Patent Application
20060270997
1. Field of the Invention
The present invention relates to the management of medical treatments. More specifically it relates to a permission-based fluid dispensing device.
2. Description of the Prior Art
Despite remarkable advances in health care technology and delivery, a large number of patients die or are disabled as a result of medical errors. These errors occur in health care settings, such as hospitals, clinics, nursing homes, urgent care centers, physicians' offices, pharmacies, and the care delivered in the home, and they usually result from systems problems rather than one single action or decision.
For many years, bar code labelling has been the technology of choice in ensuring patient safety. Recently, the Food and Drug Administration (FDA) issued a new rule which requires certain human drug and biological product labels to have bar codes. As such, the bar code for human drug products and biological products (other than blood, blood components, and devices regulated by the Center for Biologics Evaluation and Research) must contain the National Drug Code (NDC) number in a linear barcode. The rule is geared toward reducing the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. The rule also requires the use of machine-readable information on blood and blood component container labels to help reduce medication errors.
However, bar codes require line of sight with a reader in order to be read and they cannot store additional information apart from simple identification data, such as a serial no. or a SKU. For example, a bar-coded wristband on a patient is not easy to read if the patient gets it wet or is sleeping on top of the arm bearing the wristband, or when the patient is on an emergency room gurney or operating table; these are instances where mistakes in medication or blood transfusion are most prevalent.
It is an object of the present invention to mitigate or obviate at least one of the above-mentioned disadvantages.
In one of its aspects, the present invention provides a syringe for use with a patient in a biological fluid treatment system, the patient having a patient identifier, the syringe comprising:
a syringe inlet;
a syringe chamber for receiving the treated biological fluid;
a syringe outlet in communication with the chamber via a passage;
a syringe outlet valve to control the discharge of the treated biological fluid via the syringe outlet;
an incremental counter for recording temporal data corresponding to biological fluid treatment events, treated biological fluid events and delivery events;
a unique identifier associated with the syringe, the unique identifier correlatable to the patient identifier;
a releasable lock to operate the syringe outlet valve between a plurality of states;
a computer readable medium for storing the unique identifier, the patient identifier, temporal data, and data related to biological fluid treatment events, treated biological fluid events and delivery events;
a processor for comparing the unique identifier to the patient identifier to confirm the correlation between same; and for receiving the temporal data to determine at least one time delay between the events and for determining whether the at least one time delay is within a predefined range;
a release signal generator for issuing a release signal in response to an outcome from the processor, the release signal to operate the releasable lock.
In another aspect of the invention, there is provided a syringe device for use with a patient in a treatment process, the syringe device comprising:
a syringe inlet;
a syringe chamber for receiving the treated biological fluid;
a syringe outlet in communication with the chamber via a passage;
a syringe outlet valve to control the discharge of the treated biological fluid via the syringe outlet;
a releasable lock to operate the syringe outlet valve between a closed state, an open state and a permanently closed state;
an incremental counter for recording temporal data corresponding to biological fluid treatment events, treated biological fluid events and delivery events;
a unique identifier associated with the syringe, the unique identifier correlatable to the patient identifier;
a release signal generator for issuing a release signal to operate the releasable lock following acceptability of the temporal data and the correlation of the patient identifier and the unique identifier;
the releasable lock including:
Advantageously, the syringe can be irreversibly locked by placing the outlet valve in a permanent closed state, thus, subsequent use of the syringe is precluded, to substantially eliminate contamination risks.
These and other features of the preferred embodiments of the invention will become more apparent in the following detailed description in which reference is made to the appended drawings wherein:
As shown
Following treatment, the treated blood sample is extracted to the blood delivery syringe 10, from which the treated blood sample is administered to the patient. At one or more critical stages, the system provides for a verification check, aimed at reducing the possibility of error, and thus ensure that the correct blood sample is returned to the correct originating patient. The verification check includes the steps of matching the blood sample, either in its treated or untreated form or both, with the originating patient. Typically, the wristband, the blood collection syringe, the blood delivery syringe 10, the sample management unit 12, may include circuitry for transmitting and receiving data related to the syringe and/or its contents, or a patient, such as identification data, SKU, serial no., manufacturing date, expiry date, fluid data, health facility data, health practitioner data, medication data, authentication data, and so forth. The data, or portions of the data, may also be secured via encryption algorithms and schemes, to ensure data integrity and/or authenticity of the entity. The circuitry may include, but is not limited to, a transmitter, a receiver, logic means or processor, a memory for data storage, a timing circuit, an antenna, a power source, input/out devices such as a display, an LED, a speaker, and a switch.
Below is a description of the post-treatment portion of the blood treatment process involving the use of the syringe 10 which ensures that the correct blood sample is returned to the correct originating patient. As shown in
Within the channel portion 22 is a printed circuit board (PCB) 32 having circuitry for transmitting, receiving and storing data related to the syringe and/or its contents or the originating patient. As described above, the circuitry includes, but is not limited to, a transmitter, a receiver, logic means or processor, a computer readable medium, a timing circuit, an antenna and a power source. Additionally, the circuitry includes RFID reader/writer functionality for reading RFID tags associated with entities within the treatment system. Also coupled to the PCB 32 are input/output devices such as a display, LED 33, a speaker or a button. In addition, the PCB 32 also includes circuitry for controlling the operation of the locking mechanism 30. A compartment 34 houses a power supply unit 36 comprising one or more batteries, and a power circuit resident on the PCB 32 for regulating the power therein and the input/output devices. The syringe 10 is typically maintained in a low power state, when not in use, to conserve battery energy. However, when the sample management unit is introduced into the blood treatment unit, the syringe 10 is placed into an operating state from the lower power state. Such a transition may be effected via a mechanical switch which is closed before insertion of the sample management unit into the blood treatment unit, or the switch is closed by the blood treatment unit following insertion of the sample management unit into the blood treatment unit. Other ways include an electronic switch actuable by an RF signal or a DC signal from the blood treatment unit, or a DC magnetic reed relay enabled by a magnet in the blood treatment unit. The batteries 36 may be removed after a single use of the syringe 10, in order to allow for proper recycling in compliance with environmental regulations. In order to facilitate easy battery installation or removal, the batteries 36 may be placed on a tray which is slidably received by the battery compartment 34.
As shown in
The blood transfer portion 22 is further provided with a releasable lock means shown generally at 30 for operating the syringe outlet port 16 between an open position and a closed position. As will be described, the locking mechanism 30 is operable in response to a release signal from the PCB 32, as shown in FIGS. 6(a) to 6(d). With the locking mechanism 30 unlocked, the syringe outlet port 16 is operable to form fluid coupling with a fluid fitting on a common blood sample delivery unit with a complementary Luer 46 or similar fitting, such as the needle 48, as shown in
As best shown in
The first actuating means 62 takes the form of a plurality of first actuating elements 66 which extend outwardly from a central web 68, and also includes second actuating means such as a tab 70 extending therefrom. The central web 68 is fixed to a block 72 positioned in the channel 24 in the body portion 22 of the syringe 10, as shown in
The outlet port 16 is operable between three states, a locked state, an open state and a permanently locked state, by a releasable lock means, such as locking mechanism 30, as shown in FIGS. 6(a) to 6(d). The locking mechanism 30 includes a pawl 82 coupled to the outlet valve means 54 to control the coupling of the female Luer 46 to the male Luer insert 50 of the syringe 10. The pawl 82 has one end 84 with an opening 86 for receiving a pivoting pin 88 protruding from a board 90 to allow pivoting thereabout. The pawl 82 is positioned between a first spring plate 92 and a second spring plate 94 which control its swinging motion. Typically, the first spring plate 92 is made from a fuse material or shape-memory wire (“muscle wire”), which temporarily changes consistency under the presence of a predetermined electric current signal, such as nickel titanium naval ordinance laboratory intermetallic material (NITINOL). Nitinol exhibits superelasticity and shape memory, such that nitinol is caused to heat up due to the predetermined electric current signal, as such it is mechanically deformed under stress above a specific temperature, and returns to the pre-stressed position when the stress is removed.
On the other end 96 of the pawl 82 is a first finger 98 and a second finger 100 defining a recess 102 with an opening 104. Adjacent to the recess 102 is a punched out slot 106 which includes a plurality of interconnected slots 108, 110, and 112. These interconnected slots 108, 110, and 112 correspond to the above-mentioned locked state, the open state and permanently locked state, respectively. The slots 108 and 112 are opposite each other and separated by a pawl tooth 113 on one side of the slot 106, and linked to one another by slot 110 on the other side of the slot 106. The slot 108 is L-shaped and includes one arm 114 and another arm 116 which links to slot 110.
The first spring plate 92 is secured to the board 90 at one end and includes an arcuate portion 118 positioned above the pawl 82. The arcuate portion 118 is bent at approximately 90 degrees at point 120, and adjacent thereto is an abutment flange 122 which engages the arm 114 of slot 108, in the locked position, as shown in
The motion of the pawl 82 through the three different positions will now be described. Starting in the rest position, the abutment flange 122 is positioned in the arm 114 of slot 108. Upon receipt of the release signal following the verification process, a predetermined electric signal is caused to flow through the first spring plate 92, and the electric signal is sufficient to cause the first spring plate 92 to relax. The first spring plate 92 is sufficiently relaxed such that the second spring plate 94 forces the abutment flange 122 out of the arm 114 into arm 116, and finally into slot 110 corresponding to the open position, as shown in
After a predetermined time, such as 20 minutes, the predetermined electric signal is once again caused to flow through the first spring plate 92, and causes the first spring plate 92 to relax. The second spring plate 94 forces the abutment flange 122 out of the slot 110 into slot 112 corresponding to the permanently locked position, as shown in
The operation of the outlet valve means 54 in conjunction with the locking mechanism 30 will now be described with particular reference to FIGS. 6 to 9. In the locked position of the syringe 10, the tab 70 rests on the finger 98 and thus restricts the central web 68 from longitudinal displacement away from the opening 104. Any attempt to couple a female Luer 46 fails, since the complementary first actuating elements cannot displace the first actuating elements 66, and therefore the female Luer 46 and male Luer insert 50 cannot mate. Correspondingly, the outlet valve means 54 is biased closed by the pair of resilient members 64 acting on the central web 68, and thus the central bore 74 within the valve stem 76 is closed.
Upon energising the first spring plate 92, the pawl 82 is caused to rotate in a clockwise direction and the abutment flange 122 is forced out of the arm 114 into arm 116, and slides into slot 110 corresponding to the unlocked or open position. Concurrently, the finger 98 of the pawl 82 moves away from the tab 70 such that the tab 70 is now aligned with the recess 102. The female Luer 46 can now be introduced into the male Luer insert 50. As such, the complementary first actuating elements abut the first actuating elements 66 and the force applied to mate the female Luer 46 to the male Luer insert 50 displaces the first actuating element 66 away from the opening 104. The central web 68 moves in sympathy, and the tab 70 enters the recess 102 via the opening 104 and travels the length of the recess 102. The force applied to couple the LUERs 46 and 50 is sufficient to compress the resilient members 64 and thus open the central bore 74 within the valve stem 76.
As the treated blood often includes bubbles of gases used during treatment, therefore, the syringe 10 includes a de-bubbling system or bubble removal mechanism to expel gas from syringe. Alternatively, a separate vent cap is attached to the proximal end 13 to interface with the LUER 50. The vent cap includes a hydrophobic gas permeable membrane to prevent blood from escaping. Generally, more air can be introduced into the chamber 21 to coalesce the existing bubbles, thus facilitating removal of otherwise small bubbles. Thus, the barrel 13 is transparent such that a user can inspect the treated blood sample to verify that gas bubbles have been removed, after which the treated blood sample is ready for administration to the originating patient.
After the treated blood has been administered to the patient, the female Luer 46 is uncoupled from the male Luer insert 50, as the needle 48 is removed. With the complementary first actuating elements removed from the male Luer insert 50, the resilient members 64 expand to push the central web 68 towards the opening 56 and the tab 70 travels out of the recess 102 and faces the recess opening 104. At the predetermined time, a predetermined electric signal is caused to flow through the first spring plate 92, and the abutment flange 122 is forced out of the slot 110 into slot 112. The tab 70 now abuts the finger 100, and thus any longitudinal displacement of the central web 68 from away from the opening 56 is precluded. With the abutment flange 122 unable to be forced to return to slot 110, the syringe 10 is now permanently locked, and so a female Luer 46 can not be subsequently coupled to the male Luer insert 50, as shown in
As will be described, the circuitry of PCB 32 of the syringe 10 includes portions responsible for performing a number of verification checks to ensure that the correct treated blood sample is delivered to the correct originating patient, and that certain events in the collection, treatment and delivery of the blood sample to the patient occur within prescribed time periods, as part of a verification. To that end, and as shown in
As shown in
The verification means 126 also includes counter means 136 which provides temporal data related to a predetermined event including and/or between an untreated blood sample collection event and a treated blood sample delivery event. The temporal data may also include at least one elapsed time value between predetermined events related to an untreated blood sample collection event, a blood sample treatment event, or a treated blood sample delivery event. The counter means 136 may be implemented as an incremental counter 138 or a real-time clock. In this case, the incremental counter 138 tracks the events related to the treatment and post treatment events. The power supply 36 is sufficient to maintain substantial accuracy of the internal clock within the time period from collection of the untreated blood sample to the delivery of the treated blood sample to the patient. Therefore, the possibility of losing time or decreasing clock accuracy as the battery's power runs down is substantially eliminated.
Before treatment of the untreated blood sample, the verification means 126 is also operable to prevent treatment of the blood sample if the elapsed time value following the blood withdrawal from the patient has exceeded a predetermined value. Post-treatment, the verification means 126 issues an appropriate signal to the releasable locking means 30 to prevent opening of the syringe outlet 16 when the elapsed time value has exceeded a predetermined value. Also, the verification means 126 is operable to verify an identity match between the untreated blood sample in the syringe 10 and the originating patient, or a correlation between the identity data of same. Therefore, the syringe 10 then verifies whether the treated blood sample was withdrawn from originating patient, and a release signal is provided to the locking mechanism 30 to allow discharge of the blood.
The blood sample transfer portion 22 of the syringe 10 includes a filtered vent outlet (not shown) in the passage 62 for expelling one or more gas constituents in the treated blood sample. The vent outlet may also include a barrier layer which allows gaseous constituents in the blood sample to be expressed from the syringe 10 while retaining the treated blood sample therein
In another embodiment the circuitry may include a radio identification (RFID) integrated circuit associated with an antenna or an RFID tag. Additionally, any of the other above mentioned entities may include an RFID reader/writer associated with the afore-mentioned verification. As such, these other entities read the RFID tag on the syringe 10 or receive data from the computer readable medium to perform the verification check. The RFID tag on the syringe 10 is read by an RFID reader/writer, such the blood treatment unit 14 RFID reader/writer to verify authenticity of the syringe 10. Also, subsequent to the administration of the treated blood sample to the patient, the RFID tag on the syringe 10 receives a disable code from the blood treatment unit 14, thereby preventing the reuse of the syringe 10. Alternatively, the RFID tag may be rendered inoperable by an external signal causing a fuse to be blown therein or to destroy the antenna or receiver/transmitter.
In yet another embodiment, the system includes a locking mechanism 30 operable by a solenoid or motorized means configured to receive the release signal.
In another embodiment, the identification means, verification means and/or the release signal generating means may be located on other entities of the system 10. For example, verification means and/or the release signal generating means may be located on the wristband, or on the blood sample transfer portion 22, or the blood treatment unit.
The invention may be used with other autologous samples other than blood samples, such as bone marrow or, lymphatic fluids, semen, ova-fluid mixtures, other bodily fluids or other medical fluids which may or may not be “autologous”, for example fluid mixtures perhaps containing a patient desired solid sample such as from organs, body cells and cell tissue, skin cells and skin samples, spinal cords. The syringe 10 may also be used for medical testing where it is important to ensure that test results of a particular test can be delivered to the originating patient.
While the present invention has been described for what are presently considered the preferred embodiments, the invention is not so limited. To the contrary, the invention is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.
This application claims the benefit of priority to U.S. Provisional Application Ser. No. 60/683,280, filed May 19, 2005.
| Number | Date | Country | |
|---|---|---|---|
| 60683280 | May 2005 | US |
