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EP-4190247-B1 - A FISTULA TREATMENT DEVICE

EP4190247B1EP 4190247 B1EP4190247 B1EP 4190247B1EP-4190247-B1

Inventors

  • BAMBURY, EOIN
  • ZILVERSMIT, MOSHE

Dates

Publication Date
20260506
Application Date
20170609

Claims (8)

  1. A fistula treatment system comprising a guide (1101) which is adapted to extend at least partially around a tissue tract, and an implant element (1102) which is adapted to track the pathway of the guide, characterized in that , the implant element has a tracking configuration in which the implant element follows the pathway of the guide and an activated configuration, the implant in the activated configuration being adapted to draw tissue surrounding a tract inwardly, the implant element comprises an anchor and the anchor comprises at least one barb (1107), the guide comprises a guide coil, the guide coil has a uniform lateral extent along a length thereof, the guide coil comprises a rail for the implant element, and the guide coil comprises a sharp distal tip (1103).
  2. A system as claimed in claim 1, wherein the implant element is at least partially bioabsorbable.
  3. A closure system as claimed in claim 1 or claim 2, wherein the guide coil is tapered along a length thereof.
  4. A closure system as claimed in any of claims 1 to 3, wherein the guide coil is solid.
  5. A system as claimed in any of claims 1 to 4, wherein the system comprises a drain or seton having an anchoring feature for anchoring the drain in situ.
  6. A system as claimed in claim 5, wherein the anchoring feature comprises a step or projection on the seton, such as one or more of a knot, a barb or a quill.
  7. A system as claimed in either of claims 5 or 6, wherein the seton is solid.
  8. A system as claimed in any of claims 5 to 7, wherein at least a portion of the implant is bioabsorbable and at least a portion of the seton is configured to bioabsorb in advance of bioabsorption of the implant.

Description

Introduction The invention relates to a device and a system for the treatment of perianal fistulas. A perianal fistula is an artificial tunnel that, in the majority of cases, develops from an infection that begins within a blocked anal gland. If the infection cannot be cleared from the anal gland an abscess forms and the infection burrows though the sphincteric muscles and exits at the buttocks integument. Patients experience pain associated with the tract and associated abscesses and suffer faecal and blood discharge from the fistula tract. Perianal fistulas may also result from gastrointestinal diseases such as Crohn's disease, ulcerative colitis, colorectal cancers and their associated treatment and complications due to rectal fissures and trauma. The global incidence of perianal fistula is 2 per 10,000 population. Over 100,000 fistula procedures are performed between the United States and Western Europe each year. Thirty percent of the procedures performed are reoperations due to treatment failure contributing to a significant preventable cost to the healthcare systems. Given the inadequate treatment options and poor surgical outcomes there is a defined clinical need for a more effective perianal treatment device. There is currently no single "gold standard" technique that a surgeon can perform to effectively cure a perianal fistula and not render the patient incontinent. A common fistula treatment is a fistulotomy procedure. A fistulotomy involves the dissection of the sphincteric muscles and the laying open of the fistula tract. Fistulotomies have a relatively high cure rate, however, this procedure results in a high risk of faecal incontinence. From a patient's point of view, many are happy to assume the risk of incontinence in order to resolve the painful fistula tract. However, this is obviously not an ideal treatment pathway and for many patient population groups the secondary outcome is far from acceptable. Another commonly used fistula treatment methodology is the use of a seton. Setons are used as a sphincter sparing technique and is simply a suture or vascular strap that is passed through the tract of the fistula and the rectum and tied in a loop. The seton maintains tract patency allowing the infection in the fistula tract to drain, help the tract constrict in length and may cure the tract. If the tract is not cured by the seton the physician can perform a fistulotomy. This approach of trying to preserve the sphincter with setons has been used for over 2500 years and is still the preferred method used by surgeons today. In an effort to provide a non-destructive perianal fistula treatment various glues and plugs have been developed and introduced to colorectal surgeons in the past 20 years. However, these techniques are not very successful and their use is not widespread. Such glues which are injected into the fistula tract generally become brittle and are not able to occlude the tract for a long enough period to fully heal, faeces re-enter the tract resulting in abscess formation and refistulisation. Physicians often attempt to treat perianal fistulas with glues and plugs even though there may only be a 10 percent chance of effectiveness because it is a sphincter sparing technique and they can always resort to a seton and eventual fistulotomy if all fails. Attempts have also been made to use plugs to occlude perianal fistula tracts. For example, US2005/004426A describes a plug-like fistula closure device with an attached flexible application string which also serves to evacuate liquids out of a fistula. However, generally the plugs fail because they become extruded from the tract, allowing faeces to enter the tract resulting in reinfection, abscess formation and refistulisation. WO02016189107 (prior-art according to Article 54(3) EPC) describe a fistula treatment device, and WO2012/103546 describes systems for treating a tissue wall puncture. There is therefore a need for an improved method and device for the treatment of perianal fistulas. Statements of Invention The invention provides a fistula treatment system as set out in claim 1, and optional features are set out in the dependent claims 2-8. Brief Description of the Drawings The invention will be more clearly understood from the following description of an embodiment thereof, given by way of example only, with reference to the accompanying drawings, in which Figs. 1-61 describe devices which do not have all of the features of the invention, and in which: Fig. 1 is a cross-sectional view of an anatomy and disease state addressed by the invention;Fig. 2 is a cross-sectional view of the treatment devicebeing delivered through the fistula tract;Fig. 3 is cross-sectional view of the device at a point of apposition to the mucosal surface at the site of the internal opening of the fistula tract;Fig. 4 is cross-sectional view of the device partially delivered through the mucosal surface and into the sphincter muscle complex;Fig. 5 is cross-sect