Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-08-20
2001-06-19
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S207000
Reexamination Certificate
active
06248090
ABSTRACT:
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a 35 U.S.C. 371 national application of PCT/DK97/00077 filed Feb. 20, 1997 and claims priority under 35 U.S.C. 119 of Danish application 0199/96 filed Feb. 23, 1996, the contents of which are fully incorporated herein by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not Applicable
BACKGROUND OF THE INVENTION
The invention relates to syringes of the type having a dose setting mechanism, a button operable to carry out an injection movement to inject the set dose, a switch operated when an injection is made at the start or at the completion of this injection, or at a time between the start and the completion of this injection, and an electronic representation of relevant parameters such as of a set dose and the latest injected dose.
The electronic representation usually is in the form of an electronic display showing numbers indicating the numbers of international units of the medicament in the set and the latest injected dose. However, to show consideration to visually impaired people the electronic representation may be effected by a speech circuit which announces the numbers rather than displaying them. Alternatively the numbers may also by electronic or electromechanical means be transformed into a tactile code, or the numbers may be communicated through a suitable interface for presentation by any external means, e.g. TV screens, PC monitors etc.
Diabetics who have to frequently inject themselves with insulin may wish to know not only the magnitude of the latest injected dose but also how long time has passed since the latest injection was made.
EP 87 491 discloses a kit comprising a storage box for insulin vials and a syringe which kit is provided with a timer device by which the time for the latest injection may be set manually. Further the hour for the next injection may be set and the timing device may function as an alarm clock sounding an alarm when it is time for this next injection. However, in a world where people may in a short time cross from one time zone to another, and the hours in the time zones even may shift from summer to winter time, a reference to the hour is uncertain. Here the count down is more adequate but has the drawback that unless you are ready to take an injection immediately when the alarm sounds you will have a new time account to handle, e.g. for how long an interval was the alarm set and how long time has passed from the sound of the alarm till the injection is actually made.
BRIEF SUMMARY OF THE INVENTION
It is an object of the application to provide a syringe by which these problems are overcome.
Another object of the invention is to have the relevant parameters represented electronically in a way which enables presentation of these parameters in any preferred way. When an LCD display is chosen the digits may be arbitrarily large as their size is not dependent on the magnitude of the mechanical movement represented by the displayed parameter. The information may be transformed into sound or Braille and may be transmitted to external displays.
This is obtained by a syringe having a dose setting mechanism, a button operable to carry out an injection movement to inject the set dose, a switch operated at the start or at the completion of the injection, or at a time between the start and the completion of the injection, and an electronic representation of relevant parameters such as of a set dose and latest injected dose, which syringe is according to the invention characterised in that it comprises a stop watch which is reset and started when the switch is operated, the status of the stop watch function being electronically represented.
When the stop watch counts the number of hours passed from the latest operation of the switch, i.e from the latest injection, the user may have a comprehensive view of the time which has passed after the latest injection and the size of this last injection. In this way the user is able to set the next dose with regard to these parameters.
When according to the invention a stop watch is reset and started when the switch is operated, e.g. when the injection movement of the button is completed, the watch is automatically started when an injection is made.
According to an embodiment of the invention, the status of the stop watch immediately after the operation of the switch is displayed in a way indicating the number of seconds passed after said operation. This may guide the user to keep the injection needle inserted for some seconds after the button has been pressed home which is desirable to allow the injected liquid to be adopted in the tissue before the needle is drawn out, as the liquid may else leak out through the wound left by the needle so that a dose minor lower than the intended one is absorbed in the body, and is desirable to allow the full dose to be completely delivered by the syringe. A resting time of 4 to 10 and preferably 6 seconds has been shown to be appropriate.
WO 90/09202 disclosure a syringe in which a timer counts the seconds passing from the beginning of the injection till the injection is completed. This time, however is of less importance and it is recommended that the user himself controls the injection speed as he immediately may feel if the liquid is injected faster than the tissue can absorb it.
According to an embodiment of the syringe according to the invention, the electronic representation of the status of the stop watch is an electronic display on which the status is indicated by segments of which one is activated for each hour passed from the completion of the injection, i.e. after the switch was operated.
During the first seconds of the running of the stop watch the electronic display may be used for guiding the patient to maintain the needle inserted for some seconds after the injection movement of the button has been completed. This guiding is obtained by activating one or more segments per second passing immediately after the completion of the injection movement of the button until all segments of the dial are activated. Thereafter all the segments are deactivated and are reactivated one by one for each hour passing after the switch was operated, i.e. since the latest injection was made.
According to an embodiment of the invention the electronic display may comprise twelve circle segments forming a watch dial and when the segments are activated one per hour passed after the operation of the switch it is done in a sequence so that the segment between the twelve o'clock position and the one o'clock position is activated after one hour, a segment between one o'clock and the two o'clock position is further activated after two hours, and so on.
The same watch dial may conveniently be used to indicate the passage of the first few seconds after the operation of the switch, with the difference that two segments are activated for each second passed after the home pressing of the button. The two segments first activated may e.g. be the segments between the five o'clock and six o'clock position and between the six o'clock and seven o'clock position, the next two segments may be the segments between the seven and eight o'clock and the four and five o'clock positions and so on so that all the segments in the dial are activated during six seconds beginning from the bottom of the dial and spreading clockwise and counter clockwise to the top of the dial. When all the segments have been activated during these first seconds of the running of the stop watch, they are switched off and are then reactivated, one per hour passed since the operation of the switch.
According to an embodiment of the syringe according to the invention said syringe may be equipped with a memory storing data comprising the sizes of a predetermined number of previously injected doses and the time intervals between these doses and the insulin type used by the injections.
REFERENCES:
patent: 3871361 (1975-03-01), Kamen
patent: 4275727 (1981-06-01), Keeri-Szanto
patent: 4529401 (1985-
Jensen Jens Moller
Poulsen Jens Ulrik
Smedegaard Jorgen K.
Mendez Manuel
Novo Nordisk A S
Zelson, Esq. Steve T.
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