WO1991001769A1 - Blood/solution administration sets and components therefor - Google Patents

Blood/solution administration sets and components therefor Download PDF

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Publication number
WO1991001769A1
WO1991001769A1 PCT/AU1990/000318 AU9000318W WO9101769A1 WO 1991001769 A1 WO1991001769 A1 WO 1991001769A1 AU 9000318 W AU9000318 W AU 9000318W WO 9101769 A1 WO9101769 A1 WO 9101769A1
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WO
WIPO (PCT)
Prior art keywords
blood
solution
flow
cannula
valve
Prior art date
Application number
PCT/AU1990/000318
Other languages
French (fr)
Inventor
Edgar Malcolm Stubbersfield
Original Assignee
Stubbersfield, Beryl, Grace
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 Stubbersfield, Beryl, Grace filed Critical Stubbersfield, Beryl, Grace
Publication of WO1991001769A1 publication Critical patent/WO1991001769A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means 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
    • A61M5/16831Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16854Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/36Devices 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
    • A61M5/40Devices 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

Definitions

  • This invention relates to blood/solution administration sets and components therefor.
  • the air that enters the line comes from the air that is in the administration set itself and from the air which is in the top of the bags of blood/solution.
  • the suction of the vein allows the blood/solution to empty from the body of the administration set before sufficient vacuum is created in the system to stem the flow.
  • the air has to be removed from the line, either by forcing it back up the line into the administration set of by sucking it up into a hypodermic needle.
  • a number of accessories are provided along the tubing of the administration set. These include a slide valve, or roller regulator as it is commonly called, to control the flow of blood or solution, a one way valve to prevent liquids flowing back up the tubing towards the bag and an injection port.
  • the injection port allows the medical staff to give a patient an injection without having to actually place the needle in the patient himself.
  • the slide valve is operated by the anaesthesist and during a major operation, there may be a number of doctors working on the same patient and the anaesthesist has to control the flow of solution from a distance.
  • the draw back with the slide valve is that though it is simple to use it only relies on friction between smooth plastic parts to stay in adjustment. These often slip and the nursing staff have to constantly monitor the flow of solution.
  • the one way valve and the injection port need to be as close to each other and to the patient as is practical. This is to ensure that any medication that is administered goes directly to the patient and does not travel up the administration tubing.
  • the steel cannula has given way to a soft flexible tube which has, at one end, a flared fitting.
  • This fitting has an internal taper called a luer, the dimensions of which are internationally standard.
  • the outside of this fitting may have two lugs which allow a screw fitting, called a luer lock, to secure the administration set to the cannula.
  • a trochar is used while it is being inserted.
  • This trochar is hollow to allow blood to flow out of it freely when the cannula is correctly inserted in the vein. When the doctor is happy with the placement of the cannula, the trochar is removed and a primed administration set connected.
  • This simple device which is intended to preserve the life of a patient, can actually be the direct cause of injury to the patient and/or the medical staff.
  • the patient is at risk because the flexible cannula can detach from the luer fitting and be sucked up the vein and lodge in either the heart or the brain.
  • the cannula tube must be opaque to X-rays to enable a surgeon to locate and remove these before death ensures.
  • Another risk to life is the luer connection itself. It is often used without the lock and then only relies on friction to remain in place. Should the administration set become detached from the cannula when the patient is either asleep or debilitated, he could easily bleed to death.
  • Another problem with the cannula is the fact that as it is made of flexible material, it frequently kinks and interrupts the flow of liquid into the vein.
  • a degree of misalignment in the cannula as some of the administration set tubing and the flared fitting are taped parallel to the outer surface of the arm with its centre line about 2 to 3mm above the surface while the vein is under the surface.
  • this is only a nuisance to the medical staff but depending on the seriousness of the patient's condition and the liquid being administered, this can be critical.
  • This problem of misalignment is compounded if a luer lock is used, as it raises the flared fitting by another millimeter. Often when a luer lock is fitted to an administration set, the lock itself is not used because of its nuisance value.
  • the present invention resides in a flow unit for a blood/solution administration set including: a body; an inlet in the body connectable to a blood/solution bag; an outlet from the body connectable to a line; wherein: the body is separated into an upper chamber, connected to the inlet, and a lower chamber connected to the outlet, by a dividing wall having a flow passage therethrough; a valve seat is provided in the flow passage in the upper chamber; and a buoyant valve member in the upper chamber is engageable with the valve seat to seal the flow passage when the upper chamber is empty.
  • the buoyant valve member is spherical and is unseated where there is blood/solution in the upper chamber.
  • the dividing wall is formed by the drip former in the body.
  • a filter is provided in the upper chamber upstream of the valve member.
  • a pressure switch may be fitted to the lower chamber to trigger an alarm when the bottom chamber is empty.
  • the line may be provided with a flow regulator or tap and may be connected to a hypodermic needle or cannula.
  • the present invention resides in a one-way valve for a blood/solution administration set including: a tubular body having an inlet and an outlet connectable to respective lengths of tubing; a valve body in a chamber in the body intermediate the inlet and the outlet; a plurality of flow passages through the valve body; and a reed or diaphragm valve adjacent the outlet side of the valve body having at least one flexible portion operable to open the flow passages to allow blood/solution to flow from the inlet to the outlet but operable to close the flow passages to prevent flow in the opposite direction.
  • an injection port unit for a blood/solution administration set including: a one-way valve as hereinbefore described; and at least one injection port tube formed integrally with the body, the tube having an injection inlet to receive a solution from a syringe and an injection outlet in communication with the chamber between the valve body and the outlet of the tubular body.
  • the present invention resides in a multiple injection port unit for a blood/solution administration set, including: a one-way valve as hereinbefore described; an injection head having a plurality of injection inlets to receive solutions from respective syringes, rotatably mounted on the body; and an injection passage interconnecting the head and the chamber between the valve body and the outlet, so arranged that the head is selectively rotatable to align a respective one of the injection inlets with the injection passage.
  • a respective cap or plug is provided for each injection inlet and is disposed of when its inlet has been used for the administration of solution.
  • a tap may be provided upstream of the one-way valve and may be incorporated in the tubular body.
  • the present invention resides in a safe cannula and trochar system for a blood/solution administration set including: a cannula of the type having a tubular body with a female luer at one end; and a trochar assembly, said assembly including a tubular guard engageable with the female luer, an operating rod slidably mounted in the guard and a trochar mounted at one end of the operating rod extendible by the operating rod into the cannula when the latter is inserted into the patient's vein and retractable into the guard when blood flows from the vein into the cannula.
  • the cannula has at least one concertina-like configuration in the tubular body adjacent the female luer.
  • the female luer has a peripheral rim or lugs engageable by a clip on a complementary male luer on a tube connected to the cannula.
  • FIG 1 is a schematic view of a blood/solution administration set in use
  • FIG 2 is a schematic view of a portion of the set on a larger scale
  • FIG 3 is a sectional side view of the cannula/trochar assembly for installation of the cannula;
  • FIG 4 is a sectional side view showing the trochar retracted into its guard;
  • FIG 5 is an end view corresponding to FIG 4;
  • FIG 6 is a sectional side view of an alternative embodiment of the trochar assembly
  • FIG 7 is a sectional side view of the cannula;
  • FIG 8 is a similar view showing the operation of the concertina during insertion of the cannula;
  • FIG 9 is a similar view showing the operation of the concertina during misalignment.
  • FIG 10 shows the operation of the concertina if the cannula becomes detached
  • FIG 11 is a sectional side view showing a tube clipped to the cannula
  • FIG 12 is a front view of the luer clip
  • FIG 13 is a sectional side view of the flow unit
  • FIG 14 is a sectional side view of an alternative flow unit
  • FIG 15 is a sectional side view of an alarm unit fitted to the flow unit;
  • FIG 16 is a sectional plan view of a single injection port fitted with a one-way valve and tap;
  • FIG 17 is a sectional side view of the tap
  • FIGS 18 and 19 are plan views of the valve body and reed valve for the one-way valve;
  • FIG 20 is a side view of an alternative diaphragm one-way valve;
  • FIGS 21 and 22 are respective plan and sectional side views of the diaphragm valve.
  • FIG 23 is an isometric view of a multiple injection site; and FIG 24 is a sectional side view of the multiple injection site.
  • the blood/solution administration set (FIGS 1 and 2) 10 has a blood or solution bag 11 supported from a stand 12 and supplies blood, saline solution or the like to a cannula assembly 13 in the patient's arm 14.
  • the solution flows through a flow unit 15
  • FIG 1 A male luer 20 connects the tubing to the cannula 13.
  • the cannula 13 has a flexible plastic tubular body 21 with a flared fitting
  • the assembly 24 has a tubular plastic body 25, open at one end and closed by an end wall 26 at the other end.
  • An operating rod 27 is slidably mounted in the end wall 26 and has ratchet teeth 28 engageable by a pawl in the end wall
  • a metal trochar 29 is attached to the rod 27 by a head 30 which has an opening 31.
  • the trochar 29 is inserted in to the cannula 13 as shown in FIG 3, and the cannula 13 is inserted into a vein in the patient's arm 14.
  • the operating rod 27 is pulled to withdraw the trochar 29 into the guard 25 so that its tip is enclosed (see FIG 4).
  • the trochar assembly 24 is removed and the male luer 20 can be attached to the cannula 13 as hereinafter described.
  • the guard 33 has a cap 34 which engages the female luer 23 of the cannula 13.
  • the cap 34 has integral finger grips and this version collects the patient's blood more efficiently when the cannula is inserted and the trochar 35 is withdrawn.
  • a concertina-like formation 36 is provided in the tubular body 21 adjacent the fitting 22.
  • the formation is even about its circumference (see FIG 7) but is compressed when the cannula 13 and trochar are installed so that the ends of the tube 21 on each side of the formation 36 bear against each other giving almost the strength of a continuous piece of tube.
  • the tube will kink at the formation 36 but flow will be unobstructed. If the tube and flanged fitting 22 should become detached, the formation 36 will act as a guard to prevent the tube 21 being sucked into the vein. The tube 21 can be gripped in the fingers and safely withdrawn.
  • a luer clip 37 (FIGS 11, 12) may be used to releasably secure the male luer 20 on the tubing 19 to the cannula 13.
  • the clip has a pair of lugs 38 which engage the rim of the flanged fitting 22 on the cannula 13 and an internal ring 39 which engages on the rear face of the peripheral rim (or lugs) 40 on the male luer 20.
  • the clip can be released by squeezing a pair of finger grips 41 to spread the lugs 38 and release them from the cannula 13.
  • the clip 37 could be moulded integrally with the male luer fitting 20.
  • the flow unit 42 has a two-part body 43 where the upper chamber 44 has an inlet 45 connected to the blood/solution bag 11 and a lower
  • SUBSTITUTESHEET chamber 46 with an outlet 47 connected to the tubing 19 leading to the flow regulator 16.
  • the upper and lower chambers 44, 46 are separated by a drip former 48 which as a flow passage 49 surrounded by a valve seat 50.
  • a buoyant valve ball 51 floats above the valve seat 50, in the solution, constrained by a filter 52.
  • valve ball 51 When the solution is flowing into the upper chamber 44 from the bag 11, the valve ball 51 floats above the valve seat 50 and the solution can flow into the lower chamber 46. When the bag is emptied, the solution level in the upper chamber 44 will drop until the valve ball 51 seats on the valve seat 50. The suction created in the lower chamber 46 by the flow of solution to the patient's arm will hold the valve ball
  • the bag 11 may be changed for a fresh blood/solution bag and when the solution flows into the upper chamber 44, it will unseat the valve ball 51 and flow to the patient will recommence without the problem of air entering the lower chamber 46.
  • FIG 14 shows an alternative embodiment of the flow unit 53 where the valve unit 54, drip former 55 and filter 56 are contained in the upper portion 57a of the body 57.
  • a pressure switch 58 may be fitted to a side port 59 in the lower chamber 60 of the flow unit 61, below the valve unit 62 and drip former 63.
  • SUBSTITUTESHEET receiver 66 at a nurse's station to trip an audible alarm 67 and visual alarm 68.
  • FIGS 16 to 19 show a single injection unit 69 which incorporates an injection port 70, a one-way valve 71 and tap 72.
  • the unit 69 has a two-piece plastic body 73 with respective inlet and outlet connectors 74, 75 for the plastic tubing 19.
  • the injection port 70 is formed integrally with the body 73, being inclined thereto and directed in a downstream direction, below the one-way valve 71.
  • the port 70 may have a rubber membrane 76 to be pierced by a hypodermic needle, or a removable cap, not shown, to enable the nose of a syringe to be engaged with the port.
  • a tap 72 controls the flow of solution through the unit 69 and has a cylindrical tap member 77 with a transverse bore 78, the tap member has a spigot 79 releasably engageable by a handle 80 with a complementary bore to the spigot.
  • the one-way valve 71 allows the solution to flow to the cannula but is arranged to close and prevent reverse flow of the solution.
  • the valve also closes where, the pressure in the unit 69, downstream of the valve 71, increases when the solution is injected into the unit via port 71 so that the solution will not flow upstream.
  • the valve 71 has a disc-like valve body 82 (see FIG 18) with four fluid passages 83.
  • a reed valve 84 is located on the downstream side of the valve body 82 and has a plurality of flexible leaves 85 which selectively open and close the fluid passages 83.
  • diaphragm 87 is fitted to the underside of the valve body 82 and it has a flexible annular inner portion 88 which is movable to selectively allow flow of
  • the unit 69 may be modified to incorporate two or more injection ports, preferably equidistantly spaced around the tubular body 73.
  • the multiple injection site unit 89 has a tubular body 90 with a female luer fitting 91 at the upstream end and a male luer fitting 92 at the downstream end.
  • a tap 93 and one-way valve 94, of the respective types hereinbefore described, are provided in the body 90.
  • a head 95 is rotatably mounted on the body 90 and has four injection ports 96-99, each with an internal flow restriction and a standard female luer fitting.
  • An inclined injection passage 100 is provided in the main body 90 and selectively communicates with one of the injection ports 96-99 as the head 95 is rotated.
  • a pawl 101 on the head 95 engages a ratchet formation 102 on the body so that the head can only be rotated in one direction and the abutment forces on ratchet formation 102, when engaged by the pawl 101, ensures the injection passage 100 and its adjacent injection ports 96-99 are aligned.
  • a removable cap 104 is provided for each in ection port 96-99 and is removed when its respective port has been used to indicate that the port is no longer available. If preferred, the anaestetist may rotate the head 95 so that the injection passage 100 is intermediate two ports 96-99 when he inserts, or removes, the syringe from the luer fittings in the injection ports.
  • a rectangular base 105 stabilizes the unit 89 on the patient's arm 14.
  • SUBSTITUTESHEET injection unit BO may also be used for the extraction of blood from the patient's veins for testing.

Abstract

A blood/solution administration set (10) has a blood/solution bag (11) supplying blood, saline solution or the like to a patient via a cannula (13) in his arm (14). A flow unit (15) has a valve which shuts off the flow through the tubing (19) when the bag (11) is emptied and prevents air entering the tubing (19) when the bag (11) is replaced. A multiple injection site unit (17) enables an anaesthetist to inject medication into the solution flow through respective injection ports which are only used once.

Description

TITLE: "BLOOD/SOLUTION ADMINISTRATION SETS AND COMPONENTS THEREFOR"
BACKGROUND OF THE INVENTION
1. Field of the Invention This invention relates to blood/solution administration sets and components therefor.
2. Prior Art
It is a common problem with blood/solution administration sets that when a bag of blood/solution runs dry, the bag cannot be simply changed for another and the tap turned on as air has entered the' line.
To allow a large amount of air to enter the blood stream could have fatal consequences. A great deal of nursing time could be saved if the air could be prevented from entering the line in the first place and the exclusion of the air would increase safety markedly.
The air that enters the line comes from the air that is in the administration set itself and from the air which is in the top of the bags of blood/solution. The suction of the vein allows the blood/solution to empty from the body of the administration set before sufficient vacuum is created in the system to stem the flow.
Should the administration set be left for a period of time without liquid travelling through the tubing, the vein in which it is inserted soon collapses. Because of this, it is important to replace the bag of solution or remove the cannula as quickly as possible after the flow stops. At present, there is no simple means for preventing the air from entering the line. A known burette has a flap valve in its base but has proved a failure as the valve is liable to stick. Electronic drip monitors are available but are expensive and prone to false alarms.
The air has to be removed from the line, either by forcing it back up the line into the administration set of by sucking it up into a hypodermic needle.
A number of accessories are provided along the tubing of the administration set. These include a slide valve, or roller regulator as it is commonly called, to control the flow of blood or solution, a one way valve to prevent liquids flowing back up the tubing towards the bag and an injection port. The injection port allows the medical staff to give a patient an injection without having to actually place the needle in the patient himself.
It has always been the practice of manufacturers of medical equipment to make these as three separate items and fit them separately. Unfortunately, this is often necessary with the slide valve.
During an operation, the slide valve is operated by the anaesthesist and during a major operation, there may be a number of doctors working on the same patient and the anaesthesist has to control the flow of solution from a distance. The draw back with the slide valve is that though it is simple to use it only relies on friction between smooth plastic parts to stay in adjustment. These often slip and the nursing staff have to constantly monitor the flow of solution. The one way valve and the injection port need to be as close to each other and to the patient as is practical. This is to ensure that any medication that is administered goes directly to the patient and does not travel up the administration tubing.
Though the slide valve and injection port are economically priced, the one way valve is quite expensive. The most popular style, termed a duckbill valve, because of its similarity in appearance to a duck's bill, can cost almost as much as the rest of the administration set. A typical system can involve six moulded pieces, require five glue joints and one slip over assembly. As these items are made by the millions, any savings that can be made through simplifying the construction of these accessories would be substantial.
When a patient has to undergo major surgery, the anaesthetist may have to give further injections to the one that initially rendered him unconscious. These injections could number five or six in total. In the past, there has been several ways of doing this. One of the simplest has been a Y port directly behind the cannula. This has the draw back of requiring the syringe to be inserted into the same luer fitting (as the internationally standard taper joint is called) each time and increases the risk of infection. This is because after the first injection, the luer fitting becomes moist and may become a breeding ground for bacteria. Anaesthetists are now very conscious for the need to have a dry port for each injection. It is possible to use the Y port in the administration set in conjunction with a hypodermic needle, but this is too far from the cannula to be very satisfactory.
Recently, various products have come on the market which attempt to fill this need. These have not gained universal acceptance, not because they do not work well, rather, due to their complexity they have proved too expensive in a very cost conscious industry. Another reason for their non-acceptance is because they do not offer a sufficient number of injection sites. A doctor could simply use a hypodermic each time as when the cannula itself was installed but because of the risk of infectious diseases being caught through an accidental prick with a contaminated needle, this alternative is no longer acceptable. The injection site must save the doctor the risk of using a hypodermic. The doctor is further at risk if he has to take a blood
SUBSTITUTESHEET sample with a hypodermic as is often done during an operation. Any injection port should be capable of operating in reverse and permit the taking of samples.
When a patient has to be given a bag of blood, saline or other solution, this has to be given directly into a vein. To do this, the bag is hung above the patient and the fluid runs through the administration set into a cannula inserted directly into a vein.
Over recent years, the steel cannula has given way to a soft flexible tube which has, at one end, a flared fitting. This fitting has an internal taper called a luer, the dimensions of which are internationally standard. The outside of this fitting may have two lugs which allow a screw fitting, called a luer lock, to secure the administration set to the cannula. As the cannula is flexible, it cannot pierce the skin and an internal reinforcement called a trochar is used while it is being inserted. This trochar is hollow to allow blood to flow out of it freely when the cannula is correctly inserted in the vein. When the doctor is happy with the placement of the cannula, the trochar is removed and a primed administration set connected.
This simple device, which is intended to preserve the life of a patient, can actually be the direct cause of injury to the patient and/or the medical staff.
The risk to the medical staff is through the spread of dangerous diseases such as AIDS and Hepatitis. After the trochar is withdrawn from the patient, it must be capped with a plastic guard. Most accidental jabs actually occur when the medical staff are trying to make the trochar safe by capping it. Common causes of this accident are simply missing the mouth of the guard or pushing the trochar through the thin plastic guard. A further danger to the staff occurs when a luer lock is installed into the cannula. This can be a slow process because of the small sizes of the components and the extreme care necessary not to kink the cannula. Because of the time taken, a sizeable quantity of blood may escape and with it, the increased risk of infection.
The patient is at risk because the flexible cannula can detach from the luer fitting and be sucked up the vein and lodge in either the heart or the brain. Under Australian law, the cannula tube must be opaque to X-rays to enable a surgeon to locate and remove these before death ensures. Another risk to life is the luer connection itself. It is often used without the lock and then only relies on friction to remain in place. Should the administration set become detached from the cannula when the patient is either asleep or debilitated, he could easily bleed to death.
Another problem with the cannula is the fact that as it is made of flexible material, it frequently kinks and interrupts the flow of liquid into the vein. There is of necessity a degree of misalignment in the cannula as some of the administration set tubing and the flared fitting are taped parallel to the outer surface of the arm with its centre line about 2 to 3mm above the surface while the vein is under the surface. Often, this is only a nuisance to the medical staff but depending on the seriousness of the patient's condition and the liquid being administered, this can be critical. This problem of misalignment is compounded if a luer lock is used, as it raises the flared fitting by another millimeter. Often when a luer lock is fitted to an administration set, the lock itself is not used because of its nuisance value.
SUMMARY OF THE PRESENT INVENTION It is an object of the present invention to provide improvements in one or more components in an administration set to make the operation of the set simpler and/or safer for the medical staff.
It is a preferred object to make such improvements which improve the safety of the patient. It is a further preferred object to provide a simple valve in the flow unit for an administration set which will seal the administration set when the blood/solution is emptied from the bag.
It is a further preferred object to provide such a valve where the seating of the valve is aided by moisture on the seat and the suction by the vein.
It is a still further preferred object to provide a valve where the air above the valve is separated from the air below and does not enter the line.
It is a still further preferred object to provide a simple, efficient one way valve which can be close to an injection port.
It is a still further preferred object to provide a multiple injection site which reduces the risk of infection to medical staff and the patient.
It is a still further preferred object to provide a multiple injection site which indicates which injection sites have been used to prevent re-use. It is a still further preferred object to provide a cannula and trochar system which is safe for both the patient and the medical staff.
It is a still further preferred object to provide a means of removing the trochar in such a manner as to make it impossible for the medical staff to jab themselves.
It is a still further preferred object to provide a means of preventing a detached cannula tube from being drawn up a patient's vein. It is a still further preferred object to provide a means of preventing the luer fitting coming apart.
It is a still further preferred object to provide a means of allowing for a free flow of fluid through a misaligned cannula.
Other preferred objects of the present invention will become apparent from the following description.
In one aspect, the present invention resides in a flow unit for a blood/solution administration set including: a body; an inlet in the body connectable to a blood/solution bag; an outlet from the body connectable to a line; wherein: the body is separated into an upper chamber, connected to the inlet, and a lower chamber connected to the outlet, by a dividing wall having a flow passage therethrough; a valve seat is provided in the flow passage in the upper chamber; and a buoyant valve member in the upper chamber is engageable with the valve seat to seal the flow passage when the upper chamber is empty.
Preferably, the buoyant valve member is spherical and is unseated where there is blood/solution in the upper chamber.
Preferably, the dividing wall is formed by the drip former in the body. Preferably, a filter is provided in the upper chamber upstream of the valve member.
A pressure switch may be fitted to the lower chamber to trigger an alarm when the bottom chamber is empty. 8
The line may be provided with a flow regulator or tap and may be connected to a hypodermic needle or cannula.
In a second aspect, the present invention resides in a one-way valve for a blood/solution administration set including: a tubular body having an inlet and an outlet connectable to respective lengths of tubing; a valve body in a chamber in the body intermediate the inlet and the outlet; a plurality of flow passages through the valve body; and a reed or diaphragm valve adjacent the outlet side of the valve body having at least one flexible portion operable to open the flow passages to allow blood/solution to flow from the inlet to the outlet but operable to close the flow passages to prevent flow in the opposite direction.
In a third aspect, the present invention resides in an injection port unit for a blood/solution administration set including: a one-way valve as hereinbefore described; and at least one injection port tube formed integrally with the body, the tube having an injection inlet to receive a solution from a syringe and an injection outlet in communication with the chamber between the valve body and the outlet of the tubular body. In a fourth aspect, the present invention resides in a multiple injection port unit for a blood/solution administration set, including: a one-way valve as hereinbefore described; an injection head having a plurality of injection inlets to receive solutions from respective syringes, rotatably mounted on the body; and an injection passage interconnecting the head and the chamber between the valve body and the outlet, so arranged that the head is selectively rotatable to align a respective one of the injection inlets with the injection passage.
Preferably, a respective cap or plug is provided for each injection inlet and is disposed of when its inlet has been used for the administration of solution. A tap may be provided upstream of the one-way valve and may be incorporated in the tubular body.
In a fifth aspect, the present invention resides in a safe cannula and trochar system for a blood/solution administration set including: a cannula of the type having a tubular body with a female luer at one end; and a trochar assembly, said assembly including a tubular guard engageable with the female luer, an operating rod slidably mounted in the guard and a trochar mounted at one end of the operating rod extendible by the operating rod into the cannula when the latter is inserted into the patient's vein and retractable into the guard when blood flows from the vein into the cannula. Preferably, the cannula has at least one concertina-like configuration in the tubular body adjacent the female luer.
Preferably, the female luer has a peripheral rim or lugs engageable by a clip on a complementary male luer on a tube connected to the cannula.
BRIEF DESCRIPTION OF THE DRAWINGS To enable the invention to be fully understood, a number of preferred embodiments will now be described with reference to the accompanying drawings, in which:
SUBSTITUTESHEET FIG 1 is a schematic view of a blood/solution administration set in use;
FIG 2 is a schematic view of a portion of the set on a larger scale; FIG 3 is a sectional side view of the cannula/trochar assembly for installation of the cannula;
FIG 4 is a sectional side view showing the trochar retracted into its guard; FIG 5 is an end view corresponding to FIG 4;
FIG 6 is a sectional side view of an alternative embodiment of the trochar assembly;
FIG 7 is a sectional side view of the cannula; FIG 8 is a similar view showing the operation of the concertina during insertion of the cannula;
FIG 9 is a similar view showing the operation of the concertina during misalignment;
FIG 10 shows the operation of the concertina if the cannula becomes detached;
FIG 11 is a sectional side view showing a tube clipped to the cannula;
FIG 12 is a front view of the luer clip;
FIG 13 is a sectional side view of the flow unit;
FIG 14 is a sectional side view of an alternative flow unit;
FIG 15 is a sectional side view of an alarm unit fitted to the flow unit; FIG 16 is a sectional plan view of a single injection port fitted with a one-way valve and tap;
FIG 17 is a sectional side view of the tap;
FIGS 18 and 19 are plan views of the valve body and reed valve for the one-way valve; FIG 20 is a side view of an alternative diaphragm one-way valve;
SUBSTITUTESHEET FIGS 21 and 22 are respective plan and sectional side views of the diaphragm valve; and
FIG 23 is an isometric view of a multiple injection site; and FIG 24 is a sectional side view of the multiple injection site.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The blood/solution administration set (FIGS 1 and 2) 10 has a blood or solution bag 11 supported from a stand 12 and supplies blood, saline solution or the like to a cannula assembly 13 in the patient's arm 14.
The solution flows through a flow unit 15
(with a drip former), a flow regulator 16, a multiple injection site 17 (FIG 1) or single injection site 18 (FIG 2) to the cannula via clear plastic tubing 19. A male luer 20 connects the tubing to the cannula 13.
Referring to FIGS 3 to 5, the cannula 13 has a flexible plastic tubular body 21 with a flared fitting
22 provided with a female luer 23. To insert the cannula 13 into the patient's
■ arm 14, a trochar assembly 24 is used. The assembly 24 has a tubular plastic body 25, open at one end and closed by an end wall 26 at the other end. An operating rod 27 is slidably mounted in the end wall 26 and has ratchet teeth 28 engageable by a pawl in the end wall
26. A metal trochar 29 is attached to the rod 27 by a head 30 which has an opening 31.
In use, the trochar 29 is inserted in to the cannula 13 as shown in FIG 3, and the cannula 13 is inserted into a vein in the patient's arm 14. When blood flows through the opening 31, the operating rod 27 is pulled to withdraw the trochar 29 into the guard 25 so that its tip is enclosed (see FIG 4). The trochar assembly 24 is removed and the male luer 20 can be attached to the cannula 13 as hereinafter described.
SUBSTITUTESHEET In the modified form of the trochar assembly 32 of FIG 6, the guard 33 has a cap 34 which engages the female luer 23 of the cannula 13. The cap 34 has integral finger grips and this version collects the patient's blood more efficiently when the cannula is inserted and the trochar 35 is withdrawn.
As shown in more detail in FIG 7 to 10, a concertina-like formation 36 is provided in the tubular body 21 adjacent the fitting 22. When the cannula is unstressed, the formation is even about its circumference (see FIG 7) but is compressed when the cannula 13 and trochar are installed so that the ends of the tube 21 on each side of the formation 36 bear against each other giving almost the strength of a continuous piece of tube.
If the cannula should become misaligned (see FIG 9), the tube will kink at the formation 36 but flow will be unobstructed. If the tube and flanged fitting 22 should become detached, the formation 36 will act as a guard to prevent the tube 21 being sucked into the vein. The tube 21 can be gripped in the fingers and safely withdrawn.
A luer clip 37 (FIGS 11, 12) may be used to releasably secure the male luer 20 on the tubing 19 to the cannula 13. The clip has a pair of lugs 38 which engage the rim of the flanged fitting 22 on the cannula 13 and an internal ring 39 which engages on the rear face of the peripheral rim (or lugs) 40 on the male luer 20. The clip can be released by squeezing a pair of finger grips 41 to spread the lugs 38 and release them from the cannula 13. (The clip 37 could be moulded integrally with the male luer fitting 20. )
Referring to FIG 13, the flow unit 42 has a two-part body 43 where the upper chamber 44 has an inlet 45 connected to the blood/solution bag 11 and a lower
SUBSTITUTESHEET chamber 46 with an outlet 47 connected to the tubing 19 leading to the flow regulator 16.
The upper and lower chambers 44, 46 are separated by a drip former 48 which as a flow passage 49 surrounded by a valve seat 50. A buoyant valve ball 51 floats above the valve seat 50, in the solution, constrained by a filter 52.
When the solution is flowing into the upper chamber 44 from the bag 11, the valve ball 51 floats above the valve seat 50 and the solution can flow into the lower chamber 46. When the bag is emptied, the solution level in the upper chamber 44 will drop until the valve ball 51 seats on the valve seat 50. The suction created in the lower chamber 46 by the flow of solution to the patient's arm will hold the valve ball
51 on the valve seat, the moisture on the ball aiding the sealing.
The bag 11 may be changed for a fresh blood/solution bag and when the solution flows into the upper chamber 44, it will unseat the valve ball 51 and flow to the patient will recommence without the problem of air entering the lower chamber 46.
FIG 14 shows an alternative embodiment of the flow unit 53 where the valve unit 54, drip former 55 and filter 56 are contained in the upper portion 57a of the body 57.
Referring to FIG 15, a pressure switch 58 may be fitted to a side port 59 in the lower chamber 60 of the flow unit 61, below the valve unit 62 and drip former 63.
When the upper chamber 64 becomes empty and the valve unit 62 closes the flow passage through the drip former 63, the reduction in pressure in the lower chamber 60 causes the pressure switch 58 to operate and trigger a small transmitter 65 which sends a signal to a
SUBSTITUTESHEET receiver 66 at a nurse's station to trip an audible alarm 67 and visual alarm 68.
FIGS 16 to 19 show a single injection unit 69 which incorporates an injection port 70, a one-way valve 71 and tap 72.
The unit 69 has a two-piece plastic body 73 with respective inlet and outlet connectors 74, 75 for the plastic tubing 19. The injection port 70 is formed integrally with the body 73, being inclined thereto and directed in a downstream direction, below the one-way valve 71. The port 70 may have a rubber membrane 76 to be pierced by a hypodermic needle, or a removable cap, not shown, to enable the nose of a syringe to be engaged with the port. A tap 72 controls the flow of solution through the unit 69 and has a cylindrical tap member 77 with a transverse bore 78, the tap member has a spigot 79 releasably engageable by a handle 80 with a complementary bore to the spigot. The one-way valve 71 allows the solution to flow to the cannula but is arranged to close and prevent reverse flow of the solution. The valve also closes where, the pressure in the unit 69, downstream of the valve 71, increases when the solution is injected into the unit via port 71 so that the solution will not flow upstream.
The valve 71 has a disc-like valve body 82 (see FIG 18) with four fluid passages 83. A reed valve 84 is located on the downstream side of the valve body 82 and has a plurality of flexible leaves 85 which selectively open and close the fluid passages 83.
In a modified form of the one-way valve 86 (see FIGS 20-22) diaphragm 87 is fitted to the underside of the valve body 82 and it has a flexible annular inner portion 88 which is movable to selectively allow flow of
SUBSTITUTESHEET the solution through the fluid passages 83 in the direction of the arrows in FIG 20.
The unit 69 may be modified to incorporate two or more injection ports, preferably equidistantly spaced around the tubular body 73.
Referring to FIGS 23 and 24, the multiple injection site unit 89 has a tubular body 90 with a female luer fitting 91 at the upstream end and a male luer fitting 92 at the downstream end. A tap 93 and one-way valve 94, of the respective types hereinbefore described, are provided in the body 90.
A head 95 is rotatably mounted on the body 90 and has four injection ports 96-99, each with an internal flow restriction and a standard female luer fitting. An inclined injection passage 100 is provided in the main body 90 and selectively communicates with one of the injection ports 96-99 as the head 95 is rotated. A pawl 101 on the head 95 engages a ratchet formation 102 on the body so that the head can only be rotated in one direction and the abutment forces on ratchet formation 102, when engaged by the pawl 101, ensures the injection passage 100 and its adjacent injection ports 96-99 are aligned.
A removable cap 104 is provided for each in ection port 96-99 and is removed when its respective port has been used to indicate that the port is no longer available. If preferred, the anaestetist may rotate the head 95 so that the injection passage 100 is intermediate two ports 96-99 when he inserts, or removes, the syringe from the luer fittings in the injection ports.
A rectangular base 105 stabilizes the unit 89 on the patient's arm 14.
It will be readily apparent to the skilled addrsesee that the single injection unit 69 and multiple
SUBSTITUTESHEET injection unit BO may also be used for the extraction of blood from the patient's veins for testing.
The invention described and illustrated provides simple, yet efficient improvements to the blood/solution administration sets currently available. Various changes and modifications may be made to the embodiments described and illustrated without departing from the scope of the present invention defined in the appended claims.
SUBSTITUTESHEET

Claims

1. A flow unit for a blood/solution administration set including: a body; an inlet in the body connectable to a blood/solution bag; an outlet from the body connectable to a line; wherein: the body is separated into an upper chamber, connected to the inlet, and a lower chamber connected to the outlet, by a dividing wall having a flow passage therethrough; a valve seat is provided in the flow passage in the upper chamber; and a buoyant valve member in the upper chamber is engageable with the valve seat to seal the flow passage when the upper chamber is empty.
2. A flow unit according to Claim 1 wherein: the buoyant valve member is spherical and is unseated when there is blood/solution in the upper chamber and is held on the valve seat by suction in the lower chamber when the upper chamber is empty.
3. A flow unit according to Claim 1 or Claim 2 wherein: the dividing wall is formed by the drip former in the body; and a filter is provided in the upper chamber upstream of the valve member to constrain the valve member when there is solution in the upper chamber.
4. A flow unit according to any one of Claims 1 to 3 wherein: a pressure switch is fitted to the lower chamber to trigger an alarm when the lower chamber is empty, the switch being triggered by the suction in the lower chamber due to the flow of blood/solution from the lower chamber.
SUBSTITUTESHEET
5. A one-way valve for a blood/solution administration unit including: a tubular body having an inlet and an outlet connectable to respective lengths of tubing; a valve body in a chamber in the body intermediate the inlet and the outlet; a plurality of flow passages through the valve body; and a reed or diaphragm valve adjacent the outlet side of the valve body having at least one flexible portion operable to open the flow passages to allow blood/solution to flow from the inlet to the outlet but operable to close the flow passages to prevent flow in the opposite direction.
6. An injection port unit for a blood/solution administration set including: a one-way valve as claimed in Claim 5; and at least one injection port tube formed integrally with the body, the tube having an injection inlet to receive a solution from a syringe and an injection outlet in communication with the chamber between the valve body and the outlet of the tubular body.
7. A multiple injection port unit for a blood/solution administration set including: a one-way valve as claimed in Claim 5; an injection head having a plurality of injection inlets to receive solutions from respective syringes, rotatably mounted on the body; and an injection passage interconnecting the head and the chamber between the valve body and the outlet, so arranged that the head is selectively rotatable to align a respective one of the injection inlets with the injection passage.
8. An injection port unit as claimed in Claim 6 or Claim 7 wherein:
SUBSTITUTESHEET a cap or plug is provided for the or each injection inlet and is disposed of when its inlet has been used for the administration of solution to provide visual indication that the inlet is not to be re-used.
9. An injection port unit as claimed in any one of Claims 6 to 8 wherein: a tap is provided in the tubular body upstream of the one-way valve.
10. A safe cannula and trochar system for a blood/solution administration set including: a cannula of the type having a tubular body with a female luer at one end; and a trochar assembly, said assembly including a tubular guard engageable with the female luer, an operating rod slidably mounted in the guard and a trochar mounted at one end of the operating rod extendible by the operating rod into the cannula when the latter is inserted into the patient's vein and retractable into the guard when blood flows from the vein into the cannula.
11. A system according to Claim 10 wherein: the cannula has at least one concertina-like formation in the tubular body adjacent the female luer to enable unrestricted flow through the cannula when it becomes misaligned.
12. A system according to Claim 10 or Claim 11 wherein: the female luer is provided in a fitting having a peripheral rim or lugs engageable by a clip on a complementary male luer on a tube to releasably secure the tube to the cannula.
13. A blood/solution administration set incorporating the flow unit of any one of Claims 1 to 4.
14. A blood/solution administration set incorporating the one-way valve of Claim 5.
SUBSTITUTE SHEET
15. A ' blood/ solution administration set incorporating the single injection port unit of any one of Claims 6, 8 or 9.
16. A blood/ solution administration set incorporating the multiple injection site unit of any one of Claims 7 to 9.
17. A blood/ solution administration set incorporating the safe cannula and trochar system of any one of Claims 10 to 12.
SUBSTITUTE SHEET
PCT/AU1990/000318 1989-07-31 1990-07-31 Blood/solution administration sets and components therefor WO1991001769A1 (en)

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
AUPJ549689 1989-07-31
AUPJ5496 1989-07-31
AUPJ852589 1990-02-09
AUPJ8525 1990-02-09
AUPJ852690 1990-02-09
AUPJ8526 1990-02-09
AUPJ8588 1990-02-13
AUPJ858890 1990-02-13
AUPK065590 1990-06-18
AUPK0655 1990-06-18

Publications (1)

Publication Number Publication Date
WO1991001769A1 true WO1991001769A1 (en) 1991-02-21

Family

ID=27507408

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU1990/000318 WO1991001769A1 (en) 1989-07-31 1990-07-31 Blood/solution administration sets and components therefor

Country Status (1)

Country Link
WO (1) WO1991001769A1 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2756185A1 (en) * 1996-11-22 1998-05-29 Eurequa Medical solution administering device
EP0893094A1 (en) * 1997-07-23 1999-01-27 pvb medizintechnik gmbh & co. kg Blood sampling device
EP0895751A1 (en) * 1997-07-23 1999-02-10 pvb medizintechnik gmbh & co. kg Blood sampling device

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GB1000441A (en) * 1962-09-21 1965-08-04 Sterilon Corp Intravenous feeding apparatus
US3459189A (en) * 1965-07-28 1969-08-05 Brunswick Corp Trocar catheter
US3465784A (en) * 1967-05-08 1969-09-09 Gen Time Corp Check valve for intravenous administration of liquids
US3536073A (en) * 1968-06-18 1970-10-27 Baxter Laboratories Inc Catheter placement apparatus
US3625211A (en) * 1969-06-06 1971-12-07 Cutter Lab Failsafe apparatus for administering a parenteral solution
US3656505A (en) * 1970-05-06 1972-04-18 Ellen M O Brian Automatic cut-off for intravenous equipment
US3667464A (en) * 1970-09-04 1972-06-06 Lawrence M Alligood Jr Fluid dispensing device
US3905375A (en) * 1974-01-23 1975-09-16 Philip M Toyama Acupuncture needle
US4141379A (en) * 1977-05-16 1979-02-27 Cutter Laboratories, Inc. Check valve
US4175558A (en) * 1977-07-15 1979-11-27 Baxter Travenol Laboratories, Inc. Apparatus for administering parenteral liquid in sequential units provided with a ball valve float
GB2052018A (en) * 1979-06-21 1981-01-21 Chubb Panorama Non-return Valves
US4290454A (en) * 1980-06-30 1981-09-22 Shetler Earl B Back flow valve
US4346704A (en) * 1980-09-09 1982-08-31 Baxter Travenol Laboratories, Inc. Sleeve valve for parenteral solution device
GB2178135A (en) * 1985-07-25 1987-02-04 Cheng Kuo Fang A controlling device for an intravenous feeding or medicating device
EP0265193A2 (en) * 1986-10-17 1988-04-27 United States Surgical Corporation A trocar
US4900310A (en) * 1988-10-07 1990-02-13 International Medication Systems Limited Protective device for cannula used to draw blood

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2672051A (en) * 1951-10-29 1954-03-16 Cutter Lab Valved flow meter for parenteral solution injection sets
GB995977A (en) * 1962-09-12 1965-06-23 Bendix Corp Check valve
GB1000441A (en) * 1962-09-21 1965-08-04 Sterilon Corp Intravenous feeding apparatus
US3459189A (en) * 1965-07-28 1969-08-05 Brunswick Corp Trocar catheter
US3465784A (en) * 1967-05-08 1969-09-09 Gen Time Corp Check valve for intravenous administration of liquids
US3536073A (en) * 1968-06-18 1970-10-27 Baxter Laboratories Inc Catheter placement apparatus
US3625211A (en) * 1969-06-06 1971-12-07 Cutter Lab Failsafe apparatus for administering a parenteral solution
US3656505A (en) * 1970-05-06 1972-04-18 Ellen M O Brian Automatic cut-off for intravenous equipment
US3667464A (en) * 1970-09-04 1972-06-06 Lawrence M Alligood Jr Fluid dispensing device
US3905375A (en) * 1974-01-23 1975-09-16 Philip M Toyama Acupuncture needle
US4141379A (en) * 1977-05-16 1979-02-27 Cutter Laboratories, Inc. Check valve
US4175558A (en) * 1977-07-15 1979-11-27 Baxter Travenol Laboratories, Inc. Apparatus for administering parenteral liquid in sequential units provided with a ball valve float
GB2052018A (en) * 1979-06-21 1981-01-21 Chubb Panorama Non-return Valves
US4290454A (en) * 1980-06-30 1981-09-22 Shetler Earl B Back flow valve
US4346704A (en) * 1980-09-09 1982-08-31 Baxter Travenol Laboratories, Inc. Sleeve valve for parenteral solution device
GB2178135A (en) * 1985-07-25 1987-02-04 Cheng Kuo Fang A controlling device for an intravenous feeding or medicating device
EP0265193A2 (en) * 1986-10-17 1988-04-27 United States Surgical Corporation A trocar
US4900310A (en) * 1988-10-07 1990-02-13 International Medication Systems Limited Protective device for cannula used to draw blood

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2756185A1 (en) * 1996-11-22 1998-05-29 Eurequa Medical solution administering device
EP0893094A1 (en) * 1997-07-23 1999-01-27 pvb medizintechnik gmbh & co. kg Blood sampling device
EP0895751A1 (en) * 1997-07-23 1999-02-10 pvb medizintechnik gmbh & co. kg Blood sampling device

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