Note: Descriptions are shown in the official language in which they were submitted.
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SURGICAL FASTENING DEVICE
Cross-reference to Related Applications
This application claims the benefit of priority to U.S. Provisional
Application No.
62/312,597, which was filed on March 24, 2016.
Technical Field =
Surgical fastening devices, surgical fasteners, and surgical methods of
fastening a mesh
to tissue.
Background
Prolapse is a medical condition in which organs, such as the uterus, fall down
or slip out
of place. For example, pelvic organ prolapse involves a loosening of
connective tissue that holds
the uterus, allowing the uterus to descend into the vagina. It is estimated
that half of all women
older than 50 years may experience symptomatic prolapse. The health care
impact of prolapse is
likely to expand. based on an aging population. Surgical repair of prolapse
has been one of the
most common procedures performed in women over 70.
Laparoscopic sacrocolpopexy is a surgical technique for repairing pelvic organ
prolapse
in which a piece of a pre-shaped mesh is inserted into the abdomen and
attached at one end to the
vaginal tissue and at the other end to the back portion of the sacral
promontory, thereby lifting
the vagina and preventing the prolapse, Attachment or the mesh to the vagina
wall by suturing is
challenging because it requires the insertion of the suture to a specific
depth into the vaginal
wall. The suture must provide a secure attachment, but should not pass through
the vagina wall
since that could cause serious complications.
Summary
The invention provides devices and methods for delivering surgical fasteners
to a
controlled, specific depth in tissue and locking the fasteners closed to
provide a secure and
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reliable attachment. Devices may be used to secure a mesh to tissue, and thus
may be used in
sacrocolpopexy procedures to treat prolapse conditions such as pelvic organ
prolapse. The
surgical fastening device will automatically apply individual fasteners
through the mesh and into
the vaginal wall. The suture is inserted into a fixed depth, minimizing risk
of piercing through
the vagina wall and providing a reliable attachment. Because the device locks
the individual
fasteners into closed loops, there is no need for knot tying and thus devices
and methods of this
disclosure reduce the time and skill required to perform such a procedure.
Because the procedure
can be performed more readily and quickly than by other methods, the procedure
will be less
expensive and thus more widely available. Device of the invention will allow a
greater number
of people to be treated to alleviate suffering from prolapse conditions.
Surgical fastening devices and fasteners described herein provide benefits and
advantages
for surgical procedures such as laparoscopic sacrocolpopexy for pelvic organ
prolapse (POP).
For example, because a fastener can be wider than a shaft diameter, the
fastener is not limited in
the width to the 5 mm diameter of a laparoscopic instrument. Even for
fasteners that will
penetrate only to a shallow depth, they can be wide (e.g., wider than the
penetration depth). The
generous width contributes to reliably securing a mesh to tissue.
Additionally, devices have a tip that is angled in relation to the tissue or
the shaft of the
device. This means that the device shaft need not point straight towards the
target tissue surface
and a fastener can be deployed somewhat towards the side of the tip of the
shaft. This may be
prove convenient in many procedures.
Devices may be used to apply fasteners into only a very small depth, which is
important
for several applications. Because the device contains a driver member that
extends from a tissue-
facing surface at an acute angle and curves back to the tissue facing surface,
the penetration
depth can be very shallow. The acute angle may preferably he between 5' and 60
. The closed
loop of the fastener can span a width across the tissue that is wide and
therefore strong. In fact,
the width can be wider than a diameter of the shaft of the device. The very
shallow penetration
depth is important in applications such as laparoscopic sacrocolpopexy is
which the fastener
must provide a secure attachment without passing through the vagina wall.
Additionally, the fasteners disclosed herein have no sharp edges pointing into
the tissue.
Such sharp edges may otherwise irritate the nerves and tissue. The disclosed
fasteners, when
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closed, contain all points or barbs within a smooth bowl of material and
present only smooth
surfaces to the surrounding tissue.
The surgical fastening device includes a driver member that extends from a
tissue-
facing surface at an acute angle and curves back to the tissue facing surface.
The driver
member is made of a super-elastic material such as Nitinol. Such a material is
advantageous
because it gives the driver member the strength and shape necessary to allow
it to fasten the
fastener in the shallow, broad, edge-free configuration useful and beneficial
for procedure
such as laparoscopic sacrocolpopexy.
In certain aspects, the invention provides a surgical fastening device. The
device
.. includes a body with a handle with a trigger extending therefrom; a shaft
extending from the
body, the shaft comprising a proximal end and a distal end extending from the
body; a
delivery tip at the distal end of the shaft; a driver member disposed within
the shaft; and a
fastener held at the delivery tip. The fastener has an extended body with a
barbed end and a
receiving end. Operation of the trigger causes the driver member to: push the
barbed end of
the fastener out of a tissue-facing surface of the delivery tip, along a
curved path and back
to the tissue-facing surface, and into the receiving end, thereby forming the
fastener into a
closed fastener; release from the closed fastener; and retract back into the
shaft and engage
a second fastener. Preferably, only a single driver member extends from the
delivery tip to
fasten the fastener. The delivery tip may protrude from the shaft and present
a tissue-facing
surface with an exit port thereon. The fastener is held at the delivery tip at
least partially
within a guide slot in spatial communication with the exit port. Preferably,
the delivery tip
is biased away from the shaft such that an axis of the shaft and the tissue-
facing surface
form an acute angle.
The driver member comprises a shape-memory material that biases the driver
member into a curved shape. When the driver member is disposed within the
shaft, the driver
member is constrained by the shaft into a straight shape. In some embodiments,
the barbed
end of the fastener includes one or more barbs and a pushable surface engaged
with a distal
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tip of the driver member, e.g., disposed within a delivery slot that
terminates at the exit port.
The receiving end of the fastener may define a bowl with an opening and a lip
that overhangs
the opening. The receiving end may be positioned for delivery within a distal
end of the guide
slot within the delivery tip. In certain embodiments, the exit port
encompasses the distal end
of the delivery slot and is in spatial communication with a distal end of the
guide slot.
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Operation of the trigger causes the driver member to: push the barbed end of
the fastener
out of the distal end of the delivery slot, along a curved path to the distal
end of the guide slot,
and into the receiving end of the fastener such that the one or more barbs are
engaged with the
lip of the bowl of receiving end, thereby forming the fastener into a closed
fastener. Preferably,
placing the tissue-facing surface against tissue and pulling the trigger
causes the driver member
to push the barbed end through the tissue and into the receiving end of the
fastener outside of the
tissue such that the closed fastener spans a width W across a surface of the
tissue and penetrates
to a depth H within the tissue. The shaft may have a length L of at least 15
cm and has a diameter
D of less than 1 cm. In certain embodiments, L? 25 cm and D < 7 mm and H <D
<W.
The delivery tip may be bendable towards the axis of the shaft.
The device may include additional fasteners disposed with the shaft, wherein
each
operation of the trigger delivers a single fastener and advances the
additional fasteners towards
the delivery tip.
Aspects of the invention provide a surgical fastener that includes an extended
body, at
least a portion of the extended body being flexibly deformable, the extended
body terminating at
a barbed end and a receiving end, wherein the receiving end defines a bowl
with an opening and
a lip that overhangs the opening. Bending the deformable portion of the
extended body and
inserting the barbed end into the receiving end locks the fastener in a closed
loop. Preferably, the
barbed end comprises a pointed tip for piercing through tissue. When the
fastener is locked in the
closed loop, the pointed tip is confined within the bowl. The closed loop may
include: the barbed
end confined within the bowl, a first portion of the extended body extending
substantially
straight from the bowl, a bent portion of the extended body at an end of the
first portion, and a
bowed portion of the extended body defining a curve between the barbed end and
the bent
portion. In certain embodiments, the closed loop spans a width W from the
barbed end confined
within the bowl to the bent portion and the bowed portion is spaced apart from
the first portion
no greater than a depth H. Preferably, 3 cm > W > H, H <6 mm, or both.
In some embodiments, the barbed end comprises one or more barbs and when the
fastener is locked in the closed loop, the barbs are retained by the lip that
overhangs the opening
of the bowl. When the fastener is locked in the closed loop, the barbs are
confined within the
bowl. The barbed end may include a pushable surface behind the pointed tip.
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In some aspects, the invention provides a surgical fastener that includes an
extended
body, at least a portion of the extended body being flexibly deformable, the
extended body
terminating at a round end and a receiving end defining a loop. The round end
comprises a
bulbous shape that requires the loop to elastically deform for the round end
to pass through the
5 loop. Bending the deformable portion of the extended body and inserting
the round end into the
receiving end locks the fastener in a closed loop. In certain embodiments, the
closed loop spans a
width W from the barbed end confined within the bowl to the bent portion and
the bowed portion
is spaced apart from the first portion no greater than a depth H. Preferably,
3 cm > W > H, H < 6
mm, or both.
In related aspects, the invention provides a surgical fastening device that
includes a body
with a handle extending therefrom; a trigger on the handle; a shaft extending
from the body; a
delivery tip at a distal end of the shaft, the delivery tip protruding from
the shaft and presenting a
tissue-facing surface with an exit port thereon, wherein the delivery tip is
biased away from the
shaft such that an axis of the shaft and the tissue-facing surface form an
acute angle, wherein the
delivery tip is bendable towards the axis of the shaft, and wherein the exit
port includes a distal
end of a delivery slot that carries a barbed end of a fastener positioned
within the shaft and the
exit port is in spatial communication with a distal portion of a guide channel
that includes a
receiving end of the fastener; a driver member disposed within the shaft, the
driver member
comprising a shape-memory material that biases the driver member into a curved
shape, and
wherein when the driver member is disposed within the shaft, the driver member
is constrained
by the shaft into a straight shape; and at least one fastener having an
extended body with a
barbed end held by the delivery slot and a receiving end held by the guide
slot, wherein the
barbed end comprises one or more barbs and a pushable surface engaged with a
distal tip of the
pushing member, and wherein the receiving end defines a bowl with an opening
and a lip that
overhangs the opening, wherein operation of the trigger causes the driver
member to: push the
barbed end of the fastener out of the distal end of the delivery slot, along a
curved path to a distal
end of the guide slot, and into the receiving end of the fastener such that
the one or more barbs
are engaged with the lip of the bowl of receiving end, thereby forming the
fastener into a closed
fastener; release the closed fastener out from a release port; and retract
back into the shaft to
engage a second fastener.
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In some aspects, the invention provides a surgical method of attaching a mesh.
The
method includes obtaining a surgical fastening device that includes a body
with a handle with a
trigger extending therefrom; a shaft extending from the body; a delivery tip
at a distal end of the
shaft; a driver member disposed within the shaft; and a fastener held at the
delivery tip. The
fastener has an extended body with a barbed end and a receiving end.
The method includes operating the trigger to cause the driver member to: push
the barbed
end of the fastener out of the delivery tip, along a curved path, and into the
receiving end,
thereby forming the fastener into a closed fastener; release from the closed
fastener; and retract
back into the shaft and engage a second fastener. Preferably, the delivery tip
protrudes from the
shaft and presents a tissue-facing surface with an exit port thereon. The
fastener is held at the
delivery tip at least partially within a delivery slot terminating at the exit
port. Preferably, a distal
end of the fastener is held within a distal end of a guide slot that extends
through the shaft. In
preferred embodiments of the method, the delivery tip is biased away from the
shaft such that an
axis of the shaft and the tissue-facing surface form an acute angle and the
driver member
comprises a shape-memory material that biases the driver member into a curved
shape.
The method includes constraining the driver member in a straight shape by
having the
driver member disposed within the shaft.
Preferably, the barbed end of the fastener comprises one or more barbs and a
pushable
surface engaged with a distal tip of the driver member and the receiving end
of the fastener
defines a bowl with an opening and a lip that overhangs the opening. The
barbed end may be
held by the delivery slot and the receiving end may be held by the guide slot
(e.g., at the distal
ends of the delivery and guide slots).
The method may include operating the trigger to cause the driver member to:
push the
barbed end of the fastener out of the distal end of the delivery slot, along a
curved path to the
distal end of the guide slot, and into the receiving end of the fastener such
that the one or more
barbs are engaged with the lip of the bowl of receiving end, thereby forming
the fastener into a
closed fastener.
Preferably, the method also includes placing the tissue-facing surface against
tissue and
pulling the trigger, causing the driver member to push the barbed end through
a mesh and the
tissue and into the receiving end of the fastener outside of the tissue such
that the closed fastener
spans a width W across a surface of the tissue and penetrates to a depth H
within the tissue. The
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shaft may have a length L of at least 15 cm and has a diameter D of less than
1.55 cm. In
preferred embodiments of the method, L > 25 cm and D < 10 mm. Also, H <D <W.
The method may include bending the delivery tip towards the axis of the shaft
(e.g., for
insertion through a standard trocar or incision during minimally-invasive
surgery). Method may
include delivering one or more additional fasteners from the shaft, by
operating the trigger to
deliver a single fastener and advance any remaining fasteners towards the
delivery tip.
Brief Description of the Drawings
FIG. 1 shows a surgical fastening device.
FIG. 2 shows a delivery tip of the device.
FIG. 3 shows a surgical fastener of the invention.
FIG. 4 shows the fastener formed into the closed loop.
FIG. 5 shows the fastener being held within the delivery tip.
FIG. 6 gives a detailed view of a barbed end of the fastener and a driver
member.
FIG. 7 shows the driver member extended along a curved path.
FIG. 8 shows the driver member released from the closed fastener.
FIG. 9 shows the closed fastener released from a guide slot.
FIG. 10 shows the fastener formed into a closed loop.
FIG. 11 shows positioning the device against a surface of tissue.
FIG. 12 shows the driver member extended through the tissue.
FIG. 13 shows the closed loop holding a mesh to the tissue.
FIG. 14 shows a device loaded with multiple fasteners.
FIG. 15 is a profile of the delivery tip.
FIG. 16 shows the delivery tip bent.
FIG. 17 shows slits that may be included on the delivery tip.
FIG. 18 illustrates pelvic organ prolapse.
FIG. 19 diagrams a sacrocolpopexy procedure.
Detailed Description
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Devices and methods for delivering surgical fasteners to a specific depth in
tissue and
locking the fasteners to secure a mesh to tissue are useful for sacrocolpopexy
procedures to treat
prolapse conditions such as pelvic organ prolapse. Devices of the invention
generally have a
body with a handle and an extended shaft dimensioned for minimally invasive
surgery. That is,
the shaft is preferably smaller in diameter than a standard trocar (e.g., may
be < about 15.5 mm
in diameter, preferably < 10 mm). The shaft is preferably long enough to reach
a surgical target,
e.g., at least about 15 cm long, preferably at least 25 cm long. The shaft
terminates in a delivery
tip that presents a tissue-facing surface at an acute angle to an axis of the
shaft. Due to this
arrangement, when a driver member extends from the shaft while the tissue-
facing surface is
held against a surface of target tissue, the driver member initially
penetrates the tissue at an acute
angle (e.g., between about 25 and 65 ), which allows the fastener to be wide
while limiting
penetration depth, minimizing risk of piercing through the tissue (e.g.,
vagina wall) and
providing a reliable attachment. The fastener may be wider than a diameter of
a shaft of the
device, the fastener is not limited in the width to the diameter of a
laparoscopic instrument. Even
for fasteners that will penetrate only to a shallow depth, they can he wide
(e.g., wider than the
penetration depth). The closed loop of the fastener can span a width across
the tissue that is wide
and therefore strong. In fact, the width can be wider than a diameter of the
shaft of the device.
The fasteners preferably capture any point or barbs within a smooth bowl once
fastened and thus
have no sharp edges that would otherwise irritate the nerves and tissue. The
driver member is
made of a super-elastic material such as Nitinol. Such a material is
advantageous because it gives
the driver member the strength and shape necessary to allow it to fasten the
fastener in the
shallow, broad, edge-free configuration useful and beneficial for procedure
such as laparoscopic
sacrocolpopexy.
FTG. 1 shows a surgical fastening device 101. The device 101 includes a body
109 with a
handle 113 with a trigger 117 extending therefrom; a shaft 103 extending from
the body 109; and
a delivery tip 201 at a distal end of the shaft. The trigger 117 is operably
engaged with a driver
member that extends through shaft 103. Any suitable engagement may be used.
For example, the
trigger may present a curved, geared surface within the body 109. The curved
geared surface
may engage a geared slot wheel (through any optional stepper gears that
increase or decrease a
magnitude of rotation imparted when the trigger 117 is squeezed to rotate
about a pivot). The
geared slot wheel within handle 109 may include an eccentric slot and a
proximal end of the
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driver member may have a pin engaged into the slot. Squeezing the trigger
causes the slot wheel
to rotate. The eccentric slot pushes the pin in a direction that includes
displacement parallel to an
axis of the shaft 103. The displacement of the pin pushes the driver member in
a direction distal
along shaft 103 and then pull the driver member back in a proximal direction.
Thus, squeezing
the trigger 117 causes the driver member to translate along the shaft outwards
and back to deliver
a fastener as described below. A suitable geared trigger with slot wheel and
pin that may be
modified for use with the invention is shown in U.S. Pat. 8,535,339 (e.g., see
FIG. 14 and
accompanying text).
FIG, 2 shows the delivery tip 201. The delivery tip 201 includes an extension
205
protruding from the shaft 103 and presenting a tissue-facing surface 207 with
an exit port 221 in
spatial communication with a guide slot 215. The exit port 221 is proximal to
the axis of the
shaft and include a distal end of a delivery slot 225. The guide slot 215
extends from within the
shaft 103 and curve through the extension 205 and terminates at a release port
209. The delivery
slot 225 opens into the exit port 221, which allows a driver member to be
pushed outwards from
the shaft and through the exit port 221. The delivery tip 201 is biased away
from the shaft 103
such that an axis of the shaft and the tissue-facing surface 207 form an acute
angle. The guide
slot 215 holds an end of a fastener 301 therein.
FIG. 3 shows the surgical fastener 301. The fastener 301 includes an extended
body 321,
at least a portion 319 of the extended body 321 being flexibly deformable. The
extended body
321 terminates at a barbed end 305 and a receiving end 339. Preferably, the
receiving end 339
defines a bowl 327 with an opening and a lip 333 that overhangs the opening.
The barbed end 305 may include a pointed tip 341 for piercing through tissue.
Bending the deformable portion 319 of the extended body and inserting the
barbed end
305 into the receiving end 339 locks the fastener 301 in a closed loop 401.
The barbed end 305 of the fastener 301 has one or more barbs 311. In preferred
embodiments, the barbed end 305 includes one or more pushable surfaces 317
behind the pointed
tip 341.
FIG. 4 shows the fastener 301 formed into the closed loop 401. When the
fastener 301 is
locked in the closed loop 401, the pointed tip 341 is confined within the
bowl. Preferably, the
closed loop 401 includes the barbed end 305 confined within the bowl 327, a
first portion 415 of
the extended body 321 extending substantially straight from the bowl 327, a
bent portion 411 of
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the extended body 321 at an end of the first portion 415, and a bowed portion
407 of the
extended body 321 defining a curve between the barbed end 305 and the bent
portion 411. When
the fastener 301 is locked in the closed loop 401, the barbs are confined
within the bowl 327.
Specifically, when the fastener 301 is locked in the closed loop 401, the
barbs 311 are
5 retained by the lip 333 that overhangs the opening of the bowl 327.
FIG. 5 shows the fastener 301 being held within the delivery tip 201. A driver
member
601 is disposed within the shaft 103, in which the driver member 601 is
channeled and guided by
a delivery slot 225 that extends within the shaft 103. It can be seen that the
receiving end 339 of
the fastener 301 is held within the guide slot 225. The barbed end 305 of the
fastener 301 is held
10 by the delivery slot 225. The pushable surface 317 on the barbed end 305
is oriented to engage
with a distal tip 611 of the driver member 601. The exit port 221 defines a
space through which
the driver member 601 can push the barbed end 305 of the fastener 301 out of
the shaft 103.
As shown in FIG. 5, the guide slot 215 holds the receiving end 339 of the
fastener 301
and the delivery slot 225 holds the barbed end 305 of the fastener 301. The
receiving end 339 is
held in place during operation of the device 101 to prevent its retraction
back into the shaft 103
due to tension at the fastener. The guide slot 215 is open at a release port
209 on a distal end of
the guide slot 215 in order to facilitate release of the closed fastener 401
from the device once the
fastener is delivered and locked. Preferably, the guide slot 215 is
characterized by having a
narrow width along the tissue-facing surface 207 in order to hold the
receiving end 339 during its
.. advance along the slot 215. In some embodiments, the device 101 includes a
spring-loaded
mechanism in the operation handle in order to facilitate faster application
which can be necessary
for better penetration through tissue.
FIG. 6 gives a detailed view of the barbed end 305 of the fastener 301 and the
distal tip
611 of the driver member 601. The pushable surface 317 includes a recess
defined to receive the
distal tip 611. The driver member 601 may also include a thinner extension
portion 607 to fully
engage with the pushable surface 317 on the barbed end 305 of the fastener
301. The barbed end
305 of the fastener 301 has barbs and a pushablc surface 317 engaged with a
distal tip 611 of the
driver member 601 (in FIG. 6, the pushable surface 317 and the distal tip 611
are spaced apart to
aid visualization, but one will readily appreciate that the distal tip 611
engages the pushable
surface 317). FIGS. 6-10 illustrate operation of the surgical fastening device
101 in response to
one operation of the trigger 117.
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Pulling the trigger 117 causes the driver member 601 to push the barbed end
305 of the
fastener out of the delivery slot 225 on the delivery tip 201, along a curved
path, and into the
receiving end 339, thereby forming the fastener into a closed fastener 401,
release from the
closed fastener 401, and retract back into the shaft 103 and engage a second
fastener.
FIG. 7 shows the driver member 601 extended along a curved path, pushing the
barbed
end 305 of the fastener 301 into the receiving end 339. It will be appreciated
that the driver
member 601 includes a shape-memory material that biases the driver member 601
into a curved
shape as seen in FIG. 7. When the driver member 601 is disposed within the
shaft 103, the driver
member 601 is constrained by the delivery slot 225 in the shaft 103 into a
straight shape.
FIG. 8 shows the driver member 601 released from the closed fastener 401.
Specifically,
operation of the trigger 117 has caused the driver member 601 to push the
barbed end 305 of the
fastener 301 out of the exit port 221 on the delivery tip 201, along a curved
path and into the
receiving end 339 held within the guide slot 215, such that the one or more
barbs 311 are
engaged with the lip 333 of the bowl 327 of receiving end 339, thereby forming
the fastener 301
into a closed fastener 401.
FIG. 9 shows the closed fastener 401 released through the release port 209 as
the driver
member 601 retracts back into the shaft 103 and engage a second fastener.
An important feature of the surgical fastening device 101 is the control over
delivery
depth and the fastening strength that are afforded by the particular
dimensional relationships of
the fastener 301 and the device 101. Placing the tissue-facing surface 207
against tissue and
pulling the trigger 117 causes the driver member 601 to push the barbed end
through the tissue
and into the receiving end 339 of the fastener back on the outside of the
tissue, forming the
fastener 301 into the closed loop 401.
FIG. 10 shows a fastener 301 formed into the closed loop 401 with the delivery
tip 201
still in place against tissue 505. Here, the device 101 has been used to
fasten a mesh 511 to the
tissue 505. The shaft 103 is positioned such that the tissue-facing surface
207 of the delivery tip
201 faces the mesh 511 and a surface of the tissue 505. The closed fastener
401 spans a width W
across a surface of the tissue and penetrates to a depth H within the tissue.
Because the delivery
tip 201 is biased away from the shaft 103 such that an axis of the shaft 103
and the tissue facing
surface 207 form an acute angle, A, the shaft 103 forms the angle A with the
surface of the tissue
505. In preferred embodiments, the shaft is dimensioned for minimally-invasive
surgery and has
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a length L of at least 15 cm and has a diameter D of less than 1 cm. More
preferably, L > 25 cm
and D < 7 nam, Most preferably, H < D <W.
FIGS. 11-13 show operation of the device 101.
FIG. 11 shows positioning the tissue-facing surface 207 against a surface of
tissue 505,
and specifically against a mesh 511 to be fastened to the tissue.
FIG. 12 shows the driver member 601 extended through the tissue 505 to form
the
fastener 301 into the closed loop 401.
FIG. 13 shows the closed loop 401 holding the tissue 511 to the tissue 505.
The closed
loop 401 includes the barbed end 305 confined within the bowl 327, a first
portion 415 of the
extended body 321 extending substantially straight from the bowl 327, a bent
portion 411 of the
extended body 321 at an end of the first portion 415, and a bowed portion 407
of the extended
body 321 defining a curve extending through the tissue 505 between the barbed
end 305 and the
bent portion 411. For successfully surgical procedures, the closed fastener
401 preferably spans a
width W from the barbed end 305 confined within the bowl 327 to the bent
portion 411 and the
bowed portion 407 is preferably spaced apart from the first portion 415 no
greater than a depth
H. In preferred embodiments, 3 cm > W > H. Additionally or alternatively, it
may be preferable
that H < 6 mm.
As discussed above, pulling the trigger 117 causes the device 101 to form the
fastener
into a closed fastener 401, release from the closed fastener 401, and retract
back into the shaft
103 and engage a second fastener.
FIG. 14 shows a device 101 loaded with the fastener 301, a second fastener
399, and
three additional fasteners 1401 disposed with the shaft. Visible within shaft
103 are the delivery
slot 225 extending to the exit port 221 and also the guide slot 215 extending
to the release port
209. Each fastener 301 is held within the shaft 103 in an open configuration,
with the receiving
end held in the guide slot 215 and the barbed end 205 held in the delivery
slot 225. The device
101 may be loaded with any suitable number of the fasteners 301. Each
operation of the trigger
delivers a single fastener and advances the additional fasteners towards the
delivery tip.
For minimally-invasive surgery, it may be preferable for the delivery tip 201
to be
bendable towards the axis of the shaft 103, i.e., so that the extended shaft
may most easily pass
through a standard surgical trocar.
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FIG. 15 is a profile of the delivery tip 201. It can be seen that the delivery
tip 201 is
biased away from the shaft 103 such that an axis X of the shaft 103 and the
tissue-facing surface
207 form an acute angle. It may be preferable lobe able to deform the delivery
tip 201, e.g., for
ease of insertion of the shaft 103 through a standard surgical trocar.
FIG. 16 shows the delivery tip 201 bent towards the axis X.
FIG. 17 shows a compression slit 1701 and an expansion slit 1709 that may be
included
so that the delivery tip 201 may be more readily bent towards the axis X of
the shaft 103. It will
be appreciated that the axis X is an idealized geometrical concept defined by
the generally
cylindrical nature of the shaft 103 and that there need not be any tangible
shaft axis. The axis X
is referred to so that one may comprehend the configuration of the delivery
tip 201.
Thus it can be seen that the disclosure includes a surgical fastening device
101 that
includes a body 109 with a handle 113 extending therefrom; a trigger 117 on
the handle; a shaft
013 extending from the body; a delivery tip 201 at a distal end of the shaft
103, the delivery tip
201 protruding from the shaft 103 and presenting a tissue-facing surface 207
with an exit port
221 and a guide slot 215, wherein the delivery tip 201 is biased away from the
shaft 103 such
that an axis of the shaft 103 and the tissue-facing surface 207 form an acute
angle, wherein the
delivery tip 201 is bendable towards the axis of the shaft 103, and wherein
the exit port 221
includes an end of a delivery slot 225; a driver member 601 disposed within
the shaft 103, the
driver member 601 comprising a shape-memory material that biases the driver
member 601 into
a curved shape, wherein when the driver member 601 is disposed within the
shaft 103, the driver
pushing member 601 is constrained by the shaft 103 into a straight shape; and
at least one
fastener 301 held at the delivery tip 201 at least partially within a guide
slot 215, the fastener
having an extended body 321 with a barbed end 305 and a receiving end 339,
wherein the barbed
end 305 comprises one or more barbs 311 and a pushable surface 317 engaged
with a distal tip
611 of the driver member 601, and wherein the receiving end 339 defines a bowl
327 with an
opening and a lip 333 that overhangs the opening, wherein operation of the
trigger 117 causes
the driver member 601 to: push the barbed end 305 of the fastener 301 out of
the exit port 221,
along a curved path to the receiving end 339 being held by the guide slot 215,
and into the
receiving end 339 of the fastener 301 such that the one or more barbs 311 are
engaged with the
lip 333 of the bowl 327 of the receiving end 339. thereby forming the fastener
301 into a closed
84508769
14
fastener 401, release the closed fastener from a release port 209, and,
retract back into the shaft
103 to engage a second fastener 399.
References to other documents, such as patents, patent publications, and
articles, are
made in this disclosure.
Various modifications of the invention and many further embodiments thereof,
in
addition to those shown and described herein, will become apparent to those
skilled in the art
from the full contents of this document, including references to the
scientific and patent literature
cited herein. The disclosure herein contains information, exemplification and
guidance that can
be adapted to the practice of this invention in its various embodiments and
equivalents thereof.
Examples
Laparoscopic sacrocolpopexy for pelvic organ prolapse (POP).
FIG, 18 illustrates pelvic organ prolapse. As reported in Swift, 2000, Am J
Obstet
Gynecol 183(2):277-85, approximately half of all women older than 50 years
complain of
symptomatic prolapse.
The health care impact of prolapse is likely to expand, based upon estimates
of an
increasing prevalence in the growing population of elderly women. See Wu et
al., 2009,
Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to
2050, Obstet
Gynecol 114:1278; Surgical repair of prolapse was the most common inpatient
procedure
performed in women older than 70 years from 1979 to 2006. See Oliphant et al.,
2010,
Trends over time with commonly performed obstetric and gynecologic inpatient
procedures,
Obstet Gynecol 116:926.
Laparoscopic sacrocolpopexy is a surgical technique for repairing pelvic organ
prolapse.
FIG. 19 diagrams the sacrocolpopexy procedure. During this procedure a piece
of a pre-
shaped mesh is inserted into the abdomen and attached to the vaginal wall,
then, the other end of
the mesh is attached to the back portion of the pelvic (sacral promontory)
therefore, lifting the
vagina and preventing the prolapse. Attachment of the mesh to the vagina wall
by suturing is
challenging because it require the insertion of the suture to a specific depth
into the vaginal wall.
The suture must provide a secure attachment, but should not pass through the
vagina wall since
that may cause serious complications.
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The mesh may be attached using a method of attaching a mesh according to this
disclosure. The method includes obtaining a surgical fastening device that
includes a body with a
handle with a trigger extending therefrom; a shaft extending from the body; a
delivery tip at a
distal end of the shaft; a driver member disposed within the shaft; and a
fastener held at the
5 delivery tip. The fastener has an extended body with a barbed end and a
receiving end.
The method includes operating the trigger to cause the driver member to: push
the barbed
end of the fastener out of the delivery tip, along a curved path, and into the
receiving end,
thereby forming the fastener into a closed fastener; release from the closed
fastener; and retract
back into the shaft and engage a second fastener. Preferably, the delivery tip
protrudes from the
10 shaft and presents a tissue-facing surface that presents an exit port.
The fastener is held at the
delivery tip at least partially within a guide slot. In preferred embodiments
of the method, the
delivery tip is biased away from the shaft such that an axis of the shaft and
the tissue-facing
surface form an acute angle and the driver member comprises a shape-memory
material that
biases the driver member into a curved shape.
15 The method includes constraining the driver member in a straight shape
by having the
driver member disposed within the shaft within a delivery slot.
Preferably, the barbed end of the fastener comprises one or more barbs and a
pushable
surface engaged with a distal tip of the driver member and the receiving end
of the fastener
defines a bowl with an opening and a lip that overhangs the opening. It may be
that the exit port
encompasses an end of the delivery slot.
The method may include operating the trigger to cause the driver member to:
push the
barbed end of the fastener out of the distal end of the delivery slot, along a
curved path to the
distal end of the guide slot, and into the receiving end of the fastener such
that the one or more
barbs are engaged with the lip of the bowl of receiving end, thereby forming
the fastener into a
.. closed fastener.
Preferably, the method also includes placing the tissue-facing surface against
tissue and
pulling the trigger, causing the driver member to push the barbed end through
the tissue and into
the receiving end of the fastener outside of the tissue such that the closed
fastener spans a width
W across a surface of the tissue and penetrates to a depth H within the
tissue. The shaft may have
a length L of at least 15 cm and has a diameter D of less than 1 cm. In
preferred embodiments of
the method, L > 25 cm and D < 7 mm. Also, H < D <W.
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The method may include bending the delivery tip towards the axis of the shaft
(e.g., for
insertion through a standard trocar or incision during minimally-invasive
surgery). Method may
include delivering one or more additional fasteners from the shaft, by
operating the trigger to
deliver a single fastener and advance any remaining fasteners towards the
delivery tip.
