BREAST PUMP INSERT

Abstract

A breast pump funnel integral or engageable with a breast pump providing intermittent pumping for drawing breast milk into a connected container, the breast pump funnel having: an outer frame and an inner malleable liner located at least partially within the outer frame and, in use, forming a contact surface to the breast. The outer frame, the inner malleable liner or both form a continuous restricting funnel for receiving an intermittent negative pressure pumping.

Claims

1-37. (canceled)

38. A breast pump funnel integral or engageable with a breast pump providing intermittent pumping for drawing breast milk into a connected container, the breast pump funnel comprising: a) an outer frame; b) an inner malleable liner located at least partially within the outer frame and configured to form a contact surface to the breast, wherein the inner malleable liner has a shaped back engaging the outer frame at a pivot and on each cycle of the intermittent negative pressure pumping the inner malleable liner rocks on the pivot; and wherein the outer frame, the inner malleable liner or both form a continuous restricting funnel for receiving an intermittent negative pressure pumping.

39. The breast pump funnel according to claim 38, wherein the shaped back comprises: a plurality of concentric resilient compressible rings contacting with the outer frame; at least one transition structure located between a first and second funnel contact ring, wherein the second funnel contact ring acts as a pivot on a contact surface portion of the outer frame by the first transition structure; and wherein under negative pressure the second funnel contact ring pivots allowing resilient deformable movement of the first funnel contact ring substantially in unison with the breast and nipple at the throat to minimize contact between the nipple and the tube portion of the breast cap.

40. A breast pump insert adapted to fit onto a fixed shaped funnel portion of a breast cap used in a vacuum generating breast pump, the breast pump insert comprising: an inner malleable liner having: a breast receiving side including a mouth having an open end shaped to receive and contact the areola of a woman's breast and a throat of reduced size to receive a woman's nipple; and a shaped back opposite the breast receiving side configured for mounting the funnel portion of the cap, the shaped back and breast receiving side separated by an edge, wherein the shaped back has a plurality of concentric resilient compressible funnel contact rings formed by the edge adapted to mount the funnel portion of the breast cap in a sealing condition, wherein a first funnel contact ring is located about the throat and is adapted to contact an inner surface portion of the funnel portion of the breast cap adjacent to and above a tube portion of the breast cap; at least one transition structure in the edge located between the first funnel contact ring and a second funnel contact ring upstream from the throat; wherein the second funnel contact ring acts as a pivot on a surface contact portion of the funnel portion by the first transition structure; and wherein, under negative pressure, the second funnel contact ring pivots on the surface contact portion of the funnel portion allowing resilient deformable movement of the first funnel contact ring substantially in unison with the breast and nipple at the throat to minimize contact between the nipple and the tube portion of the breast cap.

41. The breast pump insert according to claim 40, wherein the first resilient funnel contact ring is an inner compression ring and the second resilient funnel contact ring is an outer compression ring, and wherein the at least one transition structure therebetween comprises at least a first and second curved transitions to provide structural continuity between the outer compression ring and the inner compression ring.

42. The breast pump insert according to claim 40, wherein the first curved transition of the at least one transition structure is formed by an outer edge of the inner compression ring which is turned back in on itself, wherein the first curved transition is effective to create sufficient resilience to the insert to substantially maintain a circular or rounded throat when subjected to negative pressure.

43. The breast pump insert according to claim 40, wherein the breast insert comprises a third circumferential funnel contact ring forming a lip for connecting the mouth to an external surface portion of the breast pump funnel portion, wherein the lip folds back on itself to form a funnel edge recess adapted to receive an edge portion of the funnel therein, and wherein the third circumferential funnel contact ring is adapted to contact an external surface portion of the funnel to form a pressure tight seal therewith.

44. The breast pump insert according to claim 40, wherein the first, second, and third concentric funnel contact rings include a funnel contact surface portion in substantial alignment with each other for contacting the inner and outer surfaces of the funnel of the breast cap in a sealable condition for effective suction.

45. The breast pump insert according to claim 40, further including a second transition structure in the edge between the outer compression ring and the third circumferential funnel contact ring, wherein the second transition structure includes a curved transition adjacent the outer compression ring which provides structural continuity between the funnel edge recess and the outer compression ring.

46. The breast pump insert according to claim 40, wherein the extent of deformation of the inner compression ring is limited such that the diameter of the throat is constricted sufficiently to maintain a light compressive pressure on the nipple and in turn to maintain a seal with the breast pump insert, the nipple and breast, and the breast pump funnel.

47. The breast pump insert according to claim 40, wherein the mouth comprises a cushion surface effective for contact with human skin.

48. A breast pump insert adapted to fit onto a funnel portion of a breast cap used in a vacuum generating breast pump, the breast pump insert comprising: a breast receiving side including a mouth having an open end shaped to receive and contact the areola of a woman's breast and a throat of reduced size to receive a woman's nipple; a funnel mounting side opposite the breast receiving side separated by an edge, the funnel mounting side having a plurality of concentric resilient compressible funnel contact rings formed by the edge adapted to mount the funnel portion of the breast cap in a sealing condition, wherein a first funnel contact ring is located about the throat and is adapted to contact an inner surface portion of the funnel portion of the breast cap adjacent to and above a tube portion of the breast cap; at least one transition structure in the edge located between the first funnel contact ring and a second funnel contact ring upstream from the throat; wherein the second funnel contact ring acts as a pivot on an inner surface portion of the funnel portion by the first transition structure, and wherein under negative pressure the second funnel contact ring pivots allowing resilient deformable movement of the first funnel contact ring substantially in unison with the breast and nipple at the throat to minimize contact between the nipple and the tube portion of the breast cap.

49. The breast pump insert according to claim 48, wherein the first resilient funnel contact ring is an inner compression ring and the second resilient funnel contact ring is an outer compression ring, wherein the at least one transition structure therebetween comprises at least a first and second curved transitions to provide structural continuity between the outer compression ring and the inner compression ring.

50. The breast pump insert according to claim 48, wherein the breast insert comprises a third circumferential funnel contact ring forming a lip for connecting the mouth to an external surface portion of the breast pump funnel portion, wherein the lip folds back on itself to form a funnel edge recess adapted to receive an edge portion of the funnel therein, and wherein the third circumferential funnel contact ring is adapted to contact an external surface portion of the funnel to form a pressure tight seal therewith.

51. The breast pump insert according to claim 48, wherein the first, second and third concentric funnel contact rings include a funnel contact surface portion in substantial alignment with each other for contacting the inner and outer surfaces of the funnel of the breast cap in a sealable condition for effective suction.

52. The breast pump insert according to claim 48, further including a second transition structure in the edge between the outer compression ring and the third circumferential funnel contact ring, wherein the second transition structure includes a curved transition adjacent the outer compression ring which provides structural continuity between the funnel edge recess and the outer compression ring.

53. The breast pump insert according to claim 48, wherein the extent of deformation of the inner compression ring is limited such that the diameter of the throat is constricted sufficiently to maintain a light compressive pressure on the nipple and in turn to maintain a seal with the breast pump cap, the nipple and breast.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0069] Notwithstanding any other forms which may fall within the scope of the present invention, preferred embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0070] FIG. 1 is a cross-section schematic representation of a breast pump funnel integral or engageable with a breast pump in accordance with a preferred embodiment of the present invention;

[0071] FIG. 2 is a cross-sectional perspective schematic representation of the breast pump funnel integral or engageable with a breast pump of FIG. 1;

[0072] FIG. 3 is a cross-section schematic representation of a breast insert in accordance with a preferred embodiment of the present invention positioned in a rigid funnel of a breast cap;

[0073] FIG. 4 is a cross-sectional perspective schematic representation of the breast insert of FIG. 3 positioned in a rigid funnel of a breast cap;

[0074] FIG. 5 is a close up schematic representation of a part of the breast insert shown in FIG. 4;

[0075] FIG. 6 is a cross-section schematic representation of a breast insert in accordance with an alternate embodiment of the present invention;

[0076] FIG. 7 is a schematic representation of the breast insert of FIG. 6 in a side elevation;

[0077] FIG. 8 is a schematic representation of the breast insert of FIGS. 6 and 7 in overhead plan view;

[0078] FIG. 9 is a cross-section schematic representation of a breast insert in accordance with a further alternate embodiment of the present invention with breast cap in dotted outline;

[0079] FIG. 10 is a schematic representation of the breast insert of FIG. 9 in a side elevation;

[0080] FIG. 11 is a schematic representation of the breast insert of FIGS. 9 and 10 in overhead plan view;

[0081] FIG. 12 is a cross-section schematic representation of a breast insert in accordance with a further alternate embodiment of the present invention with breast cap in dotted outline;

[0082] FIG. 13 is a schematic representation of the breast insert of FIG. 12 in a side elevation;

[0083] FIG. 14 is a schematic representation of the breast insert of FIGS. 12 and 13 in overhead plan view;

[0084] FIG. 15 is a cross-section schematic representation of a breast insert in accordance with a further embodiment of the present invention;

[0085] FIG. 16 is a schematic representation of the breast insert of FIG. 15 in a side elevation;

[0086] FIG. 17 is a schematic representation of the breast insert of FIGS. 15 and 16 in overhead plan view;

[0087] FIG. 18 is a cross-section schematic representation of a breast insert in accordance with a further embodiment of the present invention;

[0088] FIG. 19 is a schematic representation of the breast insert of FIG. 18 in a side elevation;

[0089] FIG. 20 is a schematic representation of the breast insert of FIGS. 18 and 19 in overhead plan view;

[0090] FIG. 21 is a cross-section schematic representation of a breast insert in accordance with a further embodiment of the present invention;

[0091] FIG. 22 is a schematic representation of the breast insert of FIG. 21 in a side elevation;

[0092] FIG. 23 is a schematic representation of the breast insert of FIGS. 21 and 22 in overhead plan view;

[0093] FIG. 24 is a cross-section schematic representation of a breast insert in accordance with a further preferred embodiment of the present invention positioned in a rigid funnel in a static condition;

[0094] FIG. 25 is a cross-section schematic representation of the breast insert in FIG. 24 positioned in a rigid funnel of a breast cap, showing static position in dotted outline, under application of negative pressure;

[0095] FIG. 26 is a cross-section schematic representation of a breast insert in accordance with a further embodiment of the present invention;

[0096] FIG. 27 is a cross-section schematic representation of the breast insert of FIG. 26 in a rigid funnel in a static condition;

[0097] FIG. 28 is a cross-section schematic representation of the breast insert in FIG. 27 positioned in a rigid funnel of a breast cap, showing static position in dotted outline, under application of negative pressure;

[0098] FIG. 29 shows results of study participants characteristics—number of children, pump type and use;

[0099] FIG. 30 shows results of study participants characteristics—Comfort rating of pumping with a breast pump insert of the present invention attached (out of 10);

[0100] FIG. 31 shows results of study participants characteristics—Change in median scores of nipple swelling, nipple redness/colour change, broken skin/chaffing and comfort;

[0101] FIG. 32 shows results of study participants characteristics—Change in ‘feel’ of the cushion, starting from 5/10 setpoint;

[0102] FIG. 33 shows results of study participants characteristics—Milk Collected

DESCRIPTION OF PREFERRED EMBODIMENTS

[0103] It should be noted in the following description that like or the same reference numerals in different embodiments denote the same or similar features.

[0104] Referring to FIG. 1 there is shown a breast pump funnel 100 integral or engageable with a breast pump (not shown) providing intermittent pumping for drawing breast milk into a connected container, the breast pump funnel having an outer frame 101, an inner malleable liner 102 located at least partially within the outer frame and in use forming a contact surface to the breast; wherein the outer frame 101, the inner malleable liner 102 or both form a continuous restricting funnel for receiving an intermittent negative pressure pumping by the breast pump. The inner malleable liner of the breast pump is adapted to change shape on each cycle of the intermittent negative pressure pumping wherein a suckling effect occurs

[0105] As shown, the inner malleable liner 102 has a shaped back 103 engaging the outer frame 101 at a pivot 104. On each cycle of the intermittent negative pressure pumping by the breast pump, the inner malleable liner rocks on the pivot 104. This is shown in FIG. 2 where continuous lines 105 show deformation under negative pressure from a normal position (shown in dashed lines 106). In an operating condition, under negative pressure, the shaped back of the inner malleable liner 102 pivots allowing resilient deformable movement of the breast pump funnel substantially in unison with the breast and nipple. This improves comfort and provides a close physical approximation to a suckling baby.

[0106] Referring to FIGS. 3 to 20, there is shown a breast pump insert 100 adapted to fit into an outer frame such as a funnel portion 13 of a breast cap 25 used in a vacuum generating breast pump (not shown) to approximate the suckling reflex of a baby and to allow improved cushioning to alleviate pain otherwise commonly associated with using a breast pump.

[0107] The breast pump insert 100 comprises an inner malleable liner having a shaped back including a plurality of concentric resilient compressible rings contacting with the funnel portion 13 of the outer frame 25. When a negative pressure is applied, at least the inner malleable liner compresses and deforms creating a suckling effect on each cycle of the intermittent negative pressure pumping.

[0108] The breast pump insert includes breast receiving side 24 including a mouth 26 having an open end shaped to receive and contact the areola of a woman's breast and a throat 27 sized to receive the woman's nipple; and a funnel mounting side 28 opposite the breast receiving side separated by an edge 29. In FIG. 3, the funnel mounting side 28 includes three concentric resilient funnel contact rings 30, 31 and 32 formed by the edge 29. As best shown in FIGS. 3, 4, and 8 to 12, the resilient funnel contact rings 30, 31 and 32 are in substantial alignment to mount opposite sides of the funnel portion 13 in a sealing engagement. Sealing engagement is shown by ring 32 contacting and extending circumferentially about an external surface of the funnel 13 and both resilient funnel contact rings 30 and 31 contacting and extending circumferentially about an internal surface of the funnel 13 in spaced apart relation.

[0109] As shown in the figures, the resilient funnel contact ring 30 is an inner compression ring formed about the throat 27 and is adapted to contact an inside surface portion of the funnel portion 13 of the breast cap or outer frame 25 adjacent to and above the tube portion 14 of the breast cap. The resilient funnel contact ring 31 is an outer compression ring adapted to contact an inside surface portion of the funnel portion 13 spaced from the inner compression ring. In one embodiment the inner malleable liner is fabricated from a soft silicone.

[0110] The figures each show at least one transition structure 33 in the edge 29 located between the inner compression ring 30 and the outer compression ring 31. The configuration of the first transition structure 33 includes an inner curved transition surface 39 adjacent the inner compression ring 30 and an outer curved transition surface 40 close to the outer compression ring 31.

[0111] The at least one transition structure 33 is configured by the inner and outer curved transition surfaces 39 and 40 such that the outer compression ring 31 acts as a pivot point on the funnel surface.

[0112] FIGS. 5, 6, 11 17, 20, 23, and 24 show a second structural transition recess 34 between the outer compression ring 31 and the resilient funnel contact ring 32. In this embodiment the second structural transition recess includes an inner curved transition surface 41 which structurally supports the pivot action of the outer compression ring 31 on the surface of the funnel which it is in contact with.

[0113] As shown in close up view in FIG. 5, the resilient funnel contact ring 32 turns back on itself forming a funnel edge recess 7. The recess has a defined depth ‘x’ and width ‘w’ configured to receive a funnel lip 15 of the rigid funnel portion 13 therein. The resilient funnel contact ring 32 is further configured to align with the inner and outer compression rings 30 and 31 so that ring 32 makes contact with an outside surface of the funnel portion 13 while the inner and outer compression rings contact an inside surface portion of the funnel providing an air tight seal.

[0114] The breast insert can be made of soft materials such as silicones which possess physical characteristics including compressibility and malleability without causing any harmful allergic reactions by contact.

[0115] FIGS. 24 and 25 and FIGS. 27 and 28 show the effect of the insert 100 under applied vacuum, where the diameter of the throat 27 progressively decreases with deformation of the inner compression ring 30. FIG. 24 shows the breast pump insert positioned in sealing engagement on the funnel prior to application of a vacuum where points A and C represent normal positions of the inner and outer compression rings 30 and 31 respectively and where the throat 27 has a resting diameter ‘X’.

[0116] In an operating condition (see FIG. 25) under a negative pressure (vacuum), the outer compression ring 31 pivots at the contact surface with the funnel 13 (shown by “B”) and the inner compression ring deforms to an extent shown by ‘D’ beyond its resting contact point with the funnel progressively decreasing the diameter at the throat represented by ‘Y’. As the vacuum is applied, the inner compression ring is displaced resulting in progressively decreasing the diameter of the throat where the nipple is located. This change at the inner compression ring allows compliant deformation of the inner compression ring at or close to the throat 27 sufficient to compliment movement of the breast under a vacuum so as to minimize abrasion of the nipple with the tube portion 13 of the breast cap 25, which would otherwise cause rubbing of the nipple on the tube portion, and the deformation of the inner ring approximates a suckling reflex of an infant which promotes milk production.

[0117] The ability of the second funnel contact ring acting as a pivot on a surface portion of the funnel portion as provided by the first transition structure, allows for the resilient movement of the inner ring and contraction of the throat relative thereto to compliantly deform under negative pressure substantially in unison with the breast and nipple while distributing pressure to evenly support the mouth portion of the breast pump insert.

Example 1— Comfort Analysis

[0118] Method

[0119] 28 participants were used taken from a local community mothers' group targeting a population of lactating women using a range of conventional breast pumps. The participants were divided into two groups based on their response to the question “How comfortable is your current pump?”. Cohort A: scores of 5 or more out of 10 (i.e. relatively comfortable), n=15. Cohort B: scores of less than 5 out of 10 (i.e. uncomfortable), n=13.

[0120] Each participant completed a pre-pump survey (n=28), tried the breast pump insert according to an embodiment of the present invention on their pump and then completed a post-pump survey (n=26, 2 did not complete). Most participants also completed a follow-up interview.

[0121] The surveys were structured to gather information in five areas: [0122] 1. Background information on breast pump use of participant [0123] 2. Comfort [0124] 3. Nipple redness, swelling, chaffing/broken skin [0125] 4. Feel Volumes.

[0126] The surveys included both quantitative and qualitative questions.

Results

[0127] Observations on Breast Pump Use

[0128] FIG. 29 describes the distribution of participants across number of children, pump type, pumping sessions per day and session time per pump.

[0129] Observations on comfort and nipple swelling, redness and chaffing.

[0130] FIG. 30 shows the distribution of comfort ranking (out of 10) with the cushion attached. Note that instant ‘comfort’ rating is inverse to ‘pain’ ratings where represents “very comfortable” and 0 represents “very uncomfortable”. Our swelling, redness and chaffing ratings are more typical, with 10 representing “severe” and 0 representing “none at all”.

[0131] FIG. 31 shows the change in median scores of nipple swelling, nipple redness/colour change, broken skin/chaffing and comfort, from using the pump without the cushion (dark) to using the pump with the cushion (light). The first chart shows all participants, the second and third charts show the results for each cohort: uncomfortable (comfort score starting at less than 5 out of 10) and comfortable (comfort score starting at more than 5 out of 10).

[0132] The following changes were observed: [0133] increased comfort (median score: 5/10 to 9/10 for all cohort) [0134] relief from swelling (median score: 6/10 to 0/10) [0135] relief from redness and colour change (median score: 4/10 to 0/10) [0136] relief from broken skin and chaffing (4/10 to 0/10) for cohort of women self-describing as finding pumping uncomfortable without the cushion.

[0137] Observations on Cushion ‘Feel’

[0138] FIG. 32 shows the change in ‘feel’ of the cushion, starting from a set base of ‘5’ for each variable. Participants recorded: • feeling more ‘like a baby’ (median score: 5/10 to 7/10) • feeling more relaxed (median score: 5/10 to 7/10) • feeling ‘empty’ (median score: unchanged)

[0139] Observations on Milk Volumes Collected

[0140] FIG. 33 shows the change in perception of milk volume collected. Volumes weren't measured or tracked before or after; our objective was to identify if there was a major impediment to milk flow rather than identifying incremental and measurable changes in milk volumes. We may investigate this at a later stage. Participants recorded no change in milk volume collected (median score unchanged). Most participants (73%) collected a bit less, same or more milk; however some participants (12%) were unable to gather milk or have a letdown at all.

[0141] After interviewing these participants, a further breast pump insert according to FIGS. 26 to 28 with less ‘bulk’ was provided that allows for more stimulation at the breast. Preliminary testing, and preliminary results using this embodiment show that 5 out of 6 participants who had struggled with letdown or low volumes were able to collect equivalent or more milk than pumping without the breast pump insert in addition to being more comfortable.

Benefits of the Invention Include

[0142] The inner compression ring prevents the nipple from being sucked into the breast pump tube preventing the nipple from rubbing on the breast pump tube surfaces.

[0143] The constriction of the throat by deformation of the inner compression ring under vacuum approximates a suckling reflex, which encourages a physiological response to promote greater milk production.

[0144] Greater airtight seal formed between the concentric rings, funnel and breasts/nipple to reduce milk loss.

[0145] Interpretation

EMBODIMENTS

[0146] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

[0147] Similarly it should be appreciated that in the above description of example embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description of Specific Embodiments are hereby expressly incorporated into this Detailed Description of Specific Embodiments, with each claim standing on its own as a separate embodiment of this invention.

[0148] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

[0149] Different Instances of Objects

[0150] As used herein, unless otherwise specified the use of the ordinal adjectives “first”, “second”, “third”, etc., to describe a common object, merely indicate that different instances of like objects are being referred to, and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner.

[0151] Specific Details

[0152] In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

Terminology

[0153] In describing the preferred embodiment of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar technical purpose. Terms such as “forward”, “rearward”, “radially”, “peripherally”, “upwardly”, “downwardly”, and the like are used as words of convenience to provide reference points and are not to be construed as limiting terms.

[0154] Comprising and Including

[0155] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” are used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

[0156] Any one of the terms: including or which includes or that includes as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising.

[0157] Scope of Invention

[0158] Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as fall within the scope of the invention. For example, any formulas given above are merely representative of procedures that may be used. Functionality may be added or deleted from the block diagrams and operations may be interchanged among functional blocks. Steps may be added or deleted to methods described within the scope of the present invention.

[0159] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

INDUSTRIAL APPLICABILITY

[0160] It is apparent from the above, that the arrangements described are applicable to a breast insert or cap for a breast pump to improve comfort and milk production efficiency.