This invention relates to an apparatus and a method for varying the internal design of a prior art spout while maintaining the external design of the prior art spout, in order to increase flowrates of fluid passing through the prior art spout and also to reduce fill times in the manufacturing processes. This invention also relates to caps for tube feeding containers that have 2 or more connection portal types for feeding patients through 2 or more tube feeding systems.
Some conventional spouts have a standardized design of a body, particularly when used for small-bore connectors for liquids and/or gases in a healthcare application, and the standardized design often includes the spout having a standardized upper portion, a standardized external thread on the standardized upper portion, and a standardized internal flange interfering with a fluid flow through the spout. Also, some conventional standards prevent or deter from varying the internal dimensions or internal configuration and/or design of the spout, particularly spouts following or made according to International Standard ISO 80369-3, which requires the external or outside design, dimensions and/or shapes of the spout to remain constant. There is an apparent need for a standardized spout that can be modified internally while maintaining constant dimensions and shapes of the spout which are important, including the standardized upper portion and the standardized external thread on the standardized upper portion.
Several conventional systems and methods for attaching or connecting tube feeding systems have different designs for completing a food delivery system or method, for example, an enteral feeding tube to a patient. Conventional caps have been used to close or seal containers for food used in enteral feeding. Many conventional systems and methods include relatively high-cost equipment that cannot be easily reused and consistently interchanged between different feeding components of the feeding systems and methods.
Many different known devices and methods are used as an enteral feeding tube or a tube feeding system to deliver a liquid food to a patient. For example, Ingram et al., U.S. Pat. No. 10,307,335, the entire disclosure of which is incorporated into this specification by reference thereto, describes a container for collecting, transporting, storing, delivering and dispensing fluid. The container has a hollow tube with an outer circumference diameter and is configured to receive a plunger. A collection adaptor and a dispensing adaptor provide interchangeable coupling of a variable volume container, such as a syringe with a collection device and a dispensing device. The container has a circumferential seal assembly secured at one end of the hollow tube. The seal assembly outer diameter is substantially similar to the hollow tube outer diameter.
A number of other tube feeding systems exist in the marketplace, which has complicated the manufacturing process for making caps and for capping the variously sized and shaped tube feeding containers. There is an apparent need for a simplified method of capping a variety of differently sized and shaped tube feeding containers.
According to different embodiments of this invention, a direct connect tube feeding nutrition device or system can include or be a complete system or a turnkey solution, particularly one that does not require non-standard or unique enteral or other nutrition filling equipment tooling.
According to some embodiments of this invention, it is possible to quickly and efficiently change over the nutrition filling equipment machine to produce different tube feeding containers while maintaining any required cleanliness and safety requirements or standards corresponding to the different tube feeding systems.
In some embodiments according to this invention, it is possible to change the internal design of a standardized conventional or prior art spout, such as spouts made according to particular standards and specifications, for example, to increase flowrates of fluids flowing or passing through the spout and to reduce filling times necessary for manufacturing processes, while maintaining any required external design of the prior art spout to maintain or keep the standardized prior art spout so that the spout can be easily and consistently attached and/or adapted to in the field or public, particularly in connection with and when used for small-bore connectors for liquids and/or gases in healthcare applications.
In some embodiments of this invention, there is a complete process or a “turn-key” system that allows customers or users to fill any suitable product, such as a food, into a custom pouch or a container that provides the flexibility of using one outer cap design with two different types of cap connections. In some embodiments of this invention, the filling line provides a reduced set up time through the use of a capping system that will use the same feeder bowl and tracks to deliver either style cap without extra set-up time. In some embodiments of this invention, this is achieved through the design of an ENFit cap to share the same outside geometry as a conventional 9 mm cap already in the marketplace. Some embodiments of this invention provide for a lab filling line as well as a production filling line that uses these shared tracks and feeder bowls for the caps. In some embodiments of this invention, the fitments load on the same rails but require unique feeder bowls.
Different objects of this invention can be accomplished with certain spouts, caps and/or other elements of enteral or tube feeding systems or devices, according to different embodiments of this invention, wherein:
As shown in
As shown in
According to some embodiments of this invention, particularly with rapid commercialization process 20, such as shown in
During a manufacturing process for filling container 24, according to some embodiments of this invention, such as shown in
In some embodiments according to this invention, an improvement relates to increasing the opening of internal void 37 to allow or permit the insertion of a larger filling nozzle into internal void 37. According to some embodiments of this invention, reducing internal flange 40 allows or permits the use of a larger filling nozzle.
In some embodiments of this invention, an internal geometry, such as of internal flange 40 is eliminated or enlarged to allow improved flow through spout 26. In some embodiments where geometry is important or critical, it is beneficial to define a current range versus an improved range. For example, in some embodiments of this invention the standardized design typically has an internal geometry with a body, a common range of internal openings and an area flow path with certain parameters. In other embodiments of this invention the non-standardized or improved design has certain other improved internal geometry with a body, an improved range of internal openings and an area flow path with certain parameters. In some embodiments of this invention, the improved design offers a significant increase in the flow path area, which enhances filling speeds and can be better suited for filling higher viscosity products which pass through spout 26.
In some embodiments of this invention, such as shown in
In some embodiments of this invention, removing flange 40 does not affect fluid flowing in a reverse direction, such as when using container 24 for feeding purposes. Also, when varying the internal dimensions or internal configuration and/or design of spout 26, according to International Standard ISO 80369-3, in some embodiments of this invention, the external or outside design, dimensions and/or shapes of spout 26 can remain constant but the internal design of spout 26 can be changed or modified and still allow spout 26 to conform to International Standard ISO 80369-3.
In some embodiments according to this invention, such as shown in
As shown in
According to some embodiments of this invention, cap 28 as shown in
According to some embodiments of this invention,
In some embodiments of this invention, it is possible to provide a turnkey contract manufacturing operation, which can include services related to product design, prototyping, tooling and assembly line production, acquisition of materials, testing, product certifications and/or complete supply chain management through filling operations processes and/or methods.
In some embodiments of this invention, particularly in healthcare applications and settings, body 35 has a standardized design and is used in connection with known or conventional small-bore connectors which are particularly useful for liquids and/or gases in hospital settings or other healthcare applications.
According to some embodiments of this invention, spout 26 has a standardized upper portion 39. In some embodiments, upper portion 39 has a standardized external thread with standard dimensions and/or shapes that correspond to one or more standard and/or conventional designs, for example, according to International Standard ISO 80369-3. In other embodiments of this invention, upper portion 39 has a non-standardized external thread with non-standard dimensions and/or shapes that correspond to one or more non-standard designs, and these other embodiments may or may not be used in healthcare applications.
In some embodiments of this invention, such as those having a standardized internal flange 40, an improvement to internal flange 40 includes removing or deleting, either partially or completely, the standardized or non-standardized internal flange 40. According to some embodiments of this invention, body 35 has or forms internal void 37 though which any suitable liquids and/or gases flow or can pass or flow. In some embodiments of this invention, at least a portion or all of the standardized or non-standardized internal flange 40 is removed, for example, to reduce a fluidic flow restriction caused by the standardized internal flange 40 and increase a flow area and/or a cross-sectional area of internal void 37. In some embodiments of this invention, eliminating or reducing at least a portion of or eliminating or reducing all of internal flange 40 reduces the flow restriction and thus allows the liquids and/or gases to flow and/or pass as a fluid through internal void 37 of body 35. The amount of internal flange 40 removed or deleted can be varied to correspondingly vary the fluidic flow characteristics of the liquids and/or gases and thus can be used to improve one or more fluidic flow characteristics and thereby achieve increased flowrates, reduced flow times and/or reduced pressure drops of the fluid, such as the liquids and/or gases, flowing and/or passing through internal void 37 of body 35.
In some embodiments of this invention, the entire standardized internal flange 40 is removed to increase the fluidic flowrate and thereby reduce the time necessary to fill another connected and/or attached device, such as one or more containers 24 according to this invention. According to some embodiments of this invention, internal void 37 is sized large enough and/or sized in shapes and/or dimensions to reduce or minimize the fluidic flow restriction and thereby improve and/or otherwise vary the fluidic flow characteristics.
In some embodiments of this invention, for example as shown in
According to some embodiments of this invention, internal wall 36 forms and/or has a straight wall section of wall 38, such as shown in
In some embodiments of this invention, in a filling flow direction, for example as shown or represented by arrow 42 in
In some embodiments of this invention, to accomplish a fill of container 24, for example, a conventional filling nozzle 21, such as shown in
According to some embodiments of this invention, methods can be used to improve standardized designs of body 35, including but not limited to small-bore connectors used for or in connection with liquids and/or gases, particularly in healthcare applications. In some embodiments, the standardized designs include or have spout 26 with a standardized upper portion 39, a standardized external thread on the standardized upper portion 39, and body 35 forms a standardized internal flange. In some embodiments, the improved method includes forming or creating internal void 37 though which the liquids and/or gases flow or pass through body 35 and removing at least a portion of or all of the standardized internal flange 40. According to some embodiments, increasing a flow area or a cross-sectional area of internal void 37 can be used to reduce a flow restriction caused by standardized internal flange 40 and thus result in increased manufacturing efficiencies including but not limited to reduced filling times of containers 24 and corresponding manufacturing cost savings.
While in the foregoing detailed description this invention has been described in relation to certain preferred embodiments thereof, and many details have been set forth for purposes of illustration, it will be apparent to those skilled in the art that this invention is susceptible to additional embodiments and that certain of the details described herein can be varied considerably without departing from the basic principles of this invention.
This Patent Application claims the benefit of U.S. Provisional Application, Ser. No. 63/014,512, filed on 23 Apr. 2020, and U.S. Provisional Application, Ser. No. 63/162,828, filed on 18 Mar. 2021. By the above claim, both U.S. Provisional Patent Applications are incorporated by reference into this specification, each in its entirety and each is made a part of this specification, including but not limited to the following disclosure.
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