U.S. patent application number 15/418428 was filed with the patent office on 2017-05-18 for filled balloon arteriotomy locator for vascular closure devices and methods.
This patent application is currently assigned to St. Jude Medical Puerto Rico LLC. The applicant listed for this patent is St. Jude Medical Puerto Rico LLC. Invention is credited to Valerie J. Glazier, Scott A. Kramer, Catherine A. Pipenhagen.
Application Number | 20170135682 15/418428 |
Document ID | / |
Family ID | 46148998 |
Filed Date | 2017-05-18 |
United States Patent
Application |
20170135682 |
Kind Code |
A1 |
Glazier; Valerie J. ; et
al. |
May 18, 2017 |
FILLED BALLOON ARTERIOTOMY LOCATOR FOR VASCULAR CLOSURE DEVICES AND
METHODS
Abstract
A tissue puncture locator device includes an anchor assembly and
a sealing member. The anchor assembly includes an anchor portion, a
tube portion, and a filling member. The anchor portion is
positioned at a distal end of the tube portion and configured for
placement through a vascular incision into a vessel. The anchor
member has an unexpanded configuration that permits passage through
the vascular incision and an expanded configuration that limits
passage through the vascular incision. The filling member is
retained in the tube portion and adapted for insertion from the
tube portion into the anchor member to provide the expanded
configuration, and adapted for retraction from the anchor member
into the tube portion to provide the unexpanded configuration. The
sealing member is configured for placement adjacent the vascular
incision outside the vessel.
Inventors: |
Glazier; Valerie J.; (Eden
Prairie, MN) ; Kramer; Scott A.; (Minneapolis,
MN) ; Pipenhagen; Catherine A.; (Plymouth,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
St. Jude Medical Puerto Rico LLC |
Caguas |
PR |
US |
|
|
Assignee: |
St. Jude Medical Puerto Rico
LLC
Caguas
PR
|
Family ID: |
46148998 |
Appl. No.: |
15/418428 |
Filed: |
January 27, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14116284 |
Dec 10, 2013 |
9592039 |
|
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PCT/US2012/037877 |
May 15, 2012 |
|
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15418428 |
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61486470 |
May 16, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00659
20130101; A61B 2017/00637 20130101; A61B 2017/00867 20130101; A61B
17/0057 20130101; A61B 2017/00654 20130101 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1. A tissue puncture closure device adapted for insertion into and
sealing of a tissue puncture in an internal tissue wall that is
accessible through a percutaneous incision, the device comprising:
an anchor disposed on a distal side of the internal tissue wall; a
filling material positioned in the tissue puncture closure device
and movable from a first position removed from the anchor, to a
second position inserted within the anchor to expand the anchor,
and back to the first position, the filling material having a
random orientation in the second position; a sealing member
disposed on a proximal side of the internal tissue wall, the anchor
being movable through the sealing member when the filling material
is in the first position.
2. The tissue puncture closure device of claim 1, further
comprising an elongate shaft, the anchor being positioned at a
distal end of the elongate shaft, the filling material being
positioned in the elongate shaft in the first position.
3. The tissue puncture closure device of claim 1, wherein the
filling material is shaped as an elongate structure.
4. The tissue puncture closure device of claim 1, wherein the
filling material maintains a solid or semi-solid state when in the
first and second positions.
5. The tissue puncture closure device of claim 1, wherein the
sealing member comprises a collagen material.
6. The tissue puncture closure device of claim 1, further
comprising a sheath, the sealing member being positioned in the
sheath before being disposed on the proximal side of the internal
tissue wall.
7. The tissue puncture closure device of claim 6, further
comprising a tamping member configured to advance the sealing
member out of the sheath.
8. A method of sealing a tissue puncture in an internal tissue wall
accessible through a percutaneous incision, the method comprising:
providing a tissue puncture closure device that includes an anchor
portion, a filling member, and a sealing plug, inserting the anchor
portion through the tissue puncture to a distal side of the tissue
puncture; moving the filling member into the anchor portion to
expand the anchor portion to a size sufficient to resist movement
of the anchor portion proximally through the tissue puncture, the
filling member having a random configuration within the anchor
portion and a linear configuration when removed from the anchor
portion; disposing the sealing plug in the percutaneous incision
adjacent a proximal side of the tissue puncture; moving the filling
member out of the anchor portion to reduce a size of the anchor
portion; withdrawing the anchor portion through the tissue puncture
and sealing plug.
9. The method of claim 8, wherein the filling member is a solid or
semi-solid member, and moving the filling member into the anchor
portion includes maintaining a cross-sectional shape and size of
the filling member.
10. The method of claim 8, wherein moving the filling member
includes advancing the filling member distally from a first
position in the tissue puncture closure device to a second position
at least partially positioned in the anchor portion.
11. The method of claim 8, wherein the tissue puncture closure
device further includes a shaft portion, and moving the filling
member out of the anchor portion includes positioning the filling
member in the shaft portion.
12. The method of claim 8, wherein the filling member is selected
from a group consisting of a wire structure, a polymeric strand
structure, and a gel strand structure, and moving the filling
member into or out of the anchor portion includes actuating an
actuator mechanism to advance and retract the filling member.
13. The method of claim 8, wherein disposing the sealing plug
includes compressing the sealing plug against the internal tissue
wall.
14. The method of claim 8, wherein the tissue puncture closure
device further includes an actuator, the actuator connected to the
filling material, and moving the filling material includes
actuating the actuator to move the filling material in a proximal
direction or a distal direction.
Description
RELATED APPLICATIONS
[0001] This is a divisional of U.S. patent application Ser. No.
14/116,284 filed 7 Nov. 2013 (with a 371(c) date of 10 Dec. 2013),
now pending, which is a 371 of PCT App. No. PCT/US2012/037877,
filed 15 May 2012, which claims the benefit of U.S. Provisional
App. No. 61/486,470, filed 16 May 2011, the disclosures of which
are incorporated, in their entireties, by this reference.
TECHNICAL FIELD
[0002] The present disclosure relates generally to medical devices
and more particularly to vascular closure devices.
BACKGROUND
[0003] Various surgical procedures are routinely carried out
intravascularly or intraluminally. For example, in the treatment of
vascular disease, such as arteriosclerosis, it is a common practice
to invade the artery and insert an instrument (e.g., a balloon or
other type of catheter) to carry out a procedure within the artery.
Such procedures usually involve the percutaneous puncture of the
artery so that an insertion sheath can be placed in the artery and
thereafter instruments (e.g., a catheter) can pass through the
sheath and to an operative position within the artery.
Intravascular and intraluminal procedures unavoidably present the
problem of stopping the bleeding at the percutaneous puncture after
the procedure has been completed and after the instruments (and any
insertion sheaths used therewith) have been removed. Bleeding from
puncture sites, particularly in the case of femoral arterial
punctures, may be stopped by utilizing vascular closure devices,
such as those described in U.S. Pat. Nos. 6,090,130 and 6,045,569,
which are hereby incorporated in their entireties by this
reference.
[0004] Typical closure devices such as the ones described in the
above-mentioned patents place a sealing plug at the tissue puncture
site. Successful deployment of the sealing plug involves ejecting
the sealing plug from within the closure device sheath to a
location in alignment with and adjacent to the tissue puncture
along an outer surface of the vessel. Misalignment of the sealing
plug relative to the tissue puncture may result in improper sealing
of the tissue puncture. Failure to contact the sealing plug against
the outer surface of the vessel may also result in an improper
seal.
SUMMARY
[0005] One aspect of the present disclosure relates to a tissue
puncture locator device that includes an anchor assembly and a
sealing member. The anchor assembly includes an anchor portion, a
tube portion, and a filling member. The anchor portion is
positioned at a distal end of the tube portion and configured for
placement through a vascular incision into a vessel. The anchor
member has an unexpanded configuration that permits passage through
the vascular incision and an expanded configuration that limits
passage through the vascular incision. The filling member is
retained in the tube portion and adapted for insertion from the
tube portion into the anchor member to provide the expanded
configuration. The filling member is also adapted for retraction
from the anchor member into the tube portion to provide the
unexpanded configuration. The filling member may have a random
arrangement within the anchor member. The sealing member is
configured for placement adjacent to the vascular incision outside
of the vessel. Typically, the anchor member may retract through the
sealing member when in the unexpanded configuration.
[0006] The filling member may be selected from one of a wire
member, a polymer strand, and a gel strand. The device may further
include a handle portion, wherein the tube portion extends from the
handle portion to the anchor portion. The sealing member may be
movable along the tube member to a position adjacent to the
vascular incision. The sealing member may comprise a collagen pad.
The anchor assembly may further include an actuator configured to
move the filling member into the anchor member and retract the
filling member from the anchor member.
[0007] Another aspect of the present disclosure relates to a tissue
puncture closure device that is adapted for insertion into and
sealing of a tissue puncture in an internal tissue wall that is
accessible through a percutaneous incision. The device includes an
anchor, a filling material, and a sealing member. The anchor is
disposed on a distal side of the internal tissue wall. The filling
material is positioned in the tissue puncture closure device and
movable from a first position removed from the anchor, to a second
position inserted within the anchor to expand the anchor, and back
to the first position. The filling material may have a random
orientation in the second position. The sealing member is disposed
on a proximal side of the internal tissue wall. The anchor is
movable through the sealing member when the filling material is in
the first position.
[0008] The device may further include an elongate shaft, wherein
the anchor is positioned at a distal end of the elongate shaft and
the filling material is positioned in the elongate shaft in the
first position. The filling material may be shaped as an elongate
structure. The filling material may maintain a solid or semi-solid
state when in the first and second positions. The sealing member
may include a collagen material. The device may further include a
sheath, wherein the sealing member is positioned in the sheath
before being disposed on the proximal side of the internal tissue
wall. The device may also include a tamping member configured to
advance the sealing member out of the sheath.
[0009] A further aspect of the present disclosure relates to a
method of sealing a tissue puncture in an internal tissue wall that
is accessible through a percutaneous incision. The method may
include providing a tissue puncture closure device that includes an
anchor portion, a filling member, and a sealing plug, inserting the
anchor portion through the tissue puncture to a distal side of the
tissue puncture, and moving the filling member into the anchor
portion to expand the anchor portion to a size sufficient to resist
movement of the anchor member proximally through the tissue
puncture. The filling member may have a random arrangement within
the anchor portion and a linear configuration when removed from the
anchor portion. The method may further include disposing the
sealing plug in the percutaneous incision adjacent a proximal side
of the tissue puncture, moving the filling member out of the anchor
portion to reduce a size of the anchor portion, and withdrawing the
anchor portion through the tissue puncture and sealing plug.
[0010] The filling member may be a solid or semi-solid member, and
moving the filling member into the anchor portion includes
maintaining a cross-sectional shape and size of the filling member.
Moving the filling member may include advancing the filling member
distally from a first position in the tissue puncture closure
device to a second position at least partially positioned in the
anchor portion. The tissue puncture closure device may further
include a shaft portion, and moving the filling member out of the
anchor portion includes positioning the filling member in the shaft
portion. The filling member may be one of a wire structure, a
polymeric strand structure, and a gel strand structure. Moving the
filling member into or out of the anchor portion may include
actuating an actuator mechanism to advance and retract the filling
member. Disposing the sealing plug may include compressing the
sealing plug against the internal tissue wall. The tissue puncture
closure device may also include an actuator that is connected to
the filling material, and moving the filling material includes
actuating the actuator to move the filling material in a proximal
direction or a distal direction.
[0011] Additional advantages and novel features will be set forth
in the description which follows or can be learned by those skilled
in the art through reading these materials or practicing the
examples disclosed herein. The advantages of the invention can be
achieved through the features recited in the attached claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The accompanying drawings illustrate various embodiments of
the present disclosure and are a part of the specification. The
illustrated embodiments are merely examples and do not limit the
scope of the invention.
[0013] FIG. 1 is a cross-sectional side view of a portion of an
example locator wire assembly in accordance with the present
disclosure with an expandable member in an unexpanded state.
[0014] FIG. 2 is an end view of the locator wire assembly of FIG.
1.
[0015] FIG. 3 is a cross-sectional side view of the locator wire
assembly of FIG. 1 with the expandable member in an expanded state
and a filling member in a first configuration.
[0016] FIG. 4 is an end view of the locator wire assembly of FIG.
3.
[0017] FIG. 5 is a cross-sectional side view of the locator wire
assembly of FIG. 1 with the expandable member in an expanded state
and the filling member in a second configuration.
[0018] FIG. 6 is a partially exploded perspective view of another
example locator wire assembly in accordance with the present
disclosure.
[0019] FIG. 7 is a partially exploded perspective view of another
example locator wire assembly in accordance with the present
disclosure.
[0020] FIG. 8 is a side view of an example tissue puncture
treatment assembly in accordance with the present disclosure,
wherein an introducer is inserted into a vessel and a locator wire
assembly is positioned for insertion into the introducer.
[0021] FIG. 9 is a side view of the tissue puncture treatment
assembly of FIG. 8 with the locator wire assembly inserted into the
introducer and into the vessel.
[0022] FIGS. 10 and 10A are side views of the tissue puncture
treatment assembly of FIG. 9 with a filling member of the locator
wire assembly being distally advanced to expand an expandable
portion of the locator wire assembly within the vessel.
[0023] FIGS. 11 and 11A are side views of the tissue puncture
treatment assembly of FIG. 10 with the locator wire assembly being
retracted to engage the expandable portion against a distal end of
the introducer.
[0024] FIGS. 12 and 12A are side views of the tissue puncture
treatment assembly of FIG. 11 with the introducer and locator wire
assembly being retracted to engage the expandable portion against
an interior wall of the vessel.
[0025] FIGS. 13 and 13A are side views of the tissue puncture
treatment assembly of FIG. 12 with the introducer removed.
[0026] FIGS. 14 and 14A are side views of the tissue puncture
treatment assembly of FIG. 13 with a tissue tract dilator advanced
over the locator wire assembly and into the percutaneous
incision.
[0027] FIGS. 15 and 15A are side views of the tissue puncture
treatment assembly of FIG. 14 with the tissue tract dilator removed
and a sealing pad delivery device advanced over the locator wire
assembly and into the percutaneous incision.
[0028] FIG. 16 is a side view of the tissue puncture treatment
assembly of FIG. 15 with the sealing pad delivery device locked
onto the locator wire assembly.
[0029] FIG. 17 is a side view of the tissue puncture treatment
assembly of FIG. 16 with the sealing pad delivery device actuated
to expose a sealing pad within the percutaneous incision.
[0030] FIG. 18 is a side view of the tissue puncture treatment
assembly of FIG. 17 with the sealing pad delivery device released
from the locator wire assembly.
[0031] FIG. 19 is a side view of the tissue puncture treatment
assembly of FIG. 18 with the locator wire assembly advanced
distally to separate the expandable portion from the vessel
wall.
[0032] FIGS. 20 and 20A are side views of the tissue puncture
treatment assembly FIG. 19 with the locator wire assembly being
actuated to move the filling member proximally to permit the
expandable portion to return to an unexpanded state.
[0033] FIG. 21 is a side view of the tissue puncture treatment
assembly of FIG. 20 with the locator wire assembly being retracted
through the sealing pad and removed from the sealing pad delivery
device.
[0034] FIG. 22 is a side view of the tissue puncture treatment
assembly of FIG. 21 with the sealing pad delivery device removed
from the percutaneous incision.
[0035] Throughout the drawings, identical reference numbers
designate similar, but not necessarily identical, elements.
DETAILED DESCRIPTION
[0036] As mentioned above, vascular procedures are conducted
throughout the world and require access to an artery through a
puncture. Most often, the artery is a femoral artery. To close the
puncture following completion of the procedure, many times a
closure device is used to position a sealing plug within a
percutaneous incision adjacent to the puncture. Orientation of the
sealing plug relative to the puncture may be particularly useful
for successful sealing of the puncture.
[0037] Compressing the sealing plug against the puncture typically
improves sealing of the puncture. In order to apply a compressing
force to the sealing plug, it is helpful to provide an anchor
positioned within the vessel on an opposite side of the vascular
wall from the sealing plug. The anchor may be pulled proximally
against the vessel wall as the sealing member is compressed or
advanced generally in the distal direction to create a seal against
the outer surface of the vessel in the area adjacent to the
puncture.
[0038] An anchor positioned within the vessel may also provide a
sealing function for the puncture prior to disposing the sealing
plug adjacent to the puncture. The anchor may be constructed and
positioned within the vessel to at least partially block or occlude
a flow of blood through the puncture. Some types of anchors for use
with closure devices are constructed as an inflatable balloon. The
anchor, once positioned in the vessel, is filled with a gas or
liquid from a source of fluid that is coupled to the vascular
closure device. Fluid-filled balloon anchors may pose a risk of
bursting while in the vessel, which could cause serious
complications for the patient. Further, connecting the source of
fluid to the closure device for use in filling the balloon adds
substantial complexity and size to the closure device that may
limit ease of use for the operator.
[0039] Other types of anchors include a metal cage or basket
construction that is expandable within a balloon membrane.
Typically, the cage structure is maintained within the balloon
membrane at all times during use of the closure device. When the
anchor is positioned within the vessel, the cage structure is
expanded to expand the balloon membrane. The anchor is retracted to
a position against an inner wall of the vessel. The cage structure
is moved to its original unexpanded position after the sealing plug
is properly deployed on an opposite side of the vessel wall. Such
cage structures are typically complex mechanical devices that
require costly manufacturing and assembly processes.
[0040] While the vascular instruments shown in the attached figures
and described below include procedural sheaths and puncture sealing
devices, the application of principles described herein are not
limited to the specific devices shown. The principles described
herein may be used with any medical device. Therefore, while the
description below is directed primarily to arterial procedures and
certain embodiments of a vascular closure device, the methods and
apparatus are only limited by the appended claims. Applications of
closure devices including those implementing principles described
herein include closure of a percutaneous puncture or incision in
tissue separating two internal portions of a living body, such as
punctures or incisions in blood vessels, ducts or lumens, gall
bladders, livers, hearts, etc.
[0041] As used in this specification and the appended claims, the
term "engage" and "engagable" are also used broadly to mean
interlock, mesh, or contact between two devices. Likewise
"disengage" or "disengagable" means to remove or capable of being
removed from interlock, mesh, or contact. A "tube" is an elongated
device with a passageway. The passageway may be enclosed or open
(e.g., a trough). A "lumen" refers to any open space or cavity in a
bodily organ, especially in a blood vessel. The words "including"
and "having," as used in the specification, including the claims,
have the same meaning as the word "comprising."
[0042] FIGS. 1-5 illustrate an example locator wire assembly 106
for use with a tissue puncture treatment assembly 100 as will be
described in further detail below. The locator wire assembly 106
(also referred to herein as a "locator wire" or a "wire assembly")
includes a locator tube 140, a distal end portion 142, a proximal
end portion 144, a stop or plug member 146, and an expandable
portion 145 positioned at the distal end portion 142. The locator
wire assembly 106 further includes a filling member 148 (also
referred to herein as a "strand" or a "strand member") that is
positioned within the locator tube 140 and is movable into and out
of the expandable portion 145. The filling member 148 is typically
operable from a location proximal of the expandable portion 145 and
is axially movable relative to the locator tube 140. Typically, the
filling member 148 is moved axially a predetermined distance to
fill and expand the expandable portion 145, and to retract from and
permit return of the expandable portion 145 to an unexpanded
state.
[0043] Referring to FIG. 1, the locator wire assembly 106 is shown
with the expandable portion 145 in an unexpanded state. The
expandable portion 145 has a maximum diameter or dimension D.sub.1.
Typically, the dimension D.sub.1 is smaller than a minimum internal
dimension of an introducer into which the expandable portion 145 is
inserted, and smaller than a minimum size of a vessel incision
through which the locator wire assembly 106 is inserted, as will be
described below with reference to FIGS. 8-22. The filling member
148 is shown spaced proximal of the expandable portion 145. In
other arrangements, a distal end portion 149 of the filling member
148 may be at least partially positioned within the expandable
portion 145 prior to advancing the filling member 148 to expand the
expandable portion 145.
[0044] The locator wire assembly 106 may include a follower member
154 that moves within a track 156 defined in the locator tube 140.
The follower member 154 is typically coupled to the filling member
148 so that restrictions in axial movement of the follower member
154 relative to the track 156 corresponds to restrictions in axial
movement of the filling member 148 relative to locator tube 140. In
some arrangements (not shown in the figures), the filling member
148 may extend along only a portion of the length of the locator
tube 140 (e.g., from the expandable portion 145 proximally to a
location distal of the track 156), and an extension or actuator
portion is connected to and extends proximally from the filling
member 148. Such an extension or actuator portion may include the
follower member 154 extending radially outward through the track
156.
[0045] In some arrangements, an internal dimension or diameter
D.sub.3 of the locator tube 140 is substantially greater than an
outer diameter or dimension D.sub.4 of the filling member 148 as
shown in FIG. 1. Alternatively, the internal dimension D.sub.3 may
be similar in size to the dimension D.sub.4. In one example, the
dimension D.sub.3 is in the range of about 100 percent to about 200
percent of the dimension D.sub.4. More closely matching the size of
the dimensions D.sub.3, D.sub.4 may help promote axial movement of
the filling member 148 within the locator tube 140 without the
filling member 148 buckling while being advanced into and retracted
from the expandable portion 145.
[0046] FIGS. 3 and 4 illustrate the locator wire assembly 106 with
the filling member 148 advanced distally into the expandable
portion 145. A distal end portion 149 of the filling member 148
collects within the expandable portion 145 in a configuration that
promotes radially outward expansion of the expandable portion 145
to a dimension D.sub.2.
[0047] As the filling member 148 is advanced distally, the distal
end portion 149 engages the plug 146 and begins to bend into a
random, contorted configuration or orientation. Further distally
advancing the filling member 148 increases the greater the radially
outward force applied by the filling member 148 within the
expandable portion 145. Typically, the greater the radially outward
force applied by filling member 148, the further radially outward
the expandable portion 145 expands. While the configuration of the
filling member 148 within the expandable portion 145 is typically
random (i.e., has no preformed shape or configuration), it may be
possible to consistently provide the diameter D.sub.2 within a
certain range of sizes by advancing the filling member 148 distally
a predetermined distance (i.e., a distance defined by a length
L.sub.1 of the track 156). In some examples, the dimension D.sub.2
is in a range of 1 to about 8 millimeters and more preferably in a
range of about 2 to 4 millimeters.
[0048] The axial length of movement of the filling member 148 to
provide the diameter D.sub.2 may vary depending on a number of
factors such as, for example, the material composition,
cross-sectional size, and a cross-sectional shape of the filling
member 148. Other features include the unexpanded size D.sub.1,
wall thickness T.sub.1 (see FIG. 1), length L.sub.2, and material
composition of the expandable portion 145.
[0049] In one example, the length of filling member 148 that is
inserted into the expandable portion 145 is in the range of about
0.5 to about 5 centimeters, and more preferable in the range of
about 1 to about 3 centimeters. The length L.sub.1 of the track 156
may correlate directly with the length of filling member 148 that
is inserted into the expandable portion 145 to provide the
dimension D.sub.2.
[0050] FIG. 5 illustrates another configuration or orientation of
the filling member 148 within the expandable portion 145. The
comparison of FIGS. 3 and 5 illustrates at least in part how the
same filling member 148 may bend and contort into various shapes
and configurations within the expandable portion 145 to provide
expansion of the expandable portion 145 to the dimension
D.sub.2.
[0051] The filling member 148 may be advanced and retracted
relative to the locator 140 using various actuator devices in place
of or in addition to the follower 154 and track 156. FIG. 6
illustrates a filling member actuator 280 that advances and
retracts a filling member 248. The filling member actuator 280
includes a housing 282, an actuator 284, and an actuator track 286
within which the actuator 284 is operable. The actuator 284 is
coupled to the filling member 248 such that operation of the
actuator 284 within the actuator track 286 advances or retracts the
filling member 248 relative to the housing 282. The actuator 284
may be configured as a scroll member. The scroll member may
directly or indirectly contact the filling member 248 to axially
move the filling member 248.
[0052] A distal end 249 of the filling member 248 may be inserted
into a proximal end portion 244 of a locator tube 240 of a locator
wire assembly 206. With the filling member 248 positioned within
the locator tube 240 and the actuator 284 positioned proximally
within the actuator track 286, an expandable portion 245 of the
locator wire 206 is provided in an unexpanded state shown in solid
lines. Advancing the filling member 248 in the distal direction by
advancing the actuator 284 within the actuator track 286 causes the
distal end 249 of the filling member 248 to collect within an
expandable portion 245. The expandable portion 240 expands in the
radially outward direction as the filling member 248 is advanced
distally (i.e., see the expandable portion 245 in the broken line
in FIG. 6). Retraction of the filling member 248 by moving the
actuator 284 proximally in the actuator track 286 removes the
filling member 248 from within the expandable portion 245 at least
an amount sufficient to permit the expandable portion 245 to return
to the unexpanded state shown in solid line in FIG. 6. Typically,
the filling member 248 remains within the locator tube 240 prior to
expanding the expandable portion 245 and after the expandable
portion 245 has returned to an unexpanded state.
[0053] FIG. 7 illustrates another example filling member actuator
380 that includes a housing 382, an actuator 384, and a filling
member 348. The housing 382 includes an actuator track 386 within
which the actuator 384 operates. The filling member 348 has a
distal end 349 that is insertable into a distal end portion 344 of
a locator tube 340 of a locator wire assembly 306.
[0054] The actuator 384 is configured as a thumb actuator wherein
the operator applies a radially inward and axial force to the
actuator 384 to move the actuator 384 within the track 386. After
positioning the filling member 348 within the locator tube 340, the
actuator 384 may be advanced distally within the track 386 to fill
and expand an expandable portion 345 from an unexpanded state shown
in solid lines in FIG. 7 to an expanded state shown in broken lines
in FIG. 7.
[0055] The example filling members 148, 248, 348 described above
and shown in the attached figures may comprise various materials.
In one example, the filling member includes a metal material such
as stainless steel or Nitinol. Nitinol may be particularly useful
because of its elastic properties that provide return to an
original shape after being deformed. In one example, the original
shape of the filling member may be the generally elongate linear
shape when positioned in the locator tube, and the deformed shape
is whatever random shape the filling member takes when collected
within the expandable portion.
[0056] Other materials suitable for the filling member may include,
for example, semi-solid or solid gel materials, polymers, and coil
structures of various material composition.
[0057] Referring now to FIGS. 8-22, an example tissue puncture
treatment assembly 100 is described with reference to treatment of
a vessel puncture 114. The tissue puncture treatment assembly 100
includes a sealing pad delivery device 102, an introducer 104, a
locator wire assembly 106 (i.e., the locator wire assembly 106
described above with reference to FIGS. 1-5), and a tissue tract
dilator 108. The tissue puncture treatment assembly 100 is used to
seal closed a vessel puncture 114 in a vessel 112. The vessel 112
includes a vessel interior 116. The vessel puncture 114 is
accessible from outside a patient via a percutaneous incision
118.
[0058] Referring first to FIG. 8, the introducer 104 is inserted
through the percutaneous incision 118 and vessel puncture 114 until
a distal end 172 of the introducer 104 is positioned within the
vessel interior 116. A hub 170 is positioned at proximal end 171 of
the introducer 104. The hub 170 defines an opening into the
introducer through which the locator wire assembly 106 is advanced.
The locator wire assembly 106 includes a distal end portion 142 and
a proximal end portion 144. Typically, the distal end portion 142
is advanced through the hub 170 until the distal end portion 142
(including the expandable portion 145) extends distally beyond the
distal end 172 of the introducer.
[0059] The tissue tract dilator 108 may be advanced into the
introducer 104 concurrently with advancement of the locator wire
assembly 106 into the introducer 104. Alternatively, the tissue
tract dilator 108 may be advanced prior to or after insertion of
the locator wire assembly 106 into the introducer 104. In some
arrangements, the tissue tract dilator 108 may be advanced over the
locator wire assembly 106 after the locator wire assembly has been
advanced into the vessel 112.
[0060] Referring now to FIGS. 9 and 9A, the locator wire assembly
106 is advanced distally through the introducer 104 until the
distal end portion 142 is positioned within the vessel interior 116
at a location distal of the distal end 172 of the introducer.
Proper positioning of the distal end portion 142 may be confirmed
by visualizing a first marker 158 at a location adjacent to the hub
170, as shown in FIG. 9A.
[0061] Referring now to FIGS. 10 and 10A, the locator 106 is
actuated to compress the expandable portion 145 into a radially
outward expanded state. In one example, the locator wire assembly
106 includes a filling member 148 that is positioned within a
locator tube 140 and is movable into and out of the expandable
portion 145. A first grasping member 150 may be positioned at a
proximal end of the locator tube 140, and a second grasping member
152 is positioned at proximal end of the filling member 148. A
follower member 158 extends from an outer surface of the filling
member 148. The follower member 154 moves within a track 156 that
is defined in an outer surface of the tube member 140. The track
156 includes a proximal locking portion 155A and a distal locking
portion 155B.
[0062] The operator rotates the filling member 148 relative to the
tube member 140 in the direction R.sub.1 to move the follower 154
out of the locking portion 155A of the track 156. The operator then
applies an axial force in the direction A.sub.1 via the first
grasping member 150 while applying a force in the opposite
direction A.sub.2 to the filling member 148 via the second grasping
member 152. When the follower member 154 reaches the distal end of
the track 156, the operator applies a rotational force in the
direction R.sub.2 to move the follower member 154 into locking
portion 155B of the track 156.
[0063] Applying the axial compression forces shown and described
with reference to FIGS. 10 and 10A causes the filling member 148 to
move into and expand the expandable portion 145 radially outward as
shown in FIGS. 11 and 11A. Typically, the filling member 148 is
randomly arranged in the expandable portion 145 as discussed above
with reference to FIGS. 3 and 5. The expandable portion 145 has a
maximum diameter or width dimension D.sub.2 when in the expanded
state shown in FIG. 11A. Typically, the dimension D.sub.2 is
greater than a maximum width dimension of the vessel puncture 114.
The dimension D.sub.2 is also typically greater than an internal
dimension of the introducer 104 at the distal end 172 of the
introducer 104.
[0064] Referring to FIGS. 11 and 11A, the operator applies a
retraction force to locator wire assembly 106 in the proximal
direction A.sub.1 to contact the expandable portion 145 against a
distal end surface of the introducer 104.
[0065] Referring to FIGS. 12 and 12A, the operator retracts the
introducer 104 and locator wire assembly 106 in the direction
A.sub.1 until the expandable portion 145 contacts against an inner
surface of the vessel 112 adjacent to the vessel puncture 114.
Typically, the expandable portion 145 provide hemostasis at the
vessel puncture 114. The operator may feel a slight resistance to
retraction in the direction A.sub.1 once the expanded expandable
portion 145 contacts against the inner surface of the vessel
112.
[0066] Referring to FIGS. 13 and 13A, the operator maintains at
least some tension on the locator wire assembly 106 in the
direction A.sub.1 to maintain hemostasis while removing the
introducer 104 in direction A.sub.1 from off the locator wire
assembly 106. A second marker 162 is usually at least partially
visible outside of the percutaneous incision 118 after removal of
the introducer 104.
[0067] Referring now to FIGS. 14 and 14A, a tissue tract dilator
108 may be advanced distally over the locator wire assembly 106 and
into the percutaneous incision 118. The tissue tract dilator 108
may be advanced distally until the first marker 158 is at least
partially visible outside a proximal end of the tissue tract
dilator 108. At least some tension is usually applied to the
locator wire assembly 106 to maintain hemostasis during advancement
of the tissue tract dilator 108 into the percutaneous incision 118.
The tissue tract dilator 108 may be used in some circumstances when
the size or shape of the percutaneous incision 118 is not
sufficient for placement of a sealing pad or positioning of the
sealing pad delivery device 102.
[0068] Referring now to FIGS. 15 and 15A, the tissue tract dilator
108 is removed from percutaneous incision 118 and off from the
locator wire assembly 106 in the direction A.sub.1. At least some
tension is typically applied to the locator wire assembly 106 in
the proximal direction A.sub.1 while removing the tissue tract
dilator 108 to maintain hemostasis. The sealing pad delivery device
102 is then advanced distally over the locator wire assembly 106
and into the percutaneous incision 118. In at least some
arrangements, the sealing pad delivery device 102 is advanced
distally in the direction A.sub.2 until the first marker 158 is at
least partially visible at a location proximal of the sealing pad
delivery device 102.
[0069] The sealing pad delivery device 102 includes a housing 120,
a carrier tube 122 extending from a distal end of the housing 120,
a positioning tube 124 positioned within the carrier tube 122, and
a sealing pad or plug 126 positioned within the carrier tube 122.
The sealing pad 126 is located distal of the positioning tube 124.
The sealing pad delivery device 102 may also include a wire locking
member 128, a tube retracting actuator 130, and a wire aperture
132. The wire aperture 132 extends from a proximal end of the
housing 120 to a distal end of the carrier tube 122. The wire
aperture 132 defines a path through which the locator wire assembly
106 passes.
[0070] Referring now to FIG. 16, once the sealing pad delivery
device 102 is positioned within the percutaneous incision 118 with
the first marker 158 at least partially visible and tension being
applied to the locator wire assembly 106, the wire locking member
128 is actuated to fix an axially position of the sealing pad
delivery device 102 relative to the locator wire assembly 106. In
at least one example, the wire locking member 128 contacts the
locator wire assembly 106 directly with a force sufficient to limit
movement of the sealing pad delivery device 102 in the axial
direction relative to the wire assembly 106 when applying forces
that are typical in treating a vessel puncture 114. Many
constructions are possible for the wire locking member 128 to
provide the desired resistance to relative movement between the
sealing pad delivery device 102 and the locator wire assembly
106.
[0071] Referring now to FIG. 17, a force is applied to the
retraction actuator 130 in the proximal direction A.sub.1 to
retract the carrier tube 122 at least partially into the housing
120. Typically, the carrier tube 122 is retracted with the tube
retractor actuator 130 a distance sufficient to fully expose the
sealing pad 126 within the percutaneous incision 118.
[0072] In at least some arrangements, exposing the sealing pad 126
within the percutaneous incision 118 also advances the sealing pad
126 at least partially in the distal direction A.sub.2. In one
example, the positioning tube 124 may be used to distally advance
and compress the sealing pad 126. In other arrangements, the
positioning tube 124 limits proximal movement of the sealing pad
during retraction of the carrier tube 122.
[0073] The expandable portion 145, held in contact with the inner
surface of the vessel 112 adjacent to the vessel puncture 114, may
provide an anchor that resists axial forces applied to the sealing
pad 126 in the distal direction A.sub.2. The anchor function of
expandable portion 145 limits movement of the sealing pad 126
through the vessel puncture 114 and may facilitate at least some
compression of the sealing pad 126 toward the vessel puncture 114.
The expandable portion 145 may be referenced herein as an anchor or
anchor member.
[0074] Referring now to FIG. 18, the wire locking member 128 is
released so that the sealing pad delivery device 102 may be moved
relative to the locator wire assembly 106. The locator wire
assembly 106 is then advanced distally in the direction A.sub.2 as
shown in FIG. 19 until the expandable portion 145 is moved out of
contact with an inner wall 115 of the vessel 112.
[0075] FIGS. 20 and 20A illustrate the expandable portion 145 moved
into the unexpanded state after being spaced distally away from the
vessel puncture 114. The operator rotates the filling member 148
relative to the locator tube 140 in the direction R.sub.1 to move
the follower member 154 out of locking portion 155B. The operator
may then apply a force to the locator tube 140 in the distal
direction A.sub.2 via the first grasping member 150 while applying
an opposite force to the filling member 148 in the proximal
direction A.sub.1 via the second grasping member 152. After the
follower member 154 reaches a proximal end of the track 156, the
operator rotates the filling member 148 in the direction R.sub.2 to
move the follower member 154 into the locking portion 155A. The
maximum width dimension of the expandable portion 145 is reduced
from a size D.sub.2 to a size that is smaller than the maximum
dimension of the vessel puncture 114 (e.g., the dimension D.sub.1
shown in FIG. 1).
[0076] Referring to FIG. 21, the locator wire assembly 106 is
retracted proximally in the direction A.sub.1 out of the vessel
112, through the sealing pad 126, and out of the sealing pad
delivery device 102 while holding the sealing pad delivery device
102 in a fixed position relative to the vessel 112.
[0077] Referring to FIG. 22, the sealing delivery device 102 is
retracted proximally in the direction A.sub.1 out of the
percutaneous incision 118. The sealing pad 126 is left behind
within the percutaneous incision 118 at a position adjacent the
vessel puncture 114. Typically the sealing pad 126 comprises an
expandable material that expands to fill the percutaneous incision
118 at a location adjacent to the vessel puncture 114. In at least
one example, the sealing pad 126 comprises a collagen material. The
sealing pad 126 is typically configured to provide hemostasis for
the vessel puncture 114.
[0078] Many other constructions are possible for the various
features of the tissue puncture treatment assembly 100 described
above with reference to the attached figures. In particular, the
aspects of the locator wire assembly 106 including various
arrangements for the expandable portion 145 and filling member 148
described above may be changed or modified in accordance with the
teachings provided herein.
[0079] The preceding description has been presented only to
illustrate and describe exemplary embodiments of the present
disclosure. It is not intended to be exhaustive or to limit the
invention to any precise form disclosed. Many modifications and
variations are possible in light of the above teaching. It is
intended that the scope of the invention be defined by the
following claims.
* * * * *