CLIAMS:1. The DISPOSABLE, NONTRAUMATIC AND COST EFFECTIVE SUCTION DEVICE FOR PERFORMING FIRST TRIMESTER ABORTIONS is to be used to perform surgical first trimester abortions, missed abortions or incomplete abortions upto 10 weeks of gestation, which is easy to assemble, transparent, technically easy to use as well as flexible and non-traumatic, hence there will be less chances of serious complications like uterine and bowel perforations with this device whose easy assembly also makes this device user friendly and time saving as it combines the virtues of both the conventional methods of suction and evacuation while it eliminates their disadvantages and as this device is cheap as well as disposable, thus providing an economical as well as more aseptic option for all the patients. ,TagSPECI:FORM 2

THE PATENT ACT 1970

(39 OF 1970)

&

THE PATENTS RULES, 2003

COMPLETE SPECIFICATION

(See SECTION 10, RULE 13)

1. TITLE OF THE INVENTION :

DISPOSABLE,NONTRAUMATIC AND COST EFFECTIVE SUCTION DEVICE FOR PERFORMING FIRST TRIMESTER ABORTIONS
2. APPLICANT

NAME : KRISHNA INSTITUTE OF MEDICAL SCIENCES

NATIONALITY: DEEMED TO BE UNIVERSITY DECLARED U/S 3 OF UGC ACT, 1956 VIDE NOTIFICATION NO. F.9-15 / 2001 – U-3 OF THE MINISTRY OF HUMAN RESOURCES DEVELOPMENT, GOVT.OF INDIA

ADDRESS : KRISHNA INSTITUTE OF MEDICAL SCIENCES,
NEAR DHEBEWADI ROAD, MALKAPUR, KARAD 415110, MAHARASHTRA, INDIA

3. PREAMBLE TO THE DESCRIPTION

PROVISIONAL
N / A
COMPLETE

The following Specification particularly describes the nature of this invention and the manner in which it is to be performed :

4. TECHNICAL FIELD

The present invention relates to medical sciences and more particularly to the field of obstetrics and gynaecology wherein a simple flexible, non-traumatic, cheap and disposable suction tubing is designed for performing procedures like surgical termination of pregnancy upto 10 weeks of gestation, missed abortion, incomplete abortions etc.

This tubing is to be used for suction and evacuation of products of conception and menstrual regulation upto 10 weeks of pregnancy.

5. BACKGROUND

Surgical abortion is one of the most common procedures performed in women of the reproductive age group throughout the world. Dilation (or dilatation) and evacuation (D&E) refers to the dilation (widening/opening) of the cervix and surgical removal of part of the lining of the uterus and/or contents of the uterus by aspirating and scooping (curettage). It is a method of first trimester abortion, and for incomplete abortion. The cervical canal is first dilated with a Hegar’s Dilator; uterocervical length is measured by inserting the uterine sound followed by suctioning of the products of conception.

Currently, in India medical termination of pregnancy and suction and evacuation is done either by a rigid metallic cannula or with the help of manual vacuum aspirator (MVA) made up of plastic.

The metallic cannula is easy to use and is autoclavable, hence cost effective in the Indian scenario, but the chances of inadvertent uterine and subsequent bowel perforation is high, especially in inexperienced hands are very commonly reported in literature. It is non- transparent hence products of conception in the tubing are not visualized.

The manual vacuum aspirator (MVA) overcomes this problem as it is non- traumatic as well as transparent .it is also reusable. But the assembling the various parts of the MVA is extremely cumbersome and time consuming. Also repeated charging and discharging of the piston is required during the procedure which is tedious and time consuming. The MVA also becomes stubborn after repeated charging and discharging.

6. SUMMERY

Hence this disposable non traumatic, flexible suction device eliminates the disadvantages of both the conventional methods mentioned above and combines the advantages of both. It is technically easy to use like the metallic cannula but safe and non-traumatic and transparent like the manual vacuum aspirator (MVA) as well as cheap and disposable, hence cost effective as well as reduced risk of infection. The assembly is absolutely simple and easy and takes not more than few seconds to assemble. The markings over the body of the device provides an added advantage by measuring the uterocervical distance and thus eliminates the use of the uterine sound in the procedure.

The device mainly consists of long transparent PVC tubing 50 cms in length with an open bevelled patient end as well as a side hole and four pinhole openings for better suctioning. The internal diameter of the suction tubing is 16/18/20 FG (French unit)i.e.5.3/6/6.7mm. The body also has markings in inches and an adjustable, movable flange to determine the uterocervical length. The other end consists of a conical open end which fits into a larger diameter tubing which in turn is connected to the suction machine. It also has an option of attaching a detachable mini collection bowl assembly for collecting the sucked products for further examination etc.

The actual procedure of suction and evacuation is as follows:
Dilatation of the cervix will be done initially with 6/8/10 No. Hegar’s dilator. The suction device will now be connected to a working suction machine or centralized suction device. The patient end is now introduced into the uterine cavity through the dilated cervical canal, uterocervical length measured and products of conception sucked out. Procedure is concluded by check curettage with a curette to confirm complete evacuation of the products of conception. The actual procedure is as follows:
The main tubing (1) with its bevelled tip (4) acts as the patient end which enters the uterine cavity. This tubing (1) acts as the main conduit for suctioning of the products of conception. Initially, the uterocervical length is measured with the help of the markings (7) provided on the tubing. Once the length of insertion is measured the adjustable flange (8) is moved up and fixed at that length. This step avoids the use of the uterine sound which is conventionally used to measure the uterocervical length which in itself has the danger of perforating the uterus with its hard, traumatic nature, especially in the hands of novices. The connector (2) helps to connect the main tubing (1) to the collection bowl assembly (3) or directly to the other tubing with a larger diameter than the main tubing to the suction assembly. Vacuum is created in this main tubing with the help of the suction machine. This suction machine may be either electrically driven or can be attached to centralized vacuum assembly as per the hospital set-up. This vacuum is the driving force for the suctioning of the uterine cavity. The patient end is open, bevelled (4) through which the products are sucked in from the uterine cavity. Bevelling makes suctioning easier and faster than a rounded tip since it increases the surface area available for suctioning. The margins of the bevelled end are smoothened and are non-traumatic to avoid trauma and chances of perforation. The side hole (5) also has the same role as (4) and assists in better and speedy suctioning of products as well as serves as an extra port for suctioning should the main port get blocked with the debris. The four pinhole sized openings on the opposite side of the side port (6) mainly help in suctioning of the blood and other fluids whilst the solid products are mainly sucked through the ports (4) and (5). The ports (4), (5) and (6) together make the suctioning more efficient as well as faster. While performing the procedure the suction tubing is to be held at its distal end which is roughened a bit fine, horizontal serrations (9) for better gripping and hold of the instrument. Suction machine is turned on and the products of conception are sucked in through the tubing (1) and get collected in the collection bowl (10) if the assembly is attached or directly gets sucked into the larger tubing into the bigger suction bottle if the collection bowl assembly (3) is not used. Products of conception can be visualized through the transparent tubing (1) while suctioning. These products can be collected in the collection bowl (10) by attaching the assembly (3) to the connector (2) while suctioning and these products can be easily retrieved for further sampling or examination, if any, required.

7. BRIEF DESCRIPTION OF DRAWING:
Fig No.1 is the schematic representation of the DISPOSABLE, NONTRAUMATIC AND COST EFFECTIVE SUCTION DEVICE FOR PERFORMING FIRST TRIMESTER ABORTIONS.

8. DETAILED DESCRIPTION OF DRAWINGS :

Fig No.1 shows the main body of the main suction tubing 50 cm long (1) transparent, flexible and non-traumatic with an internal diameter of 16/18/20 FG (5.3mm/6mm/6.7mm) and the connector (2 )which is 3cm long (the total length of the tubing along with the connector is 53cm) which can be connected directly with a conventional hollow long connecting with a larger variable diameter that connects the main tubing (1) with the suction device which can be either an electrically driven suction machine or centralized suction device or it or it can also be attached to the specially designed collection bowl assembly (3). The patient end of the suction tubing (1) has a bevelled end (4) with non-traumatic rounded edges. The angle of bevel will be approximately 40o±10o. It also has an open side port (5) for better suctioning of products. This port also serves as an accessory port for suctioning should the bevelled end get blocked with the products. The opposite side of the suction tubing is provided with four pinhole openings arranged vertically (6). These openings serve for suctioning of the blood and other fluids whilst the openings (4) and (5) manly suck the solid products of conception. The four pin hole openings are placed vertically at a distance of 0.5cm from each other. The body of the suction tube is also provided with markings (in inches) from 2-12 (7) which is the distance of the given point from the bevelled tip of the suction tubing. These markings help to determine the uterocervical length. An adjustable, movable plastic flange (8) is also provided to be fixed in place once the uterocervical length is measured. The distal end of the suction tubing (1) beyond the markings and the adjustable flange is provided with fine horizontal, roughened serrations on its surface (9) for better grip of the instrument by the operator while performing the procedure.

The collection bowl assembly (3) is an optional detachable attachment which can be attached to the connector end (2). This assembly will mainly help in collection of the sucked products into the bowl, should they be required for any further examination or need to be sent for any laboratory investigations etc. This assembly mainly consists of a small plastic bowl (10) which s of 30 ml capacity with an air tight plastic lid (11) with two openings over it which tightly hold the inlet (12) and outlet (13) tubing into it without any air leak. The outlet end (13) in turn gets connected to the large bore suction tubing and the suction producing device. The products from the bowl (10) can be emptied by opening it by circular twisting movements against the lid in anti-clockwise direction and sealing it back in place in clockwise manner.

9. I claim

1. The DISPOSABLE, NONTRAUMATIC AND COST EFFECTIVE SUCTION DEVICE FOR PERFORMING FIRST TRIMESTER ABORTIONS is to be used to perform surgical first trimester abortions, missed abortions or incomplete abortions upto 10 weeks of gestation, which is easy to assemble, transparent, technically easy to use as well as flexible and non-traumatic, hence there will be less chances of serious complications like uterine and bowel perforations with this device whose easy assembly also makes this device user friendly and time saving as it combines the virtues of both the conventional methods of suction and evacuation while it eliminates their disadvantages and as this device is cheap as well as disposable, thus providing an economical as well as more aseptic option for all the patients.

Dated this 27th June, 2013.

DR.M.V.GHORPADE
(REGISTRAR)
FOR KRISHNA INSTITUTE OF MEDICAL SCIENCES

To
The Controller of Patents,
The patent office,
At Mumbai – 400 037

10. ABSTRACT OF THE INVENTION

A disposable, cheap, easy to use, safe and non-traumatic suction tubing and assembly is devised for the first time for performing first trimester surgical abortions, incomplete abortions and missed abortions upto 10 weeks of gestation.

This device is not only cost effective and easy to assemble and use but also safe since it is non-traumatic to the tissues and being disposable it is free of infective complications.

This device is really effective and helpful for surgical termination of first trimester of pregnancy even at smaller centres.

DR.M.V.GHORPADE
(REGISTRAR)
FOR KRISHNA INSTITUTE OF MEDICAL SCIENCES