WO2011014164A1 - Poche de perfusion intraveineuse exempt d'air - Google Patents

Poche de perfusion intraveineuse exempt d'air Download PDF

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Publication number
WO2011014164A1
WO2011014164A1 PCT/US2009/052040 US2009052040W WO2011014164A1 WO 2011014164 A1 WO2011014164 A1 WO 2011014164A1 US 2009052040 W US2009052040 W US 2009052040W WO 2011014164 A1 WO2011014164 A1 WO 2011014164A1
Authority
WO
WIPO (PCT)
Prior art keywords
intravenous
solution
airless
air
bag system
Prior art date
Application number
PCT/US2009/052040
Other languages
English (en)
Inventor
Jeremy Scott Curry
Original Assignee
Jeremy Scott Curry
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jeremy Scott Curry filed Critical Jeremy Scott Curry
Priority to CA2769242A priority Critical patent/CA2769242A1/fr
Priority to EP09847907A priority patent/EP2459257A1/fr
Priority to PCT/US2009/052040 priority patent/WO2011014164A1/fr
Publication of WO2011014164A1 publication Critical patent/WO2011014164A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
    • A61M5/40—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body using low-level float-valve to cut off media flow from reservoir
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • 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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/70—Device provided with specific sensor or indicating means
    • A61J2200/76—Device provided with specific sensor or indicating means for fluid level

Definitions

  • the present invention relates to the field of intravenous bag systems, and more particularly, to an airless intravenous bag system that eliminates the need for priming the intravenous line when exchanging intravenous bags.
  • Re -priming involves placing a syringe and needle into a port on the intravenous tubing and withdrawing the air from the tubing. This takes time that can be problematic when the patient needs intravenous medications or acute fluid administration for a sudden change in their vital signs (i.e. blood pressure, heart rate, etc.). In fact, these intravenous bags usually are not noticed "running dry" during emergencies because everyone's attention is usually focused on other things. During true emergent traumas, a patient may be getting intravenous solution more rapidly then with the standard gravity drip.
  • the intravenous bags are placed in pressurized bags or machines that literally squeeze the bag forcing the solution into the patient via the intravenous tubing.
  • the entrapped air is next forced through the intravenous tubing, potentially into the patient.
  • Air in the intravenous tubing is potentially disastrous because enough air may cause a "vapor-lock" phenomena whereby the right ventricle of the heart fills with air. Normal contractions are ineffective to push blood through the pulmonary vasculature where it is oxygenated and delivered to the left ventricle to be pushed out and circulated into the body. In other words, vapor-lock is a sudden cardiovascular collapse where no more blood can be circulated. An adult would need a high amount of air but a pediatric patient with a smaller heart would require much less air to cause this fatal scenario. Another potential problem is that air may not collect in the right ventricle, but may get pushed into the pulmonary vasculature. The name for this potentially lethal event is called pulmonary embolism.
  • the above two scenarios are certainly possible but require large amounts of air.
  • the most likely scenario for air entering into the vasculature and causing a devastating complication is via a probe patent or even an open Foramen Ovale.
  • the Foramen Ovale is a unique fetal adaptation the human heart has while the fetus in the uterus. Blood is shunted away from the lungs (since the fetus is not breathing) and into the main vasculature. One way this blood is shunted past the lungs in through a hole in the septum between the right and left atrium of the heart. This hole is called the Foramen Ovale. Normally this hole closes right after birth as the human heart now directs blood into the lungs than past them.
  • Probe patent means that a probe can be pushed through the Foramen Ovale which is only partially closed, or in other situations, it might be completely open. If a small air bubble makes it to the right atrium, the normal mechanism of passing into the right ventricle and then getting lodged into the palmary vasculature is bypassed. Instead, this air bubble may pass through the Foramen Ovale into the left atrium (bypassing the lungs), entering into the left ventricle, and then squeezed out into the body. If this air bubble goes to the brain, a devastating stroke may ensue. Central lines, which are long catheters intravenously placed into large veins and threaded close to the heart are more likely to cause this situation, however, even a small peripheral intravenous line can still elicit this situation especially in the setting of a small pediatric patient.
  • FIG. 1 is a front view of an airless intravenous bag according to one embodiment of the disclosure.
  • FIG. 2 is a further illustration of the airless intravenous bag according to one embodiment of the disclosure.
  • FIGs. 3 and 4 are further illustrations of the second chamber of the airless intravenous bag according to one embodiment of the disclosure.
  • FIG. 5 is a front view of the airless intravenous bag in the open position.
  • FIG. 6 is a front view of the airless intravenous bag in the closed position.
  • FIG. 7 is a further illustration of the airless intravenous bag in the open position.
  • FIG. 8 is a further illustration of the airless intravenous bag in the closed position.
  • FIG. 9 is a front view of the airless intravenous bag shown filled with LV. solution.
  • FIG. 10 is a further illustration of the airless intravenous bag shown filled with
  • the present disclosure provides for an airless intravenous (IV) bag which contains a specialized device, referred to herein as the airless intravasculature infusion device (AIVID).
  • the AIVID allows one to view the amount of fluid in the IV bag and substantially decrease or completely prohibit the risk of an inadvertent air infusion.
  • the disclosed airless intravenous bag 10 comprises a standard pliable plastic IV bag that is divided into two asymmetrical compartments along its vertical axis, the larger of the two compartments, referred to herein as the IV solution compartment 12 holds the IV solution to be infused into the patient devoid of any air.
  • IV solution compartment 12 is comprised of a pliable plastic bag.
  • the second, smaller compartment is air chamber 14.
  • air chamber 14 is comprised of two parts, air reservoir 16 and air column 18.
  • the air reservoir 16 is separated from the IV solution compartment 12 by horizontal seam 20.
  • Air reservoir 18 is also comprised of the same pliable plastic material as IV solution compartment 12.
  • Air column 18 is comprised of a hard plastic column separated from IV solution compartment 12 by vertical seam 22.
  • Air column 18 also comprises a mesh network 24 at the top of air column 18, and between air reservoir 16 and air column 18. Air column 18 terminates into funnel aperture 26.
  • AIVID 28 Surrounding funnel aperture 26 is airless intravasculature infusion device (AIVID) 28.
  • AIVID 28 is constructed of soft pliable plastic and include hard plastic half beads 38 embedded within the soft pliable plastic matrix of AIVID 28.
  • buoyant bead 30 Shown in FIG. 2 at the base of funnel aperture 26 is buoyant bead 30.
  • solution channel 32 Extending down vertically from funnel aperture 26 and into IV solution compartment 12 is solution channel 32. IV solution compartment 12 then terminates at its base with an injection port 34 and a docking port 36 for the IV drip chamber.
  • IV bag 10 also comprises a pre-cut tab 40 for hanging the IV bag 10, as needed, and printed measurement markings 42 on the outside of IV bag 10.
  • AIVID 28 is a small less pliable plastic component that has a small channel (solution channel 32) through it center that connects it to air column 18 (part of air chamber 14).
  • Air column 18 also contains the top of the AIVID 28 which forming a funnel that decreases in size from top to bottom, referred to herein as funnel aperture 26. Stretching upwards from funnel aperture 26 is a long clear harder plastic tube, as described above, air column 18. Air column 18 is designed so that it cannot be easily compressed.
  • the top of air column 18 has a thin mesh, namely mesh network 24, over the top of air column 18, but still opens into a small compartment, air reservoir 16 where air can be stored.
  • air reservoir 16 is comprised of the same pliable material as the IV solution compartment 12.
  • the primary purpose of the air reservoir 16 is to allow one to visualize the fluid level 52, including the remaining fluid in the IV solution compartment 12 without the risk of inadvertent air administration. As shown in FIGs. 9 and 10, this is accomplished with a small blue or red colored buoyant bead 30 that floats on the surface of the IV solution in solution channel 32.
  • FIGs. 6 and 8 when the buoyant bead is just below the funnel aperture 26 in AIVID 28, this is considered the closed position.
  • FIGs. 6 and 8 specifically illustrate the details of the "closed position" of IV bag 10.
  • the "closed position” is required for shipping purposes. Specifically, when IV bag 10 with buoyant bead 30 is in the closed position, a barrier is formed effectively blocking the solution channel 32 so that IV solution and/or air cannot traverse to opposite sides (enter each other's compartments). This is facilitated by the tight fit of the buoyant bead 30 within the AIVID 28.
  • the "closed position” may also be referred to as the "locked position.”
  • measurement numbers 42 and corresponding lines are printed on the outside of IV bag 10 so that the medical professional may observe the amount of IV solution being used. The medical professional can then easily view the amount of IV solution left by visualizing the buoyant bead 30 on the meniscus 52 formed within air column 18 and then comparing that to corresponding measurement number 42 printed on the outside of IV bag 10.
  • the IV solution compartment 12 empties. As the IV solution compartment 12 empties, the fluid level (indicated by meniscus 52) within the air column 18 also begins to drop. Air from air reservoir 16 then replaces the vacant space left by the dropping meniscus 52.
  • a particular unique and novel feature of IV bag 10 is that when the IV solution compartment 12 reaches a very low residual volume, the meniscus 52 begins to drop into the funnel aperture 26 of the AIVID 28. As this happens, buoyant bead 30 floating on the surface of meniscus 52 is slowly aligned to the center by the walls of funnel aperture 26.
  • buoyant bead 30 is guided down atop the opening to solution channel 32. This effectively blocks any air from crossing back through solution channel 32 into IV solution compartment 12. In preventing air from crossing back into IV solution compartment 12 this consequently also prevents air from entering into the IV tubing itself.
  • this new novel airless intravenous bag system allows a medical professional or other user to accurately measure the amount of IV fluid given, while reducing the risk of an inadvertent air infusion.
  • the presently disclosed airless intravenous bag system reduces or eliminates the potentially life threatening or disabling consequences of air infusion into a patient via the IV line.

Abstract

La présente invention propose une poche de perfusion intraveineuse (IV) exempt d'air qui contient un dispositif spécialisé, appelé ici dispositif de perfusion intravasculaire sans air (AIVID). L'AIVID permet à un opérateur de voir la quantité de fluide présente dans la poche de perfusion IV mais diminue fortement ou empêche complètement le risque de perfuser de l'air par inadvertance à un patient.
PCT/US2009/052040 2009-07-29 2009-07-29 Poche de perfusion intraveineuse exempt d'air WO2011014164A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CA2769242A CA2769242A1 (fr) 2009-07-29 2009-07-29 Poche de perfusion intraveineuse exempt d'air
EP09847907A EP2459257A1 (fr) 2009-07-29 2009-07-29 Poche de perfusion intraveineuse exempt d'air
PCT/US2009/052040 WO2011014164A1 (fr) 2009-07-29 2009-07-29 Poche de perfusion intraveineuse exempt d'air

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2009/052040 WO2011014164A1 (fr) 2009-07-29 2009-07-29 Poche de perfusion intraveineuse exempt d'air

Publications (1)

Publication Number Publication Date
WO2011014164A1 true WO2011014164A1 (fr) 2011-02-03

Family

ID=43529586

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/052040 WO2011014164A1 (fr) 2009-07-29 2009-07-29 Poche de perfusion intraveineuse exempt d'air

Country Status (3)

Country Link
EP (1) EP2459257A1 (fr)
CA (1) CA2769242A1 (fr)
WO (1) WO2011014164A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2853069A (en) * 1955-05-09 1958-09-23 Cutter Lab Flexible container with integral flow control
US3648697A (en) * 1969-08-01 1972-03-14 Gardner Newell J Intravenous feeding container and method of preparing the same
US4187847A (en) * 1977-07-11 1980-02-12 Loeser Edward A Airless intravenous fluid system
US5352213A (en) * 1993-11-16 1994-10-04 Woodard Robert W Intravenous fluid flow monitor
US5853388A (en) * 1997-08-21 1998-12-29 Semel; David Intravenous bag with separate compartment

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2853069A (en) * 1955-05-09 1958-09-23 Cutter Lab Flexible container with integral flow control
US3648697A (en) * 1969-08-01 1972-03-14 Gardner Newell J Intravenous feeding container and method of preparing the same
US4187847A (en) * 1977-07-11 1980-02-12 Loeser Edward A Airless intravenous fluid system
US5352213A (en) * 1993-11-16 1994-10-04 Woodard Robert W Intravenous fluid flow monitor
US5853388A (en) * 1997-08-21 1998-12-29 Semel; David Intravenous bag with separate compartment

Also Published As

Publication number Publication date
EP2459257A1 (fr) 2012-06-06
CA2769242A1 (fr) 2011-02-03

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