WO2016176632A1 - Wearable maternal device for use during sleep - Google Patents

Abstract

A belt for altering sleeping position for a pregnant woman.

Description

Title: Wearable Maternal Device For Use During Sleep

FIELD OF THE INVENTION

The field of the invention is devices to prevent a pregnant woman from sleeping in a position which could be harmful to her fetus.

STATEMENT OF PRIORITY

This application claims the full benefit of, and priority to, US provisional patent application number 62/154,547 filed on April 29, 2015, and incorporates application number 62/154,547 in its entirety.

BRIEF DESCRIPTION OF THE FIGURES

Fig. 1 is a rear view of the outside of an embodiment of the invention capable of receiving rearwardly mounted obstructions.

Fig. 2 is a front view of the inside of an embodiment of the invention capable of receiving rearwardly mounted obstructions.

Fig. 3 is a rear view of the outside of an embodiment of the invention with rearwardly mounted balls and with right side mounted balls. Fig. 4 is a right side view of an embodiment of the invention with rear- wardly mounted balls and with right side mounted balls which is being worn by a pregnant woman.

Fig. 5 is a rear view of an embodiment of the invention with rearwardly mounted balls and with right side mounted balls which is being worn by a pregnant woman.

Fig. 6 is one embodiment of the stabilizing panels with cutouts on the right panel and with balls inserted into the cut outs on the left panel.

DETAILED DESCRIPTION

In obstetrics, it is well-known that the supine position in pregnant women alters maternal cardiovascular parameters, particularly during labor. Only recently has research identified the maternal supine sleeping position as a possible novel modifiable risk factor for stillbirth and low birth weight. It has also been demonstrated that low birthweight mediates the effects of supine sleep on stillbirth, it is estimated that up to 26% of stillbirths and 17% of low birth weights may be averted through modification of this novel risk factor.

In addition to this, it has been shown that the physiological and hormonal changes associated with pregnancy result in changes in sleep architecture, which place pregnant women at higher risk for the development of sleep-disordered breathing, which refers to a wide spectrum of sleep-related breathing abnormalities including increased upper airway resistance (snoring) and obstructive sleep apnea-hypopnea syndrome. The incidence of both snoring and obstructive sleep apnea has been shown to be increased in pregnant women, which may further put the fetus at risk. Indeed, the prevalence of obstructive sleep apnea in the non- pregnant population of reproductive age women is estimated to be 0.7-6.5 %. However, in the 1^st and 3^rd trimesters of pregnancy, the prevalence is 8.4and 19.7 %, respectively. Positional therapy (PT) is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or mild to moderate obstructive sleep apnea from sleeping supine - a position that exacerbates their condition.

There are several techniques used for PT such as positional alarms, verbal instructions, special pillows, tennis balls, vests, and "shark fins". The latter three techniques prevent the wearer from lying supine in a passive manner by physically preventing the wearer from turning into a supine position. In contrast, the present invention decreases the time spent in the supine position by utilizing pressure points against the body which the body avoids by moving during sleep. The present invention is the first PT device that has been designed specifically for use by pregnant women.

Some pregnant women sleep with many pillows supporting their body, including a pillow behind their back to avoid the supine position. Maternal body pillows, regular pillows, and pelvic belts (lumbar support) have been used by pregnant women during sleep without reports of serious adverse effects for the mother or neonate. Asking women to sleep on their left increases the percentage of left sided sleep to approximately 60% of the night; however, this may come at a cost of reduced sleep duration (which is known to be detrimental), perhaps due to the feeling they need to make a conscious effort to maintain sleep position.

The present invention will remove the need for the woman to make a conscious effort to avoid the supine sleeping position. The present invention is a simple, low-cost, belt PT device designed specifically for pregnant women. While the invention does not prevent the user from lying supine during sleep, it will decrease significantly the amount of time she spends in this position. The invention is worn at the level of the waist. By virtue of its design and position on the user's body, the device comprises obstructions which create pressure points on the buttocks and lower back of the user when she lies supine. These pressure points activate her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains supine.

The invention is also designed for adjustability and comfort. In one embodiment the device has two rear pockets 5 on the outside of a back panel 3 which is positioned over the buttocks. In one embodiment the left and right panels are approximately 5 inches wide and within a range of 16 - 18 inches long, and the rear is approximately 12 inches long and 16 inches from top to bottom. The buttocks is a part of the body that is always fully pressed against a surface such as a mattress when the woman is in the supine position. In this embodiment, each of the rear pockets 5 contains a stabilizing panel 9 which has at least one hole or cutout 10 which secures at least one firm plastic ball 11 which resists compression in a range of varying amounts under the weight of a body. It is also possible to configure the obstructions in the rear in one pocket instead of two. In one embodiment the stabilizing panels are plastic foam approximately ½ inch wide and 6 and 13/16 inches long and 3 and ¾ inches wide, and the cutouts are approximately 1 and 7/8 inches. The rear pockets 5 are positioned along the belt such that the obstructions, for example, the plastic balls 11, which may vary in size, shape and stiffness, provide at least one pressure point on the buttocks when the user assumes the supine position. The invention permits maximum adjustment for a comfortable and secure fit and enabling easy removal with a stretch looped belt surface and Velcro hook attachment.

In one embodiment the invention has hip pockets 8 for housing plastic balls (either with or without stabilizing panels) which are about two inches high and 1 and V2 inches wide along the right side of the woman's hip to prevent the woman from sleeping on her right side. Sleeping on the right side has also been associated with adverse effects on a pregnancy. CONSTRUCTION OF THE DEVICE

In one embodiment the device may consist of three main sections: l, a left panel; 2, a right panel; and 3, a back panel. The left and right panels are, in one embodiment, constructed from 2mm thick neoprene foam rubber or other similar elastic material, and the back panel 3 is constructed from elastic jersey or other similar material. The neoprene is faced with a 100% nylon loop A on one side and a 100% nylon knit face B on the other. The loop face lA acts as one part of the attachable surface for a Velcro hook strip 4 to hook into, while the knit-face B provides smooth comfort, moisture wicking properties. The neoprene also provides added support for the user's lower back, and assists with the weight of the belly.

The back panel 3, in one embodiment, is constructed from one or more pieces of knit jersey material (e.g., 92% Polyester and 8% Spandex) which features high stretch, soft hand, fast moisture wicking and antibacterial/anti-odor properties, which allows for easy care. The back panel 3 may be folded and sewn to generate two large pockets 5. The outside opening of a pocket may have a flap 7 which ensures that a stabilizing panel 9 placed within a pocket 5 does not slip out. Each of these pockets are designed to accommodate the stabilizing panel, which in one embodiment consists of a piece of polyethylene foam die cut into a strategically designed shape with two round cutouts to hold plastic balls 11 in place. Additionally, the stabilizing panel may have 3 rounded corners for ease of assembly (insertion and removal from the pocket) and one square corner for orthogonal alignment within the pocket. The location of the cutouts 10 are strategically placed to ensure that the balls 11 apply pressure to the appropriate muscular tissues of the buttocks and lower back. The location of the cutouts 10 may vary to optimize the location of where pressure is applied to the user. Additionally, balls 11 of varying size, density, composition, or stiffness may be placed within the cutouts 10 to determine the ideal intensity of the pressure applied to the user. In one embodiment, the device may be fitted at the location indicated in Figs, l and 2 or in any other convenient location. These wearable electronic elements 12 are capable of tracking over time a variety of bodily measurements and are selected from a group including maternal respiration, maternal heart rate, maternal temperature, maternal oxygenation, maternal sleeping position, fetal movements, fetal heart rate, and/or contractions of the uterus. Maternal sleep position, respiration data, fetal movements, and uterine contractions may be determined using 3D accelerometers imbedded into the device. Alternatively, respiration, fetal movements, and uterine contractions can be determined using strain-gauges and inertial sensors embedded in the elastic portions of the device. Maternal oxygenation and heart rate can be determined using optical sensors embedded in the device at the interface of skin. Maternal temperature can be determined using infrared sensors imbedded into the device. In another embodiment, these data can be wirelessly uploaded or monitored in real time using a smart phone. The data pertaining to sleep position can be used as a biofeedback step during the initial nights of use of the device. Balls of increasing stiffness may be used consecutively over successive nights until an ideal maternal response is attained. The ideal set of balls 11 may vary from patient to patient but could consist of the set of balls that resulted in the least percentage of sleep time spent in supine position.

In another embodiment, a row of hip pockets 8 which, in one embodiment, are smaller than the rear pockets, may be sewn or otherwise attached onto the right panel 2. Balls may then be placed into these smaller pockets, which may have the same flap mechanism as the rear pockets. These balls serve to result in pressure on the right buttocks and thigh and hip when the patient lays on her right side and thereby help inhibit right-sided sleep as well as supine sleep.

The embodiment with the rearwardly mounted balls but without the right- side mounted balls was tested in a cohort of 25 pregnant women in late pregnancy (32-38 weeks gestation). Each subject was monitored in her home over a 2 night period. The subjects were randomized to wear no device (control) or the device (intervention) on the first or second night. On both nights an infra-red video was used to confirm sleep position, and a portable diagnostic device for obstructive sleep apnea was used to assess sleep/wake activity and respiratory parameters (i.e. Apnea-Hypopnea Index [AHI], Oxygen Desaturation Index [ODI]). The AHI is used to indicate the severity of sleep apnea. It is calculated by dividing the number of apnea events by the number of hours of sleep. The AHI values are categorized as: Normal, 0-4; Mild sleep apnea, 5-14; Moderate sleep apnea, 15-29; and Severe sleep apnea, 30 or more. The ODI is the number of times per hour of sleep that the blood's oxygen level drops by 3 percent or more from baseline. In addition to assessment of maternal sleep parameters, an ambulatory fetal monitor was used to collect continuous fetal heart rate during maternal sleep.

Sleep duration and subjective sleep quality were not significantly altered between the control night and the intervention night. This is important given that an ideal PT device should not result in sleep fragmentation or alterations in sleep duration/quality, and instead should alter the wearer's sleep position. The device was found to reduce the proportion of participants reporting supine sleep from 45% during the control night to 20% during the intervention night. Thirty percent of the participants met threshold values for mild sleep apnea (AHI>=5). For those with an AHI>5 during the control night, AHI was significantly reduced during the intervention night (jKO.05). Maternal oxygenation parameters were significantly improved during the intervention night as evidenced by increased minimum o₂ (P<o.oi) and decreased ODI (Ρ=ο.θ2). Moreover, there were significantly fewer fetal heart rate decelerations on the intervention night compared to the control night (P=o.02).

Overall, these data demonstrate that the invention is effective during late pregnancy for reducing supine sleep, and as a result, improving maternal oxygen ation and reducing fetal heart rate deceleration without negatively impacting the length and quality of maternal sleep.

Claims

A belt for modifying a pregnant woman's sleeping position comprising a back panel, a left panel and a right panel, said belt fitting snugly on the hips and across the buttocks, said belt further comprising obstructions embedded in the rear of the belt, such that when the pregnant woman is sleeping in a supine position, pressure points are created by the obstructions, thus causing her body to move from a supine position.

The belt as in claim 1, further comprising obstructions embedded on the right panel of the belt, thus causing pressure points on the pregnant woman's right side and causing her body to move from a right-sided position.

The belt as in claim 1, further comprising pockets wherein the obstructions are inserted.

The belt as in claim 3, wherein the obstructions comprise balls inserted into at least one stabilizing panel.

The belt as in claim 1 wherein the stabilizing panel is removable and may be fitted with obstructions of varying size and stiffness to achieve optimal maternal sleep.

The belt as in claim 1 comprising electronic elements to record and track maternal and fetal physiological parameters.