Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-07-12
2001-08-14
Dawson, Glenn K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06273868
ABSTRACT:
FIELD OF THE INVENTION
The present application relates to a human breast milking apparatus which simulates a suckling infant comprising a breast cup, a collecting means, a vacuum source, and a regulating means.
BACKGROUND OF THE INVENTION
In recent years the number of women who breast-feed their infants has increased steadily. It is considered to be best for both mother and child from a nutritious and a psychological point of view.
The most usual way in which to give an infant mother's milk is to let the infant suck directly from the breast. However, there are a number of cases where it is not appropriate or possible to allow the infant to suck straight from the breast. Examples of such cases may be:
when the infant is premature and unable to suck,
when the mother has insufficient milk,
when the mother is ill and needs stronger stimulus,
medically indicated mastitis where the mother cannot give milk to the infant due to the treatment, and where the breast must be depleted of milk.
For purely practical reasons it may also be desirable to enable persons other than the mother to feed the infant.
There are a number of physiological and psychological factors which affect milk production, and which can arrest it. An essential factor is the stimulation of the breast to initiate milk production. The stimulation of the breast comprises a total of three components which must be present if milk production is to commence:
Stimulation of the breast itself, where the greatest stimulus is at the edge of the areola. There lie the so-called “milk lakes”, which, when subjected to pressure, release oxytocin from the pituitary gland. This hormone has a direct impact on the lactiferous ducts so that these are expanded and opened for depletion. This happens when the infant grasps around the breast by opening its mouth wide. The jaw and the lips will then stimulate the areola, which is about 2.5 to 3 cm from the base of the nipple.
Stimulation of the actual nipple, wherein it is squeezed and massaged. This happens in that the infant's tongue and palate encircle the nipple. Tactile stimulation results in a strong stimulus and thus a hormonal response.
The actual sucking which takes place when the infant sucks.
A number of different breast cups and associated breast pumps have been developed which to some degree simulate some of the aforementioned factors.
In addition to having to be capable of simulating these factors, the breast pumps must also be comfortable to use, they must be soft and adaptable to different shapes and sizes of breasts. At the same time, they must be easy to use.
A number of different breast pumps are known which consist of a cup or similar device, which is placed over the breast, a manual or mechanical vacuum pump connected to the cup which generates an intermittent vacuum in the cup, and a receptacle for the expressed milk. The expressed milk flows typically from the body and into a receiving container for storage and later use.
U.S. Pat. No. 5,049,126 discloses an insert for a breast cup or hood for a breast pump, the object of which is to achieve a more realistic simulation of an infant pressing and massaging the nipple. The insert consists of a funnel-shaped portion in the form of a truncated cone with a tubular portion provided at that part of the funnel-shaped portion which is smallest in diameter. In the tubular portion there is provided at least one elongated opening located at a point overlying the nipple when the apparatus is in use. This elongated opening in the tubular portion is provided with a flexible membrane. When a negative pressure is created in the insert with the aid of a vacuum pump, the flexible membrane will be drawn into the insert and will gently squeeze and massage the nipple to enhance the production of milk. This insert will not stimulate the rest of the breast or the area around the nipple. According to the description, the actual funnel-shaped portion seems to be made of a rigid material, so that it may be difficult to adapt the insert to different breast shapes and sizes. Since the insert is rigid, this could cause some discomfort to the user. In addition, the insert is intended to be put into the breast cup of an already existing breast pump.
U.S. Pat. No. 4,680,028 discloses a breast cup or receptor for a breast pump, which breast cup is made of a transparent, flexible material, for example, silicone rubber. The breast cup is in the form of a funnel-shaped portion having a tubular extension. In the transition area between the funnel-shaped portion and the tubular portion, the wall thickness is reduced with a view to massaging the nipple and the surrounding area as a result of the suction effect which is produced by a vacuum pump. There is also a reduction in the thickness of the wall in an area of the funnel-shaped portion having largest diameter, permitting the fingers of the mother to massage the underlying other parts of the breast.
EP-198 469 describes a breast pump, including a vacuum pump. The breast cup of this apparatus consists of parts which are to simulate the mouth, throat and jaw of an infant. The breast cup grips around the breast by means of pressure generated by the pump. An aperture valve controls the pressure. During use, the woman can massage her breast and control the rhythm.
WO-92/07593 describes an elastomeric liner or insert for a breast cup of a breast pump, which insert has recesses and grooves to enable it to be better adapted to the breast. The insert consists of a funnel-shaped portion in the form of a truncated cone and a tubular portion which is connected to that part of the funnel-shaped portion which is smallest in diameter. On the outside of the funnel-shaped portion there are arranged arcuate, oval recesses to provide a thin membrane in the insert at the area around the nipple. According to the description, the purpose of this is to prolong the duration of suction effect produced by the pump stroke, so that the milk production increases and that the insert is softer and more comfortable to the user. This insert will not be capable of giving the desired stimulus to the nipple or to the rest of the breast. In addition, according to the description, this insert is intended to be placed into an already existing breast cup of a breast pump.
U.S. Pat. No. 4,964,851 discloses an electrically-powered breast pump, consisting of a breast cup of a partly flexible plastic material, a suction pump and a rotatable valve. The rotatable valve directs the suction from the pump in alternating fashion between the breast cup and the receiving container, so that there is a reciprocal suction action on the breast.
EP 727 234 discloses an insert for a funnel-shaped breast cup. The insert is provided with portions of reduced thickness to enable these portions to move towards the inside of the funnel-shaped breast cup and in this way give some stimulation to the aerola region when a vacuum is generated in the breast cup. However, the vacuum and the frequency which provide this stimulation cannot be adjusted independent of one another and it will therefore not be possible to produce a “pulsating wave” from the breast towards the nipple. It may therefore be difficult to achieve the desired degree of stimulation and a large vacuum can at worst cause an obstructive squeezing against the lactiferous ducts, thereby preventing expression of milk.
A major disadvantage with the solutions described above is the lack of stimulation of the area of the breast at and beyond the areola. Most of the solutions described above stimulate only the nipple and the area of the breast immediately around the nipple. Stimulation of this kind is not sufficient to instigate satisfactory milk production. The area of the breast, the areola, which is about 2.5 to 3 cm from the base of the nipple contains a number of so-called “milk lakes” which, when stimulated, will open the lactiferous glands. It is this area which is stimulated by the infant's lips during breast-feeding and which gives a hormonal response in the form of oxytocin. A second disadvant
Browdy & Neimark
Dawson Glenn K.
Mamma Lactans AS
Serke Catherine
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