WO2000041744A1

WO2000041744A1 - Breast pump apparatus for facilitating a milk ejection reflex and methods of using

Info

Publication number: WO2000041744A1
Application number: PCT/US2000/000738
Authority: WO
Inventors: Elena Taggart Medo
Original assignee: Elena Taggart Medo
Priority date: 1999-01-12
Filing date: 2000-01-12
Publication date: 2000-07-20
Also published as: AU2503200A

Abstract

A novel apparatus, a multicomponent system, and methods for using this system, for facilitating and augmenting milk removal from the breast of a mammal. Specifically, the system of the invention facilitates initiation of the mother's milk ejection reflex. It accomplishes this by providing auditory stimulus of the form of various sounds to the mother to facilitate to initiation, intensity, and sustaining of her milk ejection reflex. The auditory stimulus is played in conjunction with the action of a breast pump (10).

Description

BREAST PUMP APPARATUS FOR FACILITATING A MILK EJECTION REFLEX AND METHODS OF USING

RELATED APPLICATIONS

This application incorporates by reference and claims the benefit of priority under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 60/115,561, filed January 12,

1999. The present application also incorporates by reference USSN / , for

"BREAST PUMP WITH OVERFLOW SENSOR AND AUTOMATIC FLUSH FEATURE" (attorney docket No.: 10547-003001), filed concurrently on January 11, 2000 (hereinafter "003001"). Each of the aforementioned applications is explicitly incorporated herein by reference in their entirety and for all purposes.

TECHNICAL FIELD

This invention generally pertains to the fields of physiology and child care, including breast pumps. In particular, the invention relates to a novel system for facilitating a milk ejection reflex in a mammal.

BACKGROUND

Breast pumps are convenient for nursing mothers, because, among other things, they allow the nursing mother to draw off breast milk to feed to the child at a later time when the mother may not be present. For some mothers, breast pumps are required, particularly when the child has sucking difficulties or if the mother has problems with excessive or deficient milk production, or cannot empty completely. Some mothers also require breast pumps in the event of soreness or injury of the mammilla, or sunken mammilla.

One problem associated with the use of breast pumps is that there is an absolute requirement that the mother experience a "milk ejection reflex" (MER) or "let-down reflex" before any milk can be extracted by either baby or pump. MER can be very difficult to achieve, particularly when the mother is anxious, tired or nervous about her surroundings. If a mother is experiencing this problem and cannot extract milk without a pump, the problem exacerbates because of the inevitable frustration which accompanies "let-down" failure. The present invention addresses these and other needs.

SUMMARY OF THE INVENTION

The invention provides a system for facilitating a milk ejection reflex in a mammal comprising a breast pump and an apparatus for producing an auditory stimulus, wherein the auditory stimulus is timed for use in conjunction with the breast pump. In this system, the auditory stimulus apparatus is timed to begin before the start-up of the breast pump; i.e., the sound playback is timed to begin at some preset period before start-up of the breast pump. Alternatively, the system can have a means to detect the flow of milk to signal the start-up of the breast pump. In another embodiment, the auditory stimulus apparatus is timed to begin simultaneously with the breast pump. The "communication" between components can be by simple hard wired switches, or, can be controlled by microprocessors and/or computers (e.g., "PCs"), as discussed further, below.

In the systems of the invention the breast pump and the auditory stimulus apparatus can be in the same housing, or, they can be not in the same housing, i.e., remote to each other. However, they can be "attached" by means of a garment, e.g., a vest, to be worn by the mother using the device. The system of the invention can be entirely portable, or, separate components can be portable, e.g., a non-portable vacuum pump with a portable sound playback system; these can be connected to each other and/or to a separate control or other device (e.g., computer, microprocessor, telephone) by hard wiring or by wireless components.

In alternative embodiments, the breast pump and the auditory stimulus apparatus are hard wire connected, or, the breast pump and the auditory stimulus apparatus are connected by wireless communication components. The wireless communication components can comprise infrared or radio transmission components.

In the system of the invention, the auditory stimulus can be any sound that stimulates lactation or the MER. These include, e.g., music, "white sound," natural sounds (e.g., rain or surf), animal sounds, or a sound of an infant, particular an infant of the same species as the mother, or, the actual nursing offspring of the mother using the system of the invention. The auditory stimulus apparatus of the invention can comprise an electronic sound reproduction device comprising a speaker and a sound playback device. The sound playback device can be an analog or a digital or a magnetic tape playback device. The auditory stimulus apparatus (including sound reproduction components) can comprise a microprocessor chip, a magnetic tape, an optically readable disc, or a magnetically readable disc.

The system of the invention can further comprise a sound recording device. This feature is particularly applicable for recording sounds of the infants of the mother for playback during operation of the system of the invention. The sound recording device can also comprise a removable or an inset microphone.

In alternative embodiments, the components of the system, including the breast pump, sound reproduction or recording components, vacuum, switches, lights, computer (e.g., microprocessor), or other components (see below), are electrically powered, or battery powered, or both. The breast pump can also be manually powered. The invention also provides a method for facilitating a milk ejection reflex from a breast of a mammal comprising producing an auditory stimulus (i.e., sound) in association with applying suction to a breast to remove milk from the breast by the system of the invention. The method of claim 16, wherein the auditory stimulus comprises a sound produced by an infant or music. The sound can be produced by an infant of a mother using the system. The system can also be programmed to contain a variety of sound options, including more than one type of baby sound.

The invention also provides a method for ameliorating lactation failure in a mammal comprising producing an auditory stimulus in association with applying suction to a breast by the system of the invention, thereby facilitating milk removal from the breast and ameliorating lactation failure in the mammal. In this method the mammal can be a primate (e.g., a human), a canine, a feline, an equine, a bovine or a porcine.

A further understanding of the nature and advantages of the present invention is realized by reference to the remaining portions of the specification, the figures and claims. All publications, patents and patent applications cited herein are hereby expressly incorporated by reference for all purposes. BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 shows an exemplary system of the invention wherein all components of the system are contained within the same housing.

Figure 2 shows a control panel for an exemplary system comprising a breast pump with an auto-flush feature and an infrared sensor for overflow control; the control panel including an on/off switch, controls for adjusting suction levels; controls for adjusting timing of suction; an autoflush control switch and an overflow indicator light.

Figure 3 shows a control panel for an exemplary system comprising a breast pump with an auto-flush feature; the control panel including an on/off switch, controls for adjusting suction levels; controls for adjusting timing of suction; and an autoflush control switch ("milk ejection helper" switch).

Figure 4 shows a control panel for an exemplary system comprising a breast pump with an auto-flush feature and auditory stimulus apparatus (including recording sound and playback option); the control panel including an on/off switch, controls for adjusting suction levels; controls for adjusting timing of suction; and an autoflush control switch

("milk ejection helper" switch); record sound switches (including off/select/record); several noise option switches (including baby sounds, music, nature sounds, white noise).

Figure 5 shows a schematic for an exemplary system comprising a breast pump with an auto-flush feature and auditory stimulus apparatus; the auditory stimulus apparatus is contained in the microprocessor "PC" board. Speakers can be connected to the PC board (not shown).

Figures 6 to 9 show an exemplary system incorporating a manual breast pump. Figure 6 shows a perspective view of the system. Figure 7A shows a cross-sectional view of the inner pumping cylinder or plunger 14. Figure 7B shows a cross-sectional view of the outer pumping cylinder 12. Figures 8 A is a top view and 8B is a cross-sectional view of a pumping seal. Figures 9A is a top view, 9B and 9C cross-sectional views of the one-way valve of Figure 9A.

Figure 10 illustrates an exemplary embodiment of system of the invention that incorporates a motor driven http://l 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l &u=/netahtml/ - h47http://l 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - h49breast pump. Figure 11 is a schematic diagram illustrating a side-view of the embodiment of Fig. 10 showing the connection of the regulator to a vacuum source and a reservoir. Figure 12 is a schematic of a regulator of the embodiment of Fig. 10.

DETAILED DESCRIPTION

The present invention provides a novel apparatus, a multi-component system, for facilitating and augmenting milk removal from the breast of a mammal. Specifically, the system of the invention facilitates initiation of the mother's "milk ejection" or "let-down" reflex. When a baby starts to suckle at the breast, or a nipple is stimulated by pumping, a message is sent to the pituitary gland in the brain. The pituitary gland releases two hormones: prolactin and oxytocin. Prolactin tells the body to start producing milk and oxytocin releases the milk from the alveoli. This sudden release of milk from the breast is the so-called "let-down" or "milk-ejection" reflex. It may take seconds or several minutes of nursing or pumping for this release of milk to occur. The invention facilitates this process by providing auditory stimulus of the form of various sounds to the mother. This facilitates the initiation, sustaining, intensity and numbers of "let-downs" per nursing session. The auditory stimulus (or multiple stimuli, as programmed into the system of the invention, as discussed below) are played in conjunction with the action of a breast pump.

Intra-System Component Communication In the system of the invention, the auditory stimulus is timed for use in conjunction with the breast pump. In one embodiment, the auditory stimulus apparatus is timed to begin before the start-up of the breast pump. The amount of time can be preset and can be adjustable. Alternatively, the auditory stimulus apparatus can be timed to begin simultaneously with the breast pump. To coordinate the "communication" between the auditory signal, the control panel, and the pump, these independent aspects of the system can be "hard wired" together, as when all components of the system are in the same housing.

Alternatively, a wireless communication system can be used for one aspect of the system to communicate with another aspect. The "wireless" mode of transmission and component communication can be, e.g., via radio or infrared transmission. Thus, one or more component(s) can be independently housed, as, e.g., the audio and/or recording components of the system. In one embodiment, the audio signal can be "real time," e.g., a telephone hookup with the baby at a remote location. See, e.g., U.S. Patent No. 5,903,322. Any type of electrical components that can be used in this and other aspects and components of the invention, including, e.g., computers ("PCs"), pump controls, sound recording and playback systems, wireless communication devices (e.g., radios/ microwaves), integrated circuits, transistors, capacitors, resistors, etc. are generally well known in the art.

Auditory Stimulus and Auditory (Sound Producing and Recording) Apparatus

The auditory stimulus apparatus can play any sound or sounds that facilitate the milk ejection reflex or any aspect of lactation. These sounds include, e.g., music, sounds of nature, "white noise," and the like. Sounds of babies have been proposed to stimulate lactation; e.g., auditory exteroceptive stimulus emanating from a lactating rat and the litter while suckling was used to facilitate milk ejection in another "induced" mother suckled by her own litter, see, e.g., Deis (1984) Exp. Brain Res. 55:177-179. Thus, in another embodiment, sounds of a baby of the same species as the mother are played. In one embodiment, the system plays recordings of the mother's own child. To facilitate this aspect, the system of the invention can further include a recording/playback device. See Figure 3. The mother and clinician can select and program the most appropriate sound for each particular individual (mother or baby or babies) or setting.

Mammalian babies behave variably while at the breast, making a variety of sounds, including, e.g., "mewing" and occasional crying or fussing are typical. During nursing, these sounds serve to elicit multiple "let-down" reflexes; the number of "let-down" reflexes a mother is capable of may vary, depending on the species, the individual, and specific circumstances. During human nursing, mothers often experience 2 to 4 distinct "letdown" reflexes per nursing session. Accordingly, the invention provides ways to reproduce not only the appropriate baby sounds, but the system of the invention provides a way to mimick (play back) the frequency and duration of such sounds (and can select the most effective sounds for a particular specie or individual) to optimize milk production through (not only) achieving letdown, but also achieving strong let-down reflexes. The "stronger" let-down may occur because appropriate aural stimuli may initiate oxytocin secretion, which in turn causes increased and more milk to be delivered to the lactiferous sinus area. Thus, the methods of the invention provide a means to increase oxytocin secretion in a mammal. Typically, each let-down reflex is weaker than the one before, but there is value in achieving multiple let-downs while nursing. The invention addresses this by providing the best appropriate auditory stimulus. The auditory apparatus of the invention's systems' computer can be programmed to provide various types, durations of or increased or decreased volume of sounds for multiple "let-down" stimuli (optimal settings can be tested empirically). If an appropriate baby is not available for recording by the mother or her health care professional, or for a breeder of a non-human animal, appropriate sounds ("let-down noises") can be located, e.g., on the internet.

The auditory stimulus apparatus can be any known means of producing sound, including, e.g., a microprocessor chip, a magnetic tape, an optically readable disc, or a magnetically readable disc. Any magnetic recording/playback medium can be used, such as, e.g., a magnetic tape, a magnetic disk, a magnetic card, digital audio (see, e.g., U.S. Patent No. 910,991), etc. (see also U.S. Patent No. 6,001,446). Any form of volume control can be used (see Figures 2 and 3). Electronic sound cards, such as programmable sound cards with a read/write audio signal storage memory can be used (see, e.g., U.S. Patent No. 5,908,354). Directional speakers can be used for a single listener (the mother) seated near the system without disturbing others nearby, see, e.g., U.S. Patent No. 5,956,411. Miniature speakers can be used, U.S. Patent Nos. 5,637,840; 5,910,991. Alternatively, headphones can be used (see, e.g., U.S. Patent Nos. 5,844,998, 5,761,314); or, a head-mounted audio-display that can playback sound and project an image from an image generator such as a cathode ray tube (CRT) or a liquid crystal display (LCD) (see, e.g., U.S. Patent No. 6,011,653).

The auditory signal can be programmed or set for any volume or length of time. For example, the system can be preset to begin several minutes before the pump is set to begin and to last for a (programmable) "average" time of let-down, or, for the entire duration of the milking session, to shut off when the pump is shut off. The mother and clinician can select and program the most appropriate amount of time for each particular individual or setting.

Breast Pumps

The system of the invention can incorporate any known milk pump, including any means to generate vacuum. Breast pumps for extracting or expressing breastmilk from a woman's breasts for later use by an infant have been available for years and are well known in the art (see below). As the system of the invention can be adapted to be used for all mammals, breast pumps will vary, depending on which species the invention is practiced. Milk pumps for domesticated animals can be readily adapted for use on wild animals.

Breast pumps typically include a funnel-shaped "hood," or "shield," or flange suitable for coupling to a breast (one or, optionally, both breasts at the same time), that is placed over the nipple and a substantial portion of the breast. A reduced pressure or vacuum is intermittently generated in the hood to cause milk to be expressed from the breast within the hood. The milk then flows from the hood to a storage container, or reservoir, for later use. Reservoirs can be removable. Generally, two types of breast pumps have been marketed for use by nursing women: motor-driven pumps; and manually-operated pumps.

Manually-operated breast pumps, the intermittent suction action is typically generated by means of a compressible bulb or, more frequently, a piston-type pump. The piston pump may include a piston cylinder connected to the hood, and a piston disposed within the piston cylinder that is reciprocated by a hand-drivable piston rod milk (see, e.g., U.S. Patent No. 9,971,952). In general, a manual http://l 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l &u=/netahtml/ - h26http://l 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - h28breast pump consists of a plunger that freely slides within an outer cylinder. A seal is fitted around the outside of the plunger to seal against the inner surface of the outer cylinder. In this way, the plunger can slide within the outer cylinder to form a pump stroke. A breast flange or funnel is fluidly connected to the outer cylinder. The mother applies suction to the breast by supporting the breast flange against the breast and pulling the plunger outwardly from the outer cylinder. Suction is created in the space which is expanded within the inside of the outer cylinder. The removed milk may be retained within the interior space of the outer cylinder or alternatively may be pumped out into a baby bottle or nurser bag that is connected to the outer cylinder. An exemplary system of the invention with a manual breast pump is described in Example 1, below. Motor-driven pumps typically either have a separate vacuum pump attached to the hood by tubing, or the motor is built into the hood assembly itself. Central or portable vacuum units can be used. Motor-driven pumps can be either battery operated or AC or DC powered devices. Any form of vacuum pump can be used, see, e.g., U.S. Patent No. 5,970,999; including micropumps, see, e.g., U.S. Patent No. 6,003,737. The action or amount of negative pressure (vacuum) generated by the pump can be continuous or variable (e.g., "alternating" or "rhythmic"); timing and vacuum pressure can be regulated by control dials or by a programmable component, e.g., a microprocessor or a computer (e.g., a "PC"). An exemplary system of the invention with a motor-driven breast pump is described in Example 2, below.

In another embodiment of the invention, the breast pump and the apparatus for producing the auditory stimulus are controlled by a microprocessor. In addition to coordination pump activity and sound, vacuum magnitude and cycle frequency can also be controlled by the microprocessor (see, e.g., U.S. Pat. No. http://164.195.100.i l/netacgi/ - hlhttp://164.195.100.11/netacgi/ - h35,571,084). A keypad/controller assembly is also included in this system. A microprocessor controlled vacuum cycle can closely mimics an infant's natural sucking frequency. Whether regulated by microprocessor of other convention means, the pump regulator is typically adapted to automatically modulate the application of suction to the http://164.195.100.i l/netacgi/nph- Parser?Sect 1 =PTO2&Sect2=HITOFF&p= 1 &u=/netahtml/search- bool.html&r=2&f=G&l=50&co 1 =AND&d=pall&s 1 =Medo.INZZ.&s2=breast&OS=IN/Med o+AND+breast&RS=IN/ - h77http://l 64.195.100.11/netacgi/nph-

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The breast pump can also comprise an infrared sensor for overflow milk control, see co-pending U.S. Patent Application 003001 .

The systems of the invention can be "table top" models or "portables." An example of the latter includes incorporation of the system into a "fanny pack" or a "vest" (see, e.g., U.S. Pat. No. http://164.195.100.i l/netacgi/ - hlhttp://164.195.100.11/netacgi/ - h35,571,084). Portable systems are typically powered by battery packs, see, e.g., U.S. Patent No. 6,004,690.

Non-Human Uses Alternative systems of the invention are used to stimulate milk from both domesticated and wild animals. "Species specific" milk is recognized as an integral part of any endangered species breeding program. Animals in captivity experience difficulty in rearing their young and for the same reasons are difficult to milk. "Hand-milking" does little to elicit the "let-down" reflex in the mother. In the absence of the "let-down" reflex pumps cannot effectively remove milk from a breast or udder. Application of the system of the invention will allow zookeepers and breeders to successfully and reliably obtain mammalian milk from any wild or domesticated animal.

The systems of the invention, particularly the breast pump components, can be readily adapted for use in both domesticated and wild animals. Milk vacuum pumps for domesticated animals (e.g., cows), well known in the art (see, e.g., 5,896,827), can be incorporated into the systems of the invention.

Additional Features

The systems of the invention can further comprise any number of additional features, such as, e.g., blood pressure monitoring (see, e.g., U.S. Patent No. 6,004,274), visual displays, particularly, of the mother's own baby, and the like. In one embodiment, the system can include a wireless data communication system. For example, a microphone or headphone jack of a portable phone can be incorporated and the system may be constructed with, e.g., a computer modem; a http://l 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hOhttp://! 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - h2microphone jack and a headphone jack of a portable computer (see, e.g., U.S. Patent No. 6,006, 109). As a wireless http:// 164.195.100.11 /netacgi/nph-Parser?Sect 1 =PTO2&Sect2=HITOFF&p=l &u=/netahtml/ - h8http://l 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hlOcommunication device, the system of the invention may also include facilities for transmitting and receiving video, graphics, and data files over a wide bandwidth (see, e.g., U.S. Patent No. 6,006,105). The system can also include a portable and compact motion simulator apparatus whose action can be coordinated with the action of the breast pump, see, e.g., U.S. Patent No. 5,954,508. In another embodiment, the milk reservoir contains a thermostat that is automatically cooled by a refrigeration component that is activated when the computer, or "PC" system of the invention, detects that a predetermined amount of milk has entered the reservoir, see, e.g., U.S. Patent No. 5,957,081. The system can also comprise a heating element that is manually or automatically activated upon placement of the pump on the breast, see, e.g., U.S. Patent No. 5,897,580.

DEFINITIONS

Unless defined otherwise, all technical and scientific terms used herein have the meaning commonly understood by a person skilled in the art to which this invention belongs. As used herein, the following terms have the meanings ascribed to them unless specified otherwise. The term "breast pump" includes any breast pump for extracting milk from the breast of a mammal. The system of the invention incorporates all known breast pumps, which are well known in the art, including, e.g., as described in U.S. Patent No. Des. 251,015; U.S. Patent Nos. http://164.195.100.i l/netacgi/ - hlhttp://164.195.100.11/netacgi/ - hβ_4,607,596; 4,740,196; 4,772,262; 4,794,915; http://164.195.100.i l/netacgi/ - hlhttp://164.195.100.11/netacgi/ - h34,857,051 4,892,517; http://164.195.100.i l/netacgi/ - hlhttp://164.195.100.11/netacgi/ - h34,929,229; 4,961,726; 5,009,638; 5,295,957; http://164.195.100.i l/netacgi/ - hlhttp://164.195.100.11/netacgi/ - h35,542.921: 5,601,531; 5,616,125; 5,571,084; 5,749,850; 5,797, 875; 5,810,772; 5,843,029; 5,902,267; 5, 947,923; 5,971,952; and 6,004,288.

The term "milk ejection reflex" or "let-down reflex" means any reflex or physiologic activity required for milk release or that facilitates or enhances milk release from the breast of a lactating mammal (increase amount or intensity of release, or the number of "let-down reflexes" per nursing session), see, e.g., Knight, (1994) J. Endocrinol. 142:471- 473; Cobo (19930 J. Perinat. Med. 21:77-85; Mulford (1990) J. Hum. Lact. 6(4):177-178.

Numerous variations and modifications of the invention will become readily apparent to those skilled in the art. Accordingly, the invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The detailed embodiment is to be considered in all respects only as illustrative and not restrictive and the scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope. It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and scope of the appended claims. EXAMPLES

The following example is offered to illustrate, but not to limit the claimed invention.

Example 1: System for Facilitating a Milk Ejection Reflex Incorporating a Manual Breast Pump The following example describes an exemplary system of the invention that incorporates a manual breast pump. Figure 6 illustrates an exemplary embodiment of system of the invention that incorporates a http://l 64.195.100.11 /netacgi/nph- Parser?Sectl =PTO2&Sect2=HITOFF&p= 1 &u=/netahtml/ - h47http://l 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - h49breast pump 10. The http://l 64.195.100.11 /netacgi/nph-Parser?Sect 1 =PTO2&Sect2=HITOFF&p=l &u=/netahtml/ - h48http://l 64.195.100.11/netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - h50breast pump 10 includes an outer pumping cylinder 12, an inner pumping cylinder or plunger 14 and a pumping seal 16 disposed between the inner and outer cylinders 12 and 14. The http://l 64.195.100.1 l/netacgi/nph-Parser?Sectl=PTO2&Sect2=HITOFF&p=l &u=/netahtml/

- h49http://l 64.195.100.11/netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&ρ=l&u=/netahtml/ - h51breast pump also includes a one-way valve 18 mounted on the outer cylinder 12. A collection container 20 may be fitted onto the outer pumping cylinder for containing the pumped milk. Also contained anywhere within the breast pump 10 is an auditory stimulus apparatus. The operation of the auditory stimulus apparatus can be through a control panel (e.g., similar to that shown in Figure 3) that is hard wired and on or connected to the housing or remote, communicating by wireless means, as discussed above.

In Figure 7 A the inner pumping cylinder or plunger 14 is shown in greater detail. The plunger 14 is generally a hollow cylinder with a closed end or base 22 at one end and an open opposing end 24. The plunger 10 generally has a smooth outer surface 26 which provides generally frictionless contact with the outer cylinder 12. An annular ring or mechanical stop 28 may be provided which extends outwardly from the outer surface 26. External threads 30 are provided adjacent to the open end 24. An annular groove or slot 32 is provided adjacent to the base end 22. Figure 7B shows the outer pumping cylinder 12 in greater detail. The outer pumping cylinder 12 is generally a hollow cylinder having an interior wall 34, an open first end 36 and an open second end 38. An interior annular ring 40 projects inwardly from the hollow interior wall 34 to form an annular groove 42. The annular ring 40 separates the outer pumping cylinder 12 into a first pumping chamber 44 and a second pumping chamber 46. A nipple 48 extends outwardly from the outer pumping cylinder 12 and has a passageway 50 connecting the first pumping chamber 44 to the exterior of the outer pumping cylinder 12. The interior wall 34 of the second pumping chamber 46 may be fitted with interior threads 52 or other fastening grooves or means known in the art. Figures 8 A and 8B illustrate a pumping seal 16. The pumping seal 16 includes an inner diameter 54 and a rim 56 which defines the outer diameter 58. The pumping seal 16 is generally designed to fit within the annular groove or slot 32 of the plunger 14. The rim 56 generally has an outwardly tapered surface for contacting the interior wall 34 of the outer cylinder 12. In this way, the pumping seal 16 provides a generally fluid- tight seal between the interior wall 34 of the outer pumping cylinder 12 and the plunger 14. The pumping seal 16 may be made from any material which is flexible, durable and non- toxic, such as seals commonly used in the food and milk industries.

Figures 9 A, 9B and 9C show an exemplary one-way valve 18. The one-way valve 18 is generally a single piece valve made from a flexible material. Similar to the pumping seal 16, the one-way valve 18 can be made from a material that is flexible, durable, non-toxic and very compatible with milk. The one-way valve 18 generally has a flat lower surface defining an outer rim 60 that narrows into a duck bill valve 62 having a slit 64. In this way, milk can enter through the outer rim 60 and pass through the slit 64 of the duck bill valve 62, but cannot return through the slit 64 of the duck bill valve 62. The one-way valve 18 is generally configured to fit within the second pumping chamber 46 of the outer cylinder 12. Specifically, the outer rim 60 may be sized to fit within the annular groove 42. This fit may require stretching the outer rim to form a snug-tight fit within the annular groove 42. The fit acts to retain the one-way valve 18 in the second pumping chamber 18 and prevents the leakage of milk under the outer rim 60. The height of the duck bill valve 62 may be limited such that the one-way valve 18 generally does not extend out of the second pumping chamber 46. In this way, the one-way valve 18 is less likely to be knocked off or otherwise dislodged when removing or connecting a collection container.

In operating this exemplary system, the plunger 14 is inserted inside the outer pumping cylinder 12. The plunger 14 may be made from any material that is durable, non- toxic, compatible with milk and generally has a frictionless outer surface 26. The plunger 14 may be made from a plastic. The plunger 14 may be fitted with the pumping seal 16 within the annular slot 32. The pumping seal 16 provides a seal between the plunger 14 and the inner wall 34 of the outer cylinder 12. The stop 28 may be provided on the outer surface 26 to prevent over insertion of the plunger 14 into the outer pumping cylinder 12. This stop may be a mechanical stop such as an outwardly extending annular ring 28. However, any means of mechanically preventing the plunger 14 from being over inserted into the outer pumping cylinder 12 may be used. A cap 66 can be removably fitted over the open end 24. In this way, the plunger 14 is also a container having a removable cap 66. To provide increased utility, the cap 66 may be fitted on the plunger 14 through use of the external threads 30. These external threads 30 may be sized to fit a conventional baby bottle or other collection container. Other means of securing the cap 66 to the plunger 14 as are commonly known may also be used. The cap 66 may also be fitted with various devices for filling and venting the interior of the plunger 14 as are known in the art of filling containers. The outer cylinder 12 can also include an outwardly protruding nipple 48 or other coupling device. A breast flange or funnel 68 may be fitted to the nipple 48 to provide an apparatus for removing milk from the woman's breasts and transporting it into the http://l 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l &u=/netahtml/ - h5 lhttp://! 64.195.100.11/netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - h53breast pump 10. The nipple 48 can have an outer diameter suitable for use with conventional breast flanges 68, such as, e.g., the SOFT-CUP™ breast flange (White River Concepts, Inc., San Clemente, CA), see U.S. Pat. No. 4,772,262. Alternatively, the nipple 48 may be connected to a tubing or other device for connection with the breast flange 68 or the woman's breast. In this way, the pump 10 may be actuated while being supported away from the patient's breast. The outer pumping cylinder 12 may be made from a material, like the plunger 14, which is also durable, non-toxic, and compatible with milk. The outer cylinder 12 can have a smooth interior wall 34 for smooth operation with the seal 16 and the outer wall of the plunger 14. The one-way valve 18 may be fitted into the second pumping chamber 46 of the outer pumping cylinder 12 to allow passage of the pumped milk into a collection container 20. In general, the one-way valve 18 is provided with a single orifice having a single slit 64. However, any type of one-way valve that provides smooth passage of milk from the first pumping chamber 44 into a collection container without allowing the milk to return through the valve may be used. A collection container 20 is fitted onto the outer pumping cylinder 12. More specifically, the collection container 20 which may be a baby bottle, a nursing bag or any other type of collection container for use with milk may be attached to the second end 38 of the outer pumping cylinder 12 using any method of fastening which prevents leakage as well as the formation or ingress of contamination. The collection container 20 is fitted with exterior threads that mate with the interior threads 52 of the second pumping chamber 46. In this way, the collection container may be threaded into the second pumping chamber 46 creating a simple to install and leak proof connection. These interior threads 52 can be sized to mate with a conventional baby bottle or other collection container 20. In operation, a collection container 20 is connected to the second end 38 of the outer pumping cylinder 12. A breast flange or funnel 68 is fitted over or otherwise connected to the nipple 48. The plunger 14 is fitted with the pumping seal 16 and inserted into the outer pumping cylinder 12. A removable cap 66 is fitted onto the open end 24 of the plunger 14 to prevent the ingress of contamination. The breast flange 68 is then secured against the woman's breasts while the outer pumping cylinder 12 is held firmly. The plunger 14 is pulled outwardly from the outer pumping cylinder 12 creating a suction in the breast flange 68. This suction withdraws milk from the patient's breasts; the milk is then is transferred through the passageway 50 in the nipple 48 and into the first pumping chamber 44. The plunger 14 is then pushed back into the outer pumping cylinder 12 while the breast flange 68 is held secured against the patient's breasts. In this way, the milk in the first pumping chamber 44 is forced into the second pumping chamber 46 through the one-way valve 18 and into the collection container 20. The process is then repeated with the plunger 14 being pulled outwardly from the outer pumping cylinder 12. The one-way valve 18 prevents milk within the collection container 20 from being drawn into the outer pumping cylinder 12. Once the collection container 20 is filled, the patient may stop pumping operation, remove the collection container 20 from the outer pumping cylinder 12 and well as the removable cap 66 from the plunger 14, and fill the hollow interior of the plunger 14 with milk from the container 20. After the plunger 14 is filled, the removable cap 66 is replaced. In this fashion, milk from the collection container 20 is poured into the plunger 14 making addition space available in the collection container 20 and allowing for additional removal of milk from the patient's breasts. Alternatively, the removable cap 66 may be removed from the plunger 1 providing a container that may be filled with milk being simultaneously pumped from the patient's opposing breast. In this way, both breasts may be pumped simultaneously. The cap 66 may be fitted with various devices to facilitate the filling of the plunger 14 without having to remove the plunger 14 from the outer pumping cylinder 12.

Example 2: System for Facilitating a Milk Ejection Reflex Incorporating a Motor- Driven Breast Pump The following example describes an exemplary system of the invention that incorporates a motor-driven breast pump and an auditory stimulus apparatus. Figure 10 illustrates a http://l 64.195.100.11/netacgi/nρh- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hi OOhttp://! 64.195.100.11/netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - h!02breast pump system 10 comprising a regulator 12, tubing 14, a reservoir 16, and a http://l 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hl01http://164.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - h!03breast pump flange 18.

Also contained anywhere within the breast pump 10 is an auditory stimulus apparatus. The operation of the auditory stimulus apparatus can be through a control panel (e.g., similar to that shown in Figure 3) that is hard wired and on or connected to the housing or remote, communicating by wireless means, as discussed above. The regulator 12 is connected to a vacuum source 21 , which can be a local (portable) unit or a central vacuum system as common in offices and hospitals. An output line 23 is connected to the tubing 14 of the regulator 12. The regulator 12 can also have a suction level gauge 25 and an on-off switch 27.

Figure 11 illustrates a side elevational view of the regulator 12. The regulator 12 can have a wall connection 30, which is adapted to be connected to the vacuum source 21 via a wall connector (not shown). A bacteria filter 32 can be connected between the regulator 12 and the output line 23.

Figure 12 illustrates a schematic diagram of a exemplary two-stage regulation system of the regulator 12. A fixed regulator 34 receives a suction from the vacuum source 21, which typically comprises a pressure ranging from 320 to 720 mm Hg. The fixed regulator 34 regulates the pressure to a constant pressure within a range of 260 mm Hg to 300 mm Hg. The fixed regulator 34 provides this regulated pressure to a timing circuit (not shown) of the regulator 12. The pressure from 260 mm Hg to 300 mm Hg can be supplied by the fixed regulator 34, is output to the adjustable regulator 36. The adjustable regulator 36 adjusts the pressure to a range of 0 mm Hg to 300 mm Hg, depending upon the position of the suction level gauge 25. A safety relief valve 38 is adapted to maintain a pressure output from the adjustable regulator 36 below 300 mm Hg. The maximum pressure allowed by the safety relief valve 38 is preferably set within a range of 260 mm Hg and 300 mm Hg. The timing circuit (not shown) of the regulator 12 can be fixed to provide suction intervals of approximately one second to the http://l 64.195.100.11 /netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l &u=/netahtml/ - hi 02http://l 64.195.100.11/netacgi/nph-

Parser?Sectl=PTQ2&Sect2=HITOFF&p=l&u=/netahtml/ - h!04breast pump flange 18. In this way, the fixed-suction from the vacuum source 21 is regulated and modulated by the regulator 12. The http://l 64.195.100.11 /netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l &u=/netahtml/ - hi 04http://l 64.195.100.11/netacgi nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hlOόbreast pump flange 18 can be driven by the modulated pressure from the regulator 12 and, if in this configuration, does not require any electrical input. The http:// 164.195.100.11/netacgi/nph-

Parser?Sectl =PTO2&Sect2=HITOFF&p= 1 &u=/netahtml/ - hl05http://164.195.100.11/netacgi nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - h!07breast pump flange 18 can have both a soft material and a configuration optimized to mimic the suckling produced by a nursing baby. The http://l 64.195.100.i l /netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hl 06http://l 64.195.100.11/netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&ρ=l&u=/netahtml/ - h!08breast pump flange 18 can be, e.g., the Soft Cup Funnel™ and the tubing 14 and reservoir 16 can comprise a http://164.195.100.11/netacgi/nph-Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtm

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Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - h!09Breast Pump Kit™ manufactured by White River Concepts, San Clemente, CA. The regulator 12 can be a

Vacutron™ suction regulator (Allied Health Care Products, St. Louis, MO). An example of a http://l 64.195.100.11/netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hi 1 Ohttp://! 64.195.100.11/netacgi/nph-

Parser?Sectl-PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hi 12breast pump having a soft http://l 64.195.100.1 l/netacgi/nph-Parser?Sectl=PTO2&Sect2=HITOFF&p=l &u=/netahtml/

- hi 1 lhttp://! 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hi 13breast pump flange is described in U.S. Pat. No. 4,772,262.

One embodiment of the system comprises an electronic controller that causes the regulator 12 to perform a series of different suck/release patterns which closely simulate the habits of a nursing baby during an average feeding. By mimicking these patterns, the http://164.19S.100.l l /netacgi/nph-Parser?Sectl =PTO2&Sect2=HITOFF&p=l &u=/netahtml/

- hi 12http://164.195.100.11/netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hi 14breast is allowed ample time to refill the ducts after the suck/swallow has occurred. By approximating these patterns, the mother is able to stimulate further production of her milk by vigorously stimulating her nipples and emptying more milk in a shorter period of time. This method would also apply to suction at the http:// 164.195.100.i l /netacgi/nph-

Parser?Sect 1 =PTO2&Sect2=HITOFF&p= 1 &u=/netahtml/ - hi 14http://164.195.100.11/netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hi lόbreast using the wall suction regulator along with a http ://! 64.195.100.11 /netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hl 15http://l 64.195.100.11/netacgi/nph-

Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hi 17breast cup. The electronic controller can be part of an overall control component, such as a microprocessor, that coordinates the functioning of the pump, vacuum, and the auditory stimulus apparatus.

The interface between the wall suction and the lactating http://164.195.100.11/netacgi/nph-Parser?Sectl=PTO2«feSect2=HITOFF&p=l&u=/netahtml/

- hi 16http://164.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hi 18breast can be a soft cone molded in a soft silicone or thermoplastic rubber. The cone latches onto the http://l 64.195.100.1 l/netacgi/nph-Parser?Sectl=PTO2&Sect2=HITOFF&p=l &u=/netahtml/ - hi 17http://l 64.195.100.11/netacgi/nph-

Parser?Sectl=PTO2&Sect2=fflTOFF&p=l&u=/netahtml/ - hi 19breast and performs compression patterns that are similar to those of a breastfeeding baby. In order to ensure that compression is accomplished directly over the lactiferous sinuses, an accurate match must occur between the soft cone and the woman's http://l 64.195.100.11 /netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - hl 18http://l 64.195.100.11/netacgi/nph- Parser?Sectl=PTO2&Sect2=HITOFF&p=l&u=/netahtml/ - h!20breast.

Claims

What is claimed is:

1. A system for facilitating a milk ejection reflex in a mammal comprising a breast pump and an apparatus for producing an auditory stimulus, wherein the auditory stimulus is timed for use in conjunction with the breast pump.

2. The system of claim 1, wherein the auditory stimulus apparatus is timed to begin before the start-up of the breast pump.

3. The system of claim 1, wherein the auditory stimulus apparatus is timed to begin simultaneously with the breast pump.

4. The system of claim 1 , wherein the breast pump and the auditory stimulus apparatus are in the same housing.

5. The system of claim 1 , wherein the breast pump and the auditory stimulus apparatus are not in the same housing.

6. The system of claim 1 , wherein the breast pump and the auditory stimulus apparatus are hard wire connected.

7. The system of claim 1, wherein the breast pump and the auditory stimulus apparatus are connected by wireless communication components.

8. The system of claim 1, wherein, the wireless communication components comprise infrared or radio transmission components.

9. The system of claim 1, wherein the auditory stimulus is music or a sound of an infant.

10. The system of claim 1, wherein the auditory stimulus apparatus comprises an electronic sound reproduction device comprising a speaker and a sound playback device.

11. The system of claim 10, wherein the sound playback device is an analog or a digital or a magnetic tape playback device.

12. The system of claim 10, wherein the auditory stimulus apparatus comprises a microprocessor chip, a magnetic tape, an optically readable disc, or a magnetically readable disc.

13. The system of claim 1 , further comprising a sound recording device.

14. The system of claim 13, wherein the sound recording device comprises a removable or an inset microphone.

15. The system of claim 1, wherein the breast pump is manually powered, electrically powered, or battery powered.

16. A method for facilitating a milk ejection reflex from a breast of a mammal comprising producing an auditory stimulus in association with applying suction to a breast to remove milk from the breast by the system of claim 1.

17. The method of claim 16, wherein the auditory stimulus comprises a sound produced by an infant or music.

18. The method of claim 17, wherein the sound is produced by an infant of a mother using the system.

19. A method for ameliorating lactation failure in a mammal comprising producing an auditory stimulus in association with applying suction to a breast by the system of claim 1, thereby facilitating milk removal from the breast and ameliorating lactation failure in the mammal.

20. The method of claim 16 or 19, wherein the mammal is primate, canine, feline, equine, bovine or porcine.

21. The method of claim 20, wherein the primate is a human.