WO2023113752A2

WO2023113752A2 - Perineal and vaginal enlargement apparatus in vaginal delivery

Info

Publication number: WO2023113752A2
Application number: PCT/TR2022/051482
Authority: WO
Inventors: Elif YILMAZ; Nese KARAKAYA
Original assignee: Ondokuz Mayis Universitesi
Priority date: 2021-12-15
Filing date: 2022-12-12
Publication date: 2023-06-22
Also published as: WO2023113752A3; TR2021020117A2

Abstract

The invention relates to the perineal expander apparatus with thermal properties, produced from flexible silicone or rubber, prevents uncontrolled perineal tears and soft tissue damage that may occur during childbirth, and comprises pressure tubes that cover the anterior and posterior parts of the perineum, have a massage feature at the bottom of the apparatus, and act as an expander, evenly distributed to every aspect of the apparatus. Said apparatus comprises the ball, which is connected from the side of the apparatus and can be added or removed to provide more perineal width when necessary during labor, and silicon dioxide gel with heat retention property embedded in the surface texture of the apparatus for hot application.

Description

PERINEAL AND VAGINAL ENLARGEMENT APPARATUS IN VAGINAL

DELIVERY

Technical Field of the Invention

The invention relates to an apparatus that is applied to the perineum and posterior fornix in women in the second stage of vaginal delivery, prevents uncontrolled perineal tears and soft tissue damage that may occur during childbirth, and expands the vagina and perineum without resorting to episiotomy.

State of the Art

Episiotomy, called birth suture, is a surgical incision made in the bulbocavernosus muscle in the perineum in order to ensure the enlargement of the vaginal orifis and vaginal canal before the baby's head comes out, prevent uncontrolled perineal tears and facilitate delivery in the second stage of labour. This incision can be centre line towards the rectum (Lateral episiotomy) or cut from the side (mediolateral episiotomy). When the baby is bom, it is closed separately with absorbable sutures that do not need to be removed after recovery. Episiotomy is one of the most applied surgical procedures in normal vaginal delivery. The recommendation of the World Health Organization is that episiotomy should not be used routinely. Studies suggest that episiotomy should be excluded from routine practice, should be limited, and performed when necessary. The frequency of episiotomy in our country is different from developed countries; traditionally, it is known that episiotomy is performed routinely in primiparas and when necessary in multiparas. Episiotomy application adversely affects the daily lives of women in the partum and postpartum period and has long term negative effects such as painful sexual intercourse, anal sphincter damage, uncontrolled pelvic tears, stool and urinary incontinence, perineal pain, delayed attachment of mother and baby, delayed breastfeeding, and delayed recovery of the mother.

The international patent application number 2016/20345 mentions a surgical method to prevent possible damage to the vagina and surrounding connective tissues by using an elastic band that protects the intact tissues during the delivery process. However, in said document, there is no explanation for a gel with hot-cold application, a technique that provides manual expansion of the main body in the vagina, and an apparatus with local anaesthetic drug application points.

Due to the facts that the episiotomy application in the state of the art adversely affects the daily lives of women in the partum and postpartum period and has long term negative effects such as painful sexual intercourse, anal sphincter damage, uncontrolled pelvic tears, stool and urinary incontinence, perineal pain, delayed attachment of mother and baby, delayed breastfeeding, and delayed recovery of the mother, and additionally the facts that the apparatus in the state of the art only protects a part of the perineum and cannot be used comfortably everywhere due to the electrical operation, it has been necessary to make a development in this area.

Brief Description and Aims of the Invention

The invention relates to the perineal expander apparatus with thermal properties, produced from flexible silicone or rubber, prevents uncontrolled perineal tears and soft tissue damage that may occur during childbirth, and comprises pressure tubes that cover the anterior and posterior parts of the perineum, have a massage feature at the bottom of the apparatus, and act as an expander, evenly distributed to every part of the apparatus.

An aim of the invention is to minimize or eliminate the long term negative effects such as dyspareunia, anal sphincter damage, uncontrolled pelvic tears, stool and urinary incontinence, perineal pain, delayed attachment of mother and baby, delayed breastfeeding initiation, and delayed recovery of the mother, which affects the daily lives of women adversely after the trauma, and prevent intense pain, infection and bleeding caused by trauma.

Another aim of the invention is to increase the quality of pre-illness health services, that is, preventive health services that will minimize or prevent the risk, seventy and duration of possible future disease and disability, diagnose the disease before the symptoms of which the patient is unaware, and provide the treatment in the early stages of the disease. Another aim of the invention is that “preventive health services” have a higher priority than others in the provision of health services. Because prevention costs much less than treatment. Especially depending on the development level of the country, the efficiency of these services increases. In this direction, it is to contribute to the development level of the country.

Another aim of the invention is to reduce postpartum perineal pain, dyspareunia, and aesthetic concerns that cause women to avoid normal vaginal delivery and turn to elective cesarean section. Cesarean section causes high maternal mortality, late recovery, increased risks of future births, extended hospital stay, and increased hospital costs. Therefore, it imposes a severe burden on the country's economy. Due to the low cost of the invention, it can be quickly produced, easily purchased, and thus accessible to many women.

Another aim of the invention is to provide an opening without episiotomy in the perineum and vagina as much as the apparatus is required to deliver the baby's head since the apparatus can be expanded and controlled.

Another aim of the invention is to reduce the pressure on the nerve endings, to reduce the effects such as tension and hypoxia, to provide sedation, and to relieve pain by creating relief in the patient as a result of changing the viscoelastic properties of the tissues by applying heat to the areas with thermal properties on the apparatus.

Another purpose of the invention is to protect the woman's privacy by covering the exposed perineum during childbirth. It has been observed that health-related issues are the least shared topics by individuals, even with the people closest to them, and that the people they trust the most in sharing these issues are midwives, nurses, and doctors; therefore, the device protects the privacy and increases trust in relations between patients and healthcare professionals.

Another aim of the invention is to prevent the formation of scars on the body and deterioration in the body image of the woman since there is no need for an extra incision.

Another aim of the invention is to provide an elective and easy application to healthcare personnel through the ergonomic structure of the apparatus. With the invention, an apparatus that does not require an electrical connection prevents uncontrolled perineal tears and soft tissue damage that may occur during childbirth, wraps the anterior and posterior parts of the perineum, and has a massage property at the bottom of the apparatus is provided.

Description of Drawings

Figure 1 . Front perspective view of the apparatus

Figure 2. Side perspective view of the apparatus

Description of Reference Numbers

1. Main Body

2. Interlayer

3. Pressure tube

4. Air pump connected to pressure tube

5. Safety valve

6. Front curtain

7. Rear curtain

8. Cylindrical part

9. Local anaesthetic application point

10. Plastic nut

11. Gel

12. Baby’s head

Detailed Description of the Invention

The invention relates to the perineal expander apparatus with thermal properties, produced from flexible silicone or rubber, prevents uncontrolled perineal tears and soft tissue damage that may occur during childbirth, and comprises pressure tubes that cover the anterior and posterior parts of the perineum, have a massage feature at the bottom of the apparatus, and act as an expander, evenly distributed to every part of the apparatus. Apparatus, which is applied to the perineum and posterior vaginal wall in women in the second stage of labor, preventing uncontrolled perineal tears and soft tissue damage that may occur during childbirth, has a main body (1 ) consisting of two layers of biocompatible medical rubber, silicone or a mixture thereof, in the interlayer (2) located between the main bodies, there is a silicon dioxide gel (11 ) that provides sedation by reducing the effects such as pressure, stretching and hypoxia on the nerve endings as a result of changes in the viscoelastic properties of the tissues, reduces pain by creating relief in the patient, and makes hot-cold application. There is a pressure tube

(3) attached to the body, which can be removed and inserted from the main body, which is also suitable for individual home use in order to stretch the perineum in the weeks close to birth and prepare it for birth, a plastic nut (10) that allows the fixed pressure tube to be attached and removed, air pump connected to the pressure tube

(4) that provides manual expansion of the main body in the vagina, a safety valve (5) to limit the maximum pressure, a front curtain (6) that surrounds and supports and protects the main body (1 ) of the perineum, a hollow cylindrical part (8) which surrounds the vaginal tissue of the main body (1 ) and widens the vagina, allowing the baby (12) to pass through the canal, and a rear curtain (7). There are local anesthetic application points (9) on the front curtain (6) that minimize pain during delivery. For each use before and during birth, the apparatus can be used with suitable sterilized or disposable material after use.

The invention can be produced in a low-cost, easy way in any branch of the industry and can be used for its intended purpose.

Claims

1. An expander apparatus to protect perineal and vaginal tissue during vaginal delivery, comprising the main body (1 ) consisting of two layers, silicon dioxide gel (11 ) applying hot-cold application in the interlayer (2) between the main bodies, a pressure tube (3) connected to the main body (1 ) which is detachable from the main body, air pump connected to the pressure tube (4) that provides manual expansion of the main body in the vagina.

2. An expander apparatus to protect perineal and vaginal tissue according to Claim 1 , wherein the main body (1 ) comprises a front curtain (6) that surrounds and supports the perineum and ensures its uninterrupted expansion.

3. An expander apparatus to protect perineal and vaginal tissue according to Claim 1 , wherein the main body (1 ) comprises the plastic nut (10) for attaching and removing the pressure tube (3) fixed to a front curtain (6) that surrounds and supports the perineum and ensures its uninterrupted expansion.

4. An expander apparatus to protect perineal and vaginal tissue according to Claim 1 , comprising a safety valve (5) to limit the maximum pressure fixed to the air pump connected to the pressure tube (4).

5. An expander apparatus to protect perineal and vaginal tissue according to Claim 1 , wherein the main body (1 ) comprises a rear curtain (7) that surrounds the vaginal tissue and allows the baby to pass through the canal.

6. An expander apparatus to protect perineal and vaginal tissue according to Claim 1 , wherein the main body (1 ) comprises a hollow cylindrical part (8) that surrounds the vaginal tissue and allows the baby to pass through the canal.

7. An expander apparatus to protect perineal and vaginal tissue according to Claim 1 , wherein the apparatus is made of rubber, silicone or a mixture thereof.

8. An expander apparatus to protect perineal and vaginal tissue according to Claim 1 , comprising at least one local anesthetic application point (9) that minimizes pain during labor.

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