WO2018087587A1

WO2018087587A1 - A surgical equipment and a method for treatment of enterocutaneous fistula

Info

Publication number: WO2018087587A1
Application number: PCT/IB2017/000073
Authority: WO
Inventors: R. M. Salah HUSEIN
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-11-11
Filing date: 2017-01-23
Publication date: 2018-05-17
Anticipated expiration: 2019-05-11

Abstract

This invention relates to a surgical equipment for treatment of enterocutaneous fistula which comprises an outer membrane accommodating a cover with an inflating tube thereinside wherein distal end of the inflating tube is connected to a stent. Further, this invention relates to a method for treatment of enterocutaneous fistula comprising steps of:- - Radiological identification of fistula anatomy, - Determination of bowel diameter and fistula tract followed by stent sizing, - Insertion of the outer membrane into fistula tract, - Insertion of stent covered by a cover with inflation tube thereinside through the outer membrane, - Inflation of said stent. It is associated with the following advantageous features:- - Less time consuming treatment. - Short hospital stay. - Less invasive procedure. - Prevention of the skin contact with the bowel content. - Cost effective.

Description

TITLE

A surgical equipment and a method for treatment of enterocutaneous fistula.

FIELD OF INVENTION

This invention relates to a surgical equipment and a method for treatment of enterocutaneous fistula.

BACKGROUND/PRIOR ART

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 Γ. 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.

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.

However, the fistula still possesses a common surgical issue, requiring multiple steps of treatment with a long course of management, and long hospital stay.

In view of the above, it is required to devise a novel surgical equipment and a method for treatment of enterocutaneous fistula which can address prior art issues and serve the purpose efficiently.

OBJECTS OF THE INVENTION

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.

SUMMARY OF THE INVENTION According to this invention, there is provided 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.

The treatment of 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.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

Further objects and advantages of this invention will be more apparent from the ensuing description when read in conjunction with the accompanying drawings of the exemplary embodiments and wherein:

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.

DETAIL DESCRIPTION OF THE PRESENT INVENTION WITH REFERENCE TO THE ACCOMPANYING DRAWINGS

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. When deflated and prior to insertion it can be folded on itself so as to allow passage thereof through the fistula tract to reach its final destination i.e. bowel lumen. Here, the stent is water proof. Now the aforementioned equipment will be described in detail with reference to the figure 1, 2 and 3.

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.

Now, reference may be made to fig 2. Further, 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. However, 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.

Thus, 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.

Once the stent is in place 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.

Now referring to fig. 3 regarding inflated stent, pusher, contracted rubber band to seal the stent and keep the same inflated.

As soon as the stent is completely inflated, 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. However, the pusher can't provide coverage to the stent and rubber band. Hence, with the application of a little force for pushing the pusher over the inflating tube, the pusher slides till it touches the attached part of the stent with said inflating tube and pushes the stent till it slips to be completely separated from the inflating tube.

As soon as the inflated stent is separated, 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.

Thus, 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.

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.

There are different kinds of 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.

Treatment Procedure of Enterocutaneous Fistula

- Radiological identification of the fistula anatomy, using fistulogram, and/or CT scan.

- Measurement of bowel diameter and fistula tract according to radiological image.

- Sizing of stent according to above measurements.

- Insertion of the outer sheath (outer membrane) into the fistula tract using the flexible probe (guide wire).

- X-ray (fistulogram) to identify the position of the outer sheath and to confirm the bowel lumen diameter.

- Removal of probe leaving the sheath in place. - Insertion of the stent (covered by the second sheath i.e. cover) through the outer sheath with its inflation tube. Upon reaching the bowel lumen, there is advancement of the inflation tube with the stent into the lumen while keeping both sheaths (outer membrane and cover) in place.

- 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.

- As soon as the stent is in the place, 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 outer membrane (1) is pulled out.

- One ml of patient's blood is injected into the tract to facilitate wound healing.

- Vac dressing is applied after 24-48 hours.

- Skin grafting is conducted as soon as there is a good granulation of tissue.

- The stent is followed up with x-ray as it contains contrast.

- As 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. Here 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.

All of the above mentioned procedure reduces cost enormously thereby rendering the same highly cost effective, which also benefits the patient compared to current methods of fistula management.

Thus, 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.

Advantageous Features

- Less time consuming treatment.

- Short hospital stay.

- Less invasive procedure.

- Prevention of the skin contact with the bowel content.

- Cost effective.

It is to be noted that the present invention is susceptible to modifications, adaptations and changes by those skilled in the art. Such variant embodiments employing the concepts and features of this invention are intended to be within the scope of the present invention, which is further set forth under the following claims: -

Claims

A surgical equipment for treatment of enterocutaneous fistula comprises an outer membrane accommodating a cover with an inflating tube thereinside wherein distal end of the inflating tube is connected to a stent.

A surgical equipment for treatment of enterocutaneous fistula as claimed in claim 1, wherein the outer membrane comprises a tubular part provided with a guide wire therewithin so as to guide said membrane into the fistula tract for correct placement of the same inside bowel.

A surgical equipment for treatment of enterocutaneous fistula as claimed in claim 1 or 2, wherein proximal end of the inflating tube is connected to a syringe so as to inflate the stent with fluid such as radio-opaque constrast through said tube.

A surgical equipment for treatment of enterocutaneous fistula as claimed in any of the preceding claims wherein said distal end of the inflating tube is in connection to the stent by means of a small tube therebetween.

5. A surgical equipment for treatment of enterocutaneous fistula as claimed in any of the preceding claims wherein the cover is replaceable by a pusher when the stent is completely inflated, in which the pusher is smaller than the cover.

6. A surgical equipment for treatment of enterocutaneous fistula as claimed in any of the preceding claims wherein the stent forms a double layered structure having a rough outer layer and smooth inner layer connected at ends thereof to form a tubular part upon inflation having a profile confirming to the shape of bowel lumen.

7. A method for treatment of enterocutaneous fistula comprising steps of:-

- Radiological identification of fistula anatomy,

- Determination of bowel diameter and fistula tract followed by stent sizing,

- Insertion of the outer membrane into fistula tract,

- Insertion of stent covered by a cover with inflation tube thereinside through the outer membrane,

- Inflation of said stent.

8. The method for treatment of enterocutaneous fistula as claimed in claim 7 wherein the insertion of the outer membrane into fistula tract is carried out with the help of a guide wire.

9. The method for treatment of enterocutaneous fistula as claimed in claim 7 or 8 comprising identification of the position of the outer membrane and confirmation of the bowel lumen diameter by fistulogram followed by removal of the guide wire keeping the outer membrane in place.

10. The method for treatment of enterocutaneous fistula as claimed in any of the preceding claims wherein the stent is inflated by injecting fluid such as soluble contrast through said inflation tube, in which the stent lines the bowel lumen.

11. The method for treatment of enterocutaneous fistula as claimed in any of the preceding claims wherein the inflation tube and cover are pulled out when the inflated stent is in its place followed by deployment of rubber band seal from the inflation tube to prevent leakage of contrast from the stent and maintain the same inflated.

The method for treatment of enterocutaneous fistula as claimed in any of the preceding claims wherein the outer membrane is pulled out followed by injecting patient's blood into the tract, vac dressing and skin grafting.