WO2016094727A2 - Dispositifs et procédés de traitement de fistules - Google Patents

Dispositifs et procédés de traitement de fistules Download PDF

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Publication number
WO2016094727A2
WO2016094727A2 PCT/US2015/065107 US2015065107W WO2016094727A2 WO 2016094727 A2 WO2016094727 A2 WO 2016094727A2 US 2015065107 W US2015065107 W US 2015065107W WO 2016094727 A2 WO2016094727 A2 WO 2016094727A2
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WO
WIPO (PCT)
Prior art keywords
fistula
sealing element
sleeve
tissue
vacuum
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Application number
PCT/US2015/065107
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English (en)
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WO2016094727A3 (fr
Inventor
Eliot Kim
Original Assignee
Eliot Kim
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 Eliot Kim filed Critical Eliot Kim
Publication of WO2016094727A2 publication Critical patent/WO2016094727A2/fr
Publication of WO2016094727A3 publication Critical patent/WO2016094727A3/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
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00561—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated creating a vacuum
    • 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

Definitions

  • the present invention is in the field of fistula closure.
  • the invention disclosed relates to fistulas of the digestive system and the urogenital system (e.g. anal, rectal, intestinal, vaginal and urinary tract fistulas).
  • This invention may also be applied to fistulas of other physiological systems.
  • Fistulas may form for a variety of reasons. Flow of enteric matter, fecal matter, urine, or other matter through the fistula tract may maintain the patency of the tract and prevent the tract from healing and closing.
  • Gastrointestinal and anal fistulas are also currently treated with implants that attempt to plug the tract.
  • the fistula plug devices have shown limited success. Anchoring the plugs within the tract while blocking the flow of enteric or fecal matter has proven to be challenging. Blocking the flow of enteric or fecal matter at the inner ostium of the fistula tract, as most of the plug devices attempt to do, is often ineffective due to the challenging environment of the gastrointestinal tract.
  • the present invention includes devices and methods to divert or block the flow of enteric matter, fecal matter, urine, or any matter interfering with the natural healing process from entering a fistula. By isolating the fistula, the normal physiological healing response is allowed to occur and promote fistula closure.
  • Various embodiments of the invention are comprised of a sealing component, an anchoring component, and a flow transport lumen.
  • One component may serve as both the sealing and anchoring function.
  • the sealing component seals the normal anatomical lumen such that the flow is directed into and through the flow transport lumen. In this manner the flow is isolated from a fistula tract or other conditions present within the normal anatomical lumen such as a diverticulum or abscess.
  • the sealing and/or anchoring components may be self-expanding or expanded by a separate mechanism.
  • the sealing and/or anchoring components may be constructed using shape memory alloys such as nitinol, stainless steel, plastics, rubber or other materials suitable for the target environment.
  • the structures may be made as braided wires, cut tubes, or other radially expanding structures.
  • the flow transport lumen may be constructed as sleeves from thin membranes that are suitable for the target environment and are flexible to allow the anatomy to perform the natural functions such as peristalsis and muscle contractions in the intestines, bladder, rectum, and sphincter.
  • the sleeve may be made from materials such as silicone, polyurethane, PTFE, ePTFE, and animal intestine.
  • the flow transport lumen may also be constructed, in part or in whole, as a radially stiff lumen such that the lumen is resistant to kinking or occlusion.
  • the sleeves may be attached to the sealing and anchoring components by various means such as adhesive, solvent bonding, thermal bonding, over-molding, or stitching.
  • Subject devices with self-expanding sealing and/or anchoring components may be delivered by radially compressing the components such that the device may be loaded into a delivery catheter or tube. After delivering the system to the target site, the delivery catheter may be retracted and the subject device left to expand into the target location.
  • Subject devices with self-expanding sealing and/or anchoring components may be delivered by radially compressing the components and maintaining the compressed configuration with a structure preventing radial expansion such as a loop of suture. After delivering the system to the target site, the external structure can be released and the subject device left to expand into the target lesion.
  • Subject devices with non-self-expanding sealing and/or anchoring components may be delivered to the target site in a compressed state and expanded using an expansion mechanism such as a balloon catheter or a mechanical radially expanding mechanism.
  • the flow-diverting devices may include a tether, pull string, or similar to allow for the device to be withdrawn from the anatomy, retracted into a removal catheter or tube, or compressed radially for easy removal.
  • a combination of subject devices may be used for conditions in which more than one source of flow interfering with the healing process are present, such as a fistula connecting the bladder to the rectum.
  • Various embodiments of the invention include a means to block the fluid flow from entering the full length of the fistula tract or a large portion of the tract. In this manner, the the fistula tract or a large portion of the tract is isolated from the fluid flow to promote the healing of the tract.
  • the advantages of the present invention include, without limitation, the promotion of the natural healing of fistula tracts. By reducing the required surgical intervention, the risks associated with surgery are consequently reduced. All of the embodiments may be deployed using the natural body orifices (anus, vaginal, urethra, mouth) or through the fistula tract without a need for incisions.
  • Some embodiments of this invention may be deployed in a doctor's office setting outside of a hospital. Additionally, the deployment of the devices may be performed in remote locations to address issues in developing countries.
  • the flow-diverting devices may also be used to isolate the flow from the linings of the vessels. These devices may be advantageous if the linings of the vessels require isolation from the fluid due to a condition, such as an abscess or irritation of the rectal wall or inflammation of the intestinal wall.
  • FIG. 1 shows a cross-sectional view of the lower rectum, anus with an anal fistula, and the fistula flow diversion device in situ in accordance with the present invention.
  • FIG. 2 shows another embodiment of the sealing and fixation mechanism.
  • FIG. 3 shows another embodiment of the sealing and fixation mechanism.
  • Fig. 4 shows another embodiment of the sealing and fixation mechanism.
  • Fig. 5 shows a cross-sectional view of the rectum with a rectal fistula, anus, and the fistula flow diversion device in use in accordance with the present invention.
  • FIG. 6 shows another embodiment of the sealing and fixation mechanism.
  • FIG. 7 shows another embodiment of the sealing and fixation mechanism.
  • Fig. 8 shows a cross-sectional view of the stomach, small intestine with an intestinal fistula, and the fistula flow diversion device in use in accordance with the present invention.
  • FIG. 9 shows another embodiment of the sealing and fixation mechanism.
  • Fig. 10 shows another embodiment of the sealing and fixation mechanism.
  • FIG. 11 shows another embodiment of the sealing and fixation mechanism.
  • Fig. 12 shows a cross-sectional view of the kidneys, ureters, bladder with a bladder fistula, urethra with a urethra fistula, and the fistula flow diversion device in use in accordance with the present invention.
  • Fig. 13 shows another embodiment of the sealing and fixation mechanism.
  • Fig. 14 shows another embodiment of the sealing and fixation mechanism.
  • Fig. 15 shows another embodiment of the sealing and fixation mechanism.
  • Fig. 16 shows another embodiment of the sealing and fixation mechanism with locking minimum diameter features.
  • Fig. 17 shows another embodiment of the sealing and fixation mechanism with a non-expanding portion.
  • Fig. 18 shows another embodiment of the sealing and fixation mechanism with a feature to engage approximate tissue.
  • Fig. 19 shows another embodiment of the sealing and fixation mechanism positioned at the junction of the colon and rectum.
  • Fig. 20 shows another embodiment of the sealing and fixation mechanism with features to engage the approximate tissue.
  • Fig. 21 shows a pull in resistant structure.
  • Fig. 22 shows a tissue clamp
  • Fig. 23 shows a cauterizing catheter.
  • Fig. 24 shows the application of vacuum.
  • Fig. 25 shows an alternate embodiment of the application of vacuum.
  • Fig. 26 shows an alternate embodiment of the application of vacuum used to increase the anchoring of the anchor component.
  • Fig. 27 shows a sealing component in the intestine. DETAILED DESCRIPTION OF THE INVENTION
  • Fig. 1 shows one variation of a flow-diverting device 10 having an expanded anchor 12 (which can have dimensions of, e.g., 25mm length x 75mm diameter fully expanded) attached to a thin walled (e.g., 0.6mm), flexible sleeve 14.
  • the fully expanded state of the anchor assumes a cylindrical or substantially cylindrical form, wherein the cylindrical form is defined by the sections of the anchor present on the outer portion of the anchor.
  • the anchor provides radial force sufficient to seal within the target lumen LM.
  • the expandability of the anchor 12 allows for a small profile during introduction of the device 10 into the target lumen LM and an expanded diameter sufficient to anchor the device at an appropriate anchor location such as the transition from the rectum RC to the anal canal AC or other narrowings within the gastrointestinal tract.
  • the anchor may be self-expanding or expanded by a separate mechanism such as a balloon or mechanical expansion device.
  • the flexibility and thickness (e.g., 0.6mm) of the sleeve 14 are such that discomfort is minimized for the patient while the device is in place.
  • the length (e.g., 150mm) of the sleeve 14 is sufficient to cover the inner opening FO of the fistula tract FS.
  • FIG. 2 there is shown a device 20 having an anchor 22 having a geometry that increases the anchoring force as stool is forced through the body 24 of the anchor.
  • FIG. 3 there is shown an anchor comprised of a simple ring 30.
  • This ring 30 may be self-expanding or expanded by a separate mechanism.
  • the ring 30 may be sized such that it is slightly larger than the anal canal to prevent the ring 30 from being expelled during defecation or the ring may be larger in diameter than the inner lumen of the rectum.
  • An oversized ring 30 (e.g., 75mm in diameter) may conform to the rectum and take a position off axis from the central axis of the rectum. The oversized ring 30 may provide additional sealing.
  • FIG. 4 there is shown an anchor comprised of multiple rings 40,
  • the anchor may be delivered by pulling the points of the rings 40, 40' opposite the hinge 42 away from each other. This reduces the profile of the anchor and allows entry through the anal canal.
  • the rings Once internal to the rectum, the rings may be allowed to expand and conform to the rectal wall. The points of the rings opposite the hinge may be locked at a specified distance from each other to increase the sealing and anchoring forces.
  • an external control element may be added to any of the mentioned embodiments.
  • the external control element may be a member extending from the anchor, through the anal canal, and externally exposed.
  • the external control element is constructed such that the axial stiffness is sufficient to maintain the position of the anchor while the external end is held in place by an attachment to the outer anatomy, such as tape or suture, or by grasping the external control element by hand or similar.
  • a flow-diverting device in place within the rectum.
  • the proximal end of the device includes a sealing feature to divert any fecal matter flow into the inner lumen of the device.
  • the proximal sealing feature 50 is held in position by a connection 52 to the distal anchoring feature 54 found at the transition from the rectum to the anal canal.
  • the thin sleeve 14 is shown extending from the proximal sealing feature through the anal canal and external to the body. As shown, any fecal matter entering the proximal sealing feature bypasses the rectum and the anal canal and exits the distal end of the sleeve.
  • FIG. 6 there is shown a flow-diverting device in place within the rectum with multiple linked expandable rings 60, 62, 64, 66.
  • the rings serve as the sealing features and the anchoring feature.
  • a flow-diverting device consisting of an expandable structure.
  • the expandable structure 70, 72, 74 may be segmented, e.g., linked by members 76, 78, as shown or a continuous assembly.
  • the expandable structure may be self- expanding or expanded by another force such as the force applied by a balloon expansion.
  • a self-expanding structure may be more appropriate for conforming to the rectal anatomy during defection.
  • Rectal flow-diverting devices such as those shown in Fig. 5, Fig. 6, and Fig. 7 may be used to treat rectal fistulas or anal fistulas.
  • Similar flow-diverting devices may also be used to treat intestinal fistulas.
  • FIG. 8 there is shown a device within the small intestines FN.
  • An anchor 80 is shown at the duodenal bulb or pylorus of the stomach ST with a thin flexible sleeve 14 extending through the intestine FN past the site of the fistula FS. In this manner any of the stomach contents or enteric matter would pass through the inner lumen of the sleeve and bypass the fistula opening FS.
  • a secondary sealing mechanism may be added to the end of the sleeve downstream from the fistula to prevent enteric contents from travelling back towards the stomach between the sleeve and the intestinal lining.
  • the device shown consists of an anchor 90 at the duodenal bulb or pylorus with tethers 92 extending to a sealing member 94 downstream.
  • the sealing member is located upstream from the fistula opening FO and diverts enteric flow through the sleeve 14 of the device.
  • the position of the sealing member 94 is maintained by the tethers to the anchor.
  • the section of the device without a sleeve allows the normal digestive processes and nutrient uptake to occur.
  • Fig. 10 and Fig. 11 show alternative locations for the anchor feature 1000, 1100 positioned in proximity to the pylorus PY, shown in Fig. 10, or in proximity to the
  • gastroesophageal junction GEJ shown in Fig. 11.
  • Similar flow-diverting devices may also be used to treat urinary tract fistulas.
  • a device within the urinary tract there is shown a device within the urinary tract.
  • Sealing anchors 1200, 1200' are shown at the renal pelvises. From each anchor 1200, 1200' a thin sleeve 1202, 1202' extends through the ureter UR, UR' and connects to a larger section 1204 within the bladder BL that allows for the normal filling of the bladder with urine while preventing urine from flowing through one or more fistulas FS, FS' .
  • another thin sleeve 1206 is present through the urethra UT and ends external to the body.
  • the section within the bladder is flexible and conformable such that the bladder may fill and empty as usual.
  • the external opening of the sleeve in the urethra may be trimmed flush to the body, external to the body, or connected to a urine collection system.
  • FIG. 13 there is shown an alternative location for the anchor.
  • the anchor 1300, 1300' By anchoring along a long length of the ureter, the anchor 1300, 1300' provides the required anchoring force as well as the sealing feature.
  • FIG. 14 there is shown a device that consists of sealing anchors
  • the radial stiffness of the catheter shafts prevents the lumens of the shafts from kinking or becoming pinched.
  • This embodiment produces a constant flow of urine external to the body.
  • the urine may be contained within a pouch or similar container 1404 external to the body.
  • a device may also consist of a combination of the flexible catheter shafts 1402,
  • a sealing anchor 1500 composed of wires of shape memory alloy intertwined to form a braid.
  • the braid may be formed by weaving the wires into the braided structure and heat setting the structure to establish the shape memory. As the braid compresses in diameter the overall length of the structure elongates as shown in Fig. 15 A. The axial length is directly related to the radial dimension.
  • Fig. 15B shows the sealing anchor component 1500 in a partially expanded configuration.
  • Fig. 15C shows the sealing anchor component 1500 in a configuration with greater expansion than Fig 15B exemplary of the rectum filling with feces.
  • a sealing anchor 1600 with a locking minimum diameter such that the anchor is capable of being compressed to a dimension suitable for introduction into the target anatomy.
  • the anchor component Once introduced to the target anatomy, the anchor component would be allowed to expand to the diameter of the target anatomy.
  • the anchor component will consist of a predetermined locking minimum diameter. As the anchor component expands past this locking minimum diameter, features will engage such that the anchor component will no longer able to be compressed to a dimension smaller than the locking minimum diameter. In this configuration the anchor will be present within the target anatomy and allowed to expand and contract from the locking minimum diameter to the maximum diameter of the anchor. This active expandability will allow the anchor component to adjust to the expansion and contraction of the target anatomy.
  • the locking minimum diameter will prevent the anchor from passing through a narrowing in the surrounding anatomy.
  • This configuration may be used in the treatment of anal fistula such that the anchor component is positioned within the rectum in proximity to the ano-rectal junction. As the rectum expands to accommodate feces, the anchor component will expand to maintain the seal with the rectal wall and divert the incoming feces through the inner lumen of the anchor and associated sleeve.
  • the locking minimum diameter will prevent the anchor component from passing through the anal canal and will maintain the anchor position within the rectum.
  • the locking function of the locking minimum diameter may be achieved using locking tethers 1601. By engaging the locking features 1602 1603 the structure is no longer capable of elongating in length greater than the locked configuration or compressing radially less than the locked configuration. Tethers at a fixed length, however, do not prevent the structure from further expansion in diameter. As the diameter increases, the overall length decreases and slack is introduced into the tethers. Additional tethers 1604 can be attached to the locking feature 1602 in order to assist in tensioning and engaging the locking features 1602 and 1603 and allowing for disengagement when removal of the sealing anchor component is desired. [0072]
  • the locking function may also be achieved using locking features on the braid that controls the angulation or displacement of the members of the structure relative to each other. These features may be separate components added to the structure or wire forms in the wire structure.
  • the locking function may be present throughout the anchor component or may be present in a portion of the anchoring component such that a portion of the anchoring component is not restricted in compressibility.
  • the locking function may include the ability to be unlocked such that the anchor component may be compressed radially when needed such as during anchor component removal.
  • the anchor component 1700 includes a fixed diameter portion 1701. The remaining portion of the anchor component is allowed to expand or compress as necessary.
  • Fig. 17B shows the anchor component positioned within the rectum for the treatment of anal fistula. In this configuration the anchor component is capable of adjusting for the rectal expansion as the rectum is filled with feces (Fig. 17 A) and the rectal compression during defecation (Fig. 17C). During defecation, the fixed diameter portion 1701 of the anchor component prevents the passage of the anchor component through the anal canal.
  • the sleeve component may be coated with a biomaterial such that the biomaterial facilitates the healing and tissue regeneration of the internal fistula opening. Such a coating may also promote temporary adhesions between the lining of the anal canal and the sleeve by allowing tissue ingrowth into the biomaterial. Some tissue debridement may be necessary prior to the introduction of the sleeve in order to initiate the tissue ingrowth.
  • the sleeve and coating may be fabricated from resorbable biomaterials, non-resorbable biomaterials, or a combination thereof.
  • the sleeve component may be coated with an antibiotic or antimicrobial coating to reduce any infections near the internal opening of the fistula tract.
  • a sleeve device or patch may be constructed with a highly porous layer in contact with the anal canal and a non-porous layer facing the inner lumen of the anal canal.
  • the sleeve or patch is deployed within the anal canal and allowed to cover any internal fistula openings.
  • the sleeve or patch would be maintained in position such that tissue ingrowth is allowed to occur and adhesions are allowed to form. Some debridement of the anal canal may be necessary prior to placing the sleeve.
  • the sleeve or patch may be maintained in position with the use of a transanal stent or similar, sutures, or a combination thereof.
  • a stent would allow the contact to be maintained between the sleeve or patch and the wall of the anal canal while fecal matter would be allowed to pass through the inner lumen of the stent.
  • this configuration would be maintained only for the length of time required to form adhesions between the wall of the anal canal and the sleeve.
  • the stent would be removed and the sleeve or patch would remain in place to continue to isolate the fistula tract from fecal contamination.
  • the sleeve or patch may be fabricated using resorbable biomaterials, non- resorbable biomaterials, or a combination thereof.
  • Another embodiment of this invention includes the use of a magnetic field to maintain the anchor position.
  • a magnetic field may be present near the junction of the rectum and anal canal such that the anchor would not be allowed to pass the field under normal defecation forces.
  • the magnetic field may be produced by an external source held near the anus or buttocks. This external source may be incorporated into a toilet seat or a toilet seat cover.
  • the magnetic field may also be produced by a source implanted in the ischioanal fossa space surrounding the anal canal.
  • the anchor component 1800 may be present over the Houston's valve 1801 and include features 1802 to engage or clamp the valves.
  • the anchor component 1900 may be positioned at the junction RCJ between the rectum RC and the colon CO.
  • the anchor would be flexible to allow introduction. Once in position, the anchor is locked into an angulated configuration such that the fixed structure would not be allowed to pass through the angulated junction between the colon and rectum.
  • the position of the anchor component may be maintained using features to engage the surrounding tissues. Rectal tissue has been shown to tolerate superficial punctures well. Superficial punctures of the rectal tissue also do not cause pain.
  • barbs 2001 or similar are present on the external surface of the anchor component 2000 such that the barbs 2001 would interface with the rectal tissue and create secure anchoring. The barbs would interface with the mucosa, submucosa, and muscularis basement of the rectal wall without puncturing the full thickness of the muscularis basement. The barbs would be retractable such that the anchor component may be easily removed when necessary.
  • Fig. 20 shows an anchor with retractable barbs pointed in one direction.
  • barbs may be included in both directions to ensure the anchor is not allowed to move distally or proximally.
  • the retractable barbs may be fabricated from sharpened nitinol heat-set in the curved configuration. Pulling the nitinol into a straight lumen 2002 allows the barb to be retracted for introduction and removal.
  • the barbs or tissue interfacing features may also be made of resorbable materials such that the features would degrade over time.
  • the surrounding tissue may also be engaged using surgical stitches, staples, or similar.
  • Features to allow attachment of the anchor to the rectal tissue e.g., holes or structures that allow for effective stitching may be incorporated into the structure.
  • the sleeve extending externally may be trimmed flush with the anus or within the anal canal dependent on the location of the fistula. If left external to the body, the external end of the sleeve may be left open or closed when defecation is not being performed or connected to a container for fecal collection. In one embodiment of the external end of the sleeve, the length of sleeve external to the body may be rolled to form a ring, similar to a packaged condom. This configuration may maintain the opening and allow for easy cleaning following defecation.
  • the opening may be closed using simple closure mechanisms such as clamps.
  • Another form of closure would be to flatten the exposed sleeve material and fold repeatedly similar to the closure of "Dry Bags" used in outdoor activities.
  • a stiffer material may be included in the external structure.
  • the structure would be shaped such that it would not induce pain to the anus and allow for the natural movements of the buttocks.
  • FIG 21 A there is shown a structure resistant to pull-in 2100 configured to allow fecal matter to pass through the inner circle.
  • the ring has bend sections 2101 capable of easily bending to adapt to the shape of the buttocks near the anus as shown in Fig. 21B.
  • the stiffer sections 2102 ensure the structure cannot be pulled into the anal canal.
  • This structure may be attached to and wrapped with the sleeve material.
  • the majority of anal fistulas include an abscess in the intersphincteric space.
  • a structure may be deployed in the intersphincteric space such that any fecal contamination is not allowed to pass the intersphincteric space.
  • the structure may be coated with a biomaterial to allow tissue ingrowth and adhesions.
  • the delivery system 2201 is removed.
  • a seton 2202 may be left in the outer portion of the fistula tract to facilitate drainage.
  • the clamp 2200 may be fabricated from resorbable or non-resorbable biomaterials.
  • the delivery system may allow for multiple clamps to be delivered.
  • the clamp may provide clamping force in multiple planes by including a multitude of jaws.
  • Fig. 23 there is shown a device to cauterize the cryptoglandular tissue present within the intersphincteric space. Infection of the anal glands in this space is believed to be the source of cryptoglandular anal fistulas.
  • the shaft of the device 2300 is configured to allow easy access to the intersphincteric space from the anal canal.
  • the end of the device would include a cauterizing feature 2301 mounted on a section perpendicular to the shaft section within the fistula tract.
  • the perpendicular angulation would allow the tip of the device to reach into the intersphincteric space.
  • the section of the device within the intersphincteric space may extend and also be rotated such that the entire interphincteric space may be cauterized.
  • the invention would also be capable of treating areas of the fistula tract distal and proximal to the intersphincteric space.
  • the cauterization may be accomplished using RF energy, heated features, ultrasound, laser, cryoablation or similar method.
  • a combination of cauterization and the implant of a clamp may be combined.
  • Vacuum or negative pressure wound treatment may be used in conjunction with the above described inventions. Vacuum may also be used in conjunction with an adhesive such as fibrin glue or a curable fistula tract filler biomaterial.
  • a constant vacuum source is required.
  • the vacuum source may be an electronically driven vacuum pump, a portable syringe driven by constant force springs, or similar.
  • vacuum wound treatment may be applied directly to the internal fistula opening FO using a tissue engagement component 2400, vacuum tubing 2401, and a vacuum source 2402 as shown.
  • vacuum wound treatment may be applied to the internal sphincter from within the intersphincteric space using a tissue engagement component 2400, vacuum tubing 2401, and a vacuum source 2402 as shown. This would allow for closure of the internal opening or other portion of the tract while providing drainage for the distal portion of the fistula tract.
  • a clamping mechanism may be included in the vacuum interface such that large fistula tracts may be clamped closed prior to administering vacuum.
  • a non-porous biomaterial plug may be included to plug large fistula tracts prior to administering vacuum.
  • vacuum may also be used to increase the anchoring abilities of the anchor component.
  • a vacuum feature 2600 may be included in the anchor structure 2601 such that when vacuum is administered to the feature the feature engages the surrounding tissue. In this manner the vacuum would help secure the anchor to the rectal tissue.
  • the vacuum feature would be in communication with an external vacuum source 2402 by means of tubing 2401. The vacuum source may be simultaneously attached to a fistula tract treatment.
  • Vacuum wound treatment may be used on multiple vacuum circuits
  • one or more circuits are communicating with a tissue engagement component to provide closure of a portion of the fistula tract while one or more circuits are communicating with the external opening or the length of the tract to provide for active drainage of the fistula tract.
  • An open cell foam or similar may be placed within the tract to assist in drainage.
  • Elastic, flexible material in the form of a curved surface similar to suction cups may be used on the external surface of the anchor component to apply vacuum to the rectal walls in order to increase the anchoring abilities of the anchor component.
  • the geometry of the fistula tract may be set into the cured material.
  • the natural variations in the tract geometry would produce a biomaterial unlikely of being extruded from the tract. This is especially evident in the majority of fistula tracts that include a large abscess region in the intersphincteric space.
  • IN provides enteric diversion for the treatment of intestinal fistula.
  • This structure would be maintained in position with a resorbable anchor 2701 at the internal fistula opening FO.
  • the structure itself would be fabricated using resorbable features to hold the structure together.
  • the anchor 2701 and components of the stent structure 2700 would degrade and allow the non-resorbable components to be passed through the gastrointestinal tract.

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Abstract

La présente invention concerne des dispositifs et des procédés pour traiter des fistules. Les traitements comprennent la déviation ou l'isolement de l'écoulement de matière entérique, de matières fécales, d'urine ou de toute matière entrant dans la fistule et interférant avec les processus de cicatrisation naturelle. En isolant la fistule de l'écoulement, la réponse de cicatrisation normale est rendue possible ce qui permet de favoriser la fermeture de la fistule.
PCT/US2015/065107 2014-12-10 2015-12-10 Dispositifs et procédés de traitement de fistules WO2016094727A2 (fr)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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US11357487B2 (en) 2016-12-16 2022-06-14 Xiros Limited Medical probe, assembly and method
PL126965U1 (pl) * 2018-01-19 2019-07-29 Marek Bronowski Sonda do przetok leczonych metodą Hipokratesa
CN113143350A (zh) * 2021-03-26 2021-07-23 重庆尚业医疗器械有限公司 一种栓塞式肛瘘内口封堵器

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