MULTIPURPOSE VAGINAL OCCLUSION AND DISTENSION DEVICE WITH DISTENSION CONTROLLER
20210022770 ยท 2021-01-28
Inventors
Cpc classification
A61B2017/00221
HUMAN NECESSITIES
A61F2230/0091
HUMAN NECESSITIES
A61H9/0078
HUMAN NECESSITIES
A61B17/12099
HUMAN NECESSITIES
A61B17/42
HUMAN NECESSITIES
A61F2/005
HUMAN NECESSITIES
A61H2201/169
HUMAN NECESSITIES
A61F6/08
HUMAN NECESSITIES
A61B2017/00805
HUMAN NECESSITIES
International classification
A61B17/42
HUMAN NECESSITIES
A61B17/12
HUMAN NECESSITIES
A61F5/455
HUMAN NECESSITIES
Abstract
The invention relates to a Multipurpose Vaginal Occlusion and Distension Device with Distension Controller, which helps patients with Female Stress Urinary Incontinence and for Fecal Incontinence. It comprises of double layered cylindrical body (101) making inflatable annular space and with closed anterior (103) and posterior (104) wall provided with inflatable tubular silicon ribs (103a, 104a), but the posterior end is provided with gas flow tube (106) connectable to the Distension control and release mechanism by which the cylindrical cavity (107), annular space, tubular ribs at both the end can be inflated. But the same device can be used, if the anterior end (301) is opened for collecting menstrual blood during Menstrual Cycle as an alternative to menstrual cups and pads. The same can be used preferably with partly opened mouth (403) by Doctors during Laparoscopic Surgeries as a pneumoseal and as a vaginal blocker to prevent the gas leakage through the vaginal canal while performing the colpotomy and thereafter during vaginal vault suturing.
Claims
1. Multipurpose vaginal occlusion and distension device with distension controller comprises of a cylindrical body (101) having dia ranging from 1 cm to 8 cm and length ranging from 2 cm to 8 cm, made of a double layer polymeric membrane (102) having a thickness of 0.5 to 4. mm with both anterior wall (103) and posterior wall (104) closed with similar double layered membrane making, an annular space between said two layers as well as cylindrical hollow internal space, which are inflatable, and both anterior and posterior circular edge of the said cylindrical vessel is having tubular silicon ribs (103a) and (104a) formed by semi flexible metallic ring engulfed inside the silicon rib which are also inflatable, but the posterior end is provided with a tubular opening having gas flow tube (106) and is connected to the connector port (201) of the Distension control and release mechanism having the gas pumping bellows chamber (202) by means of a Coupling port (205) with gas releasing and locking valve, and the out let of the gas pumping bellows chamber (202) is connected to the gas inflow and outflow tube (203) provided with gas inlet/out valve (204), having multiple channel to inflate the cavity (107) of the cylindrical body, flexible annular space, flexible tubular rib at the anterior circular edge (103a) as well as at the posterior circular edge (104a)
2. The Multipurpose vaginal occlusion and distension device as claimed in claim 1, wherein the outer layer of the cylindrical vessel (102a) is corrugated so that it helps to make the cylindrical body part comfortably fit inside the vaginal canal as per the choice of the user.
3. The Multipurpose vaginal occlusion and distension device as claimed in in any of the claim 1, wherein the cylindrical body (101) is reinforced by a tubular rib (105) spirally wound around the cylindrical body which is inflatable, made of silicon with or without metallic soft spring thread engulfed by silicon, and connected to the tubular rib at the anterior circular edge (103a) as well as at the posterior circular edge (104a), so that air pumping bellows (202) of the Distension control and release mechanism simultaneously inflates them, wherein once the cylindrical body is inserted inside the vaginal cavity, it comfortably fit inside the vaginal canal as per the choice of the user so as to prevent stress urinary incontinence and for fecal incontinence
4. The Multipurpose vaginal occlusion and distension device as claimed in any of the claim 1, wherein Distension control and release mechanism having the gas pumping bellows chamber (202) by means of a Coupling port with gas releasing and locking valve (205), and the out let of the gas pumping bellows chamber (202) is connected to the gas inflow and outflow tube (203) provided with gas inlet/out valve (204), having multiple channel to inflate which not only fills the flexible annular space formed by the double layered polymeric membrane (102), flexible tubular rib at the anterior circular edge (103a), posterior circular edge (104a), tubular rib spirally wound (105) around the cylindrical body, but also the cylindrical cavity (107).
5. The Multipurpose vaginal occlusion and distension device as claimed in claim 4, wherein the cylindrical body (305) is having dia ranging from 1 cm to 8 cm and length ranging from 2 cm to 8 cm, is made of a single or double layer polymeric membrane with smooth outer layer (302) having a thickness of 0.5 to 4. mm with fully opened anterior end (301) and closed posterior end provided with a tubular opening reinforced with tubular rib (103a), (104a) respectively formed by semi flexible metallic ring engulfed inside the silicon rib which are inflatable along with flexible annular space formed at the cylindrical wall, while the posterior end is provided with a tubular opening having gas flow tube (106), a passage to the cylindrical cavity, which is connected to the connector port (201) of said Distension control and release mechanism by means of Coupling port (205) with gas releasing and locking valve and the out let of the air pumping bellows chamber (202) is connected to the gas inflow and outflow tube (203) provided with gas inlet/out valve (204) and wherein the cylindrical body is insertable in the vaginal cavity for holding menstrual blood during menstrual period.
6. The Multipurpose vaginal occlusion and distension device as claimed in claim 5, wherein the cylindrical wall of the device is of double layered one and the outer layer is corrugated (303) so that it helps to make it comfortably to fit inside the vaginal canal, once the cylindrical body is inserted for collecting the menstrual blood.
7. The Multipurpose vaginal occlusion and distension device as claimed in any of the claim 5, wherein, the cylindrical body is reinforced by a tubular spiral rib (105) wound around the cylindrical body which is inflatable made of silicon with or without metallic soft spring engulfed by silicon, and connected to the tubular silicon rib of the mouth and posterior end respectively, so that air pumping bellows (202) of the Distension control and release mechanism simultaneously inflating inflatable tubular rib at the anterior edge (103a) of the cylindrical body, inflatable tubular rib at the posterior edge (104a); inflatable tubular rib spirally wound around the cylindrical body (305) opened at the anterior end and the annular space formed in between the wall of the cylinder wall.
8. The Multipurpose vaginal occlusion and distension device as claimed in any of the claim 5, wherein the gas inflow inlet tube is made to extend (304) inside the cylindrical cavity of the device, the height of which will be 0.5 cm below the mouth opening (301) and the portion protruding outside the cylinder is provided with coupling port with gas releasing and locking valve (205), so that the menstrual blood will not come out through the gas inflow inlet tube and once valve is closed the quantity of blood collected can be measured during every usage of the device and the sensor chips (306, 306a,306b and 306c) embedded at the blood level marker (307) at the internal space of cylindrical body, gives an alarm warning, based on the setting, by an application which is programmable and can be linked with the users wristwatch or mobile phone.
9. The Multipurpose vaginal occlusion and distension device as claimed in any of the claim 5, wherein, in the event, if the device is filled more than the desired level, the censer chips embedded at different level inside the device, based on the settings, sense and measure the quantity of blood collected during every usage of the device in menstrual cycle.
10. The Multipurpose vaginal occlusion and distension device as claimed in any of the claim 5, wherein said device is an alternative to vaginal/menstrual cups and pads that collects menstrual blood during Menstrual Cycle, once the cylindrical part of the device is inserted inside the vaginal cavity.
11. The Multipurpose vaginal occlusion and distension device as claimed in any of the claim 5, once the cylindrical part of the device is inserted inside the vaginal cavity and coupling port with gas releasing and locking valve (205) provided on the extended gas inflow inlet tube (106) protruding outside the cylinder requires to be closed, and the detachable Distension control and release mechanism is detached and it is to be deployed again only when the mensural blood is required to be emptied.
12. The Multipurpose vaginal occlusion and distension device as claimed in claim 1, wherein the cylindrical body having dia ranging from 1 cm to 8 cm and length ranging from 2 cm to 8 cm, is made with single or double layered polymeric membrane having a thickness of 0.5 to 4. mm and the anterior end is fully opened (401) and the circular cylindrical mouth as well as the posterior end are reinforced with tubular rib (103a), (104a) respectively formed by semi flexible metallic ring engulfed inside the silicon rib which are inflatable along with flexible annular space formed at the cylindrical wall, in the case of double layered wall, while the posterior wall is provided with a tubular opening having gas flow tube (405) and is connected to the connector port (201) of the Distension control and release mechanism having the gas pumping bellows chamber (202) by means of a Coupling port (205) with gas releasing and locking valve, and the out let of the air pumping bellows chamber (202) is connected to the gas inflow and outflow tube (203) provided with gas inlet/out valve (204), so that it is insertable in the vaginal cavity before colpotomy, so that abdominal cavity which is filled with gas, forming pneumoperitoneum to allow the laparoscopic surgeon to see and move instruments and perform surgical procedure, especially vaginal vault suturing inside the abdominal cavity without any gas loss.
13. The Multipurpose vaginal occlusion and distension device as claimed in claim 12, wherein the outer layer of the cylindrical body is corrugated so that it helps to make it comfortably fit inside the vaginal canal, once the cylindrical body is inserted prior to laparoscopic surgery.
14. The Multipurpose vaginal occlusion and distension device as claimed in any of the claim 12, wherein, the cylindrical body is reinforced by a tubular rib (105) wound spirally around the cylindrical body which is inflatable made of silicon with or without metallic soft spring engulfed by silicon, and connected to the tubular silicon rib of the anterior/mouth and posterior end respectively, so that air pumping bellows (202) of the Distension control and release mechanism simultaneously inflates tubular rib at the anterior end/mouth (103a), at the posterior edge (104a), inflatable tubular rib (105) spirally wound around the cylindrical body and the annular space formed in between the wall of the cylindrical body, facilitating to make it comfortably fit inside the vaginal canal, during laparoscopic surgery.
15. The Multipurpose vaginal occlusion and distension device as claimed in any of the claim 13, wherein instead of fully opened at the anterior end of the circular cylindrical mouth (401), it is partly closed with circular openings (402) or with multiple circular openings (403), so that it gives structural pressure support to the pelvic floor during laparoscopic surgery.
16. The Multipurpose vaginal occlusion and distension device as claimed in any of the claim 13, wherein, once the device is inserted inside the vaginal cavity, inflated with CO2, using the Distension control and release mechanism, and followed by detaching the same, once the purpose is over, the gas flow tube (405) at the posterior end of the cylindrical device fixed with Coupling port (205) with gas releasing and locking valve functions as retractor means for removing the device from the vaginal cavity, once the surgical procedure is over.
17. The Multipurpose vaginal occlusion and distension device as claimed in any of the claim 13, wherein the posterior wall of the cylindrical device is closed and provided with a flexible silicon thread (404), functions as retractor means for removing the device from the vaginal cavity, once the surgical procedure is over, in place of said gas flow tube (405) at the posterior end of the cylindrical device fixed with Coupling port (205) with gas releasing and locking valve that is closed.
18. The Multipurpose vaginal occlusion and distension device as claimed in in any of the claim 13, wherein the device functions as a pneumoseal to prevent gas leakage and as vaginal blocker during colpotomy (incising the vaginal vault), and specially at the time of vaginal vault suturing by the Laparoscopic Surgeons, wherein the device is squeezed, inserted into the vaginal cavity, the CO2 gas already available inside the abdomen helps to fill up the cylindrical cavity of the device at the time of colpotomy and vaginal vault suturing.
19. The Multipurpose vaginal occlusion and distension device as claimed in in any of the claim 13, wherein and the Distension control and release mechanism is made use of for filling up the cylindrical cavity with CO2 gas, if required, before it is detached from the gas flow tube (405) after closing the on off valve (205) provided therein.
Description
DETAILS OF THE DRAWINGS
[0043] These objectives and other features, aspects, and advantages of the present invention will be better understood when the detailed description is read with reference to the following drawings according to a preferred embodiment under the invention.
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[0061] Wherein the Parts of the Multipurpose Vaginal Occlusion and Distension Device and Figure indicators are named below:
[0062] 101Cylindrical body made of double layered polymeric membrane; 102Double layer polymeric membrane of the cylindrical body; 102aCorrugated outer layer of the cylindrical body; 103Anterior wall of the cylindrical body; 103aInflatable tubular rib at the anterior edge of the cylindrical body; 104Posterior wall of the cylindrical body; 104aPosterior tubular rib at the posterior edge of the cylindrical body; 105Inflatable tubular rib spirally wound around the cylindrical body; 106Gas flow pipe fixed at the tubular opening at the posterior end of the cylinder; 107Cavity of the cylindrical body of the device; 201Connector port of the Distension control and release mechanism; 202Gas pumping bellows chamber of the Distension control and release mechanism; 203Gas inflow and outflow tube of the Distension control and release mechanism; 204Gas inlet/out valve having multiple channel of the Distension control and release mechanism; 205Coupling port with gas releasing and locking valve that can be connected to the Distension control and release mechanism; 301Circular mouth of the fully opened cylindrical body; 302Smooth outer layer of the cylindrical body; 303Corrugated outer layer of the cylindrical body; 304Extended gas inflow inlet tube inserted inside the cylindrical cavity of the device; 305Cylindrical body opened at the anterior end; 306,306a,306b, and 306cSensor chip embedded at the Blood level marker inside the cylindrical body of the device; 307Blood level marker inside the cylindrical body of the device; 401Fully opened mouth of the cylindrical body; 402Partly opened mouth of the cylindrical body; 403Mouth with multiple opening of the cylindrical body; 404Flexible silicon thread functioning as retractor means; 405Gas flow tube connected with Coupling port (205) with gas releasing and locking valve that can be connected to the Distension control and release mechanism so that it functions as retractor means, once the Distension control and release mechanism is detached; 501Vaginal canal; 601The circular rib at the anterior part of the traditional vaginal/Menstrual cup as per prior art; 602The conical body of the vaginal cup/Menstrual cup as per prior art;
DETAILED DESCRIPTION OF THE INVENTION
[0063] Features of the present invention will become apparent to those skilled in the art upon reading the following detailed description of the instant invention.
[0064] The Multipurpose Vaginal Occlusion and Distension Device according to the instant invention, will be an important device for patients as an alternative as an easy to use and effective device where the new Multipurpose Vaginal Occlusion and Distension Device helps to control the stress urinary incontinence easily. Being light weight, adjustable distention and pressure control mechanism and controlled release and fit in the vaginal canal, the ease to inflate and deflate the device using the Distension Control and Release Mechanism and uniform pressure applied throughout the sphincter muscle helps the patients in better control of Stress Urinary Incontinence. Apart from stress urinary incontinence, the multi ribbed and structurally tensioned device helps in supporting Fecal Incontinence.
[0065] Menstrual cups and pads are often used during menstrual period. The need to frequently change the pads, disposal issues and also the drawback of the present menstrual cups which fall off from the vagina where it is placed due to the conical shape of such devices make it important for ladies of their menstrual age to use the innovative Multipurpose Vaginal Occlusion and Distension Device with Distension Control and Release Mechanism for collecting menstrual blood during menstrual cycle. The squeezable double layered cylindrical device with its circular mouth which will get snuggly fit to the vaginal walls, with reinforced and inflatable tubular ribs and annular space to keep the device inflated and to keep comfortably inside the vaginal canal and the closed posterior wall of the device with gas inflow inlet connected to the Distension Control and Release Mechanism makes it convenient to women for easy and safe use of the Multipurpose Vaginal Occlusion and Distension Device which will not be slipped off from vagina canal and can be taken out as and when needed using the Distension Control and Release Mechanism and also the device is available in different diameter and length and with varying features.
[0066] Laparoscopic procedures require the abdominal cavity to be filled with gas, forming pneumoperitoneum to allow the surgeon to see and move instruments and perform procedure inside the abdominal cavity. During laparoscopic gynecology surgeries, since using the vaginal canal as a route for extraction of the abdominal tissues masses after colpotomy, the gas tends to escape through the vaginal opening, making it difficult to maintain the vision for the doctors, during the laparoscopic surgical procedures. In addition, the size of women's vaginal canal varies considerably and that demands the use of the new Multipurpose Vaginal Occlusion and Distension Device as it can block the gas leakage and also give enough and controlled distension to the vaginal canal uniformly using the Distension Control and Release Mechanism of the device. The squeezable and inflatable device with its cylindrical construction, tubular ribs make it snuggly fit inside the vaginal canal so that it will not be slipped off. The opening at the anterior wall of the device makes the device to get filled with CO2, such that the device will work as pnuemoseal and the closed posterior wall of the device having a tubular retractor means allow the device to be taken out after usage.
[0067] The Multipurpose Vaginal Occlusion and Distension Device for Stress Urinary Incontinence and for Fecal Incontinence is a squeezable and inflatable device is shown in
[0068] In a preferred embodiment under the invention, as shown in
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[0070] According to another embodiment under the invention, the Multipurpose Vaginal Occlusion and Distension Device for Stress Urinary Incontinence and for Fecal Incontinence can be modified so as to use the same for collecting menstrual blood during Menstrual Cycle as an alternative to vaginal/menstrual cups and pads with a detachable Distension control and release mechanism.
[0071] As shown in
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[0074] According to
[0075] Once the cylindrical part of the device is inserted inside the vaginal cavity and coupling port with gas releasing and locking valve (205) provided on the extended gas inflow inlet tube (106) protruding outside the cylinder requires to be closed, the detachable Distension control and release mechanism is detached and is deployed only when the mensural blood is required to be emptied.
[0076] According to another embodiment under the invention, the Multipurpose vaginal occlusion and distension device can be made use by Doctors during Laparoscopic Surgeries as a pneumoseal and as a vaginal blocker to prevent the gas leakage through the vaginal canal while performing the colpotomy and thereafter during vaginal vault suturing, without applying any manual pressure using cotton gauze or plastic vaginal tubes which are currently used during hysterectomies and similar surgeries. The cylindrical body having dia ranges from 1 cm to 8 cm and length ranging from 2 cm to 8 cm, is made single or double layer polymeric membrane having a thickness of 0.5 to 4. mm and the anterior end is fully opened (401) or partially opened (402) or having multiple circular opening (403) as shown in
[0077] The Distension control and release mechanism can be used to inflate not only the cavity (107) of the cylindrical body, but also the flexible annular space formed by the double layered polymeric membrane (102), flexible tubular rib at the anterior circular edge (103a), posterior circular edge (104a), tubular rib spirally wound (105) around the cylindrical body as shown in
[0078] During the laparoscopic surgery, the CO2 gas will get filled in the device through the fully opened mouth (401), partly opened mouth (402) or mouth with multiple opening (403) of the cylindrical body depending on the usage of the type the device having different type of cylindrical body used during colpotomy and vaginal vault suturing. The cylindrical cavity of the device can also be filled up even using the distension control and release mechanism connected through gas pipe line provided at the posterior end of the device and or with an external gas connection, if the device is not getting properly filled up during colpotomy and vaginal vault suturing with the CO2 filled up the abdominal cavity. However, the unopened portion of anterior wall of the device as shown in
[0079] This gas inflow inlet can be connected the Distension control and release mechanism helps to give additional distention to the device in case, the distension from the abdominal cavity is insufficient. Said Distension control and release mechanism can be removed after filling the cylindrical cavity of the device with adequate quantity of CO2, if it was necessitated during colpotomy and vaginal vault suturing.
[0080] According to another embodiment under the invention, Multipurpose Vaginal Occlusion and Distension Device as shown in
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[0082] It can be seen from the
[0083] 1. Procedure for Using the Device in the Female Stress Urinary Incontinence and Fecal Incontinence:
[0084] The squeezable and inflatable Multipurpose Vaginal Occlusion and Distension Device with the closed anterior and posterior walls with the Distention Control and release Mechanism connected at the posterior wall as shown in
[0085] 2. Procedure for Using the Device as the Multipurpose Vaginal Occlusion and Distension Device for Collecting Menstrual Blood as an Alternative to Vaginal Cups and Pads:
[0086] The squeezable and inflatable Multipurpose Vaginal Occlusion and Distension Device with a fully opened anterior wall with a circular mouth of same inner diameter both at the anterior end and at the posterior end with single smooth layer on the cylindrical wall. The posterior wall having the gas inflow inlet is connected to the detachable Distention Control and release Mechanism (
[0087] According to a preferred embodiment under the invention, the multipurpose Vaginal Occlusion and Distension Device attached with Distension control and release mechanism explained above was modified to have additional features as shown in
[0088] In the event, if the device is filled with more blood than the desired level, the sensor chip embedded at the blood level marking (307), based on its settings, will give indicator alarm by the application which can be programmed to the users wrist watch or mobile phone and also the censer chips embedded at different level inside the device sense and measure the quantity of blood collected during every usage of the device.
[0089] 3. Procedure to Use the Device as Multipurpose Vaginal Occlusion and Distension Device for Laparoscopic Surgeries.
[0090] The squeezable and inflatable Multipurpose Vaginal Occlusion and Distension Device with a full mouth opening having its diameter equal to that of the device or partly opened circular mouth or with circular multiple openings on the anterior wall with the posterior wall having gas inflow inlet and outflow tube connected with Coupling port with gas releasing and locking valve (205) that can be attached to Distention Control and release Mechanism is used for Laparoscopic Surgeries is shown in Fig.
[0091] According to another embodiment under the invention, in its simpler version, the squeezable and inflatable Multipurpose Vaginal Occlusion and Distension Device with a full mouth opening having its diameter equal to that of the device or partly opened circular mouth or with circular multiple openings on the anterior wall, the posterior wall is closed and provided with flexible silicon thread (404) which functions as retractor means for removing the device from vaginal cavity as shown in
[0092] I have brought out the novel features of the invention by explaining some of the preferred embodiments under the invention, enabling a person in the art to understand and visualize our invention. It is also to be understood that the invention is not limited in its application to the details set forth in the above description or illustrated in the drawings. Although the invention has been described in considerable detail with reference to certain preferred embodiments thereof, various modifications can be made without departing from the spirit and scope of the invention as described herein above and as defined in the following Claims.