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WO1997003714A1 - Dispositif pour intraveineuses controlant le debit par gravite - Google Patents

Dispositif pour intraveineuses controlant le debit par gravite Download PDF

Info

Publication number
WO1997003714A1
WO1997003714A1 PCT/US1996/010809 US9610809W WO9703714A1 WO 1997003714 A1 WO1997003714 A1 WO 1997003714A1 US 9610809 W US9610809 W US 9610809W WO 9703714 A1 WO9703714 A1 WO 9703714A1
Authority
WO
WIPO (PCT)
Prior art keywords
administration set
fluid administration
tubing
flow controlling
length
Prior art date
Application number
PCT/US1996/010809
Other languages
English (en)
Inventor
George T. Walker, Iii
Robert S. Vasko
Ronald J. Vidischak
Thomas K. Roberts
Original Assignee
Block Medical, Inc.
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 Block Medical, Inc. filed Critical Block Medical, Inc.
Priority to AU62893/96A priority Critical patent/AU6289396A/en
Publication of WO1997003714A1 publication Critical patent/WO1997003714A1/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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16818—Flow controllers by changing the height of the reservoir
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/141—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor with capillaries for restricting fluid flow

Definitions

  • the present invention relates to intravenous (I.V.) infusion apparatus and pertains particularly to an I.V. ⁇ set for controlling the rate of flow from gravity feed infusion apparatus.
  • I.V. intravenous
  • Intravenous therapy is a widely used method of fluid and drug delivery to a patient. Many different types of intravenous drug delivery systems exist and are in use today. Where cost is not a factor, electronically controlled, electrically-driven pumps are used and typically provide highly accurate and highly reliable infusion systems. However, cost is a major factor in a high percentage of health care situations today.
  • the flow rate is the volume infused over a certain period of time.
  • the flow rate is determined by the pressure of the fluid and resistance in the delivery lines.
  • the pressure or head of a gravity feed I.V. device is determined by the head height.
  • the head height is the distance between the fluid level in the container and the patient's I.V. site.
  • the head height must be sufficient to establish sufficient pressure to overcome the back pressure of the venous system, which is approximately 0.6 psi.
  • Gravity generates approximately 0.5 psi per foot of head height.
  • Resistance to flow in the system arises from many sources, including fluid viscosity, vein size and other factors. Establishing and maintaining the prescribed flow rate is one of the most difficult and time consuming problems in I.V. therapy. It is critical to establish and maintain an accurate flow rate in order to promote safe, effective therapy.
  • roller clamps operate by compressing the tubing to provide a restriction to control the flow rate. Roller clamps are not very accurate and are considered unacceptable in some clinical situations. Furthermore,, accidental or inadvertent disengagement of the roller clamp can cause overinfusion.
  • a number of in-line manually adjustable flow regulators are also available. These provide some form of adjustable restriction in the line to control flow. Nevertheless, they are expensive and can be tampered with by patients.
  • the present invention comprises a flow controlling fluid administration set and method for using it to administer fluids to patients at an accurate, predetermined flow rate.
  • the proximal end of the administration set may comprise a connector, such as a luer connector, a spike, or a valve, suitable for receiving the fluid to be administered, or it may comprise an integral fluid reservoir, such as an I.V. bag.
  • the distal end of the administration set comprises a connector, such as a luer connector or a valve-operated connector, suitable for removably attaching an I.V. needle or other fluid administration device.
  • the administration set also comprises at least one length of pliant tubing between the proximal and distal ends.
  • the administration set has an orifice, the diameter and length of which are determinative of the flow rate at a given pressure in accordance with Bernoulli's formula.
  • the orifice should have a diameter less than approximately .030 inches.
  • the dimensions of the orifice should be selected to provide a flow rate that is lower than that provided by any other component of the fluid administration set.
  • the orifice may be integrally formed with the pliant tubing.
  • the orifice may be defined by a length of micro-bore tubing.
  • the orifice may be a separate element, such as a tube made of glass, stainless steel, ceramic or other rigid material.
  • the orifice may have any suitable length; it may be coextensive with the length of administration set, or it may be disposed at any point on the administration set.
  • Gravity is used to generate pressure by disposing the proximal end of the administration set at a suitable head height.
  • Suitable indicia referred to herein for convenience as a “flag, " may be disposed on the administration set for indicating its flow rate.
  • the flag may be disposed at a predetermined distance from the proximal end equal to the head height at which a user should place the proximal end when setting up the apparatus to achieve the indicated flow rate.
  • the administration set may be used to administer fluids intravenously, enterally, or in any other suitable manner.
  • Fig. 1 is a diagrammatic illustration showing a patient receiving an I.V. infusion from an apparatus according to the invention
  • Fig. 2 illustrates a first exemplary embodiment
  • FIG. 3 illustrates a second exemplary embodiment
  • Fig. 4 illustrates a third exemplary embodiment
  • Fig. 5 illustrates a fourth exemplary embodiment
  • Fig. 6 illustrates a fifth exemplary embodiment
  • Fig. 7 illustrates a sixth exemplary embodiment
  • Fig. 8 illustrates a seventh exemplary embodiment
  • Fig. 9 illustrates an eighth exemplary embodiment
  • Fig. 1 0 illustrates a ninth exemplary embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • the present invention may be used to administer an I.V. infusion to a patient 10 at a site 1 2.
  • An I.V. site is defined as the place where a catheter or other instrument is inserted into the patient for the intravenous infusion.
  • a fluid administration set 1 8 is connected in-line between an I.V. bag or similar fluid reservoir 20 and I.V. site 1 2.
  • Fluid administration set 1 8 establishes a precise, predetermined flow rate of the fluid to the patient.
  • Fluid administration set 1 8 may be used in a home care or hospital environment where parenteral solutions are delivered from a single dose I.V. set.
  • Fluid administration set 1 8 is connected between a small length of tubing 14, which is attached to the catheter (not shown), and another length of tubing 22, which is attached to reservoir 20.
  • the connection between tubing 14 and the catheter is well-known in the art and not described herein.
  • connection between tubing 22 and reservoir 20 may utilize any suitable type of connector known in the art, such as a spike (not shown).
  • Reservoir 20 is positioned at a head height H above the infusion site.
  • the effect of gravity on a fluid column at a head height H establishes a predetermined pressure P of approximately 0.5 psi per foot of head height.
  • the head height H should be greater than or equal to about 24 inches to provide sufficient pressure to overcome venous backpressure.
  • the head height H is preferably less than or equal to about 48 inches because it is inconvenient and unwieldy to mount a reservoir at a greater height. This range of head heights H yields a range of pressures of between approximately one and two psi.
  • a preferred head height H is 36 inches.
  • a clamp 26, such as a Roberts clamp or pinch clamp, may be applied to tubing 22 to stop the flow when desired.
  • fluid administration set 1 8 comprises a single piece of micro-bore tubing 1 9 having a male luer connector 30 on the proximal or upstream end and a female luer connector 28 on the distal or downstream end. Nevertheless, in other embodiments, either end may have either a male or female connector.
  • "Micro-bore" tubing is a well-known term of art that generally refers to tubing having an inside diameter less than about .030 inches.
  • Micro-bore tubing 1 9 is preferably made of non-DEHP PVC. Micro-bore tubing 1 9 has dimensions that produce a precise flow rate, which is typically measured in milliliters per hour (ml/hr), in accordance with Bernoulli's formula:
  • micro-bore tubing 1 9 alone defines the orifice; the length L of the orifice is equal to the length of micro- bore tubing 1 9, and the radius R of the orifice is equal to one-half the inside diameter (ID) of micro-bore tubing 1 9.
  • ID inside diameter
  • a non-vented male luer connector cap 32 is provided for capping female luer connector 28, and a non-vented female luer connector cap 34 is provided for capping male luer connector 30.
  • male luer connector 30 is connected to a female luer connector 31 on tubing 22
  • female luer connector 28 is connected to a male luer connector 1 6 on tubing 14.
  • fluid administration set 1 8 is shown connected in-line between two other lengths of non-flow-controlling tubing ( 14 and 22), in other embodiments a fluid administration set may be connected directly between a needle and a fluid reservoir if suitable connectors are provided, as illustrated more clearly with respect to certain embodiments described below.
  • Fluid administration set 1 8 also comprises a color-coded flag 36. The color indicates the flow rate of that particular fluid administration set 1 8 at a predetermined head height, such as 36 inches.
  • a group of fluid administration sets (not shown), each having a different flow rate at a head height of 36 inches, as indicated by a uniquely colored flag 36, may be provided. A user may place I.V.
  • a fluid administration set comprises a length of micro-bore tubing 40 integrally connected, e.g., by RF or ultrasonic welding or by bonding, to another length of tubing 42.
  • Micro-bore tubing 40 is preferably as described above with respect to the embodiment illustrated in Fig. 2 and is selected to produce the desired flow rate.
  • Tubing 42 is selected to allow a flow rate greater than that allowed by micro-bore tubing 40.
  • Micro-bore tubing 40 thus controls the flow rate in the same manner as described above with respect to the embodiment illustrated in Fig. 2.
  • a fluid reservoir 44 is integrally connected, e.g., by RF or ultrasonic welding or by bonding, to tubing 42, and a luer connector 46 is attached to the distal end of micro- bore tubing 40.
  • the fluid administration set may include a rate flag 47 as described above with respect to the embodiment illustrated in Fig. 2.
  • the fluid administration set may be used in a manner similar to that described above with respect to Fig. 1 .
  • flag 36 is preferably attached to the fluid administration set at a distance from the proximal end equal to the head height H required to generate the indicated flow rate.
  • a fluid administration set comprises two lengths of tubing 48 and 50, between which is disposed a glass tube 52.
  • Glass tube 52 is preferably encased in plastic to provide strength and resistance to breakage.
  • the inside diameter and length of glass tube 52 define the orifice diameter and length, respectively.
  • Tubing 48 and 50 are selected to allow a flow rate greater than that allowed by glass tube 52. Glass tube 52 thus controls the flow rate in the same manner as described above with respect to other embodiments.
  • a male luer connector 54 is attached to the proximal end of tubing 48, and a female luer connector 56 is attached to the distal end of tubing 50. Nevertheless, either a male or female luer connector may be attached to either end of the fluid administration set.
  • the fluid administration set may include a rate flag 57.
  • the fluid administration set may be used in the manner described above with respect to other embodiments.
  • a fluid administration set comprises a length of tubing 58.
  • tubing 58 may be micro-bore tubing that controls the flow rate
  • a glass tube 60 shown in broken line, may be disposed in-line in tubing 58 to control the flow rate.
  • a spike connector 62 of the type commonly used in I.V. administration sets is attached to the proximal end of tubing 58, and a luer connector 64 is attached to the distal end of tubing 58.
  • Spike connector 62 may be connected to fluid reservoir 20 as noted above with respect to Fig. 1 .
  • the fluid administration set may include a rate flag 65.
  • the fluid administration set may be used in the manner described above with respect to other embodiments.
  • a fluid administration set comprises a length of tubing 66.
  • tubing 66 may be micro-bore tubing that controls the flow rate
  • a glass tube 68 shown in broken line, may be disposed in-line in tubing 66 to control the flow rate.
  • a valve-operated connector 70 is attached to the proximal end of tubing 66, and a luer connector 72 is attached to the distal end of tubing 66.
  • Valve-operated connector 70 is normally closed, but opens in response to mating with a corresponding connector (not shown).
  • Valve-operated connector 70 includes a resilient member (not shown), such as a spring or elastomeric diaphragm, that biases the valve into the closed position.
  • a suitable valve-operated connector 70 is manufactured and sold by Burron Medical Inc., a division of Braun, under the trademark SAFSITE ® and is described in U.S. Patent No. 4,683,91 6.
  • the fluid administration set may include a rate flag 73. The fluid administration set may be used in the manner described above with respect to other embodiments.
  • a fluid administration set comprises a length of tubing 74.
  • tubing 74 may be micro-bore tubing that controls the flow rate
  • a glass tube 76 shown in broken line, may be disposed in-line in tubing 74 to control the flow rate.
  • the proximal end of tubing 74 is integrally connected, e.g., by RF or ultrasonic welding or by bonding, to a fluid reservoir 78, and the distal end of tubing 74 is attached to a luer connector 80.
  • the fluid administration set may include a rate flag 81 .
  • the fluid administration set may be used in the manner described above with respect to other embodiments.
  • a fluid administration set comprises a length of tubing 82.
  • tubing 82 may be micro-bore tubing that controls the flow rate
  • a glass tube 84 shown in broken line, may be disposed in-line in tubing 82 to control the flow rate.
  • a spike connector 86 is attached to the proximal end of tubing 82, and a valve-operated connector 88 is attached to the distal end of tubing 82.
  • the fluid administration set may include a rate flag 89.
  • the fluid administration set may be used in the manner described above with respect to other embodiments.
  • a fluid administration set comprises a length of tubing 90.
  • tubing 90 may be micro-bore tubing that controls the flow rate
  • a glass tube 92 shown in broken line, may be disposed in-line in tubing 90 to control the fiow rate.
  • the proximal end of tubing 90 is integrally connected, e.g., by RF or ultrasonic welding or by bonding, to a fluid reservoir 94, and the distal end of tubing 90 is attached to a valve-operated connector 96.
  • the fluid administration set may include a rate flag 97.
  • the fluid administration set may be used in the manner described above with respect to other embodiments.
  • a fluid administration set comprises a length of tubing 98.
  • tubing 98 may be micro-bore tubing that controls the flow rate
  • a glass tube 1 00 shown in broken line, may be disposed in-line in tubing 98 to control the flow rate.
  • a valve-operated connector 102 is attached to the proximal end of tubing 98, and another valve-operated connector 104 is attached to the distal end of tubing 82.
  • the fluid administration set may include a rate flag 105.
  • the fluid administration set may be used in the manner described above with respect to other embodiments. Obviously, other embodiments and modifications of the present invention will occur readily to those of ordinary skill in the art in view of these teachings. Therefore, this invention is to be limited only by the following claims, which include all such other embodiments and modifications when viewed in conjunction with the above specification and accompanying drawings.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Dispositif d'administration de liquides par gravité assurant un débit prédéterminé pour une différence de niveau prédéterminée. Le dispositif comprend au moins une longueur de tube souple, qui peut être microporeux, ainsi qu'un raccord permettant à un utilisateur de raccorder une extrémité du dispositif à une aiguille destinée à un patient. L'autre extrémité du dispositif peut comporter soit un autre raccord soit un réservoir intégré de liquide, tel qu'une poche pour intraveineuses. Le dispositif comporte un orifice de diamètre et de longueur préétablis qui, pour une différence de niveau prédéterminée, correspond au débit selon la formule de Bernoulli. L'orifice peut être défini par une longueur de tube microporeux ou par un élément rigide tel qu'un tube de verre.
PCT/US1996/010809 1995-07-24 1996-06-24 Dispositif pour intraveineuses controlant le debit par gravite WO1997003714A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU62893/96A AU6289396A (en) 1995-07-24 1996-06-24 Gravity feed flow controlling i.v. administration set

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US50642695A 1995-07-24 1995-07-24
US08/506,426 1995-07-24

Publications (1)

Publication Number Publication Date
WO1997003714A1 true WO1997003714A1 (fr) 1997-02-06

Family

ID=24014549

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/010809 WO1997003714A1 (fr) 1995-07-24 1996-06-24 Dispositif pour intraveineuses controlant le debit par gravite

Country Status (2)

Country Link
AU (1) AU6289396A (fr)
WO (1) WO1997003714A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3298367A (en) * 1964-01-10 1967-01-17 Richard I Bergman Apparatus for administering parenteral liquids
FR2441150A1 (fr) * 1978-11-08 1980-06-06 Minnesota Mining & Mfg Dispositif de distribution de fluide
EP0032792A2 (fr) * 1980-01-18 1981-07-29 Alza Corporation Appareil pour infusion médicale
WO1986003978A1 (fr) * 1985-01-07 1986-07-17 Baxter Travenol Laboratories, Inc. Perfuseur ayant un regulateur d'ecoulement distal
US5409477A (en) * 1993-09-23 1995-04-25 Abbott Laboratories Solution administration apparatus with orifice flow control device
WO1995021643A1 (fr) * 1994-02-09 1995-08-17 Matef Dispositif de tubulure a petit debit et appareil d'injection de produit pharmaceutique utilisant un tel dispositif

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3298367A (en) * 1964-01-10 1967-01-17 Richard I Bergman Apparatus for administering parenteral liquids
FR2441150A1 (fr) * 1978-11-08 1980-06-06 Minnesota Mining & Mfg Dispositif de distribution de fluide
EP0032792A2 (fr) * 1980-01-18 1981-07-29 Alza Corporation Appareil pour infusion médicale
WO1986003978A1 (fr) * 1985-01-07 1986-07-17 Baxter Travenol Laboratories, Inc. Perfuseur ayant un regulateur d'ecoulement distal
US5409477A (en) * 1993-09-23 1995-04-25 Abbott Laboratories Solution administration apparatus with orifice flow control device
WO1995021643A1 (fr) * 1994-02-09 1995-08-17 Matef Dispositif de tubulure a petit debit et appareil d'injection de produit pharmaceutique utilisant un tel dispositif

Also Published As

Publication number Publication date
AU6289396A (en) 1997-02-18

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