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WO2018087587A1 - Équipement chirurgical et procédé de traitement d'une fistule entérocutanée - Google Patents

Équipement chirurgical et procédé de traitement d'une fistule entérocutanée Download PDF

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Publication number
WO2018087587A1
WO2018087587A1 PCT/IB2017/000073 IB2017000073W WO2018087587A1 WO 2018087587 A1 WO2018087587 A1 WO 2018087587A1 IB 2017000073 W IB2017000073 W IB 2017000073W WO 2018087587 A1 WO2018087587 A1 WO 2018087587A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
fistula
treatment
outer membrane
enterocutaneous
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2017/000073
Other languages
English (en)
Inventor
R. M. Salah HUSEIN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO2018087587A1 publication Critical patent/WO2018087587A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/94—Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B2017/00535—Surgical instruments, devices or methods pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B2017/00575—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 closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas

Definitions

  • a surgical equipment and a method for treatment of enterocutaneous fistula are provided.
  • This invention relates to a surgical equipment and a method for treatment of enterocutaneous fistula.
  • a fistula constitutes an abnormal communication between two structures.
  • the fistula can be called as enteric fistulas, which can be classified as internal or external depending upon whether they drain externally to the skin or internally to the gastrointestinal tract or other organ (eg, bladder, vagina).
  • This present invention focuses on (enterocutaneous) external fistulas that drain from the bowel (small, and large) to the outside of the body through the anterior abdominal wall as in fig ⁇ .
  • This type of fistula has different classifications, out of which the widely used one is low, intermediate, and high output depending on the amount it drains i.e. less than 200 ml, 200-500 ml, and more than 500 ml respectively.
  • the causes of fistula formation include foreign body, radiation, inflammation or infection (e.g. tuberculosis), epithelialization, neoplasia (cancer), iatrogenic (surgical complications), trauma, and distal obstruction.
  • enteric fistulas In general the initial treatment of enteric fistulas focuses on the correction of fluid and electrolyte imbalance, treatment of infection, nutritional support using total parental nutrition with or without enteral feeding, and control of the effluent drainage and skin care. Further, there is also, a need to control the amount of fistula secretion using medications, skin care by stoma therapists, and care of kidneys to avoid renal failure, beside the nutrition.
  • Negative pressure wound therapy may accelerate fistula closure by promoting wound healing.
  • Definitive surgical closure is indicated in some cases wherein enteroatmospheric fistulas do not heal spontaneously because of the absence of overlying soft tissue. Immediate surgery is indicated for patients with a deep enteroatmospheric fistula to contain spillage of enteric contents and managing peritonitis. Drainage from superficial or deep fistulas is controlled until skin grafts can be applied to the granulation bed to allow bag drainage of the stoma(s). Definitive surgical closure of the fistula should not be considered until the skin graft is supple and can be pinched between the thumb and index finger, which signifies the existence of a plane between the graft and underlying bowel.
  • the fistula still possesses a common surgical issue, requiring multiple steps of treatment with a long course of management, and long hospital stay.
  • An object of the present invention is to provide a surgical equipment and a method for treatment of enterocutaneous fistula which obviates shortcomings of the prior arts.
  • Another object of the present invention is to provide a surgical equipment and a method for treatment of enterocutaneous fistula which is simple and cost effective.
  • Further object of the present invention is to provide a surgical equipment and a method for treatment of enterocutaneous fistula which requires shorter time for treatment and shorter hospital stay, leading to quicker fistula closing.
  • a surgical equipment for treatment of enterocutaneous fistula comprises an outer membrane accommodating a cover with an inflating tube there inside wherein distal end of the inflating tube is connected to a stent.
  • This invention proposes an inflatable, flexible, waterproof, absorbable stent, folded on itself that can be pushed into the bowel lumen through the fistula tract followed by inflation to seal the bowel lumen and ultimately the fistula tract, thereby maintaining bowel continuity.
  • enterocutaneous fistula can be carried out under local anaesthesia requiring a shorter time of treatment and shorter hospital stay, which results in quicker fistula closing.
  • Fig. shows: Enterocutaneous Fistula.
  • Fig. 1 shows: Outer membrane and guide wire of present invention.
  • Fig. 2 shows: Inflating tube, cover, rubber tube and stent according to invention.
  • Fig. 3 shows: Inflated stent, pusher and rubber tube in accordance with invention.
  • the present invention is pertinent to a surgical equipment and a method for treatment of enterpcutaneous fistula.
  • the surgical equipment forms an inflatable double layer stent inserted through the fistula tract to line the bowel lumen from inside.
  • the stent is having a profile corresponding to that of said bowel lumen. It is held in place by gentle pressure exerted against the bowel lumen when inflated, as well as by the outer surface thereof which is rugged in nature allowing the bowel to keep its continuity, and sealing the fistula tract and mitigating the chances of migration.
  • the stent is absorbable by losing its strength gradually (over a week). Thus, the stent is finally absorbed by the body or lost with defecation if deflated prior to being absorbed by the body.
  • the equipment comprises an outer membrane (1) accommodating a guide wire (2) as indicated in the figure which is flexible to follow the fistula tract from skin opening to the bowel.
  • the guide wire guides the outer membrane (1) into the fistula tract during insertion thereof so as to place the outer membrane at the correct location inside bowel.
  • the equipment includes an inflating tube (3) with its ' cover (4), which are again flexible enough to pass through the fistula tract to the bowel by being housed inside the outer membrane (1).
  • the proximal end (A) of the inflating tube (3) can be connected to syringe to inflate the stent by injecting radio-opaque contrast therethrough and other end of which is connected to a stent (6) by means of a small rubber tube (5) which is easy to slip if pushed with a pusher, so the inflating tube (3) can be pulled back leaving the inflated stent (7) in place.
  • the stent when the stent is deflated it can be covered with the inflating tube (3) inside the cover (4) to facilitate their passage from skin to bowel. Pushing uncovered proximal inflating tube (3) while holding the cover between the finger and thumb allows the stent to come out from the other side of the cover (4) which is inflated with the syringe.
  • a flexible probe covered with an outer sheath is provided with the device to identify the exact tract and protect the tract before passing the stent into the bowel.
  • a second sheath covering the stent along with the inflation tube can be inserted through the outer sheath lining the fistula tract to reach the bowl lumen safely.
  • the inflation tube is pulled out, and a rubber band that accompanies the main device snaps into place closing the system to prevent stent deflation.
  • the cover (4) is pulled back, which is replaced by a pusher (8).
  • the pusher (8) is similar to said cover (4), but smaller in diameter comparatively that slips over the inflating tube (3) to cover the same.
  • the pusher can't provide coverage to the stent and rubber band.
  • the rubber band contracts > (due to rubber elastic property) (5), which keeps the stent inflated as it blocks the back leakage of radio-opaque liquid from the stent (6).
  • the inflated stent constituting rough outer surface and smooth inner surface exerts pressure against the bowel wall thereby helping itself to stay in place.
  • the stent forms a double layer, absorbable, and flexible structure.
  • the double layer includes rough outer layer and smooth inner layer connected together at ends thereof to form preferably a cylindrical shaped tube upon inflation.
  • the space between the two layers is potentially small that the cylindrical lumen is wider.
  • the stent When the stent is deflated it can be folded on itself at both ends so as to be smaller to be covered by the cover with the inflating tube.
  • the stent is made of absorbable material that the body can absorb it. In other words the stent ruptures after a while as the body ingests and absorbs it. Upon rupture the radio-opaque liquid leaks out, as a result the stent does not stay inflated any more. Therefore, it is removed with defecation, or ingested and absorbed if still inside the bowel.
  • absorbable materials either synthetic or biologic available with different half lives.
  • the synthetic ones are preferable because they are highly cost effective and easier to fold onto itself to facilitate insertion into the fistula tract.
  • a syringe filled with soluble contrast is connected to the inflating tube.
  • the contrast is injected through the inflating tube to inflate the stent which expands like a cylinder to line the bowel lumen.
  • the inflating tube (3) and the cover (4) are pulled out. Thereafter, the tight rubber band seal (5) is deployed from the inflating tube to prevent leakage of contrast from the stent and keep it inflated.
  • the stent is followed up with x-ray as it contains contrast.
  • the stent is absorbable, it disappears with time, which is confirmed by x-ray.
  • the present invention is easy to adopt which doesn't require general anaesthesia.
  • the patient does not need total parental nutrition which is almost always part of the current fistula management, thus avoiding its complication.
  • the patient can eat as soon as the treatment procedure is complete. It doesn't need repeated monitoring of the blood electrolytes, because the patient can take normal diet.
  • the patient can be discharged on the second day and come back for skin graft, or stay till the skin graft is done, which is usually less than ten days compared to other modalities of treatment which take months.
  • follow up can be done on an out patient basis with abdominal x-rays.
  • the instant invention can be implemented by sealing the bowel defect from inside the bowel lumen, preventing its content from leaking outside and establishing the gastrointestinal continuity by performing minimal access surgery.

Landscapes

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

Abstract

La présente invention concerne un équipement chirurgical pour le traitement d'une fistule entérocutanée qui comprend une membrane externe recevant un couvercle avec un tube de gonflage dans celle-ci, l'extrémité distale du tube de gonflage étant raccordée à un stent. En outre, l'invention concerne un procédé de traitement d'une fistule entérocutanée comprenant les étapes de : - identification radiologique de l'anatomie d'une fistule, - détermination du diamètre de l'intestin et du tractus de fistule suivi du dimensionnement du stent, - insertion de la membrane externe dans le tractus de fistule, - insertion de stent recouvert par un couvercle avec un tube de gonflage à l'intérieur de celui-ci à travers la membrane externe, - gonflage dudit stent. Celui-ci est associé aux caractéristiques avantageuses suivantes : - traitement moins consommateur de temps. - Court séjour à l'hôpital. - Procédure moins invasive. - Prévention du contact de la peau avec le contenu de l'intestin. - Économique.
PCT/IB2017/000073 2016-11-11 2017-01-23 Équipement chirurgical et procédé de traitement d'une fistule entérocutanée Ceased WO2018087587A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201611038619 2016-11-11
IN201611038619 2016-11-11

Publications (1)

Publication Number Publication Date
WO2018087587A1 true WO2018087587A1 (fr) 2018-05-17

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111330094A (zh) * 2020-03-09 2020-06-26 上海交通大学医学院附属第九人民医院 一种集成了给药、引流和封堵功能的肠瘘处理装置
WO2024088089A1 (fr) * 2022-10-26 2024-05-02 宁波大学附属第一医院 Tube de sécurité postopératoire réglable et son procédé d'utilisation et ensemble de formation de passage d'observation médicale

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110054492A1 (en) * 2009-08-26 2011-03-03 Abbott Laboratories Medical device for repairing a fistula
WO2014113461A2 (fr) * 2013-01-15 2014-07-24 Curaseal Inc. Dispositifs et méthodes de traitement des fistules

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110054492A1 (en) * 2009-08-26 2011-03-03 Abbott Laboratories Medical device for repairing a fistula
WO2014113461A2 (fr) * 2013-01-15 2014-07-24 Curaseal Inc. Dispositifs et méthodes de traitement des fistules

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111330094A (zh) * 2020-03-09 2020-06-26 上海交通大学医学院附属第九人民医院 一种集成了给药、引流和封堵功能的肠瘘处理装置
WO2024088089A1 (fr) * 2022-10-26 2024-05-02 宁波大学附属第一医院 Tube de sécurité postopératoire réglable et son procédé d'utilisation et ensemble de formation de passage d'observation médicale

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