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WO2006027014A1 - Surgical stapling instrument - Google Patents

Surgical stapling instrument Download PDF

Info

Publication number
WO2006027014A1
WO2006027014A1 PCT/EP2004/010138 EP2004010138W WO2006027014A1 WO 2006027014 A1 WO2006027014 A1 WO 2006027014A1 EP 2004010138 W EP2004010138 W EP 2004010138W WO 2006027014 A1 WO2006027014 A1 WO 2006027014A1
Authority
WO
WIPO (PCT)
Prior art keywords
stapling instrument
anvil
staple
instrument according
cartridge
Prior art date
Application number
PCT/EP2004/010138
Other languages
French (fr)
Inventor
Jesse James Kuhns
Michele D'arcangelo
Federico Bilotti
Antonio Longo
Original Assignee
Ethicon Endo-Surgery, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to JP2007530590A priority Critical patent/JP4879900B2/en
Priority to CNB2004800441916A priority patent/CN100569190C/en
Priority to AU2004323140A priority patent/AU2004323140B2/en
Priority to PCT/EP2004/010138 priority patent/WO2006027014A1/en
Priority to EP04786932A priority patent/EP1788954A1/en
Priority to CA2579606A priority patent/CA2579606C/en
Application filed by Ethicon Endo-Surgery, Inc. filed Critical Ethicon Endo-Surgery, Inc.
Priority to MX2007002841A priority patent/MX2007002841A/en
Priority to BRPI0419039A priority patent/BRPI0419039B8/en
Priority to US11/662,105 priority patent/US7810690B2/en
Publication of WO2006027014A1 publication Critical patent/WO2006027014A1/en
Priority to IL181648A priority patent/IL181648A0/en
Priority to US12/699,910 priority patent/US20100133320A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00131—Accessories for endoscopes
    • A61B1/0014—Fastening element for attaching accessories to the outside of an endoscope, e.g. clips, clamps or bands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00296—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means mounted on an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07221—Stapler heads curved
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/0725—Stapler heads with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2901—Details of shaft
    • A61B2017/2905—Details of shaft flexible

Definitions

  • the invention relates to a surgical stapling instrument, which can be used, e.g., in the diagnosis and/or therapy of patholo ⁇ gies of the lower gastrointestinal tract.
  • WO 01/91646 Al discloses a surgical stapling instrument having a staple fastening assembly located in the distal end region of the stapling instrument, a rigid shaft, and a handle extending from the shaft in the proximal end region of the stapling instrument.
  • the staple fastening assembly includes a curved cartridge device, which comprises several curved open rows of staples having a concave side and a convex side.
  • a curved anvil is arranged opposite to the cartridge device. The anvil has a staple forming face and is adapted to cooperate
  • the anvil can be moved relatively with respect to the cartridge device from a spaced position for positioning tissue therebetween to a closed posi- tion for clamping the tissue.
  • a knife is contained in the cartridge device and is positioned on the concave side of at least one row of staples and optionally the convex side of at least one row of staples.
  • the surgical stapling instrument disclosed in WO 01/91646 Al can be used to excise tissue, e.g. polyps, and to stop bleed ⁇ ing virtually immediately.
  • the sta ⁇ pling instrument is introduced, e.g., into the anal canal and moved to the site of the tissue to be resected.
  • the tissue to be excised can be pulled into the area between the anvil and the cartridge device, when the cartridge device and the anvil are in a spaced or open position, by means of a separate tis ⁇ sue grasping instrument.
  • the anvil is moved rela ⁇ tively with respect to the cartridge device in order to clamp the tissue.
  • the surgeon can "fire" the in ⁇ strument, which means that the staples are driven out of the cartridge device, penetrate the tissue, whereupon the ends are bent by the anvil, and the knife is moved towards the anvil in order to cut the tissue.
  • the instrument is opened, the completely excised tissue can be safely removed from the pa ⁇ tient's body together with or prior to removing the instrument itself.
  • a particular advantage of the surgical stapling instrument disclosed in WO 01/91646 Al is the shape of the staple fasten- ing assembly in which the cartridge device and the anvil have a generally arc-like shape in a cross-sectional plane. This allows for unobstructed view and access towards the concave inner faces of the cartridge device and of the anvil.
  • gas- troenterologists e.g. GI
  • the surgical stapling instrument comprises, in the distal end region of the instrument, a sta ⁇ ple fastening assembly including a curved cartridge device and, opposite to the cartridge device, a curved anvil.
  • the cartridge device comprises at least one curved open row of staples having a concave side and a convex side.
  • the anvil has a staple forming face and is adapted to cooperate with the cartridge device for forming the ends of the staples exiting frora the cartridge device.
  • a moving device is adapted to move the anvil relatively with respect to the cartridge de ⁇ vice, essentially in parallel relationship, from a spaced posi ⁇ tion for positioning tissue therebetween to a closed position for clamping the tissue.
  • a staple driving device is adapted to drive the staples out of the cartridge device towards the anvil.
  • a handle is opera- tively connected to the staple fastening assembly and comprises actuating members coupled to force transmitters of the moving device and of the staple driving device.
  • the stapling instrument includes a knife, which is contained in the cartridge device and which is positioned on the concave side of at least one row of staples and possibly the convex side of at least one row of staples.
  • the knife can be moved towards the anvil by means of a knife actuating device, which is preferably coupled to the staple driving device, e.g. such that, upon actuation of the actuating member of the staple driving device, the staples and the knife advance simultane- ously, the knife following the staples such that the tissue is cut after having been stapled.
  • a flexible backbone is arranged be ⁇ tween the handle and the staple fastening assembly.
  • the flexible backbone is a kind of flexible shaft or flexible connection be ⁇ tween the handle and the staple fastening assembly and guides the force transmitters of the moving device and of the staple driving device.
  • the flexible backbone can be rather long. It en ⁇ ables the stapling instrument to be introduced, e.g., into the anal canal and to be moved forward for a rather long distance to allow for the treatment of tissue at a site remote from the anus. Upon advancement of the stapling instrument, the flexible backbone adapts to the curvature of the intestine.
  • the flexible backbone comprises a flexible endoscope, which preferably is removably mounted (i.e. it can be detached from the rest of the instru ⁇ ment) .
  • the endoscope usually includes observational optics and a light source and optionally comprises a working channel in its longitudinal direction.
  • the working channel can be utilized to place surgical tools at the site of surgery, e.g. an endoscopic gripping instrument for pulling tissue into the space between the cartridge device and the anvil.
  • the application of a flexi ⁇ ble endoscope in the backbone of the stapling instrument has the advantage that a standard component is used which can provide flexibility as well as strength to the stapling instrument.
  • the stapling instrument can be adapted to be used with an inde ⁇ pendent flexible endoscope forming at least part of the flexible backbone. That means, the stapling instrument according to the invention is distributed without the endoscope, and in order to put it into an operational state, the independently or sepa ⁇ rately distributed endoscope is connected to the other parts of the instrument.
  • the flexible endoscope is a com ⁇ ponent or even an integral component of the stapling instrument.
  • the force transmit ⁇ ters of the moving device and of the staple driving device are located at the outside of the endoscope and are attached to the endoscope by a plurality of spaced holders. If the knife actuat- ing device has an independent actuating member at the handle, a force transmitter of the knife actuating device can be arranged at the outside of the endoscope as well.
  • This design uses the endoscope as the only structural connection between the handle and the staple fastening assembly and is particularly simple.
  • the flexible backbone comprises a flexible guide, which is arranged alongside the endoscope and which ac ⁇ commodates the force transmitters of the moving device and of the staple driving device.
  • the guide depending on its design, can connect the handle and the staple fastening assembly in a structural sense.
  • At least one of the force transmitters of the moving device and of the staple driv ⁇ ing device comprises a flexible rotary rod adapted to be rotated around its longitudinal axis upon actuation of the related actu ⁇ ating member of the handle and adapted to transform its rotary motion to a longitudinal motion at the staple fastening assem- bly.
  • the term flexible rod is to be understood in a rather broad sense; it includes, e.g., a tightly wound helix, which is flexi ⁇ ble and can transmit torque, and even designs comprising linked members.
  • At least one of the force transmitters is adapted to be rotated via a gear transmission operated by the related actu ⁇ ating member.
  • at least one of the force transmitters can be adapted to transform its rotary motion to a longitudinal motion (required for the relative movement of the anvil with re ⁇ spect to the cartridge device or for expelling the staples) via a screw drive.
  • the staple forming face of the anvil can be generally planar, but other shapes, e.g. an undulated shape, are conceivable as well.
  • the staple fasten ⁇ ing assembly is adapted to allow unobstructed access towards concave inner faces of the cartridge device and of the anvil.
  • Such design which is generally known from WO 01/91646 Al, largely facilitates the handling of the stapling instrument in a surgical procedure.
  • the cartridge device and the anvil have a generally arc-like shape in a cross-sectional plane, the arc extending over an angle in the range 10° to 350°.
  • the anvil is supported by means of at least one arm extending from an end of the anvil and generally running in parallel to the direction of relative movement of the anvil with respect to the cartridge device.
  • This arm can be driven by the moving device if the anvil is movable with respect to a fixed cartridge device.
  • An optional second arm, preferably at the other end of the anvil, provides addi ⁇ tional strength and facilitates an accurate alignment of the an- vil with respect to the cartridge device, which is important for a precise alignment of the ends of the staples with the staple forming face of the anvil. This kind of support allows for a large unobstructed area between the cartridge device and the an- vil.
  • the distance between the cartridge device and the anvil in the closed position is adjustable.
  • the moving device can comprise an adjustable stop, e.g. at the re- lated actuating member of the handle, in order to prevent the cartridge device (or anvil) from moving beyond the stop posi ⁇ tion and from clamping the tissue too much.
  • a series of cartridge devices with different built-in tissue stops can be used according to the tissue thickness. It is also conceivable to use a series of cartridge devices which have different lon ⁇ gitudinal dimensions which are adapted to the desired distance between the cartridge device and the anvil in the closed posi ⁇ tion.
  • the cartridge device comprises a replaceable cartridge containing the staples.
  • a used cartridge without staples can be replaced with a fresh one, if required. This is particularly beneficial when the instrument is to be used sev ⁇ eral times in the same patient.
  • the staple fastening assembly and/or the handle are removably mounted, relative to the flexible backbone, which al- lows for easier handling and/or partial replacement of the sta ⁇ pling instrument.
  • WO 01/91646 Al Some of the features discussed above are already known from WO 01/91646 Al, in particular an arc-like shape of the cartridge device and the anvil and a support arm extending from an end of the anvil, which enables an easy access to the site of sur ⁇ gery, e.g., for endoscopic optics or additional surgical in ⁇ struments.
  • the stapling instrument according to the invention can be used in all kinds of surgery disclosed in WO 01/91646 Al, which is incorporated by reference herein.
  • a par ⁇ ticular advantage of the invention is the ability to perform such surgery at locations more remote from an opening in the patient's body and using GI techniques (e.g. non- surgical) , such as local anesthesia or sedation.
  • the term "staple” is used in a 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 form ⁇ ing face” also have a broad meaning which includes, in the case of two-part synthetic fasteners, the anvil-like tool and its face where the retainer members are held, and similar de- vices.
  • Fig. 1 an overall isometric view of a first embodiment of the surgical stapling instrument according to the invention, including an endoscope, a staple fastening assembly in the distal end region and a handle in the proximal end region,
  • Fig. 2 an isometric view of the distal portion of the sta- pling instrument of Fig. 1,
  • Fig. 3 an isometric view of one of several holders spaced along the endoscope
  • Fig. 4 an isometric view of the internal mechanism of the handle
  • Fig. 5 a side view of the internal mechanism of the handle
  • Fig. 6 an isometric view of the distal end of the endoscope, the staple fastening assembly being removed
  • Fig. 7 an isometric view of the components of the staple fastening assembly driven by the mechanism in the handle, i.e. an arm supporting the anvil and a pusher base used for expel- ling the staples,
  • Fig. 8 an isometric view similar to Fig. 7, with the staples and a knife added,
  • Fig. 9 an isometric view of some parts of Fig. 8 in a dif ⁇ ferent perspective
  • Fig. 10 an isometric view of the staple forming face of the anvil and two guide rails used for guiding the knife
  • Fig. 11 an isometric view of the fully assembled staple fas ⁇ tening assembly with the anvil being in a spaced position
  • Fig. 12 an isometric view of the staple fastening assembly, a housing being removed, with the anvil being in a closed posi ⁇ tion and the staples just fired,
  • Fig. 13 an isometric view of parts of Fig. 12 from a differ ⁇ ent perspective
  • Fig. 14 an isometric view similar to Fig. 12 with the housing being attached and including the endoscope,
  • Fig. 15 an exploded view of the staple fastening assembly
  • Fig. 16 an isometric overall view of a second embodiment of the surgical stapling instrument according to the invention, including a flexible guide and an endoscope, and
  • Fig. 17 an isometric view of the distal end region of the em ⁇ bodiment of Fig. 16.
  • Fig. 1 is an isometric overall view of the surgical stapling instrument 1 according to a first embodiment.
  • the stapling in- strument 1 comprises, in its distal end region, a stapling fastening assembly 2 and, in its proximal end region, a handle 4.
  • the handle 4 and the staple fastening assembly 2 are con ⁇ nected via a flexible endoscope 6.
  • the en ⁇ doscope 6 is a commercially available endoscope which is not modified in order to be used in the stapling instrument.
  • the endoscope 6 serves as a flexible backbone and provides struc ⁇ tural strength.
  • two force transmitters 8 and 9 run- ning from the handle 4 to the staple fastening assembly 2 are guided by the endoscope 6.
  • the force transmitters are used for transmitting forces from the handle 4 to the staple fastening assembly 2 in order to perform the functions of the stapling instrument 1.
  • the main components of the staple fastening assembly 2 are a cartridge device 10, which contains several curved open rows of staples as well as a knife, and a curved anvil 12, which has a staple forming face and is adapted to cooperate with the cartridge device for forming the ends of the staples expelled from the cartridge device when stapling instrument 1 is "fired".
  • the anvil 12 can be moved with respect to the cartridge device 10 in a parallel relationship, i.e. in a direction parallel to the longitudinal axis of the distal end portion of the endo ⁇ scope 6. In the view of Fig. 2, the anvil 12 has been entirely moved towards the cartridge device 10.
  • Fig. 2 illustrates that the cartridge device 10 and the anvil 12 have a generally arc-like shape. This design enables an easy access to the working area between cartridge device 10 and anvil 12.
  • Fig. 2 illustrates the arrangement of the distal portion of the endoscope 6 and the staple fastening assembly 2.
  • the distal end face of endoscope 6 has two openings, one for observational optics 14 and one for a light source 15.
  • the endoscope can include a working channel which allows the introduction of a surgical instrument having a flexible shaft through the working channel of the endoscope to the site of surgery, i.e. to the area of the staple fastening assembly 2.
  • the force transmitters 8 and 9 are attached to the endoscope 6 by means of a plurality of spaced holders 16.
  • Fig. 3 shows one of the holders 16 in enlarged view.
  • Each holder 16 has a lock 17 and two recesses 18 ' and 19 for accom- modating the force transmitters 8 and 9, respectively.
  • the lock 17, which comprises a dovetail-shaped pro ⁇ trusion and a notch fitting thereto, can be opened.
  • the mechanical connection between the endoscope 6 and the sta ⁇ ple fastening assembly 2 or the handle 4 can be entirely ac ⁇ complished by means of the holders 16 and the force transmit ⁇ ters 8, 9.
  • the flexi- bility of this design, with no rigid attachment of the handle 4 to the endoscope 6, can be advantageous.
  • the endoscope 6 may be addi ⁇ tionally fixed to the cartridge device 10 of the staple fas ⁇ tening assembly 2, e.g. by bonding.
  • Figs. 4 and 5 illustrate the internal mechanism of the handle 4.
  • Handle 4 comprises a grip 20 designed to rest in the opera ⁇ tor's palm and a gear housing 22.
  • An actuating member 24 is part of the moving device.
  • ac- tuating member 24, which is swivellably mounted is moved to ⁇ wards grip 20, a rack 26 shifts in distal direction and ro ⁇ tates gears 28.
  • the direction of the rotational axis is changed by 90° by means of a pinion 29 at the proximal end of a bearing 30, which supports the proximal end of the force transmitter 8 of the moving device.
  • the force transmitter 8 comprises a rotary rod (see below) , the proximal end of which is fixed to pinion 29.
  • the rotary rod of the force transmitter 8 is caused to a rotary movement about a longitudinal axis. Because of the gear ratio provided by gears 28 and pinion 29, this rotational movement is relatively fast.
  • a rack 34 shifts in distal direction and drives gears 36 and a pinion 37 at the proximal end of a bearing 38, which results in a relatively fast rotational movement of a rotary rod of the force transmitter 9 of the staple driving device.
  • a release button 40 has to be pressed against the force exerted by a spring 41. After “fir ⁇ ing” and before pressing release button 40, a catch 42 engages to a protrusion of the staple driving device and keeps rack 34 in a distal position.
  • rack 26 is held forward and in place by this mechanism as well, while actuating member 32 is pressed. Pressing release button 40 lifts the catch 42, which releases the protrusion of the staple driving device such that, via the action of spring 33, rack 34 returns to its original proximal position.
  • a safety feature (not shown in detail) is a pin held by a part 44 until part 44 is pushed out of the way upon actuation of actuating member 24. This ensures that actuating member 32 cannot be used prior to actuating member 24.
  • Fig. 6 shows the distal end region of the force transmitters 8 of the moving device and 9 of the staple driving device, in- eluding the most distal holder 16 and the distal end area of endoscope 6.
  • Force transmitter 8 comprises a flexible rotary rod 50 which is rotatably mounted in a flexible sheath 51.
  • rotary rod 50 is a single flexible structure all along. Different designs, e.g. a structure comprising flexibly linked short rigid members or a tightly wound helix, are conceivable as well.
  • rotary rod 50 is fixed to a con ⁇ nector 52 which is attached to the proximal end of a drive screw 53.
  • force transmitter 9 includes a ro- tary rod 54, which is guided in a sheath 55 and ends at a con ⁇ nector 56 fixed to a drive screw 57.
  • Fig. 7 displays the components driven by the screws 53 and 57, but not yet the guiding parts or rails for these components .
  • Screw 53 fits into a threaded hole extending into longitudinal direction inside an arm 60 which supports an anvil housing 62.
  • screw 57 fits into a threaded hole in a pusher base 64.
  • the arm 60 and the pusher base 64 are moved in longitudinal direc ⁇ tion of the staple fastening assembly 2.
  • Fig. 8 shows additional components of the staple fastening as ⁇ sembly 2. Both screws 53 and 57 are guided by bores in an ar- cuate base 65 of the staple fastening assembly 2.
  • Pusher base 64 supports (via an intermediate part 67) a pusher platform 66 from which a plurality of pusher fingers 68 extend longitudi ⁇ nally.
  • Each of the pusher fingers 68 supports a staple 70 such that the pointed ends of the staples 70 are aligned in distal direction.
  • the pusher fingers 68 and the related staples 70 are guided in individual slots (not shown in Fig. 8) formed in the housing of the cartridge device 10.
  • the interme ⁇ diate part 67 supports an arcuate knife 72 having a concave side (seen in Fig. 8), a convex side opposite to the concave side and a cutting edge 73.
  • Fig. 8 also shows a guide arm 74 of the anvil 12 which extends from the anvil housing 62 and runs in parallel to arm 60.
  • Fig. 9 provides a better impression of the arrangement of the staples 70 (which are not shown in Fig. 9 but indicated by the locations of the pusher fingers 68) and the knife 72.
  • the cartridge device 10 comprises three curved open rows of staples, i.e. two rows 76 and 77 on the convex side of knife 72 and one row 78 on the concave side of knife 72.
  • a staple forming face 80 which is mounted on the anvil hous ⁇ ing 62 (see Fig. 8), is shown in Fig. 10.
  • the staple forming face 80 is preferably made of metal and comprises three rows of staple forming depression 82, which are aligned to the pointed ends of staples 70.
  • Fig. 10 displays a knife depression 84, which is aligned to the cutting edge 73 of knife 72 and preferably filled with a plastics material which acts as cutting block but can be cut by the knife 72.
  • the staple forming face 80 Fixed to the staple forming face 80, there are two guide rails 86 and 87 which have a lateral slot each for precisely guiding the knife 72, even when it is very close to the staple forming face 80, as illustrated in Fig. 10.
  • the guide rails 86 and 87 move in longitudinal direc ⁇ tion as well and slide through holes 88 and 89 (see Fig. 9) provided in the intermediate part 67 and the pusher platform 66. This movement does not affect the position of the knife 72, because knife 72 is fixed to the intermediate part 67.
  • Fig. 11 is a view similar to Fig. 8, but the cartridge device 10 has been completed by a housing 90.
  • the housing 90 is an injection-molded part made of medical grade plastics material.
  • Fig. 11 illustrates the state in which the anvil 12 has been moved to a spaced position, i.e. to a position in which the distance between the cartridge device 10 and the staple form ⁇ ing face 80 of the anvil 12 is large. This corresponds to a large exposed area of drive screw 53 in Fig. 8. In this spaced position, tissue of a patient to be excised can be pulled bet ⁇ ween the staple forming face 80 of anvil 12 and the cartridge device 10.
  • actuating member 24 of the moving de ⁇ vice is pressed towards grip 20, which causes a rotational movement of rotary rod 50 and drive screw 53, resulting in a shift of the anvil 12 in proximal direction. In this way, the anvil 12 reaches a closed position and the tissue is clamped.
  • Fig. 12 shows the next step of the procedure.
  • the anvil 12 has been moved to a closed position, which is evident from a small exposed area of drive screw 53.
  • actuating member 32 has been pressed, which results in a rotational movement of screw 57 and a longitudinal movement in distal direction of the pusher base 64, the intermediate part 67, the pusher plat ⁇ form 66, the pusher fingers 68, the staples 70 and the knife 72, wherein the cutting edge 73 of knife 72 follows the pointed ends of the staples 70.
  • Fig. 12 shows the state when the staples 70 have been formed by staple forming face 80.
  • Fig. 13 displays the same state.
  • Fig. 14 shows a complete view of the cartridge device 10, the anvil 12 and the distal end region of endoscope 6 in the same state.
  • the tissue After the tissue has been stapled, it is cut and ex- cised by the knife 72.
  • the tissue to stay with the patient is safely stapled by the rows 76 and 77 of staples on the convex side of knife 72, which immediately stops bleed ⁇ ing, whereas the part of the tissue to be removed from the pa ⁇ tient is stapled and held together by the staples of row 78.
  • release button 40 is pressed, such that rack 34 and actuating member 32, by means of the force exerted by spring 33, return to their original positions.
  • this effects a reverse motion of the moving device, increasing the distance between the anvil 12 and the cartridge device 10 in order to release the clamped tissue and to be able to re- move the stapling instrument 1 from the patient.
  • the excised portion of the tissue remains in the staple fastening assembly 2.
  • Fig. 15 illustrates the components of the staple fastening as- sembly 2 of the embodiment described so far in an exploded view. Screws 92 and 93 are used to attach the arcuate base 65 to part of the housing 90 of cartridge device 10.
  • Figs. 16 and 17 display a second embodiment of the surgical stapling instrument, i.e. the stapling instrument 100.
  • Its staple fastening assembly 102 and its handle 104 have a simi ⁇ lar design as the staple fastening assembly 2 and the handle 4 of the first embodiment.
  • the force transmitters are not exposed at the outer periphery of endoscope 106, but are accommodated in a flexible guide 108.
  • the endoscope 106 and the flexible guide 108 form the flexible backbone of stapling instrument 100.
  • the flexible guide 108 is made of plastics material and comprises two longitudinal channels for guiding rotary rods of the force transmitters of the moving device and of the staple driving device.
  • An open channel 109 longitudi ⁇ nally extends alongside flexible guide 108.
  • the endoscope 106 can rest within open channel 109, as shown in Fig. 16 and 17.
  • the function and use of the stapling instrument 100 are the same as those of stapling instrument 1.

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Abstract

A surgical stapling instrument (1) comprises a staple fastening assembly (2) including a curved cartridge device (10) and a curved anvil (12). The cartridge device (10) comprises at least one curved open row of staples which are formed by a staple forming face of the anvil (12). The anvil (12) can be moved relatively with respect to the cartridge device (10). A handle (4) in the proximal end region of the instrument is operatively connected to the staple fastening assembly (2). A flexible backbone, preferably an endoscope (6), is arranged between the handle (4) and the staple fastening assembly (2) and guides force transmitters (8, 9) of the moving device and the staple driving device.

Description

Surgical stapling instrument
The invention relates to a surgical stapling instrument, which can be used, e.g., in the diagnosis and/or therapy of patholo¬ gies of the lower gastrointestinal tract.
Such a surgical stapling instrument is known from WO 01/91646 Al. WO 01/91646 Al discloses a surgical stapling instrument having a staple fastening assembly located in the distal end region of the stapling instrument, a rigid shaft, and a handle extending from the shaft in the proximal end region of the stapling instrument. The staple fastening assembly includes a curved cartridge device, which comprises several curved open rows of staples having a concave side and a convex side. A curved anvil is arranged opposite to the cartridge device. The anvil has a staple forming face and is adapted to cooperate
_ o _
with the cartridge device for forming the ends of the staples exiting from the cartridge device. The anvil can be moved relatively with respect to the cartridge device from a spaced position for positioning tissue therebetween to a closed posi- tion for clamping the tissue. Moreover, a knife is contained in the cartridge device and is positioned on the concave side of at least one row of staples and optionally the convex side of at least one row of staples.
The surgical stapling instrument disclosed in WO 01/91646 Al can be used to excise tissue, e.g. polyps, and to stop bleed¬ ing virtually immediately. In a surgical procedure, the sta¬ pling instrument is introduced, e.g., into the anal canal and moved to the site of the tissue to be resected. The tissue to be excised can be pulled into the area between the anvil and the cartridge device, when the cartridge device and the anvil are in a spaced or open position, by means of a separate tis¬ sue grasping instrument. Afterwards, the anvil is moved rela¬ tively with respect to the cartridge device in order to clamp the tissue. When the cartridge device and the anvil have reached the closed position, the surgeon can "fire" the in¬ strument, which means that the staples are driven out of the cartridge device, penetrate the tissue, whereupon the ends are bent by the anvil, and the knife is moved towards the anvil in order to cut the tissue. When the instrument is opened, the completely excised tissue can be safely removed from the pa¬ tient's body together with or prior to removing the instrument itself.
A particular advantage of the surgical stapling instrument disclosed in WO 01/91646 Al is the shape of the staple fasten- ing assembly in which the cartridge device and the anvil have a generally arc-like shape in a cross-sectional plane. This allows for unobstructed view and access towards the concave inner faces of the cartridge device and of the anvil.
When introduced, e.g., into the anal canal, the operational range of the instrument known from WO 01/91646 Al is re¬ stricted, however, and it cannot be used to excise tissue more remote from the rectum because of its limited shaft length.
It is the object of the invention to provide a surgical sta¬ pling instrument which has at least two major benefits, i.e. a larger operational range than the stapling instrument dis¬ closed in WO 01/91646 Al and the ability of being used by gas- troenterologists (e.g. GI) in a colonoscopy setting thanks to the possibility to provide the stapling instrument in a size noticeable smaller than the one disclosed in the stapling in¬ strument of WO 01/91646 Al.
This problem is solved by a surgical stapling instrument hav¬ ing the features of claim 1. Advantageous versions of the in¬ vention follow from the dependent claims.
The surgical stapling instrument according to the invention comprises, in the distal end region of the instrument, a sta¬ ple fastening assembly including a curved cartridge device and, opposite to the cartridge device, a curved anvil. The cartridge device comprises at least one curved open row of staples having a concave side and a convex side. The anvil has a staple forming face and is adapted to cooperate with the cartridge device for forming the ends of the staples exiting frora the cartridge device. Moreover, a moving device is adapted to move the anvil relatively with respect to the cartridge de¬ vice, essentially in parallel relationship, from a spaced posi¬ tion for positioning tissue therebetween to a closed position for clamping the tissue. A staple driving device is adapted to drive the staples out of the cartridge device towards the anvil. In the proximal end region of the instrument, a handle is opera- tively connected to the staple fastening assembly and comprises actuating members coupled to force transmitters of the moving device and of the staple driving device.
Optionally, the stapling instrument includes a knife, which is contained in the cartridge device and which is positioned on the concave side of at least one row of staples and possibly the convex side of at least one row of staples. The knife can be moved towards the anvil by means of a knife actuating device, which is preferably coupled to the staple driving device, e.g. such that, upon actuation of the actuating member of the staple driving device, the staples and the knife advance simultane- ously, the knife following the staples such that the tissue is cut after having been stapled.
According to the invention, a flexible backbone is arranged be¬ tween the handle and the staple fastening assembly. The flexible backbone is a kind of flexible shaft or flexible connection be¬ tween the handle and the staple fastening assembly and guides the force transmitters of the moving device and of the staple driving device. The flexible backbone can be rather long. It en¬ ables the stapling instrument to be introduced, e.g., into the anal canal and to be moved forward for a rather long distance to allow for the treatment of tissue at a site remote from the anus. Upon advancement of the stapling instrument, the flexible backbone adapts to the curvature of the intestine.
In a preferred version of the invention, the flexible backbone comprises a flexible endoscope, which preferably is removably mounted (i.e. it can be detached from the rest of the instru¬ ment) . The endoscope usually includes observational optics and a light source and optionally comprises a working channel in its longitudinal direction. The working channel can be utilized to place surgical tools at the site of surgery, e.g. an endoscopic gripping instrument for pulling tissue into the space between the cartridge device and the anvil. The application of a flexi¬ ble endoscope in the backbone of the stapling instrument has the advantage that a standard component is used which can provide flexibility as well as strength to the stapling instrument.
The stapling instrument can be adapted to be used with an inde¬ pendent flexible endoscope forming at least part of the flexible backbone. That means, the stapling instrument according to the invention is distributed without the endoscope, and in order to put it into an operational state, the independently or sepa¬ rately distributed endoscope is connected to the other parts of the instrument. Alternatively, the flexible endoscope is a com¬ ponent or even an integral component of the stapling instrument. These options allow for a large design versatility and cost ef¬ fectiveness.
In an advantageous version of the invention, the force transmit¬ ters of the moving device and of the staple driving device are located at the outside of the endoscope and are attached to the endoscope by a plurality of spaced holders. If the knife actuat- ing device has an independent actuating member at the handle, a force transmitter of the knife actuating device can be arranged at the outside of the endoscope as well. This design uses the endoscope as the only structural connection between the handle and the staple fastening assembly and is particularly simple.
In another version, the flexible backbone comprises a flexible guide, which is arranged alongside the endoscope and which ac¬ commodates the force transmitters of the moving device and of the staple driving device. The guide, depending on its design, can connect the handle and the staple fastening assembly in a structural sense.
In a preferred version of the invention, at least one of the force transmitters of the moving device and of the staple driv¬ ing device comprises a flexible rotary rod adapted to be rotated around its longitudinal axis upon actuation of the related actu¬ ating member of the handle and adapted to transform its rotary motion to a longitudinal motion at the staple fastening assem- bly. The term flexible rod is to be understood in a rather broad sense; it includes, e.g., a tightly wound helix, which is flexi¬ ble and can transmit torque, and even designs comprising linked members. When force is transmitted from the actuating member at the handle to the staple fastening assembly via a rotary motion, the actual curved shape of the flexible backbone is not affected by this rotary action in which the rotary rod rotates in some guide or sheath. In contrast thereto, a translational movement of force transmitters in a curved flexible shaft tends to straighten the shaft, which would be a great disadvantage in the use of such instrument. Preferably, at least one of the force transmitters is adapted to be rotated via a gear transmission operated by the related actu¬ ating member. Moreover, at least one of the force transmitters can be adapted to transform its rotary motion to a longitudinal motion (required for the relative movement of the anvil with re¬ spect to the cartridge device or for expelling the staples) via a screw drive.
The staple forming face of the anvil can be generally planar, but other shapes, e.g. an undulated shape, are conceivable as well.
In an advantageous version of the invention, the staple fasten¬ ing assembly is adapted to allow unobstructed access towards concave inner faces of the cartridge device and of the anvil. Such design, which is generally known from WO 01/91646 Al, largely facilitates the handling of the stapling instrument in a surgical procedure.
Preferably, the cartridge device and the anvil have a generally arc-like shape in a cross-sectional plane, the arc extending over an angle in the range 10° to 350°.
In a preferred version of the invention, the anvil is supported by means of at least one arm extending from an end of the anvil and generally running in parallel to the direction of relative movement of the anvil with respect to the cartridge device. This arm can be driven by the moving device if the anvil is movable with respect to a fixed cartridge device. An optional second arm, preferably at the other end of the anvil, provides addi¬ tional strength and facilitates an accurate alignment of the an- vil with respect to the cartridge device, which is important for a precise alignment of the ends of the staples with the staple forming face of the anvil. This kind of support allows for a large unobstructed area between the cartridge device and the an- vil.
Preferably, the distance between the cartridge device and the anvil in the closed position is adjustable. For example, the moving device can comprise an adjustable stop, e.g. at the re- lated actuating member of the handle, in order to prevent the cartridge device (or anvil) from moving beyond the stop posi¬ tion and from clamping the tissue too much. Or a series of cartridge devices with different built-in tissue stops can be used according to the tissue thickness. It is also conceivable to use a series of cartridge devices which have different lon¬ gitudinal dimensions which are adapted to the desired distance between the cartridge device and the anvil in the closed posi¬ tion. By adjusting the distance between the cartridge device and the anvil in the closed position, the instrument can be matched to the thickness and type of tissue to be stapled.
In an advantageous version of the surgical stapling instru¬ ment, the cartridge device comprises a replaceable cartridge containing the staples. In this way, a used cartridge without staples can be replaced with a fresh one, if required. This is particularly beneficial when the instrument is to be used sev¬ eral times in the same patient.
Preferably, the staple fastening assembly and/or the handle are removably mounted, relative to the flexible backbone, which al- lows for easier handling and/or partial replacement of the sta¬ pling instrument.
Some of the features discussed above are already known from WO 01/91646 Al, in particular an arc-like shape of the cartridge device and the anvil and a support arm extending from an end of the anvil, which enables an easy access to the site of sur¬ gery, e.g., for endoscopic optics or additional surgical in¬ struments. Generally, the stapling instrument according to the invention can be used in all kinds of surgery disclosed in WO 01/91646 Al, which is incorporated by reference herein. A par¬ ticular advantage of the invention, however, is the ability to perform such surgery at locations more remote from an opening in the patient's body and using GI techniques (e.g. non- surgical) , such as local anesthesia or sedation.
Herein, the term "staple" is used in a 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 form¬ ing face" also have a broad meaning which includes, in the case of two-part synthetic fasteners, the anvil-like tool and its face where the retainer members are held, and similar de- vices.
In the following, the invention is described in more detail by means of embodiments. The drawings show in
Fig. 1 an overall isometric view of a first embodiment of the surgical stapling instrument according to the invention, including an endoscope, a staple fastening assembly in the distal end region and a handle in the proximal end region,
Fig. 2 an isometric view of the distal portion of the sta- pling instrument of Fig. 1,
Fig. 3 an isometric view of one of several holders spaced along the endoscope,
Fig. 4 an isometric view of the internal mechanism of the handle, Fig. 5 a side view of the internal mechanism of the handle,
Fig. 6 an isometric view of the distal end of the endoscope, the staple fastening assembly being removed,
Fig. 7 an isometric view of the components of the staple fastening assembly driven by the mechanism in the handle, i.e. an arm supporting the anvil and a pusher base used for expel- ling the staples,
Fig. 8 an isometric view similar to Fig. 7, with the staples and a knife added,
Fig. 9 an isometric view of some parts of Fig. 8 in a dif¬ ferent perspective,
Fig. 10 an isometric view of the staple forming face of the anvil and two guide rails used for guiding the knife, Fig. 11 an isometric view of the fully assembled staple fas¬ tening assembly with the anvil being in a spaced position,
Fig. 12 an isometric view of the staple fastening assembly, a housing being removed, with the anvil being in a closed posi¬ tion and the staples just fired,
Fig. 13 an isometric view of parts of Fig. 12 from a differ¬ ent perspective,
Fig. 14 an isometric view similar to Fig. 12 with the housing being attached and including the endoscope,
Fig. 15 an exploded view of the staple fastening assembly,
Fig. 16 an isometric overall view of a second embodiment of the surgical stapling instrument according to the invention, including a flexible guide and an endoscope, and
Fig. 17 an isometric view of the distal end region of the em¬ bodiment of Fig. 16.
Fig. 1 is an isometric overall view of the surgical stapling instrument 1 according to a first embodiment. The stapling in- strument 1 comprises, in its distal end region, a stapling fastening assembly 2 and, in its proximal end region, a handle 4. The handle 4 and the staple fastening assembly 2 are con¬ nected via a flexible endoscope 6. In the embodiment, the en¬ doscope 6 is a commercially available endoscope which is not modified in order to be used in the stapling instrument. The endoscope 6 serves as a flexible backbone and provides struc¬ tural strength.
As shown in Fig. 1 and 2, two force transmitters 8 and 9 run- ning from the handle 4 to the staple fastening assembly 2 are guided by the endoscope 6. The force transmitters are used for transmitting forces from the handle 4 to the staple fastening assembly 2 in order to perform the functions of the stapling instrument 1.
The main components of the staple fastening assembly 2 are a cartridge device 10, which contains several curved open rows of staples as well as a knife, and a curved anvil 12, which has a staple forming face and is adapted to cooperate with the cartridge device for forming the ends of the staples expelled from the cartridge device when stapling instrument 1 is "fired".
The anvil 12 can be moved with respect to the cartridge device 10 in a parallel relationship, i.e. in a direction parallel to the longitudinal axis of the distal end portion of the endo¬ scope 6. In the view of Fig. 2, the anvil 12 has been entirely moved towards the cartridge device 10.
The mechanism and its components of the stapling instrument 1 used for moving anvil 12 relative to cartridge device 10 are generally called moving device, whereas the mechanism and the components used for advancing the staples are generally called staple driving device. Fig. 2 illustrates that the cartridge device 10 and the anvil 12 have a generally arc-like shape. This design enables an easy access to the working area between cartridge device 10 and anvil 12.
Moreover, Fig. 2 illustrates the arrangement of the distal portion of the endoscope 6 and the staple fastening assembly 2. The distal end face of endoscope 6 has two openings, one for observational optics 14 and one for a light source 15. Op- tionally, the endoscope can include a working channel which allows the introduction of a surgical instrument having a flexible shaft through the working channel of the endoscope to the site of surgery, i.e. to the area of the staple fastening assembly 2.
In the embodiment, the force transmitters 8 and 9 are attached to the endoscope 6 by means of a plurality of spaced holders 16. Fig. 3 shows one of the holders 16 in enlarged view. Each holder 16 has a lock 17 and two recesses 18 ' and 19 for accom- modating the force transmitters 8 and 9, respectively. For as¬ semblage, the lock 17, which comprises a dovetail-shaped pro¬ trusion and a notch fitting thereto, can be opened. The holder 16, which is manufactured from flexible material, allows the insertion of the endoscope 6.
The mechanical connection between the endoscope 6 and the sta¬ ple fastening assembly 2 or the handle 4 can be entirely ac¬ complished by means of the holders 16 and the force transmit¬ ters 8, 9. In particular in the area of handle 4, the flexi- bility of this design, with no rigid attachment of the handle 4 to the endoscope 6, can be advantageous. In the distal end region of stapling instrument 1, the endoscope 6 may be addi¬ tionally fixed to the cartridge device 10 of the staple fas¬ tening assembly 2, e.g. by bonding.
Figs. 4 and 5 illustrate the internal mechanism of the handle 4. Handle 4 comprises a grip 20 designed to rest in the opera¬ tor's palm and a gear housing 22.
An actuating member 24 is part of the moving device. When ac- tuating member 24, which is swivellably mounted, is moved to¬ wards grip 20, a rack 26 shifts in distal direction and ro¬ tates gears 28. The direction of the rotational axis is changed by 90° by means of a pinion 29 at the proximal end of a bearing 30, which supports the proximal end of the force transmitter 8 of the moving device. The force transmitter 8 comprises a rotary rod (see below) , the proximal end of which is fixed to pinion 29. Thus, upon pressing the actuating mem¬ ber 24, the rotary rod of the force transmitter 8 is caused to a rotary movement about a longitudinal axis. Because of the gear ratio provided by gears 28 and pinion 29, this rotational movement is relatively fast.
In a similar way, upon pressing a swivellably mounted actuat¬ ing member 32 against the force of a spring 33 ("firing" the instrument) , a rack 34 shifts in distal direction and drives gears 36 and a pinion 37 at the proximal end of a bearing 38, which results in a relatively fast rotational movement of a rotary rod of the force transmitter 9 of the staple driving device. In order to release (retract) the staple driving device after the staples have been "fired", a release button 40 has to be pressed against the force exerted by a spring 41. After "fir¬ ing" and before pressing release button 40, a catch 42 engages to a protrusion of the staple driving device and keeps rack 34 in a distal position. Moreover, rack 26 is held forward and in place by this mechanism as well, while actuating member 32 is pressed. Pressing release button 40 lifts the catch 42, which releases the protrusion of the staple driving device such that, via the action of spring 33, rack 34 returns to its original proximal position.
A safety feature (not shown in detail) is a pin held by a part 44 until part 44 is pushed out of the way upon actuation of actuating member 24. This ensures that actuating member 32 cannot be used prior to actuating member 24.
Fig. 6 shows the distal end region of the force transmitters 8 of the moving device and 9 of the staple driving device, in- eluding the most distal holder 16 and the distal end area of endoscope 6.
Force transmitter 8 comprises a flexible rotary rod 50 which is rotatably mounted in a flexible sheath 51. In the embodi- ment, rotary rod 50 is a single flexible structure all along. Different designs, e.g. a structure comprising flexibly linked short rigid members or a tightly wound helix, are conceivable as well. At its distal end, rotary rod 50 is fixed to a con¬ nector 52 which is attached to the proximal end of a drive screw 53. In a similar way, force transmitter 9 includes a ro- tary rod 54, which is guided in a sheath 55 and ends at a con¬ nector 56 fixed to a drive screw 57.
Fig. 7 displays the components driven by the screws 53 and 57, but not yet the guiding parts or rails for these components . Screw 53 fits into a threaded hole extending into longitudinal direction inside an arm 60 which supports an anvil housing 62. Similarly, screw 57 fits into a threaded hole in a pusher base 64. Thus, by rotating rotary rods 50 or 54, the arm 60 and the pusher base 64, respectively, are moved in longitudinal direc¬ tion of the staple fastening assembly 2.
Fig. 8 shows additional components of the staple fastening as¬ sembly 2. Both screws 53 and 57 are guided by bores in an ar- cuate base 65 of the staple fastening assembly 2. Pusher base 64 supports (via an intermediate part 67) a pusher platform 66 from which a plurality of pusher fingers 68 extend longitudi¬ nally. Each of the pusher fingers 68 supports a staple 70 such that the pointed ends of the staples 70 are aligned in distal direction. The pusher fingers 68 and the related staples 70 are guided in individual slots (not shown in Fig. 8) formed in the housing of the cartridge device 10. Moreover, the interme¬ diate part 67 supports an arcuate knife 72 having a concave side (seen in Fig. 8), a convex side opposite to the concave side and a cutting edge 73. Fig. 8 also shows a guide arm 74 of the anvil 12 which extends from the anvil housing 62 and runs in parallel to arm 60.
Fig. 9 provides a better impression of the arrangement of the staples 70 (which are not shown in Fig. 9 but indicated by the locations of the pusher fingers 68) and the knife 72. The cartridge device 10 comprises three curved open rows of staples, i.e. two rows 76 and 77 on the convex side of knife 72 and one row 78 on the concave side of knife 72.
A staple forming face 80, which is mounted on the anvil hous¬ ing 62 (see Fig. 8), is shown in Fig. 10. The staple forming face 80 is preferably made of metal and comprises three rows of staple forming depression 82, which are aligned to the pointed ends of staples 70. Moreover, Fig. 10 displays a knife depression 84, which is aligned to the cutting edge 73 of knife 72 and preferably filled with a plastics material which acts as cutting block but can be cut by the knife 72.
Fixed to the staple forming face 80, there are two guide rails 86 and 87 which have a lateral slot each for precisely guiding the knife 72, even when it is very close to the staple forming face 80, as illustrated in Fig. 10. When the anvil 12 is moved with respect to the cartridge device 10 by means of the moving device, the guide rails 86 and 87 move in longitudinal direc¬ tion as well and slide through holes 88 and 89 (see Fig. 9) provided in the intermediate part 67 and the pusher platform 66. This movement does not affect the position of the knife 72, because knife 72 is fixed to the intermediate part 67.
Fig. 11 is a view similar to Fig. 8, but the cartridge device 10 has been completed by a housing 90. In the embodiment, the housing 90 is an injection-molded part made of medical grade plastics material. Fig. 11 illustrates the state in which the anvil 12 has been moved to a spaced position, i.e. to a position in which the distance between the cartridge device 10 and the staple form¬ ing face 80 of the anvil 12 is large. This corresponds to a large exposed area of drive screw 53 in Fig. 8. In this spaced position, tissue of a patient to be excised can be pulled bet¬ ween the staple forming face 80 of anvil 12 and the cartridge device 10. Thereafter, actuating member 24 of the moving de¬ vice is pressed towards grip 20, which causes a rotational movement of rotary rod 50 and drive screw 53, resulting in a shift of the anvil 12 in proximal direction. In this way, the anvil 12 reaches a closed position and the tissue is clamped.
The next step of the procedure is shown in Fig. 12 (in which the housing 90 is removed) . As explained, the anvil 12 has been moved to a closed position, which is evident from a small exposed area of drive screw 53. Moreover, actuating member 32 has been pressed, which results in a rotational movement of screw 57 and a longitudinal movement in distal direction of the pusher base 64, the intermediate part 67, the pusher plat¬ form 66, the pusher fingers 68, the staples 70 and the knife 72, wherein the cutting edge 73 of knife 72 follows the pointed ends of the staples 70. Fig. 12 shows the state when the staples 70 have been formed by staple forming face 80. Fig. 13 displays the same state.
Fig. 14 shows a complete view of the cartridge device 10, the anvil 12 and the distal end region of endoscope 6 in the same state. After the tissue has been stapled, it is cut and ex- cised by the knife 72. In this way, the tissue to stay with the patient is safely stapled by the rows 76 and 77 of staples on the convex side of knife 72, which immediately stops bleed¬ ing, whereas the part of the tissue to be removed from the pa¬ tient is stapled and held together by the staples of row 78. After stapling, release button 40 is pressed, such that rack 34 and actuating member 32, by means of the force exerted by spring 33, return to their original positions. Additionally, this effects a reverse motion of the moving device, increasing the distance between the anvil 12 and the cartridge device 10 in order to release the clamped tissue and to be able to re- move the stapling instrument 1 from the patient. The excised portion of the tissue remains in the staple fastening assembly 2.
Fig. 15 illustrates the components of the staple fastening as- sembly 2 of the embodiment described so far in an exploded view. Screws 92 and 93 are used to attach the arcuate base 65 to part of the housing 90 of cartridge device 10.
Figs. 16 and 17 display a second embodiment of the surgical stapling instrument, i.e. the stapling instrument 100. Its staple fastening assembly 102 and its handle 104 have a simi¬ lar design as the staple fastening assembly 2 and the handle 4 of the first embodiment. In contrast thereto, however, the force transmitters are not exposed at the outer periphery of endoscope 106, but are accommodated in a flexible guide 108. The endoscope 106 and the flexible guide 108 form the flexible backbone of stapling instrument 100.
In the embodiment, the flexible guide 108 is made of plastics material and comprises two longitudinal channels for guiding rotary rods of the force transmitters of the moving device and of the staple driving device. An open channel 109 longitudi¬ nally extends alongside flexible guide 108. The endoscope 106 can rest within open channel 109, as shown in Fig. 16 and 17.
The function and use of the stapling instrument 100 are the same as those of stapling instrument 1.

Claims

Claims
1. Surgical stapling instrument comprising:
- a staple fastening assembly (2; 102) in the distal end re- gion of the instrument (1/ 100), including a curved car¬ tridge device (10) , which comprises at least one curved open row (76, 77, 78) of staples (70) having a concave side and a convex side, and, opposite to the cartridge device (10) , a curved anvil (12) , which has a staple forming face (80) and is adapted to cooperate with the cartridge device (10) for forming the ends of the staples (70) exiting from the car¬ tridge device (10) ,
- a moving device (8, 24, 26, 28, 29, 30, 53, 60) adapted to move the anvil (12) relatively with respect to the cartridge device (10), essentially in parallel relationship, from a spaced position for positioning tissue therebetween to a closed position for clamping the tissue,
- a staple driving device (9, 32, 34, 36, 37, 38, 57, 64) adapted to drive the staples (70) out of the cartridge de- vice (10) towards the anvil (12),
- a handle (4; 104) in the proximal end region of the in¬ strument (1; 100), which handle (4/ 104) is operatively con¬ nected to the staple fastening assembly (2; 102) and which comprises actuating members (24, 32) coupled to force trans- mitters (8, 9) of the moving device and of the staple dri¬ ving device,
- characterized in that a flexible backbone (6; 106, 108) is arranged between the handle (4; 104) and the staple fasten¬ ing assembly (2; 102), which flexible backbone (6; 106, 108) guides the force transmitters (8, 9) of the moving device and of the staple driving device.
2. Stapling instrument according to claim 1, characterized by
- a knife (72) , which is contained in the cartridge device (10) and which is positioned on the concave side of at least one row (76, 77) of staples (70) , and
- a knife actuating device (9, 32, 34, 36, 37, 38, 57, 64) adapted to move the knife (72) towards the anvil (12), which knife actuating device preferably is coupled to the staple driving device.
3. Stapling instrument according to claim 1 or 2, characterized in that the flexible backbone (6; 106, 108) comprises a flexible endoscope (6; 106) , which preferably is removably mounted.
4. Stapling instrument according to claim 1 or 2, characterized in that the stapling instrument (1; 100) is adapted to be used with an independent flexible endoscope (6; 106) forming at least part of the flexible backbone (6; 106, 108) .
5. Stapling instrument according to claim 3 or 4, characterized in that the force transmitters (8, 9) of the moving device and of the staple driving device are located at the outside of the endoscope (6) and are attached to the endoscope (6) by a plurality of spaced holders (16) .
6. Stapling instrument according to claim 3 or 4, characterized in that the flexible backbone (106, 108) comprises a flexi¬ ble guide (108) , which is arranged alongside the endoscope (106) and which accommodates the force transmitters of the moving device and of the staple driving device.
7. Stapling instrument according to one of claims 1 to 6, cha¬ racterized in that at least one of the force transmitters (8, 9) of the moving device and of the staple driving device comprises a flexible rotary rod (50, 54) adapted to be ro¬ tated around its longitudinal axis upon actuation of the re¬ lated actuating member (24, 32) of the handle (4) and adapted to transform its rotary motion to a longitudinal mo¬ tion at the staple fastening assembly (2) .
8. Stapling instrument according to claim 7, characterized in that the at least one of the force transmitters (8, 9) is adapted to be rotated via a gear transmission (26, 28, 29; 34, 36, 37) operated by the related actuating member (24, 32) .
9. Stapling instrument according to claim 7 or 8, characterized in that the at least one of the force transmitters (8, 9) is adapted to transform its rotary motion to a longitudinal mo- tion via a screw drive (53, 57) .
10. Stapling instrument according to one of claims 1 to 9, cha¬ racterized in that the staple fastening assembly (2) is adapted to allow unobstructed access towards concave inner faces of the cartridge device (10) and of the anvil (12) .
11. Stapling instrument according to one of claims 1 to 10, cha¬ racterized in that the staple forming face (80) of the anvil (12) is generally planar.
12. Stapling instrument according to one of claims 1 to 11, characterized in that the cartridge device (10) and the an¬ vil (12) have a generally arc-like shape in a cross-sectio¬ nal plane, the arc extending over an angle in the range 10° to 350°.
13. Stapling instrument according to one of claims 1 to 12, cha¬ racterized in that the anvil (12) is supported by means of at least one arm (60, 74) extending from an end of the anvil (12) and generally running in parallel to the direction of relative movement of the anvil (12) with respect to the car¬ tridge device (10) .
14. Stapling instrument according to one of claims 1 to 13, cha- racterized in that the distance between the cartridge device
(10) and the anvil (12) in the closed position is adjusta¬ ble.
15. Stapling instrument according to one of claims 1 to 14, cha- racterized in that the cartridge device comprises a replace¬ able cartridge containing the staples.
16. Stapling instrument according to one of claims 1 to 15, cha¬ racterized in that the staple fastening assembly is remo- vably mounted.
17. Stapling instrument according to one of claims 1 to 16, cha¬ racterized in that the handle is removably mounted.
PCT/EP2004/010138 2004-09-10 2004-09-10 Surgical stapling instrument WO2006027014A1 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
CNB2004800441916A CN100569190C (en) 2004-09-10 2004-09-10 Surgery suturing appliance
AU2004323140A AU2004323140B2 (en) 2004-09-10 2004-09-10 Surgical stapling instrument
PCT/EP2004/010138 WO2006027014A1 (en) 2004-09-10 2004-09-10 Surgical stapling instrument
EP04786932A EP1788954A1 (en) 2004-09-10 2004-09-10 Surgical stapling instrument
CA2579606A CA2579606C (en) 2004-09-10 2004-09-10 Surgical stapling instrument
JP2007530590A JP4879900B2 (en) 2004-09-10 2004-09-10 Surgical stapling instrument
MX2007002841A MX2007002841A (en) 2004-09-10 2004-09-10 Surgical stapling instrument.
BRPI0419039A BRPI0419039B8 (en) 2004-09-10 2004-09-10 surgical stapling instrument
US11/662,105 US7810690B2 (en) 2004-09-10 2004-10-09 Surgical stapling instrument
IL181648A IL181648A0 (en) 2004-09-10 2007-03-01 Surgical stapling instrument
US12/699,910 US20100133320A1 (en) 2004-09-10 2010-02-04 Surgical Stapling Instrument

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US20090236399A1 (en) 2009-09-24
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AU2004323140B2 (en) 2011-11-24
MX2007002841A (en) 2007-04-30
IL181648A0 (en) 2007-07-04
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BRPI0419039B1 (en) 2015-11-10
US7810690B2 (en) 2010-10-12
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