Breast pump insert

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S075000

Reexamination Certificate

active

06579258

ABSTRACT:

This invention relates to a flexible resilient breast pump insert which is adapted to be fitted to a vacuum generating breast pump and more particularly to an insert which is designed to massage the user's nipple with a peristaltic action which resembles more closely the natural suckling action created by a baby.
Research has shown that when a baby is feeding at its mothers breast, it applies a peristaltic type of pressure to the mother's nipple sandwiched between its tongue and the roof of its mouth when it sucks on the nipple. This peristaltic pressure on the nipple draws milk from it. When the pressure is released, as the baby takes a breath, a new supply of milk flows into the nipple ready for the baby to extract it again once the “let down” reflex is activated due to the mothers “oxytocin” release.
It is known from GB 2297913A to provide a flexible resilient breast pump insert adapted to fit into a rigid funnel portion of a vacuum generating breast pump operable to generate a negative pressure, the insert comprising a mouth portion having an open end shaped to receive and contact the areola of a woman's breast and an inner portion of reduced size to receive the woman's nipple and having a wall with an inner and outer surface, connection means around the mouth portion to connect said mouth portion to a rigid breast pump funnel portion to form a pressure tight seal therewith, the mouth portion having a wall with an inner surface adapted to contact the woman's areola around the nipple and an outer surface with at least one recess formed therein, the thickness of the wall of the mouth portion in the region of the or each recess being less than that of the remainder of the mouth portion and means operable to connect the or each recess with the source of negative pressure. Whilst this insert has been found to work extremely well, it tends to apply pressure to the areola area of the breast rather than the nipple itself.
It is an object of the present invention therefore to provide an improved insert for use with a breast pump which is specifically designed to stimulate the area of the breast adjacent the nipple and the nipple itself when a cyclically generated negative pressure is applied to a mothers breast positioned within the insert.
A flexible resilient breast pump insert according to the present invention is characterised in that at least one additional recess is formed in the outer surface of the inner portion, the thickness of the wall of the inner portion in the region of the or each additional recess being less than the remainder of the inner portion; said means operable to connect the or each recess with the source of negative pressure also being operable to connect the or each additional recess with the source of negative pressure whereby, in use, the or each region of reduced wall thickness in the mouth and inner portion is deformed and deflected into contact with the inner surface of the rigid funnel portion of the breast pump in response to a negative pressure applied to the outer surface of the wall of said mouth and inner portion thereby massaging the areola and nipple region of the breast and stimulating the lactation of milk from the nipple.
In a preferred embodiment, the thickness of the wall of the mouth portion in the region of each recess is different to the thickness of the wall of the inner portion in the region of each additional recess, such that in use, the or each recess and the or each additional recess are sequentially deformed and deflected into contact with the inner surface of the rigid funnel portion of the breast pump in response to a negative pressure applied to the outer surface of the wall of said mouth portion, the recess and additional recess returning to their original configuration on release of the negative pressure.
Preferably, a plurality of inter connected discrete recesses spaced circumferentially around the insert are provided. Alternatively, there may be a single annular recess or pocket. Conveniently, the recesses are circumferentially spaced from each other by equal distance.
The connection means on the mouth portion can comprise an annular lip adapted to fit over and engage with the outer edge of the rigid funnel of the breast pump. Suitably the annular lip is molded to provide an undercut or rebate which cooperates with the connection means on the mouth portion to form a pressure tight seal therewith.
Conveniently, the means operable to connect the or each recess and the or each additional recess with the source of negative pressure is a pair of conduits or channels formed in the outer surface of the inner portion, one conduit leading from one of said recesses to the remote end of said inner portion of the insert, and the other conduit leading from one of said additional recesses to the remote end of the insert. The recesses can be any convenient shape but in the preferred embodiment, they are pear-shaped, the major axis of each recess being aligned with the main longitudinal axis of the insert, the additional recesses being generally circular. In this embodiment, the pear-shaped recesses are provided mainly on the mouth portion of the insert whereas the circular recesses are arranged circumferentially around the inner portion of the insert which receives the users nipple.
In the preferred embodiment, each conduit is an open channel formed in the outer surface of the wall of the inner portion and a continuous upstanding bead extends along both sides of the channels and around each recess and additional recess, said bead being operable, in use, to form a fluidtight seal with the inside surface of the funnel.
Preferably the or each recess and the or each additional recess protrudes inwardly from the inner surface of the insert. The bottom of each pocket is preferably arcuate to provide the or each protrusion. Due to the natural resilience of the material from which the insert is molded, each recess and each additional recess will deform outwardly into contact with the breast pump funnel on the application of a negative pressure thereto but it will reform to its normal configuration on release of the negative pressure due to the natural resilience of the material form which the insert is molded, preferably natural or synthetic rubber or silicon. It should be noted that it is an important feature of the invention that the gentle pressure is applied to the nipple or the areola as a result of the recesses and additional recesses reconfiguring to their original shape provides excellent stimulation for lactation. Thus, the negative pressure initially deforms the recesses and additional recesses in a direction away from the breast but they then reconfigure due to the natural resilience of the silicon rubber from which the insert is molded to apply a gentle pressure to the breast. In some of the prior art devices, the negative pressure deforms the recesses inwardly and draws them into firmer contact with the users breast thereby directly massaging it. Users have found these prior art arrangements to be unsatisfactory as too great a negative pressure can be applied directly to the breast and nipple area which the mothers find uncomfortable and it can make them tense which can result in poor lactation.
Preferably, the surface area of the or each recess is greater than that of the or each additional recess so that the or each recess of larger surface area will deform outwardly of the insert before the or each recess of lesser surface area for each cycle of negative pressured applied thereto. Alternatively, the thickness of the recess walls can be varied or a combination of both can be used.


REFERENCES:
patent: 4263912 (1981-04-01), Adams
patent: 4799922 (1989-01-01), Beer et al.
patent: 5049126 (1991-09-01), Larsson
patent: 5100406 (1992-03-01), Panchula
patent: 5885246 (1999-03-01), Ford
patent: 1 067 421 (1954-06-01), None
patent: 2 297 913 (1996-08-01), None
patent: 98/22160 (1998-05-01), None
patent: 99/44650 (1999-09-01), None

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