WO2012072138A1 - Applicateur et procédé d'ancrage d'un revêtement intérieur à un organe creux - Google Patents

Applicateur et procédé d'ancrage d'un revêtement intérieur à un organe creux Download PDF

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Publication number
WO2012072138A1
WO2012072138A1 PCT/EP2010/068670 EP2010068670W WO2012072138A1 WO 2012072138 A1 WO2012072138 A1 WO 2012072138A1 EP 2010068670 W EP2010068670 W EP 2010068670W WO 2012072138 A1 WO2012072138 A1 WO 2012072138A1
Authority
WO
WIPO (PCT)
Prior art keywords
lining
applier
clamping
anvil
endoluminal
Prior art date
Application number
PCT/EP2010/068670
Other languages
English (en)
Inventor
Michele D'arcangelo
Jason Harris
Edward Anton
Michael A. Murray
Federico Bilotti
Alessandro Pastorelli
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/EP2010/068670 priority Critical patent/WO2012072138A1/fr
Priority to CN201080070442.3A priority patent/CN103237505B/zh
Publication of WO2012072138A1 publication Critical patent/WO2012072138A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • 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
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • 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
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • 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
    • 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
    • A61B2017/07257—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
    • A61B17/068—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
    • A61B2017/07271—Stapler heads characterised by its cartridge
    • 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
    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0089—Instruments for placement or removal

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 visual control and verification of the correct target site for anchoring the endoluminal sleeves.
  • 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.
  • the present invention provides for an improved 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.
  • a method for applying a tubular lining to a hollow organ, particularly to a lumen of the gastrointestinal tract comprising attaching the tubular lining to an applier such that an elongate body portion of the lining is held in a collapsed (substantially ring shaped), e.g.
  • the wall of the lumen is partially inverted to create the suitable area for the application of the at least one fastener and, possibly, the fastener is extended to penetrate at least two adjacent layers of tissue arranged by partially inverting the wall of the lumen.
  • the method further comprises the step of endoscopically examining the at least one attached fastener.
  • the tubular lining is removed endoscopically from the lumen.
  • an endoluminal applier for anchoring a tubular lining to a hollow organ
  • the applier comprising a staple fastening assembly with a cartridge device which houses at least one closed annular 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 ring shaped tissue portion between the first and second clamping surfaces and forming the ends of the staples exiting from the cartridge device.
  • 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 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 of the lining is held to overlap one of said clamping surfaces and said annular row of staples.
  • the staple fastening assembly forms a central channel extending longitudinally through the cartridge device and through the anvil and opening laterally into the space between the first and second clamping surfaces, the central channel being adapted for the passage of an endoscope to visualize both the space between the first and second clamping surfaces and the space distally ahead of the staple fastening assembly and, possibly, to slide the applier endoluminally along said endoscope to a target site in the hollow organ.
  • the applier allows an improved guidance through the Gl tract and continuous visualization by the endoscope received in the central channel, both during endoluminal insertion and withdrawal of the applier and during fastening of the staples.
  • the applier 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 be arranged in the staple fastening assembly between the central channel and the staple row, i.e. radially external of the central channel and radially internal of the annular staple row, thereby allowing complete visual access also during tissue acquisition .
  • the tissue acquisition mechanism and the endoscope may be configured to be received together and contemporaneously in the central channel, e.g. by passing the tissue acquisition mechanism through an instrument channel of the endoscope while the endoscope is received in the central channel of the staple fastening assembly.
  • the tissue acquisition mechanism may comprise mechanical gaspers or suction means.
  • the anvil is translatably connected to the cartridge device by at least one, preferably two diametrically opposite anvil shafts slidably received in one or more guide holes of the cartridge device and connected with a moving mechanism adapted to move the anvil relative to the cartridge device.
  • the guide holes and the anvil shafts are arranged in the annular region between the central channel and the staple row, i.e. radially external of the central channel and radially internal of the annular staple row, thereby allowing complete visual access also during anvil approximation and clamping of the acquired tissue.
  • the anvil shafts can have a very limited circumferential extension to not obstruct the visualization of the tissue clamping space.
  • FIG. 1 illustrates an endoluminal applier for anchoring a tubular lining to a hollow organ in a closed configuration
  • FIG. 2 illustrates the applier of figure 1 in an open configuration
  • FIG. 3 illustrates the transoral introduction of the applier of figure 1 to the duodenum
  • FIG. 4 is a close up view of the applier in a closed configuration inside a lumen
  • FIG. 5 illustrates a method step in which the applier is opened after positioning in the target location in the Gl tract
  • FIG. 6 is a close up view of the applier in the opened configuration inside a lumen
  • FIG. 7 illustrates an especially adapted applier 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. 8 illustrates the applier 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 applier ready for the application of the fasteners;
  • FIG. 9 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. 10 illustrates the tubular lining after anchoring and full extension within a section of the Gl tract
  • FIG. 1 1 illustrates a further embodiment of the method, in which the tubular lining is anchored by the applier directly below the Lower Esophageal Sphincter (LES) to create a gastro-jejunal lining or a gastric lining from the LES down to the pylorus;
  • LES Lower Esophageal Sphincter
  • FIG. 12 illustrates different possible positions of the tubular lining within the Gl tract of a patient
  • FIG. 1 3 is a partial side view of the applier in accordance with a further embodiment
  • FIG. 14 is sectional view in plane XIV-XIV in figure 13;
  • FIG. 1 5 is a partial side view of the applier in accordance with a further embodiment
  • FIG. 16 is sectional view in plane XVI-XVI in figure 15;
  • FIG. 17 is sectional view showing a distal end of a cartridge device of the applier in accordance with a further embodiment
  • FIGS. 18 and 19 are partial side views of the applier during method steps in accordance with a further embodiment
  • FIG. 20 illustrates the applier in accordance with a further embodiment in an open configuration.
  • figure 1 depicts an endoluminal applier 1 for anchoring a tubular lining 9 to a hollow organ 10, particularly to a section of the Gl tract of a patient.
  • the applier 1 comprises a staple fastening assembly 2 with a cartridge device 3 which houses at least one closed annular row of staples 4 and whose distal end surface defines a first clamping surface 5.
  • the staple fastening assembly 2 comprises further an anvil 6 which forms a staple forming surface and a second clamping surface 7 facing the first clamping surface 5.
  • the anvil 6 is movable relative to the cartridge device 3 and is adapted to cooperate with the cartridge device 3 for clamping a ring shaped tissue portion between the first and second clamping surfaces 5, 7 and forming the ends of the staples 4 exiting from the cartridge device 3.
  • the staples 4 may comprise titanium staples intended to permanently remain anchored in the stapled tissue ring or, time dependency biodegradable or bioabsorbable staples for the temporary anchoring of bypass sleeves in the hollow organ.
  • the staple fastening assembly 2 comprises a ring shaped lining seat 8 adapted to receive the tubular lining 9 such that an elongate body portion 1 1 of the lining 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 12 of the lining 9 is held to overlap one of said first and second clamping surfaces 5, 7 and said annular row of staples 4.
  • the lining seat 8 is formed in the anvil 6 and comprises a distal containment wall 29 ( Figure 13) against which the collapsed and "packed" tubular lining 9, e.g.
  • the lining seat 8 is configured so that, during closure of the staple fastening assembly 2, at least part of the body portion 1 1 of the lining 9 is forcedly pushed distally over the containment wall 29 and out of the lining seat 8.
  • the lining seat 8 may comprise a clamping edge 30 arranged near the second clamping surface 7 of the anvil 6 and adapted to hold the anchoring portion 12 in its correct position until it is withdrawn from the clamping edge 30 by an external force, e.g. during withdrawal of the anvil 6 from the anchored sleeve 9.
  • the clamping edge is elastically supported or magnetically biased in order to resiliency hold the anchoring portion 12 and allow a relatively easy withdrawal of the latter.
  • the clamping edge 30 may comprise a plate which can be screwed into the anvil 6 to clamp the anchoring portion 12 of the sleeve 9 and hold it in the correct position.
  • the staple fastening assembly 2 comprises cutting means, such as a circular cutting plate (not shown) adapted to cut the anchoring portion 12 of the lining away from the lining seat 8, particularly from the clamping edge 30.
  • cutting means such as a circular cutting plate (not shown) adapted to cut the anchoring portion 12 of the lining away from the lining seat 8, particularly from the clamping edge 30.
  • the cutting means are arranged and operable to cut the anchoring portion 12 at a distance from the clamped tissue, e.g. in a position distal of the second clamping surface 7.
  • the staple fasten ing assem bly 2 forms a centra l chan nel 13 extending longitudinally through the cartridge device 3 and through the anvil 6 and opening laterally into a clamping space 14 between the first and second clamping surfaces 5, 7.
  • the central channel 13 is adapted for the passage of an endoscope 15 to enable visualization of both the clamping space 14 and the space distally ahead of the staple fastening assembly 2 and, possibly, to slide the entire applier 1 or at least the staple fastening assembly 2 endoluminally along the endoscope 15 to a target site in the hollow organ 10 or to guide the entire applier 1 or at least the staple fastening assembly 2 by means of the endoscope 15 endoluminally to said target site.
  • the thus configured applier 1 allows an improved guidance through the Gl tract and continuous visualization by the endoscope 15 received in the central channel 13, both during endoluminal insertion and withdrawal of the applier 1 and during fastening the staples 4 to anchor the tubular lining 9.
  • the endoscope 15 can be a flexible standard endoscope or a component of the applier 1 especially configured to fit in the central channel 13 thereof and to perform, additional to visualization and guidance, further functions of the applier, such as e.g. tissue acquisition which will be described further below.
  • the staple fastening assembly 2 is provided at a distal end 16 of a flexible hollow shaft 17 through which the central channel 13 extends proximally to a proximal aperture thereof (not shown in the figures) and which can be completely inserted over the endoscope 15.
  • the staple fastening assembly 2 of the applier 1 is adapted to receive the endoscope 15 within the central channel 13 and to be guided by the endoscope 15 to the target site for anchoring the lining 9 and the flexible shaft 17 may be adapted to extend laterally of the endoscope 15 shaft.
  • the cartridge device 3 with the first clamping surface 5 and the anvil 6 with the second clamping surface 7 define both a complete closed annulus around the central channel 13 so that a continuous annular staple line is obtainable by a single tissue clamping and staple firing step.
  • the anvil 6 is translatably connected to the cartridge device 3 by at least one, preferably two diametrically opposite anvil shafts 25 slidably received in one or more guide holes 28 of the cartridge device 3 and connected with a moving mechanism adapted to move the anvil 6 relative to the cartridge device 3.
  • the guide holes 28 and the anvil shafts 25 are arranged in a region between the central channel 13 and the staple row, i.e. radially external of the central channel 1 3 and radially internal of the annular staple row, thereby allowi ng complete endoscope access and visual ization also d u ring anvi l approximation and clamping of the acquired tissue.
  • the anvil shafts 25 can have a very limited circumferential extension to not obstruct the visualization of the tissue clamping space 14.
  • the anvil shafts 25 comprise preferably hollow tubular profiles with a high torque resistance for a given external dimension and their total circumferential extension with regard to a longitudinal axis of the applier 1 is less than 100°, preferably less than 60° , even more preferably less than 45° , i n order to leave sufficient unobstructed space between the shafts 25 to allow the clamping space 14 to be comfortably visualized and accessed from the central channel 13.
  • the applier 1 comprises a tissue acquisition mechanism 18 adapted to acquire a substantially ring shaped tissue portion 19 of the hollow organ 10 in the clamping space 14 between the first and second clamping surfaces 5, 7.
  • the tissue acquisition mechanism 18 may be arranged in the staple fastening assembly 2 between the central channel 13 and the row of staples 4, i.e. radially external of the central channel 13 and radially internal of the annular row of staples 4. In this way, the central channel 13 is not obstructed by the tissue acquisition mechanism 1 8 and al lows unobstructed access and visualization by the endoscope 15 also during tissue acquisition.
  • the tissue acquisition mechanism 18 and the endoscope 15 may be configured to be received together and contemporaneously in the central channel 13, e.g.
  • the tissue acquisition mechanism 18 may comprise mechanical gaspers or suction means.
  • Figure 7 shows an exemplary embodiment, in which at least one, preferably a plurality of pairs of graspers 21 are arranged and operable to move from the clamping space 14 radially outward and grasp opposite portions of tissue of the hollow organ 10 and pull the grasped portions of tissue into the clamping space 14, for instance by partial or complete withdrawal of the graspers 21 inside the cartridge device 3.
  • the graspers 21 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 applier 1 or near a proximal end portion of the endoscope 15.
  • the graspers 21 may be connected directly or indirectly with the staple fastening assembly 2, particularly with the cartridge device 3 in a region radially external of the central channel 13 and radially internal of the annular row of staples 4 or, alternatively, the graspers 21 and the endoscope 15 may be configured to be received together and contemporaneously in the central channel 1 3, e.g. by passing the graspers 21 through the instrument channel 20 of the endoscope 15 while the endoscope 15 is received in the central channel 13 of the staple fastening assembly 2. In both embodiments, the visualization by the endoscope of the acquisition of tissue in the clamping space is assured and unobstructed.
  • the tissue acquisition mechanism 18 comprises one or more suction apertures 22, 23, 24 connected to a preferably extracorporeal suction pump.
  • the suction apertures 22, 23, 24 are arranged and operable to apply a vacuum or suction in the clamping space 14 to acquire surrounding tissue and hold it between the first and second clamping surfaces 5, 7.
  • the suction apertures 22, 23 can be formed in the first clamping surface 5 of the cartridge device 3 in an annular region extending between the central channel 13 and the annular row of staples 4. Moreover, suction apertures 23 may be also formed in the region of the anvil shaft 25 or anvil shafts 25. In this case ( Figure 17) a first plurality of suction apertures 22 may be formed in a region extending between the anvil shafts 25 and radially inside the row of staples 4 and a second plurality of suction apertures 23 is formed in a region between the anvil shaft 25 and the surrounding row of staples 4.
  • Suction apertures 22, 23 may be also formed in a radially external surface of a ring shaped suction wall 26 provided in the clamping space 14 radially outside the central channel 13 and radially inside the row of staples 4.
  • the suction wall 26 may be slidably housed in a ring shaped seat in the cartridge device and movable from a rest position in which the suction wall 26 is proximally retracted inside the cartridge device 3 to an activated position in which the suction wall 26 is distally protracted towards the anvil 6 (see arrow 27 in figures 13 and 15).
  • the movement of the suction wall 26 between the rest position and the activated position can be linked to and operated in dependency from the movement of the anvil 6 with respect to the cartridge device 3. For instance, upon opening the staple fastening assembly 2, the anvil is moved distally away from the cartridge device 3 and the suction wall 26 is moved in its activated position and upon closing the staple fastening assembly 2, the anvil 6 moves proximally towards the cartridge device 3 and the suction wall 26 is retracted in its rest position.
  • the suction wall can be formed by one ring wall extending radially outside the anvil shaft or shafts 25 and radially inside the row of staples 4 or by one or more arch shaped wall sections extending e.g. only in the regions outside the anvil shaft or shafts 25. It is further contemplated that a third plurality of suction apertures 24 may be formed in a radially external surface of the anvil shaft or shafts 25 ( Figures 15, 1 6). In this case, a portion of the anvil shaft 25 or shafts forming suction apertures 24 can form a part of the suction wall 26 and may be connected to the suction wall 26 so that they move together.
  • the suction wall 26 when moved in the activated position, leaves a free unobstructed space between a distal end of the suction wall 26 and the second clamping surface 7 of the anvil 6, thereby assuring at least partial visualization of the clamping space 14.
  • the tubular lining 9 or sleeve is held in its substantially ring shaped collapsed or "packed" configuration by means of a removable wrap 31 , e.g. a casing or packing string.
  • the wrap 31 has a stripping portion 32 connectable to the applier 1 , preferably to a dedicated stripping catch of the lining seat 8, such that upon removing the applier 1 from the anchored lining 9, the stripping portion 32 is pulled and breaks or removes the wrap 31 from the lining 9 ( Figure 19), which is now released to expand longitudinally.
  • a distal sleeve end may be provided with one or more concentrated masses 34, such as metallic rings or spheres which facilitate a longitudinal extension of the sleeve along the planned section of the Gl tract.
  • the anchoring portion 12 of the tubular lining 9 comprises a rigid or semi-rigid connector plate which is connectable by snap fit or interference fit to the lining seat 8.
  • the connector plate may be configured to break into fragments during stapling in order to allow the anvil to be withdrawn proximally through the stapled annular anchoring site.
  • the applier 1 may be provided with multiple annular rows of slots, housing multiple rows of staples 4.
  • the lining 9 intended to form an endoluminal bypass conduit may be formed of any suitable biocompatible graft material such as polyester or PTFE, rubber, Teflon, Nylon, Dacron, polyethylene, polystyrene, polyurethane, polyethylene terephtalate, etc.
  • both the lining 9 and the staples 4 could be bioabsorbable and adapted to completely dissolve over time.
  • the applier 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 applier 1 , as well as a staple driving mechanism adapted to drive the staples 4 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 proxi mal handle portion of the applier 1 .
  • Both the anvil movement transmitters and the driving movement transmitters are arranged inside the flexible shaft 17.
  • Figure 20 illustrates an exemplary embodiment of the applier, in which the first clamping surface 5 of the cartridge device and the second clamping surface 7 (which provides the staple forming surface) of the anvil 6 have a generally wavy shape, preferably but not necessarily constituted by two opposite peaks 35 and two opposite valleys 36 angularly spaced at about 90° and forming a two-peaks-two- valleys-wave.
  • the wavy shape of the clamping surfaces 5, 7 may be obtained by a locally stepped or otherwise offset configuration which "oscillates" about the wavy shape.
  • the stepped first clamping surface 5 is composed of a series of lands 37 and risers 38, wherein the lands 37 are perpendicular to the longitudinal axis X of the staple fastening assembly 2 and the exit openings of the staple 4 slots are defined in the lands 37.
  • the second clamping surface 7 of the anvil is composed of a series of lands 39 and risers 40, wherein the lands 39 are perpendicular to the longitudinal axis X of the staple fastening assembly 2 and the staple forming recesses are defined in the lands 39.
  • the lands 37, 39 define with the risers 38, 40 an obtuse angle in order to reduce local tissue tensioning during clamping and stapling.
  • All staple guide slots may extend in a substantially normal direction to the corresponding lands 37 and parallel with respect to the longitudinal axis X.
  • all staples 4 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 5, 7 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 5 and the second clamping surface 7, as well as the annular line defined by the at least one row of staples 4 onto that plane is circular.
  • the ring shaped anchoring portion 12 of the lining 9 may be held to overlap one of the first and second clamping surfaces 5, 7 and the annular row of staples 4 by the same features and methods previously described in connection with the embodiments of figures 1 to 19. Additionally or alternatively, the anchoring portion 12 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 12 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 12 in the flattened shape is greater than the passage opening of the anchoring portion in the wavy shape.
  • 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 operator can prepare the applier 1 with the compacted tubular lining 9 placed over the lining seat 8, as shown in FIG.
  • the physician uses the endoscope 15 placed in the central channel 13 of the applier 1 to view and select an area suitable for the application of the fastener, i.e. the staples.
  • FIGS. 3 through 8 illustrate the following method steps and action of the applier within the target section of intestine.
  • the staple fastening assembly 2 is opened by distal movement of the anvil 6, to expose the clamping space 14 to the surrounding tissue within the duodenum and the tissue acquisition mechanism, either vacuum or mechanical grasping, may be activated and tissue 19 may be d rawn i nto the clamping space 14 in an entirely circumferential manner or a substantially circumferential manner, i.e., at least partially about the circumference of the applier at some point less than 360 degrees relative to a longitudinal axis of the applier.
  • the entire tissue acquisition step may be directly endoscopically visualized thanks to the central channel 13 opening into the clamping space 14.
  • anvil 6 and cartridge device 3 may be moved towards one another such that the acquired tissue ring 19 is clamped therebetween.
  • the staple driving mechanism of applier 1 is then actuated to engage the annular closed row of staples or fastening element through the acquired tissue ring 19 and through the anchoring portion 12 of lining 9 which is arranged on the anvil to overlap the second clamping surface and the staple position, thereby fastening the lining 9 in place in a circumferential fashion.
  • the ri ng sh aped anch orin g place can be d i rectly endoscopically visualized by passing the endoscope 15 distally through the anvil 3.
  • applier 1 is removed. I n doing so, the anvil 6 of the applier 1 may be carefully pulled through the newly-created ring or plication of stapled tissue 19 and anchoring portion 12 of the lining 9, leaving the yet compacted lining 9 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. Moreover, upon firing of the applier or withdrawal of the applier from the anchored lining, a wrap 31 which holds the lining in the compacted shape may be broken or removed from the lining, allowing the latter to expand longitudinally along the planned section of the hollow organ, as shown in figures 9 and 10.
  • the described procedures and devices help to mimic the effects of gastric bypass in resolution of type 2 diabetes and facilitating weight loss, improve glycemic control and reduce or eliminate other co-morbidities of severe obesity.
  • the described procedures and devices may be advantageously used in conjunction with other therapeutic regimes for the treatment of type 2 diabetes and its co-morbidities and address the patients fear of invasive surgery.
  • the described procedures and devices allow a reversible procedure with a relatively easy removal or self-removal (by biodegradation) of the endoluminal lining or sleeve once the desired effect has been achieved.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un applicateur endoluminal (1) pour l'ancrage d'un revêtement intérieur tubulaire (9) à un organe creux (10), l'applicateur (1) comprenant un ensemble de fixation par agrafes (2) pour le clampage et l'agrafage d'une partie de tissu en forme d'anneau entre les première et seconde surfaces de clampage (5, 7), l'ensemble de fixation par agrafes (2) comprenant une assise de revêtement intérieur (8) adaptée pour recevoir le revêtement intérieur tubulaire (9) de sorte qu'une partie de corps allongée (11) du revêtement intérieur soit maintenue dans une configuration en forme d'anneau compactée et qu'une partie d'ancrage en forme d'anneau (12) du revêtement intérieur (9) soit maintenue pour chevaucher une desdites première et seconde surfaces de clampage (5, 7) et une rangée annulaire d'agrafes (4).
PCT/EP2010/068670 2010-12-01 2010-12-01 Applicateur et procédé d'ancrage d'un revêtement intérieur à un organe creux WO2012072138A1 (fr)

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PCT/EP2010/068670 WO2012072138A1 (fr) 2010-12-01 2010-12-01 Applicateur et procédé d'ancrage d'un revêtement intérieur à un organe creux
CN201080070442.3A CN103237505B (zh) 2010-12-01 2010-12-01 将衬垫锚固至中空器官的施加器和方法

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013087092A1 (fr) * 2011-12-13 2013-06-20 Ethicon Endo-Surgery, Inc. Applicateur et procédé pour ancrer un revêtement à un organe creux
US9456917B2 (en) 2013-08-28 2016-10-04 Ethicon Endo-Surgery, Inc. Endoscopic transoral duodenal sleeve applier
WO2018148474A1 (fr) * 2017-02-09 2018-08-16 Southern Research Institute Dispositif d'agrafage anastomotique endo-luminal
EP3366234A1 (fr) * 2017-02-24 2018-08-29 Covidien LP Ensemble enclume d'une agrafeuse circulaire comprenant des cannelures d'alignement
US10350099B2 (en) 2006-09-01 2019-07-16 Ethicon Endo-Surgery, Inc. Devices and methods for anchoring an endoluminal sleeve in the GI tract
WO2023275682A1 (fr) * 2021-06-30 2023-01-05 Covidien Lp Dispositif d'agrafage circulaire à éléments de préhension de tissu
EP4302731A1 (fr) * 2022-07-07 2024-01-10 Caranx Medical SAS Dispositif de fourniture d'un implant gastro-intestinal

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10966717B2 (en) * 2016-01-07 2021-04-06 Covidien Lp Surgical fastener apparatus

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997047231A2 (fr) * 1996-06-14 1997-12-18 Boston Scientific Corporation Agrafeuses endoscopiques
WO2004037064A2 (fr) * 2002-10-23 2004-05-06 Satiety, Inc. Methode et dispositif utilises dans des interventions endoscopiques d'organes
EP1875868A1 (fr) * 2006-07-07 2008-01-09 Ethicon Endo-Surgery, Inc. Agrafeuse chirurgicale et cartouche d'agrafes et des agrafes pour un tel instrument

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6254642B1 (en) * 1997-12-09 2001-07-03 Thomas V. Taylor Perorally insertable gastroesophageal anti-reflux valve prosthesis and tool for implantation thereof
US9060844B2 (en) * 2002-11-01 2015-06-23 Valentx, Inc. Apparatus and methods for treatment of morbid obesity
US20080255678A1 (en) * 2007-04-13 2008-10-16 Cully Edward H Medical apparatus and method of making the same

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997047231A2 (fr) * 1996-06-14 1997-12-18 Boston Scientific Corporation Agrafeuses endoscopiques
WO2004037064A2 (fr) * 2002-10-23 2004-05-06 Satiety, Inc. Methode et dispositif utilises dans des interventions endoscopiques d'organes
US7220237B2 (en) 2002-10-23 2007-05-22 Satiety, Inc. Method and device for use in endoscopic organ procedures
EP1875868A1 (fr) * 2006-07-07 2008-01-09 Ethicon Endo-Surgery, Inc. Agrafeuse chirurgicale et cartouche d'agrafes et des agrafes pour un tel instrument

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10350099B2 (en) 2006-09-01 2019-07-16 Ethicon Endo-Surgery, Inc. Devices and methods for anchoring an endoluminal sleeve in the GI tract
WO2013087092A1 (fr) * 2011-12-13 2013-06-20 Ethicon Endo-Surgery, Inc. Applicateur et procédé pour ancrer un revêtement à un organe creux
US9456917B2 (en) 2013-08-28 2016-10-04 Ethicon Endo-Surgery, Inc. Endoscopic transoral duodenal sleeve applier
US10307280B2 (en) 2013-08-28 2019-06-04 Ethicon Endo-Surgery, Inc. Endoscopic transoral duodenal sleeve applier
WO2018148474A1 (fr) * 2017-02-09 2018-08-16 Southern Research Institute Dispositif d'agrafage anastomotique endo-luminal
EP3366234A1 (fr) * 2017-02-24 2018-08-29 Covidien LP Ensemble enclume d'une agrafeuse circulaire comprenant des cannelures d'alignement
US10542993B2 (en) 2017-02-24 2020-01-28 Covidien Lp Anvil assembly of circular stapling device including alignment splines
US11324508B2 (en) 2017-02-24 2022-05-10 Covidien Lp Anvil assembly of circular stapling device including alignment splines
WO2023275682A1 (fr) * 2021-06-30 2023-01-05 Covidien Lp Dispositif d'agrafage circulaire à éléments de préhension de tissu
US20230000495A1 (en) * 2021-06-30 2023-01-05 Covidien Lp Circular stapling device with tissue grasping members
EP4302731A1 (fr) * 2022-07-07 2024-01-10 Caranx Medical SAS Dispositif de fourniture d'un implant gastro-intestinal

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CN103237505A (zh) 2013-08-07

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