WO2012150578A1 - Dispositif et procédé de formation d'une anastomose - Google Patents

Dispositif et procédé de formation d'une anastomose Download PDF

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Publication number
WO2012150578A1
WO2012150578A1 PCT/IB2012/052247 IB2012052247W WO2012150578A1 WO 2012150578 A1 WO2012150578 A1 WO 2012150578A1 IB 2012052247 W IB2012052247 W IB 2012052247W WO 2012150578 A1 WO2012150578 A1 WO 2012150578A1
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WO
WIPO (PCT)
Prior art keywords
guide member
male
parts
female
leading portion
Prior art date
Application number
PCT/IB2012/052247
Other languages
English (en)
Inventor
Charles Alexander Mosse
Christopher Paul Swain
Original Assignee
Charles Alexander Mosse
Christopher Paul Swain
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 Charles Alexander Mosse, Christopher Paul Swain filed Critical Charles Alexander Mosse
Publication of WO2012150578A1 publication Critical patent/WO2012150578A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—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
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for 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
    • A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00469—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for insertion of instruments, e.g. guide wire, optical fibre
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61B2017/1117—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus adapted for discharge after necrotisation, e.g. by evacuation, expulsion or excretion
    • 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
    • A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/144—Wire
    • 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

Definitions

  • the present invention relates to devices and methods for performing surgical procedures, and in particular to methods and devices for forming anastomoses.
  • An anastomosis is the joining of luminal (i.e. hollow) structures within the body by way of collateral channels, for example, when the natural channels are blocked.
  • luminal i.e. hollow
  • colonic anastomosis in which two portions of the colon are joined together.
  • Creating an anastomosis is a critical step in many surgical procedures, including those that address diseases as wide-ranging as cancer and obesity.
  • a gastrojejunostomy anastomosis may be created between the stomach and the jejunum to treat blockages in the duodenum, for example due to malignancy in the head of the pancreas or for malabsorption, e.g., gastric bypass surgery.
  • An entero-enteral anastomosis may be created for jejuno-jeunal bariatric purposes, a colon to ileum anastomosis may be created for bypassing colorectal cancer, and a biliary duodenal anastomosis may be created between the bile duct and the duodenum above a malignant or benign obstruction in the bile duct.
  • An anastomosis may be created using open surgical procedures requiring the patient to be placed under general anaesthesia, or using endoscopic or laparoscopic procedures that are much less invasive but still generally require general
  • compression or suture-less techniques can also be used to create an anastomosis.
  • a compression anastomosis is formed by necrotic ischemia caused by the occlusion of the blood supply to the compressed tissue. Compression is applied to the tissue using one or more parts to sandwich the tissue in the target area.
  • One compression anastomosis technique employs a compression button that erodes through the bowel wall over several days because of ischemic necrosis resulting in a leak-free anastomosis.
  • Another suture-less compression anastomosis technique employs a bio-fragmentable ring to create an anastomosis in the bowel.
  • Anastomoses may be created using flexible endoscopy techniques employing spring compression buttons.
  • Flexible endoscopy anastomosis techniques may employ ultrasonography techniques when access is limited to a single endoscopic lumen.
  • Magnets also have been used to form compression anastomoses when access is possible to both transgastric lumens or by passing a device through the jejunum.
  • Magnetic compression gastroenteric anastomoses may be formed by introducing magnets perorally with endoscopic and fluoroscopic guidance and mated across the gastric and jejunal walls. Compression anastomoses may be formed between bile ducts using magnets following duct stenosis in liver transplant patients.
  • Compression anastomoses in general suffer the disadvantage that they do not provide an instantaneous hole or opening between two lumens unlike stapled anastomoses and that their final lumen size is not achieved for several days until the device(s) fall through or break up. It would be advantageous if a functioning passage could be provided between the two anastomosed hollow organs of sufficient size to allow the unobstructed passage of food or fluid through the hole or opening.
  • Compression anastomoses also suffer from the disadvantage that they sometimes provide an opening, which is small in diameter and tends to close or obstruct the passage of food or fluid over time. This issue can be addressed by dilatation or the placement of a stent to open up the passage through the narrowed anastomosis. This requires an extra surgical or endoscopic procedure, which adds cost, discomfort and inconvenience to the patient. Forming anastomoses of a sufficient size at the initial surgery would be advantageous. Less invasive surgery or flexible endoscopic anastomosis formation offers advantages by limiting the trauma of introducing large devices through the wall of the abdomen.
  • anastomoses are to be formed using less invasive laparoscopic or flexible endoscopic means, these devices may need to change their shape to facilitate introduction through small channels and then to expand or to be assembled in order to form anastomoses of an optimal size.
  • linear staplers generally requires the placement of a large port or trocar through the skin and muscle of the abdominal wall, typically of 2 mm size.
  • Circular staplers are also used but require even larger incisions or ports to introduce the anvils or stapler heads depending on the dimensions of the required anastomosis. Incisions are required into the two hollow organs to be anastomosed. Because of the large size of the linear stapler arms, large incisions are required to pass the arms inside the tissue. Forceps may be used to pull the intestine over the open arm of the stapler. There is a tendency to cause the small intestine, which is very thin, to tear during the insertion of the arms of a stapler. The incision may be traumatic.
  • the devices could be reduced in size to allow introduction through the skin, and the abdominal wall if used laparoscopically for example through a trocar, and reduced in size or their form altered to allow introduction into the small intestine, stomach or colon through smaller incisions.
  • a device for forming a compression anastomosis comprising a male part adapted to cooperate with a flexible guide member and having a leading portion adapted to dilate a passage through the walls of two body organs to be anastomosed, and a female part configured to receive a portion of the male part, wherein the male and female parts have cooperating means for compressing organ walls therebetween in a region surrounding the passage.
  • the male part of the device is adapted to cooperate with a flexible guide member
  • the device according to the first aspect of the present invention and any embodiments thereof need not include the flexible guide member.
  • the male part is preferably adapted to be move on or slidable along a flexible guide member, such as by having an axial bore.
  • the invention also extends to a kit including a device as aforesaid in combination with a guide member, such as a guide wire, on which the male part and the female part can be moved relative to one another.
  • the device can be used to form a compression anastomosis or fistula between two hollow organs, such as a patient's stomach and small intestine.
  • a compression anastomosis is formed when the tissues of the walls of two organs compressed by the compression device undergo necrotic ischemia caused by the occlusion of the blood supply to the compressed tissue.
  • the leading portion of the male part is that portion at the front of the male part as it moves along or on a flexible guide member.
  • the leading portion will be the first portion of the male part that reaches the walls of the organs to be anastomosed.
  • the leading portion of the male part is adapted to pass through the walls of the two organs thus dilating a passage.
  • the passage may be originally formed by a puncture in the organ walls created by the guide member or by a needle attached to the guide member, the guide member extending through the puncture. As such, passing the leading portion through the passage opens up or increases the diameter of this passage. This is advantageous as a larger diameter anastomosis can be formed between the two organs.
  • the term 'diameter' refers to the width of the passage in the radial direction and does not mean that the passage necessarily has a circular cross-section.
  • the male and female parts of the device comprise cooperating means for compressing organ walls between the cooperating means.
  • the male part has a first cooperating means and the female part has a second cooperating means and the first and second cooperating means are adapted to interact such that when located on either side of first and second walls of first and second organs to be compressed (and subsequently anastomosed), the organ walls will be sandwiched between the cooperating means and compressed.
  • the first and second cooperating means are preferably configured such that a compressive force is generated and manufactured therebetween when the parts are interengaged.
  • the female part is slidable or movable along or on a flexible guide member. It preferably also is provided with an axial bore configured to receive a guide member.
  • the male and female parts being movable on a flexible guide member means that these parts can be positioned in use on first and second externally accessible ends of a flexible guide member, such as a flexible guide wire, which has previously been positioned in the body to pass through the walls of the body organs to be anastomised (as discussed in more detail below), and then moved relative to one another on the guide member within the body until they are either side of the first and second walls of first and second organs to be anastomised.
  • the male and female parts can then be moved into interengagement such that the leading edge of the male part dilates the passage initially formed by the guide wire, whereafter the organ walls are compressed between the cooperating means of the device.
  • the device thus allows a less invasive method of anastomosis, since the guide member is effective to locate the compression device.
  • Engaging the male and female parts preferably only requires the two parts to be slid together into engagement (i.e. towards each other in a translational manner). In other words, to engage the parts, they do not need to be moved in any other manner, such as rotationally in the case of the parts being screwed together. This provides a simpler, less complex procedure.
  • the male part is elongated so that a portion thereof, for example its leading portion, extends through the walls of the two organs and into the female part.
  • the female part is adapted to receive at least the leading portion of the male part.
  • at least the leading portion of the male part can be inserted into the female part to bring the male and female cooperating means together.
  • the female part may receive another portion of the male part.
  • the leading portion of the male part may be removable from another trailing portion of the male part.
  • the male part may comprise at least two separate portions, one of which being the leading portion.
  • the leading portion may be removable from the trailing portion while the trailing portion is engaged with the female portion.
  • the trailing portion defines a conduit.
  • the conduit preferably has a minimum cross-section (i.e. a cross-section at its narrowest point) of at least 6 mm, at least 10 mm or most preferably at least 15 mm.
  • the leading portion of the male part is tapered.
  • the apex of the taper will be positioned at the leading end of the male portion.
  • the tapering of the leading portion allows the leading portion to enter a small aperture passing through the walls of the two organs (which, in the preferred embodiment, has been defined by the guide element such as a guide wire) and dilate the apertures in each wall as it moves through the apertures.
  • the tapered leading portion of the male part may be conical or frustoconical in shape. However, other shapes not having a circular cross-section could also be used.
  • the leading end of the leading portion of the male part comprises an aperture through a flexible guide member can pass. The aperture may thus be located at the apex of a conical or frustoconical tapered leading portion.
  • the tapered portion may be hollow and provide a conduit for fluid, food or other matter to pass though the device.
  • leading portion need not be tapered.
  • the means for dilating a passage could be provided by a leading portion that is configured to expand when in position in a passage through the walls of two organs.
  • the leading portion of the male part could be configured such that its diameter can increase when in position.
  • the leading portion of the male part could be deformable such that it can be folded or rolled to reduce its diameter.
  • the leading portion of the male part could be resilient such that elongating the leading portion (i.e. stretching in a direction along which the male part can be moved on or along (e.g. slid along) the flexible guide member) causes its diameter to be reduced.
  • the leading edge of the male part may still be tapered, but this is not essential.
  • the device further comprises a holding means in which the leading portion can be held in its folded, rolled or elongated state.
  • the holding means may comprise a sleeve, sheath, catheter, trocar etc.
  • the holding means may be passed, with the folded, rolled or elongated leading portion contained therein, through the walls of the organs, such that removing the holding means from the leading portion of the male part (when it is in position in a passage through the walls of two organs) causes the leading portion to unfold, unroll or shorten in length such that it diameter increases and the passage is dilated.
  • the leading portion of the male part is preferably adapted to dilate a passage having an initial diameter of up to 3 mm to a dilated diameter of at least 6 mm, preferably at least 10 mm and more preferably at least 15 mm.
  • the leading portion may have an external dimension (i.e. diameter) that varies between up to 3 mm at its leading end to at least 6 mm.
  • the leading portion may have a diameter when compressed of up to 3 mm and a diameter when expanded, of at least 6 mm.
  • the female part has a length which is less than that of the male part.
  • pressing the cooperating means of the male and female parts together causes the leading portion of the male part to project beyond a trailing end of the female part.
  • This provides a secure engagement of the male and female parts, with the compressed walls of the organs positioned therebetween, and provides access to the leading portion of the male part in the organ into which it extends.
  • the trailing end of the female part is that end at the rear of the female part as it slides down a flexible guide member towards the male part.
  • the device defines a conduit to permit the passage of fluid and/or solid matter therethrough during formation of an anastomosis.
  • This conduit is preferably in addition to any bore or channel formed through the device to receive the flexible guide member, although some parts of the conduit and bore/channel may be shared.
  • the male part of the device defines the conduit.
  • the male part preferably extends from a first organ into a second organ, in which the female portion is located. Providing a conduit through the male portion thus allows food, fluid or other matter to move between the first and second organs.
  • the male part comprises a tubular portion.
  • the term 'tubular' should be understood to mean that the portion being referred to can be any hollow shape.
  • the tubular portion need not be cylindrical or have a circular cross-section. However, preferably the tubular portion does have a circular cross-section.
  • the tubular portion may include the leading portion (preferably tapered) or may be in addition to the leading portion. In the latter case, the tubular portion may be connected to a trailing end of the leading portion.
  • the entire male part may be a tubular portion, having a varying cross-section along its length.
  • the conduit includes an aperture extending through a wall of the tubular portion which defines an open end of the conduit.
  • This allows a relatively large aperture to be provided on a male part having a small diameter.
  • the aperture is preferably located at least partially beyond the trailing end of the female part so that the conduit is fully or partially unobstructed by the female part.
  • the aperture is at least 6 mm wide.
  • At least a part of the leading portion of the male part may be separable from the tubular portion, such that once the male and female parts are engaged, at least a part of the leading portion of the male part can be removed leaving the leading end of the tubular portion open.
  • the open end of the tubular portion defines an end of the (axial) conduit.
  • the female part also comprises a tubular portion.
  • the whole of the female portion may be tubular and preferably may be open at two ends so that the leading portion of the male part may extend through the female portion.
  • at least a leading end of the tubular portion has a greater diameter than the leading portion of the male part to prevent the female portion passing through the passage through the walls of the organs.
  • the tubular portion may be cup or dome shaped with two open ends.
  • the cooperating means of the female part comprises a rim, and in the preferred embodiment this is located at a leading end of the tubular portion of the female part and/or an interna! face of the tubular portion of the female part.
  • the cooperating means of the female part may comprise an internal face of the tubular portion of the female part.
  • the tubular portion of the female part has a circular cross-section so that an even, uniform amount of compression is applied to the walls of the organs and so that the resulting anastomosis is circular.
  • the cooperating means of the male part comprises a flange.
  • the flange may define a trailing end or base of the male part, such that when the leading portion of the male part extends through the walls of the two organs into a second organ, at least a portion of the flange is prevented from passing through the walls and remains in the first organ.
  • the leading edge or rim of the flange preferably has a circular cross-section such that an even, uniform amount of compression is applied to the walls of the organs and so that the resulting anastomosis is circular.
  • the flange may be flared and in the form of a skirt that extends radially outwards and towards a trailing end of the male portion.
  • the flange may extend from the tubular portion, preferably having a wall through which the conduit extends.
  • the walls of the organs are thus preferably compressed between the flange of the male part and the rim or internal face of the female part.
  • the male and/or female parts may comprise an axial bore or other guide means providing a path for a flexible guide element, such that the male and/or female parts can slide along the flexible guide element.
  • the device may comprise a suitable locking means for maintaining the male and female parts in an engaged relationship.
  • the locking means may be integral with or mounted on the male and/or female parts, and might comprise a mechanism or locking member carried by either part. In a preferred embodiment, there is a separate locking member which is also slidable along a flexible guide member.
  • the locking member may be tubular and open at both ends.
  • the preferred locking member is configured to receive the male part, preferably the leading portion of the male part.
  • the locking member prevents the (leading portion of the) male part from moving backwards and out of engagement with the female portion.
  • the male part comprises means for engaging a locking member.
  • the means for engaging may comprise a notch or depression in the male part which can receive and engage a locating feature on the locking member, such as a lip or rim. This is so whether the locking member is integral with the female part, or a separate member.
  • the device includes a resilient means which is configured to urge the cooperating means of the male and female parts towards one another and to maintain organ walls therebetween under a compressive force in use.
  • the resilient means may act between the locking member and the female portion in the preferred embodiment.
  • the resilient means acts to urge the female portion away from the locking member and, when the locking means is engaged with the male part, the resilient means acts to urge the female portion towards the male part.
  • the locking means and resilient means thus act to compress the walls of the two organs between the male and female parts and in particular between their cooperating means.
  • the resilient means preferably comprises a compression spring.
  • the resilient means may be carried by the female part.
  • the male part, the female part and/or a locking member are configured such that their diameter can be reduced to facilitate insertion through a narrow orifice.
  • the male part, female part and/or the locking member may also be deformable such that they can be folded or rolled in order to reduce their diameter.
  • these parts could be resilient so that elongating these parts (i.e.
  • the leading portion of the male part can be deformable or resilient and can be arranged so that passing the leading portion through the walls of two organs to be anastomosed in a folded, rolled or elongated state and then allowing the leading portion to unfold, unroll or shorten causes the diameter of the leading portion to increase and the passage through the walls to be dilated.
  • the device according to the first aspect of the present invention and any embodiments thereof, may further comprise a flexible guide member, wherein moving or sliding the male and female parts towards each other on or along the flexible guide member causes the leading portion of the male part to be received in the female part and the cooperating means of the male and female parts to press together.
  • the flexible guide member may comprise a wire, a track, a thread, a catheter or any suitable flexible means for guiding the first and second parts to the desired anastomosis location.
  • the male and female parts of the compression device may be moved on the guide member by suitable pushing catheters, or by an anchor point on the guide member such as a threaded nut engaged with a screw thread fixed to the guide member.
  • the relative movement may also be achieved by withdrawing the guide member such that it pulls the male part into engagement with the female part, which has previously been moved along the guide member to its desired location. In this case, there is relative movement between the male and female parts on the guide member, but the male part is fixed in relation to the guide member.
  • the various parts of the device may be made of a material that will disintegrate after a certain time. This is useful in the situation where a part is not fully released when the anastomosis forms or if a part becomes stuck on its way out of the patient's body.
  • the parts could be made of a biodegradable polymer such as 3-hydroxypropioic acid or polylactides.
  • said male and female parts each have cooperating means for compressing therebetween the walls of two organs to be anastomosed, and said male and female parts are each mountable on said flexible guide member, such that relatively moving said male and female parts towards each other on said flexible guide member causes a portion of said male part to be received in said female part and said cooperating means of said male and female parts to press together.
  • the device according to the second aspect of the present invention like that according to the first aspect, comprises male and female parts.
  • the device, the male and female parts may have any of the features described above in relation to the first aspect of the present invention and any embodiments thereof.
  • the device according to the second aspect also comprises a flexible guide member.
  • the flexible guide member may have any of the features described above in relation to the first aspect of the present invention and any embodiments thereof.
  • relatively moving said male and female parts towards each other on said flexible guide member may cause at least a leading portion of said male part to be received in said female part.
  • the leading portion may be removable from a trailing portion of the male part.
  • the male and female parts are configured such that moving each other together on or along the flexible guide member causes the male part to be received in the female part.
  • the male part is configured to extend through the female part, i.e. a portion of the male part, such as its leading portion, may extend beyond a trailing end of the female portion.
  • engaging the male and female parts preferably only requires the two parts to be moving together (i.e. towards each other in a translational manner).
  • a method of compressing body tissue within the body comprising the steps of:
  • the third aspect of the present invention provides a method of compressing body tissue using a guide member.
  • the guide member forms or passes through a puncture in the body tissue to be compressed
  • one of the compression parts is a male part with a leading portion
  • the method further comprising dilating a passage by extending the leading portion through the puncture and into engagement with the female part, whilst the male and female parts are both mounted on the guide member.
  • the step of dilating a passage by extending a leading portion through a puncture comprises dilating a passage having an initial diameter of up to 3 mm to a dilated diameter of at least 6 mm, preferably at least 10 mm and more preferably at least 15 mm.
  • This can be achieved by using a tapered leading portion or a leading portion that can be compressed radially and then allowed to expand when in place in the passage.
  • the body tissue comprises the walls of first and second hollow organs to be anastomosed.
  • the compression device is therefore preferably a compression anastomosis device.
  • the first and second organs may be any parts of the Gl (gastrointestinal) tract, including the small intestine, the large intestine and the stomach.
  • the step of introducing a guide member into the body so that it passes through body tissue comprises:
  • the step of passing the guide member into the first organ comprises:
  • the method may further comprise the step of passing the guide member through an abdominal wall of a patient prior to passing it through the wall of the first organ.
  • the step of passing the guide member into one end of the first organ may comprise passing the guide member through the rectum or the mouth and stomach of the patient.
  • the step of moving the guide member out of the second organ comprises pulling the guide member out of a patient's mouth.
  • At least one end of the guide member is accessible via the user's mouth.
  • compression device along the guide member comprises pushing and/or pulling the first and/or second parts along or on the guide member.
  • compression device along or on the guide member comprises using:
  • the method may comprise the step of sliding a separate locking member along the guide member to prevent disengagement of the first and second parts.
  • the method further comprises reducing the diameter of the first and/or second parts of a compression device prior to moving the first and second parts on or along the guide member.
  • the step of reducing the diameter of the first and/or second parts may comprise elongating, rolling or folding the first and second parts.
  • the method further comprises the step of holding the first and/or second parts in an elongated, rolled or folded form by inserting the first and second parts into a sheath, catheter, trocar or a wound thread.
  • the method then further comprises the step of restoring the original diameter of the first and/or second parts prior to the engagement of the first and second parts.
  • the first and second parts of a compression device may comprise the male and female parts of according to the first or second aspects of the present invention and any embodiments thereof.
  • a flexible guide member e.g. a guide-wire
  • a flexible guide member is passed through the inner wall of one hollow organ at the mid point of the site selected for anastomosis. It is then passed through the outer wall of a second hollow organ at the site to which the anastomotic connection is to be made and then routed to a place where it is accessible from the outside of the body. External access is required to both ends of the flexible guide member.
  • One part of the compression device is placed over one end of the flexible guide member and another part is placed over the other end. These parts are designed so that they can be pushed and pulled along the flexible guide member until they meet at the point to be
  • anastomosed At this point they can be locked together so that tissue is trapped between them and compressed. Compression causes ischemia so that the compression devices will fall through and pass out of the gastro-intestinal tract, typically in a few days, leaving a formed anastomosis between the two organs.
  • This pressure created by the part of the compression device can also stimulate a healing response in surrounding tissue due to increased blood flow, thus facilitating better fusion between the two anastomosed body lumens.
  • an initial smaller passage is provided to allow the passage or liquids or food while the final anastomosis is forming and healing. This passage may be created by the male part of the device according to the first or second aspects of the present invention.
  • the method can be used at many body sites to form an anastomosis, i.e., any connection between two normally separate structures, such as the oesophagus, stomach, small intestine, large intestine, colon, bile ducts, or pancreas.
  • the anastomosis can be an end-to-end anastomosis formed by joining the two ends of two organs together, a side-to-side anastomosis formed by joining a side of one organ to a side of another, or an end-to-side anastomosis formed by joining an end of an organ to a side of another.
  • the flexible guide member can be positioned with a variety of methods including laparoscopy, flexible endoscopy and under x-ray screening. If laparoscopy is used then the flexible guide member will normally need to be passed through the abdominal wall, usually through a trocar. It will need to enter the organ, e.g. the small intestine, at a site, which may be at a distance from the exit point through the organ, which is chosen to be in the centre of the anastomosis. It can then be passed into the second organ to be anastomosed and retrieved into a position where it is possible to pass one of the two parts of the compression device onto one side and another onto the other side of the tissues to be anastomosed.
  • laparoscopy is used then the flexible guide member will normally need to be passed through the abdominal wall, usually through a trocar. It will need to enter the organ, e.g. the small intestine, at a site, which may be at a distance from the exit point through the organ,
  • the preferred method also allows for an instant conduit to be formed as the compression device is placed in order to allow liquids or food to pass through the locked parts of the device while the anastomosis is forming and the tissues are healing and before the device falls away from the anastomosis site leaving the fully formed anastomosis.
  • the preferred embodiment of the present invention also allows for shape alterations in one or both parts of the anastomosis device so that they can be passed through small diameter trocars into the peritoneum, through small incisions in for example the small intestine, or can be passed through the mouth and pharynx into the oesophagus, stomach or duodenum and can then expand to dimensions that are desirable for the anastomosis before locking into position.
  • the present invention extends to a method of using the device of the first or second aspects and embodiments thereof.
  • Figure 1 is a front perspective view of an exemplary side-to-side anastomosis formed between a stomach and a small intestine;
  • Figure 2 is a side perspective view of an exemplary side-to side anastomosis formed between a gastric pouch and a loop of small intestine;
  • Figure 3 is a schematic anterior-posterior view of an abdomen showing a stomach and small intestine during the formation of an anastomosis between the stomach and the jejunum (gastro-jejunostomy) using a method according to an embodiment of the present invention
  • Figure 4 is a schematic anterior-posterior view of an abdomen during the formation of a gastro-jejunostomy using a method according to another embodiment of the present invention
  • Figure 5 is a schematic anterior-posterior view of the path of the guide-wire following on from Fig. 4;
  • Figure 6 is a schematic view of an abdomen during the formation of a gastrojejunostomy as shown in Figure 4 with a compression device, according to an embodiment of the present invention, in place;
  • Figure 7 is a perspective view of a manipulation device used during the procedure shown in Fig, 6;
  • Figure 8 is a perspective view of an anastomosis device according to an embodiment of the present invention.
  • Figure 9 shows the anastomosis device of Fig. 8 in an assembled condition compressing the walls of two organs
  • Figure 10 shows a pulling device and guide-wire that can be used with the male component shown in Fig. 8;
  • Figure 1 1 shows a male component of the device of Fig. 8 in place on the guide-wire of Fig. 10;
  • Figures 12a, 12b and 12c show male components of an anastomosis device according to an alternative embodiment of the present invention
  • FIGS 13a, 13b and 13c show female components of an anastomosis device according to an alternative embodiment of the present invention
  • Figure 14 shows the anastomosis device of Figs. 12 and 13 in an assembled condition
  • Figure 5 shows the anastomosis device of Fig. 14 on the guide wire of Fig.
  • Figure 16 shows a male component of the device of Fig. 8 and a trocar in place on the guide-wire of Fig. 10;
  • Figures 7a, 17b and 17c shows one method for compressing a portion of the male component of the device of Fig. 8;
  • Figures 18a and 18b show the compressed portion of the male component of Fig. 16 in a trocar and once it has passed through a trocar;
  • Figures 19a, 19b and 19c show an alternative method of compressing a portion of the male component of the device of Fig. 8;
  • Figure 20 shows an alternative structure of the male component of the device of Fig. 8;
  • Figures 21 a and 21 b show a method for compressing the female component and the spring of the device of Fig. 8;
  • Figure 22 shows a cross-section of the male component of Fig. 20 and a female component in an assembled condition compressing the walls of the organs;
  • Figure 23 shows a guide-wire, that can be used with the device of Fig. 8, connected to an electro-surgical generator.
  • Figure 1 depicts a side-to-side anastomosis 3 formed between the walls of the stomach 1 and small intestine 2.
  • the anastomosis 3 is defined by the presence of a first lumen 1 (the stomach), a second lumen 2 (the small intestine) and an opening 4 that permits communication between the two lumen.
  • Figure 2 illustrates an example of a side-to-side anastomosis 3 formed between a gastric pouch 1 a and the small intestine 2 during a Roux-en-Y Gastric bypass procedure.
  • Figure 3 shows an abdomen 5 containing a stomach 1 and a small intestine 2 undergoing anastomosis.
  • a laparoscope 1 1 preferably of small diameter is passed through the skin and the abdominal wall into the peritoneal cavity, usually but not always, through a trocar and positioned at a site where it is easy and convenient to operate for the surgeon.
  • a small intestinal site for the anastomosis is selected. For gastrojejunostomy this usually will involve checking the distance from the ligament of Treitz, and that there is no tension or torsion when the bowel is adjacent to the stomach 1.
  • a second laparoscopic port is inserted to allow the introduction of laparoscopic instruments, such as a laparoscope 1 1 that holds the operating field in view.
  • a catheter 4 is passed through a laparoscopic trocar such that it enters the small intestine 2 though a small incision 15 and elevates the small intestine 2 at the site selected for anastomosis.
  • a guide-wire 6 is passed through the catheter 14 and is passed through the small intestine 2 at a small puncture site to enter the peritoneal cavity where the guide-wire 6 is grasped and held by laparoscopic forceps 10. If the guide-wire 6 has a suitable exposed sharp metal tip, this can be simply pushed through the wall of the small intestine 2. Alternatively, if the guide-wire 6 is attached to a diathermy unit, cutting cautery can be used to puncture the small intestine 2.
  • the guide-wire 6 is manipulated to puncture the wall of the stomach 1 at the gastric site selected for anastomosis.
  • a flexible endoscope 12 passed through the mouth is used to view the guide-wire 6 as it enters the inwards lumen of the stomach 2 and forceps 3 passed through the accessory channel of the endoscope 12 are used to grasp the end of the guide-wire 6 in the stomach 1 in order to pull it into the oesophagus 7 and out of the mouth (9, Fig. 5) into the hands of the surgeon.
  • the guide-wire 6 has been passed through the abdominal wall via a trocar into the abdominal cavity, into the lumen of the small intestine 2 though a small incision, through a second pin-sized puncture hole in the wall of the stomach 1 and out of the mouth of the patient.
  • the guide-wire 6 can be grasped at both ends this allows it or objects placed over it to be pulled or pushed. Force exerted in both directions will allow the guide-wire 6 to be straightened. Medical guide-wire usage in medicine, particularly in radiology, cardiology and therapeutic endoscopy including ERCP (Endoscosopic retrograde cholangiopancreatography) rarely allows traction to be exerted on both ends of the guide-wire since only one end of the guide-wire is in the hands of the manipulator. With the above arrangement, more force can be exerted if required, curves can be straightened out, pulling becomes possible and pushing forces can be exerted with less loss and there is less risk of losing position or losing objects placed over the guide-wire.
  • the guide-wire 6 can be augmented in several ways including the passage of a catheter or dilator over the guide-wire 6.
  • Figure 4 depicts an alternative method which might be used to form an anastomosis between the stomach 1 and the small intestine 2 when it is possible to pass a flexible endoscope or a catheter into the stomach 1 , through the pylorus and duodenum past the ligament of Treitz 8 and into the small intestine 2 where it becomes free of retroperitoneal attachments. It could also be used to form anastomoses when a colonoscope can be advanced to a position where an anastomosis might be clinically valuable, for example allowing bypass of obstructing colonic cancer.
  • a flexible endoscope 12 is passed through the mouth into the stomach 1 via the oesophagus 7 and is then passed on through the pylorus and duodenum until it emerges past the ligament of Treitz 8. It may be helpful to restrict the inflation of the small intestine 2 during this manoeuvre.
  • Small diameter laparoscopic instruments are placed in the abdomen 5 through trocars or incisions. This could be performed using miniature diameter laparoscopic instruments for example of 3 mm diameter. It could be performed using a single incision laparoscopic surgical approach (SILS) or could be done using a trans-umbilical approach for good cosmetic results. It can be used with a
  • Figure 5 shows the path of a guide-wire through the mouth into the stomach 1 and small intestine 2 where it has passed through the wall of the small intestine 2 to laparoscopic forceps 10 and then the endoscope 12 has been removed.
  • the guide- wire 6 is then passed through the wall of the stomach with laparoscopic forceps 10 using a laparoscopic view 1 1 using electrosurgical diathermy into the lumen of the stomach 1 where the guide-wire tip has been grasped by the endoscope 12 and pulled out through the mouth 9 of the patient.
  • the light from the endoscope 12 in the stomach 1 can be seen through the stomach wall by the laparoscope 1 1 and wee versa. This allows views of the blood vessels inside the stomach wall and these can be avoided during puncture.
  • the site selected for puncture can be checked, by tapping with forceps 13 on the stomach wall from either side or by pressing with the tip of the needle.
  • the shadow of the tip of the guide-wire inside the stomach may also give clues as to the exact puncture site.
  • Diathermy applied to the tip of the guide-wire 6 assisted with directed pressure will allow the guide-wire tip to pass through the wall of the stomach 1 to be grasped by the flexible endoscopic forceps 13.
  • the onward passage of the guide-wire 6 through the small intestine 2 into the stomach 1 can be viewed and manipulated and controlled so that it is performed without undue tension being applied to the small intestinal puncture site, which is thin and may be prone to tearing.
  • a small diameter gastroscope could be passed through the wall of the stomach 1 after making an incision or guide-wire puncture with subsequent balloon dilatation. This scope could identify and grasp the guide-wire, which has been placed in the peritoneal cavity.
  • This NOTES Natural Orifice
  • Translumenal Endosurgery might make laparoscopy unnecessary for the formation of some anastomoses such as gastrojejunostomy or might be used as a hybrid method with both laparoscopy and a flexible endoscope passing through the wall of the stomach into the peritoneal cavity.
  • first and second parts 20, 30 of a compression device can be placed on either end of the guide-wire 6 and slid along or moved on the guide-wire 6 until they meet and compress the tissue of the two organs 1 , 2 to form an anastomosis.
  • the use of an oro-oesophageal over-tube may make introduction of the second part 30 easier and safer.
  • Figure 6 shows the first and second parts 20, 30 and a third locking member 40 in place on the guide-wire 6 inserted into the body as shown in Fig. 3. Both ends of the guide-wire 6 are exposed to a surgeon's hands 19a, 19b.
  • the first component 20 is a male component and is designed to be passed through the tissue of the walls of the two organs (e.g. the stomach 2 and the small intestine 1 ) and engage the second component 30 which is a female component.
  • the male component 20 is passed into the small intestine 2 using, for example, a flexible pushing catheter 51 passing through a trocar 50, with the guide-wire 6 passing through the flexible pushing catheter.
  • the male component 20 is pushed through the wall of the small intestine 2 and then the wall of the stomach 1.
  • the female component 30 and the locking member 40 are passed along the guide-wire 6 into the stomach 1.
  • a flexible endoscope 12 can then be passed over the guide-wire 6 and into the stomach as shown in Fig. 6.
  • the flexible pushing catheter 51 can be clamped onto the guide-wire, such that holding the endoscope 12 steady in the stomach 1 and pulling on the guide-wire 6 as it emerges from the endoscope 12 causes the male and female parts 20, 30 of the compression/anastomosis device to be locked together to compress the tissue of the walls trapped therebetween.
  • Gentle traction on both ends of the guide-wire 6 will reduce the chance of loops or acute angle forming in order to allow the two components 20, 30 to fit together and to be locked in position.
  • a gastroscope can be passed down by the side of the flexible endoscope 12 to observe the closure of the device in the stomach 1.
  • the locking of the male and female components 20, 30 may be watched from the peritoneal side using a laparoscope 1 and viewed on a television monitor 17 while the intragastric appearance can be viewed by means of another television monitor 18.
  • a wider section (such as tapered locating catheter 53) can be made on the guide wire 6, as illustrated in Figure 10 (described below), and this wider section can then be used to push the male component 20 as the guide wire 6 is pulled by the surgeon.
  • the guide-wire 6 is removed and the hole where the guide-wire 6 enters the small intestine (if present) is closed with sutures or clips.
  • Figure 7 shows an alternative manipulation device 90 for moving the second part 30 along the guide wire 6 into engagement with the first part 20.
  • the device 90 comprises a handle 91 connected to a 'Bowden Cable', comprising an outer sleeve 92 positioned around the guide wire 6.
  • the handle 91 is secured to the guide wire 6 via a nut 93. Once the nut 93 is tightened onto the guide wire 6, operating the handle 91 moves the guide wire 6, relative to the outer sleeve 92, towards the handle 91.
  • This provides a pushing force at the distal end 92a of the outer sleeve 92 which pushes the second part 30 along the guide wire 6 (away from the handle 91 ).
  • This device 90 provides a simpler way of pushing the second component 30 along the guide wire 6 that does not interfere with the operation of an endoscope 12.
  • Figure 8 shows the male component 20, the female component 30 and the locking member 40 according to an embodiment of the present invention.
  • the male component 20 comprises a tapered leading portion 21 having an apex 27.
  • the tapered leading portion 21 is preferably conical or frustoconical in shape and hollow.
  • a tubular middle portion 22 Secured to the leading portion 21 is a tubular middle portion 22, which is preferably cylindrical.
  • the tubular portion 22 may be secured to the tapered leading portion 21 using a screw 28.
  • Extending through a wall of the tubular portion 22 is an aperture 24, through which fluid, food and other matter can flow when the device is in place before the anastomosis forms between the two organs.
  • a flange 23 Secured to, or integrally formed with, a trailing end of the tubular portion 22 is a flange 23.
  • the flange 23 is preferably frustoconical in shape, hollow and resembles a skirt.
  • the flange 23 is made of a material that is sufficiently rigid to allow ischemic compression of the tissues held between the male and female components 20, 30 when locked.
  • the male component 20 is hollow so that it can be slidably mounted on a guide-wire 6.
  • the tapered leading portion 21 has an aperture 27 at its apex through which the guide-wire 6 can pass.
  • the tapered leading portion 21 comprises a groove 26 which can receive and engage part of the locking member 40.
  • a leading flange or rim 42 of the locking member 40 can be received in groove 26.
  • Another groove 25 is formed between the leading portion 21 and the tubular portion 22 and can also receive and engage a part of the locking member 40 (e.g. its rim 42).
  • the tapered leading portion 21 is made of metal such as stainless steel
  • the tubular portion 22 is formed of a metal support with a covering of plastic, such as silicone
  • the flange 23 is made of silicone, or alternatively both portions may be made of a biodegradable polymer such as 3-hydroxypropoic acid or polyactides.
  • the purpose of the tapered leading portion 21 is to dilate a passage through the walls of the two organs being anastomosed leaving an instant hole through which fluid or food can pass, while the anastomosis track is maturing.
  • the female component 30 comprises a cup or dome shaped tubular portion 31 having a rim 33 at its leading end.
  • the tubular portion 31 is hollow such that the guide-wire 6 and the tapered leading portion 21 of the male component 20 can pass through the female component 30.
  • the rim 33 or an inner face of the tubular portion 31 is designed to cooperate with the flange 23 of the male component 20 to compress the tissue of organ walls positioned therebetween.
  • the tubular portion 31 has sufficient stiffness to cause such compression and may be made of a plastic material such as silicone or alternatively a biodegradable material as discussed above.
  • the female component 30 is preferably attached to a compression spring 32. The compression is secured to a trailing end of the female component 32.
  • the locking member 40 comprises an open-ended cylinder 41 with a leading flange or rim 42, as discussed above.
  • the cylinder 41 has a split 43, to allow it to radially expand and snap into place over the male portion 20.
  • Figure 9 shows the anastomosis device of Figure 8 in an assembled condition.
  • the male component 20 has been passed through the walls 2a, 1 a of a small intestine 2 and a stomach 1.
  • the tapered leading portion 21 , the tubular portion 22 and a portion of the flange 23 extend into the stomach 1 , while the trailing end of the flange 23 remains in the small intestine 2.
  • the tapered leading portion 21 has dilated the passage extending through walls 2a, 1 a.
  • the female component 30, the spring 32 and the locking member 40 have been passed over an end of the guide-wire 6 and through the patient's mouth and oesophagus and into the stomach 1.
  • the male component 20 extends through the tubular portion 31 of the female component 30.
  • the locking member 40 has been slid (e.g. pushed) over the leading end of the tapered leading portion 21 of the male component 20 such that the flange 42 of the locking member 40 is engaged with the leading groove 26 on the male component 20.
  • the compression spring 32 extends between the female component 30 and the locking member 40 such that the tubular portion 31 of the female component 30 is pushed against the flange 23 of the male component 20 and the small intestine 2 and stomach 1 walls 2a, 1 a are compressed.
  • FIG. 10 shows a guide-wire 6 having a threaded nut 52 screwed to a screw thread 54 which is crimped to the guide-wire 6.
  • the nut 52 can be used to pull parts of the anastomosis device which are mounted on the guide-wire into a desired position.
  • a tapered locating catheter 53 positioned in front of a leading end of the nut 52. This arrangement allows pull force exerted on the external portion of the guide-wire 6 to be efficiently exerted on the male, female and locking components 20, 30, 40 by the nut 52 to lock the male and female components 20, 30 of the anastomosis device together.
  • Figure 1 1 shows the male component 20, as described above, on the guide- wire and pulling device of Figure 10.
  • the nut 52 is located within the male component 20, with the tapered locating catheter 53 protruding through aperture 27.
  • the tapered locating catheter 53 helps to dilate the passage and centralise the male component 20 as it passes through the walls 2a, 1a of two organs to be
  • FIGS 12 to 15 show an alternative anastomosis device according to another embodiment of the present invention.
  • Figures 12a and 12c show an alternative design for the male component 120 of an anastomosis device.
  • the male component 120 comprises a leading portion 121 ( Figure 12a) and a trailing portion 122 ( Figure 2b).
  • the leading portion 121 has a tapered leading end 25 with a leading aperture 127 and is thus similar in shape to the leading portion 21 of the male component 20 of the device of the previous embodiment shown in Figures 8, 9 and 1 1.
  • the leading portion 121 has a trailing end 128 which may comprise a flange.
  • the trailing portion 122 has a leading end 129, a groove 126, a cylindrical body 124 and a flange 123.
  • the parts of the leading and trailing portions 121 , 122 can be made of the same materials as the corresponding parts of male component 20 of Figure 8.
  • the leading end 129 of the trailing portion 122 provides a large axial bore having a diameter of at least 6 mm and preferably at least 10 mm or at least 15 mm.
  • the leading portion 121 is separable (i.e. removable) from the trailing portion 122.
  • the leading portion 121 has a narrower diameter than the trailing portion 122 so it can sit within the trailing portion 122, as shown in Figure 12c.
  • Both the leading portion 121 and the trailing portion 122 can be mounted on the guide wire 6 of Figure 10, as shown in Figure 15.
  • the guide wire 6 passes through the aperture 127 of the leading portion 121.
  • the leading end 125 of the leading portion 121 extends beyond the leading end 129 of the trailing portion 122.
  • the leading end 125 and the following tapered portion provide dilation of the passage through the walls of the two organs.
  • the leading end 29 of the trailing portion 122 may also be tapered to provide further dilation.
  • Figure 13a shows the female component 130 which may be the same as female component 30 in the previous embodiment, as shown in Figure 8, and has a tubular portion 131 and a rim 133.
  • the spring 132 ( Figure 3c) may also be the same as that shown in Figure 8.
  • the locking member 140 ( Figure 13b) is different to that of Figure 8 in that an outwardly extending flange 144 is provided on its trailing end. This enables the locking member 140, which may be of a smaller diameter than that of locking member 40 of Figure 8, to sit within spring 132 as shown in Figure 13c.
  • a rim 142 is provided on a leading end to engage groove 16 on trailing portion 122 of male part 120.
  • Figure 14 shows the anastomosis device of this embodiment comprising male component 120, female component 130, locking member 140 and spring 132 in an assembled condition.
  • the leading portion 121 can be removed by being pulled backwards on or along the guide wire 6 out of the trailing end (i.e. flange 123) of the trailing portion 122. This exposes the leading end 129 of the trailing portion 121 so that food or fluid can pass through the device while the anastomosis is being formed.
  • the male component 120 can be pulled into position by being placed on the guide wire 6 of Figure 10, with the tapered locating catheter 53 extending out of the aperture 127 at the leading end 125 of the leading portion
  • Figure 16 shows the male component 20 of Figures 8, 9 and 1 1 in place on the guide-wire 6 together with a trocar 55.
  • a trocar 55 can be used to insert the male component 20 (and other components) in a reduced diameter condition through small orifices such as in the abdominal wall or the wall 2a of the small intestine 2. It is advantageous if the component to be introduced into the abdomen 5 via a trocar 55 can be compressed radially so that a smaller trocar can be used which would be less likely to cause a complication such as port hernia.
  • the same method of compression could be used for male component 20 of Figures 12, 14 and 15.
  • Radial compression of the components can be achieved either by forming the components from a deformable material (e.g. plastic) which may be folded, rolled or pleated to reduce its radial profile, or from a material which can be elongated to reduce its radial profile.
  • a deformable material e.g. plastic
  • Figure 17 shows one method for compressing the flange 23 of the male component 20.
  • the flange 23 in its usual state has a circular cross-section (Figure 17a). It is formed from a flexible material, such as polythene or silicone rubber, that when compressed folds radially into three prongs 23a, 23b, 23c ( Figure 17b). The three prongs 23a, 23b, 23c can then be rolled up into a cylindrical shape having a much smaller diameter than the original flange 23, as shown in Figure 17c.
  • the rolled up prongs 23a, 23b, 23c can be held in this condition by being placed in a sheath 57, which can be pushed along the guide-wire 6, through a trocar 54, using a pushing catheter 58. Once the male portion 20 has exited through the trocar 55, the flange 23 can expand to its original dimensions, as shown in Figure 18b.
  • Figure 19 shows an alternative male component 20, which is formed out of a wire lattice, for example nitinol or plastic. These materials can be woven or laser cut to form the desired shape. This shape formed in a latticework is illustrated in Fig. 19a.
  • the radial size, i.e. diameter, of the male component 20 can be reduced by elongating in a longitudinal direction 70 ( Figure 19b).
  • the elongated male component 20 can then be placed in a sheath 57 with a substantial reduction in its diameter, as shown in Figure 19c.
  • a pushing catheter 58 can again be used to push the elongated male component 20 along the guide-wire 6 and out of sheath 57 so that it regains its normal dimensions.
  • Figure 20 shows an alternative construction for the male component 80 of the compression device. If the size of the diameter of the male component 80 can be reduced, due to being formed from a wire lattice, there is less need for the passage through the organ walls to be dilated to such an extent.
  • the tapered leading portion 21 of the male component 20 previously described can be replaced by an open cylindrical (or slightly conical) leading portion 81 as shown in Figure 20.
  • Such a design provides a leading aperture 87 that will allow better instantaneous flow of fluid and food than that provided by the smaller previously described aperture 24.
  • Male component 80 has groove 86 for engaging the locking member 40, a tubular middle portion 82 and a flange 83.
  • Male component 80 can be constrained inside a sheath 57 as shown in Figure- 18a.
  • a male component 80 with or without a plastic covering inside a sheath 57 with an outer diameter of 3 mm and for the male component 80 to expand on release to a maximum outer diameter of up to 20 mm if desired.
  • a guide-wire 6 has been passed through the wall of the small intestine 2 or stomach 1 it usually requires minimal force for a suitable pushing catheter 58 or sheath 57 to follow the path of the guide-wire 6.
  • Performing anastomosis through 3 or 5 mm trocars or large channel flexible endoscopes is less traumatic and invasive than using rigid devices such as staplers.
  • the sheath 57 could be inserted through the walls of the two organs such that releasing the elongated male component 20 in this position causes the passage through the organ walls to dilate due to the male component 80 expanding to its original radial dimensions.
  • the female component 30 may change its shape similarly by being sufficiently compressed to pass easily through the mouth and into the oesophagus.
  • the female component 30 may not need to alter is shape much or at all since it is usually possible to pass components from 15-18 mm in diameter through the mouth into the stomach 1 with care.
  • the female component 30 may be reduced in diameter in the same way as the male components 20, 80.
  • the female component 30 may be made from a plastic material such as a silicone rubber or latex, so that it can be folded or formed out of a compressible lattice made with nitinol or plastic so that it can be elongated.
  • a method of reducing the diameter of the female component 30 via elongation thereof is shown in Figure 21a and 22. Once elongated, the female component 30 and the spring 32 can be held in a sheath 57.
  • Figure 22 shows the male component 80 and a female component 30 in an assembled condition in a passage formed through organ walls a, 2a.
  • the female component 30 is engaged with the groove 86 on the male component 80.
  • the resilience of the male and female components may provide sufficient compressive force on the organ walls 1 a, 2a.
  • Figure 23 shows a guide-wire 6 having first and second ends 6a, 6b.
  • the bare wire is exposed from an insulated coating for a short distance at both ends 6a, 6b. This allows the guide-wire 6 to be pushed through the small intestine 2 and stomach 1 using the sharp bare end, or for an electrical cutting diathermy current to be applied to the bare end 6b of the guide-wire 6 to penetrate the tissue.
  • the rest of the guide-wire 6 is covered with an insulated coating.
  • a guide wire having a detachable insulating sheath could be used.
  • One exposed end 6b of the guide-wire 6 is connected to electrical connector 60.
  • This electrical connector 60 can in turn be connected to an electrosurgicai generator 61 which can be operated by the surgeon using a footswitch 62.

Abstract

L'invention concerne un dispositif de formation d'une anastomose par compression. Le dispositif comprend une partie mâle (20) apte à coopérer avec un élément de guidage flexible (6) et ayant une partie avant (21) apte à dilater un passage à travers les parois (1a, 2a) de deux organes corporels (1, 2) à relier par anastomose, et une partie femelle (30) adapté à recevoir une partie de la partie mâle (20), lesdites parties mâle et femelle ayant des moyens de coopération pour comprimer des parois d'organes entre elles dans une région entourant le passage. L'invention concerne également un procédé de compression d'un tissu corporel.
PCT/IB2012/052247 2011-05-05 2012-05-04 Dispositif et procédé de formation d'une anastomose WO2012150578A1 (fr)

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GB201107522A GB201107522D0 (en) 2011-05-05 2011-05-05 Methods and devices for forming anastomosis

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US4154241A (en) * 1977-07-29 1979-05-15 Rudie Peter S Anastomosis clamp
EP0335552A1 (fr) * 1988-03-29 1989-10-04 United States Surgical Corporation Dispositif d'accouplement anastomotique par compression
WO1999017662A1 (fr) * 1997-10-02 1999-04-15 Tyco Group S.A.R.L. Dispositif d'introduction d'une bague d'anastomose par la voie anale
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* Cited by examiner, † Cited by third party
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WO2019140097A1 (fr) * 2018-01-11 2019-07-18 Boston Scientific Scimed, Inc. Systèmes, méthodes et dispositifs pour relier des structures non adhérentes
US10952733B2 (en) 2018-01-11 2021-03-23 Boston Scientific Scimed, Inc. Systems, methods and devices for connecting non-adherent structures

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