AU2021101426A4

AU2021101426A4 - A device for dilation of the cervix

Info

Publication number: AU2021101426A4
Application number: AU2021101426A
Authority: AU
Inventors: Punit FULZELE; Arpita Jaiswal; Sandip Sudhakarrao KHEDKAR; Kajal ROY; Kushagra WANJARI
Original assignee: Fulzele Punit Dr; Jaiswal Arpita Dr; Khedkar Sandip Sudhakarrao Dr; Yeshwantrao Chavan College of Engineering; Jawaharlal Nehru Medical College; Datta Meghe Institute of Medical Sciences
Current assignee: Fulzele Punit Dr; Jaiswal Arpita Dr; Khedkar Sandip Sudhakarrao Dr; Yeshwantrao Chavan College of Engineering; Jawaharlal Nehru Medical College; Datta Meghe Institute of Medical Sciences
Priority date: 2021-03-19
Filing date: 2021-03-19
Publication date: 2021-05-13
Anticipated expiration: 2029-03-19

Abstract

A DEVICE FOR DILATION OF THE CERVIX The present invention relates to a device for dilation of the cervix. The object of the proposed device is to provide an effective dilation of the cervix during second trimester abortion. The main purpose of the invention is to dilate the cervix in less time with minimum labor pain. The device under present invention performs tasks like insertion of the catheter into the cervix, inflation of the balloon (102), opening of the flaps (100), dilating the cervix and removal of the catheter. The present invention focuses on creating a catheter using silicone rubber (medical grade) which will minimize the labor pain and a skin friendly to the patient. Following invention is described in detail with the help of Figure 1 of sheet 1 showing the complete assembly of the proposed device with dimensions. 1/3 Figure 1

Description

1/3

Figure 1

A DEVICE FOR DILATION OF THE CERVIX

Technical field of invention:

[001] Present invention in general relates to an auxiliary medical instrument and more specifically to a device for effective dilation of the cervix during second trimester abortion.

Background of the invention:

[002] During the later stages of pregnancy, the cervix typically undergoes numerous physical changes which provide increased safety and ease with which the fetus can be delivered. Particularly, the cervical canal tissue softens and increases in pliability, and subsequently, the diameter of the cervical canal begins to increase. Eventually, the dilation of the cervix is completed, allowing for the unobstructed passage of the fetus.

[003] During these stages of pregnancy, there are instances when the cervix fails to dilate sufficiently to allow for the safe and unobstructed passage of the fetus. Such conditions may lead to a need for forced or supplemental dilation of the cervix either mechanically or through medication.

[004] Cervical dilators are the devices that are used for effective dilation of cervix. Dilation of cervix is done during childbirth, miscarriage, induced abortion or for some gynecological surgery. A dilator is used to gently open the cervix before a gynecologic procedure that requires the cervix to be open, allowing access to the uterus and fallopian tubes. Cervical dilation reduces the risk of injury to the cervix during such a procedure. Gynecologists use various types of cervical dilators around the globe. They include mechanical dilators, osmotic dilators and medicinal drugs that induce the dilation process.

[005] Mechanical instruments such as the Hern, Hegar, Pratt, Hanks and Denniston dilators are used to sequentially dilate the cervix byincrementally increasing the diameter of the inserted dilator until the dilation procedure is complete. However,these mechanical dilators require the use of appropriate force which could permanently damage the cervical tissueand have adverse long-term effects on fertility. Theiruse is associated with various potential complications,such as uterine perforation, cervical laceration, infectionsand intraperitoneal hemorrhages.

[006] Several lines of evidence have suggested that cervical priming, accomplished by pharmacological agents (prostaglandin analogs) can prevent cervical laceration by reducing the force required for cervical dilation. The main disadvantage of pharmacological agents is that thewoman might experience bleeding and cramping prior to the surgical procedure.

[007] Typically, several mechanical and medical options have been available for creating cervical dilation, either to assist in the management of labor in obstetrical patients, or to assist in the management of gynecological patients requiring operative procedures involving the cervix and uterus. Thus some of the existing devices are found as- W02001068181A1 discloses inflatable cervical dilation device, US7713216B2 discloses a medical device for measuring and/or providing cervical dilation, US20070288051A1 discloses fluid-filled cervical dilator, CN203971147U discloses a kind of cervix uteri auxiliary expanding device, 1614/DEL/1997 discloses bionic cervix uteri dilator, US20080319472A1 discloses an improved balloon catheter for cervical dilation, EP0168507A1 discloses an osmotic cervical dilator, US20040127931A1 discloses a cervical dilator.

'0 [008] Thus, there is the need for a catheter that can be placed much easier and more comfortably for the patient, but also one that is simple in its method of action, safe and one that can shorten the length of labor. Hence the present invention provides a device for effective dilation of the cervix.

Objective of the invention

[009] An objective of the present invention is to attempt to overcome the problems of the prior art and provide an improved device for dilation of the cervix.

[0010] In a preferred embodiment, the present invention provides a device for effective dilation of the cervix during second trimester abortion.

[0011] It is therefore an object of the invention to reduce the time taken for dilation and to speed up the process of dilation.

[0012] It is therefore a further object of the invention to minimize the labor pain of patient during the surgery.

[0013] It is therefore a still further object of the invention to facilitate ease of sterilization ability and the ease of assembling and faster dilatation.

[0014] These and other objects and characteristics of the present invention will become apparent from the further disclosure to be made in the detailed description given below.

Summary of the invention:

[0015] Accordingly following invention provides a device for dilation of the cervix. The proposed device provides an effective dilation of the cervix during second trimester abortion.The proposed device is formed from silicone rubber and stainless steel based elements. The preferred embodiment comprises of (from the top) anchoring balloon (102), four flaps (100), sheath (103)for covering flaps, guiding tube (101) and propagation rod (104).A guiding tube (101) is the base part which holds all the other parts. Guiding tube (101) provides straight path for propagation rod (104).Propagation rod (104) is the solid stainless '0 steel rod. It is passed through guiding tube (101) for opening of flaps (100).Four flaps (100) is the middle portion of the device and are mounted on guiding tube (101). They open like petals of flower with the help of propagation rod (104).Sheath (103) is a thin covering on the flaps (100). At one end it is attached to guiding tube (101) and on other end it holds balloon (102). Balloon (102) is the topmost part of the device. It can be inflated and deflated and used as an anchor inside the cervix.

Brief description of drawing:

[0016] This invention is described by way of example with reference to the following drawing where,

[0017] Figure 1 of sheet 1 illustrates the complete assembly of the proposed device with dimensions.

[0018] Figure 2 of sheet 2 illustrates flap section of catheter with dimensions. Where, 100 denotes flaps, 101 denotes guiding part.

[0019] Figure 3 of sheet 3 illustrates balloon section of catheter with dimensions. Where, 102 denotes balloon, 103 denotes sheath.

[0020] Figure 4 of sheet 3 illustrates the propagation rod with dimensions. Where, 104 denotes propagation rod.

[0021] In order that the manner in which the above-cited and other advantages and objects of the invention are obtained, a more particular description of the invention briefly described above will be referred, which are illustrated in the appended drawing. Understanding that these drawing depict only typical embodiment of the invention and therefore not to be considered limiting on its scope, the invention will be described with additional specificity '0 and details through the use of the accompanying drawing.

Detailed description of the invention:

[0022] The present invention relates toa device for dilation of the cervix. The proposed invention provides a device for effective dilation of the cervix during second trimester abortion.

[0023] The present invention is a simple labor induction instrument which facilitate ease of sterilization ability and the ease of assembling and faster dilatation. The main purpose of the invention is to dilate the cervix in less time with minimum labor pain.

[0024] The propose device emphases on creating a catheter using silicone rubber (medical grade) which minimizes the labor pain and a skin friendly to the patient. The catheter includes (from the top) a balloon (102) which works just like the Foley Catheter's balloon which will be used as an anchor on the interior part of the cervix. The middle portion is the main dilator part with four flaps (100). They can open like the petals of the flower. Flaps (100) are followed by the guiding tube (101) which is useful at the time of inserting the catheter inside the cervix. Furthermore the propagation rod (104) passed through the guiding tube (101) into the core of the flaps (100) to push them apart which will put force on the cervix and will start the process of dilation.

[0025] The proposed device for dilation of the cervix is formed from silicone rubber based elements and stainless steel based element. Wherein silicone rubber based elements includes balloon (102) for anchoring, sheath (103) for covering flaps (100), four flaps and guiding tube (101). And the propagation rod (104) is formed from stainless steel based element.

[0026] In the proposed device, a guiding tube (101) is provided which is the base part of the dilationdevice and it holds all other parts. Guiding tube (101) provides straight path for propagation rod (104). Flaps (100) are mounted on guiding tube (101). Sheath (103) is mounted on flaps (100) which are followed by balloon (102).

[0027] The proposed device provides four flaps which is the middle portion of the device and the dilation process takes place when flaps (100)are open. They open like petals of flower with the help of propagation rod (104).

[0028] The top most part of the proposed device is balloon (102). It can be inflated and deflated. It is used as an anchor inside the cervix. The saline or any sterilized liquid can be used to inflate the balloon (102).

[0029] Sheath (103) is a thin covering on the flaps (100). At one end it is attached to guiding tube (101) and on other end it holds balloon (102). As the flap (100) expands it stretches the sheath (103).

[0030] Propagation rod (104) is the solid stainless steel rod. It is passed through guiding tube (101) for opening of flaps (100).

[0031] The proposed device for dilation of the cervix essentially comprise of four processes such as insertion of the catheter, inflating the balloon (102) for anchoring, opening of the flaps (100) by inserting propagation rod (104) and safely removing the catheter.

[0032] At the very first process of insertion of the catheter, when the catheter is inserted into the cervix it artificially stimulate uterine contraction leading to progressive dilation and effacement of cervix. Only after identifying the condition of the patient during the surgery the insertion of the catheter is done.

[0033] Secondly, after the insertion of the catheter into the uterus the tip of the catheter is forced into the cervix. After insertion of the catheter into the cervix the balloon (102) is inflated with injecting saline through injector. Now the balloon (102) is inflated, it slightly pulled downward to anchor it at the internal end of cervix.

[0034] In the next process, after anchoring of the balloon (102) inside the cervix, later on the dilation process is started. For this the propagation rod (104) is to be inserted in guiding tube (101) and is brought at its end. At the end of guiding tube (101) the flaps (100) are present. Now the propagation rod (104) is pushed slowly into the guiding tube (101) so as to start the opening of the flaps (100) and the dilation of cervix is started. The catheter is to be kept into this position for few hours till the natural dilation of cervix starts.

[0035] At last as the dilation of the cervix is completed, thereafter the catheter is to be '0 removed. For that first the propagation rod (104) is to be removed slowly and the flaps (100) are to be brought to their original position. After completely removing the propagation rod (104) the anchor balloon (102) is to be pulled out slowly through the cervix so the space is created in the cervix. Hence the proposed catheter takes place to dilate the cervix.

[0036] Figure 1 illustrates the complete assembly of the invented device for dilation of the cervix. The basic dimensions for CAD modelingare taken based on Foley's Catheter. The outer diameter of the Foley's Catheter was 6mm.As the average length of uterus is 7.6 cm, the length of the proposed catheter is taken as 16cm without balloon (102). The external diameter of catheter is 6mm and the internal diameter is 5mm.

[0037] The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

Claims

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

1. A device for dilation of the cervix, essentially comprises of

a guiding tube (101) as base part which is useful at the time of inserting the catheter inside the cervix,

four flaps (100) covered by a sheath (103) in middle part are mounted on such guiding tube

and a balloon (102) at a top as an anchor inside the cervix;

wherein a propagation rod (104) made of stainless steel based element passed through the guiding tube (101) into the core of the flaps (100) to push them apart which raise force on the cervix and initiate the process of dilation.

2. The device for dilation of the cervix as claimed in claim 1 wherein said balloon (102) for anchoring, the sheath (103) for covering flaps (100), the four flaps and the guiding tube (101) are made of silicone rubber based elements.

3. The device for dilation of the cervix as claimed in claim 1 wherein said sheath (103) is a thin covering on the flaps (100) which at one end attached to guiding tube (101) and on other end it holds balloon (102), as the flap (100) expands it stretches the sheath (103).