Patent Grant
12016825
The subject matter of the present invention relates generally to an elastomeric enteral feeding pump and assembly for filling an elastomeric enteral feeding pump.
There are many issues encountered by enteral feeding pump users today. Users complain of the many alarms, beeps, and other operating noises, as they can significantly impact quality of life, sleep, and ability for the patient to take part in daily activities without feeling stigmatized or isolated. Additionally, when ambulating with the pump, the patient is often required to have a large backpack in which the pump and all other supplies must be placed, making it difficult for tube feeders to be discreet about their condition when in public.
Additionally, manually filling a pump via a syringe or other transfer container is often difficult and time-consuming. The pressures required to activate the syringe can cause pain and/or injury to the person filling the pump due to these high pressures. Oftentimes, the total volume required in the pump means that multiple rounds of syringe actuation are required to finish the filling process, which can result in a time-consuming effort.
Consequently, there is a need for a discreet, e.g., non-electrically driven, enteral feeding pump that may be easily concealed. In particular, a discreet enteral feeding pump that does not require manual filling would also be useful.
Objects and advantages of the invention will be set forth in part in the following description, or may be obvious from the description, or may be learned through practice of the invention.
The present invention is directed to a non-electrically driven enteral feeding pump. The pump includes: an expandable elastomeric bladder defining a chamber; an inlet port in fluid communication with the chamber, and an outlet port in fluid communication with the chamber; and a first fluid delivery tube. The first fluid delivery tube is configured to be in fluid communication with the chamber via the outlet port. The fluid delivery tube controls the flow rate of fluid delivered by the pump.
In one particular embodiment of the enteral feeding pump, the expandable elastomeric bladder can include an outer elastomeric bladder and an inner disposable liner.
In another embodiment, the expandable elastomeric bladder can include a body formed from a single layer of inert elastomeric material, wherein the chamber can be defined by an inner wall of the body of the expandable elastomeric bladder.
In a further embodiment, the fluid delivery tube can include a connector adapted to be coupled with an enteral feeding port.
In an additional embodiment, the pump can be configured to deliver fluid at a flow rate in a range from about 20 mL/hour to about 300 mL/hour.
In yet another embodiment, the fluid delivery tube can be integrally coupled with the bladder.
In a further embodiment, the enteral feeding pump can further include a set of alternate flow rate fluid delivery tubes, wherein the first fluid delivery tube and at least one alternate flow rate fluid delivery tube of the set can be configured to be interchangeably coupled with the bladder.
In still another embodiment, the enteral feeding pump can include a drip chamber, wherein the drip chamber can include at least one transparent window configured to enable a visual indication of flow through the fluid delivery tube.
In an additional embodiment, the bladder can include a generally spherical shape.
In one more embodiment, the bladder can include a wall having varying thickness.
The present invention is further directed to an enteral feeding pump assembly. The assembly includes a non-electrically driven enteral feeding pump comprising an expandable elastomeric bladder defining a chamber, the bladder comprising an inlet port and an outlet port; a first fluid delivery tube, wherein the first fluid delivery tube is configured to be in fluid communication with the chamber via the outlet port; and a peristaltic pump. The peristaltic pump is configured to be operatively coupled to the inlet port of the expandable bladder for transferring fluid from a reservoir external to the expandable bladder into the chamber of the expandable bladder.
In one embodiment of the enteral feeding pump assembly, the expandable elastomeric bladder can include an outer elastomeric bladder and an inner disposable liner.
In another embodiment, the expandable elastomeric bladder can include a body formed from a single layer of inert elastomeric material, wherein the chamber is defined by an inner wall of the body of the expandable elastomeric bladder.
In an additional embodiment, the fluid delivery tube can include a connector adapted to be coupled with an enteral feeding port.
In a further embodiment, the pump can be configured to deliver fluid at a flow rate in a range from about 20 mL/hour to about 300 mL/hour.
In yet another embodiment, the fluid delivery tube can be removably coupled with the bladder.
In still another embodiment, the assembly can further include a set of alternate flow rate fluid delivery tubes, wherein the first fluid delivery tube and at least one alternate flow rate fluid delivery tube of the set can be configured to be interchangeably coupled with the bladder.
In an additional embodiment, the assembly can further include a drip chamber, wherein the drip chamber comprises at least one transparent window configured to enable a visual indication of flow through the fluid delivery tube.
In yet another embodiment, the bladder can include a generally spherical shape.
In a further embodiment, the bladder can include a wall having varying thickness.
In one more embodiment, the assembly can further include a bolus delivery device.
These and other features, aspects, and advantages of the present invention will become better understood with reference to the following description and appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.
A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which makes reference to the appended figures, in which:
Reference now will be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present invention covers such modifications and variations as come within the scope of the appended claims and their equivalents.
As used herein, the terms “about,” “approximately,” or “generally,” when used to modify a value, indicates that the value can be raised or lowered by 5% and remain within the disclosed embodiment. Further, when a plurality of ranges are provided, any combination of a minimum value and a maximum value described in the plurality of ranges are contemplated by the present invention. For example, if ranges of “from about 20% to about 80%” and “from about 30% to about 70%” are described, a range of “from about 20% to about 70%” or a range of “from about 30% to about 80%” are also contemplated by the present invention.
Moreover, the particular naming of the components, capitalization of terms, the attributes, data structures, or any other programming or structural aspect is not mandatory or significant, and the mechanisms that implement the invention or its features may have different names, formats, or protocols. Also, the particular division of functionality between the various components described herein is merely exemplary and not mandatory; functions performed by a single component may instead be performed by multiple components, and functions performed by multiple components may instead performed by a single component.
Further, the detailed description uses numerical and letter designations to refer to features in the drawings. Like or similar designations in the drawings and description have been used to refer to like or similar parts of the invention. As used herein, the terms “first,” “second,” and “third” may be used interchangeably to distinguish one component from another and are not intended to signify location or importance of the individual components.
Generally speaking, the present invention is directed to an enteral feeding pump that is non-electrically driven. The pump includes an expandable elastomeric bladder defining a chamber, an inlet port in fluid communication with the chamber, and an outlet port in fluid communication with the chamber. The pump further includes a first fluid delivery tube. The first fluid delivery tube is configured to be in fluid communication with the chamber via the outlet port, and the fluid delivery tube controls the flow rate of fluid from the pump. The present invention is further directed to an enteral feeding pump assembly including the enteral feeding pump and a peristaltic pump, wherein the peristaltic pump can be used for filling the expandable elastomeric bladder of the enteral feeding pump. The present inventors have found that the enteral feeding pump assembly of the present invention can allow patients who require enteral nutrition delivery to easily conceal the enteral feeding pump, allowing them to take part in daily activities without feeling stigmatized or isolated. Moreover, by filling the enteral feeding pump using a peristaltic pump that a patient is likely to already have access to for day to day enteral feeding, the enteral feeding pump can be filled easily and quickly in a mechanical manner.
The specific features of the enteral feeding pump assembly of the present invention may be better understood with reference to
Referring now to
The bladder 14, which is an inflatable reservoir, may be mounted on the mandrel 16, e.g., using a press fit or a clearance fit. The bladder 14 can be formed from a body 70 formed from an elastomeric material. The bladder 14 can include an expandable internal chamber 15 which can be inflated or expanded by a fluid, e.g., by enteral nutritive liquid. The chamber 15 may be defined by an inner surface 74 of the bladder 14. The bladder 14 may be a single sleeve or multiple sleeves, e.g., the bladder 14 may comprise an inner sleeve that is a chemically inert sleeve and an outer sleeve or sleeves that are highly elastic. Notably, it is critically important for the inner surface 74 (see
In some aspects of the present invention, as illustrated in
The central support member or mandrel 16 may extend from a first end 22 to a second end 24 of the elastomeric pump 10 and can include circular grooves (not shown) at each end 22, 24 thereof into which portions of the bladder 14 and housing 12 can be biased, e.g., by means of a pair of O-rings 28. More particularly, an O-ring 28 can secure the bladder 14 to the mandrel 16 at each of the first and second ends 22, 24 of the mandrel 16. Each O-ring 28 fits into the groove at the respective end 22, 24 such that the bladder 14 may be secured between the O-ring 28 and the groove at each end 22, 24. Further, the first end 22 can include a first cap 30, e.g., a cup-shaped cap 30 as shown in
The mandrel 16 has a body 60 extending over a length LM between the first end 22 and the opposing second end 24. More particularly, the body 60 extends from a first body end 60a to a second body end 60b, where the body ends 60a, 60b are just axially inward from the O-ring grooves defined in mandrel 16. Further, the mandrel 16 has an inlet port 62 on one end 22, 24; the inlet port 62 is defined at the first end 22 in the illustrated embodiment. A fill port 64 is defined in the body 60 between the first end 22 and the second end 24; in the depicted embodiment, the fill port 64 is defined near the first end 22. In addition, a first bore (not shown) extends within the body 60 and is in fluid communication with the inlet port 62 and fill port 64. More particularly, the first bore extends coaxially with the central axis A of the elastomeric pump 10 from the first end 22 to the fill port 64, which extends transversely through the mandrel body 60. Fluid enters the elastomeric pump 10 through the mandrel inlet port 62 and flows through the fill port 64 into the chamber 15 formed by the bladder 14. To dispense the fluid from the reservoir, the fluid enters a dispense port 66 and flows through a second coaxial bore (not shown) to an outlet port 68 defined at or near the second end 24; the outlet port 68 is in fluid communication with a tube 34 which delivers the fluid to a patient, described in further detail below. It will be appreciated that one or more check valves may be included in the infusion pump assembly, e.g., to prevent fluid from flowing from the reservoir back through the inlet port 62 or from prematurely flowing from the reservoir to the tube 34 for delivery to the patient.
It will be appreciated that the bladder 14 expands and contracts to receive and dispense a fluid. Pressure acts on the fluid as it is injected into the bladder 14 to expand the bladder from an initial unexpanded state to a maximum expanded state. The maximum expanded state accommodates a fill volume. Typically, the fluid can be injected, e.g., by a manual or powered pump such as a peristaltic pump or a syringe-type device and passes through a one-way valve connector before it enters the bladder, and the pressures upstream of the one-way valve connector generally are greater than the pressures within the bladder. As such, the upstream pressures move the liquid through the valve connector, then through one end of the mandrel 16, through a port in the mandrel, and against an inner surface 74 (see
A decreased bladder wall thickness tin the bladder midsection helps to promote uniform filling of the reservoir formed by the bladder 14 when the fill port 64 is aligned with the thinner bladder midsection, e.g., by creating a path of least resistance at the midsection, where there is less material force to overcome to initiate filling because of the decreased wall thickness t. Uniform filling may aid in providing a more consistent pressure and flow rate as the reservoir empties during the infusion.
As previously described, the thinnest bladder wall section provides a path of least resistance because, compared to sections where the bladder is thicker, there is less material force to overcome to initiate filling. As such, the crack pressure of the pump 10 may be lowered. Further, uniform filling also may help provide a more consistent pressure and flow rate as the reservoir empties during an infusion procedure.
As illustrated in
Further, the bladder wall thickness t is different at each point from the first end 70a to the second end 70b, and more specifically, the wall thickness t increases from the first end 70a to the second end 70b. As shown in
By tapering the wall thickness t as shown in
In some embodiments, the bladder 14 may be made from a silicone or a polyisoprene material. For instance, an appropriate silicone or polyisoprene material may be one that forms inflatable tubes; results in a maximum pressure, as measured a short distance downtream of the first port, within a desired range when inflated with a predetermined volume of liquid; and provides sufficent constricting forces to expell substantially all the liquid. Of course, other materials also may be suitable for forming bladder 14. Further, an exemplary range of wall thicknesses t for bladder 14 is from about 0.075 inches up to about 0.180 inches. An exemplary range of the inner diameters dB of bladder 14 is from approximately 0.355 inches to approximately 0.600 inches. Moreover, an exemplary range of durometer hardness of the elastomeric material of the bladder 14 can be from about 25 to about 50, such as from about 28 to about 45, for instance from about 30 to about 40. Various combinations of bladder length LB, wall thickness t, inner diameter dB, and suitable materials (e.g., having varying durometers) may yield bladders having fill volumes in the range of about 50 to about 1000 ml of liquid.
Referring now to
As depicted in
As illustrated in
Returning to
The connector 40 may be a suitable connector for connecting to an enteral feeding device, such as a gastrostomy tube or other enteral feeding port (not shown). In particular, an enteral-only fluid connector may be desirable in order to prevent misconnection with a non-enteral fluid source. For instance, according to example embodiments, the fluid connector 40 of the present invention may include a connector that is compatible with and adapted to the ISO 80369-3 design standard known as ENFIT and is configured for coupling engagement with ENFIT connectors according to the ENFIT design standard, ISO 80369-3, which is incorporated herein by reference. According to some example forms of the invention, the fluid connector 40 can include both enteral-only and ENFIT compatible connectors, for example, for providing compatible coupling engagement with enteral-only connectors and ENFIT compatible connectors. Preferably, the fluid connector 40 described herein can include both enteral-only and ENFIT compatible connectors as desired.
As further shown in
As further shown in
where Q is the volumetric flow rate, Δp is the pressure drop between the reservoir and the outlet pressure, r is the radius of the lumen of the flow tubing (i.e., an inner radius), μ is the viscosity of the fluid, and L is the length of the flow control tubing. When commercial enteral nutrition formula (ENF) is the fluid being delivered to the patient, the viscosity p of the ENF may be typically provided, e.g., with the packaging of the ENF. The viscosity of commercial ENF can be, for instance, in a range from about 5 to about 100 centipoise (cP). Nevertheless, the pump assembly 11 of the present invention may be used to deliver any fluid, nutritive or otherwise, to a patient P.
The flow control tubes 34 can have an inner diameter in a range from about 0.005 inches (about 0.13 mm) to about 0.03 inches (about 0.76 mm), such as from about 0.01 inches (about 0.25 mm) to about 0.02 inches (about 0.51 mm). The flow control tubes 34 can have a length in a range from about 3 inches (about 7.6 cm) to about 36 inches (about 91 cm), such as from about 5 inches (about 12.7 cm) to about 30 inches (about 76 cm), e.g., from about 6 inches (about 15 cm) to about 28 inches (about 71 cm). As described above, the length L and the inner radius r of the flow can be selected and/or modified to manipulate and control the flow rate of delivery of enteral fluid to the patient P.
For instance, the enteral feeding assembly 11 can include a set of alternative flow control tubes 34 each having different length and/or diameter characteristics in order to achieve various target flow rates. For instance, a set of tubes can include tubes configured to deliver fluid at about 50 ml per hour, about 100 ml per hour, about 200 ml per hour, and about 300 ml per hour, respectively. However, it is to be understood that the present invention contemplates a set of alternative flow control tubes 34 comprising any number, e.g., unlimited quantity, of flow control tubes having varying target flow rates in varying increments.
Additionally or alternatively, the enteral feeding assembly 11 can include an adjustable fluid flow rate tube 34a. For instance, the adjustable fluid flow rate tube 34a may be formed of an elastomeric or stretchy material. In some aspects of the present invention, the adjustable fluid flow rate tube 34a can be formed from silicone. When the elastomeric or stretchy material of the adjustable fluid flow rate tube 34a is stretched, the flow characteristics can be altered. For instance, as the adjustable fluid flow rate tube 34a is stretched, length L of the tube 34a can be increased and/or the diameter (i.e., r*2) of the tube 34a can be decreased, thereby altering the flow rate of the fluid delivered through the tube 34a according to the Hagen-Pouiselle equation.
Further, the enteral fluid pump assembly 11 can be provided with a drip chamber 82. The drip chamber 82 can be configured to enable a visual indication of flow of liquid from the elastomeric pump 10. For instance, a drip chamber 82 can be coupled to the cap 32 at the second end 24 of the bladder 14 to enable visualization of flow from the bladder 14. Additionally or alternatively, a drip chamber 82 can be coupled to the connector 40 distal from the bladder 14 to enable visualization of fluid flow from the tube 34 toward the patient P. Moreover, a drip chamber 82 may optionally be disposed anywhere along the tube 34. The drip chamber 82 can include at least one transparent window through which fluid flow may be visualized. Additionally or alternatively, all or a portion of the tube 34 can be formed from a transparent or translucent material to enable visualization of the flow of liquid through the tube 34.
In some aspects of the present invention, the enteral fluid pump assembly 11 may be configured to provide for bolus delivery. In such configurations, tube 34 may split into a continuous or primary flow path 38 and a controlled bolus flow path 138. Thus, enteral fluid may be delivered to a patient P from pump 10 via the continuous or primary flow path 38 or from a bolus delivery device 130 via the controlled bolus flow path 138. In the exemplary embodiment illustrated in
Turning now to
This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.
| Number | Name | Date | Kind |
|---|---|---|---|
| 228422 | Turner | Jun 1880 | A |
| 3398743 | Shalit | Aug 1968 | A |
| 4699615 | Fischell | Oct 1987 | A |
| 20020046751 | MacRae | Apr 2002 | A1 |
| 20030040709 | Mason | Feb 2003 | A1 |
| 20090171268 | Williams, Jr. | Jul 2009 | A1 |
| 20160008536 | Gravesen | Jan 2016 | A1 |
| 20210178030 | Xiao | Jun 2021 | A1 |
| Number | Date | Country |
|---|---|---|
| 111 150 662 | May 2020 | CN |
| Entry |
|---|
| International Search Report and Written Opinion for PCT/US2022/038672, dated Nov. 22, 2022, 10 pages. |
| Number | Date | Country | |
|---|---|---|---|
| 20230036837 A1 | Feb 2023 | US |
