Note: Within nine months of the publication of the mention of the grant of the European patent in the European

Patent
Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the
Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been
paid. (Art. 99(1) European Patent Convention).
Printed by Jouve, 75001 PARIS (FR)
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(12) EUROPEAN PATENT SPECIFICATION
(45) Date of publication and mention
of the grant of the patent:
28.05.2014 Bulletin 2014/22
(21) Application number: 98938331.0
(22) Date of filing: 03.08.1998
(51) Int Cl.:
A61B 17/04
(2006.01)
(86) International application number:
PCT/US1998/016196
(87) International publication number:
WO 1999/007291 (18.02.1999 Gazette 1999/07)
(54) SUTURE RETROGRADER
NHDRAHTZIEHVORRICHTUNG
PREHENSEUR DE FILS DE SUTURE
(84) Designated Contracting States:
DE FR GB IT
(30) Priority: 06.08.1997 US 907223
(43) Date of publication of application:
21.06.2000 Bulletin 2000/25
(60) Divisional application:
10175567.6 / 2 286 730
10179204.2 / 2 263 557
(73) Proprietor: DePuy Mitek, LLC
Raynham, MA 02767 (US)
(72) Inventors:
REIMELS, William, J.
Scituate, MA 02066 (US)
WENSTROM, Richard, F., Jr.
Norwood, MA 02062 (US)
(74) Representative: Tunstall, Christopher Stephen et
al
Carpmaels & Ransford LLP
One Southampton Row
London WC1B 5HA (GB)
(56) References cited:
US-A- 4 174 715 US-A- 5 211 650
US-A- 5 226 908 US-A- 5 250 054
US-A- 5 447 512 US-A- 5 449 366
US-A- 5 474 565 US-A- 5 501 692
US-A- 5 569 269 US-A- 5 643 292
US-A- 5 653 716
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Description
FIELD OF THE INVENTION
[0001] The invention relates to surgical instruments for
grasping a suture or similar ligature within a patients
body. More particularly, the invention relates to suture
grasping devices suitable for grasping a length of suture
and drawing or pulling the suture through tissue in either
open or closed surgical settings.
BACKGROUND OF THE INVENTION
[0002] A variety of devices and methods for grasping
free suture portions or passing suture material through
tissue are known in the art.
[0003] One method for passing a suture end through
tissue involves attaching the suture end to a needle. The
needle can then be passed through the tissue using a
needle manipulating device. Once passed through the
tissue, a separate device, known as a retrograder, may
be employed to retrieve or otherwise manipulate the nee-
dle and suture.
[0004] In other methods, sharpened needle tips having
suture grasping structures located within or near the nee-
dle tip may be used to grasp a suture, then penetrate the
tissue to leave the suture end on the far side of the tissue
where it can be grasped for further manipulation. Or, such
a device may be used to penetrate the tissue first, grasp
a suture on the far side of the tissue, and pull the suture
back through the tissue.
[0005] The suture grasping elements employable in
such devices can have various configurations. U.S. Pat-
ent No. 5,569,269 discloses the use of two wire-like el-
ements, one of which has a hook-shaped configuration.
U.S. Patent No. 5,496,335 discloses a suture grasping
element having forcep jaws with sharpened tips. U.S.
Patent No. 5,501,692 discloses a suture grasping ele-
ment in the form of a looped wire.
[0006] The known devices suffer from some draw-
backs. In closed surgery, especially in arthroscopic sur-
gery involving a joint such as a knee or shoulder, space
and visibility constraints at the surgical site render it dif-
ficult to fully extend a suture grasping device to easily
grasp a suture. Thus, it can be difficult to locate and grasp
a portion of a suture during closed surgical procedures
using the above described devices.
[0007] Also, because many of these devices have
sharp edges that help to grasp the suture, there is a risk
that the suture material will be cut while performing the
desired suture manipulation at the surgical site. Likewise,
some known suture grasper devices have grasping ele-
ments that can become caught or entangled in soft tissue
during surgery. This entanglement, in turn, can lead to
the permanent deformation of the grasping element
and/or the unintentional damaging of tissue.
SUMMARY OF THE INVENTION
[0008] The present invention provides a grasping de-
vice comprising: an elongate housing having a proximal
end, a distal end, a sidewall disposed between the prox-
imal and distal ends and a longitudinal axis; a hollow
introducer needle having a proximal end attached to the
distal end of the housing, and an open distal end having
a tissue penetrating edge; a suture grasping element dis-
posed within the open distal end of the introducer needle,
the suture grasping element being selectively movable
between at least extended and retracted positions; and
an actuator element slidably mounted on the sidewall of
the housing, the actuator being effective to move the su-
ture grasping element between extended and retracted
positions; characterized in that: the actuator element is
movable among a first position in which the suture grasp-
ing element is fully retracted within the introducer needle,
an intermediate position in which the suture grasping el-
ement is partially extended from the introducer needle
and a second position in which the suture grasping ele-
ment is fully extended from the introducer needle, and
wherein a biased detent means is provided in the housing
for releasable locking the actuator element in at least the
first and intermediate positions.
[0009] US 5653716 discloses a suture manipulating
instrument including an inner movable assembly having
an elongated element which terminates in grasping mem-
bers. The elongated element is embedded in a plunger
which terminates at its proximal end in an enlarged head
or handle.
[0010] Moreover, the actuator element may engage
detents at the extended position in order to lock the suture
grasping element in place at that positions.
[0011] In one embodiment, the suture grasping ele-
ment comprises two jaws. A first jaw includes a pod lo-
cated on a distal end thereof, while a second jaw is mov-
able between opened and closed positions. In the closed
position, the pod contacts a distal portion of the second
jaw in a manner sufficient to retain a suture between the
jaws.
[0012] In another embodiment, the suture grasping el-
ement comprises a compressible, substantially diamond-
shaped wire loop. This structure is also movable among
extended, partially retracted, and fully retracted posi-
tions. When the actuator is moved from the extended
position to the intermediate position, the wire loop com-
presses and is partially retracted into the inner bore of
the introducer needle. In this position, a portion of the
loop that is effective to retain a suture remains extended
from the introducer needle.
[0013] In still another embodiment, the suture grasping
element consists of two wire-like members with at least
one of the members having a substantially transverse
hook formed on its distal end. In the extended position,
the distal portions of the wire-like members are spaced
apart. As the actuator is moved to the intermediate po-
sition, the substantially transverse hook contacts the oth-
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er wire-like members so as to form a closed region be-
tween the members capable of slidably retaining a su-
ture.
[0014] In yet another embodiment, the suture grasping
element is in the form of a U-shaped hook element having
first and second legs, wherein the first leg is larger than
the second leg. The first leg is permanently disposed
within the introducer needle. The second leg has a prox-
imal end that is disposed within the introducer needle
when the U-shaped hook element is in the fully retracted
position and in the partially extended position. When the
actuator is in the fully extended position, the second leg
is disposed outside of the introducer needle so as to de-
fine an opening into a space within the hook element
defined by the longer and shorter legs.
[0015] In the above embodiments, the introducer nee-
dle may be oriented at a variety of angles with respect
to a longitudinal axis of the housing. The introducer nee-
dle may also be hook-shaped or of a generally corkscrew
design.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The invention will be more fully understood by
reference to the following detailed description when con-
sidered in conjunction with the accompanying drawings,
in which:
FIG. 1 is an elevated view with a partial cut-away of
a suture retrograder of the invention illustrating an
open, fully extended suture grasping element;
FIG. 2 is an elevated view with a partial cut-away of
the suture retrograder of FIG. 1, illustrating the suture
grasping element in a fully retracted, closed position;
FIG. 3 is an elevated view, with a partial cut-away,
of the suture retrograder of FIG. 1 showing the suture
grasping element in a partially retracted, intermedi-
ate position;
FIG. 4 is a view of the introducer needle portion of
the suture retrograder of FIG. 1, rotated 90;
FIG. 5 is an elevated view of one embodiment of an
introducer needle portion of a suture retrograder con-
structed according to the present invention;
FIG. 6 is an elevated view of another embodiment
of an introducer needle portion of a suture retrograd-
er in a partially formed state;
FIG. 7 is a view of the introducer needle of FIG. 6,
fully formed and rotated 90;
FIG. 8 is an elevated view of an open, extended su-
ture grasping element having two jaw elements ac-
cording to one embodiment of the invention;
FIG. 8A is an elevated view of the suture grasping
element of FIG. 8 in a partially formed state;
FIG. 8B is an elevated view of an open, extended
suture grasping element having two jaws with addi-
tional angles;
FIG. 9 is an elevated view of a distal portion of the
suture retrograder of FIGS. 1-3 illustrating the suture
grasping element in a fully extended, open position;
FIG. 10 is an elevated view, with a partial cut-away,
of the distal end of the suture retrograder of FIG. 9,
showing the suture grasping element in a partially
retracted, intermediate position;
FIG. 11 is an elevated view, with a partial cut-away,
of the distal end of the suture retrograder of FIG. 9,
showing the suture grasping element in a fully re-
tracted, closed position;
FIG. 11A is an elevated view of a distal portion of a
suture retrograder of the invention having the suture
grasping element of FIG. 8B in a fully extended, open
position;
FIG. 11B is an elevated view, with a partial cut-away,
of the distal end of the suture retrograder of FIG.
11A, showing the suture grasping element in a par-
tially retracted, intermediate position;
FIG. 11C is an elevated view, with a partial cut-away,
of the distal end of the suture retrograder of FIG.
11A, showing the suture grasping element in a fully
retracted, closed position;
FIG. 12 is an elevated view of a distal portion of an
alternative embodiment of the suture retrograder of
the invention, illustrating a looped suture grasping
element in a fully extended, open position;
FIG. 13 is a perspective view, with a partial cut-away,
of the embodiment of FIG. 12 showing the looped
suture grasping element in a partially retracted, in-
termediate position;
FIG. 14 is a perspective view, with a partial cut-away,
of the embodiment of FIG. 12 showing the looped
suture grasping element in a fully retracted, closed
position;
FIG. 15 is a perspective view of a distal portion of an
additional embodiment of the suture retrograder of
the invention, illustrating a suture grasping element
having two wire-like members in a fully extended,
open position;
FIG. 16 is a perspective view, with a partial cut-away,
of the embodiment of FIG. 15 showing the suture
grasping element having two wire-like members in
a partially retracted, intermediate position;
FIG. 17 is a perspective view, with a partial cut-away,
of the embodiment of FIG. 15 showing the suture
grasping element having two wire-like elements in a
fully retracted, closed position;
FIG. 18 is an elevated view with, with a partial cut-
away, of a handle portion of the suture retrograder
device of the invention;
FIG. 19 is an elevated view with a partial cut-away
of an alterative embodiment of a suture retrograder
of the present invention illustrating an open, fully ex-
tended suture grasping element;
FIG. 19A is a front end view of the suture grasping
element of FIG. 19;
FIG. 20 is an elevated view with a partial cut-away
of the suture retrograder of FIG. 19, illustrating the
suture grasping element in a partially retracted, in-
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termediate position;
FIG 20A is a front end view of the suture grasping
element of FIG. 20;
FIG. 21 is an elevated view with a partial cut-away
of the suture retrograder of FIG. 19, illustrating the
suture grasping element in a fully retracted, closed
position;
FIG 21A is a front end view of the suture grasping
element of FIG. 21;
FIG. 22 is an elevated view of a portion of the suture
grasping element of FIG. 19 in a partially formed
state;
FIG. 22A is a sectional view along line 22A-22A of
the suture grasping element of FIG. 22; and
FIG. 23 is a detail view of portion A of the suture
retrograder of FIG. 19.
DETAILED DESCRIPTION OF THE INVENTION
[0017] A surgical device 10 of the invention for grasp-
ing or retrograding a suture or other ligature is illustrated
in FIG. 1. This exemplary instrument includes a housing
12, a hollow introducer needle 14, a suture grasping el-
ement 16, an actuator 18 and a linking member 20 which
connects the actuator 18 to the suture grasping element
16.
[0018] The exemplary housing 12 is elongate, gener-
ally cylindrical and has opposed proximal 22 and distal
24 ends. The shape and dimensions of the housing may
be selected by a person of ordinary skill in the art to allow
the housing to be suitably grasped by a surgeon in an
operating environment.
[0019] The actuator 18 is slidably mounted on a side
wall 26 of the housing 12. In the embodiment shown in
FIG. 1, the actuator has a rectangularly-shaped base and
includes a series of flanges 28 having varying heights
and angled surfaces so as to be easily manipulated in
either of two directions by a surgeons thumb. The actu-
ator 18 is mounted so as to slide in a direction substan-
tially parallel to a longitudinal axis 30 of the housing 12.
The actuator 18 is movable between a first position
(shown in FIG. 2), wherein the actuator 18 is closest to
the proximal end 22 of the housing 12, and a second
position (shown in FIG. 1), wherein the actuator 18 is
closest to the distal end 24 of the housing 12. The actuator
may also be selectively positionable at locations between
the first and second positions as illustrated in FIG. 3.
[0020] The actuator 18 communicates with the interior
of the housing 12 through a transverse member 32. The
transverse member 32 may extend through a rectangular
slot (not shown) in the side wall 26 of the housing 12
along which the actuator 18 slides.
[0021] The transverse member 32 of the actuator 18
is connected to the linking member 20, which may be a
rigid or semi-rigid rod. Preferably, the linking member 20
extends from the transverse member 32 in the interior of
the housing 12 through the interior of the hollow intro-
ducer needle 14 to communicate with the suture grasping
element 16.
[0022] As shown in FIG. 4, the distal end 36 of the
introducer needle 14 has an opening 44, which commu-
nicates with the interior of hollow introducer needle 14.
The edges of the open distal end 46 are sharpened, com-
ing to a point 48 at the distal-most edge. The open distal
end 44 is thus suited to penetrate tissue. The hollow in-
troducer needle 14 has a proximal end 34, which is con-
nected to the distal end 24 of the housing 12, and a distal
end 36.
[0023] The distal end 36 of the introducer needle may
extend at various angles. For example, as shown in FIG.
1, the distal end 36 of the introducer needle 14 is angled
approximately 60 with respect to the longitudinal axis
30 of the housing 12. The distal end 36 of the introducer
needle 14 may take on other configurations as well, such
as a 30 curved distal end 36 (FIG. 5), or a curved distal
end 36 taking the shape of a hook (FIGS. 6 and 7).
[0024] A hook-shaped distal end 36 may be formed as
shown in FIGS. 6 and 7. As illustrated in FIG. 6, the hook
shape may be formed by creating a first curve 38 in the
distal-most region of the introducer needle. A second
curve 40 is formed proximally to the first curve 38, in the
same plane as the first curve 38, but in the opposite di-
rection from the first curve 38. Referring to FIG. 7, where-
in the needle of FIG. 6 is rotated 90, the hook is provided
with a curve 42 in a third direction which is in a plane
perpendicular to the plane in which the first 38 and sec-
ond 40 curves are formed.
[0025] FIGS. 8 through 17 and 19 through 23 illustrate
various embodiments and positions of suture grasping
elements useful with the suture retrograder of the inven-
tion.
[0026] A suture grasping element 16 having a first jaw
50 and a second jaw 52 is illustrated in FIG. 8. The first
jaw 50 is substantially straight and has a pod 54 located
on its distal end 56. The exemplary pod 54 is a cylindrical
structure which extends from the first jaw 50 toward the
second jaw 52. Generally, the pod 54 may have a height
of about 254 mm to 2.54 mm (0.010 to 0.100 inch), and
preferably about 508 mm (0.020 inch). In practice, the
pod may be provided on either or both jaws.
[0027] The second jaw 52 includes at least two seg-
ments 58, 60. The first, angled segment 58 angles away
from the first jaw 50. Accordingly, the first segment 58
has a proximal end 62 which is in proximity to the first
jaw 50, and a distal end 64 which is spaced apart from
the first jaw 50. The angle between the first segment 58
and the first jaw 50 is preferably in a range between about
15 and 45. In the exemplary embodiment of FIG. 8, the
first segment 58 is linear and forms an angle of approx-
imately 25 with the first jaw 50. It will be understood,
however, that other second jaw 52 configurations may
be used within the scope of the invention.
[0028] The second segment 60 of the second jaw 52
extends distally from the first segment 58 and is therefore
spaced apart from the first jaw 50. In the exemplary em-
bodiment of FIG. 8, the second segment 60 is substan-
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tially linear and substantially parallel to the first jaw 50.
Accordingly, the second segment 60 is spaced apart from
the first jaw 50 along its length. The spacing between the
pod 54 and the second segment 60 is generally in the
range of about 508 mm to 6.35 mm (0.020 to 0.250 inch),
and is most preferably about 2.54 mm (0.100 inch). The
spaced-apart position of the first 50 and second 52 jaws
as shown in FIG. 8 is referred to herein as the "open"
position. The flexible suture grasping element 16 is bi-
ased to the open position and achieves that position when
the suture grasping element 16 is fully extended from the
introducer needle 14.
[0029] Recessed regions 66, 68 may be provided on
the first 50 and second 52 jaws, respectively. Recessed
region 68 on the second jaw 52 is located at the distal
end of the second segment 60 and extends proximally
over approximately half the length of the second segment
60. Recessed region 66 on the first jaw 52 is provided
adjacent to the pod 54. The recessed regions 66, 68 are
arranged to provide an area wherein, when the jaws 50,
52 are pushed together (the "closed" position), a suture
may be slidably retained.
[0030] The suture grasping structure 16 may be made
from any flexible material suitable for surgical use includ-
ing metals such as stainless steel or super elastic nickel-
titanium (Nitinol) or plastic materials having elastic prop-
erties such as polyester, polypropylene or nylon. In the
exemplary embodiment of FIG. 8, the suture grasping
structure 16 is formed from nickel-titanium tubing. The
suture grasping structure 16 may also include a cut-out
portion 51 wherein approximately half of the flexible tub-
ing is cut away. The cut-out portion 51 preferably corre-
sponds to a region of the flexible tubing that travels within
the curved distal portion 36 of the introducer needle 14.
[0031] The jaws 50, 52 preferably are formed from a
single piece of tubing. In such an embodiment, the pod
54 may also be integrally formed from the same piece of
tubing. FIG. 8A illustrates the formation of the jaws 50,
52 and the pod 54 from a single piece of hypodermic
needle tubing. In the stage of formation shown, the tubing
has been machined, preferably by electric discharge ma-
chining ("EDM"), horizontally along the longitudinal axis
53 to separate two tines corresponding the first 50 and
second 52 jaws, and to create the recessed regions 66,
68. The second jaw 52 may be fully formed by bending
the tine corresponding to second jaw 52 into the form
shown in and described with respect to FIG. 8.
[0032] A vertical cut 55 is also made in the tubing to
separate a tubular portion 57 corresponding to the distal
pod 54. This tubular portion 57 may be formed into the
distal pod 54 shown in FIG. 8 by rotating the tubular por-
tion 57 approximately 90 in a counter-clockwise direc-
tion about the point 59. Preferably, the vertical cut 55 is
angled by approximately 5 so that the tubular portion
may be rotated slightly more than 90.
[0033] The two-jawed suture grasping device 16 of
FIG. 8 may also be formed with additional angles 67, 69
as shown in FIG. 8B. Angle 67 is provided in the first
segment 58 of the second jaw 52 and angle 69 is provided
in the first jaw 50. Generally, the angles are oriented in
the same direction and may range from about 10 to 60.
Furnishing the jaws 50, 52 with additional angles 67, 69
allows for greater curvature in the distal portion 36 of the
inserter needle 14 and results in a greater angular range
of operation for the suture grasping device as a whole.
The angles 67, 69 may be roughly equivalent, through it
is preferred that angle 67 be greater than angle 69 to
provide greater clearance between the jaws 50, 52 in the
open position.
[0034] Referring again to FIG. 1, the suture grasping
device 10 is shown with the suture grasping element 16
in the open, extended position. The actuator 18 is located
in its second, or distal-most, position and the linking mem-
ber 20, which connects the actuator 18 to the suture
grasping element 16, is also in its distal-most position.
Correspondingly, the suture grasping element 16 ex-
tends beyond the distal end 36 of the hollow introducer
needle 14 in its open position as shown in FIG. 9.
[0035] When the suture grasping element 16 is fully
extended, it extends approximately by a distance of about
6.35 mm to 12.7 mm (0.250 to 0.500 inch) beyond the
distal end 36 of the introducer needle 14. The distance
by which the element 16 extends may be varied by a
person of ordinary skill in the art depending upon the
circumstances under which the device of the invention
is used. However, a preferred distance is about 9.525
mm (0.375 inch) when the actuator 18 is in the second,
distal-most position.
[0036] As the actuator 18 is moved from the second,
distal-most position toward the first, proximal-most posi-
tion, the angled first segment 58 of the second jaw 52
contacts the inner wall 70 of the distal end 36 of the hollow
introducer needle 14, and the second jaw 52 is forced
towards the first jaw 50. As the actuator reaches an in-
termediate position, the second jaw 52 contacts the pod
54 on the first jaw 50 (shown in FIG. 10), thereby achiev-
ing a closed state and defining a region 72 between the
jaws 50, 52 wherein a suture may effectively be retained.
When the actuator 18 is in the intermediate position, the
suture retaining region 72 extends beyond the distal end
36 of the introducer needle 14 by a distance of about
0.050 to 12.7 mm (0.500 inch), and preferably about
3.175 mm (0.125 inch), so that a retained suture may be
slidably manipulated by the suture grasping device 10.
The actual distance by which the element 16 extends
may, of course, be varied by a person of ordinary skill in
the art depending upon the circumstances under which
the device of the invention is used.
[0037] When the actuator 18 is moved all of the way
to its first, proximal-most position, the suture grasping
element 16 is fully retracted within the distal end 36 of
the introducer needle 14. The fully retracted position of
the suture grasping element 16, and the suture grasping
region 72, is best seen by reference to FIG. 11.
[0038] The extended, intermediate and retracted posi-
tions of the suture grasping element 16 having additional
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angles 67, 69 (shown in FIG. 8B) are illustrated in FIGS.
11A, 11B and 11C, respectively.
[0039] The suture grasping device of the invention may
utilize other suture grasping element configurations,
such as the wire loop 74 suture grasping element shown
in FIGS. 12-14. As with the two-jaw suture grasping el-
ement 16, the wire loop 74 may be made from a flexible
material suitable for surgical use, including metals such
as stainless steel or super elastic nickel-titanium (Nitinol)
or plastic materials having elastic properties such as pol-
yester, polypropylene or nylon. Preferably, the wire loop
74 is constructed from Nitinol. The wire loop 74 may be
formed from a single, continuous wire element, or it may
be formed using two wire elements joined at a distal por-
tion of each.
[0040] The wire loop 74 of FIG. 12 has two leg seg-
ments 76, 78. Beginning at a proximal end of the wire
loop 74 and moving distally, the leg segments diverge
from one another, reach a point of maximum width there-
between, then converge to meet at a distal end of the
wire loop 74. The wire loop 74 thereby takes on a quad-
rangular or diamond shape when extended, as shown in
FIG. 12. In its extended position, the wire loop 74 has a
maximum width between the leg segments 76, 78 in the
range of approximately 2.54 mm to 20.32 mm (0.100 to
0.800 inch), and more preferably about 10.16 mm (0.400
inch)
[0041] Like the two-jaw suture grasping element 16,
the wire loop 74 may also be retracted to an intermediate
position as shown in FIG. 13. As the actuator 18 is moved
from its second or distal-most position to the intermediate
position, the diverging portions of the two leg segments
76, 78 contact the inner wall 70 of the distal end 36 of
the hollow introducer needle 14. This causes the quad-
rangular shaped wire loop 74 to compress, or fold up, as
it is retracted into the introducer needle 14. When the
actuator 18 reaches the intermediate position, a small
portion of the wire loop 74 remains extended beyond the
distal end 36 of the introducer needle 14 and thereby
defines a region 80 within the loop 74 where a suture
may be retained. The retained suture may then be ma-
nipulated by the suture grasping device 10. In this par-
tially retracted position, the width of the wire loop 74 il-
lustrated in FIG. 13 should be sufficient to slidably retain
a suture within the wire loop 74. This width is generally
in the range of about 0,508 to 6,35 mm (0.020 to 0.250
inch) and more preferably is approximately 1,71 mm
(0.0675 inch). The loop 74 may generally extend approx-
imately 1,71 to 6,35 mm (0.0675 to 0.250 inch), and more
preferably extends 3,18 mm (0.125 inch).
[0042] Moving the actuator 18 to its first, proximal-most
position fully retracts the wire loop 74 within the distal
end 36 of the introducer needle 14 as shown in FIG. 14.
[0043] The suture grasping device of the invention may
also utilize a two member suture grasping element 92 as
illustrated in FIGS. 15-17. The suture grasping element
92 consists of two wire-like members 94, 96. The first
wire-like member 94 has a transverse hooked end 98
which is curved toward the second wire-like member 96,
the curve being formed in a plane that is substantially
transverse to the first wire-like member 94. In general,
the hooked end 98 may be formed on either or both of
the wire-like members 94, 96. FIG. 15 illustrates the two-
member suture grasping element 92 in the fully extended,
open position. In the illustrated embodiment, both wire-
like members 94, 96 are flexible and articulatable. Pref-
erably, the wire-like members are constructed from nick-
el-titanium (Nitinol). The spacing between the transverse
hooked end 98 and the second wire-like member 96 in
the open position is generally in the range of about 1,27
to 12,7 mm (0.050 to 0.500 inch), and is preferably about
6,35 mm (0.250 inch). Fully extended, the wire-like mem-
bers 94, 96 extend a distance of about 6,35 to 12,7 mm
(0.250 to 0.500 inch) beyond the distal end of the intro-
ducer needle 14. A preferred extension distance is about
9,525 mm (0.375 inch).
[0044] The two-member suture grasping element 92
is shown in the partially retracted, intermediate position
in FIG. 16. In this position, the hooked end 98 of the first
wire-like member 94 contacts the second wire-like mem-
ber, and creates a retaining region 90 between the two
wire like members where a suture thread may be slidably
retained. In this position, the suture retaining region 90
extends beyond the distal end 36 of the introducer needle
14 by a distance of about 1.27 mm to 12.7 mm (0.050 to
0.500) inch, and preferably about 3.175 mm (0.125 inch).
[0045] In the partially retracted position, the width of
the suture retaining region 90 should be sufficient to sli-
dably retain a suture between the wire-like members 94,
96. This width is generally in the range of about 0.508
mm to 6.35 mm (0.020 to 0.250 inch), and more prefer-
ably is approximately 1.702 mm (0.067 inch).
[0046] FIG. 17 illustrates the two member suture
grasping element in the fully retracted, closed position.
[0047] Referring to FIG. 18, detents may be provided
to lock the suture grasping device 10 in the fully retracted
and intermediate positions. These detents may suitably
be provided by forming protruberances 82, 84 on the in-
terior of the housing 12 corresponding to the fully retract-
ed and intermediate positions respectively. A biased
member 86 attached to the transverse member 32 of the
actuator 18 has a recess 88 which corresponds to the
shape of the protuberances 82, 84. Accordingly, when
the actuator 18 passes into the first or intermediate po-
sition, a detent is achieved.
[0048] FIGS. 19-23 illustrate an alternate embodiment
of the suture grasping element 116 of the surgical device
100 of the present invention. In this embodiment the su-
ture grasping element 116 comprises a substantially U-
shaped hook element. Like the embodiments of the su-
ture grasping elements described above with respect to
FIGS. 1-17, suture grasping element 116 may be made
from a flexible material suitable for surgical use. In this
embodiment, suitable flexible materials of which the sub-
stantially U-shaped hook element 116 may be made in-
clude a metal such as stainless steel, or a shape memory
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metal alloy such as super elastic nickel titanium, or a
plastic having elastic properties such as polyester, poly-
propylene or nylon. Preferably, the substantially U-
shaped hook element 116 is made of either super elastic
nickel titanium or stainless steel.
[0049] Additionally, in the embodiment of the surgical
device 100 of the present invention that is shown in FIGS.
19-23, the surgical device includes similar internal com-
ponents and is operated by a surgeon in the same way
as the surgical device depicted in FIGS. 1-3. Therefore,
in this substantially U-shaped hook element embodiment
of FIGS. 19-23, the actuator element 18 communicates
with the interior of the housing 12 through a transverse
member 32 which is connected to a linking member 20
which, in turn, communicates with the substantially U-
shaped suture grasping element 116.
[0050] Thus, the substantially U-shaped hook element
116 is also selectively movable among a fully retracted
position wherein the actuator element 18 is closest to the
distal end 24 of the housing 12, a fully extended position
wherein the actuator element is closest to the proximal
end 22 of the housing, and an intermediate position
wherein the actuator element is selectively positioned at
a location between the fully retracted and fully extended
positions. It should be noted that the intermediate posi-
tion of the substantially U-shaped hook element 116 can
correspond to any position between the fully retracted
and fully extended positions of the substantially U-
shaped hook element.
[0051] Furthermore, in this embodiment of the surgical
device 100 of the present invention, the actuator element
18 may also engage detents at each of a rear position
corresponding to the fully retracted position of the sub-
stantially U-shaped hook element 116, an intermediate
position corresponding to the intermediate position of the
substantially U-shaped hook element and a forward po-
sition corresponding to the fully extended position of the
substantially U-shaped hook element. The detents may
be provided similarly to the detents shown and discussed
with respect to FIG. 18. Moreover in this embodiment,
the detents, once achieved, can be disengaged and the
actuator element 18 can be moved, by pressing the ac-
tuator downwardly against a sidewall of the housing 12.
Also, in this embodiment, the actuator element 18 may
be biased away from the sidewall of the housing by
means such as a spring mechanism (not shown).
[0052] As shown in FIGS. 19-23, the U-shaped hook
element 116 includes first and second opposed legs 190,
192 which are joined together by a curved connector seg-
ment 194. Optionally, as depicted in FIGS. 22 and 23,
the second leg 192 may include a proximal segment 192a
which is separated from second leg 192 by a gap 193.
Preferably, the first leg 190 is longer than the second leg
192.
[0053] In the fully extended position, shown in FIGS.
19, 19A and 23, the second leg 192 fully protrudes from
the distal end 36 of the introducer needle 14 such that
gap 193 defines an opening into the space within the U-
shaped hook element 116 defined by the first and second
legs 190, 192. The gap 193 may have dimensions in the
range of about 2.032 mm to 5.08 mm (0.080 inches to
0.200 inches).
[0054] In the intermediate position, shown in FIGS. 20
and 20A, the U-shaped hook element 116 is partially re-
tracted within the distal end 36 of the introducer needle
14. In this intermediate position, the second leg 192 is
partially retracted within the introducer needle 14, thus
closing gap 193. Further retraction of the U-shaped hook
element 116 to the fully retracted position, shown in FIGS.
21 and 21A, causes both the first and second legs
190,192 to be fully disposed within the distal end 36 of
the introducer needle 14.
[0055] The first leg 190 and the second leg 192, al-
though shown in FIG.22 as being parallel to one another,
need not be parallel in order for this embodiment to be
effective. Also, the spacing between the first and second
legs 190, 192 may vary depending upon the require-
ments of a given application. Generally, however, first
and second legs 190, 192 should be spaced apart from
each other by a distance D in the range of about 0.8128
mm to 1.143 mm (0.032 inches to 0.045 inches).
[0056] The width W of the first leg 190 and the second
leg 192, shown in FIG. 22A, may vary within ranges that
will be appreciated by one of ordinary skill in the art. First
and second legs 190, 192 may have the same or different
widths. Generally, the width W is in the range of about
0.381 mm to 0.762 mm (0.015 inches to 0.030 inches).
The curved connector segment 194 of the hook element
116 is shown in FIG. 22 as a substantially semi-circular
element. Depending on the spacing apart of the first leg
190 and the second leg 192, however, the curved con-
nector segment 194 can be a substantially oval or sub-
stantially elliptical element.
[0057] The first leg 190 and the second leg 192 of the
substantially U-shaped hook element 116, as depicted
in FIG. 22A, have a substantially rectangular cross sec-
tion. That is, the width W of each of first and second legs
190, 192 is greater than the height H of the legs. Gener-
ally, the width W is in the range of about 0.381 mm to
0.762 mm (0.015 inches to 0.030 inches), while the height
H is in the range of about 203.2 mm to 304.8 mm (0.008
inches to 0.012 inches). One of ordinary skill in the an
will appreciate that the substantially U-shaped hook el-
ement 116 may be configured to have dimensions other
than those noted above.
[0058] The rectangular cross sectional relationship be-
tween the first and second legs 190, 192 of the substan-
tially U-shaped hook element 116, when combined with
the shape memory metal alloy or stainless steel construc-
tion of the hook element, allows for an advantageous
hook design. For example, this design constrains bend-
ing of the substantially U-shaped hook element 116 to
one plane and prevents rotation of the substantially U-
shaped hook element as it exits the introducer needle
14, thus avoiding problems of tissue entanglement and
hook deformation as the hook element is retracted into
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the introducer needle. This design also allows for the
substantially U-shaped hook element 116 to bend about
a long side of the substantially U-shaped hook element.
[0059] As noted above, the substantially U-shaped
hook element 116 is in communication with the actuator
element 18 through, among other things, a linking mem-
ber 20. The linking member preferably extends from the
transverse member 32 in the interior of the housing 12
through the interior of the hollow introducer needle 14 to
communicate with the suture grasping hook element 116.
The hollow introducer needle 14 has a proximal end 34,
which is connected to the distal end 24 of the housing
12, and a distal end 36. As shown in FIGS. 19-21, the
introducer needle 14 may have a generally hook shaped
distal end; however, the surgical device 100 may also
support an introducer needle that has an alternate design
including, but not limited to, a generally corkscrew de-
sign.
[0060] It will be understood that the foregoing is only
illustrative of the principles of the invention, and that var-
ious modifications can be made by those skilled in the
art without departing form the scope of the claims.
Claims
1. A suture grasping device (10), comprising:
an elongate housing (12) having a proximal end
(22), a distal end (24), a sidewall (26) disposed
between the proximal and distal ends and a lon-
gitudinal axis (30);
a hollow introducer needle (14) having a proxi-
mal end (34) attached to the distal end of the
housing, and an open distal end (36) having a
tissue penetrating edge;
a suture grasping element (16, 74, 92, 116) dis-
posed within the open distal end of the introduc-
er needle, the suture grasping element being
selectively movable between at least extended
and retracted positions; and
an actuator element (18), the actuator being ef-
fective to move the suture grasping element (16,
74, 92, 116) between extended and retracted
positions; characterized in that:
the actuator element (18) is slidably mount-
ed on the sidewall of the housing, and is
movable among a first position in which the
suture grasping element (16, 74, 92, 116)
is fully retracted within the introducer nee-
dle, an intermediate position in which the
suture grasping element is partially extend-
ed from the introducer needle and a second
position in which the suture grasping ele-
ment is fully extended from the introducer
needle, and wherein a biased detent means
is provided in the housing for releasably
locking the actuator element in at least the
first and intermediate positions.
2. The device of claim 1, wherein the suture grasping
element comprises:
a first jaw (50) having a pod (54) located on a
distal end (56) thereof, and
an articulatable second jaw (52) movable be-
tween a closed position wherein a distal portion
of the second jaw contacts the pod element on
the first jaw in a manner sufficient to retain a
suture between the jaws, and an open position
wherein the second jaw is spaced apart from the
first jaw.
3. The device of claim 2, wherein when the actuator
element is in the intermediate position, the suture
grasping element is partially extended from the in-
troducer needle and the second jaw is in the closed
position, and when the actuator element is in the
second position, the suture grasping element is fully
extended from the introducer needle and the second
jaw is in the open position.
4. The device of claim 2, wherein the second jaw is
biased to the open position and moves to the closed
position from contact by the second jaw with an inner
surface of the distal end of the hollow introducer nee-
dle.
5. The device of claim 2, wherein the first jaw is sub-
stantially straight, and the second jaw consists of at
last two segments including a first segment (58)
forming an angle of between about 15 and 45 with
the first jaw, and a second segment (60), that is distal
to the first segment: substantially parallel to the first
jaw and spaced apart from the first jaw.
6. The device of claim 1, wherein the suture grasping
element comprises a wire loop (74) having at a prox-
imal end two leg segments (76, 78) that diverge from
one another and then converge to meet one another
at a distal end thereof, the suture grasping element
substantially forming a diamond shape when the su-
ture grasping element is fully extended.
7. The device of claim 6, wherein the suture grasping
element is made from a deformable material that is
able to be compressed to fit within the inner bore of
the hollow introducer needle in the retracted position
and to expand to the substantially diamond-shaped
configuration when in the extended position.
8. The device of claim 1, wherein the suture grasping
element comprises a first wire-like member (94) hav-
ing a transverse hook (98) and a second wire-like
member (96).
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9. The device of claim 8, wherein the first and second
wire-like elements are spaced apart in the fully ex-
tended position, and the transverse hook contacts
the second wire-like element in the intermediate, par-
tially extended position in a manner sufficient to re-
tain a suture between the first and second wire-like
elements.
10. The device of claim 1, wherein the suture grasping
element comprises a substantially U-shaped hook
element (116).
11. The device of claim 10, wherein the suture grasping
element further comprises a first leg (190) having
the U-shaped hook element and a second, shorter
leg (192a).
12. The device of claim 1, wherein the sumre grasping
element is sized and configured to form a closed
region to slidably retain a suture in the intermediate
position.
Patentansprche
1. Nahtmaterial-Greifvorrichtung (10), umfassend:
ein langgestrecktes Gehuse (12) mit einem
proximalen Ende (22), einem distalen Ende
(24), einer Seitenwand (26), die zwischen den
proximalen und distalen Enden angeordnet ist,
und einer Lngsachse (30);
eine hohle Einfhrungsnadel (14) mit einem pro-
ximalen Ende (34), das an dem distalen Ende
des Gehuses befestigt ist, und mit einem offe-
nen distalen Ende (36) mit einem Gewebe pe-
netrierenden Rand;
ein Nahtmaterial-Greifelement (16, 74, 92, 116),
das in dem offenen distalen Ende der Einfh-
rungsnadel angeordnet ist, wobei das Nahtma-
terial-Greifelement selektiv zumindest zwischen
ausgezogenen und
zurckgezogenen Stellungen bewegt werden
kann; und
ein Bettigungselement (18), wobei das Betti-
gungselement das Nahtmaterial-Greifelement
(16, 74, 92, 116) zwischen ausgezogenen und
zurckgezogenen Stellungen bewegen kann;
dadurch gekennzeichnet, dass:
das Bettigungselement (18) gleitend an
der Seitenwand des Gehuses befestigt ist
und zwischen einer ersten Stellung, in der
das Nahtmaterial-Greifelement (16, 74, 92,
116) vollstndig in die Einfhrungsnadel zu-
rckgezogen ist, einer Zwischenstellung, in
der das Nahtmaterial-Greifelement teilwei-
se aus der Einfhrungsnadel ausgezogen
ist, und einer zweiten Stellung, in der das
Nahtmaterial-Greifelement vollstndig aus
der Einfhrungsnadel ausgezogen ist, be-
wegt werden kann, und worin ein vorge-
spanntes Sperrmittel in dem Gehuse zur
lsbaren Arretierung des Bettigungsele-
ments zumindest in der ersten Stellung und
in der Zwischenstellung vorgesehen ist.
2. Vorrichtung nach Anspruch 1, worin das Nahtmate-
rial-Greifelement Folgendes umfasst.
eine erste Backe (50) mit einem Halter (54) auf einem
distalen Ende (56) davon, und eine gelenkig beweg-
liche zweite Backe (52), die zwischen einer ge-
schlossenen Stellung, in der ein distaler Abschnitt
der zweiten Backe mit dem Halterelement auf der
ersten Backe auf eine zum Halten eines Nahtmate-
rials zwischen den Backen ausreichende Weise in
Berhrung steht, und einer offenen Stellung, in der
die zweite Backe von der ersten Backe beabstandet
ist, bewegt werden kann.
3. Vorrichtung nach Anspruch 2, worin das Nahtmate-
rial-Greifelement teilweise aus der Einfhrungsna-
del ausgezogen ist und sich die zweite Backe in der
geschlossenen Stellung befindet, wenn sich das Be-
ttigungselement in der Zwischenstellung befindet,
und das Nahtmaterial-Greifelement vollstndig aus
der Einfhrungsnadel ausgezogen ist und sich die
zweite Backe in der offenen Stellung befindet, wenn
sich das Bettigungselement in der zweiten Stellung
befindet.
4. Vorrichtung nach Anspruch 2, worin die zweite Ba-
cke in die offene Stellung vorgespannt ist und sich
aus der Berhrung der zweiten Backe mit einer In-
nenflche des distalen Endes der hohlen Einfh-
rungsnadel in die geschlossene Stellung bewegt.
5. Vorrichtung nach Anspruch 2, worin die erste Backe
im Wesentlichen gerade ist und die zweite Backe
aus zumindest zwei Segmenten besteht,
einschlielich eines ersten Segments (58), das ei-
nen Winkel zwischen ca. 15 und 45 mit der ersten
Backe bildet, und eines zweiten Segments (60), das
distal zum ersten Segment im Wesentlichen parallel
zu der ersten Backe und im Abstand von der ersten
Backe liegt.
6. Vorrichtung nach Anspruch 1, worin das Nahtmate-
rial-Greifelement eine Drahtschlaufe (74) mit zwei
Schenkelsegmenten (76, 78) an einem proximalen
Ende, die auseinander laufen und dass wieder zu-
einander verlaufen und an einem distalen Ende da-
von aufeinandertreffen, umfasst, wobei das Nahtma-
terial-Greifelement im Wesentliche eine Diamant-
form bildet, wenn das Nahtmaterial-Greifelement
vollstndig ausgezogen ist.
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7. Vorrichtung nach Anspruch 6, worin das Nahtmate-
rial-Greifelement aus einem verformbaren Material
besteht, das zusammengedrckt werden kann, da-
mit es in die Innenbohrung der hohlen Einfhrungs-
nadel in der zurckgezogenen Stellung passt und
sich in der ausgezogenen Stellung zu der im We-
sentlichen diamantfrmigen Gestalt ausdehnen
kann.
8. Vorrichtung nach Anspruch 1, worin das Nahtmate-
rial-Greifelement ein erstes drahtartiges Element
(94) mit einem Querhaken (98) und ein zweites
drahtartiges Element (96) umfasst.
9. Vorrichtung nach Anspruch 8, worin die ersten und
zweiten drahtartigen Elemente in der vollstndig
ausgezogenen Stellung voneinander beabstandet
sind und der Querhaken das zweite drahtartige Ele-
ment in der teilweise ausgezogenen Zwischenstel-
lung auf eine zum Halten eines Nahtmaterials zwi-
schen den ersten und zweiten drahtartigen Elemen-
ten ausreichende Weise berhrt.
10. Vorrichtung nach Anspruch 1, worin das Nahtmate-
rial-Greifelement ein im Wesentlichen U-frmiges
Hakenelement (116) umfasst.
11. Vorrichtung nach Anspruch 10, worin das Nahtma-
terial-Greifelement ferner einen ersten Schenkel
(190) mit dem U-frmigen Hakenelement und einen
zweiten krzeren Schenkel (192a) umfasst.
12. Vorrichtung nach Anspruch 1, worin das Nahtmate-
rial-Greifelement eine Gre und Konfiguration zur
Bildung einer geschlossenen Region aufweist, damit
ein Nahtmaterial gleitend in der Zwischenstellung
gehalten werden kann.
Revendications
1. Dispositif (10) de saisie de fil de suture, comportant :
un botier (12) allong prsentant une extrmit
(22) proximale, une extrmit (24) distale, une
paroi latrale (26) dispose entre les extrmits
proximale et distale et un axe (30) longitudinal ;
une aiguille (14) dintroduction creuse prsen-
tant une extrmit (34) proximale fixe lextr-
mit distale du botier, et une extrmit (36) dis-
tale ouverte prsentant un bord assurant la p-
ntration des tissus ;
un lment (16, 74, 92, 116) de saisie de fil de
suture dispos lintrieur de lextrmit distale
ouverte de laiguille dintroduction, llment de
saisie de fil de suture tant mobile slectivement
entre au moins les positions rentre et sortie ; et
un lment (18) actionneur, lactionneur permet-
tant de dplacer efficacement llment (16, 74,
92, 116) de saisie de fil de suture entre les po-
sitions rentre et sortie, caractris en ce que :
llment (18) actionneur est mont de ma-
nire coulissante sur la paroi latrale du bo-
tier, et est mobile entre une premire posi-
tion dans laquelle llment (16, 74, 92, 116)
de saisie de fil de suture est entirement
rentr lintrieur de laiguille dintroduc-
tion, une position intermdiaire dans laquel-
le llment de saisie de fil de suture est
partiellement sorti de laiguille dintroduc-
tion et une seconde position dans laquelle
llment de saisie de fil de suture est en-
tirement sorti de laiguille dintroduction, et
dans lequel un moyen de dtente sollicit
est fourni dans le botier pour verrouiller de
manire librable llment actionneur
dans au moins lesdites premire position et
position intermdiaire.
2. Dispositif selon la revendication 1, dans lequel ll-
ment de saisie de fil de suture comporte :
une premire mchoire (50) dote dune cosse
(54) situe sur une extrmit (56) distale de cet-
te dernire, et une seconde mchoire (52) arti-
culable mobile entre une position ferme dans
laquelle une partie distale de la seconde m-
choire vient en contact avec llment cosse sur
la premire mchoire suffisamment pour retenir
un fil de suture entre les mchoires, et une po-
sition ouverte dans laquelle la seconde mchoi-
re est espace de la premire mchoire.
3. Dispositif selon la revendication 2, dans lequel lors-
que llment actionneur est dans la position inter-
mdiaire, llment de saisie de fil de suture est par-
tiellement sorti de laiguille dintroduction et la secon-
de mchoire est dans la position ferme, et lorsque
llment actionneur est dans la seconde position,
llment de saisie de fil de suture est entirement
sorti de laiguille dintroduction et la seconde mchoi-
re est dans la position ouverte.
4. Dispositif selon la revendication 2, dans lequel la se-
conde mchoire est sollicite vers la position ouverte
et se dplace vers la position ferme depuis son con-
tact par la seconde mchoire avec une surface in-
terne de lextrmit distale de laiguille dintroduction
creuse.
5. Dispositif selon la revendication 2, dans lequel la pre-
mire mchoire est sensiblement rectiligne, et la se-
conde mchoire comporte au moins deux segments
comprenant un premier segment (58) formant un an-
gle compris entre environ 15 et 45 avec la premire
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mchoire, et un second segment (60), qui est distal
par rapport au premier segment sensiblement paral-
lle la premire mchoire et espac de la premire
mchoire.
6. Dispositif selon la revendication 1, dans lequel ll-
ment de saisie de fil de suture comporte une boucle
(74) filaire prsentant une extrmit proximale mu-
nie de deux segments (76, 78) de branches qui di-
vergent lun par rapport lautre et convergent en-
suite pour se rencontrer au niveau dune extrmit
distale de ces derniers, llment de saisie de fil de
suture tant sensiblement en forme de losange lors-
que llment de saisie de fil de suture est entire-
ment sorti.
7. Dispositif selon la revendication 6, dans lequel ll-
ment de saisie de fil de suture est fabriqu dans une
matire dformable qui peut tre comprime pour
loger lintrieur de lalsage interne de laiguille
dintroduction creuse dans la position rentre et pour
se dployer jusqu la configuration sensiblement en
forme de losange lorsquil est dans la position sortie.
8. Dispositif selon la revendication 1, dans lequel ll-
ment de saisie de fil de suture comporte un premier
organe (94) filaire prsentant un crochet (98) trans-
versal et un second organe (96) filaire.
9. Dispositif selon la revendication 8, dans lequel les
premier et second lments filaires sont espacs lun
par rapport lautre dans la position entirement sor-
tie, et le crochet transversal vient en contact avec le
second lment filaire dans la position intermdiaire
partiellement sortie suffisamment pour retenir un fil
de suture entre les premier et second lments filai-
res.
10. Dispositif selon la revendication 1, dans lequel ll-
ment de saisie de fil de suture comporte un lment
(116) crochet sensiblement en forme de U.
11. Dispositif selon la revendication 10, dans lequel ll-
ment de saisie de fil de suture comporte en outre
une premire branche (190) munie de llment cro-
chet en forme de U et une seconde branche (192a)
plus courte.
12. Dispositif selon la revendication 1, dans lequel ll-
ment de saisie de fil de suture est dimensionn et
configur pour former une zone ferme afin de rete-
nir de manire coulissante un fil de suture dans la
position intermdiaire.
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REFERENCES CITED IN THE DESCRIPTION
This list of references cited by the applicant is for the readers convenience only. It does not form part of the European
patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be
excluded and the EPO disclaims all liability in this regard.
Patent documents cited in the description
US 5569269 A [0005]
US 5496335 A [0005]
US 5501692 A [0005]
US 5653716 A [0009]