Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • 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
  • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
  • A61B17/1114—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
• • 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
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
• • 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
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
  • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
  • A61B17/115—Staplers for performing anastomosis, e.g. 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
  • 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
  • A61B2017/07278—Stapler heads characterised by its sled or its staple holder
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
  • A61B2017/1132—End-to-end connections
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
  • A61B2017/1142—Purse-string sutures
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2217/00—General characteristics of surgical instruments
  • A61B2217/002—Auxiliary appliance
  • A61B2217/005—Auxiliary appliance with suction drainage system
• • 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
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2002/045—Stomach, intestines

Definitions

• the present invention relates to a complex surgical device useful for producing and protecting an intestinal anastomosis.
• Colorectal anastomoses have a disunity rate of around 20%.
• Disruption of anastomosis is a serious complication with mortality approaching 20%.
• a stoma between the skin and the intestine located upstream of the anastomosis to divert the digestive flow into an external pocket and avoid contact between the anastomosis. and feces.
• the stoma is closed in a second time after the healing of the anastomosis.
• the presence of stoma and the need for a reoperation to remove it constitute significant constraints for the patient and a source of significant health expenditure.
• anastomosis protection device described in FR 2941858 and EP2395942 which allows the faeces to be diverted into the intestine lumen and to avoid stomas.
• This device is composed of a flexible outer sheath secured to a stent downstream thereof, said stent being intended to be anchored upstream of the anastomosis.
• the stent is the temporary anchor element on the walls of the intestine, which holds the sheath in place and the sheath serves to divert the faeces to the anal orifice without contact with the intestinal wall at the anastomosis and thus protect the anastomosis.
• this device has been improved by adding means for controlling the anchoring or release of the stent with respect to the intestinal wall.
• the holding in place or the release of the device are reinforced by means of a tube opening into the space of a chamber delimited between an inner sheath and the stent wall that allows to create by suction suction effect by drawing the walls of the intestine against the stent to strengthen the anchor or on the contrary to breathe air or fluid to release it.
• the surgical device of WO2013 / 014353 essentially consists in taking advantage of the viscoelasticity of the intestine to attract its internal wall, towards the outer wall of the stent.
• the intestinal mucosa is flexible and elastic while the walls of the stent are relatively rigid.
• the intestinal wall can be attracted (by aspiration) and contiguous to the external walls of the stent under the effect of a negative pressure in the stent-mucous interface.
• the friction force between the intestine and the stent increases rapidly and significantly by a kind of suction effect. Consequently, the mobility of the stent becomes closely related to the suction effect, the modulation of which then acts on the behavior of the stent in the intestine.
• a temporary anchoring element whose anchorage can be modified in a controlled manner, comprising at least one first semi-rigid hollow longitudinal element of the stent type, defining a wall of revolution about a longitudinal axis comprising a running portion; multi-perforated substantially cylindrical section substantially circular said first wall, said first hollow longitudinal member being made of a material conferring radial elastic properties so that it can be compressed radially in the retracted position and adopt a said position of maximum radial expansion after relaxation of the radial compression such that said first multi-perforated wall has a first external diameter that can be controlled in a controlled manner between: a first minimum external diameter in said radial position retracted from said first wall by at most 20 mm, preferably at most 10 mm, and
• a first maximum outer diameter in said position of maximum radial expansion of said first wall preferably 18 to 45 mm
• a flexible outer sheath attached to said stent and extending from its downstream end characterized in that at least a portion, preferably the entire length, of the cylindrical inner surface of said first wall is lined with an independent sealed layer forming an inner sheath, only the longitudinal ends of said inner sheath being sealingly attached to said anchoring element by means of the first sealing means, preferably by "fusion fusing" or a annular seal of elastomeric glue, at each said longitudinal end of said inner sheath, so as to define a chamber called a vacuum chamber between said inner sheath and said first wall, said temporary anchoring element being coupled to a flexible or semi-rigid tube referred to as an injection-suction tube, extending outside of said anchor member, an open end of said injection-suction tube ration leading into said vacuum chamber.
• said injection-suction tube is connected, preferably reversibly at its free longitudinal end to a connection piece, itself reversibly connected or adapted to be reversibly connected to an injection device or suction of air or liquid such as a syringe, said connection end comprising a closure device, preferably an anti-reflux valve and a vacuum control device capable of indicating the content of the vacuum in said vacuum chamber , especially located on a vacuum bulb.
• Said chamber defines a sealed chamber between the sealed film of the inner sheath and the intestinal wall when said anchoring element is in maximum expansion position and immobilized by anchoring against the inner surface of the intestinal wall.
• said chamber loses its seal. But, it is then possible to draw air through said tube from its free end from outside the patient in order to draw the intestinal wall by suction against the external surface of said first wall on a part or even on the entire external surface of said first wall defining said chamber to stop the migration of the anchoring element by restoring the vacuum in said chamber and thus the sealing of said chamber.
• Said anchoring element can be held in retracted radial position with an instrument called “introducer” described below, the radial expansion occurring after release of the anchor element relative to the introducer.
• the introducer may be known in the known manner as a semi-rigid guide tube, of the catheter type provided at one of its ends with a handle and whose internal diameter and length make it possible to keep it lodged therein.
• said anchoring element in its retracted form and said sheath, preferably longitudinally extended.
• said device further comprises an introducer instrument comprising: a tubular outer casing adapted to contain and maintain said compressed anchoring element in said retracted position and said injection tube; suction inside the distal end of said outer casing, and long enough to further contain said sheath and said suction-suction tube, said outer casing preferably being at least 70 cm in length , preferably at least 100 cm, and means for conveying the distal end of said introducer from the anal orifice to said anchoring site in the intestine upstream of the anastomosis, and
• means for disengaging said anchoring element with respect to the outer casing more preferably consisting of a stop tube comprising a stop at its distal end, in contact where appropriate with the longitudinal end of said casing element; anchoring, said sheath downstream of the anchoring element surrounding said buffer tube inside said outer casing.
• the device for protecting the anastomosis is placed in the intestine once the anastomosis is performed with a stapler for example of the type described in FR 2 846 868.
• a stapler for example of the type described in FR 2 846 868.
• the stent opens in radial extension, and comes into contact with the intestinal walls while the sheath and the suction tube deploy in the lumen of the intestine from its anchor site. upstream of the anastomosis to the anal orifice through the anastomosis.
• a protective device that can be introduced into the intestine even before the making of the anastomosis also to facilitate the realization of the anastomosis with the anvil and the stapler, reduce the number of steps during the surgical procedure and reduce the operating time.
• the present invention has for its object:
• the device for protecting anastomosis in the lumen of the intestine upstream of an anastomosis that does not require instruments introduced through the anal orifice and through the anastomosis freshly made but using the pathological bowel excision and the opening of the upstream gut lumen required for placement of the anvil of the stapler for the prior placement of the anastomosis guard, and means for deploying the anchoring device, the outer sheath and, where appropriate, the suction tube through the anastomosis once this has been done only, the deployment of the sheath and the suction tube being carried out by and with the removal of the stapler, that is to say after the steps of: - closure of the upstream gut on the axis of the anvil with a purse,
• the present invention provides more precisely a complex surgical device consisting of a set ready to be used for performing an anastomosis in the intestine with an anvil and a circular stapler and then protecting said anastomosis in the intestine comprising:
• a protection device comprising an anchoring element consisting of at least one stent able to anchor temporarily on the inner wall of the intestine upstream of the anastomosis and a flexible outer sheath, the upstream end of which at least is attached to said stent, said outer sheath being able to extend downstream of said anchoring element and downstream of said anastomosis to allow protection of said anastomosis, especially after completion of said anastomosis and removal of said anvil and stapler, and
• first guide tube at least one first tube referred to as the first guide tube, said stent being held in radial compression inside said first tube, preferably at a distal end of said first guide tube, said first tube being a part of a guide tube of an introducer device or being able to be fixed reversibly to an introducer device, said first tube being deformable in curvature with respect to its longitudinal axis (XX '), characterized in that said flexible sheath is stored, preferably folded, inside said first guide tube, and possibly partly or even entirely inside said stent, the downstream end of said sheath being bonded to said first guide tube or to a first connecting piece independent of said first guide tube, said flexible sheath being adapted to be deployed downstream of said stent by the withdrawal of the proximal end of said first guide tube or respect to said first connecting piece to which it is attached.
• the proximal end of said first guide tube or said first connecting piece respectively comprises reversible attachment means such that said proximal end is adapted to reversibly attach itself to said anvil, said flexible sheath being adapted to be deployed downstream of said stent by the removal of said anvil reversibly fixed to the proximal end of said first guide tube or respectively to said first connecting piece.
• the proximal end of said first guide tube or said first connecting piece comprise reversible attachment means to the front end face of said anvil by gluing, screwing, clamping or magnetic connection. It is understood that the withdrawal of said anvil involves the prior separation of said anvil relative to said proximal end of said first guide tube or said first connecting piece.
• a said introducer comprises at least (i) said first deformable guide tube, (ii) a second rigid guide tube, the proximal end of said first deformable guide tube being fixed or capable of being fixed to the distal end of said second rigid guide tube, (iii) a handle connected to the proximal end of said second rigid guide tube, and (iv) a pusher extending from said handle within said second rigid guide tube and said first deformable guide tube comprising a pusher rod and a pusher stopper at the distal end of the pusher rod.
• said introducer is able to allow the implantation of the protective device upstream of the site of the anastomosis, said pusher stop being able to push said protective device outside the distal end of said first deformable guide tube for allowing the radial extension and anchoring of said stent against the wall of the intestine, the proximal end of said pusher rod being adapted to cooperate with said handle by manually controlling a relative translation of said stem; pusher relative to the first deformable guide tube.
• this type of introducer is used to introduce the stent only after completion of the anastomosis and said first deformable guide tube is longer than according to the invention since it must extend from the anal orifice until upstream of the anastomosis, in practice at least 45 cm.
• the introducer is used to introduce the stent before making the anastomosis so that the length of said first deformable guide tube is for example not more than 30 cm only, to set up the stent upstream of the site of the anastomosis.
• said first connecting piece when the downstream end of said sheath is attached to a said first connecting piece, said first connecting piece is positioned just downstream of said stent, and said reversible fixing means of said first connecting piece. , can be used successively to:
• said first tube is adapted to be reversibly attached to an introducer device, said reversible attachment means to the proximal end of said first guide tube serving successively to: -1) attach to the end of a second guide tube of the introducer secured to the handle and the pusher, during the initial phase of introduction, then
• the protective device comprises at least one flexible tube called suction tube, preferably two suction tubes, each suction tube being able to extend outside said stent. downstream thereof, especially after completion of said anastomosis and withdrawal said anvil and stapler, an open end of said suction tube emerging inside the stent in a depression chamber delimited between the inner wall of the stent and an inner film covering the inner wall of the stent, preferably said film constituting a extension of said sheath, characterized in that each said suction tube is stored, preferably folded, preferably further wound helically inside said first guide tube, and possibly partly or entirely entirely inside said stent, the downstream end of each said suction tube being connected to said first guide tube or to a said first connecting piece, each said suction tube being adapted to be deployed downstream of said stent by the withdrawal of said an anvil reversibly attached to the proximal end of said first guide tube or respectively to said first connecting piece.
• the open end of the suction tube preferably consists of
• the implementation of two suction tubes increases the anchoring force and protects against a failure of the first suction tube, for example if it closes.
• a complex device ready to be used according to the invention can be implemented in a surgical treatment method using a complex surgical device according to the invention in which the following successive steps are carried out in which: El) said surgical device is introduced into the intestine abdominally in the intestine portion upstream of the site of the anastomosis with an introducer device comprising or attached to a said first guide tube and the said element is dropped.
• the downstream end of the suction tube is connected to a device outside the patient adapted to maintain the vacuum in the vacuum chamber and thus prevent the migration of said anchoring element.
• This method is useful in particular for the temporary protection of an anastomosis on the large intestine or colon, rectum or anal canal, to prevent or reduce the risk of anastomotic fistula.
• the distance between said anchoring position upstream of said anastomosis and said anastomosis is at least 10 cm. More particularly, the distance between the anastomosis and the anchoring site is at most 20 cm.
• the device according to the invention because of its possible implantation before the anastomosis is made possible to implement a stent and a sheath of reduced dimensions on the one hand and therefore implanted at a reduced distance in upstream of the site of the anastomosis compared to what was required in previous embodiments such as in WO 2013/014355, especially at a distance of only 10 to 20cm only.
• downstream and upstream reference is made here to the direction of travel upstream downstream of the intestinal transit and to a position when the devices concerned are in place in the intestine to fulfill their function.
• downstream end of said sheath, it is understood that it is the end intended to deploy in said stent once deployed after removal of the stapler after completion of the anastomosis, even if this end swallows is initially close to the upstream end to be fixed to the inner wall of the first guide tube.
• proximal and distal reference is made herein to the position in or of the element concerned with respect to the initial insertion site in the patient's body and in practice here also with respect to the introducer handle with regard to the elements of the introducer.
• the proximal and upstream ends correspond to the downstream and upstream ends respectively for introduction through the anal orifice or part of the intestine downstream of the anastomosis.
• first deformable guide tube of the introducer, means in practice a semi-flexible tube of elastomeric material or PU thicker than said sheath and deformable by curving with respect to its longitudinal axis until it can adopt an external 90 ° curvature.
• This first deformable guide tube has graduations to control the implantation site before release.
• said sheath is sealingly attached to said anchoring element by means of sealing means, preferably by "fusing seal” or an annular seal of elastomeric glue, each said longitudinal end of said inner sheath, so as to define a vacuum chamber between said inner sheath and said first wall, said temporary anchoring element being coupled to said flexible or semi-rigid tube called suction tube, extending outside said anchoring element, an open end of said suction tube opening into said vacuum chamber.
• the downstream end of said sheath and the downstream end of said suction tube (s) are connected to the distal end of said first guide tube.
• proximal end (or downstream end) of said first guide tube comprising a second connecting piece fixed or reversibly attachable to the distal end (or upstream end) of a second rigid guide tube of an introducer device for the introduction of the protective device upstream of the anastomosis site and then able to be fixed reversibly to said anvil for producing the anastomosis.
• the second connecting piece is fixed or able to reversibly fix said first guide tube at the distal end of a second rigid guide tube of an introducer device to secure them for the introduction of the protective device upstream of the site of the anastomosis and dissociate them for removal of the introducer before the implementation of the anvil and stapler.
• said first guide tube comprising a second connecting piece at its proximal end remains inserted into the intestine during the production of the anastomosis and is removed from the intestine during withdrawal of the stapler after the performing the anastomosis because of its connection with the anvil thus allowing the unfolding and full deployment of said sheath and said suction tube downstream of said stent because of their connection with said first tube.
• downstream end of said sheath and the downstream end of (or said) suction tube (s) are connected to the distal end (or upstream end). ) of said first guide tube by gluing or by a wire.
• the sheath and the suction tube (s) are completely stowed, in particular folded or wound up, inside the stent except for their downstream parts which leave the stent at its end. end downstream to reach the upstream end of the first guide tube upstream of the stent, these outer portions of the sheath and the suction tube being interposed between the stent and the inner wall of the first guide tube.
• said second connecting piece is fixed or adapted to be fixed reversibly to an adapter itself adapted to be fixed reversibly to said stapler anvil.
• said second connecting piece is fixed or able to be fixed in a reversible manner by screwing, gluing, clamping or magnetic connection, to an adapter itself capable of being fixed reversibly to a said stapler anvil, by gluing, clamping or magnetic binding.
• said second connecting piece comprises a threading element adapted to cooperate by screwing with:
• a second complementary threading element located at the distal end of said adapter.
• said second connecting piece is reversibly fixed to the distal end of said second rigid guide tube, during the insertion and release of the protective device by said pusher to allow the introduction and then the anchoring of said stent into the intestine upstream of the site of the said anastomosis before performing the anastomosis, and
• Said second connecting piece is reversibly fixed to said anvil or said adapter after removal of said pusher for the reversible attachment of the anvil to allow the realization of said anastomosis with said stapler after said stent was anchored in the intestine upstream of the site of the said anastomosis.
• the flat proximal portion of said adapter is adapted to be fixed by gluing to the flat front face of said anvil.
• downstream end of said sheath, and preferably the downstream end of the said suction tube (s), is (or is) linked to a said first connecting piece of which at least one proximal end is disposed outside of the downstream end of said stent.
• the downstream end of said sheath and preferably the downstream end of (or said) suction tube (s) is (or are) linked (s) to a party distal from said first independent connecting piece of said first guide tube, preferably a distal tubular distal portion arranged or able to fit within the downstream end of said stent, and a proximal portion of said first connecting piece is disposed outside and at the downstream end of said stent, preferably having a flat proximal surface of larger diameter than said tubular distal portion.
• said first connecting piece is disposed inside said first guide tube.
• the sheath and the suction tube are entirely stored inside the stent except for their downstream parts which leave the stent at its downstream end to join the first connecting piece pressed against the stent. downstream end of the stent.
• the entire protective device and said first connecting piece are independent of the first guide tube and the introducer.
• downstream end of said sheath and the downstream end of the said suction tube (s) are connected to a said first connection piece by gluing or by a wire.
• said first connecting piece is able to be reversibly attached to an abutment of a pusher rod inside said first guide tube during the introduction of the protective device. upstream of the site of the anastomosis, preferably by gluing, screwing, clamping or magnetic bonding, more preferably by gluing.
• said first connecting piece is capable of being fixed reversible way directly to said anvil by gluing, screwing, clamping or magnetic bond preferably by gluing.
• the introducer device may be entirely removed from the intestine after introduction of the protective device upstream of the site of the anastomosis before performing the anastomosis, only said first connecting piece remaining inserted in the intestine to be fixed to the anvil for the purpose of performing the anastomosis, said first connecting piece being removed from the intestine during removal of the stapler after the completion of the anastomosis because of its connection with the anvil, thus allowing the complete deployment of said sheath and (or) said (s) suction tube (s) downstream of said stent because of their connection with said first connecting piece.
• said first connecting piece is reversibly fixed to said stopper of the pusher during the introduction and release of the protective device by said pusher to allow introduction and anchoring of said stent in the intestine upstream of the site of said anastomosis before performing the anastomosis
• - said first connecting piece is reversibly fixed to said stapler anvil or to said adapter after complete removal of said introducer to allow the realization of said anastomosis with said stapler after said stent has been anchored in the intestine upstream of the site of said anastomosis.
• the distal end of said first guide tube is closed by a flexible retaining member adapted to retain said protective device inside said first guide tube in the absence of thrust by a pusher rod stop, retaining element being able to deform elastically and allow the output of said protection device under the effect of the thrust by said stopper of the pusher.
• the complex surgical device according to the invention comprises a said protection device and an introducer adapted to allow the implantation of the protective device upstream of the site of the anastomosis, said introducer comprising a fixed handle and / or fit to cooperate with the following two parts of the introducer:
• a pusher comprising a deformable pusher rod bent with respect to its longitudinal axis and a said pusher stopper at the distal end of the pusher rod extending from the handle to the interior of said second rigid guide tube and said first deformable guide tube, the proximal end of said pusher rod being adapted to cooperate with said handle by manually controlling a relative translation of said pusher rod relative to the first deformable guide tube.
• the pusher rod is a spiral rod formed of a steel wire helically wound along a virtual longitudinal axis XX 'with coaxial contiguous turns of the same diameter, the diameter of the contiguous turns forming a deformable rod capable of being deformed into curving relative to said longitudinal axis to allow to adopt a curvature to form a 90 ° elbow.
• said stent comprises at least one withdrawal loop at one end of its longitudinal ends, preferably two loops at each of its longitudinal ends.
• the suction tube is a semi-rigid tube, especially of PE or PP, and has a length that is able to fit and extend inside the intestine from an anal orifice of the patient to the said element.
• anchoring preferably the length of said injection-suction tube being at least 20 cm, more preferably 50 to 150 cm, and the free end of said suction tube outside the patient is connected to a suction device or injection of gaseous or liquid fluid, especially air or a cold liquid as explained below.
• the length of the outer sheath protects the anastomosis, and protrudes from the anal orifice when said anchor member is in the anchoring position and is deployed downstream thereof.
• Said outer sheath by virtue of its elastomer constitution, has radial and longitudinal stretching properties similar to that of the intestinal wall, properties which are those of an elastomeric material in the form of said sheath, the latter having elastic properties.
• radial and longitudinal These properties of radial and longitudinal elasticity of the sheath are similar to those of the wall of the colon.
• said current portion of said first wall extends from the upstream longitudinal end of said first wall to a profiled downstream end portion of smaller diameter than that of the cylindrical running portion, the outer diameter maximum radial expansion of the downstream end of said first wall being from 20 to 40 mm, and the length of said profiled end portion of the first wall being from 10 to 30 mm, preferably from 15 to 25 mm, preferably diameter of said end portion gradually decreasing between said running portion and said downstream end of said first wall.
• said temporary anchoring element is an enteral prosthesis, said first wall of which is formed by a mesh of spiral threads, preferably metal wires.
• the radial expansion then results from the crossing of the metal son whose angular variation allows to vary the width of the rhombus or parallelogram of the mesh of said mesh of spiral son.
• said anchoring element is made of a material which gives it said expansion by radial elasticity only at a temperature at least equal to the ambient temperature of 20 ° C., especially at the temperature of the human body, said anchoring element being in said radial position retracted at a temperature below said ambient temperature, preferably below 5 ° C. It is understood that the tubular material automatically changes diameter according to the ambient temperature. More particularly, said anchoring element is an enteral prosthesis, said first wall is formed by a mesh of spiral son, preferably nitinol.
• Nitinol is a metal alloy with progressive radial expansion properties as a function of temperature, at or above ambient temperature (25 ° C), which allows it to be kept in a colder temperature shrink form, in particular at 4 ° C in storage. Once retracted at low temperature, it remains well retracted of time to be able to lodge it in the introducer tube and convey it into the intestine with the help of said introducer. Once released into the intestine, the prosthesis gradually regains its radial expansion under the effect of a higher ambient temperature, that of the human body. In fact, for the nitinol stents, the shape memory of this alloy makes it possible to modify its shape and its rigidity as a function of the ambient temperature.
• nitinol becomes soft and malleable.
• the injection of a cold liquid solution between 0 ° and 15 ° into the vacuum chamber makes it possible to make the stent malleable and to facilitate its mobilization during passage through the anastomosis or a narrowing zone, for example .
• said sheath is made of biocompatible synthetic material with a wall thickness of 0.01 to 1 mm, preferably of silicone or polyurethane elastomer material of 0.05 to 1 mm thick, and more preferably with radial and longitudinal elasticity properties, and said at least one outer sheath having shape memory properties and non-bondability properties.
• said elastomeric outer sheath has radial and longitudinal stretch properties similar to that of the intestinal wall, properties which are those of an elastomeric material in the form of said outer sheath, the latter having radial and longitudinal elasticity properties.
• These radial and longitudinal elasticity properties of the outer sheath are similar to those of the wall of the colon and allow the intestinal transit is done correctly in said outer sheath during the entire migration period of the anchor element is a duration at least 6 to 10 days.
• the longitudinal elasticity of the outer sheath elastomer may be greater than that of the intestine, without this posing any difficulty, on the contrary it has the advantage of being pulled over the outer sheath portion in excess of the anal, way to cut it and that it retracts inside upstream into the rectum. Due to its radial elasticity, said longitudinal end of the outer sheath remains fixed to said end of said anchoring element irrespective of its radial expansion level. On the other hand, the thickness characteristics of the outer sheath combined with its elasticity give it a shape memory property.
• shape memory properties means that the constituent elastomeric material of said outer sheath naturally returns to its original shape when it is deformed by folding.
• non-bondability properties means that the constituent elastomer material of said outer sheath has a coefficient of adhesion such that the two opposite inner wall surfaces of the outer sheath do not stick to one another when folding, this to create no resistance to the passage of gases and materials.
• said outer sheath has a diameter at rest substantially at least equal to said reduced outer diameter in radial retraction of said hollow anchoring element, and less than that of the resting intestine, preferably said rest diameter of said outer sheath is substantially equal to that of the intestinal wall at rest, and
• said outer sheath extends downstream from the end of said anchoring element to which it is fixed over a length corresponding to the distance between the anchoring position upstream of said anastomosis and a downstream position preferably up to at the anal orifice.
• the radial expansion then results from crossing metallic son whose angular variation allows to vary the width of the rhombus or parallelogram of the mesh of said mesh of spiral son.
• a stent is used, the design and the shape of the mesh of the spiral threads making it possible to obtain a variation in the diameter of said stent with a minimum variation in length, preferably practically without variation of length at the end of the stent. radial compression.
• FIGS. 1A, 1B and 1C are schematic views of a protection device 5 according to the invention comprising a side view with the sheath 2 and suction tube 3 deployed downstream of the stent 1 (FIG. 1A), a view frontal of the upstream end or distal end of the stent 1 mounting a lasso loop 6b ( Figure 1B) and a longitudinal sectional view of the protective device 5 showing the respective positions of the stent 1, the sheath 2 and the suction tube 3, the latter opening into a chamber 4 between the wall of the stent and the inner portion 2a of the sheath 2.
• FIG. 2 shows the different parts of an introducer device 10 disassembled.
• Figure 2A shows the introducer device 10 with the first guide tube 12 inserted into the portion of the upstream gut 100a.
• FIG. 2B shows the delivery of the stent outside the first guide tube 12 by the thrust of the push rod 15 (not visible in FIG. 2B).
• FIGS. 3A and 3B show the detail of a deformable pusher rod 15b of spiral shape in side view (FIG. 3A) and in front view of one of its ends (FIG. 3B).
• FIGS. 4A to 4C show different stages of the placement of an anvil 8 and the stapling of an anastomosis 101 between the upstream part 100a and the intestine part 100b with a stapler 9 cooperating with an anvil 8.
• FIGS. 5A-5B, 6 and 7A-7D relate to the embodiment of example 1.
• FIGS. 5A and 5B show two variants in schematic sectional views (partially exploded for FIG. 5A) of a protection device 5 with the compressed stent at the distal end of the first tube 12 in which the sheath 2 and the suction tube 3 are folded inside the stent, their down ends being adhered to the distal end of the first tube, the protection 5 being ready to be expelled by the abutment 15b of the pusher 15 outside the first guide tube 12.
• FIG. 6 schematically shows the stent 1 released on the outside with the first guide tube 12 separated from the rest of the introducer and emptied from the pusher rod after the stent has been released and the deployment of the sheath 2 and the tube. suction 3 downstream of the stent 1 due to the removal of the first guide tube 12 to which they are attached.
• FIGS. 7A to 7C show various stages of implementation of the anvil at the proximal end of the first guide tube 12 before making the anastomosis.
• Figure 7D shows the removal of the stapler integral with the first tube 12 for the deployment of the sheath 2 after completion of the anastomosis.
• Figures 8A-8B, 9A-9B, 10A-10C and 11A-11B show the embodiment of Example 2.
• FIGS. 8A and 8B show two variants of attachment of the suction tube 3 and of the sheath 2 to a first connecting piece 11 downstream of the stent 1 and independent of the first guide tube.
• FIGS. 9A and 9b show a protection device 5 with the stent 1 at the distal end of the first guide tube 12 and the sheath 2 and the suction tube 3 fixed to an adapter 11 itself fixed reversibly to the stopper 15b of a pusher 15.
• FIGS. 10A, 10B and 10C show different stages of removal of the introducer 10 including the first guide tube 12 after the stent 1 has been released and partial deployment of the sheath 2 and the suction tube 3 connected to the first connecting piece 11.
• Figure 10B shows the approach of the anvil 8 vis-à-vis the first connecting piece 11.
• Figure 10C shows the attachment of the anvil 8 in the gut upstream 10a before completion of anastomosis with the stapler 9.
• FIGS. 11A and 11B show the stapler 9 with the anvil 8 secured to the downstream ends of the sheath 2 and the tube 3 during the production of the anastomosis 101 (FIG. 11A) and after removal of the stapler and separation of the with the first connecting piece 11 after producing the anastomosis 101 (FIG. 11B).
• the anastomosis protection device 5 comprises an anchoring element consisting of a stent 1 whose inner wall is covered with an inner flexible sheath 2a delimiting an annular chamber 4 between annular joints 4a-4b sealed between the inner sheath 2a. and the wall perforated stent.
• the inner sheath 2a constitutes a sealed film forming a flexible tubular wall and is extended by a flexible outer sheath 2 extending outside of said anchoring element in the longitudinal direction of said stent.
• the entire length of the cylindrical inner surface of the inner wall of the stent is thus doubled by an independent sealing layer forming an inner sheath 2a, only the longitudinal ends of said inner sheath 2a being sealingly attached to said anchoring element 1 to using annular elastomeric seals obtained by melting at each said longitudinal end of said inner sheath.
• the stent 1 advantageously comprises at its upstream and downstream ends flared flanges as represented in the patent WO 2013/014353.
• the protection device 5 further comprises a flexible tube or semi-rigid called suction tube 3 extending outside downstream of said stent and opening into the vacuum chamber 4 between the inner sheath 2a and the wall of the stent 1.
• An upstream portion of the suction tube 3 comprising multiple perforations, extends substantially over the entire length of said chamber 4 in the longitudinal direction XX of the device.
• the suction tube 3 opens into said vacuum chamber by sealingly passing the annular elastomeric seal at the downstream end of the inner sheath 2a when the tube 3 is introduced through the anal orifice. Said suction tube 3 and said outer sheath 2 extend outside said stent from the same downstream end of said stent.
• the suction tube 3 serves to inject or suck air into the chamber 4 to suck the intestinal wall 100a against the outer face of the stent 1, and more generally to modify the anchoring characteristic of the stent 1 relative to the intestinal wall 100a.
• the portion 3a of the suction tube 3 inside the chamber 4 may be glued to the inner face of the stent 1 or to the outer face of said outer sheath 2.
• the outer sheath 2 may be attached at its upstream end to the same elastomer fusion joint 4a-4b or may be attached to the outer face of the downstream longitudinal end of the stent by covering it over a short portion. of length (not shown in the figures).
• said first multi-perforated wall has a first external diameter that can be controlled in a controlled manner between: a minimum external diameter in said retracted radial position of said first wall, of 16 mm, and
• the dimensional data as to the diameters given above correspond to appropriate dimensions for anchoring the device against the mucosa of the intestinal lining 10 at different positions between including the rectum.
• the stent is made by a mesh of 0.32mm nitinol wire braided at an angle of 30 ° and has a diameter of 34 mm in the current portion and 37mm at its flared ends, a length of 100mm.
• the proximal and distal portions of the stent, where appropriate the flanges are each equipped respectively with a lasso wire 6a, 6b, allowing the reduction of the diameter of the stent in traction.
• These lassos son 6a, 6b can be seized using a clamp or dedicated hook inserted via an endoscope.
• Said sheath 2 extends on the outside has a length covering the distance between the anastomosis and the anchoring site upstream, is at least 10 cm.
• the sheath 2 is made of biocompatible synthetic material, radiopaque in particular TPU 90 AE with 18% BaSO4, its dimensional characteristics are: thickness 100 ⁇ , rest length of 400 mm (excluding internal part of the stent), and external diameter 37 mm.
• the said suction tube 3 made of Pebax® elastomeric material (ARKEMA, France) is attached to the stent by the same fusion joints 4a-4b as the inner sheath 2a at the ends of the stent and has a length covering at least the distance between the anastomosis and the anchoring site upstream, at least 10 cm. Its characteristics are: length of 500 mm +/- 2 mm; thickness of 05 mm; internal diameter of 2 mm; and outer diameter of 3mm.
• the outer free longitudinal end of said suction tube 3 is reversibly connected to a connection piece comprising a shut-off device consisting of a antireflux valve, comprising a device for controlling the content of the vacuum in the chamber 4.
• the stent 1, the outer sheath 2 and the injection suction tube 3 are packaged in a semi-rigid plastic deformable tube 11 made of elastomeric material, hereinafter referred to as the first deformable guide tube 12.
• This first guide tube 12 is a part of a introducer device 10 described below.
• the stent is introduced in retracted form (radially compressed) at the distal end upstream of said first deformable guide tube 12, said outer sheath 2 and said suction tube 3 being folded up on themselves in several superposed layers partly inside the stent and partly inside the first guide tube 12 of the introducer 10.
• the stent is retained inside the first guide tube 12 by a device called tulip 12a forming cut tabs blocking the passage of the upstream or distal end of the first guide tube 12, which prevents the stent out in the absence of a thrust by the pusher abutment described below, said tabs being elastically deformable under the effect of a said thrust for expelling the stent outside the first guide tube 12.
• the introducer device 10 comprises a handle 14 which is fixed to a second rigid tube 13 also called second guide tube, terminating at its distal end by a connecting portion 13a with the first guide tube 12.
• This connecting portion 13a is of shape outer curved convex and larger diameter than the first deformable guide tube 12 and second rigid guide tube 13 to serve as a stop.
• Pressure actuating means or push button 14a on the handle 14 controls the longitudinal translation of a pusher rod 15a terminating in a pusher abutment 15b of a pusher 15.
• the pusher rod 15a and the pusher abutment 12b are arranged coaxially inside the second rigid tube 13.
• the proximal end of the pusher rod 15a cooperates with the push button 14a on the handle 14.
• the distal end of the stem pusher and the pusher stop are able to expel the stent outside the upstream end (distal end) of the first deformable guide tube 12 by actuation of the rod and pusher abutment in relative transaction inside the first deformable guide tube 12.
• the abutment of the pusher 15b is initially positioned just downstream of the stent inside the first deformable guide tube 12.
• the first deformable guide tube 12 of the introducer containing the radially compressed protection device 5 as described above is introduced abdominally into the upstream portion 100a. of the intestine which has undergone a section at the site 101 where the anastomosis must be performed. In this case the implantation site is located at a distance of 10 cm to 20 cm upstream of the anastomosis.
• the stent as well as the outer sheath 2 and the suction tube 3 are always packaged inside the stent, at least in part and inside the first deformable guide tube 12.
• the stent 1 In its initial form, closed and housed in the introducer, the stent 1 has a diameter reduced to the diameter of the deformable guide tube 11 is especially 10mm.
• the stent Once released outside the first deformable guide tube 12 in the lumen of the upstream intestine 100a, the stent gradually returns to its final diameter. It can be temporarily held in place by the surgeon, who pinches the stent through the walls of the intestine. At least part of the introducer is then removed without the outer sheath 2 and the suction tube 3 are unfolded and deployed downstream of the stent.
• Said first deformable guide tube 12 has an internal diameter of 10 mm, an external diameter of 17 mm and a length of at least 70 cm, preferably at least 100 cm with a graduation every 5 cm. It is made of Pebax ® material to limit friction during the introduction and removal.
• the second rigid tube 13 has a length of 176 mm including the convex curved connecting portion 13a 53 mm protruding diameter forming abutment and 46mm in length.
• the second rigid tube 13 has a central guide groove 13b controlling the translation of the inner rod of the pusher.
• the rod 15a of said pusher 15 is made of stainless steel and has a length before the abutment 15b of 487 mm.
• the rod 15a is a rod formed of a 1.4mm diameter wire helically wound along a virtual longitudinal axis XX 'with contiguous turns, the diameter of the contiguous turns forming a deformable rod with an outer diameter of 7 mm.
• Such a rod 15a can be deformed in curvature to allow to pass a curvature up to 90 °.
• FIGS. 4A to 4D the various steps of producing an anastomosis with an anvil 8 and a circular stapler 9 are shown.
• An anvil 8 is introduced into the upstream part 100a of the intestine just upstream of the site of the anastomosis 101 at the free end of the portion of the upstream bowel 100a. Then, the ligature of this free end of the intestine is made with a stocking wire 8 'around a shaft 8b behind the circular cross-section portion 8a of the anvil 8.
• the stapler 9 which comprises a hollow body 9b circular section intended to cover the circular portion 8a of the anvil and containing an axial finger 9a adapted to cooperate in an axial recess (not shown) in the shaft 8b and to engage the stapler 9 to cooperate with the anvil 8 to perform the stapling at the anastomosis 101 between the upstream intestine portion 100a and downstream portion 100b of the intestine before the anvil 8 - stapler 9 assembly is removed from the intestine as shown in FIG. 4D.
• the stapler 9 is shown downstream of a gut downstream segment for schematic purposes, it being understood that the stapler 9 is in fact initially introduced via the rectum.
• an EEA ® stapler from the company COVIDIEN (France) comprising a handle 9d and a deformable duct 9c capable of following the curvatures of the intestine to connect the handle 9d to the stapler portion 9b which cooperates with the anvil is used. 8 to control stapling.
• the end stop 15b of the pusher is made of Pebax® material, and has a diameter and a thickness in the longitudinal direction of the stem of 10 mm.
• the outer sheath 2 and the suction tube 3 are unfolded and deployed downstream of the stent by removal of the anvil after performing the stapling.
• Removal of the protective device should ideally be done after healing of the anastomotic area with a standard duration of 14 days.
• the withdrawal can be done according to two modes: a) withdrawal by inversion during an endoscopic procedure.
• a lasso loop 6b located at the distal end (or upstream) of the stent is grasped with a clamp. This has the effect of reducing the diameter of the stent.
• the second withdrawal mode comprises the use of a withdrawal tube. In this case, the outer sheath and the suction tube are introduced into a withdrawal tube.
• a lasso loop 6a located at the proximal end (or downstream) of the stent is grasped with a clip, (this gesture is guided by the use of an endoscope). This has the effect of reducing the diameter of the stent (by radial retraction). When the stent is fully retracted, it is then possible to slide it into the withdrawal tube. Advancing the withdrawal tube allows take off the tissue and collect the stent atraumatically. The withdrawal tube containing the stent is then removed anally.
• connection configuration of some of the components of the introducer between them or with the protection device 1 are different and in particular the downstream longitudinal ends of the outer sheath 3 and the outer tube.
• suction-injection 4 are connected to an element of the introducer device which is different.
• the downstream ends of the outer sheath 2 and the suction tube 3 are fixed to the distal end of said first guide tube 12 in the embodiment of Example 1 and to a first connecting piece 11 adapted to be fixed. reversibly to the abutment 15b of the pusher in the embodiment of Example 2.
• FIGS. 5A, 5B, 6 and 7A-7B show a first embodiment of a complex device according to the invention in which the downstream ends of the sheath 2 and of the suction tube 3 are fixed in 2b. -3b near the upstream or proximal end of the first deformable tube 12.
• the sheath 2 and the suction tube 3 are folded inside the stent 1 and emerge downstream of the stent beyond 4b seal to join from the outside, the upstream end of the first guide tube 12, the ends of the sheath 2 and the suction tube 3 being glued against the inner wall of the first guide tube 12 in 2b-3b to near the upstream or proximal end of the first guide tube 12.
• FIG. 5B diagrammatically shows an embodiment in which there are several folds of the sheath 2 and of the suction tube 3 inside the stent 1, which sheath 2 and suction tube 3 join the wall internal wall of the first deformable tube 12 being interposed between the outer wall of the stent 1 and the inner wall of the first guide tube 12.
• FIG. 5B there is schematically illustrated the positioning of the stent 1 inside the first tube 12 by excessively exaggerating the space between the stent 1 and the inner wall of the first guide tube 12 to show the positioning of the sheath 2 and suction tube 3 outside the stent 1.
• the stent 1 is in radial compression exerting a thrust against the inner wall of the first guide tube 12 with the sheath 2 interposed and stuck together at this initial stage.
• the abutment 15b of the pusher 15 has a cross-sectional diameter slightly greater than the diameter of the stent and therefore capable of expelling the stent towards the outlet of the proximal end 12a of the first deformable guide tube 12 under the effect the thrust in translation of the pusher 15 actuated at the handle 14 of the introducer device 10.
• FIG. 6 shows the complete deployment of the sheath 2 and of the suction tube 3 downstream of the stent 1 when, after the production of the anastomosis described hereinafter with reference to FIGS. 7A-7D, is as shown in Figure 7D with the first tube 12 removed from the intestine. In practice, this withdrawal is done until the stapler out through the anal orifice. At this moment, as shown in FIG. 7D, the sheath 2 and the suction tube 3 are cut with scissors 16 to separate them from the complex assembly of the first tube 12 secured to the stapler 9 by the second piece. connection 12b.
• the proximal end of the first deformable guide tube 12 in fact comprises a part called the second connecting piece 12b comprising an internal thread adapted to cooperate in screwing with a threading element.
• complementary 7a of a room called adapter 7, the latter being adapted to be fixed for example by reversible bonding with the front face 8c of the anvil 8.
• the second connecting piece 12b comprising an internal thread adapted to cooperate in screwing with a threading element.
• the second connecting piece 12b complementary 7a of a room called adapter 7, the latter being adapted to be fixed for example by reversible bonding with the front face 8c of the anvil 8.
• the second connecting piece 12b is located substantially at the free end of the upstream portion 100a of the intestine and is therefore in position to receive the anvil 8 via the intercalation of an adapter 7 as shown in Figs. 7A-7C.
• the anastomosis is performed with the stapler 9 as described with reference to FIGS. 4A to 4C.
• remove all the first guide tube 12 - anvil 8-stapler 9 from the outside of the patient at the anal orifice to arrive at the configuration shown in Figures 6 and 7D.
• the stapler is shown downstream of a gutter downstream segment 100b schematically with the understanding that the stapler 9 is actually removed from the intestine via the rectum.
• the sheath 2 and the suction tube 3 are not fixed directly to the end of the deformable tube 12 at 2b and 3b but via a link such as a suture (not shown)
• FIGS. 8A-8B, 9A-9B, 10A-10C and 11A-11B the distinguishing features of a second embodiment of a complex device according to the invention have been illustrated.
• downstream ends of the sheath 2 and the suction tube 3 are fixed to a first piece of connection 11 positioned just outside the downstream end of the stent 1.
• FIGS. 8A and 8B illustrate two variants of arrangement of the sheath 2 and of the suction tube 3 inside the stent 1.
• the sheath 2 and the suction tube 3 are initially arranged at the inside the stent.
• the suction tube 3 and the sheath 2 are simply fixed at a tubular portion 11a at the distal end of the first connecting piece 11 and bent inside the stent 1, the suction tube 3 not being wound on the tubular portion 11a as in the second variant of Figure 8B.
• the different stages of implementation of the complex device according to the invention according to this second embodiment are illustrated with respect to this second variant of FIG. 8B but can be transposed to the variant of FIG. 8A.
• the tubular portion 11a of the connecting piece 11 initially enters the interior of the stent 1 at its downstream end and the larger diameter portion 11b serves to support the abutment 15b of the pusher rod for the introduction phase. then serves for the reversible attachment of the connecting piece 11 against the front end face 8c of the anvil 8 for the stapling phase and making the anastomosis.
• the complex device according to the invention comprises the whole of the protection device 5 and the first connecting piece 11, which assembly is independent of the first guide tube 12.
• the first guide tube 12 can be irreversibly fixed at the connecting piece 13a at the distal end of the second rigid guide tube 13 of the introducer 10 as shown in Figure 9A.
• FIGS. 9A and 9B it is shown that initially the abutment 15b at the distal end of the rod 15a of the pusher is pressed against the flat proximal face 11b of the first connecting piece 11 to expel the stent 1 outwards. of the first guide tube 12 by translation of the rod of the pusher 15.
• the introducer 10 to leave the portion of upstream intestine 100a to leave the first connecting piece 11 at the site of the anastomosis 101.
• the abutment 15a is reversibly bonded to the first piece of connection 11 to partially open the sheath 2 and the suction tube 3 during the preliminary partial removal of the introducer 10 until the piece 11 arrives at the site of the anastomosis as shown in Figure 10B.
• the anvil 8 is reversibly fixed against the first connecting piece 11, for example by reversible bonding.
• the anastomosis is carried out as in example 1 and as illustrated in FIGS. 4A to 4C until reaching the situation shown in FIGS.
• FIGS. 11A-11B the stapler 9 is shown downstream of a gutter downstream segment 100b for schematic purposes, it being understood that the stapler 9 is in fact introduced. and removed from the intestine via the rectum the 9d handle remaining outside the rectum.
• the flexible sheath 2 and two suction tubes 2 are initially arranged in said first tube 12 but entirely outside the stent, downstream of the stent, said stent being maintained in radial compression within said first guide tube, and the two aspirating tubes 2 being arranged to extend diametrically opposite to said stent and outside the sheath.

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• 2017
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