Note: Descriptions are shown in the official language in which they were submitted.
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INSTRUMENT FOR STORING AND DISPENSING A SURGICAL
FASTENER
The present disclosure relates to a device for
deploying and ejecting a recumbent I-shaped surgical
fastener, the fastener comprising an anchoring bar, a
stop bar and a linking strip. The device is configured
for attachment at a distal end of an instrument for
storing, dispensing and positioning such fasteners. .
WO 03/075773 already discloses an instrument for
dispensing and positioning surgical fasteners with the
aim of fastening the fabric of a prosthesis to human
tissue, for example the abdominal wall of a patient. In
that document, the fasteners are positioned by means of
a hollow, bevelled needle, which passes through the
prosthesis and flesh.
Also disclosed, in document FR 2 876 020, is another
instrument for dispensing and positioning surgical
fasteners, in which the needle is replaced with an
ejection guide, the distal end of which is straight and
not bevelled. Penetration of a fastener into flesh is
ensured by the shape of the distal part of the
anchoring bar, namely a conical shape terminating in a
hemispherical shape.
At rest the ejection guide is'housed in the tubular
body of the instrument and the positioning of the
fasteners is accompanied by the translational movement
of the ejection guide towards the distal end of the
instrument, the length of the projecting part of the
ejection guide at the moment of ejection being equal to
3 mm or less. The fasteners, initially in the form of a
recumbent I, are unfolded inside the ejection guide,
therefore inside the tubular body of the instrument,
and it is only once the stop bar is straightened up
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that it leaves the tubular body.
Such an instrument may be used by introducing the
tubular body into a trocar. The tendency is to use
trocars having the smallest diameter possible, for
example around 5 mm. The diameter of the tubular body
is therefore reduced accordingly. It follows that the
fasteners, which must have dimensions sufficient to
exert their retention function on the prosthesis in
human tissue, are forced, when they are being stored in
this tubular body, to be even more folded-up. Their
deployment is therefore more tricky and, in addition,
it cannot take place in the tubular body, the diameter
of which is smaller than the size of an unfolded
fastener.
One object of the present disclosure is to provide a
device for deploying and ejecting a recumbent I-shaped
surgical fastener, which allows satisfactory deployment
of the fastener even when it is stored in a
small-diameter tubular body.
For this purpose, and according to a first aspect, the
disclosure relates to a device for deploying and
ejecting a recumbent I-shaped surgical fastener. The
fastener comprises an anchoring bar, a stop bar and a
linking strip, the device being intended to be
positioned to the distal end of an instrument for
storing, dispensing and positioning such fasteners. The
device has a longitudinal axis and a distal end that
lies in a plane approximately orthogonal to the
longitudinal axis and includes a first longitudinal
channel emerging at the proximal and distal ends of the
device, in which the anchoring bar of a fastener can
slide longitudinally up to a point where it is ejected
at the distal end of the device, the first channel
having a longitudinal slot intended for passage of the
linking strip of said fastener during said sliding.
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According to a general definition of the disclosure,
the device has an approximately longitudinal bearing
face that defines an open half-space. The device
further includes:
- a second longitudinal channel in which the stop
bar can slide towards the distal end of the device, the
second channel lying approximately in the same plane as
the first channel and the slot of the first channel,
emerging at the proximal end of the device and
extending into the open half-space against the bearing
face;
- a first cam that closes off the distal end of
the second channel and designed to form a stop surface
for the distal end of the stop bar and to allow sliding
from said distal end in the opposite direction to the
first channel so as to produce a pivoting movement of
the stop bar;
- at least one approximately transverse splaying
cam, located proximal to the first cam, capable of
cooperating with the linking strip and/or the stop bar
in order to cause a lateral splaying movement of the
proximal part of the stop bar away from the bearing
face; and
- an approximately transverse escapement cam,
located between the first cam and the one or more
splaying cams, capable of cooperating with the distal
part of the stop bar in order to allow lateral
displacement of the distal part of the stop bar away
from the bearing face, and its disengagement from the
first cam.
When the deployment of the ejection device is fixed to
the distal end of the instrument, the open half-space
lies outside the tubular body of this instrument. It is
in this half-space that the deployment of the fastener
takes place, which is therefore not impeded by the
tubular body of restricted dimensions.
This arrangement, in combination with the fact that the
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first cam is shaped so as to allow the distal end of
the stop bar to slide away from the first channel,
allows the stop bar to pass beyond the diameter of the
deployment/ejection device, both downwards (away from
the first channel) and upwards. This was not possible
with the instruments of the prior art, in which there
was only a means of blocking the distal end of the stop
bar, which did not allow the latter to slide
downwards - it was therefore necessary for the tubular
body to have a large diameter, especially so as to
permit the stop bar to pivot without the proximal end
of the latter being blocked in this movement by butting
against the internal face of the tubular body.
Moreover, owing to the fact that the distal end of the
device lies in a plane approximately orthogonal to the
longitudinal axis, the device is capable of dispensing
the fasteners with minimum trauma.
The first cam may generally lie in a plane orthogonal
to the bearing face and is inclined, on going away from
the first channel, from the proximal end of the device
towards the distal end.
Advantageously, the first cam has, seen in cross
section in a longitudinal plane orthogonal to the
bearing face, a concave shape. It thus.forms a gutter
that allows the distal end of the stop bar to be guided
during its sliding movement, while preventing it from
escaping.
In one embodiment, the device may comprise two splaying
cams designed to cause two sequenced lateral splaying
movements of the proximal part of the stop bar.
The device may also include a longitudinal rib
projecting approximately at right angles from the
bearing face. The proximal face of said rib forms a
first ramp constituting a splaying cam. Furthermore,
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the rib may have a distal part of greater height than
its proximal part, the proximal face of the distal part
of the rib forming a second ramp which, located distal
of the first ramp, constitutes the escapement cam.
In one embodiment, the device includes a cavity formed
in the bearing face, in line with the first channel,
proximal of the proximal face of the rib, the distal
face of which constitutes a subsequent splaying cam.
Moreover, the first channel may have a proximal part of
larger transverse dimension than the distal part, a
side wall of the proximal part of the first channel
forming a ramp over which the distal end of the
anchoring bar of a fastener can slide in order to cause
the lateral displacement of said anchoring bar towards
the distal part of the first channel.
In embodiments, the device may have an approximately
cylindrical shape, with a diameter less than 6 mm. It
may further include a proximal cylindrical appendage of
smaller diameter, intended to be inserted into the
distal end part of an instrument for storing,
dispensing and positioning surgical fasteners.
In one embodiment, the distal end of the device
includes a transverse -wall substantially flanking the
distal outlet of the first channel. The material added
by the presence of this transverse wall provides
further protection of the device and minimizes the
thrust of the distal end of the device against human
tissue when the fastener is being positioned.
According to a second aspect, the disclosure relates to
an instrument for storing, dispensing and positioning
recumbent I-shaped surgical fasteners. The fasteners
include an anchoring bar, a stop bar and a linking
strip. The instrument includes a gripping means
provided with an actuator that can move on a body
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between a pushed-out position and a pushed-in position.
The instrument further includes an elongate tubular
body in which fasteners are stored longitudinally one
behind another. The tubular body is fixed to the body
of the gripping means and further includes a device for
deploying and ejecting a fastener as described above.
The device is fixed to the distal end of the tubular
body so that the open half-space is located outside the
tubular body.
In one embodiment the instrument includes:
- a stationary component housed in the tubular
body and a moving component housed in the tubular body
so that it can be moved in longitudinal translation
with respect to the stationary component by means of an
advancing rod that can be actuated by the actuator.
The stationary and moving components are positioned
along a longitudinal face and each having notches
provided in said longitudinal face, with a pitch
corresponding to the length of the stop bar of a
fastener; and
- a slide placed between the longitudinal faces
of the stationary and moving components, having an
approximately planar main part, a distal part that
bears against the proximal end of the stop bar of the
proximalmost fastener and, in its proximal part, a
first resilient tongue projecting towards the moving
component and a second resilient tongue projecting
towards the,stationary component, each capable of being
engaged in a corresponding notch. The geometry of the
notches is designed so that the displacement of the
moving component with respect to the stationary
component towards the distal end of the instrument
causes, by means of the first tongue being engaged in a
notch of the moving component, the displacement of the
slide in the same direction, until the second tongue of
the slide is engaged in a notch of the stationary
component. The cooperation between the second tongue
and a notch of the stationary component prevents the
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slide from returning towards the proximal end of the
instrument when the moving component is displaced
relative to the stationary component towards the
proximal end of the instrument.
The stationary and moving components may have the form
of semicylinders, the moving component including a
radial orifice into which the curved end of the
advancing rod is inserted.
According to one embodiment, the instrument includes,
fixedly housed in the distal part of the tubular body,
a magazine for storing the fasteners. The magazine
includes a first longitudinal housing that receives the
aligned anchoring bars of the fasteners and,
contiguously, an ejection rod that can be actuated by
the actuator. The magazine further includes a second
longitudinal housing that receives the aligned stop
bars of the fasteners, and a third housing, which joins
the first and second housings, is configured for
passage of the linking strips.
The gripping means may include:
- first and second levers that can be moved, by
pushing in the actuator, between a proximal rest
position and a distal end position. Movement to the
end position causes longitudinal displacement in the
distal direction of a rod for ejecting the distalmost
fastener out of the deployment/ejection device and of a
rod for advancing the fasteners in the tubular body,
respectively;
- a member mounted so as to pivot about a pin
attached to the body of the gripping means, which
member includes a tooth capable of cooperating with a
rack formed on one of the levers during displacement of
the actuator; and
- a flexible return means, one end of which is
connected to the pivoting member and the other end of
which is connected to the body of the gripping means.
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The elastic return means and the profile of the tooth
and the rack are designed so that:
- when the actuator is pushed in as far as an
intermediate pushed-in position, the elastic return
means urges the pivoting member towards a position such
that the cooperation between the tooth of the pivoting
member and the rack of the lever prevents the actuator
from returning to the pushed-out position from said
intermediate pushed-in position; and
- after the levers have reached their distalmost
end position, upon releasing the actuator as far as an
intermediate release position, the flexible return
means urges the pivoting member towards a position such
that the cooperation between the tooth of the pivoting
member and the rack of the lever prevents the actuator
from being pushed in from said intermediate release
position.
A double non-return system may advantageously be
obtained.
Advantageously, the rack of the lever includes, at its
distal end, a tooth of larger size and the pivoting
member includes, on one side, a finger and, on the
other side, a tab that is capable of cooperating with a
stop attached to the body of the gripping means when
the finger comes into contact with the larger tooth, so
that, when the actuator has been pushed in, an elastic
deformation of the tab of the pivoting member in
contact with the stop is necessary in order for the
finger to pass beyond said larger tooth. When the
actuator is pushed in, the user therefore receives a
tactile indication that he has reached the fully
pushed-in position of the actuator, and therefore that
the fastener has been suitably ejected.
The present disclosure also relates to a recumbent
I-shaped surgical fastener having an anchoring bar, a
stop bar and a linking strip, the anchoring bar and the
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stop bar being of solid construction. The distal part
of the anchoring bar of the fastener has approximately
the shape of a truncated cone, the external slope of
the cone, turned towards the outside of the fastener
A', being more accentuated than the internal slope
turned towards the stop bar.
The fastener is deployed from an internal storage
position, in which it has a recumbent "I", shape, to an
operating position, in which it tends towards an
upright "I" configuration. The accentuation of the
external slope of the cone allows the anchoring bar to
pivot more naturally towards the stop bar when the
fastener is being deployed in tissue. Pivoting of the
fastener A' is thus favoured and its deployment towards
an upright "I" configuration is thus facilitated.
In an embodiment, the distal end of this distal part
has a hemispherical shape. Thus, the fastener
penetrates more easily into tissue during its
installation.
One embodiment of the disclosure will now be described
with reference to the appended figures, in which:
- Figure 1 is a side view of an instrument for
storing, dispensing and positioning surgical fasteners
according to an embodiment of the invention;
- Figure 2 is a side view of a recumbent I-shaped
surgical fastener in the storage position;
- Figures 3 and 4 are perspective views, from the
rear and front respectively, of a device for deploying
and ejecting a surgical fastener according to an
embodiment of the invention;
- Figure 5 is a sectional view of the
deployment/ejection device, in a longitudinal plane;
- Figures 6 to 15 illustrate successive steps in
the deployment and ejection of a fastener;
- Figure 16 is a side view showing the mechanism
of the instrument, housed inside the gripping means;
- Figure 17 is a perspective view of the slide in
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the tubular body for advancing the fasteners;
- Figure 18 is a partial schematic view of a
series of fasteners that are stored in a magazine, and
of the distal end of the slide of Figure 17; .
- Figure 19 is a partial cross-sectional view of
the tubular body in the region that receives the
magazine;
- Figures 20 to 21 are schematic representations
in a lateral sectional view of the fastener-advancing
system;
- Figures 23 and 24 are detailed views of the
inside of the gripping means, showing the non-return
system of the actuator;
- Figures 25 to 27 are detailed views of the
inside of the gripping means, showing the system for
indicating the end of push-in travel of the actuator;
- Figure 28 is a perspective view of an
alternative embodiment of the deployment/ejection
device; and
- Figure 29 is a side view of another embodiment
of a fastener intended to be ejected and deployed by
means of the deployment/ejection device.
The instrument 1 shown in Figure 1 is designed to
dispense fasteners A which have, as shown in Figure 2,
the general shape of a recumbent "I" and are composed
of two parallel bars, namely an anchoring bar 2 and a
stop bar 3, joined together by a linking strip 4. The
fastener A is made of plastic, especially a
biocompatible and preferably bioresorbable material.
The distal part 2a of the anchoring bar 2 has a conical
shape. This distal part 2a may include a notch 2b
projecting towards the stop bar 3 in order to protect
the anchoring bar 2/linking strip 4 intersection, which
is stressed at the moment when the fastener A is
ejected and positioned. Furthermore, the distal end 2c
of the anchoring bar 2 has a hemispherical shape.
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The term "proximal" relates to a location closer to the
user of the instrument 1, while the term "distal"
relates to a location further from the user.
The stop bar 3 has a distal end 3a and a proximal end
3b, and has a length L.
The linking strip 4 is joined to the anchoring bar 2,
approximately at the center of the latter, and is
joined to the stop bar 3 in a region close to the
center of the stop bar 3, but slightly offset towards
its proximal end 3b. In one embodiment, the length L of
the anchoring bar may measure 6.5 mm and the anchoring
bar/linking strip join is offset by about 0.5 mm with
respect to the center of the anchoring bar, towards the
distal end of the anchoring bar.
The proximal part, or alternatively the distalpart, of
the stop bar 3 is def ined as that part of the stop bar
3 which is located between its proximal end 3b, or
alternatively its distal end 3a, and the linking region
between the stop bar 3 and the linking strip 4.
In the storage position in the instrument 1, the
fastener A is folded so that the linking strip 4 has
two curved regions (in the vicinity of its points of
attachment to the anchoring bar 2 and the stop bar 3),
and a central zone approximately parallel to the bars
2, 3. In this position, illustrated in Figure 2, the
height H of the fastener may be about 5 mm or less. In
embodiments, the height H of the fastener is no more
than 4 mm.
As shown in Figure 1, the instrument 1 includes a
gripping means B to which a tubular body C having a
longitudinal axis is fixed. A socket D surrounds the
junction region between these two elements. From its
proximal end, the tubular body C includes, as will be
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seen later, a first zone Cl containing a step-by-step
system for advancing the fasteners A followed by a
second zone C2 in which the fasteners A are stored.
Fixedly mounted on the distal end of the tubular body C
is a device 5 for deploying and ejecting the fasteners
A, said device projecting beyond the distal end of the
tubular body C.
The longitudinal mid-plane of the instrument 1 is
defined as the plane passing through the axis of the
tubular body C and dividing the gripping means B into
two approximately identical parts (corresponding to the
plane in which the gripping means B is shown in
Figure 16). The term "transverse" denotes a direction
generally perpendicular to this plane, or a plane
orthogonal to the longitudinal axis of the tubular body
C.
The deployment/ejection device 5 will now be described
with reference to Figures 3 to 5.
The device 5 has an approximately cylindrical shape,
with a diameter of about 5 mm or less. In the example
shown, it is formed from a single metal component. In
one embodiment the device may be made of plastic and/or
formed from several components.
The proximal part of the device 5 forms a cylindrical
appendage 6 intended to be introduced into the tubular
body C. The distal part 7 of the device 5 has a larger
diameter, approximately identical to the outside
diameter of the tubular body C, and thus defines a
shoulder 8 that butts against the distal end of this
body C.
The distal part 7 has the form of a semicylinder
bounded by a bearing face 76 which, in the position in
which the device 5 is fitted onto the instrument 1,
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lies generally in the longitudinal mid-plane of the
instrument. Thus defined is an open half-space - except
upstream - which allows the fastener A to be
satisfactorily deployed. The distal end 9 of the device
5 is approximately planar and orthogonal to the
longitudinal axis. This distal end 9 of the device 5
may be slightly domed, provided that its mean plane is
generally orthogonal to the longitudinal axis of the
device 5.
The device 5 includes a first longitudinal channel 10
offset with respect to the longitudinal axis of the
device 5. For the sake of simplifying the description,
it will be considered hereafter that the first channel
10 is located in the top of the device 5, recognizing
that this device 5, once fitted onto the instrument 1,
may adopt various positions in space during use.
In the proximal part of the device 5, the first channel
10 has a larger cross section, for reasons that will be
explained later. As shown in Figure 5, which is a
sectional view in a plane passing through the
longitudinal axis of the device and orthogonal to the
longitudinal mid-plane, the junction zone between the
proximal and distal parts of the first channel 10 forms
a ramp 12 inclined from the proximal end towards the
distal end, and towards the axis of the cylindrical
distal part of the first channel 10.
The lower zone of the distal part 7 of the device 5 has
a shorter length than the first channel 10. This lower
zone includes a longitudinal rib 13, lying below the
slot 11, substantially along the longitudinal axis of
the device 5 and extending substantially from the
middle of the distal part 7 right to the distal end of
the lower zone. The rib 13 includes a proximal part 14,
the proximal face 15 of which forms a ramp, a higher
distal part 16 of the rib 13 has proximal face 17 which
also forms a ramp.
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A protuberance 18 on the distal part 16 of the rib 13
extends downwards and has a triangular shape in side
view. A proximal face 19 of protuberance 18 is
orthogonal to the longitudinal mid-plane and inclined
downwards from the proximal end of the device 5 towards
the distal end 9. In addition, this proximal face 19
has a concave shape, seen in section in a longitudinal
plane orthogonal to the longitudinal mid-plane.
The device 5 further includes a second longitudinal
channel 20, offset downwards with respect to the
longitudinal axis of the device 5. In the distal part
of the device 5, the second channel 20 is opened
laterally and defined by a zone 21 set back with
respect to the longitudinal mid-plane lying beneath the
rib 13. In the proximal part of the device 5, the
second channel 20 is approximately cylindrical and
joined to the first channel 10 by a longitudinal
housing 22 of downwardly elongate cross section.
The device 5 includes a cavity 23 provided in the wall
24 of the first channel 10, in the distal part 7 of the
device 5, upstream of the proximal face 15 of the rib
13 and close to the shoulder B. The cavity 23 has a
distal face 25 generally orthogonal to the longitudinal
mid-plane.
The description now refers to Figures 6 to 15 which
show the various phases resulting in the deployment and
ejection of a fastener A out of the instrument 1 by
means of the device 5, with a view to fixing a
prosthesis 26 to human tissue 27.
As will be seen later, Figures 5 to 15 the fasteners A
are stored in the tubular body C one behind another
with the anchoring bars 2 lying approximately along
the axis of the first channel 10 and the stop bars 3
along the axis of the second channel 20 (see Figures 5
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and 18) .
As illustrated in Figure 5, while the fasteners A are
being advanced towards the distal end 9 of the device
5, the distal end 2c of the anchoring bar 2 of the
fastener A furthest downstream butts against the ramp
12 which slides over the latter, thus causing, the
lateral displacement of said anchoring bar 2 towards
the distal part of the first channel 10. The anchoring
bar 2 is then pushed towards the distal end 9 of the
device 5, in a longitudinal sliding movement in the
first channel 10, during which the linking strip 4
slides in the slot 11 and. the stop bar 3 is made to
slide in the second channel 20.
When the distal end 3a of the stop bar butts against
the proximal face 19 of the protuberance 18, which
forms a first cam surface (Figure 6), this distal end
3a slides downwards against the proximal face 19, being
guided by the shape of the latter. This pivots the stop
bar (Figure 7) which begins to straighten, while the
anchoring bar 2 starts to project from the device 5.
The junction between the linking strip 4 and the stop
bar 3 is then in contact with the proximal face 15 of
the rib 13, forming a second cam 15 (Figure 8). Second
cam 15 causes a first lateral splaying movement of the
proximal part of the stop bar 3, as shown in top view
in Figure 9.
The proximal part of the stop bar 3 then comes into
contact with the cavity 23 (Figure 10) . As the sliding
of the anchoring bar 2 continues, the distal part of
the stop bar 3 continues to slide downwards against the
proximal face 19. The angle of pivoting of the stop
bar 3 progressively increases and the proximal part of
the stop bar 3 cooperates with the distal face 25 of
the cavity 23, forming a third cam 25. As a result, the
lateral splaying of the proximal part of the stop bar 3
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increases (Figure 11). This lateral splaying allows the
stop bar 3 to avoid the lower face of the first channel
10, which would otherwise prevent the continuation of
the pivoting movement.
Next, the proximal part of the stop bar 3 slides
against the wall 24 of the first channel 10 until the
distal part of the stop bar 3 comes into contact with
the proximal face 17 of the distal part 16 of the rib
13, forming a fourth cam 17 (Figure 12). This movement
results in the lateral displacement of the distal part
of the stop bar 3, which escapes from the proximal face
19. The stop bar 3 is then approximately upright
(Figure 13). The continuation of the thrusting movement
of the anchoring bar 2 results in it being completely
ejected from the device 5 (Figure 14) and then pivoted,
at least through an angle of at least 30 with the
linking strip 4 and preferably an angle ranging up to
90 with this linking strip 4. Preferably, the
anchoring bar 2 pivots until it is approximately
parallel to the upright stop bar 3, which is pressed
against the prosthesis 26, the linking strip 4 then
being approximately perpendicular to the two bars 2, 3
and the fastener A adopting an upright "I
configuration. In this position (Figure 15), the
fastener A holds the prosthesis 26 against the human
tissue 27.
The instrument 1 will now be described in greater
detail.
As illustrated in Figure 16, the gripping means B
includes a body 28, made in two symmetrical parts
assembled by force-fitting them or by means of rivets
or screws, and an actuator 29 mounted so as to move on
the body 28 in an articulated fashion about a
transverse pin 30 of the body 28, between a pushed-in
position and a pushed-out position. A spring 31 urges
the actuator 29 towards its pushed-out position.
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Housed in the body 29 are the following:
- a first control lever 32 articulated to a
transverse pin 33 of the body 28, the upper part of
said control lever 32 including two projections 34
separated laterally from each other (only one of them
being visible in Figure 16); and
- a second control lever 35 articulated to a
transverse pin 36, housed between the two projections
34 of the first lever 32.
The first lever 32 has a circularly arcuate lower end
provided with rack 37 and, in its distal part, with a
larger tooth 38. These projections 34 have a cam-shaped
distal face 39. Furthermore, the first lever 32
includes, in the central part, a projection 40 capable
of cooperating with a transverse lug 41 provided on the
second lever 35. The latter includes a cavity, the
bottom of which forms a transverse cam 42.
The body 28 of the gripping means B also contains a
pivoting member 43 articulated to a transverse pin 44
of the body 28. This pivoting member 43 includes a
tooth 45a (visible in Figures 23 and 24) capable of
cooperating with the rack 37 of the first lever 32, a
finger 45, larger than the tooth 45a, and a tab 46
projecting away from the finger 45. A spring 47 links
the pivoting member 43 to a transverse pin 48 of the
body 28.
The gripping means B is completed, inside the socket D,
with a cylindrical ferrule 49 in which, inside a spacer
50, a piston 51 is fitted. The piston 51 has a thinner
proximal end part 52, introduced between the two
projections 34 of the first lever 32 and, on either
side of the proximal end part 52 and distal thereof,
two curve surfaces 53 that can cooperate with the cam
39 of the projections 34.
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An ejection rod 54 is fixed (for example welded) to the
distal end of the piston 51, near its periphery. This
rod 54 extends longitudinally, approximately as far as
the distal end of the tubular body C. Moreover, the
piston 51 has an approximately central longitudinal
bore in which an advancing rod 55 can slide. The
advancing rod 55 has a proximal end that can cooperate
with the cam 42 of the second lever 35 and a curved
distal end 56, located in the zone Cl of the tubular
body C.
The tubular body C includes a hollow metal envelope 57
(cf. Figure 19) in which various elements are housed.
Fixedly mounted in the second zone C2 of the tubular
body C is a magazine 58 for storing the fasteners A. As
illustrated in Figures 18 and 19, this magazine 58
comprises a first longitudinal housing 59 that receives
the aligned anchoring bars 2 of the fasteners A and,
contiguously, the ejection rod 54, a second
longitudinal housing 60 that receives the aligned stop
bars 3 of the fasteners A, and a third housing 61,
which joins the first and second housings 59, 60, for
passage of the linking strips 4. These housings 59, 60
and 61 are placed in alignment with the channels 10, 20
and with the housing 22 (cf. Figure 3) that are
provided in the device 5. It should be noted that, in
Figure 18, the ejection rod 54 and the magazine 58 have
been truncated in their proximal part in order to make
it easier to understand the figure, all the fasteners A
being in fact housed in the magazine 58. The magazine
58 may be made in several sections joined together
longitudinally.
The first zone Cl of the tubular body C contains a
step-by-step advancing system for the fasteners A,
which system will now be described with reference to
Figures 17 to 22.
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Component 62 is fixed in the envelope 57 of the tubular
body C and is stationary relative to the tubular body
C. Component 63, which can move relative to the
stationary component 62 is also positioned in the
envelope 57. Both these components have the shape of
semicylinders superposed along their longitudinal face
(Figure 20).
Provided in the longitudinal face of each of the
components 62, 63 are notches 64, arranged with a pitch
P approximately equal to the length L of the stop bar 3
of a fastener A. Each notch 64 has an upright
transverse proximal edge 65 and a distal edge 66
inclined to the longitudinal axis of the tubular body C
towards the periphery of the latter, upon moving away
from the distal end of the tubular body C towards this
proximal end.
The stationary component 62 has a proximal cylindrical
part 67 that defines a transverse stop surface 68. The
moving component 63 includes, near its proximal end, a
radial orifice 69 into which the curved end 56 of the
advancing rod 55 is inserted. In addition, a channel
(not shown) is provided in the moving component 63 and
in the proximal cylindrical part 67 of the stationary
component 62, in order to house the ejection rod 54.
Placed between the longitudinal faces of the stationary
component 62 and the moving component 63 is a slide 70,
shown in Figure 17. The slide 70 comprises an
approximately planar main part 71, a wider distal part
72 and, in its proximal part, first and second splayed-
apart resilient tongues 73, 74. The slide 70 is for
example formed from a metal sheet, cut and then folded
onto itself, which may be bonded at the main 71 and
distal 72 parts, but not at the tongue 73, 74, which
are curved away from each other.
Initially, before the first use of the instrument 1,
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the slide 70 is mounted such that the first tongue 73,
projecting towards the moving component 63, is engaged
in the proximal notch 64 of component 63, and the
second tongue 74, projecting towards the stationary
component 62, is engaged in the proximal notch 64 of
component 62. The moving component 63 is in contact
with the transverse stop surface 68 of the stationary
component 62, and the notches 64 of the components 62,
63 face each other in pairs. The distal part 72 of the
slide 70 is engaged in the third housing 61 (Figure
19), bearing against the proximal end 3b of the stop
bar 3 of the proximalmost fastener A.
The operation of the instrument 1 will now be
described.
When a user presses on the actuator 29, it causes the
first lever 32 to start to pivot, which, through the
cooperation between the projection 40 and the lug 41,
results in the second lever 35 pivoting. Through the
cooperation between the proximal end of the advancing
rod 55 and the cam 42 of the second lever 35, the
advancing rod 55 is displaced longitudinally downwards,
taking with it the moving component 63, which slides
longitudinally relative to the stationary component 62
(Figure 21). The mechanism is designed so that this
displacement corresponds to the pitch P, and therefore
to the length L of the stop bar 3 of a fastener A. This
value is, for example, about 7 mm.
During this movement, the proximal edge 65 of the
proximal notch 64 of the moving component 63 pushes the
first tongue 73 downstream. The slide 70 is therefore
displaced downstream (the second tongue 74 deforming
elastically in order to come into the plane of the main
part 71 of the slide 70) and, at the end of the
movement, the second tongue 74 is housed in the notch
64 located immediately distal of the proximal notch of
the stationary component 62.
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The distal part 72 of the slide 70 has therefore pushed
the train of fasteners A via the stop bars 3, distally,
by the distance P, and therefore the distance L.
Consequently, the distalmost fastener A has been
displaced in the deployment and ejection device 5, and
its anchoring bar 2 has slid over the ramp 12 so as to
come into alignment with the ejection rod 54 (Figure
5) .
When the user continues to push in the actuator 29, the
second lever 35 remains immobile, as therefore do the
advancing rod 55, the moving component 63, the slide 70
and the fasteners A (with the exception of the most
downstream one). However, the pivoting of the first
lever 32 continues, which, through the cooperation
between the cams 39 of the projections 34 and the curve
surfaces 53 of the piston 51, results in the ejection
rod 54 sliding longitudinally downstream. It should be
noted that the sliding of the rods 54, 55 is not the
same, this being made possible by the fact that the
advancing rod 55 slides in the piston 51 to which the
ejection rod 54 is fixed.
The distal end of the ejection rod 54 then pushes the
anchoring bar 2 of the fastener A located furthest
downstream into the deployment/ejection device 5. Via
the steps described above (Figures 6 to 15), the
anchoring bar 2 is ejected into the tissue 27, while
the stop bar 3 pivots and the fastener A is deployed.
This deployment takes place in the open half-space of
the device 5, and therefore outside the tubular body C.
The longitudinal travel of the ejection rod 54 is, for
example, about 24 mm.
The user can then release the actuator 29. Various
elastic return means (not shown) allow the rods 54, 55
to return to their initial positions, awaiting the next
time the actuator 29 is pushed in.
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When the advancing rod 55 slides proximally, it brings
the moving component 63 back against the transverse
stop surface 68 of the stationary component 62. However
the second tongue 74, in abutment against the proximal
edge 65 of the notch 64 of the stationary component 62,
prevents the slide 70 from returning further proximal.
In Figure 22, the slide 70 has therefore advanced by
one pitch P distally relative to Figure 20, and it will
therefore be able to advance the train of fasteners A
distally by one pitch the next time the actuator 29 is
pushed in.
Finally, the double non-return system with which the
gripping means B is provided will be described with
reference to Figures 16 and 23 to 27.
Before use, the pivoting member 43 is in the neutral
position, as shown in Figure 16.
When the ac,tuator 29 is pushed in as far as an
intermediate position, wherein the tooth 45a of the
pivoting member 43 cooperates with the rack 37 of the
first lever 32, the spring 47 urges the pivoting member
43 (indicated by the arrow F in Figure 23) in such a
way that the tooth 45a, engaged in the rack 37,
prevents the actuator 29 from returning to the pushed-
out position from said intermediate position. Thus, the
user is forced to continue to press on the actuator in
order for the procedure of advancing, deploying and
ejecting the fastener A to be completely finished. It
is important that the movement of pushing in the
actuator be accomplished right to the end by the user
so as to avoid damaging both the prosthesis and the
instrument.
Towards the end of the movement of pushing in the
actuator 29, the finger 45 of the pivoting member 43
comes into contact with the larger tooth 38
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(Figure 25). This results in the pivoting member 43
pivoting about its pin 44 until the tab 46 comes into
contact with a stop 75 integral with the body 28 of the
gripping means B (Figure 26). An elastic deformation of
the tab 46 of the pivoting member 43 in contact with
the stop 75 is required for the finger 45 to pass
beyond the larger tooth 38 after the actuator has been
pushed in (Figure 27). This constitutes a hard point
felt by the user, who can therefore know whether or not
the end of travel has been reached and, -consequently,
whether the fastener A has been correctly ejected. In
addition, when the finger 45 passes beyond the larger
tooth 38, a sudden pivoting of the first lever 32 takes
place, and therefore a sudden advance of the ejection
rod 54. This impact is transmitted to the distalmost
fastener A which makes it easier to eject and pivot it.
At this step, the pivoting member 43 returns to a
neutral position, similar to that shown in Figure 16,
but this time beyond the toothing 37.
Next, when the actuator 29 is released as far as an
intermediate position, the spring 47 urges the pivoting
member 43 (indicated by the arrow F' in Figure 24) in
such a way that the tooth 45a, engaged in the rack 37,
prevents the actuator 29 from being pushed in from said
intermediate position. Thus, the user cannot start a
new cycle (advance of the train of fasteners and
ejection of the distalmost fastener) until the
mechanism has been returned to its rest position. This
prevents the mechanism from becoming blocked and
guarantees successful ejection of each of the fasteners
A.
Another embodiment of the fastener A' is shown in
Figure 29. Fastener A' has no notch. Fastener A' of
Figure 29 has the general shape of a recumbent "I" in
the storage state. The references denoting the same
elements as in Figure 2 have been preserved. The
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fastener A' comprises an anchoring bar 2 joined to a
stop bar 3 via a linking strip 4. The anchoring bar 2
and the stop bar 3 are of solid construction. The
anchoring bar 2 and the stop bar 3 therefore do not
comprise any hole. In one embodiment, the linking strip
4 is also of solid construction. The fastener A' may be
made of biocompatible and bioresorbable plastic.
The distal end 2c of the anchoring bar 2 has a
hemispherical shape and the distal part 2a of the
anchoring bar 2 has approximately the shape of a
truncated cone, the external slope 2d of the cone,
turned towards the outside of the fastener, being
however -more accentuated than the internal slope 2e,
turned towards the stop bar 3. This accentuation of the
external slope 2d of the cone allows the anchoring bar
2 of the fastener A' to pivot more naturally towards
the stop bar 3 when the fastener is being positioned in
tissue, as shown in Figures 13 to 15 - pivoting of the
fastener A' is thus favored and its deployment towards
an upright "I" configuration is thus facilitated.
In the distal part of the device 5, the first channel
10 is approximately cylindrical and has a longitudinal
slot 11 opened downwards. This first channel 10 emerges
at its distal end near the distal end 9 of the device
5. Figure 28 shows an alternative embodiment of the
device 5 of Figure 4, in which the distal end 9 of the
device 5 includes a transverse wall 9a substantially
flanking the distal outlet of the first channel 10. The
material added by the presence of this transverse wall
9a provides further protection of the device 5-and
minimizes the thrust of the distal end 9 of the device
5 against human tissue when the fastener A is being
positioned, for example during the steps shown in
Figures 6 and 7.
The invention therefore provides a definite improvement
over the prior art, by providing a device for deploying
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and ejecting surgical fasteners and an instrument for
storing, dispensing and positioning them that can be
used in small-diameter trocars, while still
guaranteeing satisfactory deployment of the fasteners
and, consequently, very good retention of a prosthesis
against human flesh.
The invention is not limited to the embodiment
described above by way of example, but on the contrary
it encompasses all alternative embodiments thereof.
