WO2025201622A1 - Method for operating a breastpump - Google Patents

Method for operating a breastpump

Info

Publication number
WO2025201622A1
WO2025201622A1 PCT/EP2024/057968 EP2024057968W WO2025201622A1 WO 2025201622 A1 WO2025201622 A1 WO 2025201622A1 EP 2024057968 W EP2024057968 W EP 2024057968W WO 2025201622 A1 WO2025201622 A1 WO 2025201622A1
Authority
WO
WIPO (PCT)
Prior art keywords
sequence
subpattern
seconds
duration
stimulation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/057968
Other languages
French (fr)
Inventor
Danielle Prime
Nienke VAN DEN ENDE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medela AG
Original Assignee
Medela AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medela AG filed Critical Medela AG
Priority to PCT/EP2024/057968 priority Critical patent/WO2025201622A1/en
Publication of WO2025201622A1 publication Critical patent/WO2025201622A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/06Milking pumps
    • A61M1/069Means for improving milking yield
    • A61M1/0693Means for improving milking yield with programmable or pre-programmed sucking patterns
    • A61M1/06935Means for improving milking yield with programmable or pre-programmed sucking patterns imitating the suckling of an infant

Definitions

  • the present invention relates generally to a method for operating a breastpump and a breastpump. It relates to a process for initiating breastmilk from a mother very shortly after giving birth, most particularly in the instance of a premature infant, using a motorized, such as electrically driven breastpump.
  • 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. Of particular instance herein is the situation confronting a mother where the infant is premature, and therefore is most always separated from the mother.
  • Electrically driven motorized breastpumps generally have a driving mechanism for generating the vacuum (negative pressure) to be applied at the breast geared to a particular sequence, or curve, of negative pressure increase (i.e. increasing suction), and then release. This is often aimed at reproducing in some sense the suckling action of a healthy infant during mature lactation, after the milk supply has been established, see for example WO 00/57934.
  • EP 2 878 317 B1 discloses breast pump providing a sequence of pattern to initiate milk flow from a mother's breast.
  • the sequence comprises a first pattern operating the breastpump at about 120 cycles per minute (cpm) with a vacuum level in the range of about 70-200 millimeters of mercury (mmHg).
  • the second pattern comprises operating the breastpump at 90 cpm with a vacuum level in the range of about 70-200 mmHg.
  • the third pattern comprises operating the breastpump between about 34 and 54 cpm, with a vacuum level in the range of about 100- 250 mmHg.
  • the first two patterns provide stimulation phases whereas the third pattern provides an expression phase.
  • the first days postpartum are particularly important for the effective initiation of lactation and therefore for subsequent long-term lactation outcomes. Milk removal at this early stage after birth can increase the efficiency of milk secretion.
  • optimized colostrum or milk expression in these first days may stimulate milk production in the long term, in terms of quantity and time after baby birth, i.e. it may stimulate a more abundant milk production and for a longer time after baby birth. Therefore there is a need to maximize the removal of milk from the breast in the first days after the birth of the baby.
  • the maintaining sequence and the stimulation sequence define a maintaining subpattern of the pattern of the inventive method.
  • the stimulation sequence is followed by the maintaining sequence.
  • the maintaining sequence and the stimulation sequence are consecutive sequences, which does not exclude a pause between those two sequences by any other sequence disposed between the stimulation sequence and the maintaining sequence and within the maintaining subpattern.
  • the maintaining sequence has duration of at least 3 minutes, preferably of at least 4 minutes, most preferably of at least 5 minutes.
  • the maintaining sequence has duration of or less than 10 minutes, preferably of or less than 8 minutes, most preferably of or less than 5 minutes.
  • the sucking pattern of the maintaining sequence is in particular adapted to express colostrum in the last minutes of the pumping session or pumping pattern.
  • the maintaining sequence follows a stimulation sequence, which is specifically suitable to yield colostrum in the subsequent maintaining sequence.
  • the pattern of the inventive method comprises or consists of a first subpattern, a second subpattern, a third subpattern and a maintaining subpattern.
  • This second subpattern may be the alternate subpattern described above.
  • First, second and third identifies the sequence of the subpattern.
  • the maintaining subpattern usually is the last subpattern of the pattern and defines the end of the pattern.
  • the expression sequence and/or the maintaining sequence have a cycle rate of 66 +/- 14 cycles per minute, preferably 66 +/- 12 cycles per minute.
  • the expression sequence and the maintenance sequence have the same cycle rate.
  • a second and short embodiment of a specific pattern which pattern comprises a first, a second and a third subpattern.
  • the total duration of the first, second and third subpattern and the maintaining pattern is not more than 10 minutes, preferably 7 minutes +/- 2 minutes more preferably 9 minutes +/- 1 minutes and most preferably 10 minutes.
  • the maintaining subpattern follows the sequence of the first, second and third subpattern.
  • the first stimulation sequence has a duration of 120 seconds +/- 20 seconds and/or the second stimulation sequence has a duration of 80 seconds +/- 10 seconds and/or the expression sequence has a duration of 40 seconds +/- 5 seconds.
  • Subpattern consists of a specific sequence of generally different “sequences”. “Sequence” is a sequence of multiple, on a regular basis identical cycles.
  • Consist means that an entity exclusively has the items of which the entity consists. As far as an entity is described to consist of a listing of items, respective listing is to be understood to provide an exhaustive enumeration.
  • “Sucking pattern” is specified by a specific cycle rate and a vacuum level.
  • Figure 1 is an illustration of a breastpump assembly for use in accordance with one embodiment of the present invention
  • figure 2 is a diagram of a process to initiate milk flow from a mother's breast in accordance with a first embodiment of the invention
  • figure 3 is a diagram of a process to initiate milk flow from a mother's breast in accordance with a second embodiment of the invention.
  • FIG. 1 is an illustration of a breastpump assembly in accordance with one embodiment of the present invention. That breastpump is generally described in U.S. Patent No. 6,547,756 or EP 2 878 317 B1 , reference thereto can be made for salient details of this breastpump. While the invention has found particular application for use with this kind of programmable breastpump and with respect to premature babies, it can be used or adapted for use with other motorized pumps capable of being operated with the varying sequences (hereinafter described), and aspects are considered adaptable to full-term babies including breastpumps wearable inside a bra, as disclosed in WO2022/268998.
  • the breastpump assembly 100 includes a breastpump 110, a plurality of the breastshield and container assemblies 120, and a user input interface 130; the user input interface is shown in the attached figures as a program card 130, but in different examples it can be of any other type.
  • Power may be provided to the breastpump apparatus 110 either through standard current via a power cord, a battery, or some other appropriate power supply.
  • the breastpump 110 may be either a double or a single pump.
  • the single pump extracts milk from one breast at a time, and the double pump can be used to extract milk from both breasts at the same time.
  • the breastpump 110 is attached to each of the plurality of breastshield and container assemblies 120 with a tube 140.
  • Each of the plurality of breastshield and container assemblies 120 comprises a breastshield 122 and a container 124.
  • the container 124 is used to store the pumped milk.
  • the breastpump 110 utilizes a controller 126 for controlling an aggregate 128.
  • the controller 126 or microprocessor-based system is provided with user input through the program card 130.
  • the breastpump 110 has a program card insert slot through which a user inserts the program card 130. Once inserted, the program card 130 is read. The particular program on the program card 130 is then communicated to the controller 126.
  • the controller 126 is provided within a housing of the breastpump 110 to control the aggregate 128 for providing the suction sequences of the suction pattern described hereinafter.
  • One embodiment contemplated, for instance, provides a sequence that can be engaged without need of a separate program card for the same.
  • the sequence is preprogrammed in the controller 126, or may otherwise be wired into the circuitry of the controller 126 or transmitted to the controller 126 in any suitable way with or without wire in a manner to override the then-existing operating program.
  • breastshields 122 are placed and centered over a mother's nipples.
  • the breastpump apparatus 110 may be turned on by a user pressing a first button 112, and in this embodiment, the program card 130 is used with the apparatus.
  • the apparatus reads the program contained on the program card 130.
  • the breastpump 110 may display instructions to the user via the interface 150. The instructions may ask the user to start the program. If the mother wants to start the program, the mother may press a second button 114.
  • the interface 150 may then show instructions and/or graphics that let the mother know that the program is starting.
  • the program card 130 may operate a preset pattern comprised of non-repeating suction sequences.
  • the program card 130 may operate a preset pattern comprised of repeating suction sequences that appear to be non-repeating to the user, due to the overall length of the pumping session such that the sequences seem to be occurring at unpredictable times in the pattern with extended pauses between some of the sequences.
  • An extended pause is a pause that is approximately greater than about five seconds in duration. Some of the pauses may be of shorter duration, however, but still of a length that yields a noticeable hiatus to the mother.
  • the sequences comprise at least one stimulation sequence and one expression sequence, and may additionally comprise further stimulation sequences and/or expression sequences.
  • Figures 2 and 3 depict examples of the method.
  • the steps in Figures 2 and 3 are designed so that a most-desired pattern of stimulation, expression, and pauses is provided.
  • This particular set of sequences and pauses is considered to more closely resemble the sucking pattern of a newly-born infant during the early days post-birth before the onset of lactogenesis II.
  • the sequences described in Figures 2 and 3 are designed to stimulate the breast and eventually achieve the lactogenesis II stage. It will be understood, however, that while the particular set of sequences and pauses set forth in the presently most-preferred embodiment have achieved significant results and advantages, the set may well be reducible, yet still achieve some or all of the desired purposes.
  • Substantially recreating the suckling pattern of a newborn baby pre-lactogenesis II is most desired, and some other mix of various stimulation cycles and pauses may serve the desired end. Precision in the patterns used, their order, and the number of pauses and duration of the same is not considered critical. It is the fact that the overall combination for the first time in a breastpumping method has the capability of reproducing the sucking pattern of the very early newborn, pre-lactogenesis II.
  • a first stimulation sequence SI is set into motion for approximately three minutes.
  • This first stimulation sequence SI has a moderate vacuum level at a higher cycle rate of about 120 cycles per minute (cpm).
  • the moderate vacuum level has a range of about 70-200 millimeters of mercury (mmHg).
  • the cycles per minute indicate the sucking rhythm, or the number of pulls and releases per minute. This means that the vacuum will alternate cyclically between a pull suction of 200 mmHg and a release suction of 70 mmHg.
  • the first stimulation sequence SI is followed by a second stimulation sequence Sil having a slower rate than the first stimulation sequence SI.
  • the rate of the second stimulation sequence SI I is about 90 cpm, which is applied for approximately two minutes.
  • the pull suction is 200 mmHg and a release suction is 70 mmHg.
  • the controller of the pump starts an expression sequence E, which follows the second stimulation sequence SI I.
  • This expression sequence E is applied for approximately one minute.
  • the expression sequence E has a relatively higher vacuum level and provides a slower cycle rate.
  • the breastpump is operated between about 34 and 54 cpm with a vacuum level in the range of about 90-250 mmHg.
  • this expression sequence does not result in milk or colostrum being expressed by the breast, but is used for stimulating the breast.
  • the sequence of the first stimulation sequence SI followed by the second stimulation sequence SI I followed by the expression sequence E defines a first subpattern SPI.
  • the breastpump is operated to provide the first subpattern SPI.
  • the first stimulation sequence SI is applied for approximately two minutes
  • the second stimulation sequence Sil is applied for approximately one minute
  • the expression sequence E is applied for approximately one minute.
  • this third subpattern SPHI has the same consecutive sequences as the first subpattern SPI, for a clear discrimination, it is identified in the drawings as a third subpattern SPHI.
  • the expression sequence E of the third subpattern SPHI generally does not result in milk or colostrum expression.
  • the breastpump is paused for ten seconds, indicated in figure 2 as third pause PHI.
  • the breastpump is operated to provide the second stimulation sequence SI I mentioned above, which is applied for approximately 80 seconds.
  • the breastpump is paused for ten seconds, indicated in figure 2 as fourth pause PIV.
  • the sequence of the second stimulation sequence SI I followed by the fourth pause PIV followed by the maintaining sequence M is a first example of a maintaining subpattern SPM.
  • the pumping session for expressing milk from the breast of a mother may be stopped or may be restarted as described above, after a pause of e.g. at least 10 seconds.
  • the first pause PI between the first subpattern SPI and the second subpattern SPII and the pause PH between the second subpattern SPII and the third subpattern SPIN each have a duration of 8 seconds.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Pediatric Medicine (AREA)
  • Hematology (AREA)
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Abstract

The present invention relates to a method for operating a breastpump within a breastpumping session in a pattern of sequences, which pattern comprises at least one stimulation sequence (SI) for stimulating the breast having a rapid cycle rate and providing a moderate vacuum level and at least one expression sequence (E) having a lower cycle rate and providing a higher vacuum level, wherein the lower cycle rate is lower than the rapid cycle rate and wherein the higher vacuum level is higher than the moderate vacuum level. In order to provide a method especially useful to express milk in the early days after birth of an infant, and most particularly to express colostrum, the present invention proposes a maintaining sequence (M) at a lower cycle rate and providing a higher vacuum level subsequent to a stimulation sequence (SII), wherein said maintaining sequence (M) and said stimulation sequence (SII) are consecutive sequences and define a maintaining subpattern (SPM) of said pattern, and wherein said maintaining sequence (SPM) has a duration of at least 3 minutes, preferably of at least 4 minutes, most preferably of at least 5 minutes.

Description

Method for Operating a breastpump
FIELD OF THE INVENTION
The present invention relates generally to a method for operating a breastpump and a breastpump. It relates to a process for initiating breastmilk from a mother very shortly after giving birth, most particularly in the instance of a premature infant, using a motorized, such as electrically driven breastpump.
BACKGROUND
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. Of particular instance herein is the situation confronting a mother where the infant is premature, and therefore is most always separated from the mother.
Electrically-driven breastpumps are commonplace, typically including a vacuum pump which has an electric motor that plugs into standard house current, and/or operates off of battery power. Advantages of this type of pump are convenience, ready controllability and regulation of the vacuum, and in many instances the ability to pump both breasts at once.
Electrically driven motorized breastpumps generally have a driving mechanism for generating the vacuum (negative pressure) to be applied at the breast geared to a particular sequence, or curve, of negative pressure increase (i.e. increasing suction), and then release. This is often aimed at reproducing in some sense the suckling action of a healthy infant during mature lactation, after the milk supply has been established, see for example WO 00/57934.
EP 2 878 317 B1 discloses breast pump providing a sequence of pattern to initiate milk flow from a mother's breast. The sequence comprises a first pattern operating the breastpump at about 120 cycles per minute (cpm) with a vacuum level in the range of about 70-200 millimeters of mercury (mmHg). The second pattern comprises operating the breastpump at 90 cpm with a vacuum level in the range of about 70-200 mmHg. The third pattern comprises operating the breastpump between about 34 and 54 cpm, with a vacuum level in the range of about 100- 250 mmHg. The first two patterns provide stimulation phases whereas the third pattern provides an expression phase. UNDERLYING PROBLEM
The first days postpartum are particularly important for the effective initiation of lactation and therefore for subsequent long-term lactation outcomes. Milk removal at this early stage after birth can increase the efficiency of milk secretion. In this connection, optimized colostrum or milk expression in these first days may stimulate milk production in the long term, in terms of quantity and time after baby birth, i.e. it may stimulate a more abundant milk production and for a longer time after baby birth. Therefore there is a need to maximize the removal of milk from the breast in the first days after the birth of the baby.
SUMMARY OF THE INVENTION
The present invention, as defined by the appended claims, provides an improved method for initiating the expression of milk for an infant.
In its preferred form, it is a method adapted for use with a motor-driven breastpump, which has an aggregate and a controller controlling said aggregate as well as an energy supply connected to the aggregate via power cord or battery. The aggregate of the breastpump can be any unit, which transforms the electric energy into suction or motion eventually generating suction. More particularly, the present invention has a principal objective of providing a method especially useful to express milk in the early days after birth of an infant, and most particularly to express colostrum.
Specifically, the present invention provides a method for operating a breastpump within a breastpumping session in a pattern of sequences, which pattern comprises at least one stimulation sequence for stimulating the breast using a rapid cycle rate and providing a moderate vacuum level and at least one expression sequence for extracting milk at a lower cycle rate and providing a higher vacuum level, wherein the lower cycle rate is lower than the rapid cycle rate and wherein the higher vacuum level is higher than the moderate vacuum level. This part of the method may be realized in general and in details as described in EP 2 878 317 B1.
In addition to the sequences described in this prior art, the pattern of the inventive method has a maintaining sequence at a lower cycle rate and providing a higher vacuum level subsequent to a stimulation sequence. The maintenance sequence causes colostrum or milk expression from the breast. Such milk or colostrum may be collected and fed to the baby or provided to other babies.
The maintaining sequence and the stimulation sequence define a maintaining subpattern of the pattern of the inventive method. In this maintaining subpattern, the stimulation sequence is followed by the maintaining sequence. In other words, the maintaining sequence and the stimulation sequence are consecutive sequences, which does not exclude a pause between those two sequences by any other sequence disposed between the stimulation sequence and the maintaining sequence and within the maintaining subpattern. The maintaining sequence has duration of at least 3 minutes, preferably of at least 4 minutes, most preferably of at least 5 minutes. The maintaining sequence has duration of or less than 10 minutes, preferably of or less than 8 minutes, most preferably of or less than 5 minutes.
The sucking pattern of the maintaining sequence is in particular adapted to express colostrum in the last minutes of the pumping session or pumping pattern. The maintaining sequence follows a stimulation sequence, which is specifically suitable to yield colostrum in the subsequent maintaining sequence.
Preferably, the pattern of the inventive method comprises a first and a second stimulation sequence followed by the expression sequence. In such a subpattern the first stimulation sequence preferably has an e.g. by about 30% higher cycle rate than the second stimulation sequence. One or more of such subpattern may form part of the pattern of the inventive method.
In addition, the pattern of the inventive method may comprise an alternate subpattern having only stimulation sequences as sequences of this subpattern. Specifically, the alternate subpattern may consist of two stimulation sequences with or without a pause in between, which stimulation sequences vary, in particular with respect to cycle rate but may have identical vacuum level including pressure difference, pull suction and release suction. In such an alternate subpattern, a stimulation sequence may follow a preceding stimulation sequence having a by about 30% lower cycle rate than the following stimulation sequence. One or more of such alternate subpattern may form part of the pattern of the inventive method.
Preferably, the pattern of the inventive method comprises or consists of a first subpattern, a second subpattern, a third subpattern and a maintaining subpattern. This second subpattern may be the alternate subpattern described above. First, second and third identifies the sequence of the subpattern. The maintaining subpattern usually is the last subpattern of the pattern and defines the end of the pattern.
In such a pattern, the first and the third subpattern comprises a first and a second stimulation sequence followed by the expression sequence. The second subpattern comprises a first and a second stimulation sequence usually without an expression sequence.
The last expression sequence of said the third subpattern is followed by the expression sequence of the maintaining subpattern. Preferably, the pattern includes pauses between certain sequences, in particular between the subpatterns. Preferably, no pauses exist within each pattern, i.e. between each sequence of each subpattern.
Preferably, the first subpattern has a longer duration than the second subpattern. Preferably, the first subpattern has a longer duration than the third subpattern. Preferably, the second subpattern has the shortest duration among the first, the second and third subpattern. Preferably, the first stimulation sequence has a cycle rate of 120 +/- 10 cycles per minute. Preferably, the second stimulation sequence has a cycle rate of 90 +/- 10 cycles per minute.
Preferably, the expression sequence and/or the maintaining sequence have a cycle rate of 66 +/- 14 cycles per minute, preferably 66 +/- 12 cycles per minute.
Preferably, the expression sequence and the maintenance sequence have the same cycle rate.
The moderate vacuum level mentioned above preferably is between 70 and 200 mmHg wherein the higher vacuum level mentioned above preferably is between 90 and 250 mmHg.
Usually, a cycle provides a pressure difference between a pull suction defining the highest vacuum level of the cycle and/or the vacuum level and a release suction defining the lowest vacuum level of the cycle and/or the vacuum level.
According to a preferred embodiment of the invention, the release suction of each cycle of each expression sequence is higher than the release suction of each cycle of said maintaining sequence. Moreover, the pressure difference of each cycle of said maintaining sequence is preferably higher than the pressure difference of each cycle of said expression sequence and/or of each cycle of said stimulation sequence.
A first and long embodiment of a specific pattern is provided, which pattern comprises a first, a second and a third subpattern.
For the first embodiment, the total duration of the first, second and third subpattern and the stimulation sequence of the maintaining pattern is not more than 15 minutes, preferably it is 13 minutes +/- 2 minutes, more preferably it is 14 minutes +/- 1 minutes and most preferably it is 15 minutes. The maintaining subpattern follows the sequence of the first, second and third subpattern. According to this first embodiment of a specific pattern and within the first subpattern the first stimulation sequence has a duration of 180 seconds +/- 20 seconds and/or the second stimulation sequence has a duration of 120 seconds +/- 10 seconds and/or the expression sequence has a duration of 60 seconds +/- 5 seconds. Further, within the second subpattern the first stimulation sequence has a duration of 120 seconds +/- 20 seconds and/or the second stimulation sequence has a duration of 60 seconds +/- 10 seconds. In the third subpattern of this first pattern embodiment, the first stimulation sequence has a duration of 120 seconds +/- 20 seconds and/or the second stimulation sequence has a duration of 60 seconds +/- 10 seconds and/or the expression sequence has a duration of 60 seconds +/- 10 seconds. In the maintaining pattern, the stimulation sequence has a duration of 90 seconds +/- 10 seconds.
Preferably, a second and short embodiment of a specific pattern is provided, which pattern comprises a first, a second and a third subpattern. For the second embodiment, the total duration of the first, second and third subpattern and the maintaining pattern is not more than 10 minutes, preferably 7 minutes +/- 2 minutes more preferably 9 minutes +/- 1 minutes and most preferably 10 minutes. The maintaining subpattern follows the sequence of the first, second and third subpattern. According to this second embodiment of a specific pattern and within the first subpattern, the first stimulation sequence has a duration of 120 seconds +/- 20 seconds and/or the second stimulation sequence has a duration of 80 seconds +/- 10 seconds and/or the expression sequence has a duration of 40 seconds +/- 5 seconds. Further, within the second subpattern the first stimulation sequence has a duration of 80 seconds +/- 20 seconds and/or the second stimulation sequence has a duration of 40 seconds +/- 10 seconds. In the third subpattern of this second pattern embodiment, the first stimulation sequence has a duration of 80 seconds +/- 20 seconds and/or the second stimulation sequence has a duration of 40 seconds +/- 10 seconds and/or the expression sequence has a duration of 40 seconds +/- 10 seconds. In the maintaining pattern, the stimulation sequence has a duration of 55 seconds +/- 10 seconds.
In connection with the description of the invention, the following terms shall be understood as follows:
“Followed” means that no further sequence of cycles exists between following sequences or the following subpattern.
“Subpattern” consists of a specific sequence of generally different “sequences”. “Sequence” is a sequence of multiple, on a regular basis identical cycles.
“Cycle” is a cyclic element of a sequence. Each “cycle” provides a vacuum profile consisting of a pull suction, reducing the pull suction to a release suction and raising the suction pressure to reach pull suction again.
“Pressure difference” is the absolute pressure difference between the pressure of pull suction and the pressure of release suction.
“Vacuum level” can be understood as the average vacuum provided by one cycle. The “vacuum level” is defined by two pressure values, one being the pressure of value pull suction, the other being the pressure value of release suction.
“Pull suction” is the suction pressure, i.e. negative pressure.
“Release suction” is the release pressure and may be positive, negative or ambient pressure.
As for as the present application refers to “high”, “higher”, “highest”, “low”, “lower” or “lowest” absolute pressure values are meant or compared.
“Consist” means that an entity exclusively has the items of which the entity consists. As far as an entity is described to consist of a listing of items, respective listing is to be understood to provide an exhaustive enumeration.
“Sucking pattern” is specified by a specific cycle rate and a vacuum level.
“Cycle rate” provides information on the cycles per time increment; “cpm” means cycles per minute. BRIEF DESCRIPTION OF THE DRAWINGS
These and other advantages of the invention will be further understood upon consideration of the following detailed description of certain embodiments, taken in conjunction with the drawings, in which:
Figure 1 is an illustration of a breastpump assembly for use in accordance with one embodiment of the present invention; figure 2 is a diagram of a process to initiate milk flow from a mother's breast in accordance with a first embodiment of the invention and figure 3 is a diagram of a process to initiate milk flow from a mother's breast in accordance with a second embodiment of the invention.
DETAILED DESCRIPTION
Figure 1 is an illustration of a breastpump assembly in accordance with one embodiment of the present invention. That breastpump is generally described in U.S. Patent No. 6,547,756 or EP 2 878 317 B1 , reference thereto can be made for salient details of this breastpump. While the invention has found particular application for use with this kind of programmable breastpump and with respect to premature babies, it can be used or adapted for use with other motorized pumps capable of being operated with the varying sequences (hereinafter described), and aspects are considered adaptable to full-term babies including breastpumps wearable inside a bra, as disclosed in WO2022/268998.
As shown in Figure 1, the breastpump assembly 100 includes a breastpump 110, a plurality of the breastshield and container assemblies 120, and a user input interface 130; the user input interface is shown in the attached figures as a program card 130, but in different examples it can be of any other type. Power may be provided to the breastpump apparatus 110 either through standard current via a power cord, a battery, or some other appropriate power supply.
The breastpump 110 may be either a double or a single pump. The single pump extracts milk from one breast at a time, and the double pump can be used to extract milk from both breasts at the same time. The breastpump 110 is attached to each of the plurality of breastshield and container assemblies 120 with a tube 140. Each of the plurality of breastshield and container assemblies 120 comprises a breastshield 122 and a container 124. The container 124 is used to store the pumped milk.
One significant aspect of the present invention is the ability to operate, as by program, the breastpump 110 with different types of suction sequences in a selected order. The breastpump 110 utilizes a controller 126 for controlling an aggregate 128. The controller 126 or microprocessor-based system is provided with user input through the program card 130. The breastpump 110 has a program card insert slot through which a user inserts the program card 130. Once inserted, the program card 130 is read. The particular program on the program card 130 is then communicated to the controller 126. The controller 126 is provided within a housing of the breastpump 110 to control the aggregate 128 for providing the suction sequences of the suction pattern described hereinafter.
One embodiment contemplated, for instance, provides a sequence that can be engaged without need of a separate program card for the same. In this embodiment, the sequence is preprogrammed in the controller 126, or may otherwise be wired into the circuitry of the controller 126 or transmitted to the controller 126 in any suitable way with or without wire in a manner to override the then-existing operating program.
To extract breastmilk from a mother, breastshields 122 are placed and centered over a mother's nipples. The breastpump apparatus 110 may be turned on by a user pressing a first button 112, and in this embodiment, the program card 130 is used with the apparatus. The apparatus reads the program contained on the program card 130. The breastpump 110 may display instructions to the user via the interface 150. The instructions may ask the user to start the program. If the mother wants to start the program, the mother may press a second button 114. The interface 150 may then show instructions and/or graphics that let the mother know that the program is starting.
The program card 130 may operate a preset pattern comprised of non-repeating suction sequences. Alternatively, the program card 130 may operate a preset pattern comprised of repeating suction sequences that appear to be non-repeating to the user, due to the overall length of the pumping session such that the sequences seem to be occurring at unpredictable times in the pattern with extended pauses between some of the sequences. An extended pause is a pause that is approximately greater than about five seconds in duration. Some of the pauses may be of shorter duration, however, but still of a length that yields a noticeable hiatus to the mother.
The sequences comprise at least one stimulation sequence and one expression sequence, and may additionally comprise further stimulation sequences and/or expression sequences.
Figures 2 and 3 depict examples of the method. The steps in Figures 2 and 3 are designed so that a most-desired pattern of stimulation, expression, and pauses is provided. This particular set of sequences and pauses is considered to more closely resemble the sucking pattern of a newly-born infant during the early days post-birth before the onset of lactogenesis II. The sequences described in Figures 2 and 3 are designed to stimulate the breast and eventually achieve the lactogenesis II stage. It will be understood, however, that while the particular set of sequences and pauses set forth in the presently most-preferred embodiment have achieved significant results and advantages, the set may well be reducible, yet still achieve some or all of the desired purposes. Substantially recreating the suckling pattern of a newborn baby pre-lactogenesis II is most desired, and some other mix of various stimulation cycles and pauses may serve the desired end. Precision in the patterns used, their order, and the number of pauses and duration of the same is not considered critical. It is the fact that the overall combination for the first time in a breastpumping method has the capability of reproducing the sucking pattern of the very early newborn, pre-lactogenesis II.
In Figure 2, at 0 seconds on the time scale (when pumping starts), a first stimulation sequence SI is set into motion for approximately three minutes. This first stimulation sequence SI has a moderate vacuum level at a higher cycle rate of about 120 cycles per minute (cpm). The moderate vacuum level has a range of about 70-200 millimeters of mercury (mmHg). The cycles per minute indicate the sucking rhythm, or the number of pulls and releases per minute. This means that the vacuum will alternate cyclically between a pull suction of 200 mmHg and a release suction of 70 mmHg. Thus, the pressure difference of each cycle is 200 mmHg -70 mmHg =130 mmHg.
At 3 minutes, the first stimulation sequence SI is followed by a second stimulation sequence Sil having a slower rate than the first stimulation sequence SI. The rate of the second stimulation sequence SI I is about 90 cpm, which is applied for approximately two minutes. As in the first stimulation sequence I, the pull suction is 200 mmHg and a release suction is 70 mmHg.
At 5 minutes, the controller of the pump starts an expression sequence E, which follows the second stimulation sequence SI I. This expression sequence E is applied for approximately one minute. The expression sequence E has a relatively higher vacuum level and provides a slower cycle rate. In the expression sequence E the breastpump is operated between about 34 and 54 cpm with a vacuum level in the range of about 90-250 mmHg. Typically this expression sequence does not result in milk or colostrum being expressed by the breast, but is used for stimulating the breast.
The sequence of the first stimulation sequence SI followed by the second stimulation sequence SI I followed by the expression sequence E defines a first subpattern SPI.
The breastpump is then paused for ten seconds. During the pause step, a zero or near zero negative pressure (ambient) within the breastpump remains relatively constant. After this first pause PI, the breastpump is operated at the cycle rate and the vacuum level of the second stimulation sequence SI I mentioned above for approximately one minute. This second stimulation sequence SI I is followed by a first stimulation sequence SI mentioned above for approximately two minutes.
The sequence of the second stimulation sequence SI I followed by the first stimulation sequence SI defines a second subpattern SPII.
Than the breastpump is paused for ten seconds, indicated in figure 2 as a second pause PH.
After this second pause PH, the breastpump is operated to provide the first subpattern SPI. However, in this subpattern the first stimulation sequence SI is applied for approximately two minutes, the second stimulation sequence Sil is applied for approximately one minute and the expression sequence E is applied for approximately one minute. While this third subpattern SPHI has the same consecutive sequences as the first subpattern SPI, for a clear discrimination, it is identified in the drawings as a third subpattern SPHI. Also the expression sequence E of the third subpattern SPHI generally does not result in milk or colostrum expression.
Then, the breastpump is paused for ten seconds, indicated in figure 2 as third pause PHI.
After this third pause PHI the breastpump is operated to provide the second stimulation sequence SI I mentioned above, which is applied for approximately 80 seconds.
Then, the breastpump is paused for ten seconds, indicated in figure 2 as fourth pause PIV.
After this fourth pause PIV, the breastpump is operated to provide a maintaining sequence M, which is applied for 5 minutes. The maintaining sequence M has a relatively higher vacuum level operated at a slower cycle rate. In the maintaining sequence M the breastpump operated between about 54 and 78 cpm with a vacuum level in the range of about 50-250 mmHg. During the maintaining sequence M, thanks to its features and duration, colostrum and/or milk expression from the breast occurs.
The sequence of the second stimulation sequence SI I followed by the fourth pause PIV followed by the maintaining sequence M is a first example of a maintaining subpattern SPM. At the end of the maintaining sequence M, the pumping session for expressing milk from the breast of a mother may be stopped or may be restarted as described above, after a pause of e.g. at least 10 seconds.
The total duration of the first, the second, the third subpattern and the second stimulation sequence SI I of the maintaining subpattern SPM of this first embodiment of figure 2 is 15 minutes.
Figure 3 shows a further embodiment of a pattern, which pattern is shorter than the pattern of the first embodiment of figure 2. However, the sequence of all sequences and pauses is the same as in the first embodiment. Moreover, the vacuum level and the cycle rate of the first and the second stimulation sequence SI, Sil as well as the expression sequence E and the maintaining sequence M is the same as in the first embodiment.
In the first subpattern SPI of the second embodiment, the first stimulation sequence SI is applied for 120 seconds, the second stimulation sequence Sil has a duration of 80 seconds and the duration of the expression sequence E is 40 seconds. In the second subpattern SPII of the second embodiment, the second stimulation sequence Sil has a duration of 40 seconds and the first stimulation sequence SI is applied for 80 seconds.
In the third subpattern SPI 11 of the second embodiment, the first stimulation sequence SI is applied for 80 seconds, the second stimulation sequence SI I has a duration of 40 seconds and the duration of the expression sequence E is 40 seconds.
The first pause PI between the first subpattern SPI and the second subpattern SPII and the pause PH between the second subpattern SPII and the third subpattern SPIN each have a duration of 8 seconds.
The second stimulation sequence SI I of the maintaining subpattern SPM is 55 seconds. The fourth pause PIV between the second stimulation sequence Sil and the maintaining sequence M has a duration of 5 seconds. The duration of the maintaining sequence M is 5 minutes. The total duration of the first, the second, the third subpattern and the maintaining subpattern SPM of this second embodiment of figure 3 is 10 minutes.
At the end of the maintaining sequence M, the pumping session for expressing milk from the breast of a mother may be stopped or may be restarted as described above, after a pause of at least 10 seconds.
Reference List
100 breastpump assembly
110 breastpump
112 first button
114 second button
120 container assembly
122 breastshield
124 container
126 controller
128 aggregate
130 program card
140 tube
150 interface
E expression sequence
M maintaining sequence
PI first pause
PH second pause
Pill third pause
PIV fourth pause
SI first stimulation sequence
Sil second stimulation sequence
SPI first subpattern
SPII second subpattern
SPIII third subpattern
SPM maintaining subpattern

Claims

Claims
1. A method for operating a breastpump (110) within a breastpumping session in a pattern of sequences, which pattern comprises at least one stimulation sequence (SI, SI I) for stimulating the breast having a rapid cycle rate and providing a moderate vacuum level and at least one expression sequence (E) having a lower cycle rate and providing a higher vacuum level, wherein the lower cycle rate is lower than the rapid cycle rate and wherein the higher vacuum level is higher than the moderate vacuum level, characterized by a maintaining sequence (M) at a lower cycle rate and providing a higher vacuum level subsequent to a stimulation sequence (Sil), wherein said maintaining sequence (M) follows said stimulation sequence (SI I), wherein said maintaining sequence (M) and said stimulation sequence (Sil) define a maintaining subpattern (SM) of said a pattern, and wherein said maintaining sequence (M) has a duration of at least 3 minutes, preferably of at least 4 minutes, most preferably of at least 5 minutes.
2. The method as defined in claim 1 , characterized in that the pattern comprises a first and a second stimulation sequence (SI; SI I) followed by the expression sequence (E), wherein the first stimulation sequence (SI) and the second stimulation sequence (Sil) have a different vacuum level and/or a cycle rate.
3. The method as defined in claim 2, characterized in that the first stimulation sequence (SI) has a higher cycle rate than the second stimulation sequence (Sil).
4. The method as defined in claim 2 or 3, characterized in that the pattern comprises a first subpattern (SPI) and a second subpattern (SPII) following the first subpattern (SPI), wherein the first subpattern (SPI) comprises a first and a second stimulation sequence (SI; SI I) followed by the expression sequence (E) of said first subpattern (SPI), wherein the second subpattern (SPII) comprises a first and a second stimulation sequence (SI; Sil), wherein a subpattern (SPI II) comprising an expression sequence (E) is followed by the stimulation sequence (Sil) of the said maintaining subpattern (SPI) and wherein the pattern includes pauses between certain sequences.
5. The method as defined in claim 4, characterized in that in the first subpattern (SPII) the second stimulation (Sil) follows the first stimulation sequence (SI) and that in the second subpattern (SPII) the first stimulation sequence (SI) follows the second stimulation sequence (SI I).
6. The method as defined in claim 4 or 5, characterized by a third subpattern (SPII I) following the second subpattern (SPII), wherein said third subpattern (SPIN) is identical with the first subpattern (SI I).
7. The method as defined in any of the claims 4 to 6, characterized by pauses between the first and the second subpattern (SPI; SPII) and/or between the second and the third subpattern (SPII; SPI II).
8. The method as defined in any of the claims 4 to 7, characterized in that the first subpattern (SPI) has a longer duration than the second subpattern (SPII) and/or that the first subpattern (SPI) has a longer duration than the third subpattern (SPI 11).
9. The method as defined in any of the claims 4 to 8, characterized in that the first stimulation sequence (SI) has a cycle rate of 120 +/- 10 cycles per minute and that the second stimulation sequence (SI I) has a cycle rate of 90 +/- 10 cycles per minute.
10. The method as defined in any of the claims 4 to 9, characterized in that the expression sequence (E) and/or the maintaining sequence (M) has a cycle rate of 66 +/- 14 cycles per minute, preferably 66 +/- 12 cycles per minute.
11. The method as defined in any of the preceding claims, characterized in that each cycle of the maintaining sequence (M) has the rate corresponding to the lower cycle rate.
12. The method as defined in any of the preceding claims, characterized in that the maintaining sequence (M) consists of between 66 +/- 14 cycles per minute, preferably 66 +/- 12 cycles per minute.
13. The method as defined in any of the preceding claims, characterized in that the moderate vacuum level is between 70 and 200 mmHg and that the higher vacuum level is between 90 and 250 mmHg.
14. The method as defined in any of the preceding claims, characterized in that each cycle provides a pressure difference between a pull suction defining the highest vacuum level of the cycle and a release suction defining the lowest vacuum level of the cycle, wherein the release suction of each cycle of each expression sequence (E) is higher than the release suction of each cycle of said maintaining sequence (M) and/or wherein the pressure difference of each cycle of said maintaining sequence (M) is higher than the pressure difference of each cycle of said expression sequence and/or of each cycle of said stimulation sequence (S).
15. The method as defined in any of the preceding claims, characterized in that
- for the first subpattern (SPI): the first stimulation sequence (SI) has a duration of 180 seconds +/- 20 seconds and/or that the second stimulation (SI I) sequence has a duration of 120 seconds +/- 10 seconds and/or that the expression sequence (E) has a duration of 60 seconds +/- 5 seconds and/or
- for the second subpattern (SPI I): the first stimulation sequence (SI) has a duration of 120 seconds +/- 20 seconds and/or that the second stimulation sequence (SI I) has a duration of 60 seconds +/- 10 seconds and/or
- for the third subpattern (SPIN): the first stimulation sequence (SI) has a duration of 120 seconds +/- 20 seconds and/or that the second stimulation sequence (SI I) has a duration of 60 seconds +/- 10 seconds and/or that the expression sequence (E) has a duration of 60 seconds +/- 10 seconds and/or
- for the maintaining pattern (SPM): the stimulation sequence (Sil) has a duration of 90 seconds +/- 10 seconds.
16. The method as defined in claim 15, characterized in that the first, the second, the third subpattern (SI; Sil ; SHI) and the stimulation sequence (Sil) the maintaining subpattern (SPM) have a total duration of not more than 15 minutes, preferably 13 minutes +/- 2 minutes, more preferably 14 minutes +/- 1 minutes, and most preferably 15 minutes.
17. The method as defined in any of the preceding claims 1 to 12, characterized in that - for the first subpattern (SPI): the first stimulation sequence (SI) has a duration of 120 seconds +/- 20 seconds and/or that the second stimulation sequence (SI I) has a duration of 80 seconds +/- 10 seconds and/or that the expression sequence (E) has a duration of 40 seconds +/- 5 seconds and/or
- for the second subpattern (SPI I): the first stimulation sequence (SI) has a duration of 80 seconds +/- 20 seconds and/or that the second stimulation sequence (SI I) has a duration of 40 seconds +/- 10 seconds and/or
- for the third subpattern (SPIN): the first stimulation sequence (SI) has a duration of 80 seconds +/- 20 seconds and/or that the second stimulation sequence (SI I) has a duration of 40 seconds +/- 10 seconds and/or that the expression sequence (E) has a duration of 40 seconds +/- 10 seconds and/or
- for the maintaining pattern (SPM): the stimulation sequence (Sil) has a duration of 55 seconds +/- 10 seconds.
18. The method as defined in claim 17, characterized in that the first, the second, the third subpattern (SPI, SPI I; SPIN) and the maintaining subpattern (SPM) have a total duration of not more than 10 minutes, preferably 7 minutes +/- 2 minutes, more preferably 9 minutes +/- 1 minutes, and most preferably 10 minutes
19. The method as defined in any of the preceding claims, characterized by a pause (PI) provided between the first and the second subpattern (SPI, SPI I) and/or a pause (PI I) provided between the second and the third subpattern (SPI I, SPI 11) and/or a pause (Pill) provided between the third subpattern (SPIN) and the maintaining subpattern (SM).
20. The breastpump system of claim 19, wherein at least some of the pauses (PI; PH; Pill) of said periods of pauses are greater than 5 seconds.
21. A breastpump (110) comprising an aggregate (128) and a controller (126) for controlling said aggregate (128), which controller (126) is adapted to operate the breastpump (110) by controlling said aggregate (128) to provide a pattern as specified in any of the claims 1 to 20.
PCT/EP2024/057968 2024-03-25 2024-03-25 Method for operating a breastpump Pending WO2025201622A1 (en)

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PCT/EP2024/057968 WO2025201622A1 (en) 2024-03-25 2024-03-25 Method for operating a breastpump

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Application Number Priority Date Filing Date Title
PCT/EP2024/057968 WO2025201622A1 (en) 2024-03-25 2024-03-25 Method for operating a breastpump

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000057934A1 (en) 1999-03-30 2000-10-05 White River Concepts Mammary gland pump system with natural suckling cycle
US6547756B1 (en) 1999-12-10 2003-04-15 Medela Holding Ag Programmable breastpump
US20110004154A1 (en) * 2007-12-21 2011-01-06 Koninklijke Philips Electronics N.V. Breast pump for expressing milk from a breast
EP2878317B1 (en) 2009-02-20 2019-03-27 Medela Holding AG Method for operating a breastpump and a breastpump
WO2022268998A1 (en) 2021-06-24 2022-12-29 Medela Holding Ag Breast pump
US20230083998A1 (en) * 2020-02-14 2023-03-16 Medela Holding Ag A Method for Regulating the Operation of a Milk Pump

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000057934A1 (en) 1999-03-30 2000-10-05 White River Concepts Mammary gland pump system with natural suckling cycle
US6547756B1 (en) 1999-12-10 2003-04-15 Medela Holding Ag Programmable breastpump
US20110004154A1 (en) * 2007-12-21 2011-01-06 Koninklijke Philips Electronics N.V. Breast pump for expressing milk from a breast
EP2878317B1 (en) 2009-02-20 2019-03-27 Medela Holding AG Method for operating a breastpump and a breastpump
US20230083998A1 (en) * 2020-02-14 2023-03-16 Medela Holding Ag A Method for Regulating the Operation of a Milk Pump
WO2022268998A1 (en) 2021-06-24 2022-12-29 Medela Holding Ag Breast pump

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