Note: Descriptions are shown in the official language in which they were submitted.
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Surgical system with a stapling instrument and
a retractor
FIELD OF TECHNOLOGY
The invention relates to a surgical system with a stapling in-
strument and a retractor and can be used, e.g., in the treatment
of gastric ref lux.
BACKGROUND
Gastroesophageal ref lux desease (GERD) is widely spread. For
example, in the United States of America, 7% of the adult popu-
lation suffers from the symptoms associated therewith, like
heartburn and regurgitations. Complications include Barrett
esophagus, adenocarcinoma and, generally, a low quality of life.
Whereas in most cases a pharmaceutical therapy with antisecreto-
ry agents is applied, in about 15% of the cases a surgical the-
rapy is indicated.
In the Nissen technique (see, e. g. , R. Nissen et al.,"20 years
in the management of ref lux disease using fundoplication", Chir-
urg 48: 10,634-9, Oct. 1977), the esophagus is fully or parti-
ally surrounded by the stomach wall at the greater curvature of
the stomach to create a more effective lower esophageal
sphincter (LES) valve. This surgery is performed endoscopically
or via an open access. The complication rate, however, is rela-
tively high. For example, 5% of the patients suffer from dis-
phagia, a constriction of the lower esophagus. And on the long
term, more than 50% of the patients have to take antisecretory
agents again.
Endoscopic techniques involve a transoral access via the esopha-
gus. In the Stretta procedure (see, e. g. , G. Ilopoulos et al.,
"The Stretta procedure for the treatment of GERD: 6 and 12 month
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follow-up of the U.S. open label trial", Gastrointest. Endosc.
55: 2, 149-56, Feb. 2002), RF energy is used to create a smooth
muscle lesion of the lower esophageal sphincter and the cardia.
This lesion heals causing tissue contraction to increase the
effectiveness of the LES valve. Up to now, little is known about
long-term complications and the occurence of disphagia.
In another endoscopic technique, by means of the apparatus dis-
closed in WO 00/78227 Al, a plication with serosa-to-serosa
opposition is sutured within 1 cm of the gastro-esophageal
junction to increase the effectiveness of the LES valve. This
results in a small reduction of the esophageal diameter, and
again, little is known about long-term complications and the
occurence of disphagia.
Another endoscopic procedure (see, e.g. http://www.ndosurgi-
cal.com/pages/procedure.html), in which a submucosal plication
is created at the gastro-esophageal junction to increase the
valve effectiveness, takes about one hour to perform, which is
rather long. In this case, long term studies (including studies
of disphagia) are missing as well.
WO 01/91646 Al discloses a surgical stapling instrument compri-
sing a body portion with a rigid shaft, a handle and a staple
fastening assembly. The staple fastening assembly includes a
curved cartridge, which comprises at least one curved open row
of staples, and a curved anvil, which is adapted to cooperate
with the cartridge for forming the ends of the staples exiting
from the cartridge. The staple fastening assembly is adapted to
allow unobstructed access towards the concave inner faces of the
cartridge and the anvil. The cartridge can be moved towards the
anvil from a spaced position for positioning tissue therebetween
to a closed position for clamping the tissue. Preferably, a
knife is contained within the cartridge and is positioned such
that there is at least one row of staples on at least one side
of the knife. This instrument is particularly useful for the
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treatment of a patient's rectum, e.g., in order to resect a
polyp.
SUMMARY
It is the object of the invention to provide a surgical possibi-
lity, in particular for a safe and effective transoral therapy
of gastroesophageal ref lux desease which principally excludes
the occurence of disphagia.
This object is achieved by a surgical system having the features
as described herein and in the attached claims. Also described
are advantageous embodiments of that system as well as
components thereof.
The surgical system according to the invention includes a stap-
ling instrument and a retractor.
The stapling instrument comprises a flexible shaft device, a
handle extending from the shaft device in the proximal end re-
gion of the stapling instrument as well as a staple fastening
assembly in the distal end region of the stapling instrument.
Here and in the following, the terms "proximal" and "distal"
relate to the user as reference, which means that the parts of
the instrument close to the user under normal operating condi-
tions are designated as "proximal". The term "shaft devive" is
to be understood in a broad sense. Generally, the shaft device
connects the handle with the staple fastening assembly, and the
shaft device can include adapter members, connectors, etc. , and
its cross-sectional shape can vary along its length.
The staple fastening assembly includes a curved cartridge, which
comprises at least one curved open row of staples, and, opposite
to the cartridge, a curved anvil, which has a staple forming
face and is adapted to cooperate with the cartridge for forming
the ends of the staples exiting from the cartridge. A moving
device is adapted to move the anvil relatively with respect to
the cartridge, essentially in parallel relationship, from a
spaced position for positioning tissue therebetween to a closed
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position for clamping the tissue. A staple driving device is
adapted to drive the staples out of the cartridge towards the
anvil. Preferably, the staple fastening assembly is adapted to
allow unobstructed access towards concave inner faces of the
cartridge and of the anvil.
Preferably, the staple forming face of the anvil is generally
planar and is arranged transversally (preferably orthogonally)
with respect to the longitudinal axis of the staple fastening
assembly. However, different geometries are conceivable as well,
e.g. curved or undulated shapes of the staple forming face,
depending on the desired shape of the arrangement of the staples
in the tissue of a patient, and even when the staple forming
face of the anvil is planar it need not be orthogonal with re-
spect to the longitudinal axis of the staple fastening assembly.
Herein, the term "cartridge" is used in the general sense of
"staple magazine". Thus, it is not restricted to a removable
component of the staple fastening assembly, although in a pre-
ferred embodiment the cartridge is removable such that it can be
replaced by a fresh one, if additional staples are needed during
a surgical procedure.
Moreover, the term "staple" is used ina very general sense. It
includes metal staples or clips, but also surgical fasteners
made of synthetic material and similar fasteners. Synthetic
fasteners usually have a counterpart (retainer member) held at
the anvil. In this sense, the terms "anvil" and "staple forming
plane" also have a broad meaning which includes, in the case of
two-part synthetic fasteners, the anvil-like tool and its plane
where the retainer members are held, and similar devices.
The retractor of the surgical system according to the invention
is adapted to draw tissue into the space between the cartridge
and the anvil, when the cartridge and the anvil are in the spa-
ced position. The retractor can be an instrument separate from
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the stapling instrument. Alternatively, the retractor is inte-
grated in the stapling instrument. In the latter case, prefera-
bly, the retractor is operated via actuating members located at
or in the proximity of the handle.
5
Preferably, the surgical system according to the invention is
used with an endoscope. The endoscope can have a working chan-
nel, for example for guiding the retractor in case the retractor
is a separate instrument. The endoscope can be a component of
the surgical system.
In a preferred application, the surgical system according to the
invention is used in the transoral therapy of gastroesophageal
reflux desease. In this case, the endoscope is a steerable en-
doscope adapted to be inserted through the esophagus as far as
into the stomach. Such an endoscope is known in the art and is
called a gastroscope.
Generally, the surgical procedure preferably is performed in the
following way: First the gastroscope is orally introduced into
the stomach, where it is moved in retrograde state viewing the
Z line. If the retractor is a separate instrument, it is intro-
duced via the working channel of the gastroscope until it con-
tacts the anterior mucosal wall, about 3 cm below the Z line.
There, the stomach tissue is "grasped" (see below for an exam-
ple) by the retractor, and traction is applied by means of the
retractor until a full thickness transversal fold of stomach
tissue is formed. While the traction is maintained, the stapling
instrument is orally introduced alongside the gastroscope, i.e.
outside the gastroscope and using the gastroscope as exterior
guide, to the site of the fold. Under retrograde view with the
gastroscope, the stapling instrument, with the cartridge and the
anvil in the spaced position, is positioned in such a way that
the transversal fold is located in the space between the car-
tridge and the anvil. Then, the anvil is moved relatively to the
cartridge in order to clamp the tissue, and the stapling instru-
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ment is activated to drive the staples out of the cartridge
towards the anvil, thus stapling the fold in place to create a
permanent protrusion below the lower esophageal sphincter. If
desired, another fold is stapled on the posterior wall, i.e.
opposite to the first fold, by means of the same instruments.
Afterwards, the stapling instrument and the retractor are ex-
tracted. After checking whether the fold(s) are correct and
close off the esophagus, the gastroscope can be extracted as
well.
The order of some of the steps of this surgical procedure can be
changed, if desired. For example, the stapling instrument may be
introduced first, and afterwards the retractor is moved to the
site below the lower esophageal sphincter to draw tissue into
the space between the cartridge and the anvil, when the cartrid-
ge and the anvil are in the spaced position.
If the retractor is integrated in the stapling instrument, the
procedure is similar, but there is no need to insert and remove
the retracting and stapling tools independently. A detailed
example is presented below.
In both cases, the result of the surgery is one or two permanent
folds in the form of generally transversal protrusions below the
lower esophageal sphincter. The folds permit food to enter the
stomach without problems. Concerning gastric ref lux, however,
they form a kind of barriers which influence the gastric circu-
lation in a beneficial way, thus avoiding or at least largely
reducing a ref lux from the stomach into the esophagus. The pro-
blem of disphagia does not occur because the lower esophagus is
not affected by this surgical technique. In particular, the
lower esophagus is not constricted. Consequently, by means of
the surgical system according to the invention, gastroesophageal
ref lux desease can be cured in an efficient manner.
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A major advantage of preferred embodiments of the stapling in-
strument is the shape of the staple fastening assembly which
allows tissue stapling through unobstructed access and unob-
structed vision. Because of the free access towards concave
inner faces of the cartridge and of the anvil, the retractor can
be used easily, effectively and safely. Moreover, the stapling
instrument can be arranged alongside a gastroscope in a space-
saving manner.
Preferably, the outer faces of the cartridge and the anvil are
ergonomically shaped to match the anatomy at the site of the
surgical procedure. The cartridge and the anvil can have a gene-
rally arc-like shape in the cross-sectional plane, the arc ex-
tending over an angle in the range 900 to 350 .
In an advantageous version, the anvil is supported by means of
at least one arm extending from an end of the anvil and general-
ly running in parallel to the longitudinal axis of the staple
fastening assembly. This arm does not interfere with the retrac-
tor and does not block the surgeon's view. Preferably, the mo-
ving device is connected to the arm in order to move the anvil
with respect to the cartridge. The staple fastening assembly can
include a curved holder which is adapted to accomodate the car-
tridge, and the holder can comprise a guide adapted to slidably
guiding the arm. Preferably, the shape of the holder is arc-like
in the cross-sectional plane and is similar to that of the car-
tridge and the anvil, allowing an unobstructed access towards
the concave inner face of the holder as well. A staple fastening
assembly designed in this way greatly facilitates the surgical
applications of the instrument.
The distance between the cartridge and the anvil in the closed
position is preferably adjustable. For example, the moving devi-
ce can comprise an adjustable stop (preferably operated by ele-
ments located at the handle) in order to prevent the anvil from
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moving beyond the stop position and from clamping the tissue too
much, thus avoiding necrosis.
In an advantageous version of the invention, the staple faste-
ning assembly comprises a retaining pin adapted to move, prefe-
rably to slide, between the cartridge and.the anvil to align the
cartridge and the anvil. Preferably, the movement of the retai-
ning pin is actuateable via an actuating member located at the
handle. The retaining pin provides an additional support for the
anvil and can be useful when other supports like the arm mentio-
ned above, for reasons of limited space, cannot be dimensioned
so large that they prevent a misalignment due to elastic defor-
mation.
Preferably, the staple driving device is adapted to simultane-
ously drive the staples out of the cartridge towards the anvil.
In an advantageous version of the invention, the flexible shaft
device comprises a plurality of vertebra members, which are
longitudinally arranged and are surrounded by a flexible sheath.
Preferably, each of the vertebra members has at least one ope-
ning, the openings of the longitudinally arranged vertebra mem-
bers forming at least one channel adapted to accomodate force
transmitting devices for transmitting forces from actuating
members located at the handle to the staple fastening assembly.
Such force transmitting devices can include, e.g., a flexible
band associated to the moving device and a flexible band asso-
ciated to the staple driving device and also additional devices,
in particular for operating the retaining pin (see above) and
for operating movable parts of a retractor which is integrated
in the stapling instrument (see below).
The staple fastening assembly can be removably mounted in the
distal end region of the flexible shaft device. This allows the
flexible shaft device and many parts of the moving device, the
staple driving device and force transmitting devices to be desi-
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gned as re-usable components, which are sterilized after each
surgical procedure, whereas the staple fastening assembly can be
replaced after each surgical procedure.
As already mentioned, the cartridge is preferably removable so
that a used cartridge without staples can be replaced with a
fresh one, if required. This is particularly advantageous if the
stapling instrument is to be used several times during the same
surgical procedure. It is also conceivable to design the stap-
ling instrument as a re-usable instrument which is sterilized
after each surgical procedure. In this case, a fresh and sterile
cartridge can be inserted during the next surgical procedure.
In case the retractor is an instrument separate from the stap-
ling instrument, in an advantageous version the retractor com-
prises a screw which is adapted to pierce and to be screwed into
tissue and which is mounted at one end of a flexible retractor-
shaft. Preferably, the screw is designed as a coil. This retrac-
tor is used by piercing the tissue at the position where it is
to be "gripped" by means of the tip of the screw and then rota-
ting the flexible retractor shaft by a few full turns such that
the screw or coil is screwed into the tissue, thus anchoring the
retractor in the tissue. Afterwards, the tissue can be drawn,
e.g. to the shape of a fold, by pulling at the retractor shaft.
After stapling the fold, the screw is rotated in the opposite
direction in order to separate it from the tissue. If the tissue
in question is the stomach wall, piercing it with the retractor
does not seriously hurt the patient.
In an advantageous design in which the retractor is integrated
in the stapling instrument, the retractor comprises a hollow
needle with an internal channel and an expandable balloon, which
is adapted to be pushed out of the piercing tip of the needle
via the channel. The needle can be designed as a curved needle.
The balloon can be mounted on a catheter. Preferably, the needle
is slidably mounted in a retractor sheath having a proximal end
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and a distal end, wherein the needle can be moved out of the
distal end region of the retractor sheath by means of a force
transmitter operated via the proximal end region of the retrac-
tor sheath. The retractor sheath can be movable, generally in
parallel to the longitudinal axis of the staple fastening assem-
bly. When using this retractor, the needle tip is exposed from
the protective retractor sheath, the tissue is pierced by means
of the needle (at the position where it is to be "gripped"), and
then the balloon is moved out of the channel of the needle and
inflated. Afterwards, the tissue can be retracted by drawing at
the retractor, the inflated balloon preventing the needle from
slipping out off the tissue. The details of this procedure are
explained below.
Whereas the preferred embodiment of the screw/coil-type retrac-
tor is a separate instrument and the preferred embodiment of the
needle/balloon-type retractor is an integrated tool of the stap-
ling instrument, it is also conceivable to integrate a screw/-
coil-type retractor in the stapling instrument or to design a
needle/balloon-type retractor as a separate instrument.
BRIEF DESCRIPTION OF THE DRAWINGS
In the following, the invention and its application in the sur-
gical treatment of gastroesophageal reflux desease are further
described by means of embodiments. The-drawings show in
Figure 1 an isometric overall view of the stapling instrument
of a first embodiment of the surgical system according
to the invention,
Figure 2 a side view of the stapling instrument of Figure 1,
Figure 3 in parts (a) and (b) isometric views of the staple fa-
stening assembly of the stapling instrument of Figure
1 from two different directions,
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Figure 4* an isometric view similar to Figure 3 (a), but with
the cartridge of the staple fastening assembly unlok-
ked and partly pulled out of its holder,
Figure 5 an isomentric view of the cartridge of the staple fa-
stening assembly of Figure 3,
Figure 6 an isometric view of the anvil of the staple fastening
assembly of Figure 3,
Figure 7 in parts (a), (b) and (c) sequential steps in actua-
ting the staple fastening assembly of Figure 3, which
illustrates how the staples are expelled from the
cartridge and are formed,
Figure 8 an exploded view of the staple fastening assembly of
Figure 3,
Figure 9 an isometric view of vertebra members forming the
backbone of the flexible shaft of the stapling instru-
ment of Figure 1,
Figure 10 a schematic isometric view showing the proximal end
region of the flexible shaft. of the stapling instru-
ment of Figure 1,
Figure 11 a schematic isometric view showing the distal end re-
gion of the flexible shaft of the stapling instrument
of Figure 1,
Figure 12 in parts (a), (b) and (c) sequential steps in actua-
ting the stapling instrument, like in Figure 7, but in
longitudinal section,
Figure 13 a schematic view of the stomach of a patient with a
gastroscop introduced through the esophagus,
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Figure 14 in parts (a), (b), (c) and (d) schematic views of se-
quential steps of a surgical procedure for the treat-
ment of gastroesophageal ref lux decease,
Figure 15 an isometric view of the distal area of the retractor
of the first embodiment of the surgical system accor-
ding to the invention,
Figure 16 a side view of the distal area of the retractor of
Figure 15,
Figure 17 in parts (a), (b), (c), (d) and (e) schematic views of
sequential steps of the use of the retractor of Figure
15,
Figure 18 in parts (a) , (b) , (c) , (d) , (e) , (f) , (g) , (h) , (i)
(j), (k) and (1) side views, partially in longitudinal
section, of the staple fastening assembly of the stap-
ling instrument and of the retractor of a second embo-
diment of the surgical system according to the inven-
tion, illustrating, in sequential steps, how this
embodiment is used in a surgical procedure for the
treatment of gastroesophageal reflux desease, and
Figure 19 the fold of the the stomach wall created in the proce-
dure illustrated in Figure 18, i. e. in part (a) in
longitudinal side view, also illustrating the staples
set in the procedure, and in part (b) in top view.
DETAILED DESCRIPTION
In a first embodiment of the surgical system, a stapling instru-
ment and a retractor are designed as separate components. This
embodiment is illustrated by means of Figures 1 to 17.
Figure 1 shows an isometric view of the stapling instrument,
whereas Figure 2 is a side elevational view. The stapling in-
strument 1 comprises a handle 2 in the proximal area of the
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instrument, a flexible shaft 4, and a staple fastening assembly
6 mounted at the distal. end of the shaft 4. A trigger 8 and a
rotatable knob 9 provided at the handle 2 can be used in order
to operate the staple fastening assembly 6, as explained below
in more detail.
In the embodiment, the stapling instrument 1 is designed for the
use in a surgical procedure for the treatment of gastroesopha-
geal ref lux desease (GERD). Thus, the staple fastening assembly
6 is dimensioned such than it can be introduced through the
mouth and the esophagus of the patient into the stomach, and the
flexible shaft 4 is somewhat longer than the esophagus. In use,
the handle 2 is outside the mouth of the patient such that the
actuating members (like the trigger 8 and the knob 9) can be
conveniently operated by the surgeon.
The stapling instrument 1 is designed as a disposable instru-
ment. A stapling instrument which is completely sterilizable or
partly sterilizable (for example with a sterilizable handle only
or with sterilizable shaft and handle) is conceiveable as well.
Figures 3 to 7 illustrate the staple fastening assembly 6 in
more detail.
A curved cartridge 10 containing staples is removably mounted in
a curved holder 12. The cartridge 10 is secured by means of a
protrusion 14 and a bayonet slot 15 in the holder 12, see in
particular Figure 3 (a) and Figure 4.
An end face 16 of the cartridge 10 is provided with slots 18. In
the embodiment, four slots 18 are arranged along a semi-circular
line. Each slot houses a staple (clip) with the free ends poin-
ting to the end face 16 (see Figure 7 (b) and additionnally
Figures 8 and 12). Thus, the slots 18 define a curved open row
of staples.
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Opposite to the cartridge 10, the staple fastening assembly 6
comprises a curved anvil 20 having an atraumatically shaped di-
stal face 22 and a staple forming face 24 which is aligned in
parallel to the end face 16 of cartrige 10. The staple forming
face 24 is provided with depressions 25, see Figure 6. The de-
pressions 25 are arranged in pairs, and each pair serves to bend
the free ends of one staple expelled from the cartridge 10, see
in particular Figure 7 (c) and Figure 12 (c).
The anvil 20 is supported by an arm 26 extending from one end of
the anvil 20 and running in parallel to the longitudinal axis of
the staple fastening assembly 6. The opposite end of the anvil
is the free end 27. The arm 26 is slidably guided in a guide
28 formed at one end of the holder 12, the cross-sectional area
15 of the guide 28 being adapted to that of the arm 26. As explai-
ned in more detail below, the anvil 20 can be moved via the arm
26 towards the cartridge 10 to a closed position for clamping
tissue and away from the cartridge 10 to a spaced position. In
the embodiment, the distance between the cartridge 10 and the
20 anvil 20 in the closed position (i.e. the gap shown in Figures
7 and 12) is adjustable by means located at the handle 2.
Figures 3, 4, 7, and 8 display a retaining pin 30 as an additio-
nal part of the staple fastening assembly 6. The retaining pin
30 has a shaft 32, a rounded or somewhat tapered distal end 34,
and a proximal end region 35 with a larger diameter than shaft
32.
The retaining pin 30 is slidably guided in a bore 36 provided at
one end of cartridge 10. The purpose of the retaining pin 30 is
to aid in the alignment of the anvil 20 with respect to the car-
tridge 10 and the holder 12. Since the dimensions of the staple
fastening assembly 6 are small, the arm 26 might not be strong
enough to prevent the free end 27 of the anvil 20 from misalign-
ment. In use, the retaining pin 30 is slidably moved in distal
direction until its distal end 34 fits into a recess 39 provided
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close to the free end 27 of the anvil 20, see Figure 6. The
shape of the recess 39 is adapted to that of the distal end 34
of the retaining pin 30 such that the anvil 20 automatically
aligns to the cartridge 10 when the distal end 34 of the retai-
ning pin 30 moves into the recess 39. A correct alignment is
important in order to form the ends of the staples in a precise
way.
Whereas the anvil 20 is actively moved by driving the arm 26,
the retaining pin 30 passively slides in the bore 36, when the
anvil 20 approaches the cartridge 10. in order to position the
retaining pin 30 with its distal end 34 resting in the recess
39, a kind of Bowden wire is used which is not illustrated in
the figures. The Bowden wire acts onto the proximal end region
35 of the retaining pin 30 and is operated from the handle 2.
Figure 8 is an exploded view of the staple fastening assembly 6.
The four staples housed in the cartridge 10 are designated by
40. The shaft 4 ends with a rigid distal shaft part 42 to which
two holder parts 44 and 45 are screwed, as indicated by the
auxiliary lines in Figure 8. When assembled,.the holder parts 44
and 45 form the holder 12 including the guide 28.
The distal end 46 of a flexible band 47-and the distal end 48 of
a flexible band 49 are shown in Figure 8. The flexible bands 47
and 49 are guided in a longitudinal channel inside the distal
shaft part 42 and along the flexible shaft 4, see also Figures
10, 11 and 12. A base part 50 of the anvil 20 is screwed to the
distal end 46 of the flexible band 47. The flexible band 47 can
be longitudinally moved inside the shaft 4 by rotating knob 9 at
the handle 2. In this way, the moving device is formed which
moves the anvil 20 with respect to the cartridge 10.
A pusher base 52 is screwed to the distal end 48 of flexible
band 49. The flexible band 49 can be longitudinally moved inside
the shaft 4, independently from the flexible band 47, by means
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of the trigger- 8 provided at the handle 2. When the trigger 8 is
actuated, i.e. drawn towards the rigid part of handle 2, the
flexible band 49 and the pusher base 52 are shifted in distal
direction. Therefore, the pusher base 52 acts onto a driver part
54 which is a component of the replacable cartridge 10. The
driver part 54 includes fingers 56, one for each staple 40,
which expell the staples 40 from the slots 18 during this "fi-
ring" actuation. These steps are also illustrated in Figures 7
and 12, where parts (a) show the initial condition with the
desired gap between the anvil 20 and the cartridge 10, parts (b)
display the moment when the free ends of the staples 40 touch
the depressions 25 in the staple forming face 24 of the anvil
20, and parts (c) show the final state with the ends of the
staples formed (bent).
The "backbone" of the flexible shaft 4 is illustrated in Figure
9. It consists of a plurality of vertebra members 60 which are
longitudinally arranged. In the embodiment, each of the vertebra
members 60 has one opening, the openings of=the longitudinally
arranged vertebra members 60 forming a channel 62 of rectangular
cross-sectional shape. The flexible bands 47 and 49 are guided
inside channel 62, see Figure 10, which shows the proximal end
region of shaft 4 (without handle 2), and Figure 11, which shows
the distal end region of shaft 4. Figures 10 and 11 also illu-
strate a flexible sheath 64 which surrounds the vertebra members
60.
The rigid vertebra members 60 abute each other. Thus, the array
of vertebra members 60 can transmit compression forces. counter-
acting tensil forces transmitted via the flexible band 47. The
flexible sheath 64 provides flexibility to the shaft 4 and is
also able to transmit tensil forces when the flexible band 49 is
exposed to compression forces during the firing of the staples.
Since the cross-sections of the channel 62 is adapted to the
combined cross section of the flexible bands 47 and 49, the
bands 47 and 49 can transmit compression forces although they
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are flexible. Because of the shape of the vertebra members 60,
the flexible shaft 4 displays flexibility in one direction only
(i.e. within one plane), as indicated in Figures 1, 2 and 9.
Mechanisms for transmitting forces and actions from actuating
members like the trigger 8 or the knob 9 are generally known in
the art, see, e.g., US Patent 5 605 272 and US Patent 4 527 724.
A surgical procedure for the treatment of gastroesophageal re-
flux desease by using a surgical system comprising the stapling
instrument described above and a retractor is generally illu-
strated in Figures 13 and 14.
Figure 13 shows a schematic cross section through the stomach 70
of a patient. The esophagus 72 enters into the upper part of the
stomach 70. In its lower part, the stomach 70 is connected to
the duodenum 74. In the view of Figure 13, a conventional gast-
roscop 80 has been introduced through the mouth of the patient
and the esophagus 72 into the stomach 70. The gastroscop 80 is
an endoscope including optics and has a steerable end region 82
which can be bent up to 180 , as shown in Figure 13.
Figure 14, in parts (a) to (d), displays a sequence of consecu-
tive steps of the surgical procedure in a somewhat more schema-
tic presentation. In the view of Figure 14 (a), it can be seen
that the gastroscop 80 includes a working channel 84 which can
be used to insert surgical instruments through the gastroscop 80
into the stomach 70.
Figure 14 (a) shows the state after the gastroscop 80 has been
introduced and moved into the retrograde state defining the Z
line, i.e. an area close to the junction of the esophagus 72 and
the stomach 70. Moreover, a retractor 86 has already been fixed
at a site 88 of the anterior mucosal wall of the stomach 70,
about 3 cm below the Z line. In Figure 14, the retractor 86 is
represented in a very schematic 'way, just to illustrate the
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principle of the surgical procedure. An actual embodiment of the
retractor 86 is explained below. The retractor 86 is designed as
a separate instrument and has been introduced through a working
channel of the gastroscop 80. According to Figure 14 (a), the
retractor 86 has already pulled the stomach wall somewhat in-
wards.
Figure 14 (b) shows a state after additional traction has been
applied to the retractor 86 to form a full thickness transversal
fold 89 of stomach wall tissue. Moreover, the stapling instru-
ment 1 has been introduced to the site of the fold 89 through
the esophagus 72 alongside the exterior wall of the gastroscop
80, using the gastroscop 80 as guide. Under retrograde view, the
staple fastening assembly 6 of the stapling instrument 1, with
the anvil 20 and the cartridge 10 in a spaced state, is positio-
ned at the fold 89 such that the fold 89 lies in the gap between
the anvil 20 and the cartridge 10.
Now the anvil 20 is moved towards the cartridge 10 by turning
knob 9 until both parts of the fold 89 touch each other but are
not squeezed too much. The optimal gap distance for this stage
can be preadjusted at the handle 2 (e.g. by means of a stop to
block further rotation of knob 9).
In the state shown in Figure 14 (c), the stapling instrument 1
is "fired" by actuating the trigger 8 and expelling the staples
40 as explained before. The free ends of the staples 40 penetra-
te both layers of the fold 89 before they are bent by the anvil
20. After extracting the stapling instrument 1, the stapled fold
89 can be checked with the gastroscop 80. Afterwards, the gast-
roscop is extracted as well.
Figure 14 (d) shows the result of the surgery: a permanent
transversal fold 89 below the LES valve. If desired, a similar
fold can be created on the posterior wall, just opposite to the
fold 89. Before stapling the second fold, the stapling instru-
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ment 1 has to be extracted and re-introduced in order to replace
the old cartridge 10 with a fresh one containing the required
staples.
The fold 89 and, if applicable, the additional fold close off
the esophagus 72 and influence the circulation pattern in the
stomach 70, such that gastric ref lux does not rise into the
esophagus 72. On the other hand, food intake is not seriously
impeded because the fold(s) yield and do not block the esopha-
gus. Since the esophagus 72 is not constricted in any way, dis-
phagia cannot occur.
Figure 14 also demonstrates that the shape of the staple faste-
ning assembly 6 and the flexible shaft 4 fit well to the shape
of the gastroscop 80. Therefore, the limited cross-sectional
area of the esophagus 72 is optimally used.
Figures 15 and 16 display an actual embodiment of a retractor
86, here designated by the reference numeral 90. In its distal
end region, the retractor 90 comprises a screw, which is desi-
gned as a helical coil 92 having a tip 94. The coil 92 is con-
nected to a base part 96 which is fixed to a flexible retractor
shaft 98 made, e.g., from a soft and tightly wound helical
spring covered by a flexible plastic sheath. Figures 15 and 16
show the distal end region of the retractor shaft 98 only. The
total length of the retractor shaft is sufficient to extend
through the esophagus and mouth of the patient such that the
retractor 90 can be manually handled via the proximal end of the
retractor shaft 98.
Figure 17 illustrates sequential steps of the use of the retrac-
tor 90. Figure 17 (a) corresponds to Figure 13 and shows the
gastroscop 80 after insertion into the stomach 70 and pointing
in retrograde view. Parts (b) to (e) of Figure 17 show the indi-
vidual steps until the state corresponding to Figure 14 (a) is
reached. In part (b), the retractor 90 is moved to the desired
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site 88 until the tip 94 of the coil 92 contacts the anterior
mucosal wall. Then, the retractor 90 is rotated, part (c), in
order to perforate the stomach wall all the way through the
serosa. Afterwards, traction is applied, part (d), until a full
thickness transversal fold is formed, i.e. the fold 89, part
(e). Following these steps, the steps displayed in Figure 14
parts (b) to (d) are performed.
The use of a second embodiment of the surgical system in a sur-
gical procedure for the treatment of gastroesophageal reflux
desease is illustrated in Figure 18. This figure, in parts (a)
to (1), shows sequential steps of the procedure. The final re-
sult, a transversal fold similar to fold 89 above, is displayed
in Figure 19.
In the second embodiment of the surgical system, the retractor
is integrated in the stapling instrument which is designated by
reference numeral 100. The parts of the instrument related to
stapling are very similar to the corresponding parts of the
stapling instrument 1. For this reason, these parts have the
same reference numerals as before (but primed) , and they are not
explained again. Figure 18 shows the essential parts of the
stapling instrument 100, in particular its staple fastening
assembly 6' including the essential parts of the retractor.
Since the retractor comprises several movable parts which are
driven and actuated via force-transmitting devices contained in
the flexible shaft of the stapling- instrument 100, there are
more actuating members for operating the force-tranmitting devi-
ces loctated at the handle than in the embodiment described
before. A person skilled in the art knows how to achieve the
movements and actions of the retractor described below. General-
ly, the flexible shaft (here 4') can be designed in a similar
way as explained by means of Figures 9 to 11, but preferably
with more than one channel in the vertebra members in order to
accomodate the larger number of force-transmitting devices.
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In Figure 18 (a), the stapling instrument 100 lies at the sto-
mach wall 102 (anterior mucosal wall) at the desired site (about
3 cm below the Z line), with the anvil 20' having a small di-
stance to the end face 16' of the cartridge 10'. In part (b) the
anvil 20' has been moved to a spaced position.
The retractor, here designated by the reference numeral 110,
includes a retractor sheath 112 with a curved end region 114.
The retractor sheath 112 is movable, generally in parallel to
the longitudinal axis of the staple fastening assembly 6'. In
Figure 18 (c) the retractor sheath 112 has been moved in distal
direction compared to parts (a) and (b) such that its distal end
115 is in the center region of the space enveloping the anvil
20' and the end face 16' of the cartridge 10'. In Figure 18 (d)
part of the cartridge 10' and the staple driving device are
shown in longitudinal section, similar to the representation in
Figure 12.
In the next step, a curved hollow needle 116 having a piercing
tip 117 is driven out of the retractor sheath 112 by means of a
hollow and flexible force transmitter 118, part of which is
displayed in Figure 18. The proximal area of the force trans-
mitter 118, which extends all the way through the flexible
shaft, is not shown in the figures. The piercing tip 117 of the
needle 116 perforates the stomach wall at a site 119 all the way
to the serosa.
Afterwards, a folded balloon 120 which is mounted on a catheter
122 inside the internal channel of the hollow needle 116 is
pushed out of the piercing tip 117 by moving the catheter 122 in
distal direction. On the serosa side, the balloon 120 is infla-
ted, the hollow catheter 122 serving as a pressurizing tube.
Then, the needle 116 is retracted into the curved end region 114
of the retractor sheath 112, leaving the inflated balloon 120 on
the serosa side, as shown in Figure 18 (f).
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Now the catheter 122 is retracted, Figure 18 (g). The balloon
120 prevents the catheter 122 from slipping through the piercing
site 119. In the next step, the retractor sheath 112 including
the catheter 122 and the balloon 120 is moved in proximal direc-
5. tion. Figure 18 (h) shows that a fold 124 of the stomach wall
102 is formed in this way. In Figure 18 (i), the retractor she-
ath 112 has reached its final position.
In the next step, the anvil 20' is moved in proximal direction
as well until it clamps the tissue of the fold 124 to the end
face 16' of the cartridge 10'. As in the first embodiment, the
desired residual gap between the anvil 20' and the cartridge 10'
can be preselected at the handle of the stapling instrument 100.
Figure 18 (j) shows this state with the tissue seen in sectional
view, whereas in Figure 18 (k) the tissue of the fold 124 is in
side view.
Finally, the stapling instrument 100 is fired by driving the
staples 40' out of the cartridge 10', as explained in detail
with respect to the first embodiment. In Figure 18 (1) a formed
staple 40' is shown in sectional view. Additionally, the balloon
120 is deflated and retracted by means of the catheter 122 into
the retractor sheath 112, i.e. into the needle 116. Afterwards,
the stapling instrument 100 and the gastroscop (not shown in the
figures) used to view the procedure can be retracted through the
esophagus and the mouth of the patient.
Figure 19 illustrates the result of the surgery: part (a) is a
longitudinal representation of the fold 124 including the formed
staples 40', and part (b) is a top view onto the fold 124 with
four staples 40' arranged along a semi-circular line.
