Note: Descriptions are shown in the official language in which they were submitted.
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HEMOSTATIC DEVICE AND ITS
METHODS OF USE
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. Patent
Application No. 13/940,766, filed July 12, 2013, entitled "HEMOSTATIC DEVICE
AND
ITS METHODS OF USE," the disclosure of which is hereby incorporated herein by
reference in its entirety.
BACKGROUND
[0002] The subject matter described herein relates generally to medical
devices and, more particularly, to a hemostatic device configured to seal a
puncture of a
vessel.
[0003] Catheter introducers are known to provide access to an artery for at
least some medical procedures including, without limitation, cardiac
catheterizations and
peripheral endovascular procedures. After conducting such medical procedures,
the
catheter introducer is removed from the access site, leaving an arterial
opening. At least
some body fluids including, without limitation, blood are discharged from the
arterial
opening. Excess blood loss may endanger and/or traumatize the patient. One
known
method of controlling blood loss is through direct manual pressure over the
arterial
opening.
BRIEF SUMMARY
[0004] In one aspect, a method for sealing a puncture of a vessel using a
hemostatic device is provided. The hemostatic device includes a first tube
defining a first
lumen, a malecot coupled to the first tube, and a second tube circumscribing
at least a
portion of the first tube and at least partially defining a second lumen and a
third lumen.
The method includes retaining a hemocoagulant agent in the second lumen, and
advancing
a distal end of the hemostatic device into the vessel until a fluid is
channeled through a first
opening of the second tube into the third lumen. The first opening is
positioned proximally
relative to the malecot. The method also includes transitioning the malecot
from a neutral
configuration to a stopper configuration, withdrawing the hemostatic device
until the
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malecot abuts an interior surface of vessel wall, and selectively orienting
the second tube
such that the hemocoagulant agent is at least partially exposed.
[0005] In another aspect, a hemostatic device for sealing a puncture of a
vessel is provided. The hemostatic device includes a first tube defining a
first lumen, and a
malecot coupled to the first tube. The malecot is selectively actuatable from
a neutral
configuration to a stopper configuration. The hemostatic device also includes
a second
tube circumscribing at least a portion of the first tube. The second tube at
least partially
defines a second lumen and a third lumen. The second tube includes a first
opening in flow
communication with the third lumen and positioned proximally relative to the
malecot.
The second tube is selectively orientable to at least partially expose a
hemocoagulant agent
retained in the second lumen.
[0006] In yet another aspect, a hemostatic device for sealing a puncture of
a vessel is provided. The hemostatic device includes a first tube defining a
first lumen, a
malecot coupled to the first tube, and a second tube circumscribing at least a
portion of the
first tube. The second tube at least partially defines a second lumen and a
third lumen. The
second tube includes a first opening in flow communication with the third
lumen and
positioned proximally relative to the malecot. The second tube is selectively
orientable to
at least partially expose a hemocoagulant agent retained in the second lumen.
The
hemostatic device also includes a plug actuator configured to transition the
malecot from a
neutral configuration to a stopper configuration.
[0007] The features, functions, and advantages described herein may be
achieved independently in various embodiments of the present disclosure or may
be
combined in yet other embodiments, further details of which may be seen with
reference to
the following description and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a perspective view of an exemplary hemostatic device;
[0009] FIG. 2 is a cross-sectional view of a distal portion of the
hemostatic device shown in FIG. 1 in a closed configuration;
[0010] FIG. 3 is a cross-sectional view of the distal portion shown in FIG.
2 in a deployed configuration;
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[0011] FIG. 4 is a partial cross-sectional view of a proximal portion of the
hemostatic device shown in FIG. 1 in a closed configuration;
[0012] FIG. 5 is a cross-sectional view of the proximal portion shown in
FIG. 4;
[0013] FIG. 6 is a cross-sectional view of the proximal portion shown in
FIG. 4 in a deployed configuration;
[0014] FIG. 7 is a flow chart illustrating an exemplary method of using the
hemostatic device shown in FIG. 1;
[0015] FIG. 8 is a partial cross-sectional view of another exemplary
hemostatic device;
[0016] FIG. 9 is a perspective view of yet another exemplary hemostatic
device in a closed configuration;
[0017] FIG. 10 is a perspective view of the hemostatic device shown in
FIG. 9 in an open configuration;
[0018] FIG. 11 is a cross-sectional view of the hemostatic device shown in
FIG. 9;
[0019] FIG. 12 is a perspective view of yet another exemplary hemostatic
device;
[0020] FIGS. 13 and 14 are cross-sectional views of a portion of the
hemostatic device shown in FIG. 12;
[0021] FIG. 15 is a cross-sectional view of yet another exemplary
hemostatic device in a closed configuration and with an exemplary malecot in a
retracted
configuration;
[0022] FIG. 16 is a cross-sectional view of the hemostatic device shown in
FIG. 15 in the closed configuration with the exemplary malecot in a neutral
configuration;
[0023] FIG. 17 is a cross-sectional view of the hemostatic device shown in
FIG. 15 in the closed configuration with the exemplary malecot in a stopper
configuration;
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[0024] FIG. 18 is a cross-sectional view of the hemostatic device shown in
FIG. 15 in a deployed configuration with the exemplary malecot in the stopper
configuration;
[0025] FIG. 19 is a cross-sectional view of an exemplary housing of the
hemostatic device shown in FIG. 15;
[0026] FIG. 20 is a cross-sectional view of the hemostatic device shown in
FIG. 15 taken along lines 20-20 shown in FIG. 15;
[0027] FIG. 21 is a perspective view of a distal portion of an exemplary
outer tube that may be used with the hemostatic device shown in FIG. 15;
[0028] FIG. 22 is a flow chart illustrating an exemplary method of using
the hemostatic device shown in FIG. 15;
[0029] FIG. 23 is a schematic view of the hemostatic device shown in
FIG. 15 in the closed configuration and positioned within a blood vessel, with
the
exemplary malecot in the neutral configuration shown in FIG. 16;
[0030] FIG. 24 is a detail of the schematic view shown in FIG. 23;
[0031] FIG. 25 is a schematic view of the hemostatic device shown in
FIG. 15 in the closed configuration and positioned within a blood vessel, with
the
exemplary malecot in the stopper configuration shown in FIG. 17;
[0032] FIG. 26 is a schematic view of the hemostatic device shown in
FIG. 15 in the deployed configuration shown in FIG. 18 and positioned within a
blood
vessel, with the exemplary malecot in the stopper configuration shown in FIG.
17;
[0033] FIG. 27 is a schematic view of the hemostatic device shown in
FIG. 15 in the deployed configuration shown in FIG. 18 and positioned within a
blood
vessel, with the exemplary malecot in the retracted configuration shown in
FIG. 15; and
[0034] FIG. 28 is a schematic view of the hemostatic device shown in
FIG. 15 with an exemplary interlock mechanism uncoupled.
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DETAILED DESCRIPTION
[0035] The methods and apparatus described herein relate to medical
devices and, more particularly, to a hemostatic device for use in sealing a
puncture of a
vessel. The hemostatic device described herein facilitates sealing an opening
of a blood
vessel. More particularly, in at least one embodiment, the hemostatic device
includes a
first tube defining a first lumen, and a second tube circumscribing at least a
portion of the
first tube and at least partially defining a second lumen configured to retain
a
hemocoagulant agent therein. A malecot is coupled to the first tube. The
second tube is
moveable with respect to the first tube, such that the hemocoagulant agent is
at least
substantially retained within the second lumen when the second tube is
oriented in a first
position, and the hemocoagulant agent is at least partially exposed when the
second tube is
oriented in a second position. The hemocoagulant agent is discharged from the
second
lumen and seals the opening to reduce a time required for hemostasis and/or
ambulation.
The malecot facilitates positioning the second tube outside the lumen of the
vessel, and
adjacent to the vessel wall, prior to the release of hemocoagulant agent, and
substantially
seals the vessel wall from penetration by the hemocoagulant agent at the
access site.
[0036] As used herein, an element or step recited in the singular and
preceded with the word "a" or "an" should be understood as not excluding
plural said
elements or steps, unless such exclusion is explicitly stated. Further,
references to an
"embodiment" or an "implementation" are not intended to be interpreted as
excluding the
existence of additional embodiments or implementations that also incorporate
the recited
features. Moreover, unless explicitly stated to the contrary, embodiments
or
implementations "comprising," "including," or "having" an element or a
plurality of
elements having a particular property may include additional such elements not
having that
property.
[0037] FIG. 1 is a perspective view of an exemplary hemostatic device
100 for sealing a puncture of a vessel (not shown). In the exemplary
embodiment,
hemostatic device 100 includes a first or inner tube 110 and a second or outer
tube 120. In
the exemplary embodiment, hemostatic device 100 has a distal end 130, a
proximal end
140, and a length 150. In the exemplary embodiment, length 150 is at least
approximately
5 inches (in.). More particularly, length 150 is between approximately 8 in.
and
approximately 12 in. Even more particularly, length 150 is approximately
10.147 in.
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Alternatively, hemostatic device 100 may have any length that enables the
methods and
systems to function as described herein. In the exemplary embodiment, a distal
end of
inner tube 110 is tapered to facilitate traversing through subcutaneous tissue
and into a
lumen of the vessel.
[0038] FIG. 2 is a cross-sectional view of a first portion of hemostatic
device 100 in a closed configuration, and FIG. 3 is a cross-sectional view of
the first
portion in a deployed configuration. In the exemplary embodiment, inner tube
110
includes a sidewall 170 that defines a first or inner lumen 160 configured to
channel blood
or, more broadly, a fluid therethrough. In the exemplary embodiment, sidewall
170
includes a first opening 180 (shown in FIG. 1) at a distal end of inner lumen
160, and a
second opening 190 (shown in FIG. 1) at a proximal end of inner lumen 160. In
the
exemplary embodiment, first opening 180 is sized to receive a guidewire (not
shown), and
second opening 190 is sized to channel the fluid through inner lumen 160 about
the
guidewire. First opening 180 and/or second opening 190 may have any size,
shape, and/or
configuration that enables inner tube 110 to function as described herein.
[0039] In the exemplary embodiment, a valve 200 (shown in FIG. 1)
proximate to second opening 190 is selectively movable between an open
configuration
and a closed configuration. More particularly, valve 200 is actuatable towards
the closed
configuration to selectively restrict access to second opening 190 and/or
inner lumen 160.
That is, in the exemplary embodiment, valve 200 enables second opening 190 to
be at least
partially closed such that a flow of the fluid through inner lumen 160 is
decreased.
Moreover, in the exemplary embodiment, valve 200 is actuatable towards the
open
configuration to selectively provide access to second opening 190 and/or inner
lumen 160.
That is, in the exemplary embodiment, valve 200 enables second opening 190 to
be at least
partially opened such that a flow of the fluid through inner lumen 160 is
increased.
[0040] In the exemplary embodiment, inner tube 110 includes a distal
portion 210 and a proximal portion 220 coupled to distal portion 210 by an
interference fit.
Alternatively, inner tube 110 may include any number of portions, and/or the
portions may
be coupled in any configuration and/or using any mechanism that enables inner
tube 110 to
function as described herein. In the exemplary embodiment, outer tube 120
houses
proximal portion 220 of inner tube 110, and distal portion 210 is generally
exposed, such
that outer tube 120 does not house distal portion 210 of inner tube 110. In
the exemplary
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embodiment, distal portion 210 includes a side opening 230 extending through
sidewall
170 that is in fluid communication with inner lumen 160 such that fluid may
enter inner
lumen 160 through side opening 230.
[0041] In the exemplary embodiment, outer tube 120 includes a sidewall
260 that at least partially defines a second or outer lumen 240 (shown in FIG.
2) configured
to retain a hemocoagulant agent 250 therein. In one implementation,
hemocoagulant agent
250 is an FDA-approved hydrogel polymer or collagen patch.
Alternatively,
hemocoagulant agent 250 may be any substance and/or composition that enables
outer tube
120 to function as described herein.
[0042] In the exemplary embodiment, outer tube 120 houses at least a
portion of inner tube 110. In the exemplary embodiment, outer tube 120 is
translatable or
longitudinally moveable with respect to inner tube 110, such that
hemocoagulant agent 250
is at least substantially retained within outer lumen 240 when outer tube 120
is in a first or
closed position, and is at least partially exposed to the environment when
outer tube 120 is
in a second or open position. Outer tube 120 is slideable in the distal
direction towards the
closed position to substantially retain hemocoagulant agent 250 within outer
lumen 240,
and is slideable in the proximal direction towards the open position to expose
hemocoagulant agent 250 to the environment. Alternatively, inner tube 110 and
outer tube
120 may move in any direction that enables hemostatic device 100 to function
as described
herein.
[0043] In the exemplary embodiment, hemostatic device 100 includes a
plug 270 that at least partially circumscribes inner tube 110. In the
exemplary
embodiment, plug 270 includes a distal portion 280 having a distal apex 290
oriented
towards the distal end of hemostatic device 100, and a proximal portion 300
having a step
310 and a proximal apex 320 oriented towards the proximal end of hemostatic
device 100.
In the exemplary embodiment, plug 270 is positioned with respect to inner tube
110, such
that plug 270 and/or a distal end of outer tube 120 are positionable outside
and
substantially adjacent an access site and/or a vessel when inner tube side
opening 230 is
within the lumen of the vessel.
[0044] In the exemplary embodiment, plug distal portion 280 is
substantially cone-shaped to facilitate traversing plug 270 through
subcutaneous tissue, and
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plug proximal portion 300 is substantially cone-shaped to facilitate
channeling or directing
hemocoagulant agent 250 radially outward from hemostatic device 100. In the
exemplary
embodiment, plug proximal portion 300 is oriented and/or configured to channel
or direct
at least some of hemocoagulant agent 250 away from inner tube 110 and/or a
center axis of
hemostatic device 100 to facilitate reducing a coagulation of hemocoagulant
agent 250
within outer lumen 240.
[0045] In the exemplary embodiment, step 310 is configured to interface
and/or receive a distal end of outer tube 120, such that hemocoagulant agent
250 is at least
substantially retained within outer lumen 240 when hemostatic device 100 is in
a closed
configuration. Step 310 enables outer tube 120 to be sealingly coupled to plug
270, such
that hemocoagulant agent 250 is at least substantially retained within outer
lumen 240. In
the exemplary embodiment, plug 270 is fabricated at least partially from a
soft and/or
pliable material that enables a seal to be provided at the plug-outer tube
interface, the
vessel, and/or the access site. For example, plug 270 may be fabricated from,
without
limitation, rubber and/or a rubber-like material. Alternatively, plug 270 may
have any
configuration that enables plug 270 to function as described herein.
[0046] FIGS. 4 and 5 are cross-sectional views of a second portion of
hemostatic device 100 in a closed configuration, and FIG. 6 is a cross-
sectional view of the
second portion in a deployed configuration. In the exemplary embodiment,
hemostatic
device 100 includes a housing 330 and an actuating mechanism 340 positioned
within
housing 330. More specifically, housing 330 includes a sidewall 350 that
defines a cavity
360, and actuating mechanism 340 includes a first or an outer tube carrier 370
that is
moveable within cavity 360 between a distal end of cavity 360 and a proximal
end of
cavity 360. In the exemplary embodiment, outer tube carrier 370 is coupled to
outer tube
120 such that outer tube 120 moves between the closed position and the open
position as
outer tube carrier 370 is moved between the distal end of cavity 360 and the
proximal end
of cavity 360, respectively. Alternatively, outer tube 120 may be moved
towards the open
position and/or the closed position using any mechanism that enables outer
tube 120 to
function as described herein.
[0047] In the exemplary embodiment, a distance 380 (shown in FIG. 1)
between side opening 230 and a distal end of housing 330 is at least
approximately 2 in.
More particularly, distance 380 is between approximately 3 in. and
approximately 6 in.
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Even more particularly, distance 380 is approximately 4.2 in. Alternatively,
distance 380
may be any length that enables the methods and systems to function as
described herein. In
the exemplary embodiment, distance 380 remains substantially constant as at
least a
portion of outer tube 120 is selectively retracted into and/or extended from
housing 330
when outer tube 120 is moved between the closed position and the open
position.
[0048] In the exemplary embodiment, hemostatic device 100 includes a
rotating mechanism 390 coupled to outer tube carrier 370. In the exemplary
embodiment,
rotating mechanism 390 is configured to move outer tube carrier 370 towards
the distal end
of cavity 360 as rotating mechanism 390 is rotated in a first direction (e.g.,
a
counterclockwise direction when looking from proximal end 140 towards distal
end 130)
and move outer tube carrier 370 towards the proximal end of cavity 360 as
rotating
mechanism 390 is rotated in a second direction (e.g., a clockwise direction
when looking
from proximal end 140 towards distal end 130). Rotating mechanism 390 is
configured to
convert rotational movement into axial movement. In the exemplary embodiment,
rotating
mechanism 390 includes a wheel 400 and a body 410 extending from wheel 400 and
at
least partially positioned within outer tube carrier 370. In the exemplary
embodiment,
wheel 400 has a diameter that is greater than and/or equal to a width of
housing 330.
[0049] In the exemplary embodiment, a peg (not shown) extending from
an inner surface of outer tube carrier 370 is retained in a groove 420 (shown
in FIG. 4)
defined in an outer surface of body 410. In the exemplary embodiment, groove
420
includes a first segment 430 (shown in FIG. 4) that extends helically about a
central axis of
body 410 and a second segment 440 (shown in FIG. 4) that at least partially
circumscribes
body 410. In the exemplary embodiment, outer tube carrier 370 longitudinally
moves with
respect to rotating mechanism 390 between the distal end of cavity 360 and the
proximal
end of cavity 360 as wheel 400 is rotated when the peg is within first segment
430.
Moreover, in the exemplary embodiment, outer tube carrier 370 is substantially
longitudinally stationary with respect to rotating mechanism 390 as wheel 400
is rotated
when the peg is within second segment 440. Alternatively, outer tube carrier
370 may be
moved between the distal end of cavity 360 and the proximal end of cavity 360
using any
mechanism that enables outer tube 120 to function as described herein. In at
least some
implementations, second segment 440 fully circumscribes body 410 to enable
wheel 400 to
be continuously rotated when the peg is within second segment 440. In at least
some
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implementations, outer tube carrier 370 is at the proximal end of cavity 360
when the peg
is within second segment 440.
[0050] In the exemplary embodiment, hemostatic device 100 includes a
first retaining mechanism 450 (shown in FIG. 4) that facilitates preventing
outer tube
carrier 370 from rotating with respect to housing 330 as wheel 400 is rotated
in the first
direction and/or in the second direction. In the exemplary embodiment,
retaining
mechanism 450 includes a peg (not shown) extending from an inner surface of
housing
330, and a slot 460 (shown in FIG. 4) defined in an outer surface of outer
tube carrier 370
sized to retain the peg. In the exemplary embodiment, slot 460 extends
substantially
longitudinally along the outer surface of outer tube carrier 370, such that
outer tube carrier
370 is longitudinally moveable, while substantially not rotating, with respect
to housing
330 as the peg is moved between a distal end of slot 460 and a proximal end of
slot 460.
Alternatively, outer tube 120 may be moved and/or restricted from movement
using any
mechanism that enables outer tube 120 to function as described herein.
[0051] In the exemplary embodiment, hemostatic device 100 includes a
plunging mechanism 470 (shown in FIGS. 5 and 6) including a plunger 480 (shown
in
FIGS. 2, 3, 5, and 6) at least partially positioned within outer lumen 240
(shown in FIGS. 2
and 3), and a second or plunger carrier 490 (shown in FIGS. 5 and 6) moveable
within a
cavity defined by outer tube carrier 370 and/or a cavity defined by rotating
mechanism
body 410 to facilitate discharging hemocoagulant agent 250.
[0052] In the exemplary embodiment, a peg (not shown) extending from
an inner surface of rotating mechanism body 410 is retained in a groove 500
(shown in
FIGS. 5 and 6) defined in an outer surface of plunger carrier 490. In the
exemplary
embodiment, groove 500 extends helically about a central axis of plunger
carrier 490 in a
direction that is opposite the direction associated with groove 420. In the
exemplary
embodiment, plunger 480 is longitudinally moveable, with respect to outer tube
120, in a
direction that is opposite the direction outer tube carrier 370 moves with
respect to housing
330 as wheel 400 is rotated. For example, in the exemplary embodiment, wheel
400 is
selectively rotatable in the first direction to simultaneously move outer tube
120 towards
the closed position and plunger 480 towards a retracted or proximal position,
or move outer
tube 120 towards the open position and plunger 480 towards a dispensing or
distal position.
Groove 420 extends at a first angle with respect to the longitudinal axis, and
groove 500
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extends at a second angle that is different from the first angle. The first
angle and/or the
second angle are predefined, such that outer tube 120 is configured to move a
first distance
with each rotation of wheel 400, and plunger 480 is configured to move a
second distance
with each rotation of wheel 400 that is less than the first distance.
Alternatively, outer tube
120 and/or plunger 480 may be moved using any mechanism that enables
hemostatic
device 100 to function as described herein.
[0053] In the exemplary embodiment, hemostatic device 100 includes a
second retaining mechanism 510 that facilitates preventing plunger carrier 490
from
rotating with respect to outer tube carrier 370 as wheel 400 is rotated. In
the exemplary
embodiment, retaining mechanism 510 includes a peg 520 (shown in FIGS. 5 and
6)
extending from an outer surface of plunger carrier 490, and a slot 530 (shown
in FIG. 4)
defined in an inner surface of outer tube carrier 370 sized to retain peg 520.
In the
exemplary embodiment, slot 530 extends substantially longitudinally along the
inner
surface of outer tube carrier 370, such that plunging mechanism 470 is
longitudinally
moveable, while substantially not rotating, with respect to outer tube carrier
370 as peg 520
is moved between a distal end of slot 530 and a proximal end of slot 530.
Alternatively,
plunging mechanism 470 may be moved and/or restricted from movement using any
mechanism that enables plunging mechanism 470 to function as described herein.
[0054] In the exemplary embodiment, hemostatic device 100 includes a
third or intermediate tube 540 (shown in FIGS. 2 and 3) positioned radially
between inner
tube 110 and outer tube 120. More specifically, intermediate tube 540 is
positioned such
that outer lumen 240 is defined between intermediate tube 540 and outer tube
120, and a
third or intermediate lumen 550 (shown in FIGS. 2 and 3) configured to channel
blood or,
more broadly, a fluid therethrough is defined between intermediate tube 540
and inner tube
110. In the exemplary embodiment, intermediate lumen 550 is in fluid
communication
with a first opening 560 (shown in FIGS. 1-3) extending through plug 270 and a
second
opening 570 (shown in FIG. 1) extending through housing 330 such that fluid
may enter
intermediate lumen 550 through first opening 560 and is dischargeable through
second
opening 570.
[0055] FIG. 7 is a flow chart illustrating an exemplary method 600 of
using hemostatic device 100 to seal a puncture of an artery or vessel with a
hydrogel
polymer or collagen patch hemocoagulant agent 250. In at least some
implementations,
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hemocoagulant agent 250 is preloaded into hemostatic device 100, such that
hemocoagulant agent is retained 610 within outer lumen 240.
Alternatively,
hemocoagulant agent 250 is loaded into hemostatic device 100, such that
hemocoagulant
agent is retained 610 within outer lumen 240, by selectively rotating wheel
400 and/or
substantially enveloping or circumscribing hemocoagulant agent 250 about inner
tube 110.
[0056] During operation, inner tube 110 is aligned such that a guidewire
(not shown) extends through first opening 180 and second opening 190, and
inner tube 110
is advanced 620 along the guidewire through subcutaneous tissue until blood is
channeled
through inner lumen 160 and/or discharged from second opening 190. In the
exemplary
embodiment, the blood discharge (i.e., reflux) from second opening 190 is a
visual
indication that inner tube side opening 230 is positioned within the vessel.
Moreover, plug
270 provides a tactile indication (e.g., resistance) that plug 270 is
positioned outside and
substantially adjacent the vessel and/or inner tube side opening 230 is
positioned within the
vessel.
[0057] In the exemplary embodiment, valve 200 is moved towards the
closed configuration to restrict access to second opening 190 and/or
facilitate reducing
blood flow through inner lumen 160. In at least some implementations,
hemostatic device
100 is advanced along the guidewire too far through subcutaneous tissue. In
such an
implementation, the blood enters plug opening 560, is channeled through
intermediate
lumen 550, and/or is discharged from housing opening 570. In such an
implementation,
the blood discharge from housing opening 570 is a visual indication that
hemostatic device
100 is advanced too far through subcutaneous tissue and/or should be at least
partially
withdrawn from the subcutaneous tissue until blood does not discharge from
housing
opening 570.
[0058] In the exemplary embodiment, wheel 400 is selectively rotated in
the second direction to move hemostatic device 100 towards the deployed
configuration
and, thus, move 630 outer tube 120 towards the open position. Accordingly, in
the
exemplary embodiment, hemocoagulant agent 250 is at least partially exposed to
the
environment. As wheel 400 is selectively rotated in the second direction,
plunger carrier
490 and, thus, plunger 480 is moved in the distal direction, such that
hemocoagulant agent
250 is pushed at least partially in the distal direction towards plug 270. In
at least some
implementations, outer tube 120 is moved 630 towards the open position and
plunger 480
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is moved towards the distal direction simultaneously. In the exemplary
embodiment, plug
proximal portion 300 channels or directs at least some of hemocoagulant agent
250 radially
outward and/or away from a center axis of hemostatic device 100.
[0059] FIG. 8 is a partial cross-sectional view of another exemplary
hemostatic device 700 for sealing a puncture of a vessel (not shown).
Hemostatic device
700 is similar to hemostatic device 100 and, in the absence of a contrary
representation, the
same reference numbers identify the same or similar elements.
[0060] FIG. 9 is a perspective view of another exemplary hemostatic
device 800 for sealing a puncture of a vessel (not shown) in a closed
configuration, and
FIG. 10 is a perspective view of hemostatic device 800 in a deployed
configuration.
Hemostatic device 800 is similar to hemostatic device 100 and 700 and, in the
absence of a
contrary representation, the same reference numbers identify the same or
similar elements.
[0061] In the exemplary embodiment, outer tube 120 is longitudinally
moveable with respect to inner tube 110, such that hemocoagulant agent 250 is
at least
substantially retained within outer lumen 240 when outer tube 120 is in the
closed position
(shown in FIG. 9), and is at least partially exposed to the environment when
outer tube 120
is in the open position (shown in FIG. 10).
[0062] FIG. 11 is a cross-sectional view of hemostatic device 800. In the
exemplary embodiment, hemostatic device 800 includes an actuating mechanism
810 that
facilitates moving outer tube 120 between the closed position and the open
position. More
specifically, actuating mechanism 810 is rotated in a first direction (e.g., a
clockwise
direction when looking from proximal end 140 towards distal end 130) to move
outer tube
120 towards the closed position, and is rotated in a second direction (e.g., a
counterclockwise direction when looking from proximal end 140 towards distal
end 130) to
move outer tube 120 towards the open position.
[0063] In the exemplary embodiment, plunger 480 is moveable within
outer lumen 240 to facilitate discharging hemocoagulant agent 250 from outer
lumen 240.
More specifically, plunger 480 is coupled to a handle 820 (shown in FIGS. 9
and 10)
configured to move plunger 480 between a retracted or proximal position and a
dispensing
or distal position.
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[0064] FIG. 12 is a perspective view of another exemplary hemostatic
device 900 for sealing a puncture of a vessel (not shown). Hemostatic device
900 is similar
to hemostatic devices 100, 700, and 800 and, in the absence of a contrary
representation,
the same reference numbers identify the same or similar elements. In the
exemplary
embodiment, plunging mechanism 470 includes a wheel 910 configured to move
plunger
480 between a retracted or proximal position and a dispensing or distal
position.
[0065] FIGS. 13 and 14 are cross-sectional views of a portion of
hemostatic device 900. In the exemplary embodiment, actuating mechanism 810
includes a
plurality of threads 920 that enables outer tube 120 to be moved between the
closed
position and the open position as actuating mechanism 810 is rotated.
[0066] In the exemplary embodiment, plunging mechanism 470 includes a
plunger shaft 930 coupled to wheel 910, and plunger 480 is threadably coupled
to plunger
shaft 930. In the exemplary embodiment, an inner surface of outer tube 120
and/or an
outer surface of plunger 480 is keyed or otherwise not round (e.g.,
substantially square-
shaped) to prevent plunger 480 from rotating with respect to outer tube 120 as
plunger
shaft 930 is rotated, such that a rotation of wheel 910 and, thus, plunger
shaft 930
longitudinally moves plunger 480 with respect to outer tube 120.
[0067] FIGS. 15-17 are cross-sectional views of a portion of another
exemplary hemostatic device 1000 for sealing a puncture of a vessel (not
shown) in a
closed configuration, and FIG. 18 is a cross-sectional view of hemostatic
device 1000 in a
deployed configuration. Hemostatic device 1000 is similar to hemostatic device
100, 700,
800, and 900 and, in the absence of a contrary representation, the same
reference numbers
identify the same or similar elements. In the exemplary embodiment, hemostatic
device
1000 includes a malecot 1070 positioned with respect to outer tube 120, such
that malecot
1070 is positionable within a lumen of a vessel and substantially adjacent a
vessel access
site when a distal end of outer tube 120 is outside and/or substantially
adjacent a vessel
access site.
[0068] Malecot 1070 includes a distal portion 1072 coupled to inner tube
110. In the exemplary embodiment, distal portion 1072 is rigidly coupled
between distal
portion 210 and proximal portion 220 of inner tube 110 by an interference fit.
Alternatively, distal portion 1072 is coupled to at least one of distal
portion 210 and
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proximal portion 220 in any configuration and/or using any mechanism that
enables
malecot 1070 to function as described herein.
[0069] In the exemplary embodiment, malecot 1070 also includes an
expandable portion 1074 proximal to distal portion 1072. Expandable portion
1074 is
disposed circumferentially about inner tube 110 proximal to inner tube side
opening 230.
In addition, at least a portion of expandable portion 1074 is disposed distal
to outer tube
120. Malecot 1070, and specifically expandable portion 1074 of malecot 1070,
is
selectively actuatable between a neutral configuration (shown in FIG. 16) and
a stopper
configuration (shown in FIG. 17). In the neutral configuration, expandable
portion 1074
has a first diameter 1080. In the stopper configuration, expandable portion
1074 has a
second diameter 1082 that is greater than first diameter 1080, and greater
than an outer
diameter 121 of outer tube 120. Moreover, in the exemplary embodiment, malecot
1070 is
configured such that second diameter 1082 is greater than a diameter of an
opening in a
vessel wall at a vessel access site, as will be described herein. Thus,
malecot 1070 in the
stopper configuration is configured to facilitate positioning outer tube
distal end 122
outside the lumen of the vessel, and adjacent to the vessel wall, prior to the
release of
hemocoagulant agent 250 from hemostatic device 1000, and to substantially seal
the vessel
wall from penetration by hemocoagulant agent 250 at the access site, as will
be described
herein.
[0070] In the exemplary embodiment, malecot 1070 is further selectively
actuatable between a retracted configuration (shown in FIG. 15) and each of
the neutral
configuration and the stopper configuration. In the retracted configuration,
expandable
portion 1074 has a third diameter 1084 that is less than first diameter 1080.
In alternative
embodiments, malecot 1070 is not selectively actuatable to the retracted
configuration.
[0071] Malecot 1070 in the neutral configuration is configured to seal a
distal end 122 of outer tube 120, such that hemocoagulant agent 250 is at
least substantially
sealed within outer lumen 240 when hemostatic device 1000 is in a closed
configuration.
For example, in the exemplary embodiment, when malecot 1070 is in the neutral
configuration, outer tube distal end 122 is configured to circumscribe a
proximal portion of
expandable portion 1074 in substantially sealing contact, such that
hemocoagulant agent
250 is substantially sealed from exposure to blood until hemostatic device
1000 is moved
to the deployed configuration. Also in the exemplary embodiment, first
diameter 1080 is
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less than or approximately equal to outer tube outer diameter 121 to
facilitate traversing
hemostatic device 1000 through subcutaneous tissue. In alternative
embodiments, first
diameter 1080 is greater than outer tube outer diameter 121.
[0072] FIG. 19 is a cross-sectional view of an exemplary housing 1030 of
hemostatic device 1000. Housing 1030 is similar to housing 330 and, in the
absence of a
contrary representation, the same reference numbers identify the same or
similar elements.
In the exemplary embodiment, however, housing 1030 includes an elongated
portion 1032
disposed proximal to wheel 400. In alternative embodiments, elongated portion
1032 is
disposed at another longitudinal location along housing 1030. In other
alternative
embodiments, housing 1030 does not include elongated portion 1032.
[0073] With reference to FIGS. 15-19, in certain embodiments, hemostatic
device 1000 includes a plug actuator 1090 coupled to malecot 1070. In the
exemplary
embodiment, plug actuator 1090 also is coupled to elongated portion 1032 of
housing
1030. In alternative embodiments, plug actuator is coupled to any suitable
portion of
housing 1030 that enables plug actuator 1090 to function as described herein.
Plug
actuator 1090 is configured to selectively actuate malecot 1070 between at
least the neutral
configuration (shown in FIG. 16) and the stopper configuration (shown in FIG.
17). In
some embodiments, plug actuator 1090 is further configured to selectively
actuate malecot
1070 between the retracted configuration (shown in FIG. 15) and the neutral
configuration
and stopper configuration.
[0074] For example, in the exemplary embodiment, each of plug actuator
1090 and malecot 1070 is operably coupled to a transfer member 1078. Transfer
member
1078 extends longitudinally between plug actuator 1090 and malecot 1070, and
is
selectively operable by plug actuator 1090 for longitudinal translation with
respect to inner
tube 110. In the exemplary embodiment, transfer member 1078 is a tube disposed
coaxially with, and radially outwardly from, inner tube 110. In alternative
embodiments,
transfer member 1078 has any suitable structure that enables malecot 1070 to
function as
described herein.
[0075] For example, in the exemplary embodiment, plug actuator 1090 is
pivotally coupled to housing 1030 at a pivot 1091, and a radially inner end
1093 of plug
actuator 1090 is coupled to transfer member 1078 such that pivotal movement of
plug
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actuator 1090 results in longitudinal translational motion of transfer member
1078. For
example, but not by way of limitation, radially inner end 1093 includes a slot
(not shown)
that cooperates with oppositely disposed, transversely extending pegs (not
shown) on
transfer member 1078. Alternatively, plug actuator 1090 and transfer member
1078 each
include any suitable structure such that pivotal movement of plug actuator
1090 results in
longitudinal translational motion of transfer member 1078.
[0076] In some embodiments, expandable portion 1074 includes a
plurality of reversibly deformable segments 1076. For example, in the
exemplary
embodiment, deformable segments 1076 are arranged circumferentially around
inner tube
110, and each deformable segment 1076 extends longitudinally over a portion of
inner tube
110. More specifically, deformable segments 1076 extend longitudinally between
malecot
distal portion 1072, which is rigidly coupled to inner tube 110, and a distal
end of transfer
member 1078. Deformable segments 1076 are configured to reversibly deform
radially
outward from inner tube proximal portion 220 to accommodate longitudinal
translation of
transfer member 1078 towards fixed malecot distal portion 1072, and to
reversibly deform
radially inward towards inner tube proximal portion 220 to accommodate
longitudinal
translation of transfer member 1078 away from fixed malecot distal portion
1072. Thus,
deformable segments 1076 selectively define each of first diameter 1080,
second diameter
1082, and third diameter 1084 of expandable portion 1074 in response to a
respective
corresponding longitudinal position of transfer member 1078 relative to inner
tube 110.
[0077] In the exemplary embodiment, plug actuator 1090 is selectively
moveable between a first position 1092, a second position 1094 (shown in
phantom lines in
FIG. 19), and a third position 1096 (shown in phantom lines in FIG. 19). In
first position
1092, transfer member 1078 is longitudinally positioned with respect to inner
tube 110
such that deformable segments 1076 radially deform to transition malecot 1070
to the
neutral configuration (shown in FIG. 16). In second position 1094, transfer
member 1078
is longitudinally positioned with respect to inner tube 110 such that
deformable segments
1076 radially deform to transition malecot 1070 to the stopper configuration
(shown in
FIG. 17). In third position 1096, transfer member 1078 is longitudinally
positioned with
respect to inner tube 110 such that deformable segments 1076 radially deform
to transition
malecot 1070 to the retracted position (shown in FIG. 15). In alternative
embodiments,
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plug actuator 1090 is selectively moveable between first position 1092 and
second position
1094, but not to third position 1096.
[0078] In certain embodiments, transfer member 1078, malecot distal
portion 1072, and expandable portion 1074 are formed unitarily from a single
tube. For
example, the single tube has a length equal to a combined length of transfer
member 1078,
expandable portion 1074 in the retracted configuration, and distal portion
1072.
Deformable segments 1076 are defined on expandable portion 1074 by a plurality
of
circumferentially disposed, longitudinally extending slots. More specifically,
each slot
extends radially through a sidewall of the tube along expandable portion 1074,
such that
each slot separates a pair of adjacent deformable segments 1076. In
alternative
embodiments, each of transfer member 1078, malecot distal portion 1072, and
expandable
portion 1074 are fabricated from any suitable number of components coupled
together in
any suitable fashion that enables malecot 1070 to function as described
herein.
[0079] In the exemplary embodiment, expandable portion 1074 is formed
from a material that provides a desired degree of deformability to deformable
segments
1076. For example, but not by way of limitation, expandable portion 1074 is
fabricated
from a Nitinol alloy. In some embodiments, transfer member 1078 and malecot
distal
portion 1072 also are formed from a Nitinol alloy. In alternative embodiments,
each of
transfer member 1078, malecot distal portion 1072, and expandable portion 1074
is
fabricated from any suitable material that enables malecot 1070 to function as
described
herein.
[0080] In the exemplary embodiment, a flexible sleeve 1086 is disposed
circumferentially around expandable portion 1074 to facilitate preventing
interaction
between deformable segments 1076 and subcutaneous tissue. For example, but not
by way
of limitation, sleeve 1086 is formed from an elastomer material. In
alternative
embodiments, hemostatic device 1000 does not include sleeve 1086.
[0081] Additionally, in the exemplary embodiment, outer tube 120 of
hemostatic device 1000 includes a proximal portion 1904 and a distal portion
1906
releasably coupled together by an interlock mechanism 1902. Interlock
mechanism 1902 is
configured to couple proximal portion 1904 and distal portion 1906 in flow
communication, such that outer tube lumen 240 is defined in, and extends
continuously
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through, each of proximal portion 1904 and distal portion 1906. Interlock
mechanism 1902
also is configured to selectively uncouple proximal portion 1904 and distal
portion 1906,
such that hemostatic device 1000 and outer tube proximal portion 1904 may be
withdrawn
and removed from subcutaneous tissue while outer tube distal portion 1906
remains
positioned within the subcutaneous tissue, for example after hemostatic device
1000 is
oriented to the deployed configuration and hemocoagulant agent 250 is
released. Interlock
mechanism 1902 is any suitable mechanism that enables proximal portion 1904
and distal
portion 1906 of outer tube 120 to be selectively uncoupled as described
herein.
[0082] FIG. 20 is a cross-sectional view of hemostatic device 1000 taken
along lines 20-20 shown in FIG. 15. With reference to FIGS. 15 and 20, in the
exemplary
embodiment, hemostatic device 1000 includes a third or intermediate tube 1040
positioned
radially between inner tube 110 and outer tube 120. More specifically,
intermediate tube
1040 is positioned such that a third or intermediate lumen 1050 configured to
channel
blood or, more broadly, a fluid therethrough is at least partially defined by
intermediate
tube 1040. In the exemplary embodiment, intermediate lumen 1050 is in fluid
communication with a first opening 1060 extending through outer tube 120. In
certain
embodiments, intermediate lumen 1050 also is in fluid communication with
second
opening 570 (shown in FIG. 1) extending through housing 330, such that fluid
may enter
intermediate lumen 1050 through first opening 1060 and is dischargeable
through second
opening 570. In alternative embodiments, intermediate lumen 1050 is in
fluid
communication with an alternative second opening 1970 (shown in FIG. 19) that
extends
through sidewall 260 of outer tube 120, distal to interlock mechanism 1902,
such that fluid
may enter intermediate lumen 1050 through first opening 1060 and is
dischargeable
through alternative second opening 1970.
[0083] In certain embodiments, a reflux of blood from a lumen of a vessel
through outer tube first opening 1060, intermediate lumen 1050, and one of
housing
opening 570 and alternative second opening 1970 provides sufficient visual
information
regarding a position of malecot 1070 as will be described herein, such that
inner tube 110
need not include inner tube side opening 230, and inner tube lumen 160 is
sized to
accommodate a guidewire (not shown) in a clearance fit from first end 130 to
second end
140, rather than to additionally channel a reflux of blood. In alternative
embodiments,
hemostatic device 1000 includes inner tube side opening 230, inner tube lumen
160 sized
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to accommodate a reflux of blood, third tube 540, and third lumen 550 as shown
in FIG. 3.
In other alternative embodiments, hemostatic device 1000 includes inner tube
side opening
230 and inner tube lumen 160 sized to accommodate a reflux of blood, and does
not
include any third tube and/or third lumen.
[0084] FIG. 21 is a perspective view of a distal portion 1122 of an
exemplary outer tube 1120 that may be used with hemostatic device 1000. Outer
tube 1120
is similar to outer tube 120 and, in the absence of a contrary representation,
the same
reference numbers identify the same or similar elements. In the exemplary
embodiment,
distal portion 1122 is substantially tapered, such that an outer diameter 1121
of outer tube
1120 decreases along distal portion 1122. Tapered distal portion 1122 is
configured to
facilitate traversing outer tube 1120 through subcutaneous tissue.
[0085] Additionally in the exemplary embodiment, an outer surface of
distal portion 1122 includes a plurality of longitudinally extending ridges
1124 spaced
circumferentially about distal portion 1122. In the exemplary embodiment,
ridges 1124 are
configured such that twice a radial distance 1126 from a centerline of outer
tube 1120 to an
outer surface of ridge 1124 is approximately equal to outer diameter 121 of
outer tube 1120
proximal to distal portion 1122. Ridges 1124 are configured to provide a
tactile indication
(e.g., resistance) that outer tube distal end 1122 has encountered and/or is
passing through a
wall of the vessel.
[0086] FIG. 22 is a flow chart illustrating an exemplary method 1200 of
using hemostatic device 1000 to seal a puncture opening 2306 in an artery or
vessel 2300
with a hydrogel polymer or collagen patch hemocoagulant agent 250. FIGS. 23-28
illustrate hemostatic device 1000 during various stages of method 1200. In at
least some
implementations, hemocoagulant agent 250 is preloaded into hemostatic device
1000, such
that hemocoagulant agent 250 is retained 1210 within outer lumen 240.
Alternatively,
hemocoagulant agent 250 is loaded into hemostatic device 1000, such that
hemocoagulant
agent is retained 1210 within outer lumen 240, by selectively rotating wheel
400 (shown in
FIGS. 4-6) and/or substantially enveloping or circumscribing hemocoagulant
agent 250
about inner tube 110. In the exemplary implementation, malecot 1070 is
positioned in the
neutral configuration (shown in FIG. 16) with respect to outer tube 120 or
outer tube 1120.
For example, malecot 1070 is positioned in the neutral configuration to
facilitate retaining
1210 hemocoagulant agent 250 within outer lumen 240.
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[0087] During operation, inner tube 110 is aligned such that a guidewire
2302 extends through first opening 180 and second opening 190, and malecot
1070 is in the
neutral position. Hemostatic device 1000 is advanced 1220 along guidewire 2302
through
subcutaneous tissue 2304 into lumen 2308 of vessel 2300 until blood is
channeled through
outer tube first opening 1060 and intermediate lumen 1050 and discharged from
one of
housing second opening 570 and alternative second opening 1970. In the
exemplary
embodiment, the blood discharge (i.e., reflux) from one of housing second
opening 570 and
alternative second opening 1970 is a visual indication that outer tube first
opening 1060 is
positioned within the vessel, as shown in FIGS. 23 and 24. In at least some
implementations, at least one of malecot 1070 and longitudinal ridges 1124
provides a
tactile indication (e.g., resistance from a wall 2310 of vessel 2300
surrounding puncture
opening 2306) that outer tube distal portion 122 or 1122 has passed through
the vessel wall.
Additionally or alternatively, in at least certain implementations, hemostatic
device 1000
includes inner tube side opening 230, and a blood discharge (i.e., reflux)
from inner tube
second opening 190 is a visual indication that inner tube side opening 230 is
positioned
within the vessel.
[0088] In the exemplary embodiment, plug actuator 1090 is selectively
moved to second position 1094 such that malecot 1070 is transitioned 1230 from
the
neutral configuration to the stopper configuration.
Malecot 1070 in the stopper
configuration has second diameter 1082 that is greater than a diameter of
opening 2306 in
vessel wall 2310, which inhibits malecot 1070 from passing back through vessel
wall 2310
and out of vessel lumen 2308. Hemostatic device 1000 is then withdrawn 1240
along
guidewire 2302 until resistance is met, indicating that malecot 1070 is
abutting an interior
surface of vessel wall 2310 and, therefore, that outer tube distal end 122 or
1122 has moved
from inside vessel lumen 2308 to outside, and adjacent to, vessel wall 2310,
as shown in
FIG. 25. In at least some implementations, the position of outer tube distal
end 122 or
1122 outside vessel lumen 2308 is confirmed by an absence or substantial
reduction of
blood discharge from one of housing second opening 570 and alternative second
opening
1970. Malecot 1070 abutting the interior surface of vessel wall 2310
facilitates ensuring
that hemocoagulant agent 250 will be released outside vessel lumen 2308 and
facilitates
occluding puncture opening 2306, such that hemocoagulant agent 250, once
released, does
not enter vessel lumen 2308.
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[0089] Further in the exemplary embodiment, outer tube 120 or 1120 is
selectively oriented 1250 such that hemocoagulant agent 250 is at least
partially exposed,
as shown in FIG. 26. For example, wheel 400 is selectively rotated in the
second direction
to move hemostatic device 1000 towards the deployed configuration and, thus,
orient 1250
outer tube 120 or outer tube 1120 towards the deployed position (shown in FIG.
18).
Accordingly, hemocoagulant agent 250 is at least partially exposed to the
environment. As
wheel 400 is selectively rotated in the second direction, plunger carrier 490
(shown in
FIGS. 5 and 6) and, thus, plunger 480 is moved in the distal direction, such
that
hemocoagulant agent 250 is pushed at least partially in the distal direction
towards outer
tube distal portion 122 or 1122. In at least some implementations, outer tube
120 or outer
tube 1120 is oriented 1240 towards the deployed position and plunger 480 is
moved
towards the distal direction simultaneously. In at least some implementations,
a
withdrawal force is maintained on hemostatic device 1000 such that malecot
1070 in the
stopper configuration is maintained in abutment against the interior surface
of vessel wall
2310.
[0090] In at least some implementations, plug actuator 1090 is selectively
moved to third position 1096 such that malecot 1070 is transitioned to the
retracted
configuration, as shown in FIG. 27, to facilitate withdrawal of hemostatic
device 1000 from
the subcutaneous tissue, leaving hemocoagulant agent 250 proximate an exterior
surface of
vessel wall 2310. In some other implementations, plug actuator 1090 is
selectively moved
to first position 1092 such that malecot 1070 is transitioned to the neutral
configuration to
facilitate withdrawal of hemostatic device 1000 from the subcutaneous tissue,
leaving
hemocoagulant agent 250 proximate an exterior surface of vessel wall 2310.
[0091] In at least some implementations, proximal portion 1904 and distal
portion 1906 of outer tube 120 are uncoupled, as shown in FIG. 28, such as by
selectively
activating interlock mechanism 1902. Forward pressure is applied to uncoupled
distal
portion 1906 to facilitate maintaining hemocoagulant agent 250 proximate the
exterior
surface of vessel wall 2310, while inner tube 110 and proximal portion 1904
are
concurrently withdrawn from vessel 2300 and subcutaneous tissue 2304. Finally,
distal
portion 1906 is withdrawn from subcutaneous tissue 2304 and pressure is
applied over
puncture opening 2306 until homeostasis is achieved.
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[0092] The methods and apparatus described herein relate to medical
devices and, more particularly, to a hemostatic device. The methods and
apparatus
described herein facilitate sealing, for example, an arterial opening. The
exemplary
hemostatic device includes a first tube defining a first lumen, a second tube
circumscribing
at least a portion of the first tube and at least partially defining a second
lumen configured
to retain a hemocoagulant agent therein, and a malecot that is selectively
actuatable
between a neutral configuration and a stopper configuration. The malecot is
transitioned to
the stopper configuration and the second tube is oriented to expose at least
some of the
hemocoagulant agent to the environment, while a plunger is moved through the
second
lumen to facilitate discharging the hemocoagulant agent. The hemocoagulant
agent
facilitates sealing the arterial opening to reduce a time required for
hemostasis and/or
ambulation.
[0093] Exemplary embodiments of medical devices are described above in
detail. The methods and systems are not limited to the specific embodiments
described
herein, but rather, operations of the methods and components of the systems
may be
utilized independently and separately from other operations and/or components
described
herein. For example, the methods and apparatus described herein may have other
industrial
and/or consumer applications and are not limited to practice with medical
devices as
described herein. Rather, one or more embodiments may be implemented and
utilized in
connection with other industries.
[0094] This written description uses examples to disclose the invention,
including the best mode, and also to enable any person skilled in the art to
practice the
invention, including making and using any devices or systems and performing
any
incorporated methods. The patentable scope of the invention is defined by the
claims, and
may include other examples that occur to those skilled in the art. Such other
examples are
intended to be within the scope of the claims if they have structural elements
that do not
differ from the literal language of the claims, or if they include equivalent
structural
elements with insubstantial differences from the literal language of the
claims.
