Note: Descriptions are shown in the official language in which they were submitted.
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TITLE OF THE INVENTION
APPARATUS FOR SUPPLYING
SURGICAL STAPLE LINE REINFORCEMENT
CROSS REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of US Application No.
12/247,710, filed October 8, 2008, which claims priority to US Provisional
Application No. 60/978,178, filed October 8, 2007.
FIELD OF THE INVENTION
The present invention relates to an apparatus for supply of
surgical staple line reinforcement material to a surgical stapler.
BACKGROUND OF THE INVENTION
Surgical stapling devices are employed by surgeons to
sequentially or simultaneously apply one or more rows of surgical
fasteners such as staples or two-part fasteners to body tissue for the
purpose of joining segments of body tissue together. Such stapling
devices generally consist of a pair of jaws (one being the cartridge side
and one being the anvil side) or arm-like structures between which body
tissue to be joined is placed. When the instrument is actuated, or "fired,"
longitudinally moving firing bars contact staple drive members in one of
the jaws, thereby pushing surgical staples through body tissue and into
an anvil in the opposite jaw which crimps the staples closed. If tissue is
to be removed, a knife blade can be provided to cut between lines of
staples. Examples of such instruments are described in U.S. Patents
4,354,628, 5,014,899 and 5,040,715, teachings of each of which are
incorporated herein by reference.
Surgical stapling devices have found widespread application in
surgical operations where body tissue must be joined or removed. such
as, bariatric, colorectal, and thoracic procedures. When operating on
thin tissue, such as thin emphysematous lung tissue, it is important to
effectively seal the tissue which can be particularly prone to air leakage.
Preventing or reducing air leakage can significantly decrease post
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operative recovery time. Inhibiting or preventing tearing at the stapled
incision site in musculoaponeurotic areas also significantly decreases
recovery time.
Thus, structures for use with surgical stapling devices which
enhance sealing at the surgical site and/or reduce tissue tearing are
desired.
U,S. Patents 5,503.638, 5,575,803, 5,549,628, 6,702,409,
5,810,855 and 5,908,427 describe surgical staple line reinforcement
devices and surgical stapling apparatus with tissue bolstering materials.
U.S. Patent 5,752,965 and U.S. Patent 6,939,358 describe
apparatus for applying surgical reinforcement material onto the working
surface of a surgical stapler without requiring removal of excess material.
The present invention provides a long felt need for an apparatus
that quickly and easily applies a thin and flexible surgical reinforcement
material to a stapler.
SUMMARY OF THE INVENTION
The present invention is an improved apparatus for quickly and
easily applying a thin and flexible surgical reinforcement material to a
surgical stapler. The present apparatus comprises a body having a
surgical reinforcement material attached to a portion of said body, the
portion of the said body having the reinforcement material thereon being
pivotable with respect to the remainder of said body. A touch-up pad
may be attached to the apparatus, or otherwise provided as part of a kit.
The apparatus further comprises a securement for temporarily fixing a
surgical reinforcement material to the apparatus. The body of the
apparatus may be configured so that orientation of the apparatus body
with respect to a surgical stapler is able to be reversed with respect to
the first side and the second side of the apparatus body.
The surgical reinforcement material may further comprise an
adhesive on the outermost surface of the surgical reinforcement material
with respect to said body. The adhesive may be any suitable adhesive
including but not limited to a pressure sensitive adhesive.
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BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a drawing of an embodiment of an apparatus of the
present invention,
Figure 2 is a drawing of an embodiment of an apparatus of the
present invention with a hinged body.
Figure 3A is a drawing of an embodiment of a reversible
apparatus of the present invention exhibiting securements in the form of
posts.
Figure 3B is a drawing of an embodiment of an apparatus of the
present invention exhibiting securements in the form of posts and an
optional touch-up pad.
Figure 4 is a drawing of an embodiment of an apparatus of the
present invention showing an optional touch-up pad attached to the body
via a connecting means
Figures 5A through 5D are drawings showing different
embodiments of touch up pads useful in the present invention. .
Figure 6 A through 6E are illustrations of the apparatus of the
present invention with the pivoting portion of the apparatus shown
bending out of the plane of the card.
FIG. 7 is a perspective view of an embodiment of an apparatus for
applying a buttress or surgical material.
FIG. 8A is a perspective view of an embodiment of an apparatus
for applying a buttress or surgical reinforcement material.
FIG, 8B is a perspective view of a base member of the apparatus
shown in FIG. 8A.
FIG. 8C is a perspective view of the buttress or surgical
reinforcement material of the apparatus shown in Fla 8A.
FIG 9A is a perspective view of an embodiment of an apparatus
for applying a buttress or surgical reinforcement material.
FIG. 9B is a perspective view of a base member of the apparatus
shown in FIG. 9A.
FIG. 10A is a drawing of an embodiment of an apparatus for
applying a buttress or surgical reinforcement material.
FIG 106 is a drawing of a base member of the apparatus shown
in FIG. 10A.
FIG. 10C is an end view of an apparatus of the present invention
with surgical buttress material disposed thereon.
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FIG. 11A is a drawing of an embodiment of an apparatus for
applying a buttress or surgical reinforcement material in an
unconstrained condition.
FIG. 11B is a drawing of an embodiment of an apparatus for
applying a buttress or surgical reinforcement material in a constrained
condition.
FIG. 12A is a drawing of an embodiment of an apparatus for
applying a buttress or surgical reinforcement material,
FIG. 12B is a drawing of a base member of the apparatus shown
in FIG, 12A.
FIG. 12C is a drawing of the buttress or surgical reinforcement
material of the apparatus shown in FIG. 12A.
Figure 120 is a drawing of the elastic component of the apparatus
shown in FIG, 12A.
Figure 13A-E is a series of perspective and end views of one
embodiment of an apparatus for applying a buttress or surgical
reinforcement material in combination with a surgical stapler cartridge
reload device.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides an apparatus for supplying
surgical reinforcement material to a surgical stapler.
As shown in Figures 1 through 6, the apparatus 1 of the present
invention comprises a body 2 sized to provide a surgical stapler with
surgical reinforcement material (Figure 1), on at least a portion of the
open stapler arms of the surgical stapler.
Figure 1 shows a schematic of the apparatus comprising a body
having a first side (illustrated in this Figure as oriented on the top of the
apparatus) and a second side. The body 2 of the apparatus also has a
first portion and a second portion. The first portion 4 of the body is
pivotable with respect to the second portion of the body. For clarity of
the invention it is to be understood that the pivotable portion of the body
as hereinafter described, is considered to be the first portion 4 of the
body of the apparatus. A surgical reinforcement material, hereinafter
referred to as "buttress material" is further disposed over an area of the
first portion 4 of said body. In one embodiment the buttress material 3 is
secured to the second portion of the body. The body is be sized
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appropriately to receive a surgical stapler in a manner that permits
application of the buttress material 3 onto the jaws of the stapler.
The body has a first side 40 and a second side 50 that may be
interchangeable for ease of loading a surgical stapler with buttress
material. While Figure 1 illustrates the pivotable first portion 4 of the body
2 as being located in a relative central position with respect to the
remainder of the body 2, it is understood that the pivotable portion 4 may
be located in other desired positions. The pivotable first portion 4 of the
body functions to break the buttress material 3 at perforated areas (such
as perforated tabs ) so that the buttress material is easily freed from
securernents 7 on the apparatus. For example, the pivoting first portion
bends out of the plane of the apparatus in at least one direction to
separate the buttress material 3 at designated areas to prepare for
application. The pivoting portion (first portion 4 of the body) of the
apparatus is shown as a rectangular shaped portion, however, it is to be
understood that other suitable shapes such as rods, loops, wires, rigid
meshes, thin strip members, or other shapes may be desired. Figure 1
also illustrates the body formed with an open central region 8. The open
central region 8 may be incorporated into the body for ease of movement
of the stapler with respect to the body.
The buttress material 3 is in contact with at least an area of the
pivotable portion 4 of said body 2. Buttress material 3 suitable for use
with the present invention can be fabricated from any material having
acceptable biocompatibility and mechanical properties. For instance, the
buttress material 3 may be formed of any suitable material and may be
either synthetic or animal-derived. While synthetic materials are
preferred due to, for example, their ability to be formed thinly as
described herein and for other manufacturing benefits, animal-derived
buttress materials may also be used. The buttress material 3 may be a
single piece which is wrapped around the body of the apparatus, as
shown in Figure 1, or may be multiple pieces.
Animal-derived buttress materials (such as, for example, bovine,
porcine, equine, and human products) may have difficulties associated
with their placement on the working surfaces (for example the anvil and
cartridge jaw surfaces) of surgical staplers. Animal-derived buttress
materials cannot typically reach the consistent and thin profiles while
maintaining the required strength associated with preferred synthetic
buttress materials. An advantage of the present invention is that unlike
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traditional applications cards which do not allow successful placement of
thin buttress materials, a buttress material 3 having a thickness less than
0.5 millimeters may be accurately and successfully positioned onto the
working surfaces of a surgical stapler using the present apparatus.
Further, animal-derived buttress materials routinely use added
steps to apply or actuate adhesives to the outer surface of their
materials. For instance, some products utilize rehydration techniques,
while others utilize paste-like or gel-type adhesives which need to be
applied and smoothed onto the buttress material 3 prior to use. Paste-
l like or gel-type adhesives allow for sliding of the buttress materials
on
the working surfaces of a surgical stapler during loading. The present
invention does not require added application or actuation steps when a
ready to use adhesive such as a pressure sensitive adhesive is
employed. A pressure sensitive adhesive can be ready to use by simple
removal of a release liner.
An unexpected advantage of the present apparatus is that thinner
buttress materials such as synthetic non-animal derived materials and
other materials particularly those less than 0.5 millimeters in thickness
are more readily applied to a stapler working surfaces than is possible
with tradifional applicator means. The buttress material 3 is able to be
readily adhered or placed back to the crotch of a surgical stapler and
successfully cover the staple lines with the present apparatus, because
the body can be made thin enough to reach to the crotch of a stapler.
This ease of placement also allows the buttress material 3 to be attached
=25 onto the working surfaces of a stapler without bunching.
Examples of suitable synthetic buttress materials include but are
not limited to: bioabsorbable or biodegradable materials or webs, non-
bioabsorbable materials or webs, expanded polytetrafluoroethylene
("ePTFE") such as disclosed in U.S. Patent 5,810,855, synthetic
materials, or other suitable buttress materials. One advantage of using
synthetic buttress materials is that there is no need to rehydrate synthetic
materials prior to use, and they will have a more consistent thickness.
The surgical buttress material 3 may further comprise an adhesive on at
least the outermost surface relative to the body of the apparatus. The
adhesive may be a ready to use adhesive such as a pressure sensitive
adhesive or further may be an activatible adhesive= which may be
moistened or otherwise activated prior to use. A release liner, such as
PET release films, or other coated webs or sheets may be applied over an
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adhesive to protect it until it is ready for use, The release liner may be
utilized to cover the buttress material 3 and pre-applied adhesive so that
the liner may readily separate from the adhesive on the surgical buttress
material 3. thus maintaining the integrity of the adhesive, and allowing it
to be easily prepared for use. One advantage of the present apparatus
is that the adhesive may be pre-applied and essentially be uniformly
distributed over the buttress material. Thus, eliminating the need for any
smoothing or spreading as required by unevenly distributed gel or paste-
like adhesives traditionally used on buttress materials (see Example 10),
The apparatus 1 is sized to apply surgical buttress material 3 onto
a surgical stapler. The apparatus may comprise the same material
throughout the body or may comprise two or more different materials,
such as, but not limited to plastics, metals, cardboards, foams, or any
other suitable materials.
The apparatus 1 further comprises one or more securements 7 for
temporarily fixing buttress material 3 to the apparatus 1. Buttress
material 3 is temporarily affixed to the apparatus via this securement to
allow the buttress material 3 to extend to about at least a section of the
first portion 4 of the body. In one embodiment, as depicted in Figure 1,
one securement is simply an affixed tab with a perforated section formed
of additional buttress material 3. The optional post is shown as
additional securement means. The securements 7 are further illustrated
in Figures 3A, 3B, and 4 as comprising a plurality of posts on each body
positioned parallel to each other near the pivotable first portion 4 of the
body. The posts may be designed to provide tension on the buttress
material 3 so that the buttress material 3 is stretched flat, with reduced
bunching or wrinkling and provide a more even contact surface to adhere
onto a stapler arm. It is to be understood that the posts can be
positioned non-parallel to each other in alternate embodiments. These
posts are sized and positioned on the bodies to fit perforations in the
surgical buttress material 3. Other forms of securement 7 include tabs
with adhesive bonding, frictional interference, ultrasonic or thermal
welding, mechanical attachments, or any other suitable means of
securing the buttress material to the body.
As shown in Figures 3A, 38, 4, 5A-D, and 6 A-6 E.. the
apparatus of the present invention may further comprise a touch-up pad
5. Figure 4 illustrates a touch-up pad 5 which may be permanently or
removably attached to the apparatus as an interconnected element,
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Alternatively, as shown in Figure 3A shows an embodiment of the
present apparatus which allows the body of the apparatus to be
reversibly inserted into a surgical stapler and perform in either inserted
configuration. The reversible embodiment of the apparatus comprises a
body having a first side 40 and a second side 50 which may be fed into a
stapler irrespective of which side is in contact with the anvil and which
side is in contact with the cartridge of the stapler. The reversible
configuration enables a practitioner the ability to easily load the body into
the stapler. Also shown in Figure 3B and 5, an optional touch-up pad 5
may be permanently or non-permanently attached to the body of the
apparatus ort one or both sides. The touch-up pad is used to maximize
the surface area contact between the buttress material 3 and the working
surface of the stapler. For instance, adhesive 6 on the outermost facing
portion of buttress material 3 adheres the buttress material 3 onto
opposed working surfaces of a surgical stapler. After the buttress
material is oriented onto the apparatus, it is sometimes desired that the
buttress material be further pressed onto a touch pad to adhere the
buttress material onto a larger surface area of the stapler. This is
especially advantageous when the adhesive on the apparatus is a
pressure sensitive adhesive disposed over the surgical buttress material.
As shown in Figures 5A through 5, the touch-up pad 5 may be of
a uniform or non-uniform topography, further the touch-up pad may
comprise of one or multiple pieces, it may be designed as a wedge (for
example, Figure 5A) , flat pad (for example, Figure 5B), raised dots( for
example, Figure 5C), or the like. It is sometimes desirable that the
touch-up pad have specific formations targeted to enhance the surface
area around the staple line, The touch-up pad is generally a material
such as, but not limited to cottons, polyesters, foams, plastics, metals, or
any other suitable materials. It is an advantage to have the touch up
pad located in an area apart from the buttress material 3 so that no
added thickness or bulk is associated with the buttress material, or
apparatus, during application of the material to the arms of the stapler,
In the embodiment shown in Figures 3, 4 and 6A through 6E, the
body of the apparatus 1 is shaped to include a finger grip 10 to facilitate
gripping of the apparatus during loading of a surgical stapler with surgical
buttress material 3. The end of the apparatus proximal to the pivotable
first portion 4 of the body further comprises a stapler restraining area 23.
The stapler restraining area 23 defines the origin or the receiving area for
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the buttress material (not shown) on the pivotable portion 4 of the body.
The created pivotable portion is formed via the restraining area 23 which
is in contact with the crotch of a stapler which allows pivoting of the
receiving area of the first portion of the body, with respect to the plane of
the second portion of the body, to affix buttress material to a stapler.
As shown in Figures 1 and 6A through 6E, the buttress material 3
is oriented on the body of the apparatus in order to allow a surgical
stapler to clamp onto the apparatus. The adhesive 6 on the buttress
material 3 adheres the buttress material 3 onto the opposed working
surfaces of the surgical stapler, lt is advantageous when the adhesive
on the apparatus is a pressure sensitive adhesive disposed over the
surgical buttress material. Prior to use, a release liner 20 may be utilized
to cover the pressure sensitive adhesive and keep the adhesive in a
ready to use form for application. Removal of the release liner exposes
the pressure sensitive adhesive, thus enabling the practitioner to easily
and quickly position the buttress material 3 onto the working surface of a
surgical stapler. Figure 6A shows a loaded apparatus 1 with a release
liner 20 disposed over the buttress material 3. Figure 6B shows a loaded
apparatus 1 where the release liner is removed from the buttress
material 3 exposing the adhesive on the buttress material and making it
ready to engage with a stapler arm. Figure 6C shows a stapler jaw 90
and the apparatus positioned so that the exposed adhesive on the
buttress material will make contact with the working surface of the stapler
jaw to adhere the buttress material onto the stapler. Figure 6D shows a
stapler jaw 90 clamped onto the apparatus 1 to allow contact between
the exposed adhesive on the buttress material and the working surface
of the stapler. Figure 6E shows a the first portion 4 of the body pivoting
out of the plane of the second portion of the body so that the stapler jaw
90 engaged with the first portion 4 moves to break the buttress material 3
at perforated areas and free the buttress material from securements 7 on
the apparatus.
Other optional features can be added to the body including color
coding of the body for ease of loading; measurement ticking, non-slip
portions, or other desirable variationsõ Ergonomic features are also
within the skill of one in the art to apply to the present apparatus such as,
finger holds, curved surfaces, ribs or other raised features for additional
tactile feel or grip ease especially with surgical gloves.
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As described above, the apparatus of the present invention
provides a simple method for applying buttress material 3 to a variety of
staplers. The body of the apparatus is pre-loaded with buttress material
3 either by an artisan or as purchased in a ready to use embodiment. By
"pre-loaded" it is meant that the buttress material 3 is attached to at least
a portion of the body which is pivotable with respect to a second portion
of said body, The release liner is removed from the buttress material,
exposing the adhesive on the exposed surface of the buttress material.
As shown in Figure 6 the apparatus 1 is then inserted between open
stapler arms and aligned with a stapler arm so that the buttress material
3 is in position to be applied to the arms of the stapler upon contact there
between. The stapler arms are closed upon the pivotable portion of the
body housing the buttress material, the pivotable region of the body is
moved away from the plane of the remainder of the body so that the
perforated tabs of the buttress material 3 are broken. If desired the
touch-up pad may be utilized to maximize the surface area of the
buttress material adhered to the stapler arms. The stapler arms are then
opened to complete the transfer of the buttress material 3 to the stapler
arms. The body of the apparatus is then rernoved from the stapler arms
and discarded and the stapler is ready for use.
Turning now to Figures 7A, another embodiment of an apparatus
100 for applying a buttress or surgical reinforcement material 102 to a
stapler jaw is shown. Figure 7B shows the apparatus 100 in
combination with the jaws of a surgical stapler.
The apparatus 100 for applying a surgical reinforcement material
may include a buttress material 102 having at least a portion 112 of
buttress material that is releaesably coupled to a support or base
member 106. The buttress material 102 may be secured to the base
member by an adhesive or by a mechanical mechanism. The buttress
material may include perforations 108 along the length of the buttress
material 102. The mechanism used to secure the buttress material 102
to the base member 106 must be sufficient to maintain the coupling of
the edges 110 of the buttress material to the base member 106 when
sufficient force is applied to separate the center portion 112 of the
buttress material from the edges 110 of the buttress material 102. In
Figures 7A and 78, the buttress material 102 is shown coupled to the
base member 106 via posts 114 extending from the base member 106.
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The base member 106 may include a pair of flexible tensioning
arms 116. The posts 114 extend from the tensioning arms 116. The
edges 110 of the buttress material include apertures 118 spaced to mate
with the posts 114 extending from the tensioning arms 116. The
apertures 118 are also spaced so that when the buttress material is
coupled to both sets of posts 114 a tension force is applied to the
tensioning arms 116. The tensioning arms 116 are designed to flex
towards each other so that the buttress material 102 may be mounted to
the base member 106. After the buttress material 102 is coupled to the
attachment posts 114, the tensioning arms 1'16 are allowed to flex
outwardly. The outward flex of the tensioning arms 116 creates tension
in the buttress material 102 that is sufficient to hold the buttress material
'102 flat. The base member 106 may also have hinges '118. The hinges
'118 allow the base member 106 to bend and deform throughout storage
while still holding the buttress material 102 in tension.
Base member 106 may further comprise an alignment mechanism
to facilitate proper alignment of the buttress material to the stapler jaw
and ensure all staple holes are ultimately covered. Such alignment
mechanism may include a flexible tongue which facilitates depth and
side to side positioning by fitting within the pivoting mechanism of the
stapler jaw. Such tongue could be located on the base member at a
point further distal to the end of the buttress material. Alternatively, a
channel in the base member which facilitates depth and side to side
positioning of the buttress material by insertion of the distal end of a
surgical stapler into the channel could provide a suitable alignment
mechanism. In yet another embodiment, the alignment mechanism
could be in the form of a plunger which engages the features on the
outside or back of the stapler jaw could likewise facilitate centering and
resist twisting of the buttress material curing loading of the stapler,
In FIGS, 8A-8C, an alternative embodiment of an apparatus 200
for applying a reinforcement or buttress material 202 is shown. The base
member 204 may be made of a continuous sheet of semi rigid material.
The base member 204 includes a coupling mechanism to secure a
buttress material 202 to the base member 204. The buttress material
202 may have a plurality of apertures 206 spaced to align with a plurality
of posts 208 on the base member 204. The buttress material may also
include perforations 210 along the length of the device. The buttress
material 202 is coupled to the base member 204 by bending the base
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member 204 into a C-shape and coupling the apertures 206 to the posts
208. The base member 204 must be rigid enough to hold the buttress
material taut but not rigid enough to tear the perforations 210 prior to
loading on the stapler jaw.
Suitable materials for the continuous sheet of semi rigid material
or base member 204 include any number of thin plastic or metallic films.
As illustrated in Figures 8A 8C, the buttress material 202 is shown
secured by posts 208, any suitable mechanical or chemical bonding
mechanisms may be used.
Figures 9A and 9B show an alternative embodiment of an
apparatus 300 for applying a reinforcement or buttress material 302.
The base member 304 may be an extruded piece of material specifically
shaped to form a flexible hinge. The base member 304 may include at
least a pair of tension or flex arms 306_ In Figure 9A, the flex arms 306
are shown in an unconstrained condition. The flex arms 306 may be
squeezed together and placed in a constrained condition by a piece of
buttress material 302 secured to the base member 304 as shown in Fig.
98. The flex arms 306 will flex outwardly towards their unconstrained
condition and provide a force to keep the buttress material 302 taut or in
tension. The base member 304 is shown having posts 308 to secure the
buttress material 302, however, any suitable retention mechanism may
be used to hold the buttress material 302 in place.
Figures 10A-10C show another alternative embodiment of an
apparatus 400 for applying a reinforcement or buttress material 402 to a
stapler jaw. The apparatus 400 has a first rigid arm 404 and a second
rigid arm 406 coupled together with a spring member 408. Figure 10B
shows the apparatus 400 in an unconstrained condition before the
buttress material 402 is mounted on the apparatus 400. The spring
member 408 provides a force that biases the first and second arms 404,
406 into an open position as shown in Figure 10B. The buttress material
402 is secured to the arms 404, 406 as shown in Figure 100. The
distance between the coupling mechanisms (not shown) on each side of
the buttress material 402 is less then the distance between the coupling
mechanisms 410 on the rigid arms 404, 406 when the apparatus 400 is
in an unconstrained state. The buttress material 402 may be stretched
to couple with the coupling mechanisms 410 bringing the rigid arms 404,
406 closer together. The spring member 408 will provide a force that will
push the rigid arms 404, 406 back towards an unconstrained condition_
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This force should be sufficient to keep the buttress material 402 in
tension, but not enough to tear any perforations that may be provided in
the buttress material.
Figures 11A and 118 show an alternative embodiment of an
apparatus 500 for applying a reinforcement or buttress material 502.
Tension is applied to the buttress material upon storage of the apparatus
500 in a package 510. In Figure 11A, the apparatus 500 is shown with a
pair of flexible arms 504 coupled together through a flexible pivot joint
506. A pair of tension arms 508 is formed in a surface of the storage
package 510. The tension arms 508 are spaced so that the arms 504
are placed in tension by the tension arms 508 of the package 510. The
package 510 may be made from a variety of materials such as
polyethylene terepthalate glycol (PETG) or high impact polystyrene
(HIPS)
Figures 12A -121D show an alternative embodiment of an
apparatus 600 for applying reinforcement or buttress material 602 to a
stapler jaw. The applicator apparatus 600 may include a buttress
material 602 secured to an applicator card 604 with an elastic
component 606. The elastic component 606 couples the buttress
material 602 to the applicator card 604 through features 608 in the
buttress material 602 and features 610 provided on the applicator card
604. These features 608, 610 are shown as holes or apertures but may
be any other feature that the elastic component 606 could be secured
through such as posts or slits, The elastic component 606 is used to
secure the buttress material 602 under tension so that any buttress
material 602 is held taut when coupled to the applicator card. The
buttress material 602 may be provided with perforations 612 so that
when the apparatus is used to apply the buttress material 602 to a
stapler only an amount needed to cover the surface of the stapler jaw is
removed from the applicator card 604. The applicator card 604 may also
include a pivoting portion 612. The pivoting portion 6'12 allows the
surgeon to bend the pivoting portion 612 of the applicator card 604 when
the surgeon is using the applicator card 604 to apply the buttress
material 602.
Figures 13A-E show another embodiment of an apparatus 704 for
applying a reinforcement or buttress material 712 to a stapler jaw. The
apparatus 704 is integrated into a cartridge reload 702. The apparatus is
made of a flexible material with features designed to releasably couple at
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tabs 708 with the cartridge reload 702, and fix the buttress material 712
at pins 706 to enable delivery in tension. The buttress material 712 is
fixed to the apparatus in an unconstrained state, in which case there is
no tension in the system. When the apparatus 704 is combined with the
cartridge reload 702, the system is placed in tension, thereby pulling the
buttress material 712 taught and flat. The material can be perforated 714
to promote transfer from the delivery apparatus to the cartridge reload
702, upon delivery of the cartridge reload 702 to a surgical stapler.
EXAMPLES
Example 1
A 30 mil (0.076 cm) thick card forming the body of the apparatus
(dimension 10 cm L x 5.7 cm W) was made by injection molding
polycarbonate and configured to aid in applying surgical staple line
buttress (SLR) material to the jaws of a commercially available stapler.
The SLR receiving area, stapler restraining area and the pivot of the SLR
card were created through a three-sided cutout (S1xS2xS3) of the
polycarbonate card using a razor tool. The lengths of the longitudinal
cuts (S1 & S3) on the card are about ¨50% of the polycarbonate card
(approximately 4.7 cm) and starting approximately 0.6 cm from one end
of the card. The length of the latitudinal cut (S2) is sized to
accommodate the width of the SLR and jaws of a commercially available
stapler (approximately 1 cm).
The receiving area is defined by the three sides of the S1, S2 and
S3 cuts. The uncut side of the receiving area defines the pivot. The end
of the card closest to the pivot is the stapler restraining area. The
restraining area defines the origin or the receiving area. The created
pivot allows pivoting of the SLR receiving area with respect to the plane
of the polycarbonate card.
Example 2
One piece of SLR material with one side having a pressure
sensitive adhesive (PSA) with a release liner for covering the PSA is
placed on the receiving area of the poiycarbonate card prepared as in
Example 1.
The SLR material is precut with connected perforated tabs that
extend beyond the width of the receiving area.
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The SLR material is adapted to fit onto the receiving area and can be
attached to the polycarbonate card on each side with perforated tabs that
extend past the width of the receiving area. The perforated tabs of the
SLR are attached to the polycarbonate card using a second PSA on the
opposite side of the first PSA liner.
Example 3
For a ready-to-use SLR card, the SLR is attached to the
polycarbonate card prior to packaging,
Example 4
After attaching the SLR to the polycarbonate card, the release
liner covering the PSA is peeled back and removed. Next, the stapler is
positioned against the restraining area of the card and then clamped
over the polycarbonate card receiving area on the SLR with the PSA
exposed adhesive This securely attaches the stapler to the SLR. Next
the card is moved perpendicularly to the stapler jaws at the opposing end
of the restraining area to break the SLR from the perforated tabs. This
releases the SLR from the card and allows the SLR to transfer
completely to the stapler.
Example 5
A 30 mil (0.076 cm) thick card (dimension 10.5cm L x 3cm W) was
made by injection molding polypropylene and configured to aid in
applying SLR material to the jaws of a commercially available stapler.
The injection molded card was designed to incorporate the SLR
receiving area, stapler restraining area, and the pivot (as in example 1) in
the mold design, Additionally, deformable posts were included in the
design.
A receding section (dimension 2.7 cm L x 1,2 cm W) is included in
the design of the card such that the recession is adjacent to the
restraining area on the opposite side of the receiving area. The receding
section assists docking and positioning of the stapler jaws on the
receiving area.
A precut SLR material (as in Example 2) with perforated tabs was
adapted with holes to fit over the deformable posts. After positioning the
SLR material onto the receiving area of the card, and positioning the
perforated tabs over the deformable posts, the deformable posts were
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thermally deformed to capture the tabs and secure the SLR material to
the card. Ultrasonic energy was used to thermally deform the posts.
Next the card is moved perpendicularly to the stapler jaws at the
opposing end of the restraining area to break the SLR from the
perforated tabs. This releases the SLR from the card and allows the
SLR to transfer completely to the stapler.
Example 6
A card with similar dimensions to Example 5 was created using
stereolithography apparatus (SLA), The design of this card was modified
to better adapt the card to a surgical stapler by creating a receiving area
that is thicker at the distal end of the card than at the proximal end of the
card. Additionally the receding section of the card was modified to allow
the card and precut SLR material to be positioned within the crotch of the
stapler and cover all cartridge and anvil holes.
Example 7
The card per example 6 was further modified to include a touch up
pad, 2,5" x .5" x 0.04" (lx w x thickness), made from the same material
as the precut SLR.
The following three examples are intended to be comparative
examples illustrating the advantages of the present invention against
alternative devices. These examples are not necessarily embodiments
of the present invention (although they may be) but serve to highlight
various important aspects of the invention. For example, comparative
Example 8 highlights the concept that a thin plastic application card of
the present invention is preferable to a necessarily thicker application
device that includes a foam receiving area. Comparative Example 9
highlights the concept that a thin synthetic buttress material fabricated
with a uniform adhesive coating as in an embodiment of the present
invention has desirable characteristics as compared to an application
device such as that described in U.S. Patent No. 5,752,965, which
applies an adhesive gel or the like that requires a foam-type resilient
equalization means to establish a uniform adhesion,
Comparative Example 8
The card per example 5 was modified by adding a 0.2" rib around
the card for ergonomic ease. Addition of the rib made the card less
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flexible. This change also provided the card with additional stiffness to
aid deployment, especially while pivoting the card.
Comparative Example 9
A card comprised of a foam receiving area (approximately 0.125
thickness) was constructed and a precut SLR material and a pressure
sensitive adhesive was attached to the foam via clips. The SLR was
then positioned onto a surgical stapler in the same manner as in
Example 41. Upon positioning the SLR into the stapler, the thickness of
the foam card caused the SLR material to prematurely touch the stapler
causing the SLR material to bunch and not cover the entire staple line,
Comparative Example 10
A Peri-Strips Dry dispenser (Synovis, Part # 73133-07588, St.
Paul MN) was modified by replacing the foam pad with a 0.035" thick
polypropylene card. The supplied adhesive (Synovis, Part # 7300-
'101023, St. Paul MN) was then added in a continuous bead to the SLR
material, per instructions for use, and the assembly was positioned within
the working surface of the stapler jaws. The supplied adhesive was gel-
like in nature, and required pressure to evenly distribute the adhesive
onto the material. The stapler (Ethicon, Proximate 75, Cincinnati OH)
was then closed and then re-opened to examine the deployment of the
SLR onto the stapler jaws. The SLR material did adhere to the working
surface of the stapler at the center of the buttress material where the
bead was applied, but the adhesive was not evenly distributed across the
entire width of the SLR to adhere the edges of the SLR to the stapler.
The foregoing disclosure of the preferred embodiments of the
present invention has been presented for purposes of illustration and
description. It is not intended to be exhaustive or to limit the invention to
the precise forms disclosed, Many variations and modifications of the
embodiments described herein will be apparent to one of ordinary skill in
the art in light of the above disclosure. The scope of the invention is to
be defined only by the claims appended hereto, and by their equivalents.
Further, in describing representative embodiments of the present
invention, the specification may have presented the method and/or
process of the present invention as a particular sequence of steps.
However, to the extent that the method or process does not rely on the
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particular order of steps set forth herein, the method or process should
not be limited to the particular sequence of steps described, As one of
ordinary skill in the art would appreciate, other sequences of steps may
be possible Therefore, the particular order of the steps set forth in the
specification should not be construed as limitations on the claims. In
addition, the claims directed to the method andfor process of the present
invention should not be limited to the performance of their steps in the
order written, and one skilled in the art can readily appreciate that the
sequences may be varied and still remain within the spirit and scope of
the present invention,
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