Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J15/00—Feeding-tubes for therapeutic purposes
  • A61J15/0026—Parts, details or accessories for feeding-tubes
  • A61J15/0092—Valves on feeding tubes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J15/00—Feeding-tubes for therapeutic purposes
  • A61J15/0026—Parts, details or accessories for feeding-tubes
  • A61J15/0076—Feeding pumps

Definitions

• Embodiments of the present invention relate to enteral feeding pump systems, and more particularly, to adapters for valve assemblies for use with enteral feeding pump systems.
• enteral feeding pump systems are used to supply fluid nutrition to patients who are unable to eat.
• the pumping system typically includes a pump and disposable tubing sets (see, e.g., FIG. 1 ).
• An enteral feeding pump may be designed to pump only liquid nutrient formula or nutrient formula and water, separately.
• a flow selector valve assembly for an enteral feeding pump system.
• the valve assembly includes a twin port adapter having first and second feeding tubes, the twin port adapter having a body, including first and second input ports each configured to receive a portion of the first and second feeding tubes therein, respectively; and an output port in communication with the first and second input ports; and a feeding tube guide rotatably connected to the body and configured to secure the first and second feeding tubes within the body.
• the twin port adapter comprises a body, including a U-shaped portion having a lower end with first and second sides and an upper end with first and second sides, first and second input ports formed in the lower end and each configured to receive a portion of the first and second feeding tubes therein, respectively, and an output port in communication with the first and second input ports.
• the twin port adapter further comprises a feeding tube guide rotatably connected to the first side of the upper end, and configured to secure the first and second feeding tubes within the body, the feeding tube guide including first and second ends, and first and second C-shaped tubereceiving members positioned between the first and second ends and configured to receive and secure the first and second feeding tubes therein, respectively.
• FIG. 1 is a front view of an exemplary motor of an exemplary enteral feeding pump system;
• FIG. 2 illustrates a first embodiment of an exemplary pinching mechanism;
• FIG. 4 is a schematic illustration of an exemplary double pinch system.
• FIG. 5 is a front view of another exemplary enteral feeding pump system.
• FIG. 6 illustrates an embodiment of exemplary pinching mechanism components
• FIG. 7 illustrates a third embodiment of an operating exemplary pinching mechanism
• FIG. 8 illustrates an exemplary disposable tubing set with an adapter that enables selective pinching of formula or water tubes
• FIG. 10A is a top perspective, partially-exploded view of the system of FIG. 9;
• FIG. 10B is a plan view of the system of FIG. 9 in which both input flexible tubing channels/tubes of the system are open;
• FIG. 10C is a plan view of the system of FIG. 9 in which one of the input flexible tubing channels/tubes of the system is pinched closed by the eccentric bearing;
• FIG. 11 A is a detailed top perspective view of an eccentric bearing of the system of FIGS. 9-10C;
• FIG. 11 B is a plan view of the system of FIGS. 9-10C in a first position in which both input flexible tubing channels/tubes of the system are open;
• FIG. 11 D is a plan view of the system of FIGS. 9-10C in a third position in which a second input flexible tubing channel/tube of the system is pinched closed by the eccentric bearing;
• FIG. 12 is a right top perspective view of a twin port adapter according to the present invention, with a feeding tube guide in an opened position;
• FIG. 13 is a left top perspective view of the twin port adapter of FIG. 12;
• FIG. 14 is a right top perspective view of the twin port adapter according of
• FIG. 12 with the feeding tube guide in a closed position
• FIG. 15 is a left top perspective view of the twin port adapter of FIGS. 12 and 14, with the feeding tube guide in the closed position;
• FIG. 16 is a top perspective view of the twin port adapter of FIGS. 12 and 14, in use with flexible feeding tubes;
• FIG. 17 is a top perspective cross-sectional view of the twin port adapter of FIGS. 12, 14 and 16, taken along lines 16 — 16 of FIG. 16;
• FIG. 19 is a top view of the twin port adapter of FIG. 12, with a feeding tube being inserted therein;
• FIG. 20 is a detailed perspective top perspective view of the twin port adapter of FIGS. 12.
• the term “approximately” or “about” in reference to a value or parameter are generally taken to include numbers that fall within a range of 5%, 10%, 15%, or 20% in either direction (greater than or less than) of the number unless otherwise stated or otherwise evident from the context (except where such number would be less than 0% or exceed 100% of a possible value).
• reference to “approximately” or “about” a value or parameter includes (and describes) embodiments that are directed to that value or parameter. For example, description referring to "about X” includes description of "X”.
• the term “or” means “and/or.”
• the term “and/or” as used in a phrase such as "A and/or B” herein is intended to include both A and B; A or B; A (alone); and B (alone).
• the term “and/or” as used in a phrase such as "A, B, and/or C” is intended to encompass each of the following embodiments: A, B, and C; A, B, or C; A or C; A or B; B or C; A and C; A and B; B and C; A (alone); B (alone); and C (alone).
• compositions, methods, and respective components thereof as described herein, which are exclusive of any element not recited in that description of the embodiment.
• FIG. 1 An exemplary motor 10 that is part of an exemplary enteral feeding pump system is illustrated and includes a disposable fluid delivery set with two separate source containers connected by tubing to a tubing adapter that combines flow from the two separate tubes into a single fluid stream, an integral peristaltic tube section, and an enteral feeding pump.
• the enteral feeding pump motor 10 includes a rotor that engages the peristaltic tube section and, when rotated, causes liquid to flow in a direction of rotation, wherein the tubing from the two fluid source containers passes through a pinching mechanism for selectively closing or opening a flow of fluid from either container into a patient.
• the pinching mechanism is actuated by an inflatable bladder linked to a micro air pump, or an inflatable bellows linked to a micro air pump.
• the inflatable bellows operates in the pressure range of 0.1 to 1 bar.
• a first embodiment of an exemplary pinching mechanism 80 includes tubing 200 residing within a single pincher 210.
• a tightening and loosening of the single pincher 210 about the tubing 200 is controlled with an inflatable bladder 220, shown here in an inflated condition.
• the inflatable bladder 200 is connected to a micro air pump (not shown).
• the micro air pump inflates the inflatable bladder 200, causing the single pincher 210 to constrict around the tubing 200.
• the tubing 200 is constricted, no fluid flows within the tubing 200.
• the micro air pump deflates the inflatable bladder 200, the single pincher 210 releases its grip on the tubing 200 and fluid flow within the tubing 200 is enabled.
• the pinching mechanism is controlled via an inflatable bellows linked to the micro air pump.
• the inflatable bellows operates in the pressure range of 0.1 to 1 bar.
• a second embodiment of an exemplary pinching mechanism 180 includes pincher 300 having a first channel 310 and a second channel 320,
• the dual pincher channels 310, 320 enable placement on tubing (not shown) in both.
• a tightening and loosening of the pincher 300 about tubing in the channels 310, 320 is controlled with an inflatable bladder (not shown) connected to a micro air pump (not shown).
• the micro air pump inflates the inflatable bladder, the first channel 310 and a second channel 320 clap down over the tubing, preventing fluid flow within the tubing.
• the micro air pump deflates the inflatable bladder, the pincher 300 releases its grip on the tubing 200 and fluid flow within the tubing in the channels 310, 320 is enabled.
• the inflatable bladder is replaced by an inflatable bellows linked to the micro air pump.
• the inflatable bellows operates in the pressure range of 0.1 to 1 bar.
• FIG. 4 is a schematic illustration of an exemplary double pinch system.
• an exemplary enteral feeding pump system 110 is illustrated and includes a disposable fluid delivery set with two separate source containers connected by tubing to a tubing adapter that combines flow from the two separate tubes into a single fluid stream, an integral peristaltic tube section, and an enteral feeding pump.
• the enteral feeding pump includes a rotor that engages the peristaltic tube section and, when rotated, causes liquid to flow in a direction of rotation, wherein the tubing from the two fluid source containers passes through an eccentric pinching mechanism for selectively closing or opening a flow of fluid from either container into a patient, the eccentric pinching mechanism actuated by one quadrant clockwise or one quadrant counterclockwise motor rotation.
• a first embodiment of an exemplary pinching mechanism 280 includes two flexible tubes (typically PVC or other flexible material), residing within the flow selector adapter 410.
• the adapter When the adapter is installed onto the eccentric bearing 150, it forms the pinch valve system.
• two views of the exemplary pinching mechanism 280 include firstly, the eccentric bearing 150 oriented in the central (neutral) position to accommodate adapter installation and, second, the eccentric bearing 150 rotated 90 degrees with sufficient force to pinch and stop fluid flow through either intervening tube. Reversing the rotation allows flow to resume through the tube. With rotation continuing 180 degrees (90 degrees beyond center position), the second intervening tubing section is pinched and fluid flow is stopped.
• FIG. 8 illustrates an exemplary disposable tubing set with adapter 410 that enables fluid flow from either selected source.
• flow selector valve assemblies for use with an enteral feeing pump.
• an exemplary motor 10 of an exemplary enteral feeding pump constitutes a durable actuator and is illustrated and is used with a disposable fluid delivery set with two separate source containers connected by tubing to a tubing adapter that combines flow from the two separate tubes into a single fluid stream, and an integral peristaltic tube section (see FIGS. 9 and 10A - 10C).
• the enteral feeding pump motor 10 includes a motor that engages a disposable tube adapter and, when rotated, controls the fluid flow through one of two tubes, as described below.
• FIGS. 9, 10A-C and 11A - 11 D illustrate an exemplary flow selector valve assembly 20 of the present invention that is used with the enteral feeding pump motor 10 of FIG. 1 .
• the flow selector valve assembly 20 is operatively connected to the enteral feeding pump motor 10, as further described below.
• the enteral feeding pump motor 10 engages the flow selector valve assembly 20 according to an embodiment of the present invention.
• the flow selector valve assembly 20 includes a disposable tube adapter 22 (i.e., a disposable set section) having two input flexible tubing channels 24, 26 and one output tubing channel 28.
• the two input tubing channels 24, 26 are configured to receive two respective tubes 24a, 24b connected to two fluid sources (not shown).
• the output tubing channel 28 is configured to receive a feeding tube (i.e., an integral peristaltic tube section) that is inserted into a patient to provide the fluids/nutrients (not shown).
• the disposable tube adapter 22 i.e., set section
• the enteral feeding pump motor 10 i.e., durable actuator
• the flow selector valve assembly 20 is configured to select either one of two fluid sources, or both simultaneously.
• the two input flexible tubing channels 24, 26 are separate from the mechanism that closes the fluid flow through either of them (i.e., their respective tubes 24a, 24b).
• the tube adapter 22 positions the flexible tubing channels 24, 26 in relation with a receiver 30.
• the receiver 30 has a central shaft 32 and an eccentric bearing 34 extending from a digitally controlled motor (e.g., in the feeding pump system 10).
• the bearing 34 is positioned at a 12 o’clock orientation, wherein neither of the input flexible tubing channels 24, 26 nor the respective tubes 24a, 26a therein is compressed. This position facilitates loading and unloading of the adapter 22/tubing assembly 20.
• the flow selector valve assembly 20 therefore operates in coordination with the enteral feeding pump motor 10 to selectively close one of the input flexible tubing channels 24, 26 and the respective tubes 24a, 26a therein.
• One advantage of the invention disclosed herein is the ease of installation of the disposable tube adapter 22 (i.e., set section) on the enteral feeding pump motor 10 (i.e., durable actuator).
• FIGS. 12-20 illustrate an embodiment of a twin port adapter (TPA) 500 for use with a flow selector valve assembly (including a pinch valve thereof) and feeding pump system according to the present invention.
• the TPA 500 includes a body having a U-shaped portion 502 having first (i.e., lower) and second (i.e., upper) ends 504, 506.
• the lower end 504 includes first and second (e.g., left and right) sides 504a, 504b
• the upper end 506 includes first and second (e.g., left and right) sides 506a, 506b.
• the TPA body further includes input ports (i.e., input tubing channels) 508a, 508b formed in the lower end 504 of the U-shaped portion 502 (i.e., between the left and rights sides 504a, 504b thereof) and extending downward therefrom, an output port (i.e., output tubing channel) 510 in communication with the input ports 504a, 504b, and a thumb handle 512 extending from the upper end 506 of the U-shaped portion 502 (i.e., between the left and rights sides 506a, 506b thereof) for mounting the TPA 500 in the feeding pump system and otherwise handling and manipulating the TPA 500.
• input ports i.e., input tubing channels
• 508a, 508b formed in the lower end 504 of the U-shaped portion 502 (i.e., between the left and rights sides 504a, 504b thereof) and extending downward therefrom
• an output port i.e., output tubing channel
• a thumb handle 512
• the TPA 500 further includes a movable feeding tube guide 514.
• the feeding tube guide 514 includes a first end 516, a second end 518 opposite the first end 516.
• the second end 518 is configured to securely engage the second side 506b of the upper end 506 of the U- shaped portion 502 (e.g., via a latch mechanism).
• the feeding tube guide 514 further includes adjoining first and second C-shaped tube-receiving members 520, 522 positioned between the first and second ends 516, 518 and configured to receive and secure flexible first and second feeding tubes 524, 526 of the feeding pump system therein (i.e., within the apertures formed thereby), respectively (see FIG. 16).
• the tubereceiving members 520, 522 each include first and second retainer bumps, or protrusions 521 , 523, respectively, that are configured to engage the first and second feeding tubes 524, 526, respectively.
• the feeding tube guide 514 further includes a central Y-shaped wall 528 common to the first and second tube-receiving members 520, 522 that separates the respective apertures formed thereby.
• the wall 528 is Y-shaped, and includes a third retainer bump, or protrusion, 530 extending into the aperture formed by the first tube-receiving member 520 (i.e., across from/opposite to the first protrusion 521 ), and a fourth retainer bump, or protrusion, 532 extending into the aperture formed by the second tube-receiving member 522 (i.e., across from/opposite to the second protrusion 523).
• the third and fourth protrusions 530, 532 are configured to engage the first and second feeding tubes 524, 526, respectively.
• Other configurations of the wall 528 are possible in alternate embodiments of the invention (e.g., not having a Y-shape).
• the first end 516 of the feeding tube guide 514 is rotatably attached to the first side 506a of the upper end 506 of the U-shaped portion 502.
• the first end 516 is attached to the first side 506a as a living hinge that is molded as a single-action tool, which enables the feeding tube guide 514 to swing out to the left or right.
• the feeding tube guide 514 is thereby moveable from an opened position, as shown in FIGS. 12 and 13, to a closed, or locked, position, as shown in FIGS. 14-17.
• the feeding tube guide 514 serves to allow a simple straight pull injection mold in its open position/configuration.
• the feeding tube guide 514 guide once molded is moved (i.e. , folded) only once to its permanently closed/locked position.
• the first and second feeding tubes 524, 526 are shown secured to the TPA 500 within the respective apertures of the first and second C-shaped tube-receiving members 520, 522 of the feeding tube guide 514, and secured by the respective first and second protrusions 521 , 523 and the third and fourth protrusions 530, 532 of the wall 528.
• the first and second feeding tubes 524, 526 are further secured to the TPA 500 by bonding the feeding tubes 524, 526 to the respective input ports 508a, 508b with an adhesive. This is illustrated in FIG. 20, wherein the feeding tube 526 is shown bonded to the inlet port 508b.
• the tubes 524, 526 and respective input ports 508a, 508b are then subjected to UV illumination with intensity and wavelength required to cure the applied adhesive, which cures (i.e., solidifies) the adhesive, thereby securing the lower ends of the feeding tubes 524, 526 to and within the respective input ports 508a, 508b.
• the UV intensity ranges from 13 to 30 W/cm 2
• the UV wavelength ranges from 300nm to 500nm.
• the first and second protrusions 521 , 523 and the third and fourth protrusions 530, 532 of the wall 528 temporarily retain the feeding tubes 524, 526 while the adhesive is applied and cured.
• the feeding tubes 524, 526 are pushed fully into the first and second C-shaped tube-receiving members 520, 522, respectively, of the feeding tube guide 514.
• the upper ends of the feeding tubes 524, 526 are not bonded in place, and are thereby repositionable to allow their movement in use.
• the TPA 500 is formed by injection molding.
• the TPA 500 is formed from rigid PVC or ABS.
• the TPA 500 may also be formed from other suitable polymers and materials.
• FIGS. 17 and 18, show that each of the input ports 508a, 508b contains a check ball 534a, 534b, respectively, which constitute and are configured as a check ball valve that acts to block fluid from moving in either direction within the input ports 508a, 508b and feeding tubes 524, 526.
• FIG. 17 is a cross-sectional view of the TPA 500 and feeding tubes 524, 526 secured therein
• FIG. 18 is a detailed view of the input ports 508a, 508b and feeding tubes 524, 526.
• the check ball 534a is supported by three concentrically-arranged ribs 536, while the check ball 534b is supported by three concentrically-arranged ribs 538 (see also FIG. 19 in which the check balls 534a, 534b are removed for clarity). In alternate embodiments, there are different numbers of ribs and/or different rib configurations.
• the blocking action of the check balls 534a, 534b keep water and food separated until a user is ready to pump same through the feeding pump system.
• the check balls 543a, 534b thereby block reverse flow when one of the tubes 524 or 526 has higher pressure than the other in either flow direction.
• the check balls 534a, 534b are formed from polyethylene.
• the check balls 534a, 534b may be formed from other materials, non-limiting examples of which include polypropylene and polystyrene.
• the feeding tubes 524, 526 are secured within the TPA 500, as described above.
• the TPA 500 (with the feeding tubes 524, 526 therein) is then coupled to an eccentric bearing pinching mechanism, the same as or similar to the exemplary pinching mechanisms shown in FIGS. 7, 10A-10C and 11 A-11 D and discussed above.
• the TPA 500 is installed onto the pinching mechanism having an eccentric bearing (see eccentric bearing 150 in FIG. 7).
• the eccentric bearing is oriented in the central (neutral) position to accommodate the TPA 500.
• the eccentric bearing is rotated 90 degrees to the left or right with sufficient force to pinch and stop fluid flow through the f irst/left feeding tube 524 or second/right feeding tube 526, respectively, as discussed above and shown in shown in FIGS. 10A-10C and 11 A-11 D.
• the TPA 500 is disposable.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)

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• 2023
  • 2023-05-30 EP EP23827945.9A patent/EP4525968A2/de active Pending
  • 2023-05-30 AU AU2023289320A patent/AU2023289320A1/en active Pending
  • 2023-05-30 WO PCT/US2023/067642 patent/WO2023250248A2/en not_active Ceased
  • 2023-05-30 JP JP2024573917A patent/JP2025519758A/ja active Pending

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