WO2012072133A1 - A surgical stapling device and a method for anchoring a liner to a hollow organ - Google Patents

A surgical stapling device and a method for anchoring a liner to a hollow organ Download PDF

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Publication number
WO2012072133A1
WO2012072133A1 PCT/EP2010/068664 EP2010068664W WO2012072133A1 WO 2012072133 A1 WO2012072133 A1 WO 2012072133A1 EP 2010068664 W EP2010068664 W EP 2010068664W WO 2012072133 A1 WO2012072133 A1 WO 2012072133A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
clamping
staples
row
detection window
Prior art date
Application number
PCT/EP2010/068664
Other languages
French (fr)
Inventor
David Cagle
Mark Steven Ortiz
Michele D'arcangelo
Jason Harris
Edward Anton
Michael A. Murray
Federico Bilotti
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
Application filed by Ethicon Endo-Surgery, Inc. filed Critical Ethicon Endo-Surgery, Inc.
Priority to PCT/EP2010/068664 priority Critical patent/WO2012072133A1/en
Publication of WO2012072133A1 publication Critical patent/WO2012072133A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • 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
    • 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
    • A61B17/07292—Reinforcements for staple line, e.g. pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • 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
    • A61B2017/07257—Stapler heads characterised by its anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30—Surgical pincettes without pivotal connections
    • A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation

Definitions

  • the present invention relates generally to medical apparatuses and methods and more particularly to devices and methods for positioning and anchoring a lining to a hollow body organ, such as a stomach, intestine or gastrointestinal tract.
  • VBG vertical banded gastroplasty
  • Roux-En-Y gastric bypass a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach's volume and subsequent bypass of the intestine.
  • endoluminal sleeves are known for partially or totally lining certain portions of the stomach and of the intestine with the aim to separate or bypass at least part of the food flow from the lined portions of the gastrointestinal tract. It has been observed that by creating a physical barrier between the ingested food and certain regions of the gastrointestinal wall by means of endoluminal sleeves, similar benefits for weight loss and improvement or resolution of type 2 diabetes may be achieved as with gastric bypass surgery. Physicians believe that by creating a physical barrier between the ingested food and selected regions of the gastrointestinal wall, it might be possible to purposefully influence the mechanism of hormonal signal activation originating from the intestine.
  • a known type of endoluminal sleeve relies on metallic expandable structures, such as a stent, to engage the surrounding hollow organ for holding the sleeve in the planned position.
  • metallic expandable structures such as a stent
  • barbs which penetrate the surrounding tissue.
  • the known devices and methods do not sufficiently address the need of a good control and verification of the correct amount and shape of acquired lumen wall to which the endoluminal sleeves are to be fastened.
  • the known devices and methods do not sufficiently address the need of creating sealed or leak tight connection regions between the endoluminal sleeve and the hollow organ in order to obtain a desired flow scheme of the food flow and the flow of bodily fluids, such as gastric juices, bile and pancreatic fluid.
  • known devices and methods allow a verification of the correct positioning of the staple row with respect to the tissue intended to be stapled only after firing of the staples, e.g. by endoscopic visual examination or by analysis of a cut out tissue doughnut.
  • endoscopic visual examination or by analysis of a cut out tissue doughnut.
  • the present invention provides for an improved surgical stapling apparatus and for a method for a reliable verification of the correct positioning of a row of staples with respect to an acquired tissue portion.
  • the present invention further provides for an improved surgical stapling apparatus and method for the transoral, or endoscopic, positioning and anchoring of an endoluminal lining within a hollow body organ, particularly the gastrointestinal tract, including, but not limited to, the esophagus, stomach, portions of or the entire length of the intestinal tract, etc., unless specified otherwise.
  • the surgeon or endoscopist may insert devices as described below through the patient's mouth, down the esophagus and into the stomach or intestine as appropriate. The procedure can be performed entirely from within the patient's stomach or other intestinal tract, and does not necessarily require any external incision.
  • an endoluminal stapling device for anchoring a tubular lining to a hollow organ but not limited to this use, the stapling device comprising a staple fastening assembly with a cartridge device which houses at least one row of staples and which forms a first clamping surface, and an anvil which forms a staple forming surface and a second clamping surface facing the first clamping surface.
  • the anvil is movable relative to the cartridge device and is adapted to cooperate with the cartridge device for clamping a tissue portion in a clamping space between the first and second clamping surfaces and forming the ends of the staples exiting from the cartridge device.
  • the stapling device comprises a tissue position indication system adapted to detect a complete overlap of the tissue portion inside the clamping space with the row of staples and provide a tissue positioning signal to an external position indicator.
  • the tissue position indication system comprises a tissue position detecting device arranged in or near the staple fastening assembly and in signal communication with the external tissue position indicator.
  • the position indicator is intended to be extracorporeal during the use of the stapling device to be easily observable by the surgeon and may comprise a visual, acoustic (or vibration-) indicator, such as a computer screen or an LED display, liquid crystal display (LCD), sound- or vibration emitter, arranged e.g. at a proximal (extracorporeal) end portion of a shaft of the stapling device or configured as a remote device structurally distinct and separate from the stapling device.
  • a visual, acoustic (or vibration-) indicator such as a computer screen or an LED display, liquid crystal display (LCD), sound- or vibration emitter, arranged e.g. at a proximal (extracorporeal) end portion of a shaft of the stapling device or configured as a remote device structurally distinct and separate from the
  • the tissue position detecting device may comprise at least one transparent detection window or window opening formed in one of the first and second clamping surfaces and extending adjacent the row of staples, e.g. an annular window adjacent an internal circumference of a closed annular row of staples, and an image detector, such as a micro-camera, arranged behind the detection window as seen from the clamping space and ada pted to captu re the i mage of th e wi ndow, thereby allowing immediate verification whether the window is covered by acquired tissue or not.
  • an image detector such as a micro-camera
  • a light sensor such as a photodiode or photodiode array
  • the tissue position indicator provides an output in dependency of the output signal of the light sensor.
  • the staple fastening assembly comprises a light source arranged to illuminate the at least one detection window from the clamping space in order to increase the contrast between covered and uncovered regions of the detection window.
  • the clamping surface opposite the detection window comprises a contrast area colored, e.g. in electric blue or green, to increase the contrast between covered and uncovered regions of the detection window.
  • the tissue position detecting device may comprise a row of photocells or infrared detectors arranged in one of the first and second clamping surfaces and extending adjacent the row of staples, e.g. an annular row of photocells adjacent an internal circumference of a closed annular row of staples, and at least one corresponding light source or infrared source, wherein the photocells are configured to provide a signal corresponding to the amount of overlap between the acquired tissue and the row of photocells.
  • the tissue position detecting device may comprise a row of exposed first electric terminals arranged in the first clamping surface and extending adjacent the row of staples, e.g. an annular row of first electric terminals adjacent an internal circumference of a closed annular row of staples, and at least one row of exposed second electric terminals arranged in the second clamping surface and aligned with the first terminals, wherein the first and second electric terminals are connected to a control circuit adapted to detect the electrical resistance between corresponding pairs of first and second terminals and to provide an output signal corresponding to the presence of acquired tissue between the rows of first and second terminals.
  • the tissue position detecting device may comprise a row of press buttons or of pressure membrane sectors connected to microswitches and arranged in one of the first and second clamping surfaces and extending adjacent the row of staples, e.g. an annular row of press buttons adjacent an internal circumference of a closed annular row of staples, wherein the microswitches are activatable by the pressure of the clamped tissue on the corresponding press button or pressure membrane sector and provide a signal corresponding to the amount of overlap between the acquired tissue and the row of press buttons or membrane sectors.
  • the staple fastening assembly comprises a ring shaped lining seat adapted to receive the tubular lining such that an elongate body portion of the lining is held in a compacted (substantially ring shaped), e.g. wrapped, folded, compressed or rolled up, configuration with regard to a lining longitudinal extension and a ring shaped anchoring portion of the lining is held to overlap one of said clamping surfaces and said annular row of staples.
  • a compacted substantially ring shaped
  • a ring shaped anchoring portion of the lining is held to overlap one of said clamping surfaces and said annular row of staples.
  • the stapling device comprises a tissue acquisition mechanism adapted to acquire a substantially ring shaped tissue portion of the hollow organ in the space between the first and second tissue clamping surfaces.
  • the tissue acquisition mechanism may comprise mechanical gaspers or suction means.
  • FIG. 1 illustrates a stapling device in accordance with an embodiment of the invention
  • FIG. 2 is a proximal view of an anvil of a stapling device in accordance with an embodiment of the invention
  • FIG. 3 is a distal view of a cartridge device of the stapling device in figure 2;
  • FIG. 4 is a proximal view of an anvil of a stapling device in accordance with an embodiment of the invention
  • FIG. 5 is a distal view of a cartridge device of the stapling device in figure 4.
  • FIG. 6 is a proximal view of an anvil of a stapling device in accordance with an embodiment of the invention
  • FIG. 7A is a distal view of a cartridge device of the stapling device in figure 6;
  • - Figure 7B is a partial side view of a cartridge device of the stapling device in figure 6;
  • FIG. 8 is a distal view of a cartridge device of a stapling device in accordance with an embodiment of the invention.
  • FIG. 9 is a distal view of a cartridge device of a stapling device in accordance with an embodiment of the invention.
  • FIG. 10 illustrates a stapling device according to an embodiment in a closed configuration and equipped with an endoluminal lining
  • Figure 1 1 illustrates the stapling device of figure 10 in an open configuration
  • FIG. 12 illustrates the transoral introduction of the stapling device of figure 10 to the duodenum
  • FIG. 13 is a close up view of the stapling device in a closed configuration inside a lumen
  • - Figure 14 illustrates a method step in which the stapling device is opened after positioning in the target location in the Gl tract;
  • - Figure 15 is a close up view of the stapling device in the opened configuration inside a lumen;
  • FIG. 16 illustrates an especially adapted stapling device and a method for acquiring tissue of the hollow organ to which the tubular lining is intended to be fastened in accordance with an embodiment
  • FIG. 17 illustrates the stapling device in a closed configuration in which the acquired tissue and an anchoring portion of the lining is clamped between an anvil and a cartridge device of the stapling device ready for the application of the fasteners;
  • FIG. 18 is a schematic cross-sectional view of a tubular lining anchored to a target location of the hollow organ, but still in a collapsed or packed shape;
  • FIG. 19 illustrates the tubular lining after anchoring and full extension within a section of the Gl tract
  • FIG. 20 illustrates the stapling device in accordance with a further embodiment in an open configuration.
  • figure 1 depicts an endoluminal stapling device 1 particularly but not only for anchoring a tubular lining 2 to a hollow organ 3, particularly to a section of the Gl tract of a patient.
  • the stapling device 1 comprises a staple fastening assembly 4 with a cartridge device 5 which houses at least one (preferably but not necessarily closed annular) row of staples 6 and whose distal end surface defines a first clamping surface 7.
  • the staple fastening assembly comprises further an anvil 8 which forms a staple forming surface 9 and a second clamping surface 10 facing the first clamping surface 7.
  • the anvil 8 is movable relative to the cartridge device 5 and is adapted to cooperate with the cartridge device 5 for clamping a (preferably but not necessarily ring shaped) tissue portion 1 1 in a clamping space 12 between the first and second clamping surfaces 7, 10 and forming the ends of the staples 6 exiting from the cartridge device 5.
  • the stapling device 1 is provided with a tissue position detecting device 13 arranged in the staple fastening assembly 4 in signal communication with an external tissue position indicator 14.
  • the detecting device 13 is adapted to detect a complete overlap of the tissue portion 1 1 inside the clamping space 12 with the row of staples 6 and to provide a tissue positioning signal to the external position indicator 14.
  • the position indicator 14 is intended to be extracorporeal during the use of the stapling device 1 to be easily observable by the surgeon and may comprise a visual, acoustic (or vibration-) indicator, such as a computer screen 15 or an LED display 16, liquid crystal display (LCD), sound- or vibration emitter, arranged e.g. at a proximal (extracorporeal) end portion 17 of a shaft 18 of the stapling device 1 or configured as a remote device structurally distinct and separate from the stapling device 1.
  • a visual, acoustic (or vibration-) indicator such as a computer screen 15 or an LED display 16, liquid crystal display (LCD), sound- or vibration emitter, arranged e.g. at a proximal (extracorporeal) end portion 17 of a shaft 18 of the stapling device 1 or configured as a remote device structurally distinct and separate from the stapling device 1.
  • the tissue position detecting device 13 comprises at least one annular transparent or translucent detection window 19 or opening formed in one of the first and second clamping surfaces 7, 10 adjacent to and internally of the closed annular row of staples 6, and an image detector, such as a micro-camera 20, arranged inside the staple fastening assembly 4 or stapler shaft 18 on a side of the detection window 1 9 opposite the clamping space 12 and adapted to capture the image of the detection window 19 and to send a corresponding signal to the external screen 15, thereby allowing immediate verification whether the detection window 19 is covered by acquired tissue or not.
  • the detection window 19 or opening is formed in the first clamping surface 7 and the image detector 20 is arranged inside a cartridge device 5 housing.
  • a light sensor 21 such as a photodiode or photodiode array, may be arranged behind the detection window 19 as seen from the clamping space 12 instead of the image detection device.
  • the tissue position indicator 14 provides an output in dependency of the output signal of the light sensor 21 .
  • the staple fastening assembly 4 may comprises a light source 22, e.g. a ring shaped shiner preferably formed in the proximal end face of the anvil 8.
  • the light source 22 is arranged to illuminate the at least one detection window 19 from the clamping space 12 in order to increase the contrast between covered and uncovered regions of the detection window 19.
  • the clamping surface 7 opposite the detection window 19 comprises a colored contrast area 23, e.g. a blue or green ring, to increase the visual contrast between covered and uncovered regions of the detection window 19.
  • a colored contrast area 23 e.g. a blue or green ring
  • the tissue position detecting device 13 comprises an annular row of photocells 24 or infrared detectors arranged i n the fi rst clamping surface 7 adjacent an internal circumference of a closed annular row of staples 6, and at least one corresponding light source 25 or infrared source, wherein the photocells 24 or infrared detectors are configured to provide a signal corresponding to the amount of overlap between the acquired tissue 1 1 and the row of photocells 24 or infrared detectors.
  • the tissue position detecting device 13 comprises an annular row of exposed first electric term i nals a rranged i n the fi rst clam pi ng su rface 7 adjacent an internal circumference of a closed annular row of staples 6, and at least one row of exposed second electric terminals arranged in the second clamping surface 10 and aligned with the first terminals, wherein the first and second electric terminals are connected to a control circuit adapted to detect the electrical resistance between corresponding pairs of first and second terminals and to provide an output signal to the position indicator 14 which corresponds to the presence of acquired tissue 1 1 between the rows of first and second terminals.
  • the tissue position detecting device 13 comprises an annular row of press buttons 26 or pressure membrane sectors connected to micro switches and arranged in one of the first and second clamping surfaces 7, 10 (preferably in the first clamping surface 7 of the cartridge device 5) and adjacent an internal circumference of the closed annular row of staples 6, wherein the microswitches are activatable by the local pressure of the clamped tissue portion 1 1 on the corresponding press button 26 or pressure membrane sector and provide a signal corresponding to the amount of overlap between the acquired tissue 1 1 and the row of press buttons 26 or membrane sectors.
  • FIG 8 illustrates a further exemplary embodiment, in which an annular suction groove 27 (which may be protected or filled by a fluid permeable shield or mesh for) extends in the first pressure surface 7 adjacent an internal circumference of the closed annular row of staples 6.
  • the suction groove 27 is in communication with a suction line 28 and a pressure sensor adapted detect a blockage of the suction groove due to complete overlap of the suction groove 27 with acquired tissue 1 1 and to generate and send a corresponding overlap signal to the tissue position indicator 14.
  • the stapling device 1 may comprise a tissue acquisition mechanism 29 adapted to acquire a substantially ring shaped tissue portion 1 1 of the hollow organ 3 in the clamping space 12 between the first and second tissue clamping surfaces 7, 10.
  • the tissue acquisition mechanism 29 may be arranged in the staple fastening assembly 4 radially internal of the tissue position detecting device 13.
  • the tissue acquisition mechanism 29 and, possibly, an endoscope 32 may be configured to be received together and contemporaneously in a central channel 33, e.g . by passing the tissue acquisition mechanism 29 through an instrument channel 34 of the endoscope 32 while the endoscope 32 is received in the central channel 33 of the staple fastening assembly 4.
  • the tissue acquisition mechanism 29 may comprise gaspers 30 ( Figure 16) or suction means 31 ( Figure 1 ).
  • Figure 16 shows an exemplary embodiment, in which at least one, preferably a plurality of pairs of graspers 30 are arranged and operable to move from the clamping space 12 radially outward and grasp opposite portions of tissue of the hollow organ 3 and pull the grasped portions of tissue into the clamping space 12, for instance by partial or complete withdrawal of the graspers 30 inside the cartridge device 5.
  • the graspers 30 can be connected through one or more acquisition activation movement transmitters with an extracorporeal acquisition activation mechanism provided e.g. at a proximal handle portion of the stapling device 1 or near a proximal end portion of the endoscope 32.
  • the tissue acquisition mechanism 29 comprises one or more suction apertures 35 connected to a preferably extracorporeal suction pump.
  • the suction apertures 35 are arranged and operable to apply a vacuum or suction in the clamping space 12 to acquire surrounding tissue and hold it between the first and second clamping surfaces 7, 10.
  • suction apertures 35 can be formed in the first clamping surface 7 of the cartridge device 5 in an annular region extending inside the annular row of staples 6. Moreover, suction apertures 35 may be also formed in the region of an anvil shaft 36 or anvil shafts 36. Alternatively or in addition, suction apertures 35 may be formed in a radially external surface of a ring shaped suction wall 37 provided in the clamping space 12 radially inside the detection window 19 or detection sensors 24, 26, 27.
  • the heretofore described stapling device 1 can be advantageously adapted for endoluminally anchoring a tubular sleeve or lining 2 within the hollow organ 3, particularly within a section of the Gl tract.
  • the staple fastening assembly 4 comprises a ring shaped lining seat 39 adapted to receive the tubular lining 2 such that an elongate body portion 40 of the lining 2 is held in a collapsed (substantially ring shaped), e.g. wrapped, folded, compressed or rolled up, configuration with regard to a lining longitudinal extension and a ring shaped anchoring portion 41 of the lining 2 is held to overlap one of said first and second clamping surfaces 7, 1 0 and said annular row of staples 6.
  • the lining seat 39 is formed in the anvil 8 and the anchoring portion 41 of the lining 2 is shaped and seated over the first clamping surface 7 such as to not interfere with the tissue position detecting device 13.
  • the staples 6 may comprise titanium staples intended to permanently remain anchored i n the sta pled tissue rin g or, time dependently biodegradable or bioabsorbable staples for the temporary sutures or temporary anchoring of bypass sleeves in the hollow organ.
  • the stapling device 1 comprises an anvil moving mechanism connected through one or more flexible anvil movement transmitters with an extracorporeal anvil movement activation mechanism provided e.g. at a proximal handle portion of the stapling device 1 , as well as a staple driving mechanism adapted to drive the staples 6 distally out of the staple slots and against the staple forming surface of the anvil.
  • the staple driving mechanism is connected through one or more flexible driving movement transmitters with an extracorporeal staple firing mechanism provided e.g. at a proximal handle portion of the stapling device 1 .
  • Both the anvil movement transmitters and the driving movement transmitters are arranged inside the flexible stapler shaft 18.
  • the stapling device 1 may comprise cutting means, such as a circular cutting plate arranged inside the annular row of staples and operable by means of a cutting activation mechanism similar to those known from conventional circular staplers.
  • Figure 20 illustrates an exemplary embodiment of the stapling device 1 , in which the first clamping surface 7 of the cartridge device and the second clamping surface 1 0 (which provides the staple forming surface 9) of the anvil 8 have a generally wavy shape, preferably but not necessarily constituted by two opposite peaks 43 and two opposite valleys 44 angularly spaced at about 90° and forming a two-peaks-two-valleys-wave.
  • the wavy shape of the clamping surfaces 7, 10 may be obtained by a locally stepped or otherwise offset configuration which "oscillates" about the wavy shape.
  • the stepped first clamping surface 7 is composed of a series of lands 45 and risers 46, wherein the lands 45 are perpendicular to the longitudinal axis X of the staple fastening assembly 4 and the exit openings of the staple 6 slots are defined in the lands 45.
  • the second clamping surface 10 of the anvil is composed of a series of lands 47 and risers 48, wherein the lands 47 are perpendicular to the longitudinal axis X of the staple fastening assembly 4 and the staple forming recesses are defined in the lands 47.
  • the lands 45, 47 define with the risers 46, 48 an obtuse angle in order to reduce local tissue tensioning during clamping and stapling.
  • All staple guide slots may extend in a su bstantially normal direction to the corresponding lands 45 and parallel with respect to the longitudinal axis X.
  • all staples 6 housed in the guide slots may be in parallel alignment with respect to the staple drive direction of the staple driving mechanism which may, hence coincide with the longitudinal axis X.
  • the described wavy and stepped shape of the clamping surfaces 7, 10 deviates from a hypothetical circular reference shape in a plane perpendicular to the longitudinal axis X only in a direction normal to that plane, such that the projection of the first clamping surface 7 and the second clamping surface 10, as well as the annular line defined by the at least one row of staples 6 onto that plane is circular.
  • the ring shaped anchoring portion 41 of the lining 2 may be held to overlap one of the first and second clamping surfaces 7, 10 and the annular row of staples 6 by the same features and methods previously described. Additionally or alternatively, the anchoring portion 41 may be detachably fixated to the wavy or stepped wavy clamping surface by an adhesive such that it is kept in the same wavy or stepped wavy shape as the clamping surfaces.
  • the ring shaped anchoring portion 41 may have a wavy or stepped wavy shape complementary to the shape of the clamping surface and be elastically deformable to a flattened shape, in which a passage opening of the anchoring portion 41 in the flattened shape is greater than the passage opening of the anchoring portion in the wavy shape.
  • the anchoring site of the tubular liner can follow within certain limits the physiological expansion and retraction movement of the intestine, e.g. during peristalsis.
  • a clinical work-up including a physical and mental assessment of the patient may be performed to determine whether a transoral deployment and anchoring of an endosleeve is clinically indicated.
  • This assessment may include inspecting the esophagus and stomach of the patient to determine whether any contraindications exist for undertaking the procedure such as ulcerations, obstructions, or other cond itions that may precl ude treatment.
  • the physician uses the endoscope 32 to view and select an area suitable for the application of the fastener, i.e. the staples.
  • FIGS. 12 through 9 illustrate the following method steps and action of the stapling device 1 within the target section of intestine.
  • the staple fastening assembly 4 is opened by distal movement of the anvil 8, to expose the clamping space 12 to the surrounding tissue within the duodenum and the tissue acquisition mechanism, either vacuum or mechanical grasping, may be activated and tissue 1 1 may be drawn into the clamping space 12 in an entirely circumferential manner.
  • the tissue acquisition Prior to stapling, the tissue acquisition is monitored by the tissue positioning detector and the position indicator device provides a visual, optical or acoustic indication of the complete and satisfactory positioning of the tissue in the clamping space 12.
  • anvil 8 and cartridge device 5 may be moved towards one another such that the acq gnad tissue ri ng 1 1 is clamped therebetween.
  • the staple driving mechanism is then actuated to engage the annular closed row of staples or fastening element through the acquired tissue ring 1 1 and through the anchoring portion 41 of lining 2 which is arranged on the anvil to overlap the second clamping surface and the staple position , thereby fastening the lining 2 i n place i n a circumferential fashion.
  • the ring shaped anchoring place can be directly endoscopically visualized.
  • stapling device 1 is removed.
  • the anvil 8 of the device 1 may be carefully pulled through the newly-created ring or plication of stapled tissue 1 1 and anchoring portion 41 of the lining 2, leaving the yet compacted lining 2 in place.
  • the lining may be pushed out of the lining seat of the anvil or during withdrawal of the applier the anvil may be pulled away from the anchored lining.
  • the lining is now allowed to expand (or pulled or insufflated to expand) longitudinally along the planned section of the hollow organ, as shown in figure 19.

Abstract

An endoluminal surgical stapling device (1) comprises a staple fastening assembly (4) for clamping a tissue portion (11) in a clamping space (12) and applying a row of staples to the clamped tissue portion (11), as well as a tissue position detecting device (13) arranged in the staple fastening assembly (4) in signal communication with an external tissue position indicator (14), wherein said detecting device (13) is adapted to detect a complete overlap of the tissue portion (11) inside the clamping space (12) with the row of staples (6) and to provide a corresponding signal to the external position indicator (14).

Description

"A SURGICAL STAPLING DEVICE AND A METHOD FOR ANCHORING A LINER TO A HOLLOW ORGAN "
DESCRIPTION
FIELD OF THE INVENTION
The present invention relates generally to medical apparatuses and methods and more particularly to devices and methods for positioning and anchoring a lining to a hollow body organ, such as a stomach, intestine or gastrointestinal tract.
BACKGROUND OF THE INVENTION
In cases of severe obesity, patients may currently undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and/or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the gastrointestinal tract. The procedures currently available include laparoscopic banding, where a device is used to "tie off" or constrict a portion of the stomach, vertical banded gastroplasty (VBG), or a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach's volume and subsequent bypass of the intestine.
Although the outcome of these stomach reduction surgeries leads to patient weight loss because patients are physically forced to eat less due to the reduced size of their stomach, several limitations exist due to the invasiveness of the procedures, including time, general anesthesia, healing of the incisions and other complications attendant to major surgery. In addition, these procedures are only available to severely obese patients (morbid obesity, Body Mass I ndex >=40) due to their complications, including the risk of death, leaving patients who are considered obese or moderately obese with few, if any, interventional options.
In addition to the above described gastrointestinal reduction surgery, endoluminal sleeves are known for partially or totally lining certain portions of the stomach and of the intestine with the aim to separate or bypass at least part of the food flow from the lined portions of the gastrointestinal tract. It has been observed that by creating a physical barrier between the ingested food and certain regions of the gastrointestinal wall by means of endoluminal sleeves, similar benefits for weight loss and improvement or resolution of type 2 diabetes may be achieved as with gastric bypass surgery. Physicians believe that by creating a physical barrier between the ingested food and selected regions of the gastrointestinal wall, it might be possible to purposefully influence the mechanism of hormonal signal activation originating from the intestine.
A known type of endoluminal sleeve relies on metallic expandable structures, such as a stent, to engage the surrounding hollow organ for holding the sleeve in the planned position. To improve anchoring and stability of the sleeve, it is further known to provide the stent with barbs which penetrate the surrounding tissue. This notwithstanding, it has been observed that the endoscopic sleeves tend to move inside the Gl tract and migrate away from their initially planned position. US patent n. 7,220,237 B2, Method and device for use in endoscopic organ procedures, to Gannoe et al. describes procedures for internally lining portions of the gastrointestinal tract, using tubular endoluminal sleeves and stapling devices for circumferentially acquiring tissue of the gastric wall and fixating a circular section of the acquired tissue to which an endoluminal sleeve is secured by shape interference.
However, the known methods and devices for placing and securing endoluminal linings within hollow organs, particularly within the gastrointestinal tract, are not yet satisfactory with regard to a reliable anchoring and conservation of the planned position of the endoluminal sleeve.
Moreover, the known devices and methods do not sufficiently address the need of a good control and verification of the correct amount and shape of acquired lumen wall to which the endoluminal sleeves are to be fastened.
Moreover, the known devices and methods do not sufficiently address the need of creating sealed or leak tight connection regions between the endoluminal sleeve and the hollow organ in order to obtain a desired flow scheme of the food flow and the flow of bodily fluids, such as gastric juices, bile and pancreatic fluid.
With particular regard to surgical stapling, known devices and methods allow a verification of the correct positioning of the staple row with respect to the tissue intended to be stapled only after firing of the staples, e.g. by endoscopic visual examination or by analysis of a cut out tissue doughnut. In case of a poor stapling results, it is often impossible to re-acquire the very same tissue portion and staple again over existing poorly fastened staples.
Accordingly, there is a need for improved devices and procedures for positioning and reliably anchoring an endoluminal sleeve in the Gl tract.
There is further a particular need for surgical stapling methods and devices which enable a reliable verification of the correct positioning of a row of staples with respect to an acquired tissue portion.
SUMMARY OF THE INVENTION
The present invention provides for an improved surgical stapling apparatus and for a method for a reliable verification of the correct positioning of a row of staples with respect to an acquired tissue portion.
The present invention further provides for an improved surgical stapling apparatus and method for the transoral, or endoscopic, positioning and anchoring of an endoluminal lining within a hollow body organ, particularly the gastrointestinal tract, including, but not limited to, the esophagus, stomach, portions of or the entire length of the intestinal tract, etc., unless specified otherwise. In the case of the present invention, the surgeon or endoscopist may insert devices as described below through the patient's mouth, down the esophagus and into the stomach or intestine as appropriate. The procedure can be performed entirely from within the patient's stomach or other intestinal tract, and does not necessarily require any external incision.
At least part of the above identified needs are met by an endoluminal stapling device for anchoring a tubular lining to a hollow organ but not limited to this use, the stapling device comprising a staple fastening assembly with a cartridge device which houses at least one row of staples and which forms a first clamping surface, and an anvil which forms a staple forming surface and a second clamping surface facing the first clamping surface. The anvil is movable relative to the cartridge device and is adapted to cooperate with the cartridge device for clamping a tissue portion in a clamping space between the first and second clamping surfaces and forming the ends of the staples exiting from the cartridge device. The stapling device comprises a tissue position indication system adapted to detect a complete overlap of the tissue portion inside the clamping space with the row of staples and provide a tissue positioning signal to an external position indicator.
This makes it possible to verify the correct positioning of the tissue acquired within the clamping space prior to firing the staples and, hence, to improve and continue tissue acquiring if necessary or to stop tissue acquiring if a sufficient amount of tissue is already adequately positioned for the fastening of the staples.
In this manner, the risk of incomplete or poor stapled sutures is strongly reduced. In accordance with an aspect of the invention, the tissue position indication system comprises a tissue position detecting device arranged in or near the staple fastening assembly and in signal communication with the external tissue position indicator. The position indicator is intended to be extracorporeal during the use of the stapling device to be easily observable by the surgeon and may comprise a visual, acoustic (or vibration-) indicator, such as a computer screen or an LED display, liquid crystal display (LCD), sound- or vibration emitter, arranged e.g. at a proximal (extracorporeal) end portion of a shaft of the stapling device or configured as a remote device structurally distinct and separate from the stapling device.
In accordance with an aspect of the invention, the tissue position detecting device may comprise at least one transparent detection window or window opening formed in one of the first and second clamping surfaces and extending adjacent the row of staples, e.g. an annular window adjacent an internal circumference of a closed annular row of staples, and an image detector, such as a micro-camera, arranged behind the detection window as seen from the clamping space and ada pted to captu re the i mage of th e wi ndow, thereby allowing immediate verification whether the window is covered by acquired tissue or not.
In accordance with a further aspect of the invention, a light sensor, such as a photodiode or photodiode array, may be arranged behind the detection window as seen from the clamping space instead of the image detection device. In this case, the tissue position indicator provides an output in dependency of the output signal of the light sensor.
In accordance with a further aspect of the invention, the staple fastening assembly comprises a light source arranged to illuminate the at least one detection window from the clamping space in order to increase the contrast between covered and uncovered regions of the detection window.
In accordance with a further aspect of the invention, the clamping surface opposite the detection window comprises a contrast area colored, e.g. in electric blue or green, to increase the contrast between covered and uncovered regions of the detection window.
In accordance with an aspect of the invention, the tissue position detecting device may comprise a row of photocells or infrared detectors arranged in one of the first and second clamping surfaces and extending adjacent the row of staples, e.g. an annular row of photocells adjacent an internal circumference of a closed annular row of staples, and at least one corresponding light source or infrared source, wherein the photocells are configured to provide a signal corresponding to the amount of overlap between the acquired tissue and the row of photocells.
In accordance with a yet further aspect of the invention, the tissue position detecting device may comprise a row of exposed first electric terminals arranged in the first clamping surface and extending adjacent the row of staples, e.g. an annular row of first electric terminals adjacent an internal circumference of a closed annular row of staples, and at least one row of exposed second electric terminals arranged in the second clamping surface and aligned with the first terminals, wherein the first and second electric terminals are connected to a control circuit adapted to detect the electrical resistance between corresponding pairs of first and second terminals and to provide an output signal corresponding to the presence of acquired tissue between the rows of first and second terminals.
In accordance with a further aspect of the invention, the tissue position detecting device may comprise a row of press buttons or of pressure membrane sectors connected to microswitches and arranged in one of the first and second clamping surfaces and extending adjacent the row of staples, e.g. an annular row of press buttons adjacent an internal circumference of a closed annular row of staples, wherein the microswitches are activatable by the pressure of the clamped tissue on the corresponding press button or pressure membrane sector and provide a signal corresponding to the amount of overlap between the acquired tissue and the row of press buttons or membrane sectors.
In accordance with a further aspect of the invention, the staple fastening assembly comprises a ring shaped lining seat adapted to receive the tubular lining such that an elongate body portion of the lining is held in a compacted (substantially ring shaped), e.g. wrapped, folded, compressed or rolled up, configuration with regard to a lining longitudinal extension and a ring shaped anchoring portion of the lining is held to overlap one of said clamping surfaces and said annular row of staples. This assures a correct relative positioning of the lining anchoring portion, the row of staples and the clamping surfaces. Moreover, the positioning of the lining on the lining seat takes place extracorporal^ and does not change during endoluminal insertion of the device and during stapling.
In accordance with a yet further aspect of the invention , the stapling device comprises a tissue acquisition mechanism adapted to acquire a substantially ring shaped tissue portion of the hollow organ in the space between the first and second tissue clamping surfaces. The tissue acquisition mechanism may comprise mechanical gaspers or suction means.
These and other aspects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof, which illustrate embodiments of the invention and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
DESCRIPTION OF THE DRAWINGS
- Figure 1 illustrates a stapling device in accordance with an embodiment of the invention;
- Figure 2 is a proximal view of an anvil of a stapling device in accordance with an embodiment of the invention;
- Figure 3 is a distal view of a cartridge device of the stapling device in figure 2;
- Figure 4 is a proximal view of an anvil of a stapling device in accordance with an embodiment of the invention;
- Figure 5 is a distal view of a cartridge device of the stapling device in figure 4;
- Figure 6 is a proximal view of an anvil of a stapling device in accordance with an embodiment of the invention;
- Figure 7A is a distal view of a cartridge device of the stapling device in figure 6; - Figure 7B is a partial side view of a cartridge device of the stapling device in figure 6;
- Figure 8 is a distal view of a cartridge device of a stapling device in accordance with an embodiment of the invention;
- Figure 9 is a distal view of a cartridge device of a stapling device in accordance with an embodiment of the invention;
- Figure 10 illustrates a stapling device according to an embodiment in a closed configuration and equipped with an endoluminal lining;
- Figure 1 1 illustrates the stapling device of figure 10 in an open configuration;
- Figure 12 illustrates the transoral introduction of the stapling device of figure 10 to the duodenum;
- Figure 13 is a close up view of the stapling device in a closed configuration inside a lumen;
- Figure 14 illustrates a method step in which the stapling device is opened after positioning in the target location in the Gl tract; - Figure 15 is a close up view of the stapling device in the opened configuration inside a lumen;
- Figure 16 illustrates an especially adapted stapling device and a method for acquiring tissue of the hollow organ to which the tubular lining is intended to be fastened in accordance with an embodiment;
- Figure 17 illustrates the stapling device in a closed configuration in which the acquired tissue and an anchoring portion of the lining is clamped between an anvil and a cartridge device of the stapling device ready for the application of the fasteners;
- Figure 18 is a schematic cross-sectional view of a tubular lining anchored to a target location of the hollow organ, but still in a collapsed or packed shape;
- Figure 19 illustrates the tubular lining after anchoring and full extension within a section of the Gl tract,
- Figure 20 illustrates the stapling device in accordance with a further embodiment in an open configuration.
DETAILED DESCRIPTION OF EMBODIMENTS
Referring to the drawings in which like numerals denote like anatomical structures and components throughout the several views, figure 1 depicts an endoluminal stapling device 1 particularly but not only for anchoring a tubular lining 2 to a hollow organ 3, particularly to a section of the Gl tract of a patient. The stapling device 1 comprises a staple fastening assembly 4 with a cartridge device 5 which houses at least one (preferably but not necessarily closed annular) row of staples 6 and whose distal end surface defines a first clamping surface 7. The staple fastening assembly comprises further an anvil 8 which forms a staple forming surface 9 and a second clamping surface 10 facing the first clamping surface 7. The anvil 8 is movable relative to the cartridge device 5 and is adapted to cooperate with the cartridge device 5 for clamping a (preferably but not necessarily ring shaped) tissue portion 1 1 in a clamping space 12 between the first and second clamping surfaces 7, 10 and forming the ends of the staples 6 exiting from the cartridge device 5. The stapling device 1 is provided with a tissue position detecting device 13 arranged in the staple fastening assembly 4 in signal communication with an external tissue position indicator 14. The detecting device 13 is adapted to detect a complete overlap of the tissue portion 1 1 inside the clamping space 12 with the row of staples 6 and to provide a tissue positioning signal to the external position indicator 14.
This makes it possible to verify the correct positioning of the tissue acquired within the clamping space 12 prior to firing the staples and, hence, to improve and continue tissue acquiring if necessary or to stop tissue acquiring if a sufficient amount of tissue is already adequately positioned for the fastening of the staples. In this manner, the risk of incomplete or poor stapled sutures is strongly reduced. The position indicator 14 is intended to be extracorporeal during the use of the stapling device 1 to be easily observable by the surgeon and may comprise a visual, acoustic (or vibration-) indicator, such as a computer screen 15 or an LED display 16, liquid crystal display (LCD), sound- or vibration emitter, arranged e.g. at a proximal (extracorporeal) end portion 17 of a shaft 18 of the stapling device 1 or configured as a remote device structurally distinct and separate from the stapling device 1.
In accordance with exemplary embodiments (Figs 1 , 2 and 3) the tissue position detecting device 13 comprises at least one annular transparent or translucent detection window 19 or opening formed in one of the first and second clamping surfaces 7, 10 adjacent to and internally of the closed annular row of staples 6, and an image detector, such as a micro-camera 20, arranged inside the staple fastening assembly 4 or stapler shaft 18 on a side of the detection window 1 9 opposite the clamping space 12 and adapted to capture the image of the detection window 19 and to send a corresponding signal to the external screen 15, thereby allowing immediate verification whether the detection window 19 is covered by acquired tissue or not. Preferably, the detection window 19 or opening is formed in the first clamping surface 7 and the image detector 20 is arranged inside a cartridge device 5 housing.
Alternatively (Figs 6, 7), a light sensor 21 , such as a photodiode or photodiode array, may be arranged behind the detection window 19 as seen from the clamping space 12 instead of the image detection device. In this case, the tissue position indicator 14 provides an output in dependency of the output signal of the light sensor 21 .
The staple fastening assembly 4 may comprises a light source 22, e.g. a ring shaped shiner preferably formed in the proximal end face of the anvil 8. The light source 22 is arranged to illuminate the at least one detection window 19 from the clamping space 12 in order to increase the contrast between covered and uncovered regions of the detection window 19.
Alternatively or in addition, the clamping surface 7 opposite the detection window 19 comprises a colored contrast area 23, e.g. a blue or green ring, to increase the visual contrast between covered and uncovered regions of the detection window 19.
I n accordance with an exemplary embodiment (Figs 4, 5), the tissue position detecting device 13 comprises an annular row of photocells 24 or infrared detectors arranged i n the fi rst clamping surface 7 adjacent an internal circumference of a closed annular row of staples 6, and at least one corresponding light source 25 or infrared source, wherein the photocells 24 or infrared detectors are configured to provide a signal corresponding to the amount of overlap between the acquired tissue 1 1 and the row of photocells 24 or infrared detectors.
In accordance with a yet further exemplary embodiment (not illustrated), the tissue position detecting device 13 comprises an annular row of exposed first electric term i nals a rranged i n the fi rst clam pi ng su rface 7 adjacent an internal circumference of a closed annular row of staples 6, and at least one row of exposed second electric terminals arranged in the second clamping surface 10 and aligned with the first terminals, wherein the first and second electric terminals are connected to a control circuit adapted to detect the electrical resistance between corresponding pairs of first and second terminals and to provide an output signal to the position indicator 14 which corresponds to the presence of acquired tissue 1 1 between the rows of first and second terminals.
In a further embodiment (Figure 9), the tissue position detecting device 13 comprises an annular row of press buttons 26 or pressure membrane sectors connected to micro switches and arranged in one of the first and second clamping surfaces 7, 10 (preferably in the first clamping surface 7 of the cartridge device 5) and adjacent an internal circumference of the closed annular row of staples 6, wherein the microswitches are activatable by the local pressure of the clamped tissue portion 1 1 on the corresponding press button 26 or pressure membrane sector and provide a signal corresponding to the amount of overlap between the acquired tissue 1 1 and the row of press buttons 26 or membrane sectors.
Figure 8 illustrates a further exemplary embodiment, in which an annular suction groove 27 (which may be protected or filled by a fluid permeable shield or mesh for) extends in the first pressure surface 7 adjacent an internal circumference of the closed annular row of staples 6. The suction groove 27 is in communication with a suction line 28 and a pressure sensor adapted detect a blockage of the suction groove due to complete overlap of the suction groove 27 with acquired tissue 1 1 and to generate and send a corresponding overlap signal to the tissue position indicator 14.
The stapling device 1 may comprise a tissue acquisition mechanism 29 adapted to acquire a substantially ring shaped tissue portion 1 1 of the hollow organ 3 in the clamping space 12 between the first and second tissue clamping surfaces 7, 10. The tissue acquisition mechanism 29 may be arranged in the staple fastening assembly 4 radially internal of the tissue position detecting device 13. Alternatively, the tissue acquisition mechanism 29 and, possibly, an endoscope 32, may be configured to be received together and contemporaneously in a central channel 33, e.g . by passing the tissue acquisition mechanism 29 through an instrument channel 34 of the endoscope 32 while the endoscope 32 is received in the central channel 33 of the staple fastening assembly 4. In accordance with embodiments, the tissue acquisition mechanism 29 may comprise gaspers 30 (Figure 16) or suction means 31 (Figure 1 ).
Figure 16 shows an exemplary embodiment, in which at least one, preferably a plurality of pairs of graspers 30 are arranged and operable to move from the clamping space 12 radially outward and grasp opposite portions of tissue of the hollow organ 3 and pull the grasped portions of tissue into the clamping space 12, for instance by partial or complete withdrawal of the graspers 30 inside the cartridge device 5. The graspers 30 can be connected through one or more acquisition activation movement transmitters with an extracorporeal acquisition activation mechanism provided e.g. at a proximal handle portion of the stapling device 1 or near a proximal end portion of the endoscope 32.
I n accordance with further exemplary embodiments (Figure 1 ), the tissue acquisition mechanism 29 comprises one or more suction apertures 35 connected to a preferably extracorporeal suction pump. The suction apertures 35 are arranged and operable to apply a vacuum or suction in the clamping space 12 to acquire surrounding tissue and hold it between the first and second clamping surfaces 7, 10.
The suction apertures 35 can be formed in the first clamping surface 7 of the cartridge device 5 in an annular region extending inside the annular row of staples 6. Moreover, suction apertures 35 may be also formed in the region of an anvil shaft 36 or anvil shafts 36. Alternatively or in addition, suction apertures 35 may be formed in a radially external surface of a ring shaped suction wall 37 provided in the clamping space 12 radially inside the detection window 19 or detection sensors 24, 26, 27.
The heretofore described stapling device 1 can be advantageously adapted for endoluminally anchoring a tubular sleeve or lining 2 within the hollow organ 3, particularly within a section of the Gl tract.
For this purpose, the staple fastening assembly 4 comprises a ring shaped lining seat 39 adapted to receive the tubular lining 2 such that an elongate body portion 40 of the lining 2 is held in a collapsed (substantially ring shaped), e.g. wrapped, folded, compressed or rolled up, configuration with regard to a lining longitudinal extension and a ring shaped anchoring portion 41 of the lining 2 is held to overlap one of said first and second clamping surfaces 7, 1 0 and said annular row of staples 6.
This assures a correct relative positioning of the lining 2 anchoring portion 41 , the row of staples 6 and the clamping surfaces 7, 10. Moreover, the positioning of the lining 2 on the lining seat 39 takes place extracorporeal^ and does not change during the endoluminal insertion of the stapling device 1 and during firing of the staples 6.
In accordance with an embodiment, the lining seat 39 is formed in the anvil 8 and the anchoring portion 41 of the lining 2 is shaped and seated over the first clamping surface 7 such as to not interfere with the tissue position detecting device 13.
The staples 6 may comprise titanium staples intended to permanently remain anchored i n the sta pled tissue rin g or, time dependently biodegradable or bioabsorbable staples for the temporary sutures or temporary anchoring of bypass sleeves in the hollow organ.
The stapling device 1 comprises an anvil moving mechanism connected through one or more flexible anvil movement transmitters with an extracorporeal anvil movement activation mechanism provided e.g. at a proximal handle portion of the stapling device 1 , as well as a staple driving mechanism adapted to drive the staples 6 distally out of the staple slots and against the staple forming surface of the anvil. Also the staple driving mechanism is connected through one or more flexible driving movement transmitters with an extracorporeal staple firing mechanism provided e.g. at a proximal handle portion of the stapling device 1 . Both the anvil movement transmitters and the driving movement transmitters are arranged inside the flexible stapler shaft 18. The stapling device 1 may comprise cutting means, such as a circular cutting plate arranged inside the annular row of staples and operable by means of a cutting activation mechanism similar to those known from conventional circular staplers.
Figure 20 illustrates an exemplary embodiment of the stapling device 1 , in which the first clamping surface 7 of the cartridge device and the second clamping surface 1 0 (which provides the staple forming surface 9) of the anvil 8 have a generally wavy shape, preferably but not necessarily constituted by two opposite peaks 43 and two opposite valleys 44 angularly spaced at about 90° and forming a two-peaks-two-valleys-wave. The wavy shape of the clamping surfaces 7, 10 may be obtained by a locally stepped or otherwise offset configuration which "oscillates" about the wavy shape. Particularly, the stepped first clamping surface 7 is composed of a series of lands 45 and risers 46, wherein the lands 45 are perpendicular to the longitudinal axis X of the staple fastening assembly 4 and the exit openings of the staple 6 slots are defined in the lands 45. Analogously, also the second clamping surface 10 of the anvil is composed of a series of lands 47 and risers 48, wherein the lands 47 are perpendicular to the longitudinal axis X of the staple fastening assembly 4 and the staple forming recesses are defined in the lands 47.
In both the first clamping surface 7 and the second clamping surface 10, the lands 45, 47 define with the risers 46, 48 an obtuse angle in order to reduce local tissue tensioning during clamping and stapling.
All staple guide slots may extend in a su bstantially normal direction to the corresponding lands 45 and parallel with respect to the longitudinal axis X.
As a result, all staples 6 housed in the guide slots may be in parallel alignment with respect to the staple drive direction of the staple driving mechanism which may, hence coincide with the longitudinal axis X.
In order to limit the diameter of the staple fastening assembly, the described wavy and stepped shape of the clamping surfaces 7, 10 deviates from a hypothetical circular reference shape in a plane perpendicular to the longitudinal axis X only in a direction normal to that plane, such that the projection of the first clamping surface 7 and the second clamping surface 10, as well as the annular line defined by the at least one row of staples 6 onto that plane is circular.
In this embodiment, the ring shaped anchoring portion 41 of the lining 2 may be held to overlap one of the first and second clamping surfaces 7, 10 and the annular row of staples 6 by the same features and methods previously described. Additionally or alternatively, the anchoring portion 41 may be detachably fixated to the wavy or stepped wavy clamping surface by an adhesive such that it is kept in the same wavy or stepped wavy shape as the clamping surfaces.
In accordance with an embodiment, the ring shaped anchoring portion 41 may have a wavy or stepped wavy shape complementary to the shape of the clamping surface and be elastically deformable to a flattened shape, in which a passage opening of the anchoring portion 41 in the flattened shape is greater than the passage opening of the anchoring portion in the wavy shape.
This allows to retract the stapling device more comfortably from the operational site and to withdraw the anvil through the stapled tissue ring and anchoring portion which can now radially expand (from the wavy shape to a flattened shape) and which would be otherwise somewhat stiff. Moreover, the anchoring site of the tubular liner can follow within certain limits the physiological expansion and retraction movement of the intestine, e.g. during peristalsis.
DETAILED DESCRIPTION OF A USE OF THE STAPLING DEVICE FOR ANCHORING THE TUBULAR LINING WITHIN A HOLLOW ORGAN
A clinical work-up, including a physical and mental assessment of the patient may be performed to determine whether a transoral deployment and anchoring of an endosleeve is clinically indicated. This assessment may include inspecting the esophagus and stomach of the patient to determine whether any contraindications exist for undertaking the procedure such as ulcerations, obstructions, or other cond itions that may precl ude treatment. Once the assessment has been completed, either in an operating room with the patient under general anesthesia, or in an endoscopy suite with the patient under sedation, the operator can prepare the stapling device 1 with the compacted tubular lining 2 placed over the lining seat 39, as shown in FIG. 1 1 , and slide the stapling device 1 over the endoscope 32 to guide it under endoscopic visualization down the patient's esophagus and stomach to a target location in the Gl tract, e.g. in the duodenum. Once in place, the physician uses the endoscope 32 to view and select an area suitable for the application of the fastener, i.e. the staples.
FIGS. 12 through 9 illustrate the following method steps and action of the stapling device 1 within the target section of intestine.
Once the stapling device 1 is positioned in the selected anatomical location, the staple fastening assembly 4 is opened by distal movement of the anvil 8, to expose the clamping space 12 to the surrounding tissue within the duodenum and the tissue acquisition mechanism, either vacuum or mechanical grasping, may be activated and tissue 1 1 may be drawn into the clamping space 12 in an entirely circumferential manner.
Prior to stapling, the tissue acquisition is monitored by the tissue positioning detector and the position indicator device provides a visual, optical or acoustic indication of the complete and satisfactory positioning of the tissue in the clamping space 12.
Then, anvil 8 and cartridge device 5 may be moved towards one another such that the acq uired tissue ri ng 1 1 is clamped therebetween. The staple driving mechanism is then actuated to engage the annular closed row of staples or fastening element through the acquired tissue ring 1 1 and through the anchoring portion 41 of lining 2 which is arranged on the anvil to overlap the second clamping surface and the staple position , thereby fastening the lining 2 i n place i n a circumferential fashion. Subsequently, the ring shaped anchoring place can be directly endoscopically visualized. Then, stapling device 1 is removed. In doing so, the anvil 8 of the device 1 may be carefully pulled through the newly-created ring or plication of stapled tissue 1 1 and anchoring portion 41 of the lining 2, leaving the yet compacted lining 2 in place. During stapling, the lining may be pushed out of the lining seat of the anvil or during withdrawal of the applier the anvil may be pulled away from the anchored lining. The lining is now allowed to expand (or pulled or insufflated to expand) longitudinally along the planned section of the hollow organ, as shown in figure 19. In this way a bypass conduit is created which would channel food directly from the anchoring place into a target place of the small intestine to achieve a malabsorptive effect in cases where such an effect may enhance weight loss, as well as the initially described effects on hormonal signaling in general.
Although preferred embodiments of the invention have been described in detail, it is not the intention of the applicant to limit the scope of the claims to such particular embodiments, but to cover all modifications and alternative constructions falling within the scope of the invention.

Claims

1. An endoluminal surgical stapling device (1 ) comprising:
- a staple fastening assembly (4) with a cartridge device (5) housing a row of staples (6) and defining a first clamping surface (7), an anvil (8) forming a staple forming surface (9) and a second clamping surface (10) facing the first clamping surface (7), said anvil (8) being adapted to cooperate with the cartridge device (5) for clamping a tissue portion (1 1 ) in a clamping space (12) between the first and second clamping surfaces (7, 10) and forming the ends of the staples (6) exiting from the cartridge device (5),
- a tissue position detecting device (13) arranged in the staple fastening assembly (4) in signal communication with an external tissue position indicator (14), wherein said detecting device (13) is adapted to detect a complete overlap of the tissue portion (1 1 ) inside the clamping space (12) with the row of staples (6) and to provide a corresponding signal to the external position indicator (14).
2. Device according to claim 1 , in which said position indicator (14) is selected in a group consisting of:
- a visual indicator,
- a computer screen (15),
- an electronic image display,
- an LED display (16),
- a liquid crystal display,
- a sound emitter
- a vibration emitter.
3. Device according to claim 1 or 2, in which said position indicator (14) is arranged at a proximal end portion (17) of a shaft (18) of the stapling device (1 ).
4. Device (1 ) according to any preceding claim, in which said tissue position detecting device (13) comprises:
- at least one annular detection window (19) formed in one of the first and second clamping surfaces (7, 10) adjacent to and internally of the closed annular row of staples (6),
- an image detector (20) arranged inside the staple fastening assembly (4) on a side of the detection window (19) opposite the clamping space (12), said image detector (20) being adapted to capture the image of the detection window (19) and to send a corresponding signal to an external screen (15).
5. Device (1 ) according to claim 4, in which the detection window (19) is formed in the first clamping surface (7) and the image detector (20) is arranged inside a cartridge device (5) housing.
6. Device (1 ) according to any of claims 1 to 3, in which said tissue position detecting device (13) comprises:
- at least one annular detection window (19) formed in one of the first and second clamping surfaces (7, 10) adjacent to and internally of the closed annular row of staples (6),
- a light sensor (21 ) arranged inside the staple fastening assembly (4) on a side of the detection window (19) opposite the clamping space (12).
7. Device (1 ) according to any one of claims 4 to 6, comprising a light source (22) arranged to illuminate the at least one detection window (19) from the clamping space (12) in order to increase the contrast between covered and uncovered regions of the detection window (19).
8. Device (1 ) according to claim 7, in which said light source (22) comprises a ring shaped shiner formed in a proximal end face of the anvil (8).
9. Device (1 ) according to any one of claims 4 to 6, in which the clamping surface (7) opposite the detection window (19) comprises a colored contrast area (23) adapted to increase the contrast between covered and uncovered regions of the detection window (19).
10. Device (1 ) according to any one of claims 1 to 3, in which the tissue position detecting device (13) comprises an annular row of photocells (24) or infrared detectors arranged in the first clam pi ng su rface (7) adjacent an internal circumference of said closed annular row of staples (6), and at least one corresponding light source (25) or infrared source, wherein the photocells (24) or infrared detectors are configured to provide a signal corresponding to the amount of overlap between the acquired tissue (1 1 ) and the row of photocells (24) or infrared detectors.
11. Device (1 ) according to any one of claims 1 to 3, in which the tissue position detecting device (13) comprises an annular row of infrared detectors arranged in the first clamping surface (7) adjacent an internal circumference of said closed annular row of staples (6), and at least one corresponding infrared light source, wherein the infrared detectors are configured to provide a signal corresponding to the amount of overlap between the acquired tissue (1 1 ) and the row of infrared detectors.
12. Device (1 ) according to any one of claims 1 to 3, in which the tissue position detecting device (13) comprises:
- an annular row of exposed first electric terminals arranged in the first clamping surface (7) adjacent an internal circumference of said closed annular row of staples
(6),
- an annular row of exposed second electric terminals arranged in the second clamping surface (10) and aligned with the first terminals,
- a control circuit connected to the first and second electric terminals and adapted to detect the electrical resistance between corresponding pairs of first and second terminals and to provide an output signal to the position indicator (14), said output signal being indicative of the presence of acquired tissue (1 1 ) between said rows of first and second terminals.
13. Device (1 ) according to any one of claims 1 to 3, in which the tissue position detecting device (13) comprises an annular row of press buttons (26) connected to micro switches and arranged in one of the first and second clamping surfaces (7, 10) adjacent an internal circumference of the closed annular row of staples (6), wherein said microswitches provide a signal corresponding to the amount of overlap between the acquired tissue (1 1 ) and the row of press buttons (26).
14. Device (1 ) according to any one of claims 1 to 3, in which the tissue position detecting device (13) comprises an annular suction groove (27) in the first pressure surface (7) adjacent an internal circumference of the closed annular row of staples (6), said suction groove (27) being in communication with a suction line (28) and a pressure sensor adapted detect a blockage of the suction groove due to complete overlap of the suction groove (27) with acquired tissue (1 1 ) and to generate and send a corresponding signal to the tissue position indicator (14).
15. Device (1 ) according to any one of the preceding claims, comprising a tissue acquisition mechanism (29) adapted to acquire a substantially ring shaped tissue portion (1 1 ) of the hollow organ (3) in the clamping space (12), said tissue acquisition mechanism (29) being arranged in the staple fastening assembly (4) radially internal of the tissue position detecting device (13).
16. Device (1 ) according to claim 15, in which said tissue acquisition mechanism (29) com prises on e or more suction apertu res (35) connectable to an extracorporeal suction pump, said suction apertures (35) being arranged and operable to apply a vacuum or suction in the clamping space (12) to acquire surrounding tissue and hold it between the first and second clamping surfaces (7, 10).
17. Device (1 ) according to claim 16, in which said suction apertures (35) are formed in a ring shaped suction wall (37) provided in the clamping space (12) radially inside the tissue position detecting devices (19, 24, 26, 27).
18. Device (1 ) according to any one of the preceding claims, in which said staple fastening assembly (4) comprises a ring shaped lining seat (39) adapted to receive the tubular lining (2) such that an elongate body portion (40) of the lining (2) is held in a compacted ring shape and an anchoring portion (41 ) of the lining (2) is held to overlap one of said first and second clamping surfaces (7, 10) and said annular row of staples (6).
19. Device (1 ) according to any one of the preceding claims, in which said first clamping surface (7) and said second clamping surface (10) have a globally wavy shape (44, 45).
20. Endoluminal applier (1 ) according to claim 19, in which said wavy shape is formed by a stepped configuration of said first and second clamping surfaces(7, 10).
21. Endoluminal applier (1 ) according to claim 18 and 19, in which said ring shaped anchoring portion (41 ) of said tubular lining (2) has a wavy shape complementary to the wavy shape of said clamping surfaces (7, 10) and is elastically deformable to a flattened shape, in which a passage opening of the anchoring portion (41 ) in the flattened shape is greater than said passage opening of the anchoring portion (41 ) in the wavy shape.
PCT/EP2010/068664 2010-12-01 2010-12-01 A surgical stapling device and a method for anchoring a liner to a hollow organ WO2012072133A1 (en)

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