1. Field of the Invention
The present invention generally relates to medical devices and methods, and more particularly relates to devices and methods for expression and collection of human breast milk.
The exemplary embodiments disclosed herein are preferably directed at expression of breast milk, but one of skill in the art will appreciate that this is not intended to be limiting and that the devices, systems and methods disclosed herein may be used for other treatments requiring application of a differential pressure.
Breast pumps are commonly used to collect breast milk in order to allow mothers to continue breastfeeding while apart from their children. Currently, there are two primary types of breast pumps: manually-actuated devices, which are small, but inefficient and tiring to use; and electrically-powered devices, which are efficient, but large and bulky. Therefore, it would be desirable to provide improved breast pumps that are small and highly efficient for expression and collection of breast milk. Additional features such as milk production quantification and communication with mobile devices are further desirable for enhanced user convenience. At least some of these objectives will be satisfied by the devices and methods disclosed below.
2. Description of the Background Art
The following US patents are related to expression and collection of human breast milk: U.S. Pat. Nos.: 6,673,036; 6,749,582; 6,840,918; 6,887,210; 7,875,000; 8,118,772; and 8,216,179.
The present invention generally relates to medical devices and methods, and more particularly relates to devices and methods for expression and collection of human breast milk.
In one aspect, a device for expression and collection of breast milk comprises an actuatable assembly and a breast interface configured to engage a breast and fluidly seal thereagainst. The breast interface comprises a movable member disposed within at least a portion thereof. The de ice further comprises a tensile element operatively coupling the actuatable assembly to the movable member, wherein the tensile element is disposed within an axial load absorbing member. Actuation of the actuatable assembly applies a tensile force to the tensile element, wherein the tensile element transmits the tensile force to the movable member to move the movable member away from the breast, thereby applying negative pressure to the breast to express milk therefrom. The axial load absorbing member may be axially stiff to absorb reactive forces of the tensile element during application of the tensile force to the tensile element.
The tensile element may extend continuously between the movable member and the actuatable assembly. The tensile element may comprise a cable, wire, or rope.
The axial load absorbing member may comprise a tube or coil having an axially stiff geometry to absorb the reactive forces of the tensile element.
The device may further comprise a tube extending between the breast interface and the actuatable assembly, wherein the tensile element and the axial load absorbing member may be disposed within the tube. The tensile element may be concentrically disposed within the axial load absorbing member, and the axial load absorbing member may be concentrically disposed within the tube.
The breast interface may further comprise an interface housing having the movable member disposed therein, and the actuatable assembly may further comprise a driving element and an assembly housing having the driving element disposed therein. The tensile element may comprise a first end coupled to the movable member and a second end opposite the first end and coupled to the driving element. The axial load absorbing member may comprise a first end coupled to the interface housing and a second end opposite the first end and coupled to the assembly housing.
The device may further comprise a driving mechanism releasably coupled with the actuatable assembly, and the actuatable assembly may comprise a driving element. Actuation of the driving mechanism may displace the driving element from a rest position to move the movable member away from the breast, or may replace the driving element to the rest position to move the movable member toward the breast.
The movable member may comprise a deformable member configured to fluidly seal against the breast. The movable member may comprise a flexible membrane. The flexible membrane may comprise a corrugated region configured to expand and collapse.
In another aspect, a device for expression and collection of breast milk comprises an actuatable assembly and a breast interface configured to engage a breast and fluidly seal thereagainst. The breast interface comprising a movable member disposed within at least a portion thereof. The device further comprises a tensile element operatively coupling the actuatable assembly to the movable member, the tensile element extending continuously between the movable member and the actuatable assembly. Actuation of the actuatable assembly applies a tensile force to the tensile element, and the tensile element transmits the tensile force to the movable member to move the movable member away from the breast, thereby applying negative pressure to the breast to express milk therefrom.
The tensile element may comprise a cable, wire, or rope.
The device may further comprise an axial load absorbing member, and the tensile element may be disposed within the axial load absorbing member that is axially stiff to absorb reactive forces of the tensile element during application of the tensile force to the tensile element. The axial load absorbing member may comprise a tube or coil having an axially stiff geometry to absorb the reactive forces of the tensile element. The device may further comprise a tube extending between the breast interface and the actuatable assembly, wherein the tensile element and the axial load absorbing member are disposed within the tube. The tensile element may be concentrically disposed within the axial load absorbing member, and the axial load absorbing member may be concentrically disposed within the tube.
The breast interface may further comprise an interface housing having the movable member disposed therein, and the actuatable assembly may further comprise a driving element and an assembly housing having the driving element disposed therein. The tensile element may comprise a first end coupled to the movable member and a second end opposite the first end and coupled to the driving element. The axial load absorbing member may comprise a first end coupled to the interface housing and a second end opposite the first end and coupled to the assembly housing.
The device may further comprise a driving mechanism releasably coupled with the actuatable assembly, wherein the actuatable assembly may comprise a driving element. Actuation of the driving mechanism may displace the driving element from a rest position to move the movable member away from the breast, or replace the driving element to the rest position to move the movable member toward the breast.
The movable member may comprise a deformable member. The movable member may comprise a flexible membrane. The flexible membrane may comprise a corrugated region configured to expand and collapse.
Other objects and features of the present invention will become apparent by a review of the specification, claims, and appended figures.
All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.
The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
Specific embodiments of the disclosed devices and methods will now be described with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to the invention. One of skill in the art will appreciate that various features or steps may be substituted or combined with one another.
The present invention will be described in relation to the expression and collection of breast milk. However, one of skill in the art will appreciate that this is not intended to be limiting, and the devices and methods disclosed herein may be used in other applications involving the creation and transmission of a pressure differential, such as in the treatment of sleep apnea and/or other remote pressure needs.
One of skill in the art will appreciate that components and features of this exemplary embodiment can be combined or substituted with components and features of any of the embodiments of the present invention as described below. Similarly, components and features of other embodiments disclosed herein may be substituted or combined with one another.
Hydraulic Pumping Device
Hydraulic systems can reduce pumping force requirements, and therefore also reduce the size of the pumping device, while maintaining high pumping efficiency. In a preferred embodiment, the pumping device can utilize a hydraulic or pneumatic pumping device to generate a pressure differential against the breast for the expression and collection of milk.
Exemplary hydraulic pumping devices are depicted in
Actuatable assembly 205 displaces fluid 230 contained within tube 225, which can be a flexible line. Fluid 230 occupies reservoir 250 within breast interface 235 and is coupled with flexible membrane 245. Flexible membrane 245 transmits vacuum pressure from fluid 230 to the deformable portion 270 of sealing element 255. When a breast is engaged into and fluidly sealed with breast interface 235 by sealing element 255, displacement of the actuatable element 215 produces substantial vacuum pressure against the breast through flexible membrane 245 and deformable portion 270, resulting in the expression of breast milk into expression area 260. The expressed milk drains through drain port 265 into collection vessel 275. Drain port 265 is configured with a flap valve 280 to provide passage of milk while maintaining vacuum pressure in expression area 260.
The fluid for the hydraulic pumping device can be any suitable fluid, such as an incompressible fluid. In many embodiments, the incompressible fluid can be water or oil. Alternatively, the fluid can be any suitable gas, such as air. Suitable incompressible fluids and gases for hydraulic systems are known to those of skill in the art.
One of skill in the art will appreciate that components and features of any of the exemplary embodiments of the hydraulic pumping device can be combined or substituted with components and features of any of the embodiments of the present invention as described herein.
Actuation Mechanism
Many actuation mechanisms known to those of skill in the art can be utilized for the actuatable assembly 205. Actuatable assembly 205 can be a piston assembly, a pump such as a diaphragm pump, or any other suitable actuation mechanism. The optimal configuration for actuatable assembly 205 can depend on a number of factors, such as: vacuum requirements; size, power, and other needs of the pumping device 200; and the properties of the fluid 230, such as viscosity, biocompatibility, and fluid life requirements.
In preferred embodiments, the actuatable assembly includes a driving element powered by a suitable driving mechanism, such as a driving mechanism residing in pendant unit 115. Many driving mechanisms are known to those of skill in the art. For instance, the driving element, such as driving element 215, may be actuated electromechanically by a motor, or manually by a suitable user-operated interface, such as a lever. Various drive modalities known to those of skill in the art can be used. In particular, implementation of the exemplary hydraulic pumping devices as described herein enables the use of suitable drive modalities such as direct drive and solenoids, owing to the reduced force requirements of hydraulic systems.
Referring now to the exemplary embodiment of
The driving mechanism can be powered by any suitable power source, such as a local battery or an AC adaptor. The driving mechanism can be controlled by hardware, such as onboard electronics located within pendant unit 115.
One of skill in the art will appreciate that components and features of any of the exemplary embodiments of the actuation mechanism can be combined or substituted with components and features of any of the embodiments of the present invention as described herein.
Flexible Membrane
In many embodiments such as the embodiment depicted in
Suitable materials for the flexible membrane are known to those of skill in the art. In many embodiments, the flexible membrane can be made of a material designed to expand and contract when subject to pressures from the coupling fluid such as silicone, polyether block amides such as PEBAX, and polychloroprenes such as neoprene. Alternatively, the flexible membrane can be fabricated from a substantially rigid material, such as stainless steel, nitinol, high durometer polymer, or high durometer elastomer. In these embodiments, the rigid material would be designed with stress and/or strain distribution elements to enable the substantial deformation of the flexible membrane without surpassing the yield point of the material.
Milk Collection and Quantification System
With reference to
In many instances, it can be desirable to track various data related to milk expression and collection, such as the amount of milk production. Currently, the tracking of milk production is commonly accomplished by manual measurements and record-keeping. Exemplary embodiments of the device described herein may provide digital-based means to automatically measure and track milk production for improved convenience, efficiency, and accuracy.
In exemplary embodiments, the pendant unit 500 communicates with a mobile phone 510 to transmit milk expression data, such as expression volume, duration, and date. The mobile phone 510 includes a mobile application to collect and aggregate the expression data and display it in an interactive format. Preferably, the mobile application includes additional features that allow the user to overlay information such as lifestyle choices, diet, and strategies for increasing milk production, in order to facilitate the comparison of such information with milk production statistics. Additionally, the pendant unit 500 can send information about the times of pump usage to the mobile phone 510 so that the mobile application can identify when pumping has occurred and set reminders at desired pumping times. Such reminders can help avoid missed pumping sessions, and thus reduce the incidence of associated complications such as mastitis.
One of skill in the art will appreciate that components and features of any of the exemplary embodiments of the milk collection and quantification system can be combined or substituted with components and features of any of the embodiments of the present invention as described herein.
Mechanical Pumping Device
The tensile element 610 can be any suitable device, such as a wire, coil, or rope, and can be made from any suitable material, such as metals, polymers, or elastomers. Axial load absorbing member 615 can be made from any suitable axially stiff materials, such as metals or polymers, and can be configured into any suitable axially stiff geometry, such as a tube or coil.
One of skill in the art will appreciate that components and features of any of the exemplary embodiments of the mechanical pumping device can be combined or substituted with components and features of any of the embodiments of the present invention as described herein.
Experimental Data
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
The present application is a continuation of U.S. patent application Ser. No. 14/221,113, filed on Mar. 20, 2014 [Attorney Docket No. 44936-703.201], which claims the benefit of U.S. Provisional Patent Application No. 61/804,722, filed on Mar. 24, 2013 [Attorney Docket No. 44936-703.101] and U.S. Provisional Patent Application No. 61/879,055, filed on Sep. 17, 2013 [Attorney Docket No. 44936-703.102], the entire contents of which are incorporated herein by reference.
Number | Date | Country | |
---|---|---|---|
61804722 | Mar 2013 | US | |
61879055 | Sep 2013 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 14221113 | Mar 2014 | US |
Child | 15450576 | US |