WO2019171393A1

WO2019171393A1 - Devices and methods for occluding fistula

Info

Publication number: WO2019171393A1
Application number: PCT/IN2019/050106
Authority: WO
Inventors: Prasad BAPAT; Vaidehi BAPAT
Original assignee: Bapat Prasad; Bapat Vaidehi
Priority date: 2018-03-08
Filing date: 2019-02-09
Publication date: 2019-09-12

Abstract

The present invention provides a device designated as Brushseton for occluding human or animal fistulae comprises a head (21), a body (22) and a tail (23), the body (22) optionally a hollow cylindrical tube having bristles and apertures (24) for injecting medicines through an opening (25). The device is used by inserting the head (21) after probing the fistula using conventional probes and then removing the head through external opening of the fistula or injecting medicines through opening (25) through apertures (24) and taken out through the internal opening of the anus. The body of the Brusheton (22) is adjusted in fistula track, locking or tying both the head (21) and tail (23) externally to fix the position of Brusheton in the fistula.

Description

Title

Devices and Methods for Occluding Fistula

Field of invention

The present invention relates to devices for occluding fistula and the methods therefore using the said devices. The devices provided by the present invention could be used with obvious modifications in diseases such as Pilonidal sinus also. However the present invention is described with fistula occluding devices and procedure thereof as an example.

Background of invention

The present invention relates to medical devices and methods for treating fistulae or diseases like Pilonidal sinus. A variety of fistulae can occur in humans. These fistulae can occur for a variety of reasons such as but not limited to, as a congenital defect, as a result of inflammatory bowel disease, such as Crohn’s disease, irradiation, trauma, such as childbirth or as a side effect from surgical procedures. Further, several different types of fistulae can occur, for example, urethra-vaginal fistulae, vesico-vaginal fistulae, tracheo- esophageal fistulae, gastro cutaneous fistulae, and any number of anorectal fistulae, such as recto-vaginal fistula, recto-vesical fistulae, recto-urethral fistulae, or recto-prostatic fistulae. Anorectal fistulae can result from infection in the anal glands, which are located around the circumference of the distal anal canal that forms the anatomic landmark known as the dentate line. Approximately 20-40 such glands are found in humans. Infection in an anal gland can result in an abscess. This abscess then can track through soft tissues (e.g., through or around the sphincter muscles) into the perianal skin, Where it drains either spontaneously or surgically. The resulting void through soft tissue is known as a fistula. The internal or inner opening of the fistula, usually located at or near the dentate line, is known as the primary opening. Any external or outer openings, which are usually located in the perianal skin, are known as secondary openings. The path which these fistulae take, and their complexity, can vary. A fistula may take a“straight line” path from the primary to the secondary opening, known as a simple fistula. Alternatively, the fistula may consist of multiple tracts ramifying from the primary opening and have multiple secondary openings. This is known as a complex fistula. The anatomic path which such fistulae take is classified according to their relationship to the anal sphincter muscles. The anal sphincter consists of two concentric bands of muscle, the inner or internal sphincter and the outer or external anal sphincter. Fistulae which pass between the two concentric anal sphincters are known as inter-sphincteric fistulae. Those which pass through both internal and external sphincters are known as trans-sphincteric fistulae, and those which pass above both sphincters are called supra-sphincteric fistula. Fistulae resulting from Crohn’s disease usually “ignore” these anatomic planes, and are known“extra anatomic” fistulae. Many complex fistulae consist of multiple tracts, some blind-ending and others leading to multiple secondary openings. One of the most common complex fistulae is known as a horseshoe fistula. In this instance, the infection starts in the anal gland (primary opening) at or near the 12 o’clock location (with the patient in the prone position). From this primary opening, fistulae pass bilaterally around the anal canal, in a circumferential manner. Multiple secondary openings from a horseshoe fistula may occur anywhere around the periphery of the anal canal, resulting in a fistula tract with a characteristic horseshoe configuration. One technique for treating perianal fistulae is to make an incision adjacent the anus until the incision contacts the fistula and then excise the fistula from the anal tissue. This surgical procedure tends to sever the fibers of the anal sphincter, and may cause incontinence. Other surgical treatment of fistulae involve passing a fistula probe through the tract of the fistula in a blind manner, using primarily only tactile sensation and experience to guide to probe. Having passed the probe through the fistula tract, the overlying tissue is surgically divided. This is known as a fistulotomy. Since a variable amount of sphincter muscle is divided during the procedure, fistulotomy also may result in impaired sphincter control, and even frank incontinence. Still other methods involve injecting sclerosant or sealant (e.g., collagen or fibrin glue) into the fistula tract which blocks it. Closure of a fistula using a sealant is typically performed as a two-stage procedure, including a first-stage seton placement and injection of the fibrin glue several weeks later. This allows residual infection to resolve and to allow the fistula tract to“mature” prior to injecting a sealant. If sealant or sclerosant were injected as a one-stage procedure, into an“unprepared” or infected fistula, this may cause a fare-up of the infection and even further abscess formation. A gastrointestinal fistula is an abnormal passage that leaks contents of the stomach or the intestine (small or large bowel) to other organs, usually other parts of the intestine or the skin. For example, gastro jejunocolic fistulae include both entero cutaneous fistulae (those occurring between the skin surface and the intestine, namely the duodenum, the jejunum, and the ileum) and gastric fistulae (those occurring between the stomach and skin surface). Another type of fistula occur ring in the gastrointestinal tract is an entero enteral fistula, which refers to a fistula occurring between two parts of the intestine. Gastrointestinal fistulae can result in malnutrition and dehydration depending on their location in the gastrointestinal tract. They can also be a source of skin problems and infection. The majority of these types of fistulae are the result of surgery (e.g., bowel surgery), although sometimes they can develop spontaneously or from trauma, especially penetrating traumas such as stab wounds or gunshot wounds. Inflammatory processes, such as infection or inflammatory bowel disease (Crohn’s disease), may also cause gastrointestinal fistulae. In fact, Crohn’s disease is the most common primary bowel disease leading to enterocutaneous fistulae, and surgical treatment may be difficult because additional enterocutaneous fistulae develop in many of these patients postoperatively. Treatment options for gastrointestinal fistulae vary. Depending on the clinical situation, patients may require IV nutrition and a period of time without food to allow the fistula time to close on its own. Indeed, nonsurgical therapy may allow spontaneous closure of the fistula, although this can be expected less than 30% of the time according to one estimate. A variable amount of time to allow spontaneous closure of fistulae has been recommended, ranging from 30 days to 6 to 8 Weeks.

During this preoperative preparation, external control of the fistula drainage prevents skin disruption and provides guidelines for fluid and electrolyte replacement. In some cases, surgery is necessary to remove the segment of intestine involved in a non-healing fistula. There remain needs for improved and / or alternative devices and methods for treating fistulae including rectovaginal fistulae.

The treatment of anal fistula remains challenging. The goals of treatment are draining infection, eradicating the fistulous tract, and avoiding persistent or recurrent disease while preserving anal sphincter function. Treatment options of anal fistula include fistulotomy, seton placement, endorectal advancement flap, dermal island flap, fistula plug, fibrin injection and ligation of the intersphincteric fistula tract. Surgical treatment of anal fistula depends on the amount of sphincter involvement and internal and external anal sphincters preservation for continence maintenance. Some surgeons prefer an extensive use of complete fistulectomy and fistulotomy in both high and low anal fistulas with an overall postoperative incontinence rates of 30-35 % Seton techniques still occupy an important position in the treatment of high anal fistulas. One technique for treating an abnormal bodily passage such as a fistula is to occlude the passage with an occluding member, such as a plug or graft.

Examples of such occluding members and related methods are disclosed in US. Application No. 2005/0070759A1 , published on March 31 , 2005, 2005/0159776A1 , published July 21 , 2005, 2006/0074447A2, published on April 6, 2006, 2007/0031508, published on Feb. 8, 2007, and US. 2007/0198059, published Aug. 23, 2007, which are hereby incorporated by reference in their entirety. Such occluding members may be pulled through the primary opening of a fistula until the occluding member is securely lodged within the fistula. The occluding member may be further secured within the fistula by the use of sutures or a cap associated with the body of the plug or graft. Typical techniques for treating a fistula involve draining infection from the fistula tract and maturing it prior to a definitive closure or sealing procedure by inserting a narrow diameter rubber drain, known as a seton, through the tract. This is usually accomplished by inserting a fistula probe through the outer (secondary) opening and gently guiding it through the fistula, and out through the inner (primary) opening. A seton, thread or tie is then a fixed to the tip of the probe, which is then withdrawn back out of the tract, leaving the seton in place. The seton may then be tied as a loop around the contained tissue and left for several Weeks or months. Another technique for treating a fistula involves the use of a plug-like closure device in combination with a drain age thread or seton, as disclosed in co-pending US patent No. 2005/0049626, published on March 3, 2005, which is hereby incorporated by reference in its entirety. In this technique, a closure device is provided with a flexible application string that can be used to drain secretions or other undesirable liquids from the fistula. A rod-like instrument is pushed into the fistula from the outer opening and is used to investigate the trajectory of the fistula. After the instrument is pushed forward enough to protrude from the inner opening, the application string is pulled through the fistula from the inner opening until the closure device “sticks” in the inner opening. The closure device is then pushed as far as necessary for it to be tightly secured

Within the fistula. Still other techniques for treating fistulas are described in US. Application No. 1 1/415,403, dated May 1 , 2006 and US patent application No. 11/766,606, dated June. 21 , 2007, which are hereby incorporated by reference in their entirety. The above techniques can be difficult for some physicians, such as endoscopists, to perform. Therefore, there remains a need for simplified procedures and new medical devices and systems for occluding fistulas. The present invention provides devices, systems and minimally invasive methods for occluding fistulas that overcome the shortcomings of the prior art and simplify the implantation of an occluding member in a fistula of a patient. The present invention may be used to occlude any type of abnormal bodily passage or fistula. For example, the claimed devices, systems, and methods may be used to occlude tracheo- esophageal fistulas, gastro-cutaneous fistulas, anorectal fistulas, fistulas occurring between the vagina and the urethra or bladder, fistulas occurring between the vascular and gastrointestinal systems, or any other type of fistula.

This invention concerns the treatment of anorectal fistulae of the human and animals. This “Brusheton” - a brush with seton, is useful for removal of infected tissue and to fasten the healing process in an anorectal fistula. It can be used in the treatment of fistula in the other parts too. It helps to avoid complex surgical process for fistula repair. Once it is inserted inside the fistula track by the doctor, patient need not visit clinic repeatedly. Patient can clean the Brusheton by pulling it out and can insert again by mounting any disinfectant (atural / artificial) on the brush part.

Anorectal fistulae result from infection in the anal glands, which are located around the circumference of the distal anal canal that forms the anatomic landmark known as the dentate line. Fig. (1 ) and (2) illustrate the typical anorectal fistulae (4) and (5) that commonly occur in humans. The dentate line is shown at (1 ) of Fig. (1 ) approximately 20-30 such glands are found in man. Infection in an anal gland usually results in an abscess, and the abscess then tracks through or around the sphincter muscles into the perianal skin, where it drains either spontaneously or surgically. The resulting tract is known as a fistula. The inner opening of the fistula, usually located at the dentate line, is known as the primary opening (2). The outer (external) opening, located in the perianal skin, is known as the secondary opening 3. The path which these fistulae take along with their complexity varies a lot. A fistula may take a “straight line” path from the primary to the secondary opening, known as a simple fistula (4). Alternatively, the fistula may consist of multiple tracts ramifying from the internal (primary) opening and have multiple external (secondary) openings. This is known as a complex fistula (5). The anatomic path which a fistula takes is classified according to its relationship to the anal sphincter muscles as shown in Fig (1 ). The anal sphincter consists of two concentric bands of muscle, the inner or internal sphincter (6) and the outer or external anal sphincter (7). Fistulae which pass between the two concentric anal sphincters are known as inter-sphincteric fistulae (8). Those which pass through both internal and external sphincters are known as trans- sphincteric fistulae (9), and those which pass above both sphincters are called supra sphincteric fistula (10). Fistulae resulting from Crohn’s disease usually“ignore” these anatomic planes, and are known as“extra-anatomic” fistulae. Many complex fistulae consist of multiple tracts, some blind-ending (1 1 ) and others leading to multiple external (secondary) openings (3). One of the most common complex fistulae is known as a horseshoe fistula (12), shown in Fig. (2). In this instance the infection starts in the anal gland (the primary opening) at the 12 o’clock location (with the patient in the prone position.) From this primary opening, fistulae pass bilaterally around the anal canal, in a circumferential manner. Multiple external (secondary) openings from a horseshoe fistula may occur anywhere around the periphery of the anal canal, resulting in a fistula tract with a characteristic horseshoe configuration (12). Failed surgical treatment leads to potential complications such as incontinence and multiple complex fistula formation.

A prior art technique for treating a perianal fistulae was to make an incision adjacent the anus until the incision contacts the fistula and then excise the fistula from the anal tissue. This surgical procedure tends to sever the fibers of the anal sphincter, and may cause incontinence. Other surgical treatment of fistulae traditionally involved passing a fistula probe through the tract of the fistula in a blind manner, using primarily only tactile sensation and experience to guide to probe. Having passed the probe through the fistula tract, the overlying tissue is surgically divided. This is known as a fistulotomy. Since a variable amount of sphincter muscle is divided during the procedure, fistulotomy also may result in impaired sphincter control, and even frank incontinence. Alternatively, the fistula tract may be surgically drained by inserting a narrow diameter rubber drain through the tract. This is known as a seton (Greek,“thread”). The seton is passed through the fistula tract and tied as a loop around the contained tissue and left for several weeks or months, prior to definitive closure or sealing of the fistula. This procedure is usually performed to drain infection from the area, and to mature the fistula tract prior to a definitive closure procedure. More recently, methods have evolved to inject sclerosant or sealant (collagen or fibrin glue) into the tract of the fistula to block the fistula. Such sealants are described in prior art, such as Rhee US. Pat. No. 5,752,974. One drawback with prior art is these glues are very viscous and clog the narrow-bore channels of the instrument as described in the current invention. Closure of a fistula using a sealant is usually performed as a two-stage procedure, including a first-stage seton placement and injection of the fibrin glue several weeks later. This allows residual infection to resolve and to allow the fistula tract to“mature” prior to injecting a sealant. If sealant or sclerosant were injected as a one-stage procedure, into an “unprepared” or infected fistula, this may cause a flare-up of the infection and even further abscess formation. Whatever method is used, accurate identification of the entire course of the fistula tract usually is a prerequisite for successful surgery. Traditionally the course of the fistula tract is determined by using a long, thin, metal probe (a fistula probe). The probe is passed into the external opening and maneuvered in a blind manner through the fistula tract, and out through the internal (primary) opening. Since the probe is passed in a blind manner, there is a hazard of “missing” the actual fistula tract, and creating additional tracts. This results in creating further fistulae, “false passages”, incorrect location of the primary opening, and persistent or recurrent fistula formation. Surgical treatment of fistulae is often problematic, and recurrence rates of up 30% are described. Surgical fistulotomy of horseshoe fistulae results in an incontinence rate in up to 60% of patients, because of the need to divide sphincter muscle during surgery. Even use of fibrin glues is associated with high recurrence rates. There are reports of failure rates of over 80% in“blind” injection of sealant into a complex fistula, generally due to the presence of unrecognized tracts and infection Within the fistula tract.

An important step in successful closure of a fistula tract is accurate identification and closure of the primary opening of the fistula. Once the internal opening has been accurately identified, effective closure is necessary to prevents recurrence. This invention is concerned with an improved process of identifying the fistula tract, removal of infection and closing the tract. The main object of the present invention is to provide devices for occluding fistula in human and animals and method of occluding the fistulae using the said device wherein the device enables such occluding without big wound.

Another object is to provide a method which is less painful, requiring minimum bed rest and no hospitalization.

Still another object is to provide device and method for occluding fistulae wherein no spinal or general anesthesia is required. Summary of the invention

The present invention provides device and method for occluding of human and animal fistulae. The method relates to removal of infected tissue by a device designated as Brusheton in the fistula tract. The Brusheton is composed of a Head, Tail and a Body which may be optionally a hollow cylindrical means with bristles which is in between the head and the tail. The device helps to clean the fistula tract, and allows disinfectant / healing medicine coated on the body of the Brusheton successfully on the tract or also allows the impregnation of the medicines through the small catheter connected to the body of the Brusheton. The present invention is a simplified para-surgical seton technique for the cure of all types of fistula without hospitalization. All existing surgical techniques are performed under general or spinal anesthesia. This increases risk management related to anesthesia. Also there is high risk of recurrence and incontinence. High recurrence rate, chances of anal incontinence, complexity increases after every surgery.

In the present invention, the treatment can be performed under local anesthesia. There is no need of hospitalization or surgery to cure fistula infection. The invention of this Brusheton allows to apply or introduce any medicine (herbal / Chinese / antibiotics, etc) in the fistula track and it helps for the drainage and removal of infection.

In the present invention, the Brusheton can be of any diameter and length as per requirement of location in the body. For inserting this Brushseton, any existing technique like probing, can be used. Local anesthesia will be enough as the seton will not damage anything inside body. Other end of seton is taken out from anal canal and tied externally. Patient is advised to walk. So that the seton can take infection out. Any antibiotics or natural healing medicine can be applied on the brush part every day. Patient can do this process at home. As infection gets removed, body will heal the fistula track. After 6 to 12 weeks, Brusheton can be removed.

Brief description of drawings

The present invention is described by figures accompanying this specification which are illustrative only and should not be construed to limit the scope of the present invention in any manner.

Following table (1 ) describe the legends used in the drawings and their descriptions.

Table (1)

Fig. (1 ) is a schematic illustration of a typical human body showing the sphincter muscles and the possible anatomic courses of various forms of anorectal fistula (longitudinal plane). Fig. (2) is a schematic illustration of a posterior of a typical human body showing the possible simple anorectal fistula and horseshoe fistula (perineal view)?

Fig. 3(a) is a schematic diagram of flexible metal probe.

Fig. 3(b) shows a schematic diagram of Brusheton.

Fig. (4) is schematic illustration of condition when Brusheton is fixed in fistula track.

Fig. (5) shows the device with hollow Brusheton with arrangement for impregnating the medicines.

Referring to Figure 3(b) and (5) A device designated as Brusheton for occluding the human or animal fistulae comprises a head (21 ), a cylindrical body (22) with bristles and a tail (23), optionally the said body (22) being a hollow cylindrical with apertures (24) for injecting medicines through the opening (25). In one of the embodiments of the present invention the Brushseton is made prepared from the sterile cotton thread, nylon thread, any biodegradable material, any biocompatible polymeric seton material or the metallic wire characterized by the one used regularly in Angiography or angioplasty techniques. In still another embodiment the length of head (21 ) may be ranging between 3 cm to 30 cm.

In still another embodiment the length of the tail (23) may be ranging between 3 cm to 30 cm.

In still another embodiment the length of the body may be ranging between 3 cms. to 30 cm. In yet another embodiment the body (22) may be a cylindrical brush or optionally a hollow cylindrical body with apertures (24) covered with bristles and opening (25) for injecting medicines.

In still another embodiment the body (22) comprising bristles forming cylindrical brush may be coated with the suitable single antiseptic or mixtures to combat infections characterized by effectively with the bio-burden or bacterial load in the fistula infection from the following natural compounds or well known antibiotics. In another embodiment of the invention Brusheton may be coated with anesthetic characterized by xylocaine or lidocaine along with the antiseptics/ antibiotics used for treatment of fistula.

In still another embodiment the brusheton may be coated with the antimicrobial from natural resources or chemicals characterized by Turmeric in combination of Apamarg, Triphala along with Alovera, Papaya latex in combination of Turmeric, Neem with Euphorbia latex, Calotropis Procera latex with Turmeric, Poly hexa methylene biguanide (PHMB) or chlorhexidine gluconate. In yet another embodiment the tip of the head (21) may be coated with radio- opaque material to get indentified while insertion under x-ray.

In yet another embodiment the length of the bristles may be 0.1 to 2 mm.

The present invention also provides for a method of occluding human or animal fistulae which comprises giving the patient lithotomic position, cleaning the anal area using spirit and antibacterial, subjecting the anal area to local anesthetic sprays, tracing the fistula by a conventional flexible probe, inserting the probe through external opening of the fistula or injecting medicines through opening (25) through apertures (24) and taken out through the internal opening of the anus, adjusting the cylindrical brush of the body (22) in the fistula track, locking or tying both the head (21 ) and tail (23) externally to fix the position of Brusheton in the fistula.

Working of the invention:

Patient is give lithotomic position. The anal area including external opening is cleaned with sprit and butadiene. Local anesthesia is given using Lidocain surface anesthesia spray. Fistula is traced by flexible probe. The probe is inserted through external opening of fistula and taken out through internal opening and anus. The body (brush part) of Brusheton is adjusted in the fistula track. Then both ends of Brusheton are locked or tied externally. Patient will be discharged immediately.

In complex fistulas structures like high anal fistula or fistula related to other organs, the Brusheton can be inserted using x-ray under C-arm. As the tip Brusheton is radio opaque, it can be visible under x-ray. Patient is given lithotomic position. Local or appropriate anesthesia is given. Radio opaque die is pushed through catheter to trace the fistula track. Head of Brusheton is inserted in the fistula track. A catheter of appropriate diameter is mounted on it. Both Brusheton and catheter are inserted slowly inside fistula track. Once the Brusheton is adjusted in the fistula track, both ends of Brusheton are tied or locked outside the body.

The diameter and length of Brusheton can be selected as per the location, diameter and length of fistula. In most of anal fistula patients, Brusheton can be inserted in the track under local anesthesia with the help of appropriate flexible probe. Under lithotomy position, the probe is inserted from external opening of fistula. Brusheton is mounted at the end of probe. The probe is taken out passing through internal opening from the anus. The Brusheton is pulled till the brush part covers the whole length of fistula track. Before positioning of the brush part in the fistula track, a disinfectant medicine (natural / artificially prepared) should be applied on it. The two ends of Brusheton are tied firmly with knot. The Brusheton should be kept loose so that patient can pull it out easily.

In special cases like recto vaginal, urethro rectal fistula or high anal fistula, the fistula brush can be inserted under general or spinal anesthesia. It can be inserted with the help of x-ray under C- arm screening under local anesthesia.

No need of hospitalization.

The brush part keeps rubbing on the inner wall of fistula while patient moves. The disinfectant on it or which has been introduced through hollow body (22) will support healing. Everyday, patient should pull brush part out from external opening, clean and apply any disinfectant medicine on it. After this, the Brusheton should be pulled from anal end so that it will be repositioned inside fistula track again. Advantages of the present invention:

The device and the method of occluding of Fistulae using the said device result in following advantages:

• No big wound

· Very less pain

• No bed rest required

• No hospitalization

• No incontinence

• No need of spinal or general anesthesia in case of anal fistulae · Can be done in special conditions like diabetes, heart problem,

epilepsy, drug allergy, kidney problems, etc.

• Can be used for pilonidal sinus

• No oral medicines required. Only local application

Claims

Claims:

1. A device designated as Brushseton for occluding the human or animal fistulae comprises a head (21 ), a cylindrical body (22) with bristles and a tail (23), optionally the said body (22) being a hollow cylindrical with apertures (24) for injecting medicines through the opening (25).

2. The Brushseton as claimed in claim (1 ) wherein the said Brushseton is made prepared from the sterile cotton thread, nylon thread, any bio degradable material, any biocompatible polymeric seton material or the metallic wire characterized by the one used regularly in Angiography or angioplasty techniques.

3. The Brushseton as claimed in claim (1 ) wherein the length of head (21 ) is between 3 cm to 30 cm.

4. The Brushseton as claimed in claim (1 ) wherein the length of the tail

(23) ranges between 3 cm to 30 cm.

5. The Brushseton as claimed in claim (1 ) wherein the length of the body ranges between 3 cm to 30 cm.

6. The Brushseton as claimed in claim (1 ) wherein the body (22) is a cylindrical brush or optionally a hollow cylindrical body with apertures

(24) covered with bristles and opening (25) for injecting medicines.

7. The Brushseton as claimed in claim (6) wherein the body (22) comprising bristles forming cylindrical brush is coated with the suitable single antiseptic or mixtures to combat infections characterized by effectively with the bio-burden or bacterial load in the fistula infection from the following natural compounds or well known antibiotics.

8. The Brusheton as claimed in claim (6) wherein the said Brusheton is coated with anesthetic characterized by xylocaine or lidocaine along with the antiseptics/ antibiotics used for treatment of fistula.

9. The Brushseton as claimed in claim (1 ) wherein the said Brusheton is coated with the antimicrobial from natural resources or chemicals characterized by Turmeric in combination of Apamarg, Triphala along with Alovera, Papaya latex in combination of Turmeric, Neem with Euphorbia latex, Calotropis Procera latex with Turmeric, Poly hexa methylene biguanide (PHMB) or chlorhexidine gluconate.

10. The Brusheton as claimed in claim (1 ) wherein the tip of the head (21 ) is coated with radio-opaque material to get indentified while insertion under x-ray.

1 1. The Brusheton as claimed in claim (6) wherein the length of the bristles is 0.1 to 2 mm.

12. The present invention also provides for a method of occluding human or animal fistulae which comprises giving the patient lithotomic position, cleaning the anal area using spirit and antibacterial, subjecting the anal area to local anesthetic sprays, tracing the fistula by a conventional flexible probe, inserting the probe through external opening of the fistula or injecting medicines through opening (25) through apertures (24) and taken out through the internal opening of the anus, adjusting the cylindrical brush of the body (22) in the fistula track, locking or tying both the head (21 ) and tail (23) externally to fix the position of Brushseton in the fistula.