Abstract:
A breast pump for continuously applying warmth at a temperature of not more than about 105 degrees Fahrenheit to a mammary gland both before and during milk withdrawal is described. The apparatus enables the mammary gland tissue to be raised to a temperature that makes milk withdrawal more comfortable, whereupon suction is applied to the gland, as the temperature is maintained in order to commence the withdrawal process and permit the milk so extracted to be administered artificially to a suckling infant.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to improvements in methods and apparatus for withdrawing milk from lactating mammary glands and, more particularly, to methods and apparatus for selectively and continuously warming to a predetermined temperature the mammary gland tissue while suction is applied to extract milk therefrom, and the like. 
     2. Background Prior Art 
     Pressures, both economic and social, place the mother of a newborn infant in a very difficult situation. For example, the overwhelming body of medical opinion is of the view that milk, drawn from the breasts of a properly nourished mother, is the best possible food for her newborn child. The conflicting need for the mother to return to work as swiftly as possible and a reluctance to nurse an infant in public places, however, are major impediments to the preferred natural feeding regimen. 
     Though the years, breast pumps have been developed to enable the lactating mother to withdraw milk from her breasts and store it to feed the infant at a later time when suckling otherwise might be awkward, inconvenient or impossible. 
     There are, of course, further situations in which breast pumps are helpful. Illustratively, some infants do not suckle very well and require the assistance of an artificial nipple and bottle combination in order to draw adequate nourishment. In this circumstance, withdrawing the mother&#39;s milk through a breast pump and transferring that milk to a nursing bottle for administration to the child may offer an acceptable method for feeding mother&#39;s milk to the child. 
     Breast pumps, moreover, are not limited in their application to human beings. Among the industrialized nations, milking machines are, perhaps, the most common way in which milk is extracted from cattle for commercial purposes. Although these machines are a more efficient way to produce milk, studies have shown that manual extraction of milk by milk maids actually results in appreciably greater milk production from the animals. Toward this end of increased milk production, various approaches have been tried with occasional success, e.g., playing soothing music in the barn during milking. 
     None of these breast pump developments have been entirely satisfactory. For instance, there is a continuing need for an improved apparatus that is capable of increasing animal milk production. Human nursing needs, moreover, appear to be considerably more complicated. In this respect, the suction apparatus for some breast pumps are applied only to the nipple and offer no support to the balance of the breast. A disadvantage to this device is the requirement for the nursing mother to use both hands in order to extract the milk—one hand to support the breast and the other hand to manipulate the pump. Further in this regard, if the nursing breast is not properly supported the subsequent milk withdrawal can be uncomfortable or, possibly, even painful. 
     As a general matter, it has been found that milk extraction is eased and made less uncomfortable if the mammary gland tissue is warmed immediately before and during the course of the extraction procedure. 
     Earlier breast pumps relied on pre-heated compresses that lost their heat as the milk was withdrawn. These devices thus were quite inefficient because they were incapable of maintaining a predetermined temperature during the extraction process. 
     Consequently, there is a need for an improved breast pump that can reduce the discomfort and inconvenience that heretofore has characterized application of these devices. 
     BRIEF DESCRIPTION OF THE INVENTION 
     These and other limitations that have characterized the prior art are overcome, to a large extent, through the practice of the invention. Illustratively, a breast cup is provided to support not less than one half of the exposed surface of a lactating breast. The cup has a soft innermost portion that bears directly against the surface of the mammary gland. This innermost portion encapsulates a heat transmitting gel that conforms to the shape of he individual breast. 
     A middle portion of the cup forms a void space that generally matches the area of the innermost portion. This void space within the middle portion accommodates a warmed, working fluid that transfers its warmth through the gel to the lactating mammary gland in order to promote and make more comfortable the extraction of milk from the breast. 
     A firm, outermost portion of the cup not only houses the middle and innermost cup portions but also provides physical support for the breast and the suction and heating connections. In this respect, a heating tube passes through the outermost portion in order to establish working fluid communication with the void space within the middle cup portion. 
     A suction device protrudes through the cup structure at a place that approximates the location of the nipple on the mammary gland. The suction device has an inner annulus that approximates the size and shape of a typical nipple. The suction device also has a centrally disposed conduit that establishes fluid communication between the nipple and a “T” coupling inlet. One of the two remaining passageways in the “T”, coupling is a discharge outlet that communicates with a reservoir for collecting the milk sucked from the breast. The other “T” coupling passageway is a vacuum port that communicates with the suction pump to apply the necessary degree of vacuum to the nipple for milk withdrawal. A suction tube couples the conduit in the suction device to a selectively energizable suction pump through the other “T”, coupling passageway. 
     The heating tube extends from the outermost portion of the cup to a thermostatically controlled heating element that maintains the temperature of the innermost portion of the cup that is applied to the breast surface at a predetermined and preferable temperature in the range of 105° F. to 110° F. The heating element also is activatable separately from the suction pump to enable the breast tissue to be warmed selectively before, during and after milk withdrawal, according to the needs and comfort characteristics of the lactating individual. 
     These and other features of the invention will become apparent through a study of the following detailed description of an illustrative embodiment of the invention. The scope of the invention, however, is limited only through the claims appended hereto. 
    
    
     BRIEF DESCRIPTION OF THE DRAWING 
     FIG. 1 is a side elevation in full section of a portion of an illustrative embodiment of the invention; 
     FIG. 2 is a front elevation of the portion of the invention shown in FIG. 1; 
     FIG. 3 is a schematic side elevation of a typical heating apparatus in accordance with principles of the invention; and 
     FIG. 4 is a side elevation of a typical suction apparatus embodying principles of the invention. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     For a more complete appreciation of the invention, attention is invited to FIG. 1 which shows a lactating mammary gland  10  that terminates in a nipple  11 . Outer surface  12  of the gland  10  is enclosed in a cup  13 . As illustrated, the cup  13  covers the entire outer surface  12  of the gland  10 . In accordance with a salient feature of the invention, the cup  13  should cover not less than one-half of the outer surface  12  of the gland  10  in order to provide physical support to the breast and thus to enhance the comfort of the person from whom milk  14  is being withdrawn. 
     The cup  13  has a soft and pliable innermost portion  15  that is filled with a heat conducting gel  16  in order to conform to the shape of the gland  10  and warm the gland  10  as described subsequently in more detail. The heat conducting gel  16  can be any suitable material, of which a silicone gel is illustrative. The innermost portion  15  also has a centrally disposed bore  18  in general alignment with the nipple  11 . 
     A middle portion  17  of the cup  13  is formed of rubber, or the like. The middle portion  17  is joined to the innermost portion  15  and overlays a somewhat smaller area of the outer surface  12  of the gland  10  than the innermost portion  15 . As shown, the middle portion  17  not only lends structural support to the pliable innermost portion  15 , but also forms a void space  20 . The illustrative embodiment of the invention in FIG. 1 shows the void space  20  as an array of interconnecting passageways  21  which terminate in a passageway  22  that selectively communicates with the ambient atmosphere and an inlet passageway  24  that is coupled to a warm working fluid or air supply tube  25 . A baffle  28  in the interconnecting passageways  21  is placed in the middle portion  17 , generally aligned with the warm air supply coupling  30  on the outermost portion  26  to better distribute inflowing warm air through the interconnecting passageways  21  and thus to avoid the development of a “hot spot” within the structure of the cup  13 . A further bore  23  is formed in the middle portion  17 , generally aligned with the nipple  11  and the bore  18  in the innermost portion  15 . 
     Firm, outermost portion  26  of the cup  13  is formed of a fairly stiff (but not hard) molded plastic. As illustrated, the outermost portion  26  is joined to the surface of the middle portion  17  and has a passageway  27  in alignment with the warm air discharge passageway  22  in the middle portion  17 . Another passageway, not shown in the drawing, is aligned with the warm air inlet passageway  24  in the middle portion  17 . A coupling  30  on the exposed external surface of the outermost portion  26  joins the warm air supply tube  25  to the cup  13  in order to establish fluid communication between the warm air supply tube  25  and the passageways  21  within the middle portion  17 . 
     An elastic warm air pressure release valve  31  controls the flow of warm air from the communicating passageways  22  and  27  to the atmosphere to maintain a throughput of warm air within the passageways, stabilize the temperature of the gel  16  and prevent the middle portion  17  from inflating. 
     The size of the outermost portion  26  of the cup  13  is generally the same as the size of the middle portion  17 , the outermost portion  26  being generally coextensive with the middle portion  17  to which it is joined. A bore  32  also is formed in the outermost portion  26  that is axially aligned with the bores  23  and  18  in the middle and innermost portions  17  and  15 , respectively, of the cup  13 . 
     The axially aligned bores  18 ,  23  and  32  in the cup  13  accommodate a suction device  33 . Typically, the suction device  33  has an annulus  34  that generally covers the surface of the nipple  11 . Central portion  35  of the suction device  33  is hollow and is seated in the bores  18 ,  23  and  32 , to protrude from the cup  13  and establish fluid communication with a “T” coupling  36 . 
     As illustrated, the “T” coupling  36  has an inlet  37  that communicates with a milk discharge outlet  40  and a vacuum port  41 . Further in this regard, the milk discharge outlet  40  is detachably connected to breast milk receptacle  42 . The receptacle  42  enables milk, sucked from the nipple  11  to accumulate in the receptacle  42  while permitting a suitable vacuum to be applied through the port  41  in the manner described subsequently in more complete detail. 
     A vacuum tube  43  establishes suction between the central portion  35  of the suction device  33  and, as illustrated in FIG. 4, a suction pump  44 . The suction pump  44  is conveniently mounted in a carrying case  45  that has an air discharge port  46  to enable air, drawn through the suction tube  43  to dissipate in the atmosphere. A suction control  47  is also provided for the suction pump  44 . The control  47  permits the lactating woman to adjust the vacuum applied to the nipple  11  (FIG. 1) in accordance with individual needs, e.g., a gentle pulsating vacuum, steady application of vacuum at a comfortable level, and the like. 
     Within the carrying case  45 , as shown in FIG. 3, air warming apparatus  50  also is provided. As illustrated, the carrying case  45  has an air inlet port  51  connected to an air inlet conduit  52  that provides a pathway from the ambient atmosphere, through an air filter  53  and a one-way air check valve  54  to an air pump  55 . The air pump  55  draws air from the atmosphere and discharges the air at a suitable pressure to a pressurized air tube  56  with a one-way check valve  58 . Heating elements  57  mounted within the pressurized air tube  56  warm the air that is discharged from the pump  55  to a predetermined temperature that is registered by a heat sensor  60 . The heat sensor  60 , in turn, automatically activates and deactivates a switch  61  in order to prevent the temperature of the heated and pressurized air from exceeding a predetermined maximum, which should be about 116° F. This selected maximum temperature for the air as it passes through the heating elements  57  should deliver air to the baffles  28  (FIG. 1) in the cup  13  at a temperature of not more than 105° F. to 110° F. This upper limit temperature range, 105° F. to 110° F., has been identified as the maximum temperature that can be applied to a typical breast and promote comfortable lactation without risk of injury to the mammary gland  10 . 
     Further in this respect, personal preferences, physiological differences and the like necessarily raise a need for flexibility in the way in which the glandular tissue is warmed in order to satisfy a range of individual requirements. The time required not only to warm the breast tissue to a suitable temperature but also to continue to warm the tissue to that temperature before suction is applied to the nipple typically will vary from person-to-person. 
     There also is a need, in accordance with the invention, to maintain a predetermined breast tissue temperature during the entire extraction process to assist in the complete and comfortable withdrawal of all of the milk from the breast. 
     Accordingly, the air warming apparatus is supplied with a separate power switch  62  (FIG. 3) to activate the air pump  55 , the heating elements  57 , the heat sensor  60  and the selectively activatable temperature limits switch  61 . A manual temperature control  63 , however, is provided to permit the lactating woman to adjust the air temperature to some individually more comfortable level that is below the maximum temperature set by the heat sensor  60  and its associated switch  61 . 
     An additional feature is illustrated in FIG.  2 . As shown in FIG. 2, an adjustable strap  64  is attached by its ends  65 ,  66  to diametrically opposite sides of the innermost portion  15  of the cup  13  that protrudes beyond the perimeter of the middle portion  17 . The strap  64  is slung over shoulder  67  of the lactating woman on the side that is opposite to the breast from which the milk is being withdrawn. The strap  64  is looped under the arm  70  in order to press the cup  13  against the lactating breast in a manner that holds the cup  13  in proper position with respect to that breast while freeing both of the woman&#39;s hands. 
     In operation, the cup  13  is applied to the mammary gland  10  and the strap  64  is adjusted to hold the cup  13  in place over the breast. It may be the preference of the lactating woman to warm the breast tissue to a suitable temperature before suction is applied to the nipple  11  (FIG.  1 ). Accordingly, and as illustrated in FIG. 3, the power switch  62  is manipulated to energize the air pump  55 ; warm the heating elements  57 ; and activate the heat sensor  60  with its associated automatic temperature limit switch  61 . The manual temperature control  63  is then operated to lower the heated air temperature to a level that the individual user finds most comfortable for withdrawal. 
     After a suitable period of time, the time depending on the physiology of the individual woman, the lactating breast tissue has warmed to a level that will promote milk flow and the suction control  47  (FIG. 4) is operated to produce suction in a manner and with a pressure that is individually comfortable for the lactating woman. The suction pump  44  draws air through the vacuum tube  43  in order to apply suction to the nipple  11  (FIG. 1) through a path that includes the suction device  33 ; the inlet  37  to the “T” coupling  36 ; the vacuum port  41 ; and the check valve  58  (FIG.  3 ). The breast milk  14  that is drawn from the nipple  11 , drains, under gravity, into the breast milk receptacle  42 . 
     Meanwhile, warm air continues to flow through the air tube  56  (FIG. 4) from the carrying case  45  to warm the mammary gland  10  (FIG. 1) through a path that includes the warm air supply tube  25 , the inlet passageway  24 , the baffle  28 , the void space  20 , the passageways  22 ,  27  and the pressure relief valve  31 . The heat, so supplied to the void space  20  and surface of the middle portion  17 , is transferred to the gel  16  in the innermost portion  15 . The nature of the gel  16  is such that it distributes this warmth in a generally uniform manner over the entire surface of the breast with which the innermost portion  15  is in contact. This application of warmth to the breast, for the purpose of reducing the discomfort that hitherto had been associated with pumped milk withdrawal, can be maintained at the predetermined temperature (or temperatures) as long as desired. 
     To deactivate the apparatus, it is only necessary to turn off the suction control switch  47  (FIG. 4) and the power switch  62 . The now de-energized manual temperature control  63  (FIG. 3) need not be changed, but can be left at the preferred setting for later use. The cup  13  (FIG. 2) and strap  64  can be removed from the shoulder  67  and the mammary gland  10 , the breast milk receptacle  42  also can be removed from the structure and its contents poured into a nursing bottle for subsequent infant feeding. 
     There are, moreover, a number of modifications that can be made to the specific embodiment of the invention described above while remaining, nevertheless, within the scope of the invention. Illustratively, some working fluid for transferring warmth to the mammary gland other than air can be used, e.g., water. This working fluid also can be re-circulated to provide further thermal efficiency. Combining the suction and air pumps into one unit is also possible to effect further savings.