Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-07-13
2003-09-02
Lazarus, Ira S. (Department: 3749)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S207000, C604S221000, C604S246000
Reexamination Certificate
active
06613019
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to the delivery of a specific dose from an injection or an infusion device.
The invention relates specifically to: A liquid medication delivery device for delivering an intended dose, said delivery device including means for holding a cartridge, a cartridge for holding a liquid to be fully or partially injected into a body, said cartridge having an outlet connected to a needle at one end and a movable wall at another end, said movable wall having an inner face and an outer face, and a piston rod being operable to engage and displace said movable wall.
The invention furthermore relates to: A method of delivering an intended dose from a liquid medication delivery device, said delivery device including means for holding a cartridge, a cartridge for holding a liquid to be fully or partially injected into a body, said cartridge having an outlet connected to a needle at one end and a movable wall at another end, said movable wall having an inner face and an outer face, and a piston rod being operable to engage and displace said movable wall.
In the present context, the term ‘piston rod being operable to engage and displace said movable wall’ is taken to mean that the piston rod may or may not be fixed to the movable wall.
The following account of the prior art relates to one of the areas of application of the present invention, insulin dosing systems.
The use of drug administration systems for self-treatment of a disease, e.g. diabetes, is subject to many inconveniencies, such as having to meet a certain time schedule in the treatment, ensuring that the correct dose of the correct medication is delivered, etc. Of great importance to a user is the time span needed for the injection of a relevant dose, i.e. the time that the needle has to be inserted in the skin to ensure that the dose is delivered. Another very important aspect for a user is to ensure that a correct intended dose is delivered.
A well-known problem that characterizes pen and dosing systems is that usually a small drop of liquid appears at the needle tip after the needle has been removed from the skin. The size of the drop depends on many factors such as dosage speed and size, friction in the cartridge, piston condition, the time span that the needle is kept in the skin, the needle dimensions, the liquid viscosity, etc. This spill further results in a reduced dose accuracy.
Existing systems typically include a relatively inflexible medication cartridge, e.g. made of glass and a relatively flexible piston, e.g. made of rubber. During a dosing event, the piston rod (and with it the ‘outer’ wall of the piston, i.e. the one that engages the piston rod) will typically advance faster than the liquid medication can be delivered from the cartridge (including the outlet via a needle). This results in the piston being compressed, including the compression of possible annular sealing rings or ribs facing towards the walls of the cartridge, and including the compression of possible small elevations in the outer wall of a rubber piston (present to facilitate the separation of identical parts during production/assembly of the cartridge/delivery device). When the displacement of the piston rod is terminated, the mentioned deformations will be relaxed (i.e. the elastically deformed materials will return to their unstrained state) and, importantly, the system will continue to dose until the relaxation is completed. This represents one of the sources for observed ‘afterdripping’ in liquid medication delivery devices. Another source is the possible use of a soft gasket or sealing in the outlet end of the cartridge that provides the possibility of replacing the needle without introducing leaks or risk of contamination.
U.S. Pat. No. 5,713,520 discloses a hydraulically actuated fuel injector designed to provide a more abrupt ending to each injection event in order to improve performance and exhaust emission quality. The abrupt ending is achieved by allowing the residual fuel pressure to dissipate into a fuel return passage rather than dribble out of the injector nozzle.
In U.S. Pat. No. 6,050,450 a microprocessor-controlled fluid dispenser for dispensing micro size fluid droplets from a syringe in accordance with programmed shot volume increments is described. Reduced dripping from the syringe is achieved by slightly retracting the plunger to relieve pressure upon ending the compressing of the fluid by the plunger (which is a fixed extension of the piston rod and in direct contact with the liquid).
The object of the present invention is to reduce the overall injection time, while improving the dose accuracy for a liquid medication delivery system.
SUMMARY OF THE INVENTION
This is achieved according to the invention in that the piston rod is adapted to sequentially advance the outer face of said movable wall to a position corresponding to a dose that is greater than the intended one, followed by a reversal of the piston rod to allow the outer face of said movable wall to return to a position corresponding to the intended dose.
In the present context the terms ‘inner’ face and ‘outer’ face of a movable wall in a liquid medication cartridge are taken to mean the face having contact with the liquid and the opposite face (typically engaging a piston rod), respectively.
The simultaneous reduction of the overall injection time and the assurance that a correct dose is delivered reduce the inconvenience and thus contribute to the well-being of the user.
An advantage of the invention is that the amount of time the needle must be kept under the skin can be reduced and thereby the total time it takes to make the injection. A dose of say 20 IU may be injected in 1-2 seconds, but due to the drip following the injection, the needle has to stay in the skin for some time (around 6 seconds) to ensure that the drip has terminated, giving a total injection time of 7-8 seconds. The present invention may decrease the total injection time significantly (e.g. by 50-75%) contributing to the user's well-being.
The invention further reduces the drip from the needle tip of a medical injection device after the injection. This has the advantageous effect that no spill of the drug in question is disposed in the tissue or on the skin, resulting in an improved dose accuracy and a more ‘clean’ injection.
Further advantages of the invention are that it improves the performance of a delivery device, while allowing the use of existing (relatively low cost) components, thus increasing the quality to cost ratio.
In a preferred embodiment said delivery device comprises actuating means for generating a force or a torque, and driving means for converting said force or torque from said actuating means into a translatory movement of said piston rod.
When said actuating means comprise an electromotor, a homogeneous and stable movement of the piston rod and thus the movable wall may be achieved.
When said delivery device comprises a microcomputer at least for controlling the actuating means, it is ensured that a precise stop of the movable wall may be provided, resulting in an improved dose accuracy. The microcomputer may further be used to receive inputs from the user on intended dose or to read such data from an associated memory. A software program governing the movement of the piston may be executed by the microcomputer. Such a program may be based on empirical rules as regards the medication, the cartridge, the needle, the dose, etc., which are used in the situation in question. Several such programs, each one governing a specific combination of physical parameters, may be stored in the memory and the relevant one be executed in a given situation. Alternatively a parametrisized program adapted for allowing one or more of the physical variables to be changed may be executed to control the medication delivery process. The program may alternatively be entirely founded on a theoretical basis and take into account parameters such as dosage speed and size, friction in the cartridge and needle, the viscosity of the liquid, piston c
Began, Esq. Marc A.
Bosk, Esq. Richard W.
Green, Esq. Reza
Lazarus Ira S.
Novo Nordisk A S
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