U.S. patent application number 11/460863 was filed with the patent office on 2006-11-23 for suture locking device and methods.
This patent application is currently assigned to ABBOTT LABORATORIES. Invention is credited to Scott A. McIntosh, Joseph Francis Paraschac.
Application Number | 20060265010 11/460863 |
Document ID | / |
Family ID | 34375294 |
Filed Date | 2006-11-23 |
United States Patent
Application |
20060265010 |
Kind Code |
A1 |
Paraschac; Joseph Francis ;
et al. |
November 23, 2006 |
SUTURE LOCKING DEVICE AND METHODS
Abstract
The present invention relates to devices and methods for
securing a pair of suture lengths together or for using a single
strand of suture to secure tissue(s) together at an operative site
in a patient without necessarily tying a knot. The suture lock
device according to the present invention includes a suturing
securing device having an outer body member having a lumen
extending therethrough, the lumen defining a suture path through
the outer body, an inner wedge member axially insertable into the
outer body member to secure a portion of a suture between the wedge
and the interior surface of the lock member, an outer tube having a
proximal end and a distal end, the outer tube carrying the outer
body member at the distal end of the outer tube, the outer tube
carrying the wedge proximal to the outer body member, and a pusher
member slidable within the outer tube to push the wedge into the
lock member.
Inventors: |
Paraschac; Joseph Francis;
(San Jose, CA) ; McIntosh; Scott A.; (Sunnyvale,
CA) |
Correspondence
Address: |
WORKMAN NYDEGGER
1000 EAGLE GATE TOWER,
60 EAST SOUTH TEMPLE
SALT LAKE CITY
UT
84111
US
|
Assignee: |
ABBOTT LABORATORIES
400 Saginaw Drive
Redwood City
CA
|
Family ID: |
34375294 |
Appl. No.: |
11/460863 |
Filed: |
July 28, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10941693 |
Sep 15, 2004 |
|
|
|
11460863 |
Jul 28, 2006 |
|
|
|
60502925 |
Sep 15, 2003 |
|
|
|
Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61B 17/12013 20130101;
A61B 2017/00243 20130101; A61B 2017/0448 20130101; A61B 2017/045
20130101; A61B 17/12009 20130101; A61B 2017/0496 20130101; A61B
17/0487 20130101; A61B 17/0467 20130101; A61B 2017/0488 20130101;
A61B 2017/0445 20130101 |
Class at
Publication: |
606/232 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A suture lock device usable to secure at least one end of a
suture and retain the suture, the suture lock device comprising: an
outer body member having a proximal end, a distal end, and an
aperture extending from said proximal end to said distal end, said
aperture defining a suture path through said outer body; and an
inner member axially insertable into said outer body member to
secure a portion of the suture between said inner member and a wall
of said aperture formed in said outer body member.
2. The suture lock device as recited in claim 1, wherein axially
inserting said inner member into said outer body member
frictionally engages the suture with said wall of said aperture
formed in said outer body member and said inner member.
3. The suture lock device as recited in claim 1, wherein said inner
member further comprises at least one of a projection or an
alignment member.
4. The suture lock device as recited in claim 1, wherein said inner
member further comprises at least one projection.
5. The suture lock device as recited in claim 1, wherein said outer
body member defines a recessed portion extending from said distal
end and partially along a length of said outer body.
6. The suture lock device as recited in claim 5, wherein said
recessed portion terminates a distance from said proximal end of
said outer body member.
7. A suture lock device usable to secure at least one end of a
suture and retain the suture, the suture lock device comprising: an
outer body member having a proximal end, a distal end, and a wall
extending from said proximal end to said distal end to define an
aperture, said aperture defining a suture path through said outer
body; and an inner member axially insertable into said aperture of
said outer body to space said inner member apart from said wall and
secure a portion of the suture between said inner member and said
wall.
8. The suture lock device as recited in claim 8, wherein said
aperture comprises a reduced diameter portion between said proximal
end and said distal end of said outer body member.
9. The suture lock device as recited in claim 8, wherein said outer
body member further comprises an increased diameter section
disposed adjacent said distal end of said outer body member.
10. The suture lock device as recited in claim 8, wherein an end of
the suture is overmolded with said outer body member.
11. The suture lock device as recited in claim 8, wherein said
outer body member and said inner member are constructed of a
bio-compatible material.
12. The suture lock device as recited in claim 11, wherein the
bio-compatible material is bio-absorbable.
13. The suture lock device as recited in claim 8, where said inner
member is an inner wedge member.
14. A suture lock device usable to secure at least one end of a
suture and retain the suture, the suture lock device comprising: a
generally cylindrical outer body member having a proximal end, a
distal end, and a wall extending from said proximal end to said
distal end to define an aperture, said aperture comprising a
defining a suture path through said outer body; and an inner member
axially insertable into said aperture of said outer body to space
said inner member apart from said wall to define a space between
said inner member and said wall and secure a portion of the suture
within said space.
15. The suture lock device as recited in claim 14, wherein a
portion of said inner member extends beyond said proximal end of
said outer body member.
16. The suture lock device as recited in claim 14, wherein said
inner member is fully received within said aperture.
17. The suture lock device as recited in claim 14, wherein the
suture secured within the space comprises a loop of suture.
18. The suture lock device as recited in claim 14, wherein said
outer body and said inner member are each constructed of plastic,
composite, metal, or ceramic.
19. The suture lock device as recited in claim 14, wherein a
portion of said aperture has a cone shape.
20. The suture lock device as recited in claim 14, wherein a
portion of said aperture has an inverted cone shape.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation application of U.S. patent
application Ser. No. 10/941,693 filed Sep. 15, 2004, and entitled
"Suture Locking Device and Methods", which claims priority to U.S.
Provisional Patent Application Ser. No. 60/502,925, filed Sep. 15,
2003, and entitled "Device and Method for Securing and Trimming
Suture", the entirety of each application is herein incorporated by
reference.
BACKGROUND OF THE INVENTION
[0002] 1. The Field of the Invention
[0003] The present invention relates to devices and methods for
securing a pair of suture lengths together or for using a single
strand of suture to secure tissue(s) together at an operative site
in a patient without necessarily tying a knot.
[0004] 2. The Relevant Technology
[0005] Sutures are used to sew tissue together, and thereby close
tissue openings, cuts or incisions during or after any of a very
wide variety of medical procedures. Additionally sutures may be
utilized to correct patent foramen ovales (PFO) which are openings
between the two atria of the heart. Typically, the surgeon manually
ties together a suture pair to close the opening. A variety of
automatic suture tying systems and suture securing mechanisms have
been developed.
[0006] Manually tying sutures together to secure tissue can be very
difficult and challenging. For example, manual knot tying requires
considerable dexterity in the context of a medical procedure where
the surgeon's hands are gloved or when the suturing is being
performed in a part of a patient's anatomy that is particularly
difficult to access. Also, in minimally invasive surgical
procedures or in the case of closure of a puncture in a femoral
artery after a catheterization procedure, the space adjacent the
wound or tissue opening to be sutured is limited by other parts of
the patient's anatomy and in many instances the opening to be
closed cannot be visualized, therefore the knot must be formed
blindly.
[0007] Also, manual knot tying can be time consuming as well as
difficult in instances where the tying process cannot be
visualized. Knot tying is further complicated by the fact that
surgical sutures generally have low friction surfaces. Therefore,
it is typically necessary for a surgeon to include many loops or
"throws" when tying a knot. Multiple throws are often required even
if an automatic knot tying device is used such as that disclosed in
U.S. Pat. No. 6,171,317 the entirety of which is hereby
incorporated by reference. Unfortunately, as the number of loops or
"throws" incorporated into the knot increases, the knot becomes
increasingly large and bulky. Manually tied knots also can become
"locked" prior to reaching the intended amount of tension to be
applied to the tissue. If the knot becomes "locked" prior to final
deployment, the surgeon may be required to remove the suture and
place a new suture if possible or resort to other closure methods
such as compression if the suture was being utilized to close an
opening in a vessel.
[0008] Moreover, the surgeon typically needs to handle suture
strands having adequate length prior to commencing manual knot
tying. Thus, manual knot tying requires considerable space both in
which to view, and to perform, the actual knot tying. Therefore,
knot tying is particularly difficult in areas of limited available
space or access, for example, at the back of the patient's heart
during a coronary artery bypass graft (CABG) operation or in a
tissue tract resulting from a percutaneous transluminal
catheterization procedure.
[0009] In addition to those problems described above, many of the
sutures utilized for surgical procedures can only be manipulated to
a certain degree before failure. For example, when tightening a
knot, the suture is placed in tension by the surgeon; too much
tension applied to the suture may cause the suture to break.
Alternatively, too much tension applied to the suture may cause the
suture to be torn from the tissue further complicating closure by
creating a larger wound or opening in the tissue which then must be
addressed.
[0010] Many knot replacement technologies for use with sutures have
been proposed over the years, one example of a knot replacement
technology is a deformable clip. Wherein the suture ends are
disposed through a deformable member which is then deformed thereby
trapping the suture therein. A shortcoming of this design is that
the deformable member must be made to be sufficiently deformable
but yet have enough strength to retain the suture therein. Further
still, there is the possibility of the suture slipping from the
deformed clip if the clip was not deformed sufficiently. Lastly,
many of these deformable clips are constructed of non-absorbable
materials and therefore remain implanted within the patient after
use, which may lead to other complications such as infection or
irritation of the surrounding tissue.
[0011] Another example of knot replacement technology is the use of
a tortuous path, wherein the suture is disposed upon or within a
device that contains a tortuous path, wherein friction between the
suture and the device is utilized to retain the suture. A potential
shortcoming of such devices is that since the suture is not
physically retained within the device there is the potential for
the suture to slip or loosen from the device. Additionally, many of
these devices require a great amount of operator skill or time to
dispose the suture therethrough, thereby adding to the complexity
of a potentially already complex surgical procedure.
[0012] Therefore, for the above reasons, it would be desirable to
provide improved devices, systems, and methods for securing at
least one length of suture that has been used to suture tissue
together to close an opening formed in the tissue such as a
vascular puncture. It would be particularly beneficial if these
improved devices provided some or all of the benefits while
overcoming one or more of the disadvantages discussed above.
[0013] It is an object of the present invention to provide methods
and devices that may be utilized in place of forming a knot in a
suture to effect a closure of the suture.
[0014] It is a further object of the present invention to provide a
knot replacement device that reduces surgical time by eliminating
the need to form a knot during a surgical procedure.
[0015] It is yet another object of the present invention to provide
a knot replacement device with is biocompatible and absorbable,
thereby reducing the amount of foreign material remaining implanted
within a patient after a surgical procedure.
[0016] These and other objects of the present invention will be
apparent from the following detailed description and the
claims.
SUMMARY OF THE INVENTION
[0017] The present invention provides methods and apparatuses that
may be utilized to secure at least one end of a suture and retain
the suture. The device according to the present invention includes
an outer body and an inner wedge member, wherein the outer body
includes an opening formed therein, the opening configured to
receive at least one suture therethrough. The opening further being
sized and configured to receive the inner wedge member therein,
whereby the suture and the inner wedge member are frictionally
retained within the opening.
[0018] In accordance with the present invention there is provided a
suture lock device, the suture lock device including an outer body
member having a lumen extending therethrough, the lumen defining a
suture path through the outer body, an inner wedge member axially
insertable into the outer body member to secure a portion of a
suture between the wedge and the interior surface of the lock
member, an outer tube having a proximal end and a distal end, the
outer tube carrying the outer body member at the distal end of the
outer tube, the outer tube carrying the wedge proximal to the outer
body member, and a pusher member slidable within the outer tube to
push the wedge into the lock member.
[0019] In accordance with the present invention there is provided a
method of securing and trimming a suture, the method comprising:
providing a suturing locking device comprising an outer body member
having an aperture disposed therethrough, the aperture defining a
suture path through the outer body member; a wedge axially
insertable into the outer body member to secure a portion of a
suture between the wedge and the interior surface of the outer body
member; an outer tube having a proximal end and a distal end, the
outer tube carrying the outer body member at the distal end of the
outer tube, the outer tube carrying the wedge proximal to the outer
body member the outer tube defining a suture tail opening; and a
pusher member slidable within the outer tube to push the wedge into
the outer body member; advancing a suture through the outer body
member and through the suture tail opening; pushing the wedge
member into the outer body member to secure the suture; and cutting
the suture by shearing the suture between the outer body member and
an edge of the suture tail opening.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Referring now to the appended drawings, wherein like
numerals are utilized to denote similar objects.
[0021] FIG. 1 is a perspective view of an exemplary embodiment of
the suture lock in accordance with the present invention.
[0022] FIG. 2 is a partial cross-sectional view of the outer body
of the suture lock of FIG. 1 as shown in the present invention.
[0023] FIG. 3 is a cross-sectional view of the suture lock in
accordance with the present invention.
[0024] FIG. 4 is a cross-sectional view of the outer body wherein
at least one suture has been disposed therein and the inner wedge
member has been partially disposed within an opening formed in the
outer body.
[0025] FIG. 5 is a plan view of a delivery device and the suture
lock in accordance with the present invention.
[0026] FIG. 6 is an exploded assembly view of the delivery device
in accordance with the present invention.
[0027] FIG. 7 is an enlarged view of the distal end of the delivery
device in accordance with the present invention.
[0028] FIG. 8 is a plan view of an alternative embodiment of a
suture lock in accordance with the present invention.
[0029] FIG. 9 is a cross-sectional view of the alternative
embodiment of the suture lock in accordance with the present
invention.
[0030] FIG. 10 is another exemplary embodiment of another
alternative embodiment of a suture lock in accordance with the
present invention.
[0031] FIG. 11 is a perspective view of a vessel having an opening
formed therein and illustrating the use of the delivery device of
the present invention with the suture lock disposed therein.
[0032] FIG. 12 is a plan view of the vessel after deployment of the
suture lock device in accordance with the present invention to
effect vessel closure.
DETAILED DESCRIPTION
[0033] Before the present invention is described in such detail, it
is to be understood that this invention is not limited to
particular variations set forth herein as various changes or
modifications may be made to the invention described and
equivalents may be substituted without departing from the true
spirit and scope of the invention. In addition, many modifications
may be made to adapt a particular situation, material, composition
of matter, process, process act(s) or step(s) to the objective(s),
spirit or scope of the present invention. All such modifications
are intended to be within the scope of the claims made herein.
[0034] Methods recited herein may be carried out in any order of
the recited events which is logically possible, as well as the
recited order of events. Furthermore, where a range of values is
provided, it is understood that every intervening value, between
the upper and lower limit of that range and any other stated or
intervening value in that stated range is encompassed within the
invention. Also, it is contemplated that any optional feature of
the inventive variations described may be set forth and claimed
independently, or in combination with any one or more of the
features described herein.
[0035] All existing subject matter mentioned herein (e.g.,
publications, patents, patent applications and hardware) is
incorporated by reference herein in its entirety except insofar as
the subject matter may conflict with that of the present invention
(in which case what is present herein shall prevail). The
referenced items are provided solely for their disclosure prior to
the filing date of the present application. Nothing herein is to be
construed as an admission that the present invention is not
entitled to antedate such material by virtue of prior
invention.
[0036] Reference to a singular item, includes the possibility that
there are plural of the same items present. More specifically, as
used herein and in the appended claims, the singular forms "a,"
"and," "said" and "the" include plural referents unless the context
clearly dictates otherwise. It is further noted that the claims may
be drafted to exclude any optional element. As such, this statement
is intended to serve as antecedent basis for use of such exclusive
terminology as "solely," "only" and the like in connection with the
recitation of claim elements, or use of a "negative" limitation.
Last, it is to be appreciated that unless defined otherwise, all
technical and scientific terms used herein have the same meaning as
commonly understood by one of ordinary skill in the art to which
this invention belongs.
[0037] In accordance with the present invention there are provided
methods and apparatuses for fixedly retaining at least one suture
without having to tie a knot in the suture. The devices in
accordance with the present invention include a suture lock device
and a delivery device, wherein the delivery device is configured to
retain and deliver the suture lock device over at least one suture.
The delivery device may further include a suture cutting mechanism,
whereby after delivery of the suture lock device the suture is
severed. The suture lock device may be constructed of a
biocompatible material such as plastics, composites, metals or
preferable of a bio-absorbable material.
[0038] Referring now to FIG. 1 there is shown an exemplary
embodiment of a suture lock device in accordance with the present
invention. The suture lock device will be initially described
herein, whereby the delivery device will be described in detail
below. The suture lock device includes an outer body, the outer
body including an aperture formed therethrough, and an inner wedge
member. The inner wedge member is sized to be received within the
aperture formed in the outer body.
[0039] As shown in FIG. 1, the suture lock 10 in accordance with
the present invention comprises an outer body 20 having a proximal
end 22 and a distal end 21. The outer body further includes an
increased diameter section 27 disposed adjacent the distal end 21,
wherein a recessed portion 25 extends from the distal end 21 and
partially along the length of the body 20. The recessed portion 25
terminating a distance from the proximal end 22 of the body 20.
[0040] The outer body 20 further includes an aperture 30 disposed
therethrough. The aperture 30 being sized and configured to receive
an inner wedge member 40, wherein the inner wedge member includes
at least one projection 44, and preferably two projections 44a and
44b disposed between the distal end 41 and the proximal end 42 of
the inner wedge member 40.
[0041] The outer body 20 and the inner wedge member 40 will
preferably be constructed of the same or similar materials.
Examples of suitable materials for construction of the outer body
20 and the inner wedge 40 include plastics, composites, metals and
ceramics. In a preferred embodiment the outer body and the wedge
are constructed of a biocompatible material and more preferably of
a biocompatible material that is also bio-absorbable. In a
preferred embodiment, the outer body 20 is generally cylindrical in
shape, though it is contemplated that the outer body 20 may be
formed having other geometric shapes or configurations.
[0042] Referring now to FIG. 2, there is shown a partial
cross-sectional view of the outer body 20 in accordance with the
present invention. As shown in FIG. 2, and as previously described,
the outer body 20 includes an aperture 30 formed therethrough,
wherein the aperture 30 is generally disposed along an axis
extending through the outer body 20. The aperture 30 includes an
upper portion 35 and a lower portion 40, wherein each of the
portions are generally formed having a specific shape. As shown,
the upper portion 35 is preferably formed in the shape of an
inverted cone or funnel, wherein the opening has a larger diameter
adjacent to its proximal end 36 and a smaller opening adjacent the
distal end 37. As described above, the aperture 30 is constructed
having two portions 35 and 40, wherein the lower portion 40 is
preferably formed in the shape of a cone or funnel and has a larger
opening adjacent its distal end 41 and a smaller opening adjacent
its proximal end 42. As shown in FIG. 2, the upper portion 35 and
the lower portion 40 of the aperture 30 are aligned along an axis
generally extending through the center of the outer body 20,
thereby forming the aperture 30 having a proximal end 32 and a
distal end 33 such that the aperture 30 includes a reduced diameter
portion 34 where the upper and lower portions intersect.
[0043] Referring now to FIG. 3 there is shown a partial
cross-sectional view of the suture lock 10 in accordance with the
present invention, wherein the inner wedge member 40 is shown
partially disposed within the aperture 30 formed in the outer body
20. As shown in FIG. 3, the inner wedge member 40 includes at least
one projection and more preferably two projections 44a and 44b,
wherein, as shown, the projection is sized such that it does not
contact the wall of the aperture 30. Thus, when the inner wedge
member 40 is disposed within the aperture 30, the projections 44
and the inner wedge member form a space 47 between the inner wedge
member 40 and the aperture 30. The inner wedge member 40 may be
configured to be fully received within the aperture 30 of the outer
body 20 or be configured such that a portion of the inner wedge
member adjacent the proximal end 42 extends beyond a proximal
surface 22 of the outer body.
[0044] Referring now to FIG. 4 there is shown a cross-sectional
view of the suture lock 10 in accordance with the present invention
wherein a loop of suture 50 has been disposed through the space 47
formed between the aperture 30 of the outer body 20 and the inner
wedge member 40. As shown in FIG. 4, the suture 50 is in
communication with the wedge 40 and the wall of the aperture 30 and
wherein projections 44 engage a surface of the suture 50. The space
47 is sized and dimensioned so that the frictional forces between
the suture and the components described above provide a sufficient
amount of force to retain the suture and the inner wedge member
within the aperture 30. As shown in FIG. 4, the inner wedge member
is not fully disposed within the aperture 30. In use, the inner
wedge member 40 would be advanced into the aperture 30 of the outer
body 20 until the projections 44a and 44b are sufficiently
contained within the aperture 30 of the outer body. It is further
contemplated that the inner wedge member may be configured to
extend beyond the proximal end of the outer body member 20 when
disposed in a final position.
[0045] Referring now to FIG. 5 of the present invention there is
shown an exemplary embodiment of a delivery device in accordance
with the present invention. The delivery device includes a handle
member including a trigger and an elongated shaft portion, wherein
the elongated shaft portion is configured to engage and deploy the
suture lock in accordance with methods of the present
invention.
[0046] As shown in FIG. 5, the delivery device 100 includes a
handle member 110 having a trigger 120 and an elongate tube member
140 extending from a distal end of the handle member 110.
[0047] Referring now to FIG. 6, there is shown an exploded view of
the delivery device 100 in accordance with the present invention
wherein only one side of the handle member 110 is shown. In
accordance with the present invention, the delivery device includes
a handle member 110 and an elongated tubular member 140. The handle
member 110 is configured to house a trigger member 120 and a pusher
member 155, wherein the trigger member 120 is configured to be in
communication with a proximal portion of a pusher member 155. The
pusher member being configured to be slidably disposed within the
elongated tubular member 140.
[0048] Referring now to the trigger member, the trigger member 120
has a distal end 121 and a proximal end 122, wherein the proximal
end includes a plurality of projections 123, whereby the plurality
of projections form a gear member 124. The trigger member 120
further includes a biasing member 127, the biasing member is
configured to be in communication with a portion of the trigger
member 120 and the handle member 110.
[0049] Referring now to the pusher member, the pusher member 155
includes a distal end 157 and a proximal end 158, wherein the
proximal end includes a plurality of projections formed therein,
wherein the projections form a gear member 159. The gear member 159
of the pusher member 155 is configured to engage the gear member
124 of the trigger member. Wherein, movement of the trigger member
120 will be translated to the pusher member 155 through the
interaction of the gear members. The distal end 157 of the pusher
member 155 is configured to engage and detachably retain the inner
wedge member 40. Further still, the pusher member 155 includes at
least one cutting member 156 disposed adjacent the distal end 157
thereof, wherein the cutting member 156 will be further described
below in connection with methods according to the present
invention.
[0050] Referring now to the elongated tubular member 140, wherein
the elongated tubular member 140 has a proximal end 142 and a
distal end 143 with a bore 141 extending therebetween. The bore 141
is configured to slidably receive the pusher member 155 as
described above. As shown in FIG. 6, a hub 144 may be disposed at
or about the proximal end of the elongated tubular member 140,
wherein the hub is configured to engage the two halves of the
handle member 110 thereby retaining the two halves of the handle
members. The distal end of the tubular member 140 will be described
in greater detail below with reference to FIG. 7.
[0051] Referring now to FIG. 7, there is shown a partial view of
the distal end 143 of the tubular member 140. The distal end 143 of
the tubular member 140 further includes at least one tab 146 formed
therein, whereby the tab is formed in the wall of the tubular
member adjacent to the distal end, such that a portion of the tab
may be configured to extend into the bore 141 of the tubular member
140. The tab 146 of the tubular body 140 is configured to engage
the recessed portion 25 of the outer housing 20 as will be
described in greater detail below with regard to the methods
according to the present invention. The tubular member 140 further
includes a suture tail opening 147 disposed adjacent to the distal
end 143, wherein the suture tail opening 147 is configured and
sized to receive a suture therethrough.
[0052] In addition to that described above, the tubular body 140
additionally includes at least one and more preferably two wedge
retention tabs 149. The wedge retention tabs 149 are formed in the
wall of the tubular body adjacent to the distal end 143 thereof.
The wedge retention tabs are configured to detachably retain the
inner wedge member in a position adjacent to the proximal end 22 of
the outer body 20 and adjacent to the suture tail opening 147. The
function of the wedge retaining tabs 149 will be described in more
detail below with regard to the methods of use of the present
invention.
[0053] Referring now to FIG. 8, there is shown an exemplary
embodiment of an alternative embodiment of a suture lock in
accordance with the present invention, wherein like numerals have
been utilized to denote similar components.
[0054] As shown in FIG. 8, the suture lock 200 in accordance with
the alternative embodiment includes an outer body 220 having a
proximal end 222 and a distal end 221 and an aperture 230 formed
therethrough. The suture lock 200 further includes an inner wedge
member 240, wherein the inner wedge member is sized and configured
to be received within the aperture 230 of the outer body 220. As
shown in FIG. 8, the inner wedge member includes a projection 244
formed on one side thereof and an alignment member 245 disposed on
the other side thereof. Suture lock 200 is configured to be used in
conjunction with a single suture tail as will be described below
with reference to FIG. 9.
[0055] Referring now to FIG. 9, there is shown the suture lock 200
in accordance with the present invention wherein a suture 5 has
been disposed through the aperture 230 of the suture lock 200. As
shown in FIG. 9, the suture 5 is configured such that the suture
only includes a single suture tail, wherein the suture includes a
pre-formed loop 6 formed therein. The pre-formed loop may be formed
by tying a knot in the suture using known knot tying methods, or
the loop may be formed in the suture during manufacture of the
suture. For example, the loop maybe formed using molding, extrusion
or heat forming. As shown in FIG. 9, the suture tail 8 is passed
through the loop 6 and then passed through the aperture 230 of the
suture lock, wherein the inner wedge member 240 is disposed within
the lumen, such that the suture is frictionally retained between
the wall of the aperture and the inner wedge member. It is
contemplated that the suture loop may be formed with a sliding knot
7, wherein the sliding knot allows the loop to close down on the
suture passed through the loop, thereby locking the suture and the
loop together.
[0056] In yet another alternative embodiment as shown in FIG. 10,
it is contemplated that one end of the suture 5 may be overmolded
with the outer body 20 as shown, thereby eliminating the need for a
suture loop as previously described. By overmolding one end of the
suture within the outer body of the suture lock, one end of the
suture is fixedly retained within the outer housing body, thereby
eliminating the need for a pre-formed suture loop. Further still,
in use, the other end of the suture does not need to be passed
through a pre-formed loop before being disposed through the
patient's tissue adjacent the opening to be closed, thereby
simplifying the closure process.
Methods of Use
[0057] The device according to the present invention will now be
described in use, the description of the methods below should be
considered exemplary in nature and should not be considered
limiting in any manner.
[0058] Referring now to FIG. 11, there is shown a cross-sectional
view of a patient's vessel, wherein a suture has been placed across
the opening in the vessel wall using a device such as that
disclosed in U.S. Pat. No. 6,136,010, the entirety of which is
herein incorporated by reference. After placing the suture across
the opening, the ends of the suture are drawn through the outer
body 20 of the suture lock 10 with the use of a suture snare 11 as
shown in FIG. 11, thereby passing the suture ends through the
aperture 30 of the outer body and wherein the ends of the suture
extend through the suture tail openings 147 formed in the elongated
tubular member 140.
[0059] After the suture ends have been disposed through the suture
lock 10 and the elongated tubular member, the operator utilizes the
handle of the delivery device 100 to place the distal end of the
suture lock adjacent to the opening formed in the vessel as shown
in FIG. 12. In addition to placing the distal end of the suture
lock adjacent to the vessel surface, the user applies tension to
the suture ends. Once the suture lock 10 is placed in a desired
position, and sufficient tension is applied to the suture ends, the
operator then actuates the trigger 120 of the delivery device.
[0060] Upon actuation of the trigger 120, the pusher member engages
the inner wedge member 40 and advances the inner wedge member 40
into the aperture 30 of the outer body 20, wherein the inner wedge
member is released from the wedge retention tabs 149 by the pusher
member 155. The pusher member 155 drives the inner wedge member 40
into the aperture 30. The projections 44a and 44b engage the suture
wherein the suture frictionally engages the inner wall member of
the aperture 30 adjacent to the inner wedge member 40. Once the
inner wedge 40 has been disposed within the aperture 30, the pusher
member 155 continues to advance thereby applying a force to the
inner wedge member, such that the force applied to the inner wedge
member is greater than the retention force applied by the tabs 146
to the outer body member 20, thereby expelling the suture lock from
the distal end of the delivery device Additionally, the suture ends
which have been disposed through the suture tail openings 143 are
severed by the distal movement of the pusher member 155.
[0061] Once the suture lock 10 has been expelled from the delivery
device 10, the delivery device can then be removed from the tissue
tract of the patient. The suture and the suture lock 10 remain
within the vessel and adjacent to the vessel to close the opening
formed in the vessel wall.
[0062] It is contemplated that the delivery device 10 may include a
lumen extending from the handle to the distal end of the device,
wherein the lumen may be configured to deliver a beneficial agent
adjacent to the opening in the vessel wall, or at any location
within the tissue tract. It is further contemplated that the suture
lock in accordance with the present invention may be deployed
through a sheath or other medical device which may be deployed
within the tissue tract.
[0063] Although the present invention has been described for use
with a suture having two suture ends it is contemplated according
to the alternative embodiments of the present invention that the
suture lock may be integrally formed with one end of the suture or
be used with a suture having a pre-formed loop, wherein the free
suture end would be passed through the suture loop, through the
vessel wall, across the opening and back through the tissue wall,
whereby the free end of the suture would then be passed through the
aperture of the suture lock. It is further contemplated that the
suture lock may be integrally formed with a suture delivery device
such as that shown and described in U.S. Pat. No. 6,136,010,
wherein the device of the '010 patent would deliver a suture across
an opening and deploy the suture lock to close the opening in the
tissue.
[0064] Although the present invention has been shown and described
as being utilized to close an opening formed in a vessel wall, it
is contemplated that the suture lock may be utilized to close other
openings in tissue, such as PFOs.
[0065] It is further contemplated that the suture and the suture
lock in accordance with the present invention may be constructed of
a bio-absorbable material, thus, at a time after the surgical
procedure no foreign material would remain within the patient's
body.
[0066] Although the present invention has been described in
connection with the preferred form of the device and methods of
practicing it and modifications thereto, those of ordinary skill in
the art will understand that many other modifications can be made
thereto within the scope of the claims that follow. Accordingly, it
is not intended that the scope of the invention in any way be
limited by the above description, but instead be determined
entirely by reference to the claims that follow.
* * * * *