Device for the treatment of anal fistula-in-ano and complex fistula-in-ano

Abstract

A device for the treatment of anal fistula-in-ano and complex fistula-in-ano includes a balloon inflation/deflation tube, a suction/drainage tube, a scooping tube, that is disposed between the balloon inflation/deflation tube and the suction/drainage tube, a diaphragm that is disposed across the balloon inflation/deflation tube and the suction/drainage tube, and an irrigation/drainage path that is disposed between a balloon and a plurality of spikes. The balloon is disposed at an end of the balloon inflation/deflation tube.

Claims

1. A device for the treatment of anal fistula-in-ano and complex fistula-in-ano, comprising: a balloon inflation or deflation tube that is configured to inflate or deflate a balloon that is disposed at an end of the balloon inflation or deflation tube, said balloon configured to create a barrier between an anal canal and a fistula of a patient; a suction or drainage tube that is configured to drain debris from an internal wound of the fistula and intersphincteric space; a scooping tube through which the internal wound of the fistula is scooped and debridement is carried out, said scooping tube being disposed adjacent to the balloon inflation or deflation tube and also adjacent to the suction or drainage tube; a diaphragm that holds the device in place and keeps a neck of the fistula wide for drainage to prevent premature closure, said diaphragm being disposed across the balloon inflation or deflation tube and the suction or drainage tube; and an irrigation or drainage path disposed on an outer surface of the balloon, said irrigation or drainage path facilitating irrigation of an abscess wall; and a plurality of spikes disposed on an external surface of said irrigation or drainage path that facilitates adhesion of the balloon inflation or deflation tube and the suction or drainage tube to a cavity.

2. The device for the treatment of anal fistula-in-ano and complex fistula-in-ano as claimed in claim 1, wherein a length of the balloon inflation or deflation tube ranges between 5 cm and 25 cm.

3. The device for the treatment of anal fistula-in-ano and complex fistula-in-ano as claimed in claim 1, wherein a length of the scooping tube ranges between 5 cm and 25 cm.

4. The device for the treatment of anal fistula-in-ano and complex fistula-in-ano as claimed in claim 1, wherein a length of the suction or drainage tube ranges between 5 cm and 25 cm.

5. The device for the treatment of anal fistula-in-ano and complex fistula-in-ano as claimed in claim 1, wherein a length of the diaphragm ranges between 1 cm and 5 cm.

6. The device for the treatment of anal fistula-in-ano and complex fistula-in-ano as claimed in claim 1, wherein an expansion capacity of the balloon ranges between 1 mL and 7 mL.

7. The device for the treatment of anal fistula-in-ano and complex fistula-in-ano as claimed in claim 1, wherein the balloon is configured to be inflated by a sterile, water-filled syringe.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 illustrates an embodiment of a device for the treatment of anal fistula-in-ano and complex fistula-in-ano, in accordance with the present disclosure.

(2) FIG. 2 illustrates a method of operation of a device for the treatment of anal fistula-in-ano and complex fistula-in-ano (before inflation), in accordance with the present disclosure.

(3) FIG. 3 illustrates a method of operation of a device for the treatment of anal fistula-in-ano and complex fistula-in-ano (after inflation), in accordance with the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

(4) Throughout this specification, the use of the word comprise and include, and variations such as comprises comprising, includes, and including may imply the inclusion of an element or elements not specifically recited.

(5) Throughout this specification, the disclosure of any range is to be construed as being inclusive of the lower limit of the range and the upper limit of the range.

(6) A device for the treatment of anal fistula-in-ano and complex fistula-in-ano is disclosed. As illustrated in FIG. 1, the device comprises: a balloon inflation/deflation tube (1); a scooping tube (2); a suction/drainage tube (3); a diaphragm (4); an irrigation/drainage path (5); a balloon (6); and a plurality of spikes (7).

(7) The device is held in place at the diaphragm (4), which also keeps the neck of fistula wide for drainage to prevent premature closure. The diaphragm (4) is disposed across the balloon inflation/deflation tube (1) and the suction/drainage tube (3).

(8) The balloon inflation/deflation tube (1) is configured to inflate or deflate the balloon (6) that is disposed at an end of the balloon inflation/deflation tube (1). The balloon creates a barrier between the anal canal and the fistula of a patient.

(9) The suction/drainage tube (3) is configured to irrigate/drain the debris from internal wound of fistula and intersphincteric space, while the wound is scooped in post-operative care and debridement is carried out through the scooping tube (2) that is disposed between the balloon inflation/deflation tube (1) and the suction/drainage tube (3).

(10) Once the intersphincteric space infection is drained, the mucosa over the internal opening gets closed. This helps in closure of the internal opening by separation. It also keeps the intersphincteric space or abscess cavity open for drainage.

(11) The plurality of spikes (7) is disposed on an outer surface of the irrigation/drainage path (5) and facilitates the adhering of the balloon inflation/deflation tube (1) and the suction/drainage tube (3) to the cavity, in addition to debridement. The irrigation/drainage path (5) is disposed between the balloon (6) and the plurality of spikes (7), and facilitates the irrigation and debridement of the abscess wall, thereby fastening the process of internal healing.

(12) The length of the balloon inflation/deflation tube (1) can be customized by a treating surgeon from case-to-case. In an embodiment of the present disclosure, the length of the balloon inflation/deflation tube (1), ranges between 5 cm and 25 cm.

(13) In another embodiment of the present disclosure, the length of the scooping tube (2) ranges between 5 cm and 25 cm.

(14) The length of the suction/drainage tube (3) can be customized by a treating surgeon from case-to-case. In yet another embodiment of the present disclosure, the length of the suction/drainage tube (3) ranges between 5 cm and 25 cm.

(15) In yet another embodiment of the present disclosure, the length of the diaphragm (4) ranges between 1 cm and 5 cm.

(16) In yet another embodiment of the present disclosure, the expansion capacity of the balloon (6) ranges between 1 ml and 7 ml.

(17) The method of operation of the device is illustrated in FIG. 2 and FIG. 3, and comprises the steps of: debriding the internal opening and draining the intersphincteric abscess; introducing the device into the fistula tract over a guide wire or fistula probe, with the balloon (6) being placed close to the internal opening; inserting the end of the balloon inflation/deflation tube (1) at which the balloon (6) is disposed, into the external opening of the fistula; passing the end of the balloon inflation/deflation tube (1) at which the balloon (6) is disposed, through the complete length of the tract till it passes through the internal opening; fixing a sterile water filled syringe (8) into the balloon inflation/deflation tube (1) and inflating the balloon (6) up to required capacity (not exceeding 20 ml); making sure that the diaphragm (4) is in its place to prevent premature closure of the fistula tract; irrigating and draining through the device by use of a cleaning solution; and removing the device once the internal opening heals.

(18) In yet another embodiment of the present disclosure, the device is made of high standard medicated latex materials.

(19) In yet another embodiment of the present disclosure, the cleaning solution is a liquid solution that comprises hydrogen peroxide, povidone-iodine, eusol, copper suphate, water, and/or saline.

(20) The disclosed device offers the following advantages: prevents premature closure of fistula wound, thereby minimizing the chances of recurrence; easy to use, thus avoiding the need for a skilled medical practitioner; sphincter remains untouched, hence does not cause incontinence; minimal pain; and less time consuming.

(21) It will be apparent to a person skilled in the art that the above description is for illustrative purposes only and should not be considered as limiting. Various modifications, additions, alterations and improvements without deviating from the spirit and the scope of the disclosure may be made by a person skilled in the art. Such modifications, additions, alterations and improvements should be construed as being within the scope of this disclosure.

LIST OF REFERENCE NUMERALS

(22) 1Balloon Inflation/Deflation Tube 2Scooping Tube/Introduction of Device over Guide Wire 3Suction/Drainage Tube 4Diaphragm 5Irrigation/Drainage Path 6Balloon 7Plurality of Spikes 8Syringe