WO2014023962A2 - Dispositif - Google Patents

Dispositif Download PDF

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Publication number
WO2014023962A2
WO2014023962A2 PCT/GB2013/052115 GB2013052115W WO2014023962A2 WO 2014023962 A2 WO2014023962 A2 WO 2014023962A2 GB 2013052115 W GB2013052115 W GB 2013052115W WO 2014023962 A2 WO2014023962 A2 WO 2014023962A2
Authority
WO
WIPO (PCT)
Prior art keywords
fistula
seton
stent
plug
access channel
Prior art date
Application number
PCT/GB2013/052115
Other languages
English (en)
Other versions
WO2014023962A3 (fr
Inventor
Michael Robert Burch KEIGHLEY
Original Assignee
Keighleycolo Limited
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 Keighleycolo Limited filed Critical Keighleycolo Limited
Publication of WO2014023962A2 publication Critical patent/WO2014023962A2/fr
Publication of WO2014023962A3 publication Critical patent/WO2014023962A3/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
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00641—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closing fistulae, e.g. anorectal fistulae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00676—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect promotion of self-sealing of the puncture
    • 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
    • A61B2017/00884—Material properties enhancing wound closure
    • 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
    • A61B2017/00893—Material properties pharmaceutically effective
    • 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
    • A61B2017/00946—Material properties malleable

Definitions

  • the present invention relates to devices and related methods for treating fistulas such as anal or recto-vaginal fistulas.
  • the device comprises a seton and a fistula plug, wherein the seton and the fistula plug are connectable together end-to-end.
  • the device comprises a seton and a fistula stent, wherein the fistula stent enables irrigation or drainage of the fistula.
  • the device comprises a seton and a threadable member, wherein the seton comprises one or more holes through which the threadable member may be thread so as to secure the threadable member to the seton.
  • An anal fistula otherwise known as an anorectal fistula, is an abnormal passage formed between the wall of the anal canal and the skin around the anus, typically the perianal skin.
  • An anal fistula usually originates from an infection in an anal gland located in the anal canal.
  • an abscess may form deep under the skin around the anus which requires surgical drainage. After drainage, a tract between the drainage site and the wall of the anal canal may form resulting in an anal fistula. Fistulas cause
  • Anal fistulas are also a common feature of inflammatory bowel diseases, especially ulcerative colitis and Crohn's disease.
  • 'Lay open' fistulotomy is the conventional surgery for treating an anal fistula and involves dividing the tissue between the fistula and the skin so as to promote tissue regeneration and hence healing of the fistula.
  • a disadvantage with this procedure is that it causes discomfort and scarring, and usually results in some level of incontinence.
  • a seton may be used which is passed through the track of the fistula by use of a fistula probe.
  • the seton is a string preferably formed out of silicon or rubber that is typically threaded through an eye of the fistula probe.
  • the probe is then passed through the track of the fistula pulling the seton along so that it extends through the entire length of the fistula.
  • the probe is passed through the anus and then removed from the seton such that the two loose ends of the seton can be tied together so as to form a loop.
  • the seton is typically either left in place long-term and assists in draining any discharge from the fistula, or is tied tight to produce a slow form of fistulotomy, that is, division of tissues superficial to the fistula. Where the seton is left in place long-term to assist in draining any discharge from the fistula, the results can be variable. In particular, where the fistula is narrow and/or the discharge is viscous, the drainage is often inadequate, prolonging and/or worsening any infection. Persistent infection makes definitive treatment difficult and less successful.
  • a device comprising a fistula plug secured to a seton is described, wherein the seton is thread through a hole in the centre of the fistula plug.
  • a fistula plug sutured to a seton is described.
  • the combined width of the fistula plug and the seton is not inconsiderable.
  • the described devices may cause discomfort when treating patients with a particularly narrow fistula tract.
  • the entire device must be removed and another device inserted into the fistula.
  • the removal and re-insertion of the devices causes the patient further discomfort and increases the risk of causing trauma to the tissue surrounding the fistula.
  • patent application WO 2011/151659 describes the use of an attachment device to secure the seton into a loop, said attachment device being locatable within the anal canal once the seton has been fitted. While it is desirable in some patients to have the means of connection located within the anal canal, such a configuration is not optimal for all patients.
  • patent application WO 2005/020823 describes a device for the treatment of anal fistulas comprising a probe attached to a drainage thread.
  • the probe is used to guide the drainage thread through the fistula, after which the probe may be removed and the two ends of the thread tied together.
  • the thread acts to ensure that the fistula channel is kept open, allowing adequate drainage.
  • a problem with this conventional technique is that the knot of the seton is bulky and the presence of a bulky knot external to the body may cause discomfort as the patient sits down.
  • the successful use of such a knot is also dependent upon the surgeon's skill in the tying the knot and the subsequent care the patient takes in the preservation of said knot.
  • the knot can loosen causing slippage and loosening of the seton.
  • the knot may become undone causing the seton to fall out of the fistula and so the process of inserting the seton may need to be repeated. This causes further discomfort and
  • a device suitable for use in a seton fistulotomy procedure is described in patent application WO 2005/096957.
  • the device described includes a silicone thread with a tip piece comprising a transversal through hole.
  • the specialised tip piece increases the complexity of the device.
  • a removable supporting j acket which serves to guide the thread through the fistula. Once the thread has been passed through the fistula, the supporting j acket is removed and the distal end of the thread is passed through the transversal through hole at the tip.
  • Fastening nodes are provided along the length of the thread so as to interfere with the internal diameter of the transversal through hole, thus tying the thread.
  • a slow cutting action is provided resulting in the opening-up, or "elastic traction" of the fistula.
  • more of the thread along with further fastening nodes may be pulled through the transversal through hole so as to ensure that the cutting action is maintained.
  • the presence of fastening nodes has disadvantages; in particular the tightness of the seton can only be adjusted by integer values determined by the distance apart of the nodes on the thread. This may result in a seton that is tighter or looser than would be preferable and hence may cause the patient further discomfort. Such a seton would be particularly unsuitable for use with a fistula plug since if it was tied too loosely it would allow the fistula plug to fall out of the fistula, whereas if it was tied too tightly it may cause an unintentional fistulotomy.
  • Another disadvantage is that the nodes provide resistance to being pulled through the holes, meaning that the surgeon has to provide force to pull the nodes through the holes which in turn may cause the patient discomfort.
  • the stiff lose end of the thread is not aligned with the surface of the patient's body after it is passed through the tip piece and may therefore cause discomfort as a patient sits down.
  • the fistula Prior to inserting the seton in any of the above procedures, the fistula may be washed out or irrigated.
  • Techniques for irrigating the fistula typically comprise inserting a tube into the fistula through which a j et of water or saline is inj ected.
  • patent application US 2005/0070759 describes a fistula visualisation probe in which irrigation fluid is infused into the fistula from the tip of the probe.
  • a disadvantage associated with the above techniques is that repeated irrigation requires reinsertion of the probe or tube into the fistula which may cause discomfort to the patient. Such repeated irrigation is particularly problematic where a drainage seton is used, since removal and reinsertion of the seton before and after irrigation may be required.
  • a further disadvantage associated with the above techniques is that the irrigation fluid is only released from the tip of the probe or tube. Extensive manual manipulation of the probe or tube may therefore be required in order to adequately clean all parts of the fistula, causing further discomfort to the patient and inconvenience to the surgeon.
  • the present invention seeks to provide devices that overcome or substantially alleviate the problems mentioned above.
  • a device suitable for treating a fistula comprising a seton and a fistula plug, wherein the seton and the fistula plug are connectable together end-to-end.
  • the seton and the fistula plug are connected together end-to-end.
  • the seton and the fistula plug are integrally formed.
  • the device of the first aspect of the present invention is configured such that the device may be formed into a loop, wherein the loop is of sufficient length to pass through the fistula and join up outside of the fistula.
  • the loop comprises part or all of the seton and part or all of the fistula plug.
  • said loop may act to secure the fistula plug in the fistula.
  • the seton and the fistula plug may be defined such that each have a longitudinal axis.
  • the seton and the fistula plug each have a longitudinal axis and when the seton and the fistula plug are connected together end-to-end, the
  • longitudinal axes extending through the end of the seton and the end of the fistula plug are approximately coaxial.
  • the seton and the fistula plug may each terminate in an end face such that their respective end faces face each other when connected together.
  • the seton and the fistula plug each have an outer diameter, wherein the overall diameter of the connected seton and the fistula plug in the region of the connection does not exceed the sum of the outer diameters of said seton and fistula plug. More preferably, the overall diameter does not exceed 2 times, or 1.5 times the outer diameter of said seton or fistula plug. Most preferably, the overall diameter does not exceed the outer diameter of said seton or fistula plug.
  • the region of the connection should be understood to mean the region where the seton engages with the fistula plug.
  • the fistula plug when connected, is resistant to disconnection from the seton when the seton and the fistula plug are pulled apart along their longitudinal axes.
  • the force required to disconnect the seton and the fistula plug when they are pulled apart along their longitudinal axes is greater than the force required to pull the seton and the fistula plug through a fistula, so as to avoid the seton detaching from the fistula plug as they are being fitted.
  • the fistula plug cannot be disconnected from the seton when the seton and the fistula plug are pulled apart by hand along their longitudinal axes.
  • a device suitable for treating a fistula comprising a seton and a fistula stent; wherein the fistula stent is configured to provide an access channel within the fistula, such that the access channel is in fluid communication with the internal surface of the fistula; and wherein the fistula stent may be secured within the fistula by the seton, such that the access channel may be accessed when the fistula stent is secured by the seton.
  • the device of the second aspect of the present invention is configured such that the device may be formed into a loop, wherein the loop is of sufficient length to pass through the fistula and join up outside of the fistula.
  • the loop comprises part or all of the seton and part or all of the fistula stent. Said loop may thus act to secure the fistula stent within the fistula.
  • the seton and the fistula stent are connectable together. More typically, the seton and the fistula stent are connected together. Optionally, the seton and the fistula stent are integrally formed. In one embodiment of the second aspect of the present invention, the seton and the fistula stent are connectable together end-to-end. Preferably, the seton and the fistula stent are connected together end-to-end.
  • the seton and the fistula stent may be defined such that each have a longitudinal axis.
  • the seton and the fistula stent each have a longitudinal axis and when the seton and the fistula stent are connected together end-to-end, the
  • longitudinal axes extending through the end of the seton and the end of the fistula stent are approximately coaxial.
  • the seton and the fistula stent may each terminate in an end face such that their respective end faces face each other when connected together.
  • the seton and the fistula stent each have an outer diameter, wherein the overall diameter of the connected seton and the fistula stent in the region of the connection does not exceed the sum of the outer diameters of said seton and fistula stent. More preferably, the overall diameter does not exceed 2 times, or 1.5 times the outer diameter of said seton or fistula stent. Most preferably, the overall diameter does not exceed the outer diameter of said seton or fistula stent.
  • the region of the connection should be understood to mean the region where the seton engages with the fistula stent.
  • the fistula stent when connected, the fistula stent is resistant to disconnection from the seton when the seton and the fistula stent are pulled apart along their longitudinal axes.
  • the force required to disconnect the seton and the fistula stent when they are pulled apart along their longitudinal axes is greater than the force required to pull the seton and the fistula stent through a fistula, so as to avoid the seton detaching from the fistula stent as they are being fitted.
  • the fistula stent cannot be disconnected from the seton when the seton and the fistula stent are pulled apart by hand along their longitudinal axes.
  • the fistula stent is elongate in shape.
  • the fistula stent is approximately circular in cross section.
  • the fistula stent may be approximately cylindrical or conical in shape.
  • the fistula stent is configured to dilate the fistula.
  • the fistula stent has an outer diameter of between 2 and lomm.
  • the fistula stent has an outer diameter of between 3 and 7mm.
  • the fistula stent has an outer diameter of about 4mm.
  • the fistula stent is from 1 to 20cm long.
  • the fistula stent is from 2 to 10cm long. More preferably, the fistula stent is from 3 to 7cm long. Most preferably, the fistula stent is about 4 cm long.
  • the fistula stent is flexible or semi-rigid.
  • the fistula stent is semi-rigid.
  • the fistula stent of the second aspect of the present invention may be defined such that it comprises a first end and a second end, with a longitudinal axis extending from the first end to the second end.
  • the first end of the fistula stent is connected or connectable to the seton and the access channel may be accessed when the first end is connected to the seton.
  • the second end of the fistula stent is also connected or connectable to the seton and the access channel may be accessed when both the first and the second ends are connected to the seton.
  • the fistula stent is configured to provide a single access channel.
  • the fistula stent may be configured to provide two or more access channels.
  • the access channel is provided by a hollow conduit within the fistula stent.
  • the hollow conduit runs substantially parallel to the longitudinal axis of the fistula stent or is approximately coaxial with the longitudinal axis of the fistula stent. Most preferably the hollow conduit is coaxial with the longitudinal axis of the fistula stent.
  • the hollow conduit is approximately circular in cross section.
  • the hollow conduit has an inner diameter of between l and 9mm.
  • the hollow conduit has an inner diameter of between 2 and 5mm. Most preferably the hollow conduit has an inner diameter of about 2.5mm.
  • the access channel is provided by a recess in the side of the fistula stent.
  • a conduit is formed wherein the walls of the conduit are defined by the walls of the recess and the internal surface of the fistula. Direct fluid communication with the internal surface of the fistula is thereby provided.
  • the recess runs substantially parallel to the longitudinal axis of the fistula stent.
  • the access channel typically has a length of at least 50% of the length of the fistula stent. More preferably, the access channel has a length of at least 75% of the length of the fistula stent. Most preferably, the access channel has a length of at least 90% of the length of the fistula stent.
  • the access channel is provided by a hollow conduit within the fistula stent, it is envisaged that the fistula stent is configured to enable fluid
  • the fistula stent is configured such that fluid may enter or exit the hollow conduit via a plurality of openings extending from the hollow conduit to the outer surface of the stent.
  • the fistula stent may contain at least 3, at least 5, or at least 10 of such openings.
  • the openings are distributed along part or all of the length of the hollow conduit.
  • the openings extend from the hollow conduit to the outer surface of the stent in one or more substantially radial directions relative to the longitudinal axis of the fistula stent. More preferably, the openings extend from the hollow conduit to the outer surface of the stent in a plurality of radial directions relative to the longitudinal axis of the fistula stent.
  • the openings are distributed along part or all of the length of the hollow conduit, preferably the openings are distributed along at least 50% of the length of the hollow conduit. More preferably, the openings are distributed along at least 75% of the length of the hollow conduit. Most preferably, the openings are distributed along at least 90% of the length of the hollow conduit.
  • openings are distributed along part or all of the length of the hollow conduit, typically the openings are distributed approximately evenly.
  • the openings have an average cross sectional area of from 0.25 to 25mm 2 .
  • the openings have an average cross sectional area of from 0.5 to 9mm 2 . More preferably, the openings have an average cross sectional area of from 1 to 3mm 2 .
  • part or all of the fistula stent is formed from a mesh, wherein the holes in the mesh provide the plurality of openings extending from the hollow conduit to the outer surface of the stent.
  • the fistula stent is perforated so as to provide the plurality of openings extending from the hollow conduit to the outer surface of the stent.
  • the fistula stent may comprise from 5 to 70 perforations. More typically, the fistula stent comprises from 20 to 60 perforations. More typically still, the fistula stent comprises from 30 to 50 perforations.
  • the perforations are approximately circular in cross-section. Typically, the perforations are approximately uniform in size. Typically, the perforations are spaced approximately evenly apart.
  • perforations are positioned in two or more substantially parallel rows, such as 2 to 5 substantially parallel rows, or 4 substantially parallel rows.
  • the rows are substantially parallel to the longitudinal axis of the fistula stent.
  • the average centre-to-centre distance between adj acent perforations is from 1 to 10mm. More preferably, the average centre-to-centre distance is from 1.5 to 5mm. Most preferably, the average centre-to-centre distance is approximately 2.5mm.
  • the fistula stent further comprises an irrigation port through which the access channel may be accessed when the fistula stent is secured by the seton.
  • the irrigation port thus facilitates the introduction and removal of fluids from within the access channel.
  • the irrigation port is located proximal to one end of the fistula stent, such as within lcm of one end of the fistula stent.
  • the irrigation port comprises a conduit extending from the access channel to the outer surface of the fistula stent.
  • the irrigation port conduit protrudes from the outer surface of the fistula stent, typically by 2 to 10mm.
  • the irrigation port conduit is approximately circular in cross-section.
  • the irrigation port conduit has an inner diameter of between 1 and 9mm. More preferably, the irrigation port conduit has an inner diameter of between 2 and 5mm. Most preferably, the irrigation port conduit has an inner diameter of about 2.5mm.
  • the device of the second aspect of the present invention comprises an irrigation port
  • the device further comprises a stopper configured to releasably block the irrigation port.
  • the stopper is a push-fit.
  • the stopper may be tethered to the fistula stent.
  • the first end of the fistula stent is connected or connectable to the seton and the irrigation port is located at or proximal to the second end of the fistula stent.
  • the second end of the fistula stent is also connected or connectable to the seton.
  • the first end of the fistula stent is connected to the seton
  • the irrigation port is located at or proximal to the second end of the fistula stent
  • the second end of the fistula stent is also connected to an attachment device to enable the seton to be secured to the second end of the fistula stent.
  • the attachment device is a threadable member as discussed in relation to the third aspect of the present invention below.
  • any connection between the fistula stent and the threadable member is tapered.
  • the seton and the fistula plug of the first aspect of the present invention have cooperating means to connect the seton to the fistula plug end- to-end.
  • the seton and the fistula stent of the second aspect of the present invention may have cooperating means to connect the seton to the fistula stent end-to-end.
  • the seton is formed with an end portion and the fistula plug or stent is moulded around the end portion so as to secure the end portion to the fistula plug or stent.
  • the fistula plug or stent may be formed with an end portion and the seton may be moulded around the end portion so as to secure the end portion to the seton.
  • the end portion may be configured to strengthen the resultant moulded joint between the seton and the fistula plug or stent.
  • the end portion may be textured and/or comprise one or more recesses or holes.
  • the end portion may be configured such that when the fistula plug or stent or the seton is moulded around the end portion, the moulding enters into and/or passes through the recesses or holes.
  • the seton and the fistula plug or stent are each formed with an end portion and the two end portions are connectable together with a crimp connection.
  • the crimp connection comprises a compressible element which may be crimped to connect the seton and the fistula plug or stent end portions together.
  • Said compressible element may be integral to the seton end portion or the fistula plug or stent end portion.
  • said compressible element may be a separate component.
  • the compressible element comprises a band surrounding both the end portion of the seton and the end portion of the fistula plug or stent.
  • the fistula plug or stent is swaged to the seton such that the fistula plug or stent and the seton are fused together.
  • the fistula plug or stent is swaged or fused to the seton by melting an end of the fistula plug or stent and an end of the seton and by locating the two melted ends against one another.
  • the ends blend together such that when the ends have cooled down, a bond is created between the fistula plug or stent and the seton.
  • the fistula plug or stent may be glued to the seton.
  • the seton may be formed with a hollow end and an end portion of the fistula plug or stent may locate in the hollow end of the seton, the connectable ends of the fistula plug or stent and the seton being moulded, crimped, fused or glued together.
  • the seton may be formed with a deformable hollow end and an end of the fistula plug or stent may be formed with a protrusion; the protrusion may locate in the hollow end of the seton and the hollow end may be crimped so as to compress the hollow end about the protrusion.
  • the protrusion comprises a flange configured so as to prevent the withdrawal of the protrusion from the hollow end once crimped.
  • the hollow end is crimped using a compressible element, such as a compressible band surrounding the hollow end, as described above.
  • the fistula plug or stent may be formed with a hollow end and an end portion of the seton may locate in the hollow end of the fistula plug or stent, the connectable ends of the fistula plug or stent and the seton being moulded, crimped, fused or glued together.
  • the fistula plug or stent may be formed with a deformable hollow end and an end of the seton may be formed with a protrusion; the protrusion may locate in the hollow end of the fistula plug or stent and the hollow end may be crimped so as to compress the hollow end about the protrusion.
  • the protrusion comprises a flange configured so as to prevent the withdrawal of the protrusion from the hollow end once crimped.
  • the hollow end is crimped using a compressible element, such as a compressible band surrounding the hollow end, as described above.
  • the seton is formed with a hollow end and an end portion of the fistula plug or stent locates in the hollow end of the seton, the hollow end of the seton being configured to tightly fit around the end portion of the fistula plug or stent.
  • the fistula plug or stent may be formed with a hollow end and an end portion of the seton may locate in the hollow end of the fistula plug or stent, the hollow end of the fistula plug or stent being configured to tightly fit around the end portion of the seton.
  • the cooperating means click-fit.
  • an end of the fistula plug or stent may be formed with a protrusion having a flange and the seton may comprise a hollow end having a recess corresponding to the shape of the flange.
  • an end of the seton may be formed with a protrusion having a flange and the fistula plug or stent may comprise a hollow end having a recess corresponding to the shape of the flange.
  • the flange and/or the hollow end is resilient, typically such that as the protrusion is pushed into the hollow end, temporary deformation occurs until the flange locates in the corresponding recess.
  • the cooperating means allow the seton and the fistula plug or stent to be releasably connected.
  • said cooperating means allow the seton and fistula plug or stent to be repeatedly connected and disconnected, preferably by hand.
  • connection and disconnection may occur without damage to the seton and/or the fistula plug or stent.
  • the seton and the fistula plug or stent may comprise a threaded screw and screw attachment means so as to enable the seton and the fistula plug or stent to be connected to each other.
  • the seton comprises a screw extending from an end and the fistula plug or stent comprises a hollow end for receiving the screw of the seton so that the fistula plug or stent can be connected to the seton.
  • the hollow end of the fistula plug or stent may be threaded.
  • the fistula plug or stent may comprise a screw extending from an end and the seton may comprise a hollow end for receiving the screw of the fistula plug or stent so that the fistula plug or stent can be connected to the seton.
  • the hollow end of the seton may be threaded.
  • the cooperating means are such that the fistula plug or stent may be disconnected from the seton when the seton and the fistula plug or stent are pulled apart in a direction other than substantially parallel to their longitudinal axes.
  • the fistula plug or stent may be disconnected from the seton when the seton and the fistula plug or stent are pulled apart in a direction approximately
  • the fistula plug or stent may comprise an end portion and the seton may comprise a hollow end for receiving the fistula plug or stent end portion, wherein the hollow end is accessed via an aperture extending from an end face of the seton to a side wall thereof.
  • the seton may comprise an end portion and the fistula plug or stent may comprise a hollow end for receiving the seton end portion, wherein the hollow end is accessed via an aperture extending from an end face of the fistula plug or stent to a side wall thereof
  • the device is configured such that the end portion may enter and be removed from the hollow end via the aperture in the side wall.
  • the device is configured such that the end face comprises retaining means, such as a flange, to prevent the end portion from being withdrawn from the hollow end via the aperture in the end face.
  • the device further comprises a neck portion, which is optionally cylindrical in shape, wherein the neck portion is configured to connect the end portion to the remainder of the fistula plug or stent or the seton as appropriate.
  • the neck portion may pass through the aperture in the side wall and the aperture in the end face.
  • the cooperating means are configured to allow the seton and the fistula plug or stent to swivel at the point of connection.
  • the end portion may be approximately ball shaped. A ball and socket joint may thus be created allowing the end portion to swivel in the hollow end.
  • the seton and the seton end portion may be integrally formed.
  • the fistula plug and the fistula plug end portion may be integrally formed.
  • the fistula stent and the fistula stent end portion may be integrally formed.
  • the fistula stent comprises a hollow end and a hollow conduit
  • the hollow conduit and the hollow end may be linked so as to form a continuous hollow portion.
  • a device suitable for treating a fistula comprising a seton and a threadable member, and wherein the seton comprises one or more holes through which the threadable member may be thread so as to secure the threadable member to the seton.
  • the seton comprises a plurality of holes through which the threadable member may be thread.
  • the seton may comprise from 5 to 30 holes. More preferably, the seton comprises from 10 to 20 holes. Where the seton comprises a plurality of holes, typically the holes are spaced approximately evenly apart.
  • the average centre-to-centre distance between adjacent holes is from 1 to 10mm. More preferably, the average centre-to-centre distance is from 2 to 5mm. Most preferably, the average centre-to-centre distance is approximately 2.5mm.
  • the holes may be spaced along the entire length of the seton.
  • the holes may be spaced along a segment of the seton.
  • said segment of the seton comprises from 10 to 90% of the length of the seton. More preferably, said segment of the seton comprises from 25 to 75% of the length of the seton. Most preferably, said segment of the seton comprises about 50% of the length of the seton.
  • the seton of the first, second or third aspect of the present invention may be defined such that it comprises a first end and a second end, with a longitudinal axis extending from the first end to the second end.
  • at least one of the holes is located within 5cm of the first end of the seton. More preferably, at least one of the holes is located within 2cm of the first end of the seton. Most preferably, at least one of the holes is located within lcm of the first end of the seton.
  • the holes are approximately circular in cross-section. Preferably, the holes are approximately uniform in size. Preferably, the holes pass through the seton approximately in parallel. Preferably, the holes pass through the seton in a direction approximately perpendicular to the longitudinal axis of the seton.
  • the holes may be between 0.5 and 3.5mm in diameter.
  • the holes are between 1.5 and 2.5mm in diameter. Most preferably the holes are approximately 2mm in diameter.
  • the device is configured such that, when the threadable member is thread through the one or more holes, the device is formed into a loop.
  • the loop is of sufficient length to pass through the fistula and j oin up outside of the fistula.
  • the threadable member may be attached to the seton.
  • the seton comprises a first end and a second end
  • one or more of the holes may be located proximal to the first end, optionally as described above, and the threadable member may be attached to the second end.
  • the threadable member and/or the seton is sufficiently flexible to allow the threadable member to be thread through more than one of the holes.
  • the threadable member and/or the seton is sufficiently flexible to allow the threadable member to be thread through two or more adj acent holes.
  • the threadable member is typically elongate in shape.
  • the threadable member is typically approximately circular in cross section.
  • the threadable member has a rounded blunt end.
  • the threadable member is between 3 and 50cm in length. More preferably, the threadable member is between 4 and 20cm in length. More preferably still, the threadable member is between 5 and 15cm in length. Most preferably, the threadable member is about 6cm in length.
  • the threadable member is between 0.05 and 5mm in diameter or cross-sectional width.
  • the threadable member is between 0.5 and 4mm in diameter or cross-sectional width. More preferably, the threadable member is between 0.5 and 2mm in diameter or cross-sectional width. Most preferably, the threadable member has a diameter or cross-sectional width of about 1.25mm.
  • the threadable member has insufficient rigidity to retain its shape when unsupported.
  • the threadable member has sufficient rigidity to retain its shape when unsupported.
  • a threadable member may be deformed by hand.
  • the threadable member may retain its new shape when deformed.
  • the threadable member may be resilient such that it reverts to its original shape after the deformation.
  • the threadable member may further comprise a stiff terminal segment.
  • the stiff terminal segment has greater rigidity than the remainder of the threadable member. Where the threadable member is attached at one end to the remainder of the device, the stiff terminal segment is typically located at the end of the threadable member distal to the point of attachment to the remainder of the device.
  • stiff terminal segment is particularly preferred when the threadable member has insufficient rigidity to retain its shape when unsupported.
  • the stiff terminal segment is thread first through the one or more holes and thus acts as a guide, aiding the threading process.
  • the stiff terminal segment is between 0.5 and 5cm in length.
  • the stiff terminal segment is between 1 and 3cm in length. Most preferably, the stiff terminal segment is about lcm in length.
  • the stiff terminal segment may, for example, comprise a blunt needle, such as a plastic or metal needle, connected to the reminder of the threadable member.
  • the blunt needle is connected to the reminder of the threadable member end-to-end.
  • the connectable ends of the blunt needle and the remainder of the threadable member may be moulded, crimped, fused or glued together.
  • an end portion of the threadable member may be stiffened so as to form the stiff terminal segment.
  • the end portion of the threadable member may be coated and/or impregnated with a stiffening medium such as a suitable stiff plastic.
  • the threadable member is free from protrusions and/or free from recesses.
  • the side walls of the threadable member are smooth.
  • the threadable member may be formed from flexible materials such as rubber, silicone, silk, flexible plastics such as nylon,
  • the threadable member may be formed from one or more biodegradable materials such as biodegradable polymers.
  • the threadable member may be made from the same material as the seton. Where rigidity is required, the threadable member may be reinforced with a reinforcing element such as a wire.
  • the device further comprises a fistula plug.
  • the loop comprises part or all of the seton and part or all of the fistula plug.
  • said loop may act to secure the fistula plug in the fistula.
  • the device further comprises a fistula stent.
  • the loop comprises part or all of the seton and part or all of the fistula stent.
  • said loop may act to secure the fistula stent in the fistula.
  • the device of the third aspect of the present invention is also a device according to any embodiment of the second aspect of the present invention. In other words, there is provided a device suitable for treating a fistula, wherein the device comprises a seton, a threadable member and a fistula stent;
  • fistula stent is configured to provide an access channel within the fistula, such that the access channel is in fluid communication with the internal surface of the fistula;
  • fistula stent may be secured within the fistula by the seton, such that the access channel may be accessed when the fistula stent is secured by the seton;
  • the seton comprises one or more holes through which the threadable member may be thread so as to secure the threadable member to the seton.
  • the fistula plug or stent is connectable to the threadable member. More preferably, the fistula plug or stent is connected to the threadable member.
  • the threadable member is formed from the same material as the fistula plug or stent.
  • Materials suitable for forming the fistula plug or stent are discussed in greater detail below.
  • the threadable member may be formed from fibrin and/or collagen.
  • the threadable member may be formed from a copolymer of glycolide and lactide.
  • the threadable member may be formed from polypropylene.
  • the threadable member is formed from the same material as the fistula plug or stent
  • the threadable member may be strengthened.
  • the threadable member may be strengthened with a reinforcing element such as a wire, or coated and/or impregnated with strengthening medium such as a suitable plastic, rubber or silicone.
  • the fistula plug or stent and the threadable member are connectable together end-to-end. More preferably, the fistula plug or stent and the threadable member are connected together end-to-end.
  • the connectable ends of the fistula plug or stent and the threadable member may be moulded, crimped, fused or glued together.
  • the fistula plug or stent and the threadable member may be integrally formed.
  • the threadable member and the fistula plug or stent each have a longitudinal axis and when the threadable member and the fistula plug or stent are connected together end-to-end, the longitudinal axes extending through the end of the threadable member and the end of the fistula plug or stent are approximately coaxial.
  • the fistula plug or stent is connectable to the seton. More preferably, the fistula plug or stent is connected to the seton.
  • fistula plug or stent is connected or connectable to the seton, and said seton comprises a first end and a second end as described above, it is preferred that the fistula plug or stent is connected or connectable to the second end of the seton.
  • one or more of the holes through which the threadable member may be thread are located proximal to the first end of the seton and in use the fistula plug or stent is connected to the second end of the seton.
  • the device of the third aspect of the present invention is configured such that a first end of the fistula plug or stent is connected or connectable to the seton, and a second end of the fistula plug or stent is connected or connectable to the threadable member. Accordingly, it can be seen that where the device according to the third aspect of the present invention is formed into a loop, it is preferred that the loop is formed from the seton, the fistula plug or stent, and the threadable member.
  • the device of the third aspect of the present invention is also a device comprising an irrigation port according to the second aspect of the present invention
  • typically the irrigation port is located at or proximal to the second end of the fistula stent.
  • the device is configured such that the first end of the fistula stent is connected or connectable to the seton, the second end of the fistula stent is connected or connectable to the threadable member, and the irrigation port is located at or proximal to the second end of the fistula stent.
  • the irrigation port is located within lcm of the end of the fistula stent which is connected or connectable to the threadable member.
  • the device of the third aspect of the present invention comprises a fistula plug
  • the device is also a device according to any embodiment of the first aspect of the present invention.
  • the seton and the fistula plug are connectable together end-to-end.
  • the seton and the fistula plug may comprise cooperating means adapted to connect the seton to the fistula plug end-to-end in accordance with any of the embodiments of the first aspect of the present invention.
  • the fistula plug as used in the device of either the first or the third aspect of the present invention may further comprise a body segment which is typically elongate in shape.
  • the fistula plug body segment is approximately circular in cross section.
  • the fistula plug body segment may be approximately cylindrical or conical in shape.
  • the fistula plug is configured such that the body segment is located inbetween the first end of the fistula plug that is connected or connectable to the seton, and the second end of the fistula plug that is connected or connectable to the threadable member.
  • the fistula plug is configured to dilate the fistula.
  • the fistula plug body segment has an outer diameter of between 2 and 10mm.
  • the fistula plug body segment has a outer diameter of between 4 and 7mm.
  • Most preferably the fistula plug body segment has a outer diameter of about 5mm.
  • the fistula plug body segment is from 1 to 20cm long.
  • the fistula plug body segment is from 2 to 10cm long. More preferably, the fistula plug body segment is from 2 to 5cm long. Most preferably, the fistula plug body segment is about 3.5cm long.
  • the fistula plug body segment adj oins a portion of the fistula plug with a smaller cross-sectional area
  • the j oin is tapered. Such tapering may act to ease the insertion of the fistula plug body segment into the fistula.
  • the fistula plug body segment as a whole may be tapered.
  • the fistula plug body segment may be approximately the same diameter as the seton at the end connectable to the seton and taper to approximately the same diameter as the threadable member at the end connectable to the threadable member.
  • the fistula plug comprises both a body segment as described above and a flexible segment.
  • the flexible segment is made from the same material as the body segment.
  • the body segment and the flexible segment are integrally formed.
  • the term "flexible segment” refers to part of the fistula plug which is relatively more flexible than the body segment of the fistula plug. Accordingly, the flexible segment provides the device with additional flexibility, particularly around the entrance or exit of the fistula, when in use.
  • the fistula plug is configured such that the flexible segment is located inbetween the body segment and the end of the fistula plug that is connected or connectable to the seton.
  • the flexible segment is approximately cylindrical or conical in shape.
  • the flexible segment is approximately cylindrical in shape.
  • the flexible segment has the same cross-sectional shape as the body segment, albeit reduced in size.
  • the body segment and the flexible segment each have a longitudinal axis, and the longitudinal axes extending through the end of the body segment and the end of the flexible segment are approximately coaxial.
  • the flexible segment and the body segment each have an outer diameter, wherein the outer diameter of the flexible segment does not exceed the outer diameter of the body segment.
  • the outer diameter of the flexible segment is from 40 to 80% of the outer diameter of the body segment. Most preferably, the outer diameter of the flexible segment is about 60% of the outer diameter of the body segment.
  • the fistula plug comprises a tissue growth promoter.
  • the tissue growth promoter may comprise or be a tissue growth promoting agent, i.e. a pharmaceutical substance which encourages tissue growth such as a growth factor.
  • Suitable growth factors include but are not limited to basic fibroblast growth factor (FGF-2), transforming growth factor beta (TGF-beta), epidermal growth factor (EGF), cartilage derived growth factor (CDGF), platelet derived growth factor (PDGF), insulin-like growth factors I and II (IGF-I and IGF-II), interferons (e.g. interferon ⁇ , ⁇ , ⁇ ) and the like.
  • the tissue growth promoter may comprise or be a tissue growth promoting matrix, i.e. a substance or structure which may act as a scaffold onto which and/or through which tissue may grow.
  • tissue may grow both onto and through the scaffold.
  • the entire fistula plug body segment and/or the entire fistula plug flexible segment is made from the tissue growth promoting matrix.
  • the entire fistula plug is made from the tissue growth promoting matrix.
  • the tissue growth promoting matrix comprises a microscopic scaffold, i.e. the scaffold structure is not visible to the naked eye.
  • the scaffold may comprise a plurality of fibrils which may be non-interwoven or preferably interwoven and/or interconnected. Said fibrils may be interwoven and/or interconnected in an ordered or disordered structure.
  • a scaffold comprises a plurality of fibrils, preferably said fibrils have a diameter of from 0.1 nm to 1000 nm, more preferably from 1 nm to 500 nm, and most preferably from 10 nm to 100 nm.
  • at least 10% by volume of the scaffold is occupied by the fibrils.
  • Preferably at least 25% by volume, and more preferably at least 50% by volume of the scaffold is occupied by the fibrils.
  • the tissue growth promoting matrix comprises a macroscopic scaffold, i.e. the scaffold structure is visible to the naked eye.
  • the scaffold may comprise a plurality of interwoven and/or interconnected strands. Said strands may be interwoven and/or interconnected in an ordered or disordered structure.
  • the fistula plug comprises a macroscopic scaffold formed about a hollow central core. More preferably, the fistula plug comprises a plurality of interwoven strands formed, typically cylindrically, about a hollow central core.
  • the interwoven strands may be spun together at one end of the fistula plug so as to form an integral threadable member.
  • one end of such a fistula plug may be connectable or connected end-to-end to a threadable member, such as any described above.
  • the fistula plug comprises a macroscopic scaffold affixed to a central core.
  • the scaffold may comprise a plurality of non-interwoven strands, such as a plurality of strands affixed to a central core, for example in a brush-like array.
  • said strands are afixed substantially perpendicularly from the central core.
  • the central core typically runs substantially parallel to the longitudinal axis of the fistula plug or is approximately coaxial with the longitudinal axis of the fistula plug. Most preferably the central core is coaxial with the longitudinal axis of the fistula plug.
  • a macroscopic scaffold comprises a plurality of strands
  • said strands have a diameter of from 1 ⁇ to 1 mm, more preferably from 10 ⁇ to 100 ⁇ .
  • a scaffold comprises a plurality of strands
  • at least 10% by volume of the scaffold is occupied by the strands.
  • Preferably at least 25% by volume, and more preferably at least 50% by volume of the scaffold is occupied by the strands.
  • the macroscopic scaffold comprises at least 10 strands per cms.
  • the macroscopic scaffold comprises at least 100 strands per cms. More preferably the macroscopic scaffold comprises at least 1000 strands per cms.
  • a fistula plug comprises a macroscopic scaffold comprising a plurality of strands
  • the fistula plug comprises a plurality of interwoven strands formed about a hollow central core
  • the strands are formed from a biodegradable polymer, such as a copolymer of glycolide and lactide as discussed below. Strands formed from a copolymer of glycolide and lactide are commercially available as a woven mesh under the name Ethicon VicrylTM.
  • the scaffold may comprise a porous structure such as a sponge-like structure.
  • Said porous structure may be microscopic or macroscopic.
  • the tissue growth promoting matrix may comprise both a
  • the macroscopic scaffold is made from, coated with or embedded in a microscopic scaffold.
  • the strands and/or porous structure of the macroscopic scaffold may comprise a microscopic scaffold.
  • At least 10% by volume of the tissue growth promoting matrix is void.
  • at least 25% by volume, and more preferably at least 50% by volume of the tissue growth promoting matrix is void.
  • the material from which the tissue growth promoting matrix is made may be biological or non-biological, or a mixture thereof.
  • the material promotes tissue remodelling and/or is remodelable.
  • the material promotes angiogenesis.
  • the tissue growth promoting matrix is made from biocompatible materials.
  • biocompatible materials refers to materials which do not have unacceptable adverse effects on the subj ect (e.g. human or other animal) to be treated.
  • the biocompatible materials do not have unacceptable adverse effects on the subj ect to be treated when left in contact with the subj ect for at least two weeks, more preferably for at least 4 weeks, and most preferably for at least 6 weeks.
  • the tissue growth promoting matrix comprises a biological material and/or a synthetic equivalent thereof.
  • the biological material and/or the synthetic equivalent thereof is fibrous.
  • the tissue growth promoting matrix comprises a microscopic scaffold
  • the microscopic scaffold comprises a biological material and/or a synthetic equivalent thereof.
  • the biological material may be xenogeneic, allogeneic (e.g. cadaveric), autogeneic, or a mixture thereof.
  • the tissue growth promoting matrix comprises a biological material
  • the biological material is processed and/or purified, preferably so that the biological material is non-cellular.
  • Suitable substances which can provide a scaffold for tissue growth include fibrin; collagens such as Type I, Type II, Type III, Type IV or Type V collagen; other extracted collagenous extracellular matrix (ECM) materials such as submucosa tissue (e.g. intestinal submucosa, urinary bladder submucosa or uterine submucosa), fascial tissue, renal capsule membrane tissue, dermal tissue (e.g. dermal collagen), dura mater, pericardium tissue, serosa, peritoneum, basement membrane layers and the like.
  • ECM extracellular matrix
  • fibrin refers to a polymer formed from fibrin monomers, which themselves have been formed by the treatment of fibrinogen with thrombin.
  • Suitable substances which can provide a scaffold for tissue growth include fibrous biological materials or synthetic equivalents thereof which have been cross-linked, for example using cross-linking agents such as dialdehydes, polyepoxides, dichloroalkanes and the like, to give material such as albumin crossed linked with glutaraldehyde.
  • Cross-linking may also be achieved by the reaction of chemical groups within the fibrous biological materials or synthetic equivalents thereof, such as by dehydration, the formation of disulphide bridges and the like.
  • the tissue growth promoting matrix is made from fibrin and/or collagen.
  • the tissue growth promoting matrix comprises a microscopic scaffold
  • the microscopic scaffold comprises fibrin and/or collagen.
  • the tissue growth promoting matrix is collagen.
  • the tissue growth promoting matrix comprises a biodegradable material.
  • the tissue growth promoting matrix comprises a macroscopic scaffold
  • the material from which the macroscopic scaffold is made is biodegradable, such as a biodegradable polymer.
  • the entire fistula plug body segment and/or the entire fistula plug flexible segment is made from biodegradable materials.
  • the entire fistula plug is made from biodegradable materials.
  • the tissue growth promoting matrix may comprise a non-biodegradable material such as a non-biodegradable polymer.
  • the tissue growth promoting matrix comprises a non-biodegradable material
  • the tissue growth promoting matrix comprises a macroscopic scaffold and the macroscopic scaffold comprises the non-biodegradable material.
  • a "biodegradable material” refers to a material that decomposes on contact with biological fluids or systems such as blood plasma, skin or sphincter muscle.
  • a “biodegradable polymer” refers to a polymer that undergoes hydrolysis on contact with biological fluids or systems such as blood plasma, skin or sphincter muscle.
  • a polymer that is "entirely biodegradable” refers to a polymer wherein at least one covalent bond in every link between constituent monomer units is able to undergo hydrolysis on contact with biological fluids or systems. It is preferred that after or during decomposition the material or polymer is absorbed into the body, i.e. the biodegradable material or polymer is also bioabsorbable.
  • non-biodegradable material or polymer refers to a material or polymer that does not substantially decompose or undergo hydrolysis on contact with biological fluids or systems.
  • a "biodegradable” material or polymer decomposes or undergoes hydrolysis on contact with an aqueous solution of pH between 5 and 9, preferably between 6 and 8, more preferably about 7.
  • a "biodegradable” material or polymer undergoes decomposition or hydrolysis on contact with biological fluids or systems at a rate such that it takes on average at least 10 days for the material or polymer to degrade into its constituent non-biodegradable sections and/or constituent monomer units.
  • a "biodegradable" material or polymer undergoes decomposition or hydrolysis on contact with biological fluids or systems at a rate such that it takes on average less than 400 days for the material or polymer to degrade into its constituent non-biodegradable sections and/or constituent monomer units. More preferably it takes on average less than 200 days for the material or polymer to degrade into its constituent non-biodegradable sections and/or constituent monomer units. Most preferably it takes on average less than 100 days for the material or polymer to degrade into its constituent nonbiodegradable sections and/or constituent monomer units.
  • Biodegradable polymers suitable for use in the present invention include but are not limited to polyesters such as poly-lactic acids, poly-lactides, polyglycolic acid, polyglycolides, polycaprolactones, polycaprolactone diols, and
  • polycaprolactone triols polyanhydrides such as poly(sebacic acids), poly(adipic acids), poly(fumaric anhydrides), poly(stilbene dicarboxylic acid anhydrides) and poly[i,6-bis(p-carboxy-phenoxy)hexane]; polyphosphoesters such as poly[i,4-bis(hydroxyethyl)-terephthalate-alt-ethyloxyphosphate];
  • polyphosphazenes such as poly(bis(i,4-dioxapentyl)phosphazenes), poly(bis(4- carboxyphenoxy)phosphazenes) and poly-[bis(i-(ethoxycarbonyl)-2- phenylethylamino)phosphazene]; polyethers such as polypropylene oxides and polyethylene glycols; other synthetic polymers such as polycarbonates, polycyanoacrylates, polydioxanones, poly(i,5-dioxepan-2-one), polyaminoacids, polyamides, polyhydroxybutyrates, polyhydroxyvalerates, polyesteramides, polyvinyl pyrrolidone, polyurethanes, polyalkylene succinates, poly(malic acid), polyalkylene oxalates, polyorthocarbonates, polyorthoesters, polyamines, polyhydroxycelluloses, polyvinyl alcohol, polyacetals, polyketals and
  • cyclodextrins such as albumin, chitin, chitosan, collagen, dextran, fibrin, fibrinogen, gelatine, polysaccharides, carrageenan, tragacanth, acacia, xanthan gum and poly(alginic acid).
  • natural polymers such as albumin, chitin, chitosan, collagen, dextran, fibrin, fibrinogen, gelatine, polysaccharides, carrageenan, tragacanth, acacia, xanthan gum and poly(alginic acid).
  • Biodegradable polymers can also include copolymers of any of the above, including alternating copolymers, periodic copolymers, random copolymers and block copolymers.
  • copolymers include poly(lactic acid-co- glycolic acids), poly(lactide-co-glycolides), poly(lactide-co-caprolactones), poly(lactide-co-caprolactone-co-glycolide), poly[(lactide-co-ethylene glycol)-co- ethyloxyphosphate], poly[(i,6-bis(p-carboxyphenoxy)hexane)-co-sebacic acid], poly(hydroxybutyric acid-co-hydroxyvaleric acid), poly[i,4- bis(hydroxyethyl)terephthalate-alt-ethyloxy-phosphate]-co-i,4- bis(hydroxyethyl)terephthalate-co-terephthalate, poly(ethylene glycol)- poly(caprolactone)
  • polycaprolactone-polytetrahydrofuran-polycaprolactone block copolymers polycaprolactone-polytetrahydrofuran-polycaprolactone block copolymers
  • polylactide-poly( ethylene glycol)-polylactide block copolymers polylactide-poly( ethylene glycol)-polylactide block copolymers
  • the tissue growth promoting matrix comprises a copolymer of glycolide and lactide, more preferably of glycolide and L-lactide.
  • a copolymer comprises about 8o-95mol% glycolide and about 5-2omol% L-lactide.
  • the copolymer comprises approximately 90mol% glycolide and approximately iomol% L-lactide.
  • a copolymer of approximately 90mol% glycolide and approximately iomol% L-lactide is available commercially under the name Ethicon VicrylTM.
  • Suitable non-biodegradable polymers for use in the present invention include celluloses such as cellulose ethers, ethyl celluloses, hydroxypropyl methyl celluloses, hydroxypropyl celluloses, hydroxyethyl celluloses,
  • non-biodegradable polymers include polyalkylenes, polyacrylates, polymethacrylates, polypyrrolidones, polyoxyethylenes, polyoxyethylene-polypropylene copolymers,
  • polymethylmethacrylatyes polybutylmethacrylates, polysiloxanes, shellac, acrylic and methacrylic acid based polymers, and copolymers thereof.
  • the tissue growth promoter may comprise one or more tissue growth promoting matrix precursors, i. e. substances which are able to react to form a tissue growth promoting matrix.
  • tissue growth promoter may be in the form of two or more agents which together are able to form a tissue growth promoting matrix, such as fibrinogen and thrombin.
  • the tissue growth promoter may also comprise a combination of one or more tissue growth promoting agents, one or more tissue growth promoting matrices, and/or agents which together are able to form tissue growth promoting matrices.
  • the tissue growth promoter may comprise a combination of a tissue growth promoting matrix and a tissue growth promoting agent; for example fibrin and a growth factor.
  • tissue growth promoting matrix may be coated or impregnated with one or more tissue growth promoting agents, and/or one or more tissue growth promoting matrix precursors, and/or one or more other pharmaceutical agents.
  • a tissue growth promoter is coated on the fistula plug, preferably such that the tissue growth promoter is released immediately on contact with the patient.
  • the tissue growth promoter is a tissue growth promoting agent and/or a tissue growth promoting matrix precursor.
  • a tissue growth promoter is impregnated or encapsulated within part or all of the fistula plug, preferably such that the tissue growth promoter is released in a delayed and/or sustained manner.
  • the tissue growth promoter may be impregnated or encapsulated within the fistula plug itself, or within a coating provided upon the fistula plug.
  • the tissue growth promoter is a tissue growth promoting agent and/or a tissue growth promoting matrix precursor.
  • the fistula stent is made from biocompatible materials.
  • the fistula stent is made from non-porous materials.
  • the fistula stent is made from one or more natural or synthetic polymers such as rubber, silicone, flexible plastics and the like.
  • the fistula stent is made from one or more non-biodegradable polymers such as any described above.
  • the fistula stent is made from one or more polyalkylenes such as polyethylene, polypropylene or polybutylene.
  • the fistula stent is made from polypropylene.
  • the fistula stent comprises a tissue growth promoting matrix, such as any discussed above in relation to the fistula plug.
  • the fistula stent may further comprise a tissue growth promoting agent and/or a tissue growth promoting matrix precursor.
  • the tissue growth promoting agent and/or the tissue growth promoting matrix precursor may be coated on the fistula stent.
  • the device of any of the first, second or third aspects of the present invention may further comprise one or more additional pharmaceutical agents.
  • the fistula plug or stent comprises the one or more additional pharmaceutical agents.
  • pharmaceutical agents are preferably selected from anti-inflammatories, antibacterial agents, immunomodulators or combinations thereof. Examples of suitable agents are listed on pages 13 to 19 of patent application WO
  • the device further comprises a probe, optionally wherein the probe and the seton are connectable together end-to-end.
  • the probe and the seton each have a longitudinal axis, and when the probe and the seton are connected together end-to-end, the longitudinal axes extending through the end of the probe and the seton are approximately coaxial.
  • the probe is connected or connectable to the seton, and said seton comprises a first end and a second end as described above, it is preferred that the probe is connected or connectable to the first end of the seton.
  • the probe is connected or connectable to the first end of the seton, and the fistula plug or stent or the threadable member is connected or connectable to the second end of the seton.
  • the probe and the seton have cooperating means to connect the prob to the seton end-to-end, optionally wherein the cooperating means allow the probe and the seton to be repeatedly connected and disconnected, preferably by hand.
  • the probe may comprise a screw extending from an end and the seton may comprise a hollow end for receiving the screw of the probe so that the seton can be connected to the probe.
  • the hollow end of the seton may be threaded.
  • the body of the probe is preferably made from a malleable material with sufficient rigidity to act as a guide when passed through the fistula.
  • a malleable material with sufficient rigidity to act as a guide when passed through the fistula.
  • suitably malleable metals or plastics may be used.
  • the probe is formed from a malleable metal such as stainless steel.
  • said stainless steel is surgical grade and/or SAE grade 316.
  • the probe is typically elongate in shape, with a rounded blunt end distal from the end connectable to the seton.
  • the probe is between 3 and 30cm in length. More preferably the probe is between 4 and 20cm in length.
  • the probe is between 5 and 15cm in length. Most preferably, the probe is about 12cm in length.
  • the body of the probe is between 0.1 and 5mm in diameter.
  • the body of the probe is between 0.2 and 4mm in diameter. More preferably still the body of the probe is between 0.5 and 2mm in diameter. Most preferably, the body of the probe is about 1.6mm in diameter
  • the rounded blunt end may have a diameter greater than the body of the probe.
  • the rounded blunt end has a diameter from 1.2 to 2.5 times the diameter of the body of the probe. More preferably, the rounded blunt end has a diameter from 1.5 to 2 times the diameter of the body of the probe. Most preferably, the rounded blunt end has a diameter of approximately 1.7 times the diameter of the body of the probe.
  • a fistula plug suitable for treating a fistula, wherein the fistula plug comprises
  • cooperating means adapted to connect the fistula plug to a seton end-to-end.
  • said fistula plug, seton and cooperating means are as described in relation to any embodiment of the first aspect of the present invention.
  • the fistula plug of the fourth aspect of the present invention may further comprise a threadable member and/or cooperating means adapted to connect the fistula plug to a threadable member.
  • the threadable member and the fistula plug are as described in relation to any embodiment of the third aspect of the present invention.
  • the fistula plug and the threadable member are typically connected or connectable together end-to-end.
  • a first end of the fistula plug is connectable to the seton, and a second end of the fistula plug is connected or connectable to the threadable member.
  • the first end of the fistula plug comprises the cooperating means adapted to connect the fistula plug to the seton, and the second end of the fistula plug is connected to the threadable member.
  • the fistula plug of fourth aspect of the present invention further comprises a body segment and/or a flexible segment, as described above in relation to the first and third aspects of the present invention.
  • the fistula plug of the fourth aspect of the present invention comprises a macroscopic scaffold formed about a hollow central core. More preferably, the fistula plug comprises a plurality of
  • the fistula plug of fourth aspect of the present invention may further comprise a tissue growth promoter as described above.
  • the fistula plug comprises a tissue growth promoting matrix such as a copolymer of glycolide and lactide, or such as fibrin and/or collagen.
  • a fistula stent configured to provide an access channel within a fistula, such that the access channel is in fluid communication with the internal surface of the fistula;
  • fistula stent is adapted to be secured within the fistula by a seton, such that the access channel may be accessed when the fistula stent is secured by the seton.
  • the fistula stent and the seton are as described in relation to any embodiment of the second aspect of the present invention.
  • the seton and the fistula stent are connectable together.
  • the seton and the fistula stent are connectable together end-to-end.
  • the fistula stent of the fifth aspect of the present invention may be defined such that it comprises a first end and a second end, with a longitudinal axis extending from the first end to the second end.
  • the first end of the fistula stent is connectable to the seton and the access channel may be accessed when the first end is connected to the seton.
  • the second end of the fistula stent is also connectable to the seton and the access channel may be accessed when both the first and the second ends are connected to the seton.
  • the access channel is provided by a hollow conduit within the fistula stent and the fistula stent is configured to enable fluid communication between the hollow conduit and the internal surface of the fistula.
  • the fistula stent further comprises an irrigation port through which the access channel may be accessed when the fistula stent is secured by the seton.
  • the first end of the fistula stent is connectable to the seton
  • the second end of the fistula stent is also connectable to the seton
  • the irrigation port is located at or proximal to the second end of the fistula stent.
  • the fistula stent of the fifth aspect of the present invention may further comprise a threadable member and/or cooperating means adapted to connect the fistula stent to a threadable member.
  • the threadable member and the fistula stent are as described in relation to any embodiment of the third aspect of the present invention.
  • the fistula stent and the threadable member are typically connected or connectable together end-to-end.
  • the fistula stent comprises an irrigation port
  • the first end of the fistula stent is connectable to the seton
  • the second end of the fistula stent is connected or connectable to the threadable member
  • the irrigation port is located at or proximal to the second end of the fistula stent.
  • a seton suitable for treating a fistula wherein the seton comprises cooperating means adapted to connect the seton to a fistula plug end-to-end.
  • the seton, fistula plug and cooperating means are as described in relation to any
  • the sixth aspect of the present invention may provide a seton suitable for treating a fistula, wherein the seton comprises cooperating means adapted to connect the seton to a fistula stent end-to-end.
  • the seton, fistula stent and cooperating means are as described in relation to any
  • a seton suitable for treating a fistula wherein the seton comprises one or more holes through which a threadable member may be thread so as to secure said threadable member to the seton.
  • the seton and threadable member are as described in relation to any embodiment of the third aspect of the present invention.
  • the seton is also a seton according to the sixth aspect of the present invention, i.e. the seton further comprises cooperating means adapted to connect the seton to a fistula plug or stent end-to-end.
  • the seton of the sixth or seventh aspect of the present invention may comprise a first end and a second end.
  • a seton suitable for treating a fistula wherein the seton comprises a first end and a second end, wherein the seton comprises a plurality of holes through which a threadable member may be thread so as to secure said threadable member to the seton, wherein at least one of said holes is located within 5cm of the first end of the seton, and wherein the second end comprises cooperating means adapted to connect the seton to a fistula plug or stent end-to-end.
  • the seton of the sixth or the seventh aspect of the present invention may further comprise cooperating means adapted to connect the seton to a probe end-to-end.
  • the seton comprises a first end and a second end
  • the first end comprises the cooperating means adapted to connect the seton to the probe.
  • said cooperating means allow the probe and the seton to be repeatedly connected and disconnected, preferably by hand.
  • the probe may comprise a screw extending from an end and the seton may comprise a hollow end for receiving the screw of the probe so that the seton can be connected to the probe.
  • the hollow end of the seton may be threaded.
  • the seton and/or the device as a whole is made from biocompatible materials.
  • the seton may be formed from flexible materials such as rubber, silicone, silk, flexible plastics such as polypropylene and the like.
  • the seton is made from flexible plastic.
  • the seton may be formed from one or more biodegradable materials such as biodegradable polymers.
  • any parts of the seton, the fistula plug, the fistula stent, and/or the threadable member to be positioned within the fistula do not contain exposed metal.
  • any parts of the seton, the fistula plug and the fistula stent to be positioned within the fistula do not contain metal.
  • the seton, the fistula plug and the fistula stent do not contain metal.
  • the seton is typically elongate in shape. Typically, in any embodiment of any aspect of the present invention, the seton is between 3 and 50cm in length. More preferably the seton is between 4 and 20cm in length. More preferably still, the seton is between 5 and 10cm in length. Most preferably, the seton is about 8.5cm in length.
  • the seton is approximately rectangular in cross-section. In another embodiment, the seton is approximately circular in cross-section.
  • the cross-section of the seton has a maximum width or diameter of between 1 and 6mm. More preferably, said cross-section has a maximum width or diameter of between 3 and 4mm.
  • the cross-section of the seton (ignoring any holes therein) has a minimum width or diameter of between 0.5 and 4mm. More preferably, said cross-section has a minimum width or diameter of between 1 and 3mm.
  • a typical rectangular cross-section may have dimensions of about 2 x 3.25mm.
  • fistula plug, fistula stent or seton is for use in the treatment of a fistula such as an anal fistula or a recto-vaginal fistula.
  • the treatment comprises inserting the device, the seton, the fistula plug and/or the fistula stent into the fistula.
  • the treatment comprises forming the device into a loop wherein the loop passes through the fistula and j oins up outside of the fistula. Most preferably said loop acts to secure a fistula plug or a fistula stent in the fistula.
  • the treatment comprises securing the fistula plug in the fistula using a seton, wherein the seton and the fistula plug together form part or all of a loop which passes through the fistula and j oins up outside of the fistula.
  • the treatment comprises securing the fistula stent in the fistula using a seton, wherein the seton and the fistula stent together form part or all of a loop which passes through the fistula and j oins up outside of the fistula.
  • the treatment comprises forming the seton together with a fistula plug or stent, and/or a threadable member into a loop, wherein the loop passes through the fistula and j oins up outside of the fistula. Most preferably said loop acts to secure a fistula plug or stent in the fistula.
  • the eighth aspect of the present invention provides a fistula plug or stent, or a device comprising a fistula plug or stent
  • the treatment comprises the dilation of the fistula by the fistula plug or stent.
  • the eighth aspect of the present invention provides a fistula stent or a device comprising a fistula stent, preferably the fistula is drained or irrigated through the access channel.
  • a fluid is used to irrigate the fistula, preferably a liquid, more preferably an aqueous liquid.
  • the fluid is sterile.
  • water, a saline solution or a liquid antiseptic is used to irrigate the fistula.
  • a tube may be inserted into the access channel and the fluid may be injected through the tube.
  • Liquid antiseptics suitable for the irrigation of fistulas include alcohols such as solutions comprising ethyl alcohol or isopropyl alcohol; benzalkonium chloride solutions such as ZephiranTM or BenzaTM; chlorhexidine gluconate solutions such as HibiclensTM, HibistatTM or ChloraPrepTM; hexachlorophene solutions such as pHisoHexTM or SeptisolTM; hydrogen peroxide solutions; povidone-iodine solutions such as BetadineTM or OperandTM; iodine povacrylex isopropyl alcohol solutions such as DuraPrepTM; and parachlorometaxylenol solutions such as SurcideTM.
  • Preferred liquid antiseptics suitable for the irrigation of fistulas are solutions of povidone-iodine or chlorhexidine gluconate.
  • a method of treating a fistula comprising the use of a device, fistula plug, fistula stent or seton according to any of the first to seventh aspects of the present invention.
  • the fistula is an anal fistula or a recto-vaginal fistula.
  • said method comprises inserting the device, the seton, the fistula plug and/or the fistula stent into the fistula.
  • the method of the ninth aspect of the present invention uses the device of the first, second or third aspect of the present invention
  • the method comprises forming the device into a loop wherein the loop passes through the fistula and j oins up outside of the fistula.
  • said loop acts to secure a fistula plug or a fistula stent in the fistula.
  • the method of the ninth aspect of the present invention uses the fistula plug of the fourth aspect of the present invention
  • the method comprises securing the fistula plug in the fistula using a seton, wherein the seton and the fistula plug together form part or all of a loop which passes through the fistula and j oins up outside of the fistula.
  • the method of the ninth aspect of the present invention uses the fistula stent of the fifth aspect of the present invention, preferably the method comprises securing the fistula stent in the fistula using a seton, wherein the seton and the fistula stent together form part or all of a loop which passes through the fistula and j oins up outside of the fistula.
  • the method of the ninth aspect of the present invention uses the seton of the sixth or the seventh aspect of the present invention
  • the method comprises forming the seton together with a fistula plug or stent, and/or a threadable member into a loop, wherein the loop passes through the fistula and j oins up outside of the fistula. Most preferably said loop acts to secure a fistula plug or stent in the fistula.
  • the method of the ninth aspect of the present invention uses a fistula plug or stent, or a device comprising a fistula plug or stent
  • the method comprises the dilation of the fistula by the fistula plug or stent.
  • the fistula is drained or irrigated through the access channel.
  • a fluid is used to irrigate the fistula, preferably a liquid, more preferably an aqueous liquid.
  • the fluid is sterile.
  • water, a saline solution or a liquid antiseptic is used to irrigate the fistula.
  • a tube may be inserted into the access channel and the fluid may be injected through the tube.
  • a fistula stent for use in the treatment of a fistula
  • fistula stent is configured to provide an access channel within the fistula, such that the access channel is in fluid communication with the internal surface of the fistula;
  • the fistula is drained or irrigated through the access channel.
  • the fistula stent is for use in the treatment of an anal fistula or a recto-vaginal fistula.
  • a method of treating a fistula comprising the irrigation or drainage of the fistula using a fistula stent, wherein the fistula stent is configured to provide an access channel within the fistula, such that the access channel is in fluid communication with the internal surface of the fistula.
  • the fistula is drained or irrigated through the access channel.
  • the method is a method of treating an anal fistula or a recto-vaginal fistula.
  • a fluid is used to irrigate the fistula, preferably a liquid, more preferably an aqueous liquid.
  • the fluid is sterile.
  • water, a saline solution or a liquid antiseptic is used to irrigate the fistula.
  • the treatment comprises the use of a fistula stent to provide an access channel within the fistula, such that the access channel is in fluid
  • the fluid is used to irrigate the fistula through the access channel.
  • the fluid is for use in the treatment of an anal fistula or a rectovaginal fistula.
  • the fluid is a liquid, more preferably an aqueous liquid.
  • the fluid is sterile.
  • the fluid is water, a saline solution or a liquid antiseptic.
  • the treatment comprises inserting the fistula stent into the fistula.
  • the treatment comprises the dilation of the fistula by the fistula stent.
  • a tube maybe inserted into the access channel and the fluid maybe injected through the tube.
  • the treatment comprises securing the fistula stent within the fistula using a seton.
  • the seton and the fistula stent together form part or all of a loop which passes through the fistula and joins up outside of the fistula.
  • the fistula stent is secured such that the access channel may be accessed when the fistula stent is secured by the seton.
  • the seton may be as described in relation to any of the previous aspects of the present invention.
  • the fistula stent is elongate in shape.
  • the fistula stent is approximately circular in cross section.
  • the fistula stent may be approximately cylindrical or conical in shape.
  • the dimensions of the fistula stent may be as described in relation to the second aspect of the present invention.
  • the fistula stent is flexible or semi-rigid.
  • the fistula stent is semi-rigid.
  • the fistula stent of any of the tenth, eleventh or twelfth aspects of the present invention may be defined such that it comprises a first end and a second end, with a longitudinal axis extending from the first end to the second end.
  • the fistula stent is configured to provide a single access channel.
  • the fistula stent may be configured to provide two or more access channels.
  • the access channel is provided by a hollow conduit within the fistula stent.
  • the hollow conduit runs substantially parallel to the longitudinal axis of the fistula stent or is approximately coaxial with the longitudinal axis of the fistula stent.
  • the hollow conduit is coaxial with the longitudinal axis of the fistula stent.
  • the hollow conduit is approximately circular in cross section and/or has dimensions as described in relation to the second aspect of the present invention.
  • the access channel is provided by a recess in the side of the fistula stent.
  • a conduit is formed wherein the walls of the conduit are defined by the walls of the recess and the internal surface of the fistula. Direct fluid communication with the internal surface of the fistula is thereby provided.
  • the recess runs substantially parallel to the longitudinal axis of the fistula stent.
  • the access channel typically has a length of at least 50% of the length of the fistula stent. More preferably, the access channel has a length of at least 75% of the length of the fistula stent. Most preferably, the access channel has a length of at least 90% of the length of the fistula stent.
  • the access channel is provided by a hollow conduit within the fistula stent, it is envisaged that the fistula stent is configured to enable fluid
  • the fistula stent is configured such that fluid may enter or exit the hollow conduit via a plurality of openings extending from the hollow conduit to the outer surface of the stent.
  • the fistula stent may contain at least 3, at least 5, or at least 10 of such openings.
  • the openings are as described in relation to any embodiment of the second aspect of the present invention.
  • the fistula stent further comprises an irrigation port through which the access channel may be accessed when the fistula stent is placed within the fistula.
  • the features of the irrigation port are as described in relation to any embodiment of the second aspect of the present invention.
  • the fistula stent is a fistula stent according to the fifth aspect of the present invention.
  • the fistula stent is part of a device according to the second or third aspect of the present invention.
  • a "fistula” refers to any abnormal passage or communication through the body between two epithelial surfaces, including those occurring naturally, e.g. as a result of infection, those occurring as a result of injury, e.g. as a result of impalement, and those man-made, for example as a result of surgery or body piercing.
  • the fistula to be treated is selected from:
  • a body piercing or skin-to-skin fistula (i) a body piercing or skin-to-skin fistula; (ii) an anal or anorectal fistula, which may be classified anatomically as intersphincteric, transphincteric, suprasphincteric or extrasphincteric;
  • a recto-vaginal fistula such as an anovulval, anovaginal, rectovulval,
  • recto-vaginal fistula may be classified anatomically as infrasphincteric, transphincteric, or suprasphincteric;
  • a gastrointestinal fistula such as a tracheo-oesophageal, gastro-cutaneous, ileo-cutaneous, colo-cutaneous, recto-cutaneous, colo-vaginal or gastrointestinal-vascular fistula;
  • a urinary fistula such as a urethrocutaneous, urethrovaginal
  • a fistula comprising a combination of any of the aforementioned fistulas, such as a recto-vesico-vaginal fistula.
  • fistulas are complete (i.e. both ends open on a mucosal or exterior surface of the body).
  • Complete fistulas may be external (i.e. between a hollow organ and an external surface of the body) or bimucosal (i.e. both ends open on a mucosal surface of the body).
  • said fistulas are simple (i.e. contain no blind tracts and contain only one opening at each end of the tract).
  • said fistulas include blind tracts and/or are complex (i.e. include more than two openings due to division of the tract).
  • An example of a complex fistula is a horseshoe fistula (where two ends of the fistula tract open on an exterior surface of the body and a third end opens into a hollow organ such as the anal canal).
  • the fistula to be treated is selected from an anal fistula or a recto-vaginal fistula. Most preferably the fistula is an anal fistula.
  • the patient to be treated in any of the preceding aspects of the present invention is a human.
  • the patient to be treated is in need of such treatment.
  • the patient may also be suffering from an inflammatory bowel disease such as Crohn's disease.
  • an inflammatory bowel disease such as Crohn's disease.
  • any embodiment of a given aspect of the present invention may occur in combination with any other embodiment of the same aspect of the present invention.
  • any preferred or optional embodiment of any aspect of the present invention should also be considered as a preferred or optional embodiment of any other aspect of the present invention.
  • Figure 1 shows a planar view of a device comprising a probe, a seton, a fistula plug and a threadable member according to the present invention.
  • Figure 2 shows an exploded view of the device of Figure 1 comprising a probe, a seton and a fistula plug with threadable member.
  • Figure 3 shows an enlarged perspective view of the connection between the fistula plug and the seton as illustrated in Figures 1 and 2.
  • Figure 4 shows an exploded view of the connection of Figure 3.
  • Figure 5 shows a perspective view of an alternate means of connection between a fistula plug and a seton.
  • Figure 6 shows a perspective view of a further means of connection between a fistula plug and a seton.
  • Figure 7 shows a perspective view of another means of connection between a fistula plug and a seton.
  • Figure 8 shows an exploded view of the connection of Figure 7.
  • Figure 9 shows an enlarged exploded view of the connection between the probe and the seton as illustrated in Figures 1 and 2.
  • Figure 10 shows a perspective view of the device of Figure 1 when formed into a loop with the probe removed.
  • Figure n shows a schematic illustration of a device of the present invention being inserted into a fistula.
  • Figure 12 shows a schematic illustration of a device of the present invention when positioned within an anal fistula.
  • Figure 13 shows a perspective view of a device according to the present invention comprising a fistula plug and a threadable member.
  • Figure 14 shows an exploded view of a device comprising a probe, a seton, a fistula stent and a threadable member according to the present invention.
  • Figure 15 shows a cutaway view of a device comprising a seton, a fistula stent, and a threadable member according to the present invention.
  • the devices of the present invention are particularly useful for the treatment of fistulas such as anal or recto-vaginal fistulas.
  • fistulas such as anal or recto-vaginal fistulas.
  • the drainage seton may optionally incorporate antibiotics and/or anti-inflammatories in order to help reduce the extent of infection.
  • the drainage seton or the fistula stent may be removed prior to the insertion of a device comprising a fistula plug according to the present invention.
  • the fistula tract may be cleaned, for example using a j et of water and/ or a suitable brush.
  • embodiment of the present invention comprising a probe 105, a seton 104, a fistula plug 103 and a threadable member 102.
  • the probe 105 comprises an elongate body having a blunt end 108 and an opposite end 109 to which the seton 104 is attached.
  • the probe 105 is inserted into the fistula with the blunt end first such that the surgeon can use the probe to discover the track of the fistula.
  • the end 108 is blunt rather than sharp so as to reduce damage to surrounding tissue and to minimise the possibility of the probe going off track creating false passages.
  • the widest point of the blunt end 108 is larger in diameter than the remainder of the probe 105; this feature enables the blunt end 108 to open up the fistula during insertion, allowing the rest of the device to be pulled through more easily.
  • the probe 105 is made out of a malleable plastic or metal, such as surgical SAE grade 316 stainless steel, which is easily bent so that it can be formed into a desired shape by the surgeon. This enables the surgeon to tailor the shape of the probe 105 to the track of the fistula so that the probe 105 can more easily be fed through the fistula with minimal damage to surrounding tissue.
  • the probe 105 may vary in size depending on the type of fistula that is to be treated. Typically however, the probe 105 shown in Figure 1 may be about 12cm long and about 1.6mm in diameter along its length, with the blunt end 108 extending to about 2.7mm in diameter.
  • the seton 104 is in the form of a flexible strap and is made out of a tough flexible rubber or plastic such as polypropylene, in particular when treating fistulas wherein the seton has to be left in position for a longer period of time.
  • the seton 104 may be formed out of a biodegradable material such as polyglycolic acid such that the seton 104 biodegrades in situ with time, thereby obviating the need to remove the seton 104 from the treatment site.
  • the seton 104 shown in Figure 1 is about 8.5cm in length.
  • the seton 104 comprises a first end 110 and a second end 111. The first end 110 of the seton 104 is connected to the probe 105 end-to-end.
  • the seton 104 comprises a plurality of holes 112 through which the threadable member 102 may be thread.
  • the number of holes 112 may vary, but in Figure 1 the seton comprises 18 holes.
  • the holes 112 are evenly spaced along a segment of the seton 104 and said segment of the seton comprises about 50% of the length of the seton.
  • the first of said holes is located within 2cm of the first end 110 of the seton 104.
  • the holes 112 are circular in cross-section and uniform in size, with a typical diameter of about 2mm.
  • the holes 112 pass through the seton 104 in parallel in a direction approximately perpendicular to the longitudinal axis of the seton 104.
  • the body of the seton 104, including the segment comprising the holes 112, is rectangular in cross section, typically being about 3mm wide and 2mm high.
  • the fistula plug 103 comprises a body segment 113 which is elongate in shape.
  • the fistula plug 103 and the body segment 113 may vary in size depending on the fistula to be treated.
  • the body segment 113 is approximately circular in cross section.
  • the body segment 113 may have an outer diameter of about 5mm and a length of about 3.5cm.
  • the fistula plug 103 further comprises a flexible segment 114.
  • the size of the flexible segment 114 may vary in size depending on the fistula to be treated and the degree of flexibility required.
  • the body segment 113 and the flexible segment 114 are integrally formed and from the same material, typically a tissue growth promoting matrix such as collagen.
  • the fistula plug 103 is configured such that the flexible segment 114 is located in-between the body segment 113 and the end portion of the fistula plug that is connected to the seton 104.
  • the flexible segment 114 and the body segment 113 each have an outer diameter, and the outer diameter of the flexible segment is about 60% of the outer diameter of the body segment.
  • the outer diameter of the body segment 113 is about 5mm
  • the outer diameter of the flexible segment 114 is about 3mm.
  • the flexible segment 114 has a length of about 9mm.
  • the flexible segment provides the device with additional flexibility, particularly around the entrance or exit of the fistula, when in use.
  • the fistula plug body segment 113 adj oins a portion of the fistula plug with a smaller cross-sectional area, such as the flexible segment 114
  • the j oin is tapered. Tapered j oins, such as tapered j oin 115, may act to ease the insertion of the fistula plug body segment into the fistula.
  • the fistula plug 103 is connected to the second end 111 of the seton 104.
  • the seton 104 and the fistula plug 103 are connected together end-to-end.
  • the longitudinal axis of the seton 104 is aligned with the longitudinal axis of the fistula plug 103 and the overall diameter of the device in the region of the connection does not exceed the outer diameter of the fistula plug.
  • the overall diameter of the device in the region of the connection may be about 4mm.
  • the threadable member 102 is elongate in shape, free from protrusions, free from recesses and approximately circular in cross section with a rounded blunt end 106.
  • the threadable member 102 is about 6cm in length and has a diameter of about 1.25mm.
  • the fistula plug 103 and the threadable member 102 are connected together end-to-end.
  • the j oin 107 is tapered. Tapered areas, such as tapered area 107, may act to ease the insertion and, if necessary, removal of the fistula plug body segment.
  • the tapered j oin 107 avoids any unnecessary chaffing from the device when in situ.
  • FIG 2 there is shown an exploded view of the device of Figure 1 comprising a fistula plug 207 with a threadable member 209, a seton 204 and a probe 201.
  • Figure 2 is an exploded view of the same embodiment described in Figure 1 a general description of the device will be omitted.
  • an end 202 of the probe 201 is shown.
  • the end 202 is formed with a threaded screw 203.
  • the seton 204 is formed with corresponding screw attachment means in that it has a first hollow end 205 (not visible).
  • the means of connection between the seton 204 and the probe 201 allow the probe and the seton to be repeatedly connected and disconnected by hand, simply by screwing in and unscrewing the probe.
  • a second hollow end 206 of the seton 204 may be seen.
  • the fistula plug 207 further comprises an end portion 208.
  • the fistula plug 303 is shown connected to the seton 301.
  • the seton 301 comprises a hollow end 302.
  • the hollow end 302 and the seton 301 are integrally formed.
  • the fistula plug 303 comprises a fistula plug body segment 304, a fistula plug flexible segment 305 and an end portion 306 as described before.
  • the end portion 306 extends from the end of the fistula plug 303 and its longitudinal axis is aligned with the longitudinal axis of the remainder of the fistula plug 303.
  • the end portion 306 and the fistula plug 303 are integrally formed and connected via a neck portion 307 of smaller diameter than the end portion 306.
  • the hollow end 302 is suitable for receiving the fistula plug end portion 306 and is accessed via an aperture extending from the end face of the seton to a side wall thereof.
  • the end portion 306 may enter and be removed from the hollow end via the aperture in the side wall.
  • the neck portion 307 may pass through the aperture in the side wall and the aperture in the end face.
  • the means of connection shown in Figure 3 allow the seton 301 and the fistula plug 303 to be releasably connected.
  • the cooperating means are such that the fistula plug 303 may be disconnected from the seton 301 when the seton and the fistula plug are pulled apart in a direction approximately perpendicular to their longitudinal axes, through the aperture in the side wall.
  • the end portion 306 is unable to pass through the aperture in the end face of the seton.
  • the fistula plug 303 is resistant to disconnection from the seton 301 when the seton 301 and the fistula plug 303 are pulled apart along their longitudinal axes, so as to avoid the seton 301 detaching from the fistula plug 303 as they are being fitted.
  • Figure 4 an exploded view of the connection of Figure 3 is shown, illustrating the fistula plug 405 and the seton 401 when disconnected.
  • Figure 4 is an exploded view of the same device described in Figures 1 to 3, a general description of the device will be omitted.
  • Figure 4 shows the hollow end 402 of the seton 401.
  • the hollow end 402 is suitable for receiving the fistula plug end portion 404 and is accessed via the aperture 403 extending from the end face 407 of the seton to a side wall 408 thereof.
  • the end portion 404 of the fistula plug 405 may enter and be removed from the hollow end 402 via the aperture 403 where it extends through the side wall 408. Where the aperture 403 extends through the end face 407, however, the aperture is too narrow to allow the end portion 404 to pass through.
  • the neck portion 406 of the fistula plug 405 may pass through the aperture 403, both where the aperture extends through the side wall 408 and where the aperture extends through the end face 407.
  • the end portion 404 is approximately ball shaped.
  • a ball and socket j oint is created, allowing the fistula plug 405 and the seton 401 to swivel at the point of connection. This provides the device with additional flexibility which allows the device to be more easily fitted into a fistula by the surgeon.
  • an end portion 502 of a seton 501 is shown.
  • the end portion 502 extends from the end of the seton 501, and its longitudinal axis is aligned with the longitudinal axis of the seton.
  • the cross-sectional area of the end portion 502 is smaller than that of the seton 501.
  • the end portion 502 and the seton 501 are integrally formed.
  • a fistula plug 505 is also shown.
  • a portion 504 of the fistula plug 505 is moulded around the end portion 502 of the seton to secure the fistula plug 505 and the end portion 502 together.
  • the end portion 502 comprises a plurality of holes 503 such that when the moulded portion 504 of the fistula plug 505 is moulded around the end portion 502, the moulding enters into and passes through the holes 503 to strengthen the resultant moulded j oint.
  • an end portion 602 of a seton 601 is shown, the end portion 602 and the seton 601 being integrally formed.
  • An end portion 603 of a fistula plug 604 is also shown, the end portion 603 and the fistula plug 604 also being integrally formed.
  • the two end portions 602 and 603 are connected together with a crimp connection.
  • the crimp connection comprises a compressible element 605 in the form of a band surrounding both the end portions 602 and 603. The band is compressed, i.e. crimped, to connect the seton and the fistula plug end portions 602 and 603 together.
  • FIG. 7 a seton 701 is shown and a deformable hollow end portion 703 of a fistula plug 702 is also shown.
  • the seton 701 is formed with a protrusion (not visible) and the protrusion is located in the deformable hollow end portion 703 of the fistula plug 702.
  • the protrusion and the deformable hollow end portion 703 of the fistula plug are connected together with a crimp connection.
  • the crimp connection comprises a compressible element 704 in the form of a band surrounding both the seton protrusion and the deformable hollow end portion 703.
  • the band is compressed, i.e. crimped, to connect the seton protrusion and the deformable hollow end portion 703 of the fistula plug together.
  • FIG 8 an exploded view of the connection of Figure 7 is shown. It can be seen that the seton 801 is formed with a protrusion 804.
  • the fistula plug 802 is formed with a deformable hollow end portion 803.
  • the protrusion 804 locates inside the deformable hollow end portion 803 and the two can be connected together with a crimp connection.
  • the crimp connection comprises a
  • the compressible element 805 in the form of a band which can surround both the seton protrusion 804 and the deformable hollow end portion 803.
  • the band is compressed, i.e. crimped, to connect the seton protrusion 804 and the deformable hollow end portion 803 of the fistula plug together.
  • the protrusion 804 comprises a neck portion 806 and a flange 807.
  • the deformable hollow end portion 803 is crimped about the neck portion 806 of the protrusion 804. Accordingly, the flange 807 prevents the withdrawal of the protrusion from the hollow end once crimped.
  • An enlarged exploded view of the connection of Figures 1 and 2 between the probe and the seton is shown in Figure 9.
  • an end 903 of a probe 904 is shown.
  • the end 903 is formed with a threaded screw.
  • the screw 903 extends from the end of the probe 904 and its longitudinal axis is aligned with the longitudinal axis of the probe 904.
  • the probe 904 and the screw 903 are integrally formed.
  • the seton 901 is formed with corresponding screw attachment means in that it has a hollow end 902.
  • An advantage of the probe and the seton being releasably connectable, such as by means of the screw attachment described above, is that in use the surgeon can rapidly interchange probes. Furthermore, the probe may be readily reused, thus saving on the equipment required and hence the cost of the procedure.
  • the device shown in Figure 10 is configured such that a first end of the fistula plug 1002 is connected to the seton 1004, and a second end of the fistula plug is connected to the threadable member 1001.
  • the threadable member 1001 is thread through holes 1005 in the seton such that the device is formed into a loop.
  • the threadable member 1001 is sufficiently flexible to allow the threadable member to be thread through two or more adjacent holes 1005, thereby securing the threadable member to the seton.
  • the threadable member 1001 is free from protrusions and free from recesses. Advantageously, this allows the threadable member 1001 to pass through the holes 1005 unhindered and without significant force required by the surgeon. It also means that the threadable member 1001 can be pulled through the holes by the surgeon to adjust the loop to the exact size required.
  • FIG 11 a schematic diagram of the device 1101 of Figure 1 being inserted into an anal fistula 1102 is shown.
  • the device is fed probe 1104 first into the anal fistula 1102 via the exterior opening 1105.
  • the probe 1104 and the seton 1106 are passed through the anal fistula into the anal canal 1103 such that the probe 1104 and the first end of the seton 1106 exit the patient via the anus 1107.
  • the device is fed through the fistula until the fistula plug 1108 resides in the desired position within the anal fistula 1102.
  • the threadable member 1109 does not fully enter the fistula, but remains accessible outside the body.
  • the threadable member 1109 may be passed through one or more holes in the seton as previously described so as to form a loop, thus securing the fistula plug 1108 in position.
  • the threadable member may be tied once it has passed through one or more of said holes so as to further secure the loop.
  • the redundant first end of the seton comprising the probe 1104 may be cut away, along with any redundant part of the threadable member 1109. Since the parts to be cut away lie outside of the body, access is good ensuring that the procedure is rapid and facile.
  • Figure 1207 a schematic diagram of the device of Figure 1 positioned within an anal fistula is shown, with the end of the seton comprising the probe having been cut-off.
  • the device 1207 therefore corresponds to that shown in Figure 10, having been inserted as described above in relation to Figure 11.
  • the threadable member 1202 has been thread through holes in the seton 1206 so that the device is formed into a loop.
  • the fastening between the threadable member 1202 and the seton 1206 is located outside the body. This may be preferred, for example, to allow for ease of adjustment of the loop of the device after the initial insertion.
  • the fastening between the threadable member 1202 and the seton 1206 is able to align with the surface of the patient's body so as to minimise discomfort.
  • the fistula plug 1203 comprises a body segment 1201 and a flexible segment 1205.
  • the flexible segment advantageously provides a link between the body segment 1201 and the seton 1206 which allows the seton 1206 to align closely with the wall of the anal canal 1204.
  • the flexible segment can adapt to the differing contours of the fistula in an individual patient to ensure that the seton 1206 is aligned with the wall of the anal canal. This alignment ensures that there is minimal discomfort to the patient and that no or minimal loss of continence occurs while the seton is in place.
  • the close fit also prevents the device from being displaced after insertion.
  • the body tissue surrounding the fistula plug 1203 will grow into the tissue growth promoting matrix at such a rate that after a period of about 4 to 6 weeks the loop of the device may be cut at the entry and exit points of the fistula. The parts of the device external to the fistula may then be removed, with body tissue continuing to grow into the tissue growth promoting matrix causing the fistula to heal.
  • the fistula plug and/or the threadable member may slowly disintegrate or biodegrade proximal to the entry and exit of the fistula, such that after a period of about 4 to 6 weeks the parts of the device external to the fistula, such as the seton 1206, fall away.
  • the fistula may thereby heal without any further medical intervention being required.
  • FIG 13 there is shown a perspective view of a device comprising a fistula plug and a threadable member according to the present invention.
  • a fistula plug 1301 is shown which comprises a macroscopic scaffold comprising a plurality of strands 1302.
  • the strands 1302 are interwoven and cylindrically formed about a hollow central core (not visible).
  • the strands are formed from a biodegradable polymer such as a copolymer of glycolide and lactide.
  • An advantage of the use of interwoven strands formed about a hollow central core is that the holes in the resultant mesh and the hollow - 6 ⁇ - central core allow air to circulate within the fistula, thereby aiding the healing process as the surrounding tissue grows onto and into the interwoven strands.
  • the strands have been spun together at one end of the fistula plug to form an integral threadable member 1303.
  • the fistula plug 1301 is attached to a seton (not shown) by the connection means described in Figures 7 and 8.
  • the interwoven strands are flexible and so the end 1305 of the fistula plug distal to the threadable member forms a deformable hollow end portion which may be crimped over a protrusion of a seton as previously described.
  • FIG. 14 there is shown an exploded view of a device according to the present invention comprising a probe 1401, a seton 1402, a fistula stent 1403 and a threadable member 1404.
  • the fistula stent 1403 is elongate in shape and may vary in size depending on the fistula to be treated.
  • the fistula stent 1403 comprises an access channel (not visible) which takes the form of a hollow conduit within the fistula stent 1403.
  • Perforations 1405 extend from the outer surface of the fistula stent to the access channel. The perforations enable fluid communication between the internal surface of a fistula and the access channel after insertion of the fistula stent into a fistula.
  • the hollow conduit extends to a first end 1406 of the fistula stent 1403 so as to form a hollow end portion.
  • the hollow end portion is configured to receive an end portion 1407 of the seton 1402 so as to form an end-to-end connection. - 6l -
  • a second end 1408 of the fistula stent 1403 is attached to the threadable member 1404, which is integrally formed with the fistula stent.
  • An irrigation port 1409 is also located at the second end 1408 of the fistula stent 1403, The irrigation port 1409 extends from the access channel and protrudes from the outer surface of the fistula stent. Irrigation port 1409 enables the introduction and/or drainage of fluid from the access channel after insertion of the fistula stent into a fistula.
  • Figure 15 an enlarged cutaway view of the fistula stent 1501, threadable member 1502 and a portion of the seton 1503 when connected is shown.
  • the access channel is provided by a hollow conduit 1504 within the fistula stent. Openings are provided by perforations 1510 extending from the outer surface of the fistula stent to the hollow conduit 1504.
  • the hollow conduit extends to a first end 1505 of the fistula stent so as to form a hollow end portion.
  • An end portion 1506 of the seton 1503 locates in the hollow end portion so as to form an end-to-end connection.
  • a second end 1507 of the fistula stent 1501 is attached to the threadable member 1502, which is integrally formed with the fistula stent.
  • An irrigation port 1508 is also located at the second end 1507 of the fistula stent 1501,
  • the irrigation port 1508 comprises an irrigation port conduit 1509 extending from the hollow conduit 1504 to the outer surface of the fistula stent.
  • the device is typically inserted into and secured within a fistula using the same technique as described in relation to Figures 11 and 12 above, where the fistula plug of Figures 11 and 12 is replaced by the fistula stent.
  • the irrigation port 1409 is located outside of the fistula and outside of the body, thus enabling the access channel to be accessed when the fistula stent 1403 is secured by the seton 1402.
  • the plurality of openings provided by the perforations 1405 enable discharge to drain from substantially the entire length of the fistula tract.
  • the provision of an access channel ensures that any discharge is able to flow freely away from the internal surface of the fistula, thus preventing blockage.
  • a further benefit is that once drained, the open structure of the fistula stent allows air to circulate within the fistula, aiding the healing process.
  • a j et of air or other suitable gas may be pumped through the access channel so as to further enhance the healing process.
  • the fistula stent also enables the fistula to be irrigated efficiently and with ease, allowing the facile removal of loose necrotic and inflammatory tissue.
  • a j et of sterile water or saline fluid e.g. from a syringe, may be injected through the irrigation port 1409 into the access channel, exiting into the fistula along its length via the perforations 1405.
  • a tube may be inserted into the access channel through the irrigation port; any irrigation fluid may then be injected via the tube.
  • the fistula stent 1403 prevents chaffing from the insertion of the tube, minimising discomfort to the patient.
  • the irrigation technique discussed above can be repeated as required with minimal discomfort to the patient because the access channel can be accessed when the fistula stent is secured within the fistula.
  • the devices according to the present invention may be used by the person skilled in the art to treat simple anal fistulas using variations of the techniques exemplified above.
  • the devices according to the present invention may also find application in many other types of fistula.
  • the devices of the present invention find particular application in fistulas adjacent to which there is a substantial body of tissue about which the seton loop may be affixed.
  • the fistulas to be treated comprise or are located near at least one external opening such that the seton loop lies partially outside of the body. That said however, the use of the devices of the present invention entirely internally is also envisaged.
  • the devices and the uses described may be best adapted by the surgeon in view of the particular fistula to be treated. For instance, where a fistula is complex, two or more such devices may be used to ensure that a tissue growth promoter or fistula stent is positioned within each tract.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne des dispositifs et des procédés associés pour traiter des fistules, telles que des fistules anales ou recto-vaginales. Selon un aspect de l'invention, le dispositif comprend un séton et un bouchon de fistule, le séton et le bouchon de fistule pouvant être reliés ensemble de bout en bout. Selon un autre aspect de l'invention, le dispositif comprend un séton et une endoprothèse de fistule, l'endoprothèse de fistule permettant l'irrigation ou le drainage de la fistule. Selon encore un autre aspect de l'invention, le dispositif comprend un séton et un élément pouvant être fileté, le séton comprenant un ou plusieurs trous à travers lesquels peut être fileté l'élément pouvant être fileté de façon à fixer l'élément pouvant être fileté au séton.
PCT/GB2013/052115 2012-08-09 2013-08-08 Dispositif WO2014023962A2 (fr)

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GBGB1214242.8A GB201214242D0 (en) 2012-08-09 2012-08-09 A device
GB1214242.8 2012-08-09

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WO2014023962A3 WO2014023962A3 (fr) 2014-04-03

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CN107754030A (zh) * 2017-11-22 2018-03-06 上海中医药大学附属龙华医院 一种自固定药线及其制作方法
CN111728669A (zh) * 2020-07-15 2020-10-02 南京市中医院 医用可控定向紧线器
US11058405B2 (en) 2016-07-20 2021-07-13 Queen Mary University Of London Surgical tool
US11357487B2 (en) 2016-12-16 2022-06-14 Xiros Limited Medical probe, assembly and method
WO2024084235A1 (fr) 2022-10-20 2024-04-25 University Hospitals Birmingham Nhs Foundation Trust Dispositif de traitement de fistule

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WO2005020823A1 (fr) 2003-09-03 2005-03-10 Stichting Sint Annadal Dispositif de traitement de fistules
US20050070759A1 (en) 2003-09-26 2005-03-31 Armstrong David N. Instrument and method for endoscopic visualization and treatment of anorectal fistula
WO2005096957A1 (fr) 2004-04-08 2005-10-20 Carmine Antropoli Dispositif medical de sondage et d'execution d'une traction elastique concomitante d'une fistule, plus particulierement de fistules perianales
WO2011151659A2 (fr) 2011-03-21 2011-12-08 Keighleycolo Ltd Dispositif

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WO2006119256A2 (fr) * 2005-04-29 2006-11-09 Cook Biotech Incorporated Greffes a adequation volumetrique pour traitement de fistules, methodes et systemes
AU2006262178B2 (en) * 2005-06-21 2012-07-05 Cook Biotech, Inc. Implantable graft to close a fistula
US20080051831A1 (en) * 2006-08-24 2008-02-28 Wilson-Cook Medical Inc. Devices And Methods For Occluding A Fistula

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WO2005020823A1 (fr) 2003-09-03 2005-03-10 Stichting Sint Annadal Dispositif de traitement de fistules
US20050070759A1 (en) 2003-09-26 2005-03-31 Armstrong David N. Instrument and method for endoscopic visualization and treatment of anorectal fistula
WO2005096957A1 (fr) 2004-04-08 2005-10-20 Carmine Antropoli Dispositif medical de sondage et d'execution d'une traction elastique concomitante d'une fistule, plus particulierement de fistules perianales
WO2011151659A2 (fr) 2011-03-21 2011-12-08 Keighleycolo Ltd Dispositif

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11058405B2 (en) 2016-07-20 2021-07-13 Queen Mary University Of London Surgical tool
US11357487B2 (en) 2016-12-16 2022-06-14 Xiros Limited Medical probe, assembly and method
CN107754030A (zh) * 2017-11-22 2018-03-06 上海中医药大学附属龙华医院 一种自固定药线及其制作方法
CN107754030B (zh) * 2017-11-22 2023-07-25 上海中医药大学附属龙华医院 一种自固定药线及其制作方法
CN111728669A (zh) * 2020-07-15 2020-10-02 南京市中医院 医用可控定向紧线器
WO2024084235A1 (fr) 2022-10-20 2024-04-25 University Hospitals Birmingham Nhs Foundation Trust Dispositif de traitement de fistule

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WO2014023962A3 (fr) 2014-04-03

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