Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-07-09
2001-09-11
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S208000, C604S211000, C604S198000, C128S919000
Reexamination Certificate
active
06287283
ABSTRACT:
The invention relates to an apparatus for the registration of the setting of a medical device e.g. for indicating the dosages of pharmaceutical to be released from an adjustable dosage unit.
Especially within the medical field many devices are used of the type where an adjustment should be set during handling of the device and where data retrieval related to the setting is increasingly needed because the use of equipment for handling and displaying data has exploded.
In the following the invention will be explained in relation to a known device in the form of an adjustable dosage unit for the release of a dose of pharmaceutical.
Preferably such a dosage unit comprises a cylindrical casing for the dose of pharmaceutical, preferably insulin. The dosage unit is preferably of the type described in EP 327 910. When used for dosing suitable quantities of insulin, the cartridge for inserting in the dosage unit usually contains 1.5 ml. The insulin is of a concentration of e.g. 100 insulin units per ml whereby the cartridge contains 150 insulin units. When using the dosage unit, a pre-determined quantity is to be delivered per injection, preferably up to 40 insulin units.
Therefore, the dosage unit can be used for several injections per cartridge. The latter procedure requires a very accurate adjustment of the dosage to be injected per injection.
The dosage unit according to EP 327 910 is a very compact pen-like device which can easily be pre-adjusted to the desired dosing quantity by revolving the pen in relation to an end cap thereof. The desired dosing quantity is read by means of a suitable measuring scale.
However, it has been, realised that children or elderly persons, especially visually impaired persons, may encounter problems when reading the measuring scale which is divided into a scale for “ones” and one for “tens”. Especially the scale of “tens” might be misinterpreted.
The object of the invention is to provide an apparatus allowing a more safe detecting of the setting of the medical device.
A further object of the invention is to provide a more safe reading of the pharmaceutical dosage given from a dosage unit.
A further object is to provide an apparatus which can be used in combination with existing dosage units e.g. of the type described in EP 327 910 for providing further information related to the dosage of pharmaceutical.
A further object is to provide for an apparatus which also allows for adopting the cap of an existing dosage unit.
These objects are accomplished by an apparatus which is intended for disconnectible engagement with the medical device, said apparatus having detector means for detecting the selected setting and information means for providing information related to said mechanical adjustment.
Preferably, the device may be a dosage unit having a pair of mutually movable elements for co-operating with respective elements in the apparatus. These elements could be mutually longitudinally displaceable but a very expedient embodiment comprises mutually revolving engagement elements of a kind also to be found on the unit known from EP 327 910. Thereby, the consumer does not need to buy a new and expensive injection unit. The apparatus according to the invention can be used as an add-on for the known pen-like injector already covering a major part of the world market.
When arranging the apparatus so that it can receive the first end of the dosage unit, whereby the adjustment of the dosage quantity is effected by revolving of the dosage unit relatively to the apparatus, the apparatus according to the invention will function just like the removable cap of the well-known insulin pen whereby the users will feel comfortable when using the new apparatus with their own and well-known insulin pen.
In a preferred embodiment the apparatus is arranged also to accommodate a removable cap of a well-known insulin pen whereby insulin which may leak from the needle will be picked up by the cap so that the insulin is prevented from causing bad smell or damaging the electronics in the apparatus according to the invention.
The apparatus according to the invention can be based on a purely mechanical or electromechanical basis. Even a purely mechanical device will enhance the safety in handling the insulin injector in that the apparatus can comprise rotating discs driven by the cooperating engagement elements, thereby making a very easily readable indication of the pre-selected dosage. Also pads with Braille can be incorporated in the apparatus.
Preferably, the detector means of the apparatus comprises a transducer for generating an electrical signal which represents the adjusted dosage quantity. The transducer is preferably arranged for providing different types of electrical signals when the dosage unit and the apparatus are turned relative to each other in one direction or in the opposite direction, respectively. Thereby it is easier to program an electronic programming unit in the apparatus.
The safety and versatile use of the apparatus can be further enhanced by incorporating an encoder in the transducer.
The information means preferably comprises a display unit which is controlled relative to the electrical signals from the transducer. Also a memory and programming unit as well as clock and timer means can be incorporated in the information means.
Preferably the apparatus is arranged to work with further add-on's, i.e. a sound module, a PC-link module, or a module for infrared transmission of information. These features can also be incorporated in the apparatus itself but when divided up in a number of add-on's, the user need not buy more than necessary.
In the following the invention will be described in more details in connection with an insulin injection unit but it will be understood that supervision of dispensing of other types of pharmaceutical can also be carried out by means of the apparatus according to the invention. E.g. an embodiment for cooperating with a dosage unit for pills is also within the scope of the invention.
REFERENCES:
patent: 4592745 (1986-06-01), Rex et al.
patent: 4636201 (1987-01-01), Ambrose et al.
patent: 4883472 (1989-11-01), Michel
patent: 4959056 (1990-09-01), Dombrowski et al.
patent: 4973318 (1990-11-01), Holm et al.
patent: 5002536 (1991-03-01), Thompson et al.
patent: 5009640 (1991-04-01), Pyret et al.
patent: 5017190 (1991-05-01), Simon et al.
patent: 5098400 (1992-03-01), Crouse et al.
patent: 5279586 (1994-01-01), Balkwill
patent: 5494036 (1996-02-01), Uber, III et al.
patent: 5509905 (1996-04-01), Michel
patent: 5522799 (1996-06-01), Furukawa
patent: 5536249 (1996-07-01), Castellano et al.
patent: 5573506 (1996-11-01), Vasko
patent: 5593390 (1997-01-01), Castellano et al.
patent: 5690618 (1997-11-01), Smith et al.
patent: 5704922 (1998-01-01), Brown
patent: 5725508 (1998-03-01), Chanoch et al.
patent: 5728074 (1998-03-01), Castellano et al.
patent: 5782814 (1998-07-01), Brown et al.
patent: 5795333 (1998-08-01), Reilly et al.
patent: 5807336 (1998-09-01), Russo et al.
patent: 5843047 (1998-12-01), Pyrozyk et al.
patent: 5873856 (1999-02-01), Hjertman et al.
patent: 5947934 (1999-09-01), Hansen et al.
patent: 0 635 277 (1995-01-01), None
Christensen Lars Hofmann
Ljunggreen Henrik
Munk Jens
Møller-Jensen Jens
Møller-Jensen Peter
Novo Nordisk A S
Seidel Richard K.
Skadden, Arps Slate Meagher & Flom LLP
Thanh Loan H.
LandOfFree
Apparatus for the registration of the setting of a medical... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Apparatus for the registration of the setting of a medical..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Apparatus for the registration of the setting of a medical... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2462054