This application claims priority with respect to New Zealand Patent Application No. 543876, filed on Nov. 29, 2005.
This invention relates to liquid drug delivery devices which prevent or minimise adverse drug advents and in particular though not solely to syringes adapted for allowing qualitative and/or quantitative monitoring of their contents.
Adverse drug events (ADEs) which are caused by the administration to a patient of intravenous medications of incorrect types, concentrations or dosages may cause irreparable damage or even death in a patient. These types of ADE are entirely preventable and attempts have been made to minimise or avoid their occurrence. An example ADE prevention system is disclosed in U.S. Pat. No. 6,847,899B, In this document plastic tubing forming part of an IV administration set between an IV bag containing 3 drug to be administered and a needle in a patient's arm is passed through a spectroscopic analyser. The analyser is capable of determining both the type of drug present in the tubing and its concentration. A comparison may be made with expected results from the intended drug type and concentration and a decision made on whether to allow an infusion to continue.
In the above described system, variation in the positioning of the tubing within the spectroscopic analyser and variation in the physical and optical properties of the tubing itself will affect the outcome of the analysis. Furthermore, an IV administration set is often used to transport more than one type of drug, at different times, to the patient. Contamination of the tubing with multiple drug types reduces the ability of the spectroscopic analyser to determine the type of drug currently present.
Accordingly, it is an object of the present invention to provide a liquid delivery device and/or optical reader for a liquid delivery device which will go at least some way towards overcoming the above disadvantages or which will at least provide the industry with a useful choice.
In one aspect the present invention may be said to consist in a liquid delivery device adapted to deliver a liquid drug to a patient or animal comprising: a reservoir adapted to contain liquid drug to be delivered, the reservoir having an outlet through which liquid drug may be dispensed, a liquid dispenser with a longitudinal axis which causes movement of the liquid drug from the reservoir to and out of the outlet, the liquid dispenser comprising optically readable markings disposed at a plurality of positions along at least a portion of the longitudinal axis, an optical reader comprising at least one optical detector arranged to detect the optically readable markings, each optical detector adapted to provide an output signal indicative of one or more detected optically readable markings, and a processor coupled to receive the output signal and generate position data indicating a position of the liquid dispenser relative to the reservoir,
Preferably the processor generates quantity data indicating a quantity of liquid drug in the reservoir.
Preferably the optically readable markings comprise a plurality of indicia positioned in a sequence along at least a portion of the longitudinal axis of the liquid dispenser, and wherein the processor generates the position data by counting the number of indicia detected by the optical detector as the liquid dispenser is moved relative to the optical detector.
Preferably the optical reader comprises at least two optical detectors arranged to detect the indicia, wherein the optical detectors are positioned at a relative separation to provide quadrature encoding signals that can be used by the processor to generate the position data and direction data indicating the direction in which the liquid dispenser is moved relative to the optical detector.
Preferably the position data is indicative of the quantity of liquid within the reservoir. Preferably the optical reader comprises a transmitter adapted to wirelessly transmit the quantity data or position data to a system.
Preferably the optical reader is detachable from the liquid delivery device.
Preferably the optical reader further comprises an energy storage device coupled to an inductive device, the inductive device adapted to inductively couple to an inductive recharging device, to receive energy for recharging the energy storage device.
In another aspect the present invention may be said to consist in an optical reader adapted to couple to a liquid delivery device and generate position data indicative of the position of a liquid delivery means of the liquid delivery device, the optical reader comprising: a coupling for attachment to a liquid delivery device, at least one optical detector arranged to detect optically readable markings on a liquid delivery means, each optical reader adapted to provide an output signal indicative of one or more detected optically readable markings, and a processor coupled to receive the output signal and generate position data indicating a position of the liquid dispenser relative to the reservoir.
Preferably the processor generates quantity data indicating a quantity of the liquid drug in the reservoir.
Preferably the optically readable markings comprise a plurality of indicia positioned in a sequence along at least a portion of a longitudinal axis of the liquid dispenser, and wherein the processor can generate the position data by counting the number of indicia detected by the optical detector as the liquid dispenser is moved relative to the optical detector.
Preferably the optical reader comprises at feast two optical detectors arranged to detect the indicia, wherein the optical detectors are positioned at a relative separation to provide quadrature encoding signals that can be used by the processor to generate the position data and direction data indicating the direction in which the liquid dispenser is moved relative to the optical detector.
Preferably the position data is indicative of a quantity of liquid within the reservoir. Preferably the reader further comprises a transmitter adapted to wirelessly transmit the quantity data or position data to a system.
Preferably the optical reader further comprises an energy storage device coupled to an inductive device, the inductive device adapted to inductively couple to an inductive recharging device to receive energy for recharging the energy storage device.
In this specification where reference has been made to patent specifications, other external documents, or other sources of information, this is generally for the purpose of providing a context for discussing the features of the invention. Unless specifically stated otherwise, reference to such external documents is not to be construed as an admission that such documents, or such sources of information, in any jurisdiction, are prior art, or form part of the common general knowledge in the art
The term “comprising” as used in this specification means “consisting at least in part of”. Related terms such as “comprise” and “comprised” are to be interpreted in the same manner.
To those skilled in the art to which the invention relates, many changes in construction and widely differing embodiments and applications of the invention will suggest themselves without departing from the scope of the invention as defined in the appended claims. The disclosures and the descriptions herein are purely illustrative and are not intended to be in any sense limiting.
a,
9
b are plan views of two optical window sections of the second embodiment,
a-10c are various views of the syringe docked in a docking station,
a,
11
b are plan views of the optical window docked in recess of the docking station,
a,
12
b are perspective views of an optical reader adapted for attachment to the syringe,
a,
15
b show the syringe markings and photodetectors in more detail,
With reference to the drawings and in particular
The syringe's plunger 3 slides within the reservoir 2 as a piston slides within a cylinder, to evacuate the contents of the reservoir through an outlet 4. The outlet may be provided with a needle fitting (not shown) for intravenous delivery of the content of the reservoir to a patient. Alternatively, as shown, an outlet fitting 11 such as a well known “luer lock” or “luer slip” fitting may be provided at the outlet of the reservoir. These fittings allow for twist lock or press fit engagement with a complimentary fitting on an inlet of a luer forming part of in IV administration set connected to an indwelling vein access device (such as a needle or cannula) inserted in a patient. Alternatively, the luer may simply be connected by tubing to a patient's indwelling vein access device (not shown).
As is well known, plunger 3 is provided with a rubber or elastomeric head 5 which is a tight fit within the substantially cylindrically shaped reservoir 2 and which forms a seal with the inner wall thereof. The end of plunger 3 furthest from the reservoir is provided with a flange 6 adapted to be pressed by a user's thumb whilst the user's first and second fingers are positioned beneath a flange at the open end of reservoir 2. In use, as is well known, a user presses flange 6 with his or her thumb whilst pulling flange 7 with the first and second fingers to cause liquid within the reservoir to be dispensed from outlet 4. The syringe may be pre-loaded with liquid or can be filled via the outlet 4 in the known way.
Reservoir 2 is preferably transparent or translucent so that a user is able to determine the amount of liquid, such as a liquid drug, held therein. Reservoir 2 may be formed from a medical grade plastics or glass material such as HDPE for example. Reservoir 2 includes an optical window section 8 which is preferably formed from a different material to the remainder of the reservoir 2. The material from which the optical window section 8 is manufactured is a high quality plastics or glass with close manufacturing tolerances for both its physical and optical properties. Suitable exemplary materials from which the optical window may be made include cast or extruded Acrylic plastics, Polycarbonate plastics (such as TEXAN® manufactured by GE Plastics), Butyrate plastics, polypropylene and Clear PVC.
In terms of the controlled physical properties, one or more of the thickness, slope and curvature of the optical window section should be within predetermined ranges. The material chosen for the optical window should have low distortion properties, no or minimal fading, shrinking lines or optical distortion. Flatness is also important as is the ability to reproduce wall thickness and, for use in a transmission mode spectroscopic system, wall separation. The wall thickness may range from about 0 6 mm to about 1.2 mm and could be 1 mm. The wall separation (the distance between the wall surface through which light enters and the surface where affected light enters the sensor opposite) may range from about 8 mm to about 12 mm, and preferably around 10 mm. Preferably, the predetermined optical characteristics include the optical density and clarity of the optical window section. Importantly, the material chosen for the optical window should be substantially transparent with low absorbance, preferably a low absorbance particularly in the near infra-red range. Polycarbonate plastics may therefore be especially suitable.
The optical window section 8 is shown in more detail in
The syringe according to the present invention is adapted to be used in conjunction with a qualitative analysis device such as a spectroscopic analyser to determine the composition of material within the reservoir 2. Accordingly, optical window section 8 is manufactured within known optical and physical tolerances so that it has a known affect on radiation passing therethrough. The optical window section 8 will therefore cause a known reduction in light intensity at known frequencies and this effect can be factored in to calculations carried out by the spectroscopic analyser. The spectroscopic analyser may then determine an accurate spectroscopic “fingerprint” of the liquid within reservoir 2 for comparison with spectroscopic data of known drugs. In this way, as a drug is being administered to a patient by the syringe or just prior to delivery of a drug using the syringe, it is possible to check that the drug being delivered is that which is intended to thereby avoid or reduce the risk of an adverse drug event.
As shown in
Any suitable method of spectroscopic analysis could be used, for example the system disclosed in our PCT application published as WO 2004/025233A. 1→HR (Fourier Transform Infra-Red spectroscopic analysis), Raman scattering, UV/VIS (ultra-violet/visible) and infra-red methods could also be employed. Some modes of magnetic resonance and low power radioactive radiation could also be used to determine the composition of the liquid within the receptacle.
Alternatively, as shown in
Although not shown, outlet 4 may include a valve to retain liquid in the receptacle until plunger 3 is pushed. The diameter and roundness of the substantially cylindrical outlet fitting section 11 is also manufactured to strict tolerances and therefore the path length of the radiation travelling through the contents of the reservoir is accurately known which is of course essential for transmission mode spectroscopic analysis. In this way, measurements are made repeatable so that useful comparisons and/or calibration can be performed. Alternatively, the substantially cylindrical outlet fitting section 11 could be provided with one or more flat sides or could be square or rectangular in cross-section. This may however require additional means to orient the syringe within housing 12 to ensure that the incident light beam is directed substantially normal to a flattened face of the outlet fitting.
To enable the combination liquid delivery device (or syringe) and housing according to the invention to remain as compact and lightweight and as possible, it is preferred that the spectroscopic analyser is positioned remotely. Accordingly, the spectroscopic analyser 16 including radiation source 17 shown in
Dependent upon the type of radiation used, other transmission mediums could be used. Alternatively, the radiation source, such as a light emitting diode (LED) could be mounted on the housing and controlled via a wired or wireless connection to the spectrum analyser.
As shown in
The two conductive electrodes form the plates of a capacitor. The dielectric constant of the material from which the wall(s) of the reservoir are formed or air is significantly different to the dielectric constant of the (often water-based) liquid drugs inside the reservoir of the syringe. As an example, a conventional 10 mL disposable plastics syringe will change capacitance from a few picofarads to tens of picofarads from empty to full of a water-based drug. These amounts obviously depend upon the size of the electrodes and the dimensions of the syringe.
Displacement of plunger 3 within reservoir 2 causes liquid within the reservoir to exit via outlet 4. The capacitance of the capacitor formed by the electrodes and air/liquid/plastics material therebetween to vary as a result. It has been found that the capacitance of the capacitor varies substantially proportionally to the amount of fluid remaining inside the reservoir. By carrying out experiments with various different liquid drugs, it is possible to develop mathematical relationships or a lookup table relating capacitance (or an indicator thereof) and the amount of fluid in the reservoir. Therefore, by simply determining the capacitance of the capacitor formed by the electrodes printed or applied to the surface or within the wall of the reservoir, it is possible to calculate the amount of Quid remaining In the reservoir. During a continuous time measurement when liquid is being evacuated from the reservoir, the flow rate of the liquid can easily be calculated.
In an alternative (or in addition) to electrodes forming the electrically conductive segments 23 and 24, coils could be provided on either side of the reservoir. The coils could be etched onto the sides of the reservoir or could be provided on adhesive labels for example. It has been found that the inductive coupling (or mutual inductance) between the two coils is substantially directly proportional to the amount of liquid remaining in the reservoir.
In either the capacitive or inductive situations, the beat frequency or phase shift of a tuned circuit may be used to determine the capacitance or inductive coupling between the conductive sections. An electronic circuit providing a high frequency oscillating voltage or current to an LC resonant tank circuit including the reservoir capacitor or inductors could be tuned to a particular resonant frequency when the reservoir is empty. The tuned circuit will be de-tuned as a result of the liquid within the reservoir and this change in resonant frequency can be detected and used to calculate capacitance or inductive coupling. The frequency or phase shift caused by the change may also be directly proportional to the amount of liquid between the capacitor plates or coils. The effect of the liquid on radio frequency transmission from an aerial positioned on the wall of the reservoir could also be used to achieve the same effect. In the case of a capacitive circuit, the electronic detector circuit may include a circuit that is tuned to detect the charge and/or discharge of an external capacitor formed by the capacitor plates and the liquid. A regular pulse train of current in the form of a square, wave (of less than 100 kHz for example) may be supplied to the capacitor and the charge and/or discharge time of the unknown capacitor used as an indicator of, or to determine its, capacitance. Alternatively, a comparator circuit could determine the time taken for the voltage across the unknown capacitor to reach a predetermined value and this could provide an indication of capacitance.
The conductive sections 23 and 24, whether electrodes or coils, require conductive terminations which could be provided near the top of reservoir 2. The conductive terminations are connected to an electronic circuit capable of determining capacitance or inductive coupling or an indication thereof or changes in one of these parameters. Alternatively, raw detected values could be transmitted to a remote device at which analysis to determine capacitance or inductive coupling or an indication of one of these parameters is conducted. The electronic circuit may include an electronic controller executing software which inputs an indication of capacitance or inductive coupling via an analogue to digital converter, analogue comparator or pulse sensing logic circuit for example. The electronic circuit could conveniently be mounted on or to syringe 1 or housing 12 with connections to the conductive terminations.
Alternatively, as shown in
Alternatively, rather than being subsequently mounted to lire syringe, sleeve 25 may be formed integrally with the reservoir.
The electronic circuit within sleeve 25 could also include a memory device such as an EEPROM (Electrically Erasable Programmable Read-Only Memory) for storing data pertinent to the syringe/reservoir and/or the intended content of the syringe. For example, one or more of the following data fields could be stored in the memory device:
a unique identifier for the syringe/reservoir,
an identifier of the type of drug intended to be used with the syringe,
the capacitance or inductive coupling value associated with the reservoir when empty, the expected capacitance or inductive coupling when the syringe is fully loaded,
calibration information or lookup table(s) to allow detected capacitance/inductance data to be accurately transformed into a remaining volume value, and
a spectroscopic fingerprint of the expected content of the reservoir for cross-checking purposes (that is, spectrum data for comparing with the output from the spectroscopic analyser to determine whether the composition of syringe's contents is as expected.
This data or portions of it along with capacitance or inductive coupling data (or data indicative thereof) could be transmitted to a remote receiving device connected to a system controller 27 as shown in
If memory device within sleeve 25 is provided with data on the expected content of the syringe or a cross-check fingerprint then this data may also be used by the system controller to advise a user whether the detected drug matches the expected drug characteristics according to the data held in the syringe. If sleeve 25 Included calibration or empty/full capacitance or inductive coupling data then this could be used in the system controller's calculations to determine the amount of fluid within the reservoir and a visual and/or audible output of this parameter could also be provided to the user.
Referring to
The syringe 1 and in particular the window 80 will be described in more detail with reference to
The window 80 of
The flat-sided optical window 80 is formed of a suitable material with close manufacturing tolerances for both its physical and optical properties. Suitable materials from which the optical window may be made comprise cast or extruded Acrylic plastics, Polycarbonate plastics, Butyrate plastics, polypropylene and Clear PVC. The planar nature of each side provides a known path for incident radiation, and the thickness of each transparent side is known to ensure it is suitable for the wavelength radiation being used.
In terms of the controlled physical properties, the thickness of the window panels 80a-80d should be within predetermined ranges. Preferably, they are 1 mm thick. The material chosen for the optical window should have low distortion properties, no or minimal fading, shrinking lines or optical distortion. Flatness is also important as is the ability to reproduce wall thickness and, for use in a transmission mode spectroscopic system, wall separation. The wall thickness may range from about 0.6 mm to about 1.2 mm and preferably 1 mm thick. The wall separation (the distance between the wall surface through which light enters and the surface where affected light, enters the sensor opposite) may range from about 8 mm to about 12 mm, and preferably around 10 mm. Preferably, the predetermined optical characteristics include the optical density and clarity of the optical window section. Importantly, the material chosen for the optical window should be substantially transparent with low absorbance, preferably a low absorbance particularly in the near infra-red range. Polycarbonate plastics may therefore be especially suitable.
Referring now to
The stand 102 has two optical terminations 105a, 105b positioned on the outer walls of the stand either side of the internal recess 110. Each termination 105a, 105b is adapted for coupling to a fibre optic cable or other optical transmission means by way of a screw mechanism or similar Each termination also has an internal aperture 113 or other optical transmission means that extends through the termination and through the exterior wall of the stand adjacent the recess to provide an optical path 111 (e.g. see
a is a top cross-sectional view showing the flat-sided window 80 of the syringe 1 positioned snugly in the recess 110 of the holder 100. In particular, the tight fit and square shape prevents rotational movement of the syringe. As noted earlier, the window 80 could be formed with a rectangular shaped cross-section. The known properties of the flat-sided window, along with its secure retention to reduce the risk of rotation provides more certainty in the optical parameters. As rotation of the window in the holder is prevented, or at least reduced, the incident radiation path 111 will be known along with the known properties of the window 80, which provides for a more accurate determination of the contents of the liquid drug. Preferably, the incident path 111 of radiation incident on the window panel 80cb from the termination 105b will be normal to the face of the window panel 80cb. Similarly, radiation 112 transmitted through or reflected from liquid in the window 80 will travel normally through the window panel 80bc and to the receiving termination 105a.
Referring to
Referring to
The syringe 1 is also adapted to be used with a detachable optical reader 120 for determining the quantity of liquid drug within the reservoir 2, as shown in
The plunger 3 comprises optically readable markings 82 on the fiat face of at least one arm of the cross 131d (see e.g.
The markings 125 can be used to determine linear movement of the plunger. As the plunger 3 is moved downwards within the reservoir 2, the optical detectors 140 detect the bars on the plunger. The optical detectors detect each bar and feed this information into the electronics, which can count the number of bars to determine the position of the plunger 3 and thereby infer how far the plunger 3 has moved within the reservoir 2. The processor of the electronics determines position data from this. This in turn indicates the quantity of liquid drag remaining within the reservoir 2. That is, the longitudinal positional movement of the plunger 3 within the reservoir 2 defines a cavity in the reservoir for liquid. Therefore assuming there is no air space in that cavity, once the position of the plunger in its longitudinal position within the reservoir is known, the size of the cavity can be determined and therefore the amount of liquid therein. Therefore by counting the number of black bars that have passed the detectors, the longitudinal movement in the reservoir can be known. This works in both directions, therefore if the plunger is retracted back to increase the cavity size, by counting the number of bars the amount of retraction is known and therefore the cavity size and the amount of liquid.
To enable determining the size of the cavity based on movement of the plunger 3 in both directions, two optical detectors are provided as shown in
As shown in
Similarly, quadrature encoding can determine when the syringe is moving in the opposite direction. When the syringe has moved upwards, the photodetectors 140a, 140b can detect the direction of movement and the number of bars they transverse indicates the increase in the size of the cavity between the bottom of the plunger and the bottom of the syringe reservoir. In turn this indicates the amount of liquid in the cavity if liquid is being drawn into the syringe through the needle.
The use of quantity analysis in this manner enables the quantity of liquid in the syringe to be determined when the syringe is actually being actuated. It is not necessary for the syringe to be installed in a holder. Therefore the syringe can provide continuous and real-time measurements of the quantity of liquid in the syringe.
The optical reader 120 can either be hard wired or preferably wirelessly connected to the spectral analyser to relay the quantity information. The optical reader 120 can also be attached and detached from the reservoir 2 as required. Other forms of optical markings and processing could be used to determine the extent that the plunger 3 has moved.
The optical reader 120 is moulded to also act as a holder to enable a person to use the device, for example as shown in
A method of use of the invention will now be described with reference to
When the syringe 1 is installed, the drug within the window 80 will sit in the recess 110 within the optical path of the source radiation 146. The analyser system 147 can then be activated and a spectral reading taken from the incident radiation on the drug within the window 80. This can be processed in the usual way and the medic advised as necessary. Simultaneously, or at another suitable time the optical reader 120 is activated to read the markings 82 on the plunger of the syringe in order to determine quantitatively the amount of liquid within the syringe 1. This can be done in real-time such that a continuous or periodic quantity reading can be made as the plunger is moved. This is also transmitted wirelessly to the computer system 151a which uses the information and provides any warnings or advice to the medic as required. When the qualitative and quantitative analysis has been made, the medic can then remove the syringe 1 from the docking station 100. Note, the syringe does not have to be in the holder to take a quantity reading. The medic can then administer the drug to a patient by holding the device 1 as shown in
As noted, the syringe is adapted to be used in conjunction with a qualitative analysis device such as the spectroscopic analyser 147 to determine the composition of material within the reservoir. Accordingly, optical window 8 is manufactured within known optical and physical tolerances so that It has a known affect on radiation passing therethrough. The optical window section 80 will therefore cause a known reduction in light intensity at known frequencies and this effect can be factored in to calculations carried out by the spectroscopic analyser 147. The spectroscopic analyser may then determine an accurate spectroscopic “fingerprint” of the liquid within reservoir for comparison with spectroscopic data of known drugs. In this way, as a drag is being administered to a patient by the syringe or just prior to delivery of a drug using the syringe, it is possible to cheek that the drug being delivered is that which is intended to thereby avoid or reduce the risk of an adverse drug event.
Reflectance mode spectroscopic analysis may be carried out on the syringe by causing light, for example in the near-infrared (NIR) spectrum, to be incident on the optical window section 80. The incident light will be transmitted through the optical window section while being effected by the optical window section in a known way, interact with the contents within receptacle and then some of the incident light will be reflected back through the optical window section to a detector having been affected in a known way as it travels back through the optical window section.
Any suitable method of spectroscopic analysis could be used, for example those mentioned in relation to the first embodiment.
Alternatively, transmission mode spectroscopy could be employed to determine the composition of the contents of the reservoir.
While this is preferred a preferred embodiment, alternatives are possible. It will be appreciated that the window could comprise more than four panels (e.g., have hexagonal, octagonal profiles or the like), or the window could comprise less that four panels, such as three. One possibility is that the window could have one or two planar panels, with the remainder being formed as a circular shape, or some other non-planar shape. In such an embodiment, the recess in the stand would be shaped accordingly to receive the window, and the plunger extension as shaped accordingly.
The present invention provides a low cost and disposable liquid delivery device (such as a syringe) and associated spectroscopic system which enables a user to determine, at a patient's bedside whether a drug which is about to be injected is what is intended. As the syringe is disposable, it will only ever hold a single type of liquid and will not therefore suffer from contamination which could otherwise skew spectroscopic analysis results. The syringe is also advantageously portable and could even be utilised (to dispense liquids) whilst located within housing 12.
Number | Date | Country | Kind |
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543876 | Nov 2005 | NZ | national |
This application is a continuation of U.S. application Ser. No. 11/564,365, filed Nov. 29, 2006, the disclosure of which is incorporated herein.
Number | Date | Country | |
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Parent | 11564365 | Nov 2006 | US |
Child | 13299433 | US |