
14. The system of claim 8, wherein the tissue engaging device
comprise a bioabsorbable material, a biodegradable material, or
bioerodible material.
15. A method for capturing tissue, the method comprising:
positioning a tissue engaging device to capture tissue, the tissue
engaging device comprising: a distal tissue penetrating tip; and
two locking portions at a proximal end, wherein the two locking
portions move radially outwardly to transition the tissue engaging
device from an unlocked configuration to a locked configuration;
capturing tissue with the tissue engaging device and deploying the
tissue engaging device from a delivery device, the delivery device
comprising: a first elongate member extending from a second
elongate member, the first elongate member being disposed within an
opening of the tissue engaging device that extends from the distal
end towards the proximal end, the first elongate member being
configured to selective extends distally past the two locking
portions; and a member with a protruding portion disposed at a
distal end of the delivery device and extending radially inwardly,
the protruding portion selectively cooperating with the proximal
end of the tissue engaging device, the cooperation of the
protruding portion and the tissue engaging device preventing
rotational movement of the tissue engaging device relative to the
delivery device; and removing the delivery device.
16. The method of claim 15, further comprising advancing a locator
through the first elongate member.
17. The method of claim 15, further comprising moving a distal end
of the second elongate member relative to the proximal end of the
tissue engaging device to deploy the tissue engaging device.
18. The method of claim 17, wherein the distal end comprises a
concave portion.
19. The method of claim 15, wherein capturing tissue with the
tissue engaging device comprises pivoting the distal tissue
penetrating tip about an intermediate portion of the tissue
engaging device.
20. The method of claim 15, wherein removing the delivery device
comprises withdrawing the protruding portion from engaging with the
tissue engaging device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/069,230, filed Mar. 14, 2016, now U.S. Pat.
No. ______, entitled "Apparatus and Methods for Engaging Tissue",
which is a continuation of U.S. patent application Ser. No.
12/122,603, filed May 16, 2008, now U.S. Pat. No. 9,282,965,
entitled "Apparatus and Methods for Engaging Tissue", the
entireties of which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical devices,
and more particularly to apparatus and methods for engaging
tissue.
BACKGROUND OF THE INVENTION
[0003] 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 guidewire may be advanced through the needle and into the
patient's blood vessel accessed by the needle. The needle is then
removed, enabling an introducer sheath to be advanced over the
guidewire into the vessel, e.g., in conjunction with or subsequent
to a dilator.
[0004] A catheter or other device may then be advanced through a
lumen of the introducer sheath and over the guidewire 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.
[0005] Upon completing the procedure, the devices and introducer
sheath are removed, leaving a puncture site in the vessel wall.
Traditionally, external pressure had often been applied to the
puncture site until clotting and wound sealing would 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.
[0006] 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.
[0007] To facilitate positioning devices that are percutaneously
inserted into a blood vessel, "bleed back" indicators have been
suggested. For instance, 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. This
device, however, requires that an anchor of the plug be positioned
within the vessel, and therefore, may increase the risk of
over-advancement of the plug itself into the vessel.
[0008] 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 in
order to engage the inner wall of the vessel, thereby facilitating
holding the sheath in a desired location with respect to the
vessel.
[0009] Accordingly, additional apparatus and methods for engaging
tissue would be useful.
BRIEF SUMMARY
[0010] An embodiment of an engaging element for engaging tissue is
described. The engaging element includes a first member having at
least one tissue engaging portion. The engaging element includes a
second member having at least one tissue engaging portion and being
pivotally connected to the first member. The engaging element
includes a locking mechanism that is operatively associated with
the first and second member. The locking mechanism is configured to
inhibit the relative motion of the first and second member.
[0011] An embodiment of an engaging system for engaging tissue is
described. The engaging system includes an engaging element for
engaging tissue. The engaging element includes a first member
having at least one tissue engaging portion. The engaging element
also includes a second member including at least one tissue
engaging portion. The second member is pivotally connected to the
first member. The engaging element further includes a locking
mechanism operatively associated with the first and second member.
The locking mechanism is configured to inhibit the relative motion
of the first and second member. The engaging system also includes
an engaging element delivery device. The engaging element delivery
device includes a transitioning member. The transitioning member is
configured to transition the engaging element from an open
configuration toward a closed configuration.
[0012] A method for engaging tissue is described. The method
includes positioning an engaging element relative to an engaging
element delivery device. The engaging element includes a first
member having at least one tissue engaging portion. The engaging
element also includes a second member having at least one tissue
engaging portion. The second member is pivotally connected to the
first member. The engaging element further includes a locking
mechanism operatively associated with the first and second member.
The locking mechanism is configured to inhibit the relative motion
of the first and second member. The engaging element delivery
device includes a retaining member. The retaining member includes a
retaining mechanism and a transitioning member. The engaging
element is positioned relative to a portion of tissue. A portion of
the tissue is engaged with at least one tissue engaging portion.
The engaging element is transitioned from an open configuration
toward a closed configuration using the transitioning member. A
locking mechanism is activated using the transitioning member to
inhibit the relative motion of the first member and the second
member.
[0013] In some embodiments of an engaging member, the first and
second member include a proximal end. In further embodiments of an
engaging member, the proximal ends of the first member and second
member are separated by a first transitioning dimension in an open
configuration and a second transitioning dimension in a closed
configuration.
[0014] The first transitioning dimension, in some embodiments of an
engaging member, is larger than said second transitioning
dimension. In other embodiments of an engaging member, the first
transitioning dimension is smaller than said second transitioning
dimension. In further embodiments of an engaging member, the
locking mechanism includes a first locking portion and a second
locking portion, such that movement of the at least one tissue
engaging portions of the first and second members is inhibited by
the operative association between the first and second locking
portions.
[0015] In some embodiments of an engaging member, the first locking
portion includes at least one tooth associated with the first
member and the second locking portion includes a locking member
associated with the second member. In other embodiments of an
engaging member, the locking member is biased toward the at least
one tooth.
[0016] The locking member and the at least one tooth, in some
embodiments of an engaging member, inhibit the at least one tissue
engaging portions of the first and second members from moving
toward the open configuration. In further embodiments of an
engaging member, the first locking portion includes a latch
associated with the first member and the second locking portion
includes a latching portion associated with the second member. In
still further embodiments of an engaging member, the latch and the
latching portion inhibit the at least one tissue engaging portion
of the first and second members from moving toward the open
configuration.
[0017] In some embodiments of an engaging member, at least one
tissue engaging portion of the first member and the at least one
tissue engaging portion of the second member are separated by a
first distal dimension in an open configuration and are separated
by a second distal dimension in a closed configuration. The first
distal dimension is larger than the second distal dimension, in
some embodiments of an engaging member.
[0018] The engaging element, in some embodiments, includes a
pivoting mechanism operatively associated with the first and the
second members. In further embodiments of an engaging member, the
pivoting mechanism includes a pivoting opening associated with one
of the first member and the second member and a pivoting member
associated with the other of the first member and the second
member.
[0019] In some embodiments of an engaging member, the engaging
element further comprises a retaining portion configured to be
operatively associated with a retaining mechanism. In further
embodiments of an engaging member, the engaging element includes
bioabsorbable, biodegradable, and/or bioerodible material. In still
further embodiments, the engaging element includes collagen,
polycaprolactone (PCL), poly-D,L-lactic acid, Poly-L-lactic acid,
poly (lactide-co-glycolide), poly(hydroxybutyrate), polyanhydrides,
and/or poly(glycolic acid).
[0020] The engaging element, in some embodiments of an engaging
system, includes a pivoting mechanism operatively associated with
said first and said second member. Further embodiments of an
engaging system include a retaining member that has a retaining
mechanism configured to selectably inhibit the relative motion of
said engaging element and said retaining member.
[0021] In some embodiments of an engaging system, a pivoting
mechanism includes a pivoting opening associated with one of the
first and second member and a pivoting member associated with the
other of the first and second member. In further embodiments of an
engaging system, the retaining mechanism is operatively associated
with the pivoting opening to selectably inhibit the relative motion
of the engaging element and the retaining member. In still further
embodiments of an engaging system, the retaining mechanism includes
a retaining detent that engages the pivoting opening to selectably
inhibit the relative motion of the engaging element and the
retaining member.
[0022] The retaining member and the transitioning member, in some
embodiments of an engaging system, are axially aligned. In further
embodiments of an engagement system, the retaining member is
configured to slidably receive the transitioning member.
[0023] In some embodiments of an engaging system, the first and
second member of the engaging element include a transitioning
portion. The transitioning member, in further embodiments, includes
a transitioning surface that is shaped to engage with the
transitioning portion of at least one of the first and second
member of the engaging element. In some embodiments, the
transitioning surface has a convex shape. In other embodiments, the
transitioning surface has a concave shape.
[0024] Some embodiments of a method for engaging tissue include
selectably retaining the engaging element using a retaining
mechanism to inhibit the relative motion of the engaging element
and the retaining member. Further embodiments of a method for
engaging tissue include disengaging the locking mechanism.
[0025] Other aspects and features of the present invention will
become apparent from consideration of the following description in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] In order to describe the manner in which the above-recited
and other advantages and features of the invention can be obtained,
a more particular description of the invention 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 to be limiting of its scope, the invention will be
described and explained with additional specificity and detail
through the use of the accompanying drawings.
[0027] FIG. 1A is a perspective partial cutaway view of an
embodiment of a system for engaging tissue with an engaging element
in an open configuration, according to an embodiment of the present
invention.
[0028] FIG. 1B is a perspective partial cutaway view of the
embodiment of a system for engaging tissue of FIG. 1A with an
engaging element in a closed configuration, according to the
present invention.
[0029] FIG. 1C is a top cutaway view of the embodiment of the
system for engaging tissue of FIG. 1A, according to the present
invention.
[0030] FIG. 2A is a perspective view of another embodiment of an
engaging element in an open configuration, according to the present
invention.
[0031] FIG. 2B is a perspective view of the embodiment of the
engaging element of FIG. 2A in a closed configuration, according to
the present invention.
[0032] FIG. 2C is a perspective view of an embodiment of a system
for engaging tissue with the embodiment of the engaging element of
FIG. 2A in an open configuration, according to the present
invention.
[0033] FIG. 2D is a perspective partial cutaway view of the
embodiment of a system for engaging tissue of FIG. 2C with the
embodiment of the engaging element of FIG. 2A in a closed
configuration, according to the present invention.
[0034] FIG. 2E is a right cutaway view of the embodiment of the
system for engaging tissue of FIG. 2C with the embodiment of the
engaging element of FIG. 2A in an open configuration, according to
the present invention.
[0035] FIG. 2F is a right cutaway view of the embodiment of the
system for engaging tissue of FIG. 2C with the embodiment of the
engaging element of FIG. 2A in a closed configuration, according to
the present invention.
[0036] FIGS. 3A-3K illustrate various steps in the deployment of an
embodiment of an engaging element to engage tissue according to one
example.
[0037] 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
[0038] Embodiments described herein extend to methods, systems, and
apparatus for engaging tissue. Some embodiments may be used to
close and/or seal openings in a blood vessel or other body lumen
formed during a diagnostic, therapeutic, and/or other procedure.
The engaging elements of the present invention may be configured to
be delivered through tissue and into an opening formed in and/or
adjacent to a wall of a blood vessel or other body lumen. The
engaging elements provided herein may reliably engage.
[0039] Moreover, the engaging elements may be made of any suitable
material, including a bioabsorbable material, such as collagen.
Other biodegradable materials may include polycaprolactone (PCL),
poly-D,L-lactic acid, Poly-L-lactic acid, poly
(lactide-co-glycolide), poly(hydroxybutyrate), polyanhydrides,
poly(glycolic acid, and/or other biodegradable materials.
[0040] Referring generally to FIGS. 1A-1C, the system 100 may
include an engaging element 110 and an engaging element delivery
device 160. The engaging element 110 may include a first member 112
and a second member 114. The first member 112 and the second member
114 may include tissue engaging portions 116 (three tissue engaging
portions 116 on each of the first member 112 and the second member
114, in the present embodiment). The tissue engaging portions 116
may include a sharpened tip, as shown, and/or may include other
tips, such as barbed tips. The tissue engaging portions 116 may be
configured to engage tissue.
[0041] The engaging element delivery device 160 may include a
retaining member 164, a transitioning member 168, a carrier member
172, a locator 176, and/or other components. The transitioning
member 168 may include a lumen. The lumen may receive the carrier
member 172, the locator 176, and/or other components. The carrier
member 172 may be configured to receive a locator 176 and/or other
components.
[0042] The engaging element 110, locator 176, carrier member 172,
transitioning member 168, and/or retaining member 164 may be
axially aligned. The carrier member 172 and/or locator 176 may be
configured to fit within a channel of the engaging element 110 in
the open configuration.
[0043] The first member 112 and second member 114 may be pivotally
connected. The first member 112 and second member 114 may be
pivotally connected by a pivoting mechanism 120. The pivoting
mechanism 120 may include a pivoting opening 122 and a pivoting
member 124. The pivoting member 124 may be located on the first
member 112 and the pivoting opening 122 may be located on the
second member 114. Alternatively, the pivoting member 124 and
pivoting opening 122 may be located on either the first member 112
or the second member 114. Other pivoting mechanisms 120 may also be
used. The pivoting member 124 of the present embodiment may include
a detent configured to engage the pivoting opening 122.
[0044] The engaging element 110 may include a transitioning portion
130 with a first transitioning dimension 132a, in the open
configuration shown in FIG. 1A, and a second transitioning
dimension 132b in the closed configuration shown in FIG. 1B.
Transitioning dimensions 132a, 132b may indicate distances between
the first member 112 and the second member 114 in various
configurations. The first transitioning dimension 132a may be
smaller than the second transitioning dimension 132b.
[0045] The engaging element 110 may include a first distal
dimension 134a in the open configuration and a second distal
dimension 134b in the closed configuration. Distal dimensions 134a,
134b may indicate distances between the first member 112 and the
second member 114 in various configurations. The first distal
dimension 134a may be larger than the second transitioning
dimension 132b.
[0046] The transitioning portion 130 may be configured to receive a
distal end of the transitioning member 168. The transitioning
member 168 may include a transitioning surface 170 located near the
distal end. The transitioning member 168 may be elongate and/or
convex. The transitioning surface 170 may be operatively associated
with the transitioning portion 130 of the engaging element 110 to
transition the engaging element 110 from the open configuration
toward the closed configuration.
[0047] Referring to FIGS. 1A and 1B, transitioning the engaging
element 110 from the open configuration toward the closed
configuration may include expanding the first transitioning
dimension 132a toward the second transitioning dimension 132b. As
the transitioning surface 170 of the transitioning member 168
engages the transitioning portion 130 of the engaging element 110,
the proximal ends of the first member 112 and second member 114 may
expand away from each other. As the proximal ends expand away from
each other (from the open configuration), the tissue engaging
portions 116 of the first member 112 and the second member 114 may
move toward each other (toward the closed configuration).
[0048] The engaging element 110 may include a locking mechanism 140
that may be configured to generally inhibit movement from the
closed configuration towards the open configuration. For example,
as the proximal ends expand away from each other, the locking
mechanism 140 may inhibit movement back toward the open
configuration.
[0049] The locking mechanism 140 may include a first locking
portion 142 and a second locking portion 144. The first locking
portion 142 and the second locking portion 144 may be operatively
associated. The first locking portion 142 and/or the second locking
portion 144 may be located near the proximal ends of the first
member 112 and/or the second member 114, respectively. The first
locking portion 142 may include at least one tooth. The at least
one tooth may be configured to receive the second locking portion
144 which may include a locking member such as a follower. The
locking member may be biased toward the at least one tooth. The use
of multiple teeth may incrementally inhibit movement toward the
open configuration.
[0050] The pivoting opening 122 may include a retaining portion.
The pivoting opening 122 may be configured to receive at least a
portion of a retaining mechanism 166 on the retaining member 164
and the pivoting member 124 of the engaging element 110. The
pivoting opening 122 and retaining mechanism 166 may be operatively
associated to limit movement of the engaging element 110 in at
least one direction. For instance, the pivoting opening 122 and
retaining mechanism 166 may limit motion of the engaging element
110 both longitudinally (i.e. through the retaining member 164) and
radially (i.e. about an axis within the retaining member 164). The
engaging element 110 may be inserted through the retaining member
164 until the retaining mechanism 166 and the pivoting opening 122
are retained. Alternatively, the retaining portion may be located
on the retaining member 164 while the retaining mechanism 166 is
located on the engaging element 110. Other retaining portion and/or
retaining mechanism combinations, such as a detent and retaining
groove combination, may be used.
[0051] In order to align the pivoting opening 122 of the engaging
element 110 with the retaining mechanism 166 of the retaining
member 164, the engaging element 110 may include an aligning
portion 150, as shown in FIGS. 1A and 1B, which may be operatively
associated with an aligning mechanism 167 of the retaining member
164. The aligning portion 150 of the engaging element 110 may
include a ridge configured to be inserted into the aligning
mechanism 167 (i.e. a corresponding slot or groove) of the
retaining member 164. In another embodiment, the aligning portion
150 of the engaging element 110 may be a slot or groove configured
to receive the aligning mechanism 167, i.e. ridge, tab, etc., of
the retaining member 164. In further embodiments, the aligning
portion 150 and/or the aligning mechanism 167 may take other forms
to align the engaging element 110 with the retaining member 164
and/or transitioning member 168.
[0052] Referring to FIGS. 2A-2F, the system 200 and engaging
element 210 of this embodiment may be at least partially
functionally similar to that of the system 100 and engaging element
210 previously described above and shown in FIG. 1 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.
[0053] The engaging element 210 may include a first member 212 and
a second member 214. The first member 212 and the second member 214
may be configured to engage tissue. The tissue engaging portions
216 may include tissue engaging portions 216 that may include a
sharpened tip, barb, and/or other tip.
[0054] The first member 212 and second member 214 may be pivotally
connected by a pivoting mechanism 220. The pivoting mechanism 220
may include a pivoting opening 222 and a pivoting member 224. The
pivoting opening 222 may be located on the first member 212 and the
pivoting member 224 may be located on the second member 214.
[0055] The engaging element 210 may include a transitioning portion
230 with a first transitioning dimension 232a, in the open
configuration shown in FIG. 2A, and a second transitioning
dimension 232b in the closed configuration shown in FIG. 2B. The
first transitioning dimension 232a may be larger than the second
transitioning dimension 232b.
[0056] The engaging element 210 may include a first distal
dimension 234a in the open configuration and a second distal
dimension 234b in the closed configuration. The first distal
dimension 134a may be larger than the second transitioning
dimension 232b.
[0057] Referring to the system 200 shown in FIGS. 2C-2D, the
engaging element delivery device 260 may include a transitioning
member 268, a retaining member 264, a carrier member 272, a locator
276, and/or other components. The transitioning portion 230 of the
engaging element 210 may be configured to receive a distal end of
the transitioning member 268. The transitioning member 268 may
include a transitioning surface 270 located near the distal end
that may be concave. The transitioning surface 270 may be
operatively associated with the transitioning portion 230 of the
engaging element 210 to transition the engaging element 210 from
the open configuration toward the closed configuration.
[0058] Referring to FIGS. 2C-2F, transitioning the engaging element
210 from the open configuration toward the closed configuration may
include moving the first transitioning dimension 232a toward the
second transitioning dimension 232b. As the transitioning surface
270 of the transitioning member 268 engages the transitioning
portion 230 of the engaging element 210, the proximal ends of the
first member 212 and second member 214 may move toward each other.
As the proximal ends move toward each other (from the open
configuration), the tissue engaging portions 216 of the first
member 212 and the second member 214 may also move toward each
other (toward the closed configuration).
[0059] The engaging element 210 may include a locking mechanism 240
that may be configured to generally inhibit movement from the
closed configuration towards the open configuration. For example,
as the proximal ends move toward each other the locking mechanism
240 may inhibit movement toward the open configuration.
[0060] The locking mechanism 240 may include a first locking
portion 242 and a second locking portion 244. The first locking
portion 242 and the second locking portion 244 may be operatively
associated. The first locking portion 242 and/or the second locking
portion 244 may be located near the proximal ends of the first
member 212 and/or the second member 214, respectively. The first
locking portion 242 may include a latch member. The latch member
may be configured to engage the second locking portion 244 which
may include a latching portion. The latch member may be biased to
engage the latching portion. Although the latch member and latching
portion may be located on the first member 212 and the second
member 214, respectively, other locations may also be used.
Furthermore, although a locking member and tooth combination and a
latch member and latching portion combination have been described,
other locking mechanisms may be used. For instance, a set of
interlocking teeth may be disposed on the first member 212 and the
second member 214 similar to the locking mechanism used for locking
forceps.
[0061] The pivoting opening 222 may include a retaining portion
that may be configured to receive a retaining mechanism 266 on the
retaining member 264. The pivoting opening 222 and retaining
mechanism 266 may be operatively associated to limit movement of
the engaging element 210 in at least one direction.
[0062] The engaging element 210 of the present embodiment may
include two types of aligning portions 250a, 250b. The aligning
portions 250a near the proximal end of the engaging element 210 may
be grooves configured to receive an aligning mechanism 271 (i.e. a
ridge) on the transitioning member 268. The aligning portions 250b
near the tissue engaging portions 216 may be ridges configured to
be inserted into a first aligning mechanism 267, i.e. a
corresponding slot or groove, of the retaining member 264. Other
alignment portions 250a, 250b, alignment mechanisms 267, 271,
and/or configurations of the same (i.e. alignment portions and/or
alignment mechanisms on the engaging element 210, retaining member
264, transitioning member 268, and/or other components) may be used
to orient the engaging element 210 relative to the engaging element
delivery device 260 such that the retaining member 264 may retain
the engaging element 210.
[0063] The transitioning member 268 may include a lumen that may
receive a carrier member 272, a locator 276, and/or other
components. The carrier member 272 may be configured to receive a
locator 276 and/or other components.
[0064] The transitioning member 268 may abut the transitioning
portion 230 of the engaging element 210. The transitioning member
268 may include a transitioning surface 270 that is concave. As the
transitioning member 268 is advanced through the retaining member
264, the transitioning member 268 may transition the engaging
member 210 toward a closed configuration. The concave transitioning
surface 270 may generally cause the proximal ends of the first
member 212 and the second member 214 to move toward each other. As
the proximal ends of the first member 212 and the second member 214
move toward each other, the tissue engaging portions 216 on the
first member 212 and the second member 214 may move toward each
other.
[0065] FIGS. 3A-3K illustrate various steps in the deployment of an
embodiment of an engaging element 310 to close a puncture according
to one example. The systems 100, 200 and engaging elements 110, 210
discussed above in connection with FIGS. 1A-1C and 2A-2F will now
be discussed in the context of a patient and with respect to a
blood vessel 390. The systems 100, 200 and engaging elements 110,
210 may also be used with body lumens other than blood vessels.
[0066] The system 300 and engaging element 310 of this embodiment
may be at least partially functionally similar to that of the
systems 100, 200 and engaging elements 110, 210 previously
described above and shown in FIGS. 1 and 2 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.
[0067] The blood vessel 390 has a vessel wall 392 with an outer
portion 392a and an inner portion 392b. The engaging element
delivery device 360 may then be used to apply the engaging element
310. In particular, a sheath 380 may be inserted or otherwise
positioned through skin 394 and tissue 396 and within the blood
vessel 390 or other body lumen via an opening 398. The sheath 380
can include a substantially flexible or semi-rigid tubular member.
Also, the sheath 380 can have a proximal end region 382a and a
distal end region 382b. The sheath 380 may further have a
predetermined length and a predetermined cross-section, both of
which can be of any suitable dimension. The sheath 380 also can
form a lumen 384 that extends along a longitudinal axis of the
sheath 380 and substantially between the proximal and distal end
regions 382a, 382b. The lumen 384 can have any suitable internal
cross-section and is suitable for receiving one or more devices
(not shown), such as a guidewire 388, a catheter, and/or other
devices.
[0068] The sheath 380 may be advanced over a guidewire 388 and/or
other rail that may have been positioned through the opening 398
and into the blood vessel 390 using conventional procedures. The
blood vessel 390 can be a peripheral blood vessel, such as a
femoral or carotid artery, although other body lumens may be
accessed using the sheath 380. The opening 398, and consequently
the sheath 380, may be oriented with respect to the blood vessel
390 such as to facilitate the introduction of devices through the
lumen 384 of the sheath 380 and into the blood vessel 390 with
minimal risk of damage to the blood vessel 390. One or more devices
(not shown), such as a catheter, or the like, may be inserted
through the sheath 380 and advanced to a preselected location
within the patient's body. For example, the devices may be used to
perform a therapeutic and/or diagnostic procedure, such as
angioplasty, atherectomy, stent implantation, and the like, within
the patient's vasculature.
[0069] After the procedure is completed, the devices may be removed
from the sheath 380. The engaging element delivery device 360 may
be prepared to be received by the lumen 384 of the sheath 380 as
shown in FIG. 3B. Alternatively, the sheath 380 may be removed and
then the engaging element delivery device 360 may be positioned
near the opening 398. The engaging element delivery device 360 may
include a retaining member 364, a transitioning member 368, a
carrier member 372, a locator 376, and/or other components. The
carrier member 372 may provide support for the engaging element
310. The locator 376 may be inserted through a channel in the
carrier member 372.
[0070] The locator 376 may include a tubular body 378 having a
distal end region 379. Being in the unexpanded state, the distal
end region 379 of the tubular body 378 of the locator 376 can be
slidably received by the lumen 384 and atraumatically advanced
distally into the blood vessel 390 as illustrated in FIGS. 3B-3C.
Advancing the distal end region 379 into the lumen 384 begins the
location of the locator 376 relative to the blood vessel 390.
[0071] Once the distal end region 379 of the tubular body 378
extends into the blood vessel 390, the distal end region 379 may
transition from the unexpanded state to the expanded state as shown
in FIG. 3D. A triggering system (not shown) of the locator 376 may
be used to transition from the unexpanded state to the expanded
state. Locators other than the expandable locator may also be used.
For instance, a bleedback lumen and/or other locator may be used to
locate the body lumen. Alternatively, no locator may be used.
Rather, the engaging element delivery device 360 may be advanced
until a technician determines that the distal end is near the
opening.
[0072] Turning to FIG. 3E, the engaging element delivery device 360
and the sheath 380 may be retracted proximally until the distal end
region 379 is substantially adjacent to an inner surface 392b of
the blood vessel wall 392. The distal end region 379 thereby may
draw the blood vessel wall 392 taut and/or may maintain the proper
position of the system 300 as the blood vessel 390 pulsates. Since
the expanded cross-section of the distal end region 379 can be
greater than or substantially equal to the cross-section of the
opening 398 and/or the cross-section of the lumen 384, the distal
end region 379 may remain in the blood vessel 390 and may engage
the inner surface 392b of the blood vessel wall 392. The distal end
region 379 may frictionally engage the inner surface 392b of the
blood vessel wall 392, thereby securing the system 300 to the blood
vessel 390. The sheath 380 can be retracted proximally such that
the distal end region 382b of the sheath 380 may be substantially
withdrawn from the blood vessel 390, as shown in FIG. 3E,
permitting system 300 to access the blood vessel wall 392.
[0073] Once the distal end region 379 of the locator 376 contacts
the inner surface 392b of the blood vessel wall 392, the engaging
element delivery device 360 may be advanced distally and may be
received within the lumen 384 of the sheath 380 as illustrated in
FIG. 3F. The sheath 380 may radially expand and/or split in
accordance with the predetermined pattern as the distal portion
advances because the internal cross-section of the sheath 380 may
be less than an outer portion of the retaining member 364.
[0074] Upon reaching the first predetermined position, the distal
portion of the retaining member 364 can be disposed substantially
adjacent to the outer surface 392a of the blood vessel wall 392
adjacent to the opening 398 such that the blood vessel wall 392
adjacent to the opening 398 may be disposed substantially between
the expanded distal region 379 of the locator 376 and the distal
portion of the retaining member 364. The engaging element 310 and
retaining member 364 may be configured such that as the retaining
member 364 approaches the distal end 379 of the locator 376, the
tissue engaging portions 316 of the engaging member 310 may engage
the outer portion 392a of the vessel wall 392.
[0075] As shown in FIG. 3G, which is rotated ninety degrees to
illustrate the interaction of the first member 312 and second
member 314 of the engaging element 310 during deployment, the
transitioning member 368 may advance distally to cause the tissue
engaging portions 316 of the engaging member 310 to move toward the
closed configuration (i.e. from the first distal dimension to the
second distal dimension). The convex transitioning surface 370 may
cause the transitioning portion 330 of the engaging element 310 to
transition toward the closed configuration (i.e. the proximal ends
of the first member 312 and the second member 314 may move away
from each other while the tissue engaging portions 316 move toward
each other).
[0076] Alternatively, other transitioning members 368 and/or
engaging elements 310 may be used. For example, the transitioning
member 268 and engaging element 210 described in connection with
FIGS. 2A-2D may be used, such that the concave transitioning
surface 270 may cause the transitioning portion 230 of the engaging
element 210 to transition toward the closed configuration (i.e. the
proximal ends of the first member 212 and the second member 214 may
move toward each other).
[0077] As the tissue engaging portions 316 move toward each other,
the distal end 379 of the locator 376 may move toward the
unexpanded configuration and/or begin to move proximally to allow
the tissue engaging portions 316 to fully engage the vessel wall
392. Alternatively, the locator 376 may remain within the blood
vessel 390 after the tissue engaging portions 316 have engaged the
vessel wall 392 and/or may be later removed.
[0078] As shown in FIGS. 3H-3L, the engaging element 310 may be
deployed. The engaging element 310 may engage the vessel wall 392
(as shown in FIG. 3F) in the open configuration. For instance, the
tissue engaging portions 316 may frictionally, piercingly, and/or
otherwise engage the vessel wall 392. As shown in FIG. 31, the
transitioning member 368 may continue to apply distal pressure to
the engaging element 310 as the retaining member 364 begins to
advance distally. The retaining member 364 may begin to disengage
from the engaging element 310. For example, the retaining mechanism
366 may begin to be removed from the pivoting opening 322 of the
engaging element 310, as shown in FIG. 3I. The retaining member 364
may be fully removed while the transitioning member 368 maintains
distal pressure on the engaging element 310, as shown in FIG. 3J.
Then the remaining components of the system 300 may be removed
through the skin 394, as shown in FIG. 3K. The engaging element 310
may remain between the outer surface 392a of the vessel wall 392
and the skin 394, i.e. within the tissue 396, while in the closed
configuration. The opening 398 in the skin 394 may be closed with a
bandage or other device.
[0079] Access to the body lumen may be restablished by unlocking
the locking mechanism (140 shown in FIG. 1). For instance, a device
(not shown) may be used to push the locking member and/or latch
member out of engagement with the teeth and/or latching portion
allowing the tissue engaging portions 316 to move away from each
other toward the open configuration.
[0080] The invention is susceptible to various modifications and
alternative means, 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 devices 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.
* * * * *