This disclosure relates generally to expression of milk and, more specifically, to a breastpump that generates and delivers a pulsed vacuum.
Breast alveoli share many functional similarities with lung alveoli. In the case of lung alveoli, oxygen and carbon dioxide are transferred between the lungs and the bloodstream, with carbon dioxide being transferred to the air and then expulsed. In the case of breast alveoli, components of breastmilk, such as nutrients, are transferred from the bloodstream to milk and then expulsed. A known treatment of occurrences of respiratory distress syndrome in full-term and near-term infants is the application of high-frequency oscillatory ventilation (HFOV). The efficacy of this form of ventilation is attributable to the fact that HFOV improves oxygenation through the lung alveoli. HFOV operates on a principle of vacuum pulse generation.
Conventional electric breastpumps deliver a cyclical vacuum, regardless of whether the breastpump is a single-stroke or accumulator style of breastpump. While strides have been made to provide breast pumps that apply forces at frequencies to the nipples that mimic those delivered by a feeding infants, the volume of milk expressed during pumping sessions utilizing conventional breastpumps can be lower than the volume of milk delivered by direct feeding. Moreover, while the fat content of milk provides some of the greatest nourishing benefits of breastfeeding, the concentration of fat within breast milk has been found to increase toward the end of a feeding or pumping session. High fat concentration milk can be the most desirable, because higher fat concentration in milk leads to a more complete removal of the milk to the feeding infant, or a more effective pump. The physiology of epithelial milk-secreting cells, however, is such that they tend to close-off as the fat concentration of the milk increases, thereby preventing the delivery of high fat concentration milk to the feeding infant or, in the case of a breastpump, to a milk collection container.
Given the functional similarities of breast alveoli and lung alveoli, we have designed a breast pump that utilizes vacuum pulse generation. By providing vacuum pulse generation in addition to (or in lieu of) a conventional cyclical vacuum, breastpumps of the present disclosure provide improved milk removal from the breast alveoli and foster the maintenance of open apertures of epithelial milk-secreting cells to provide improved milk removal from breast alveioli.
Advantageously, breastpumps of the present disclosure deliver higher volumes of collected breast milk in a single pumping session, while applying a lower effective vacuum pressure to the breast.
In a preferred embodiment, a breastpump employs a multi-stroke accumulator with inherent vacuum steps. While conventional accumulator pumps employ elastomeric diaphragms, such pumps experience losses due to the dampening effects the diaphragm and its related support structure have on the vacuum pulses generated by the motor of such pumps. Instead of an elastomeric diaphragm, the instant breastpump uses a solid piston head sealed in a cylinder. During use, the stiff piston creates a distinct vacuum step, or pulse, that can be transferred through vacuum delivery tubing to a breast shield or related device, across a media separation membrane (if necessary), and ultimately to the breast pumping mother.
Though constructed as a linear piston/cylinder-style breastpump, the system of the present disclosure takes advantage of the nature of a multi-stroke pump style in which a reciprocating member generates small increments of vacuum that are accumulated together to reach a target vacuum.
In order to deliver vacuum pulses with a solid piston, it is found beneficial to actuate the solid piston in an eccentric manner. Due to the need to maintain the integrity of a pneumatic seal between the circumference of the piston head and the walls of the vacuum cylinder despite the eccentric movement of the solid piston, a low friction compression seal having a non-circular cross-section configuration, such as the MULTISEAL® bi-directional lip style seal available from Precision Associates, Inc. of Minneapolis, Minn., USA, is employed at the interface between the piston head and the sidewall of the vacuum cylinder.
The breastpump of the present disclosure applies a distinct vacuum pulse to stimulate the breast alveoli. The instant breastpump can achieve a higher vacuum than conventional diaphragm-style accumulator breastpumps operated under similar power conditions because energy losses attributable to material stretching are eliminated. Because a rigid piston can evacuate more volume in a chamber for each individual stroke, the breastpump of the present disclosure also can be constructed to have a smaller overall footprint than a diaphragm-style accumulator breastpump. Because diaphragm-style breastpumps are prone to fatigue, and even tears in the diaphragm membrane, the rigid piston-style pump of the present disclosure possesses superior reliability. Also, based on the strong correlation between the motor's current draw and the vacuum generated, vacuum control can be performed economically, without the need for costly pressure monitors. The mechanical architecture of a breastpump constructed in accordance with the teachings of the present disclosure is also tunable, in that the vacuum pulse frequency can be optimized by modifying the volume of the displacement chamber. The larger the chamber volume (which can be created either by using a larger cylinder cross-section or by increasing the piston stroke), the greater the vacuum step, and the smaller the chamber volume, the lower the vacuum step.
With reference to
An accumulator-style pump 100 of the present disclosure is illustrated in cross-section in
The solid piston head 102 engages a sidewall 106 of the cylinder 104. Because the solid piston head 102 is actuated in an eccentric manner, the piston head 102 does not maintain a perpendicular relationship with respect to the side wall 106 throughout its travel along the interior of the cylinder 104. Rather, the disc-like piston head 102 rocks from in a tilted manner as it moves up and down (as indicated by the curved and straight arrows in
In a particular embodiment, the eccentric actuation of the solid piston head 102 can be achieved utilizing a rotatable bearing 110 that receives a bearing insert 112 having an offset axis of rotation 114. The rotatable bearing 110 and bearing insert 112 are received in a complementary circular opening 116 of the piston head 102. A motor M of the pump 100 includes a motor shaft MS that is securely received in a shaft receptacle 118 of the bearing insert 112, which shaft receptacle 118 is coaxial with the offset axis of rotation 114 of the bearing insert 112.
The sequence of actuation of the multi-stroke accumulator linear piston/cylinder-style pump of the present disclosure can be understood with reference to
With reference to
An exemplary cycle of the pump of the present disclosure is illustrated in
As illustrated in
Other embodiments that are within the scope of the present disclosure include alternate structural configurations for a vacuum pump mechanism that achieve controllable vibration pulses. For instance, rather than having a piston that undergoes an eccentric movement, a vacuum pump having a piston that maintains a vertical orientation throughout its travel along the sidewall 106 of the cylinder 104, but employs a yoke, linkages, and/or direct action (such as a solenoid, a servo motor, or a DC stepper motor capable of pulsed actuation).
The motor M of the multi-stroke accumulator pump 100 of the present disclosure has an increased torque relative to motors employed with a conventional single-stroke pump 200 or a diaphragm-style accumulator pump 10, which is necessary to achieve the discernible, predictable vacuum pulses of sufficient amplitude to achieve advantageous results, as described in more detail below. A benefit of the increased torque of the motor M is that each vacuum pulse creates a distinct load on the motor shaft MS that is directly proportional to the current draw of the motor M. As such, the vacuum load can be accurately predicted based on the current draw.
Another benefit of the correlation between the current draw of the motor M and the resulting vacuum of the multi-stroke accumulator pump 100 of the present disclosure is that the pump 100 can be controlled by monitoring the current output of the motor M without the need to include a pressure monitor. To avoid applying too strong of a vacuum, a predetermined not-to-exceed current output of the motor M can be set.
A practical effect of the predictable vacuum pulse generated by the multi-stroke accumulator pump 100 of the present disclosure when employed in a breast pump is increased oxygenation of breast alveoli and improved milk removal, as compared to vacuum supplied by conventional single-stroke pumps 200 or diaphragm-style accumulator pumps 10. The combined cyclical vacuum frequency and vacuum pulse frequency applied by the multi-stroke accumulator pump 100 imparts a high-frequency oscillatory ventilation to the breast alveoli. In a manner similar to the treatment of respiratory distress syndrome through the application of HVOC, which utilizes vacuum pulse generation to provide increased oxygenation to lung alveoli, increased stimulation of the breast alveoli during the course of a breast pumping session is found to result in an increased volume of collected breastmilk.
Percent of available milk removed, or PAMR, is a metric used to quantify the volume of collected breastmilk.
A comparison of
Moreover, it is understood that breastmilk having higher fat concentration leads to more complete removal of the milk to a feeding infant, and a more effective pump. During the course of a pumping session, it is found that the viscosity of breastmilk increases toward the end of the pumping session, indicative of an increase in fat content of the breastmilk. However, with conventional cyclical vacuum breast pumps, the less-ventilated breast alveoli tend to close up, or the viscosity of the breastmilk otherwise impedes the secretion of further breastmilk through the breast alveoli, despite the epithelial milk-secreting cells having generated additional desirable high-nutrient, relatively high-fat breastmilk. This precious additional breastmilk, when not released through the breast alveoli, goes unused. Over time, the inability to remove the all available milk from the breast alveoli, whether through baby feeding, pumping, or some combination of the two, will diminish available milk supply. Thus, an advantage of the multi-stroke accumulator pump 100 of the present disclosure, and other vacuum pump mechanisms that achieve controllable vibration pulses which are within the scope of the present disclosure, is the provision of a device that facilitates complete or near-complete emptying of the breast alveoli, which promotes increased, or at least sustained, milk supply over time. Through the use of the multi-stroke accumulator pump 100 of the present disclosure, it is found that not only is increased breastmilk collection during a given pumping cycle achieved, but also, the collected breastmilk includes the higher fat content breastmilk that heretofore went uncollected by electric and manual breastpumps.
Yet a further benefit of the multi-stroke accumulator pump 100 of the present disclosure, and other vacuum pump mechanisms that achieve controllable vibration pulses which are within the scope of the present disclosure, is that the increase in milk flow rate during the course of a pumping session is achieved via application of less vacuum pressure. Practical benefits of being able to achieve increased milk collection with lower vacuum pressure include lower power requirements (facilitating use of less-costly power supplies, lighter power supplies, and/or rechargeable power supplies that require less time to re-charge or that maintain their charge longer before they require a recharging), and greater comfort for the nursing mother. The increased pumping efficiency also affords several benefits, such as faster pumping (and therefore shorter pumping sessions), greater breastmilk collection in a single pumping session, and, as discussed above, increased, or at least less-diminished, milk supply over time.
While the present disclosure is presented with human breastpumping as its primary use, milking machines for use in the dairy industry may be constructed with pumping mechanisms that utilize a multi-stroke accumulator pump made according to the teachings of this disclosure, and other vacuum pump mechanisms that achieve controllable vibration pulses, to achieve many, if not all, of the benefits described herein. For milking machines in the dairy industry, for instance, the interface I may instead be one that receives one or more bovine teats. A single pump of the present disclosure could be used in such settings in simultaneous pneumatic communication with more than two teats, and even with more than a single lactating cow, so as to milk a plurality of cows simultaneously.
A multi-stroke accumulator pump 100 may be operated at 0.1 mmHg or higher, and a frequency below 80 Hz. The frequency can be below 30 Hz, or in the range of 10-30 Hz.
While certain embodiments are described herein, variations may be made that are still within the scope of the appended claims.
This is the non-provisional, and claims the benefit of the filing date under 35 USC § 119(e), of U.S. Provisional Appl. No. 62/815,135, filed Mar. 7, 2019, which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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62815135 | Mar 2019 | US |