US20140171857A1 - Breastpump with Letdown Feature - Google Patents

Abstract

Breastpumps and methods for use in extracting breastmilk, which can be used to generate, among other things, both a letdown or stimulation phase and a milk expression phase, are disclosed.

Description

• This application is a continuation of application Ser. No. 13/090,929 filed on Apr. 20, 2011, which is a continuation of application Ser. No. 10/413,463 filed on Apr. 14, 2003, now U.S. Pat. No. 8,282,596, which is a continuation-in-part of Ser. No. 9/475,681, filed Dec. 30, 1999, now U.S. Pat. No. 6,547,756, and U.S. patent application No. 10/114,686, filed Apr. 2, 2002, now U.S. Pat. No. 6,808,517, which is a continuation-in-part of U.S. patent application Ser. No. 9/476,076, filed Dec. 30, 1999, all of which claim the benefit of U.S. Provisional Application No. 60/170,070, filed Dec. 10, 1999.
FIELD OF THE INVENTION
• This invention relates to breastpumps for drawing breastmilk, and particularly to a breastpump whether operated manually or motorized, so as to produce both a stimulation, or a letdown phase, and an expression phase.
BACKGROUND OF THE INVENTION
• Breastpumps for use by nursing mothers are well known. They allow the nursing woman to express the breastmilk as necessary or convenient, and further provide collection of the breastmilk for later use. For some mothers, breastpumps may be a necessity, such as when the child has suckling problems, or if the mother has problems with excessive or deficient milk production, or soreness, deformation or injury of the mammilla, or like conditions which are not conducive to manual breast feeding.
• Manual breastpumps are commonplace. They are relatively inexpensive and easy to transport. Examples of such manually-driven pumps are in U.S. Pat. No. 6,497,677.
• Electrically-driven breastpumps are also commonplace. They may be of a substantially large size of a non-portable or semi-portable type, typically including a vacuum pump which has an electric motor that plugs into standard house current. Besides eliminating the efforts of manual pumping, some advantages of this type of pump include better controllability and regulation of the vacuum. The option of variable frequencies (rates) and amplitudes (suction levels) is often provided.
• Battery-driven breastpumps have also been developed. These breastpumps have the advantages of controllability and regulation of the vacuum, as well as being easily carried. Such a battery-driven portable breastpump is described in U.S. Pat. No. 4,964,851, for example. This breastpump, sold under the name MINIELECTRIC by Medela, Inc., is lightweight and achieves good vacuum (i.e., negative pressure) regulation in preferred limits, for example, between about 100 and about 220 mmHg. The LACTINA breastpump sold by Medela, Inc. is also another type of breast pump which may be driven by battery as well as house current. It is generally disclosed in U.S. Pat. No. 5,007,899.
• The prior art manual as well as motorized breastpumps have, to Applicants' knowledge, only been developed with a single type of “cycle” for a given pump. That is, the driving mechanism for generating the vacuum (negative pressure) to be applied at the breast in the more sophisticated pumps is geared to a particular sequence, or curve, of negative pressure increase (i.e., increasing suction), and then release. In these pumps, regardless of vacuum amplitude and frequency, the envelope of the curve (vacuum over time) is essentially the same, barring unintended defects occurring at extreme settings. The curve is often aimed at reproducing in some sense the suckling action of an infant, for instance.
• Breast pumping can cover a range of different conditions, however, such as where the mother's nipples are sore for some reason, there is a state of significant engorgement, some nipple stimulation may be particularly desired, letdown and relaxation may be of particular interest, it may be desired to increase milk production, and so on.
• As noted above, some breastpumps provide the user with the ability to vary the amount of vacuum being applied, as well as the speed of the pumping action (i.e., number of vacuum cycles per minute). In some instances, speed and vacuum level may influence each other, such that as speed increases so does the vacuum level. The basic “curve” remains fixed, however, as described above, and the user must adapt as best she can to making variations within that particular curve built into the machine, which typically has been generalized for the overall population of users.
• Moreover, conventional breastpumps are not made to differentiate between different phases of the milk expression process, or equipped with a mechanism or method of operation to accommodate the different phases. That process includes, for example, a period before breastfeeding, referred to as the milk ejection period, or “letdown”, in which effective removal of the milk from the breast is initiated by the suckling action of a baby's mouth and jaw to produce or stimulate an ejection reflex, in which stored milk is released and made available for general expression. It is believed that efficient expression of breastmilk is improved by stimulating milk ejection before initiating milk expression.
• “Letdown” is, of course, a well known phenomenon. The milk ejection reflex is the neurohormonal reflex resulting from the tactile stimulation of the nipple sending neuronal impulses to the hypothalamus, and the neurohypophysial release of oxytocin into the systemic circulation. The subsequent contraction of the myoepithelial cells within the breast caused by oxytocin moves milk from the alveoli into the collecting ducts and forward to the nipple. Milk ejection, or the milk ejection period, is the interval when an increased availability of milk from the nipple is caused as a result of the stimulation of the milk ejection reflex. Milk ejection in women normally lasts for approximately two minutes, but will, of course, vary from person to person. The ejection reflex will be identified in the following also as “letdown” or “ejection”.
• The level of pressure applied and the intermittency of the stimulation for initiating ejection are different than the level and intermittency of the action for actually expressing the breast milk. Conventional breastpumps do not provide a method or mechanism by which a user can easily stimulate an ejection reflex and subsequently commence to efficiently express breastmilk.
• A demand is therefore believed present for a breastpump that is usable to easily produce stimulation to initiate ejection, and in addition provides efficient expression of breastmilk, thereafter by operation thereof.
SUMMARY OF THE INVENTION
• It is a principal objective of the present invention to provide a breastpump including a mechanism that can be used to generate a letdown sequence. In one form, the breastpump further includes a plurality of differing milk expression (extraction) sequences or curves, or changing combinations of conditions over time, which effectively address different phases of breastmilk production. The invention in one form includes a breastpump comprising a breastshield having a portion within which a woman's breast is received for the expression of milk. One or more sources of pressure change (e.g., vacuum) communicate with the breastshield. The source(s) of pressure is operated so as to effectively elicit letdown and then a different phase of breastmilk production, such as general milk expression.
• The source of vacuum, in one embodiment, is operated manually, i.e., by physically manipulating a pump mechanism of the manual breastpump with the hand. The source of vacuum is operated by a motor drive or the like in another embodiment, with the motor drive being adjustable according to selections made by the user. In still another embodiment, the source of vacuum is operated by a motor, according to a controller with preset instructions or user input instructions, and may automatically transition between different operating conditions according to the preset instructions or operate according to a user's input, or both.
• It will be understood that in each of the embodiments, there is a mechanism for operating the source(s) of pressure change (e.g., vacuum) according to at least a first set of conditions and a second set of conditions. While a negative pressure is typical for breastpumps, a positive pressure is also usable in some adaptations. For purposes of the present invention, one of the set of conditions corresponds to a letdown condition. The second set of conditions is at least one sequence for pumping that is not for letdown, such as a general milk expression condition. A significant, and heretofore unavailable advantage realized by the present invention is also the ready ability to modify the breastpump suction action to a variety of desired generally expression conditions, and provide this ability to the end-user.
• In yet another aspect of the invention, an improved motorized breastpump is provided which has a pre-programmed milk letdown sequence. The letdown sequence is most advantageously made available through a button, switch or the like provided on the breastpump used to initiate the sequence.
• The present invention in another significant aspect has a manually generated letdown mechanism which is designed to be easily manipulated to produce the staccato-like action considered advantageous to the ejection reflex.
• These and other features and advantages of the present invention will be further understood and appreciated when considered in relation to the following detailed description of embodiments of the invention, taken in conjunction with the drawings, in which:
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of an embodiment of a manual breastpump according to certain aspects of the present invention;
• FIG. 2 is a side view of the breastpump ofFIG. 1;
• FIG. 3 is an exploded sectional view of the breastpump ofFIG. 1;
• FIG. 4 is a diagrammatic representation of the interaction of various components within a programmable breastpump according to another embodiment of the present invention;
• FIGS. 5 through 8 are various methods (curves) for operating a breastpump to differing ends,FIG. 7 being a curve for a letdown sequence;
• FIG. 9 is another representation of a letdown sequence;
• FIG. 10 is a front view of an embodiment of a motorized breastpump according to certain aspects of the present invention;
• FIG. 11 is a rear view of the embodiment ofFIG. 10; and
• FIG. 12 is an exploded view of the embodiment ofFIGS. 10 and 11.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
• One embodiment of the invention is a manual breastpump as detailed in U.S. Provisional Application No. 60/405,559 filed Aug. 23, 2002, incorporated herein by reference, and illustrated in FIGS. 1-3, depicted herein.
• Thebreastpump assembly110 includes ashield112, for contacting the breast. Theshield112 is attached to aconduit structure114. Avacuum pump mechanism116 is attached to theconduit structure114. Theconduit structure114 transmits vacuum generated in thevacuum pump mechanism116 to theshield112 and transmits expressed breastmilk from the shield to an attachedcontainer118.
• Theshield112 has a generally funnel shapedportion120 shaped and sized for being received onto a breast. Theshield112 extends into asleeve122 downstream from the funnel shapedportion120. Thesleeve122 is open so as to conduct expressed milk into theconduit structure114. For purposes of the instant invention, the shape of theshield112 and its formation with theconduit structure114 are incidental; the particular arrangement and details of these elements is in no way limiting.
• Theconduit structure114 is attachable to theshield112 through ashield mount124 sized and shaped to receive thesleeve122. Theconduit structure114 is generally a housing that interconnects and permits fluid communication between parts of thebreastpump assembly110. Theconduit structure114 connects to thesleeve122, by way of theshield mount124 at the one end, and terminates with a valve mechanism as is known in the art at acontainer end126. Thecontainer end126 may includethreads128 or any suitable mechanism for releasable attachment tocontainer118, which may be in the form of a milk bottle or the like.
• Theconduit structure114 includes afirst conduit130 defined by an innerfirst conduit surface132 for conducting expressed breast milk from theshield mount124 through the valve mechanism and into thecontainer118. Theconduit structure114 includes areceptacle134 for receiving thepump mechanism116. Thereceptacle134 may be a bore formed in theconduit structure114 or a bore formed in a cylindrical extension (not shown) of theconduit structure114. Thereceptacle134 further includes alongitudinal bore138 in fluid communication with asecond conduit140 for transmitting pressure changes generated in thepump mechanism116 through thereceptacle134 andconduit structure114. Thesecond conduit140 is in fluid communication with thefirst conduit130 inchamber141 so as to conduct pressure changes through theconduit structure114 to theshield112 and thence to a breast of a user.
• Thepump mechanism116 is releasably and even rotatably attachable to theconduit structure114. Thepump mechanism116 includes two main portions. A first portion is a substantially rigid shell or handle142. The second portion is a flexible movable member in the form of a diaphragm-like structure144 attached to the handle. Thehandle142 may be made of a rigid plastic similar to that of theconduit structure114. Referring toFIG. 3 in particular, handle142 has acentral portion146, which has the form of a dome or housing, and abottom edge portion148. Thedome146 includes aninner surface150, which defines avacuum chamber152 with thediaphragm144 as will be explained more fully below.
• Thehandle142 includes afirst extension154 in the form of a handle extending from aback side156 of thehandle142, which is sized and shaped to be grasped by a hand or one or more digits of the user. Drawing the distal orfirst extension154 toward theconduit structure114 and generally toward the user's body operates thefirst extension154 in one mode of operation of the breastpump. A second orproximal extension158 extends from thefront side157, opposite thefirst extension154, in the form of a tab or smaller handle extension. The proximal orsecond extension158 may be smaller than the first154 and may be operated by drawing the extension downwardly toward theconduit structure114 in another mode of operation with a single digit of the user, as described hereafter. Distal and proximal are used herein relative to theshield112.
• Thediaphragm144 includes two main parts. A first part is aflexible portion160, shaped like an inverted cup to be positioned inside thedome146 of thehandle142 adjacent theinner surface150 thereof. Theflexible portion160 includes anouter edge162 with achannel164 for tightly fitting with thedome shell edge148. Theflexible portion160 is made of a naturally resilient material so that there is a tendency for the membrane to be resiliently returned to a starting position after being deflected in use. Themembrane160 includes acentral concavity180 on an upper surface thereof and a central opening to receive apuller166. There is a thinnedtransition area149 defining the middle of theflexible portion160.
• The second part of thediaphragm144 is a rigid member orpuller166. Thepuller166 includes adisc portion168 and an extension or post170. Thedisc portion168 is a generally flattened oval member that is centrally imbedded within or attached to themembrane160 at theupper surface concavity180 and may be held in place by posts of themembrane160 inserted through holes arranged somewhat symmetrically around the disc portion. Thedisc portion168 includes acentral opening172 that is open to thevacuum chamber152 at an upper end thereof. Thepost170 is a hollow cylindrical member that is attached to thedisc portion168. Ahollow bore174 of thepost170 is aligned to be in communication with thecentral opening172 of thedisc portion168.
• Theextension170 is sized and shaped to be received within thepost receptacle134, via a press or interference fit. Preferably, the connection of theextension170 to thepost receptacle134 is releasable and rotatable or pivotable in thereceptacle134. In this manner, theentire handle116 andextension154 may be rotated to one side of the breastpump assembly for the convenience of the user. In an alternate embodiment, thepuller166 may be fixedly connected to theconduit structure114. In yet another embodiment, theassembly110 may be formed as a unitary unit. For ease of cleaning, it is preferred to provide the various elements of theassembly110 as separate elements. Accordingly, for the purpose of this invention, the term connected may refer to a releasable or a permanent connection.
• In one preferred embodiment, the lower end of thepost170 forms a half-lap feature171, which when fitted to thereceptacle134 cooperates with a conversefeature173 within the bore ofsocket134 to limit the arcuate travel ofhandle116 and prevent over-rotation.
• In operation, at a rest position, which is a start or initial position, thepump mechanism membrane160 lies against or closely adjacent to theinner surface150 of thedome portion146 of thehandle142. In this position, as shown inFIG. 1, the volume of thevacuum chamber152 is zero or at a minimum volume. When the user manipulates thefirst extension154 by pulling the extension inwardly toward theconduit structure114, thepost170 anddisc portion168 remain connected to and motionless with respect to the conduit structure while thehandle142 moves with the extension. Therigid disc portion168 pivots about a point at arear edge176 thereof, causing themembrane160 to pull away from theinner surface150 of thedome146, which expands the vacuum chamber152 a first volume to produce a first negative pressure therein. The reduced pressure is communicated through thecentral opening172 of thedisc168, through thehollow bore174 of thepost170, through thelongitudinal bore138 of thereceptacle134, through thesecond conduit140 and thence theshield112. Operation of thebreastpump110 by this mode of operation is intended to generate an amount of vacuum at a cyclical rate in order to efficiently promote milk expression from a breast, i.e., general pumping. A very easily operated one-handed manual pump mechanism is thereby provided that operates a manual breastpump in a first mode of operation to produce an efficient expression of breast milk Note also that thehandle142 freely rotates inreceptacle134, enabling the user to adjust the handle's position to a most convenient grasping orientation.
• When the user manipulates thesecond extension158 by pulling that extension downwardly (e.g., toward the conduit structure114) in the other mode of operation, themembrane160 pulls away from theinner surface150 of thedome146 at a distal region by pivoting about a point at afront edge178 of the disc, which expands the vacuum chamber152 a second volume to produce a second negative pressure therein.
• The second volume may be less than the first volume so that a lesser relative change in pressure is generated by this mode of operation as compared to the one already described for general pumping. In the present embodiment, this difference may be due to the shape and travel of the first andsecond extensions154,158. That is,second extension158 travels a shorter distance before it is stopped by thehood mount124.First extension154 has a longer distance of travel before it is stopped by theconduit structure114. In an alternate embodiment (not shown), the depth of the vacuum chamber adjacent thesecond extension158 may be formed as to be greater than the depth of the chamber adjacent thefirst extension154. When the pull of thepuller166 causes themembrane160 to pull away from theinner surface150 of thedome146, a relatively greater change in volume is created in operation of thefirst extension154 due to the greater depth of the resultant chamber as compared to manipulation of thesecond extension158.
• Operation of thebreastpump110 by manipulating theextension158 in this mode of operation is intended to generate an amount of vacuum (relatively less in absolute change) at a cyclical rate (which may be relatively more rapid) in order to efficiently promote a milk ejection reflex, i.e., letdown. It can be seen that use of asmall extension158 is possible and efficient to promote ejection due to the lesser amount of vacuum generated in the second mode of operation. Because of the lesser amount of force necessary the second mode of operation may occur relatively more rapidly, which, it has been found, is desired to produce ejection as compared to expression.
• Another embodiment of the invention is a motorized breastpump having the capability of producing vacuum and cycle frequency conditions corresponding to at least a letdown sequence and some other sequence, such as an expression sequence. The breastpump may be preprogrammed to do so, or may be user programmable as detailed in U.S. Pat. No. 6,547,756, incorporated herein by reference, or may have both capabilities. The breastpump may be operated according to the sequences and parameters detailed in U.S. patent application Ser. No. 10/114,686, incorporated herein by reference. For purposes of the present invention, the actual general expression sequence used is not limiting, since an inventive concept is the combination of a letdown feature with another sequence, such as generated by a general milk expression mechanism.
• This motorized embodiment has the ability to program the breastpump with different types of suction sequences, or cycles as they are sometimes referred to herein. With reference toFIG. 4, for instance, the breastpump utilizes a microprocessor-based system indicated at60 which is provided user input through a plurality of “chip”cards61. Each chip card contains one or more predetermined programs recorded on an EEPROM. For example, each card could contain a specific type of sequence along with a milk letdown sequence.
• An EEPROM microcontroller of the type MB90562 may be used, for one example, or the Atmel 2-wire EEPROM chipcard microcontroller AT24C164 for another. These provide about 16K of memory, which is considered presently sufficient.
• The programs (some examples of which are described hereafter) are recorded in a conventional manner, and would be provided to the mother ready to use. The programmedchip card61 engages an interface to the microprocessor. The particular program on the selectedchip card61 is then communicated to themicroprocessor60.Microprocessor60 is integrated with thedrive unit25 to effect operation of the drive unit in accordance with the selected program, drawing upon either the AC power source as converted via standard technology to DC (indicated at68 inFIG. 4), or from thebattery source39. Themicroprocessor60 can also control power management.
• One embodiment contemplated provides a milk letdown sequence (milk ejection reflex) that can be engaged without need of a chip card for the same. The milk letdown sequence (described below) is pre-programmed in themicroprocessor60, or may otherwise be wired into the circuitry in a manner to override the then-existing operating program. When the mother desires to engage this sequence, she presses thebutton49, which produces and sends an electrical signal, as to themicroprocessor60. The letdown program is then caused to be effected.
• It will be readily understood that achip card61 is but one way to program themicroprocessor60. Other input means could be used, such as more dedicated buttons likebutton49, each set to actuate a given sequence pre-programmed into themicroprocessor60. A numeric pad could be provided to input a code. The programs could be provided through an electronic data link, such as a modem, or optically, or otherwise. Furthermore, the microprocessor may be provided with the capability to automatically transition from one sequence or cycle type to another and optionally to a third or more cycle types without input from the user.
• It can thus be seen that a variety of different suction cycles or sequences can now be provided with the same breastpump equipment. An example of the kind of methods that such cycle could represent comprisesFIGS. 5 through 9.
• FIG. 5, for instance, is what is referred to by Medela, Inc. as the “Standard Classic Program”. This is a method for operating a breastpump that has been developed which is considered to provide a general optimal suction curve reminiscent of an infant's normal suckling, such as provided by the 015 “CLASSIC” breastpump sold by Medela, Inc. As indicated in the graph ofFIG. 5, negative pressure is along the y-axis (in millimeters of mercury) and time (in seconds) along the x-axis. In this particular method, the cycles are fixed at about 47 per minute; the amount of suction is generally adjustable between about 100 to about 250 mmHg.
• FIG. 6 illustrates what can be termed as a new “Sore Nipple Program” method. In comparison toFIG. 5, it will be seen that the lower end of the vacuum range is reduced to about 20 mmHg, and the overall suction cycle is extended in duration, i.e., from a low of about 25 cycles/min. to about 40. For a lower vacuum applied in this program, there is an increase in the number of cycles. In general, however, there is a slower and gentler suction compared with the “CLASSIC” program ofFIG. 5.
• FIG. 7 shows a new method for operating a breastpump which is considered to yield an increase in milk output. This is a letdown sequence. This is also a program that might be applied between regular pump sessions several times a day. In this method, the breastpump is operated at a rapid cyclical rate on the order of about 120 cycles/min., preferably with a pause after a period of vacuum application; here, 10 seconds of vacuum, then a 2 second pause. The negative pressure is in the range of about 50 to about 150 mmHg. Note the detail in the inset ofFIG. 7 showing the rapidity and steep slopes of the vacuum application.
• What has been termed a new “Superior Program” for operating a breastpump is illustrated inFIG. 8. A vacuum range of about 100 to about 250 mmHg has been chosen, with cycles ranging from about 47 to about 78 per minute. The cycle rate and the vacuum are tied, such that as, for instance, the cycles decrease, the amount of vacuum increases, i.e., there is an inverse relationship. It will be noted that this program differs from the “CLASSIC” program above in part through a sequence that initially reaches a peak negative pressure, then smoothly starts a pressure increase (less negative) along a similar (although opposite) slope to that of the negative pressure build-up, but then slows the pressure increase briefly, before continuing on essentially the initial slope for the negative pressure release. A milk letdown sequence is also incorporated in this “Superior Program,” and utilizes a vacuum range of about 50 to about 150 mmHg, with cycles ranging between about 80 to about 160 per minute.
• A preferred vacuum cycle for stimulating the milk ejection reflex by generating a rapid cyclical pressure change with a breastpump is shown in the graph ofFIG. 9. The graph includes two separate curves, but with the same envelope or overall pattern. A first curve C, which ranges in pressure from 0 mmHg (atmospheric) to about—45 mmHg (vacuum), the minimum curve C, represents the lower limit of the range of the vacuum cycle (lower amount of peak vacuum). A second curve D, which ranges in pressure from 0 mmHg to about—225 mmHg, the maximum curve D, represents the high limit of the range of the vacuum cycle (highest amount of peak vacuum). The minimum and maximum curves C, D differ in amplitude and share an envelope.
• It can also be seen from the graph ofFIG. 9 that the time duration of each of the minimum and maximum cycles C, D does not vary with the amplitude of the vacuum. In other words, in a curve cycle where the peak amplitude of the vacuum is greater, the time duration of the entire cycle is the same as that of curve having a lesser peak amplitude. In the illustrated cycle, the time duration of the cycle remains at 0.5 seconds whether at the minimum or maximum range of vacuum operation. In one preferred embodiment, no rest period is provided between cycles. Accordingly, the frequency of operation of the breastpump remains at about 120 CPM, since there is no pause between cycles in the preferred embodiment. In another embodiment, a rest period of 0.0 to 0.5 seconds is provided between vacuum cycles.
• FIGS. 10-13 show amotorized breastpump10′ with ahandle12′. In this embodiment thebreastshields17 are stored or carried in aholder26 mounted to the back of the unit.FIG. 11 shows the rear of thebreastpump10′ wherein the breastshields are attached torespective containers18, which are stored inholder26.
• FIG. 12 shows internal workings of the motorized breastpump ofFIGS. 10 and 11.Breastpump casing10′ has adrive unit25 mounted therein. There are, of course, any number of drives that may be used for diaphragm pumps such as those used in the instant embodiment. Indeed, the type of pump (diaphragm, piston, etc.) is not significant to certain aspects of the present invention. The driving mechanism for the breastpump shown for the embodiment in point, however, is a linear drive for the diaphragm pumps consisting of a reduction drive arrangement and a 12 V DC-motor28.
• Thedrive25 may be controlled according to the arrangement shown inFIG. 4, with a power supply (e.g., batteries)39 positioned in lower housing part13, which provides power to drive25 according to amicroprocessor60 positioned uponboard60′. Thebreastpump10′ includes a cover35″ and shells24′ for thediaphragm pump30. The shells24′ are mounted in a removable manner in the upper housing, as through a snap fit or interference engagement, to allow easier access for cleaning or replacing themembranes36 of the pumping mechanism, and for cleaning the shells themselves.Diaphragm members34, may be made of any suitably durable flexible and durable fluid-impervious material (to be airtight), such as silicone with a Shore A hardness in the range of30 to70. The membrane and shell are in substantially airtight engagement.
• When themembrane34 is pulled away from the shell, a vacuum is generated in the space between the shell interior and the membrane, which is connected via tubing connected tooutlet part31 to communicate the vacuum to arespective breastshield17.
• Prophylactic (protective) disposable/cleanable covers36 are additionally and advantageously provided, which form-fit over thediaphragms34 and isolate them from air and other fluid from the breastshields. Thecovers36, which can be made of the same material as the membranes but thinner, are likewise fluid-impervious.
• As shown in detail above, the microprocessor operates to control thedrive unit25 and, thereby pumpmechanism30, to produce pressure conditions to address different sequences of operation according to the present invention.
• Again, more detail on this motor-driven embodiment can be gleaned from the priority document referenced above.
• Thus, while the invention has been described herein with relation to certain embodiments and applications, those with skill in this art will recognize changes, modifications, alterations and the like which still come within the spirit of the inventive concept, and such are intended to be included within the scope of the invention as expressed in the following claims. For one example, the manually operated letdown mechanism could be a collapsible button-like device manipulated by finger pressure on a dome-shaped member to collapse the dome, which then rapidly returns to its original shape to be pressed again. The small pressure change (either positive or negative) is communicated to the nipple, and perhaps some surrounding area of the breast. Further various devices, in order to yield the letdown sequence, whether applied to a manual pump or otherwise, need not be a part of the breast shield itself or in close proximity thereto, as shown in the motorized embodiment described herein. The pressure source could further be a single source or plural sources, such as one for letdown and one for general milk expression. One source could be manually driven, while the other is motor-driven.

Claims (31)

1. (canceled)

2. A breastpump comprising:

a breastshield having a portion adapted for receiving at least part of a woman's breast;

a source of vacuum adapted for communication with said breastshield to cyclically deliver vacuum to said breastshield;

a controller operatively connected to said source of vacuum, said controller being programmed to operate at least said source of vacuum in a manner that results in at least a first vacuum cycle having a waveform with a first shape, and a second vacuum cycle having a waveform with a second shape which is different than said first shape.

3. The breastpump ofclaim 2 wherein said source of vacuum includes at least an expansible chamber device and a motorized drive system.

4. The breastpump ofclaim 3 wherein said expansible chamber device comprises a diaphragm pump.

5. The breastpump ofclaim 2 wherein said vacuum is a partial vacuum.

6. The breastpump ofclaim 2 wherein at least one of said first and second vacuum cycles is a letdown sequence.

7. The breastpump ofclaim 2 wherein both of said first and second vacuum cycles are milk expression sequences.

8. The breastpump ofclaim 2 wherein said first shape and said second shape have differences beyond differences in cyclical rate and maximum level of vacuum.

9. The breastpump ofclaim 2 wherein the maximum level of vacuum in said breastshield during said second vacuum cycle is greater than the maximum level of vacuum in said breastshield during said first vacuum cycle.

10. The breastpump ofclaim 2 wherein said controller further comprises an interface for the inputting of programs corresponding to at least said first and second vacuum cycles.

11. A breastpump comprising:

a breastshield having a portion adapted for receiving at least part of a woman's breast;

a source of vacuum adapted for communication with said breastshield to cyclically deliver vacuum to said breastshield;

a controller operatively connected to said source of vacuum, said controller being programmed to operate at least said source of vacuum in a manner that results in at least two different vacuum cycles having different shaped waveforms; and

a user-operated input device operatively connected to said controller that sends a signal to said controller to actuate each of said different vacuum cycles.

12. The breastpump ofclaim 11 wherein said source of vacuum includes at least an expansible chamber device and a motorized drive system.

13. The breastpump ofclaim 11 wherein said user-operated input device comprises one or more switches.

14. The breastpump ofclaim 11 wherein said user-operated input device comprises one or more buttons.

15. The breastpump ofclaim 11 wherein said different vacuum cycles include at least one milk letdown cycle and at least one milk expression cycle.

16. The breastpump ofclaim 11 wherein said different vacuum cycles include at least one milk letdown cycle and at least two milk expression cycles.

17. The breastpump ofclaim 11 wherein the maximum level of vacuum in said breastshield during said one of said vacuum cycles is greater than the maximum level of vacuum in said breastshield during another of said vacuum cycles.

18. A breastpump comprising:

a breastshield having a portion adapted for receiving at least part of a woman's breast;

a source of vacuum adapted for communication with said breastshield to cyclically deliver vacuum to said breastshield; and

a processor operatively connected to said source of vacuum to control said source of vacuum; and

a memory including executable instructions that, when executed by said processor, causes at least said source of vacuum to operate in a manner that results in at least a first vacuum cycle having a waveform with a first shape and a second vacuum cycle having a waveform with a second shape which is different than said first shape.

19. The breastpump ofclaim 18 wherein said source of vacuum includes at least an expansible chamber device and a motorized drive system.

20. The breastpump ofclaim 18 wherein said first shape and said second shape have differences beyond differences in cyclical rate and maximum level of vacuum.

21. The breastpump ofclaim 18 wherein at least one of said first and second vacuum cycles is a letdown sequence.

22. The breastpump ofclaim 18 wherein at least one of said first and second vacuum cycles is a milk expression sequence.

23. The breastpump ofclaim 18 wherein both of said first and second vacuum cycles are milk expression sequences.

24. The breastpump ofclaim 18 wherein one of said first and second vacuum cycles is a letdown sequence, and the other of said first and second vacuum cycles is a milk expression sequence.

25. The breastpump ofclaim 18 wherein said executable instructions, when executed by said processor, cause at least said source of vacuum to operate in a manner that results in a third vacuum cycle having a waveform with a third shape which is different than said first shape and said second shape.

26. The breastpump ofclaim 18 further comprising a user-operated input device operatively connected to said processor that sends a signal to said processor for actuating said first vacuum cycle or said second vacuum cycle.

27. The breastpump ofclaim 18 wherein the maximum level of vacuum in said breastshield during said second vacuum cycle is greater than the maximum level of vacuum in said breastshield during said first vacuum cycle.

28. The breastpump ofclaim 18 wherein said executable instructions, when executed by said processor, cause at least said source of vacuum to transition between said first vacuum cycle and said second vacuum cycle.

29. The breastpump ofclaim 28 wherein transitioning between said first vacuum cycle and said second vacuum cycle is actuated by a user-operated input device operatively connected to said processor that sends a signal to said processor to actuate said first vacuum cycle or said second vacuum cycle.

30. The breastpump ofclaim 28 wherein said executable instructions, when executed by said processor, cause at least said source of vacuum to automatically transition between said first vacuum cycle and said second vacuum cycle.

31. The breastpump ofclaim 18 wherein said executable instructions, when executed by said processor, cause at least said source of vacuum to operate in a manner that holds the level of vacuum or slows a rate of decrease in said level of vacuum during at least a portion of said first vacuum cycle or said second vacuum cycle.

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