The present invention relates generally to the medical and surgical fields, namely, obstetrics and gynecology (OB/GYN) and the field of vaginal delivery. More specifically, the present invention relates to devices, systems, and methods used as facilitating and teaching tools for both medical professionals and gravid patients/persons having a baby to do a vaginal delivery through non-medical interventions such as position change, gravity positions, massage, pelvic mobility etc. by assessing presentation of fetal head to the maternal pelvis, dilation, and effacement.
Maternity care of gravid patients and childbirth have seen medical and technological advances that have drastically reduced maternal and infant mortality. According to the World Health Organization, while most pregnancies and births are uneventful, all pregnancies are at risk. Around 15% of all pregnant women will develop a potentially life-threatening complication that calls for skilled care, and some will require major obstetrical interventions to survive. In such cases, rapid assessment and decision-making based on clinical assessment and interventions with limited reliance on laboratory or other tests becomes paramount. These are interventions that, when used appropriately, can be life-saving procedures.
On the other hand, routine use of such interventions without valid indications, training, and proper facilitation and teaching systems, tools, and methods can transform childbirth from a normal physiologic process and family life event into a medical or surgical procedure. Every such intervention presents the possibility of untoward effects and additional risks that create the need for even more interventions with their own inherent risks. Unintended consequences to intrapartum interventions make it imperative to find alternative and functional apparatuses, devices, systems, and methods for use in facilitating and teaching both medical professionals and patients/persons having a baby to achieve a vaginal delivery through non-medical interventions such as position change, gravity positions, massage, pelvic mobility etc. by assessing the presentation of fetal head to maternal pelvis, dilation and effacement to promote natural childbirth processes and advocate for policies that focus on ensuring informed consent and alternative choices.
Some interventions and procedures have been routinely used in monitoring as well as managing complications in pregnancy and childbirth. The health care workers are generally taught to begin with a table that is often used by them to rapidly assess the woman's condition and initiate appropriate treatment, if so may be required. Every pregnancy has a risk of complications, and these complications, if they arise, may be harder to detect or treat without medical intervention. Thus, non-medical interventions form a shield and require proper training and facilitation of health care workers to allow natural and vaginal delivery. In order to provide health care workers with the information needed to differentiate between normal processes and a complication, and to educate and train them on description of normal labor and childbirth, guidance is often provided in the form of charts, diagrams, and tables but it remains an issue in terms of variance in training and understanding as a teaching and management tool so as to achieve vaginal delivery with minimal medical interventions.
This has identified a need for devices, systems, and methods for training, teaching, and facilitating health care workers/medical professionals, as well as educating the gravid patients/persons having a baby about the options to achieve a vaginal delivery through non-medical interventions such as position change, gravity positions, massage, pelvic mobility, etc. by assessing the presentation of the fetal head to the maternal pelvis, dilation and effacement, where the conventional methods and systems in place are lacking. But none of the conventional devices and methods resolve the aforementioned need in the art.
Conventionally, health care workers/medical practitioners use foam cutouts for the dilation, lifesavers for the effacement, and a head-and-pelvis for the presentation. But the systems and methods for the said crucial aspects of vaginal exams are not streamlined and it is cumbersome to consult conventional charts and tables and, also may lead to confusion and discomfort for the patients.
An objective of the present invention is to provide a system and methods to address the said need. It is an aim of the present invention to overcome the problems associated with conventional systems and methods by providing a portable device of the present invention as disclosed herein that can be carried in the pocket or on a badge and can help health care workers/medical practitioners to assess uniformly in cervical exams which are made streamlined as well as can be used to teach and educate the patients to understand what is happening to their cervix. The device of the present invention is further advantageous in that it can be used multiple times being made of material that is wipe-off-able and can be cleaned and reused in a sanitary manner, is small enough to carry in a portable manner, and instills confidence and uniformity among the health care workers/medical practitioners and alleviates the constant and tedious need to run out of the room to get confirmation on the exam.
The present invention relates to devices, systems, and methods for use as educational and non-medical intervention facilitation tools for both medical professionals and gravid patients/persons having a baby to achieve a vaginal delivery through non-medical interventions such as position change, gravity positions, massage, pelvic mobility, etc. by assessing the presentation of the fetal head to the maternal pelvis, dilation, and effacement. The present invention provides a portable device for measurement of cervical dilation, presentation of fetal position relative to the maternal pelvis, and/or measurement of effacement of the cervix in a gravid patient. The device comprises semicircle open rings made of pliable material, wherein the semicircle open rings are numbered and measured in a range of 1 cm to 10 cm to measure dilation. Further, the device comprises five concentric half-circle rings to measure effacement, wherein said concentric half-circle rings are separated by 0.5 cm each. Furthermore, the device provides the presentation of fetal position relative to the maternal pelvis as assessed by a health care worker in a gravid patient. To that end, four round circles representing the fetal head with suture lines felt up and down and side to side are provided on the device.
Detailed embodiments of the present invention are disclosed herein. However, it is to be understood that the disclosed embodiments are merely exemplary of the present invention, which may be embodied in various systems. Therefore, specific details disclosed herein are not to be interpreted as limiting, but rather as a basis for teaching one skilled in the art to variously practice the present invention.
All illustrations of the drawings are for the purpose of describing selected versions of the present invention and are not intended to limit the scope of the present invention.
The present invention addresses the problem in the medical OB/GYN field of vaginal delivery in a gravid patient as discussed hereinabove by means of the references mentioned hereinabove and incorporated by reference.
The present invention provides devices, systems with guides for teaching, understanding, and facilitating natural vaginal birth with the intervention of cervical exams, and the method for health care workers/medical practitioners to perform such cervical exams and to educate the gravid patient/person giving birth to make informed decisions on childbirth and alternate options available to them to choose from to understand complications, if any, and informed decisions to tackle such complications based on real-time analysis and assessment using non-medical interventions. The present invention aims to offer a teaching tool and guide using the disclosed device and method to help everyone to use the same language and the same measurements for exams for uniformity and better and quicker decisions. The present invention is advantageous in that, a health care worker/medical practitioner can carry the disclosed piece of equipment/device since it is portable, and it can be used after a digital exam.
The following description is in reference to
As seen in
As seen in
It is an aim of the present invention to provide a multifunctional device or guiding tool for health care workers dealing with gravid patients. To that end, the plurality of effacement markings 5 is positioned along a second region 8b of the measurement panel 1, wherein the second region 8b is opposite to the first region 8a across the central aperture 2. In other words, the second region 8b constitutes a second half section of the measurement panel 1, such as a right-side section, that is opposite to the first region 8a. As used here, effacement means the thickness of the cervix. Generally, the cervix needs to get thinner (seen as a larger number of percentages of effacement) before it can dilate (stretch open). Effacement is usually measured in percentages wherein the unit of measurement is 0.5 cm and each 0.5 cm equals 25% effaced. In the disclosure of the present invention in the device, on one side of the device such as the right side of the device, as shown in
Continuing with the preferred embodiment, the plurality of presentation markings 6 is positioned within the base region 1b. Preferably, the base region 1b is the lower section of the measurement panel 1 that is positioned below the plurality of arcs 3. As used here, the plurality of presentation markings 6 or presentation may mean as to which way the fetal head is directed when compared to the maternal pelvis. This gives the health care worker/medical practitioner the required information about where the head is and how to rotate the maternal pelvis to get the fetal head to move down in the maternal pelvis. In the disclosure of the present invention in the device as shown in
The measurement of the presentation of the fetal head is in letters labeled as Occiput Posterior referred to as OP, Left Occiput Anterior referred to as LOT, Right Occiput Anterior referred to as ROT, and Occiput Anterior referred to as OA. The letters are representative of where the back (occipital) of the head is compared to the maternal pelvis. For example, the back of the fetal head is to the mother's tailbone is measured as OP or occiput posterior. The suture line would be felt like a vertical line. If the suture line is horizontal, the fetus could be ROT or LOT depending on if the back of the head is to the maternal left or right. As seen in
A more detailed description of the physical features of the present invention follows. According to the preferred embodiment, and in reference to
In the preferred embodiment, the present invention further comprises an extended region 11, and an access hole 12. Preferably, the extended region 11 laterally extends from a terminal edge 1c of the measurement panel 1, and the access hole 12 traverses through the extended region 11. As seen in
A detailed description of a preferred method of operation of the present invention follows. In an embodiment of the present invention, the method for measurement of cervical dilation, presentation of fetal position relative to the maternal pelvis, and/or measurement of effacement of the cervix in a gravid patient by conducting an exam is disclosed, the method comprising the steps of:
obtaining consent for the exam in the gravid patient after rationalizing and explaining the reason for the exam by a health care worker to the gravid patient;
laying the gravid patient flat on a surface with a roll or bump under the hips of the gravid patient;
explaining and assisting the gravid patient into position with heals together and knees apart by the health care worker;
obtaining consent from the gravid patient again to touch the vaginal area;
performing an examination of the vaginal area of the gravid patient by the health care worker for the measurement of cervical dilation, presentation of fetal position relative to the maternal pelvis, and/or measurement of effacement of the cervix in a gravid patient,
wherein the health care worker examines the vaginal area of the gravid patient by first using a gloved non-dominant hand to spread the labia of the gravid patient, then the health care worker gently while using a gloved dominant hand and doused in generous lubrication to insert a pointer finger and a middle finger of said dominant hand in the vagina of the gravid patient, wherein after entering the vagina of the gravid patient, the health care worker makes a peace sign of about 3 cm to 4 cm and feels for the anterior aspect of the vaginal wall and follows the wall backward while allowing the pointer finger and the middle finger to find the cervix and insert them into the cervix of the gravid patient to perform the exam for measurement of the distance of separation between the pointer finger and the middle finger at resting tone, and wherein subsequent measurements are done of the distance of separation between the pointer finger and the middle finger, and said measurements of the distance of separation between the pointer finger and the middle finger are seen as an increase in the measured diameter of the concentric half-circle rings of the device used as a measurement reference of the stretch of the cervix representing cervical dilation in the gravid patient said measured diameter of the concentric half-circle rings of the device providing the measurement of the cervical dilation.
Accordingly, the guiding and assessment system for cervical examination of gravid patients comprises monitoring how far an examiner's fingers can spread during examination of the gravid patient's cervix and analyzing that information to determine an estimate length to that analysis. Further, the estimate length is compared with the plurality of dilation markings 4 on the measurement panel 1 to assess an accurate dilation value in centimeters. In other words, the health care worker/medical professional measures the stretch of the cervix with their pointer finger and middle finger as per the conventional practice in the field, where the distance by which the said fingers separate indicates how dilated the cervix of the gravid patient is at a given time. Then the health care worker/medical professional takes the separated pointer finger and middle finger at the above-mentioned distance between them and compares it to the reference concentric half-circle rings on the disclosed device of the present invention, the concept is illustrated in
Similarly, in order to measure effacement, the system comprises, monitoring a thickness of the gravid patient's cervix during examination of the gravid patient's cervix and analyzing that information to determine an estimate thickness to that analysis. Further, the estimate thickness is compared to the plurality of effacement markings 5 on the measurement panel 1 to assess an accurate effacement value in percentages. As shown in
Furthermore, the system may comprise the steps of monitoring an orientation of a suture line of a fetal head through the cervix, during examination of the gravid patient's cervix. This is followed by comparing the suture line's orientation with the plurality of presentation markings to assess which way the fetal head is directed along a maternal pelvis of the gravid patient. More specifically, the presentation may mean as to which way the fetal head is directed when compared to the maternal pelvis. This gives the health care worker/medical practitioner the required information about where the head is and how to rotate the maternal pelvis to get the fetal head to move down in the maternal pelvis. It is important to understand and be able to assess and examine, the direction of the fetal head compared to the maternal pelvis to verify the direction of the fetal head or presentation of the fetal position relative to the maternal pelvis. An illustrative example of a fetal head is provided herein, in
When assessing and examining the fetal presentation, for the health care worker/medical practitioner, this is an upside-down and backward concept. This is done to see what position (or the way the head is facing) compared to the maternal pelvis as shown in a representative illustration in
In summary, in an embodiment of the present invention, a system with educational tools and a guide using the disclosed information received as dilation, effacement, and fetal presentation in the gravid patient using the disclosed portable device and method for measurement of cervical dilation, presentation of fetal position relative to the maternal pelvis, and/or measurement of effacement of the cervix in a gravid patient by conducting an exam to be used by medical professionals to reposition and evaluate labor progress, to help prevent the arrest of labor by actively managing cervical exams and using information gathered to rotate the presentation of the fetal head to the optimal position needed for pressure on the cervix to dilate and efface effectively and is used in shared decision making with patients to discuss labor progress and non-medical interventions such as a movement that can rotate a fetus into optimal position for effective dilation and effacement for vaginal delivery.
The present invention provides an educational tool for measuring cervical dilation comprising: semicircle open rings made of pliable material numbered and measured in a range of from 1 cm to 10 cm; a solid pliable piece of material with concentric half-circles where their diameter measured from distal sides and is in a range of from 1 cm to 10 cm; realistic representation of dilation whereas cervix can stretch but needs to be measured in resting tone, the concentric rings can stretch, but will be accurately measured in resting tone; an educational tool for medical professionals to gauge, measure, and train for cervical dilation exam; and an educational tool for use to teach the explanation of what exam means and next steps to the patients and/or the persons receiving the cervical dilation exam.
The present invention further provides a method of verification as to the direction of the fetal head or presentation of fetal position relative to the maternal pelvis compromising: four round circles representing the fetal head with suture lines felt up and down and side to side as defined as OA, OP, LOT, ROT, wherein the position of the fetal head compared to the maternal pelvis as recognized as suture lines represented by four circles labeled as OA, OP, LOT, ROT, wherein the information pertinent to optimal position of the fetal head compared to the maternal pelvis is obtained for successful vaginal delivery, and if the fetal head is not in an optimal position, such exam and method will give information as to next steps needed; provides a guide to repositioning patient in an optimal position, increasing pelvic mobility, for fetal head alignment compared to maternal pelvis for successful vaginal delivery; provides an educational tool for medical professionals to recognize the suture lines compared to the maternal pelvis to determine fetal presentation; and provides an educational tool used to teach the patient the fetal presentation compared to the maternal pelvis and the necessary movements required to be made to rotate the fetal presentation to an optimal position for vaginal delivery.
The present invention also provides a method of verification of measurement of effacement of cervix compromising: units of measurement of 0.5 cm which is equal to an effacement of 25%; concentric rings separated by 0.5 cm that are used to measure effacement by 25% increments, wherein larger the number, the thinner the cervix and greater the effacement; provides a guide to labor progress as to the strength and frequency of uterine contractions using the fetal head as presenting part putting pressure on the cervix to efface the cervix; provides an educational tool for medical professionals to measure thickness of the cervix as represented by percent effacement; and provides an educational tool used to teach the patient the percent effacement they are compared to the percent effacement needed to successfully deliver an infant vaginally.
Additionally, the present invention provides a guide using information received as dilation, effacement and fetal presentation compromising: educational tools used by medical professionals to reposition and evaluate labor progress; a tool used to help prevent the arrest of labor by actively managing cervical exams and using information gathered to rotate the presentation of the fetal head to an optimal position needed for pressure on the cervix to dilate and efface effectively; an educational tool used in shared decision making with patients to discuss labor progress and non-medical interventions such as a movement that can rotate a fetus into an optimal position for effective dilation and effacement for vaginal delivery. Further, the present invention provides a new and improved method which is a reliable system for multiple users to maintain uniform verbiage and units of measurement.
The target audience is anyone in the childbirth community. Nurses, doulas, midwives, doctors, and patients or persons having babies. This tool can encourage non-medical interventions that can change the outcome of the childbirth experience. The present disclosure is applicable for all the age groups, targeting all types of people.
While a specific embodiment has been shown and described, many variations are possible. With time, additional features may be employed. The particular shape or configuration of the platform or the interior configuration may be changed to suit the system or equipment with which it is used.
Although the invention has been explained in relation to its preferred embodiment, it is to be understood that many other possible modifications and variations can be made without departing from the spirit and scope of the invention as hereinafter claimed.
Number | Date | Country | |
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63276377 | Nov 2021 | US |