WO2002011664A1 - Coding on medical device - Google Patents

Coding on medical device Download PDF

Info

Publication number
WO2002011664A1
WO2002011664A1 PCT/DK2001/000495 DK0100495W WO0211664A1 WO 2002011664 A1 WO2002011664 A1 WO 2002011664A1 DK 0100495 W DK0100495 W DK 0100495W WO 0211664 A1 WO0211664 A1 WO 0211664A1
Authority
WO
WIPO (PCT)
Prior art keywords
code
edge
syringe
irregularities
cartridge
Prior art date
Application number
PCT/DK2001/000495
Other languages
French (fr)
Inventor
Søren AASMUL
Original Assignee
Novo Nordisk A/S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novo Nordisk A/S filed Critical Novo Nordisk A/S
Priority to AU2001279585A priority Critical patent/AU2001279585A1/en
Publication of WO2002011664A1 publication Critical patent/WO2002011664A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/40—General identification or selection means by shape or form, e.g. by using shape recognition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic

Definitions

  • the invention relates to code marking of devices, especially devices containing a medicine the kind of which the user want to be informed about immediately before the use.
  • Diabetics who have to frequently inject themselves with different types of insulin, want to have it confirmed immediately before the injection that the syringe contains the correct type of insulin.
  • a visual confirmation is commonly obtained by the fact that the device has at least one element which is coloured according to a colour code made for the different types of in- sulin.
  • a tactile confirmation can be established by providing the device with a relief pattern, which can be felt by a finger.
  • the label When the medicine is sucked from the vial into a syringe the label can be moved from the cap of the vial to the end of the piston rod of the syringe so that the user can feel the pattern immediately before he inject the content of the syringe.
  • the mentioned tactile coding methods presuppose the existence of an accessible plane area of the order Vz cm 2 and further it calls for a good tactile perception in the pulp of the finger. At least by some diabetics the latter can not be expected, and where a so-called pen is used, i.e. a syringe which is loaded with a cartridge containing medicine for several injections which medicine can be apportioned in a number of individually set doses, only a minor part of the cartridge is accessible for tactile examination.
  • a so-called pen i.e. a syringe which is loaded with a cartridge containing medicine for several injections which medicine can be apportioned in a number of individually set doses, only a minor part of the cartridge is accessible for tactile examination.
  • the irregularities may preferably be notches cut into the edge mainly perpendicular to this edge, but said irregularities may also be protrusions at the top or near the top of the edge or a mixture of notches and protrusions.
  • the edge may be the circumferential circular edge formed between a cylindrical surface of a needle hub receiving stud on a syringe and the end surface of said stud. This way the code according to the invention can be used on a prefilled syringe.
  • the needle-receiving stud is mounted on and changed with the cartridge.
  • the marking is following the cartridge so that the code tells the user what kind of medicine the cartridge contents and when the cartridge is mounted in a syringe the code tells what kind of medicine is in the syringe.
  • the code may contain a certain sequence of irregularities, projections and recesses, which sequence defines a start point for the code. This is especially appropriate where the edge carrying the code is a circumferential one.
  • Figure 1 shows a sectional view of an end of a syringe with a cartridge carrying a needle hub receiving code top
  • Figure 2 shows a sectional view of a code top code marked according to the invention
  • Figure 3 shows a possible coding on an edge of a code top
  • Figure 4 shows the topography met by a finger nail which follows the edge according to claim 3 to read the code
  • Figure 5 shows another possible coding of a code top
  • Figure 6 shows a possible topography met by a fingernail which follows the edge according to figure 5,
  • Figure 7 shows still another possible coding of a code top
  • Figure 8 shows a possible topography met by a finger nail when following part of the edge in figure 7.
  • Figure 1 shows a sectional view of an end of a syringe 1 wherein a cartridge 2 carrying a code top 3 is mounted so that a part of the code top 3 projects from the syringe and forms a stud on which a needle hub 4 can be received so that a needle 5 penetrates a rubber membrane 6 closing the cartridge 2.
  • Figure 2 shows a sectional view of the code top 3, which has a cylindrical surface, provided with a thread 7 onto which the needle hub 4 can be screwed.
  • a notch 8 in an edge 9, formed where the cylindrical surface and an end surface of the code top meet, can have the character of a short radial recess 8 in the annular end surface 10 of the code top 3.
  • Figure 3 shows a possible coding provided at an edge of a needle receiving stud.
  • Figure 4 shows schematically the topography which a finger nail meets when it follows the edge. First a lowering of the edge starts at 11. Thereafter a pair of irregularities 12 is met having the shape of two consecutive protrusions.
  • Figure 5 and 7 shows other possible codings with a number of irregularities 12 distributed along the perimeter of the code carrying edge.
  • Figure 6 and 8 shows different topographies illustrating that the irregularities 12 met by the reading fingernail may be as well ridges as recesses.
  • a start point can be defined by a certain sequence of projections and notches.
  • a coding as dense as one irregularity per mm. can easily be read.
  • the invention is main explained with reference to a code top which forms a needle receiving stud other placements of the edge carrying the code lies within the scope of the invention.
  • the code carrying edge can be an edge elsewhere on a syringe or cartridge or another device containing a medicine.
  • the medicine do not necessarily have to be insulin although the invention is mainly described by emphasising the advantages the coding according to the invention offers diabetics.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A device containing a medicine is coded by cutting notches in an edge formed by two surfaces of the device, which surfaces meets each other under an angle larger than 180°, so that the code can be read by following said edge by a finger nail. To define the start point a certain sequence of notches is be provided

Description

Coding on Medical Device
The invention relates to code marking of devices, especially devices containing a medicine the kind of which the user want to be informed about immediately before the use.
Diabetics, who have to frequently inject themselves with different types of insulin, want to have it confirmed immediately before the injection that the syringe contains the correct type of insulin. A visual confirmation is commonly obtained by the fact that the device has at least one element which is coloured according to a colour code made for the different types of in- sulin.
For sight impaired people a tactile confirmation can be established by providing the device with a relief pattern, which can be felt by a finger.
From US 5,730,292 it is known to provide a vial with a cap on which a relief letter indicates the kind of insulin in the vial. As normal letters may be difficult to differentiate, especially if ones tactile perception is impaired as it often is the case by diabetics, a code comprising a pattern of protrusions and/or depressions may form a better tactile confirmation of the content. WO 99/47062 describes a label which is provided with a pattern of protrusions and de- pressions. The pattern can be varied according to the medicine type it shall make the user aware of. The label is placed on the cap of a vial containing a medicine. When the medicine is sucked from the vial into a syringe the label can be moved from the cap of the vial to the end of the piston rod of the syringe so that the user can feel the pattern immediately before he inject the content of the syringe.
The mentioned tactile coding methods presuppose the existence of an accessible plane area of the order Vz cm2 and further it calls for a good tactile perception in the pulp of the finger. At least by some diabetics the latter can not be expected, and where a so-called pen is used, i.e. a syringe which is loaded with a cartridge containing medicine for several injections which medicine can be apportioned in a number of individually set doses, only a minor part of the cartridge is accessible for tactile examination.
It is an objective of the invention to provide a coding with a very little demand of space and which can easily be tactile read even by persons with impaired tactile perception. This is obtained by a code which is provided as irregularities placed along an edge formed by two surfaces meeting each other under an angle larger than 180° and which can be read by following said edge by a finger nail. When the end of a finger nail is moved along the edged a sequence of irregularities will be clearly felt due to the resistance it exerts to the further movement of the fingernail along the edge.
The irregularities may preferably be notches cut into the edge mainly perpendicular to this edge, but said irregularities may also be protrusions at the top or near the top of the edge or a mixture of notches and protrusions.
The edge may be the circumferential circular edge formed between a cylindrical surface of a needle hub receiving stud on a syringe and the end surface of said stud. This way the code according to the invention can be used on a prefilled syringe.
In some syringes designed to receive a changeable cartridge the needle-receiving stud is mounted on and changed with the cartridge. By such syringes the marking is following the cartridge so that the code tells the user what kind of medicine the cartridge contents and when the cartridge is mounted in a syringe the code tells what kind of medicine is in the syringe.
The code may contain a certain sequence of irregularities, projections and recesses, which sequence defines a start point for the code. This is especially appropriate where the edge carrying the code is a circumferential one.
In the following the invention is described in further details with references to the drawing, wherein,
Figure 1 shows a sectional view of an end of a syringe with a cartridge carrying a needle hub receiving code top,
Figure 2 shows a sectional view of a code top code marked according to the invention,
Figure 3 shows a possible coding on an edge of a code top, Figure 4 shows the topography met by a finger nail which follows the edge according to claim 3 to read the code,
Figure 5 shows another possible coding of a code top,
Figure 6 shows a possible topography met by a fingernail which follows the edge according to figure 5,
Figure 7 shows still another possible coding of a code top, and
Figure 8 shows a possible topography met by a finger nail when following part of the edge in figure 7.
Figure 1 shows a sectional view of an end of a syringe 1 wherein a cartridge 2 carrying a code top 3 is mounted so that a part of the code top 3 projects from the syringe and forms a stud on which a needle hub 4 can be received so that a needle 5 penetrates a rubber membrane 6 closing the cartridge 2.
Figure 2 shows a sectional view of the code top 3, which has a cylindrical surface, provided with a thread 7 onto which the needle hub 4 can be screwed. A notch 8 in an edge 9, formed where the cylindrical surface and an end surface of the code top meet, can have the character of a short radial recess 8 in the annular end surface 10 of the code top 3.
Figure 3 shows a possible coding provided at an edge of a needle receiving stud. Figure 4 shows schematically the topography which a finger nail meets when it follows the edge. First a lowering of the edge starts at 11. Thereafter a pair of irregularities 12 is met having the shape of two consecutive protrusions.
Figure 5 and 7 shows other possible codings with a number of irregularities 12 distributed along the perimeter of the code carrying edge. Figure 6 and 8 shows different topographies illustrating that the irregularities 12 met by the reading fingernail may be as well ridges as recesses. A start point can be defined by a certain sequence of projections and notches.
A coding as dense as one irregularity per mm. can easily be read. Although the invention is main explained with reference to a code top which forms a needle receiving stud other placements of the edge carrying the code lies within the scope of the invention. E.g the code carrying edge can be an edge elsewhere on a syringe or cartridge or another device containing a medicine. The medicine do not necessarily have to be insulin although the invention is mainly described by emphasising the advantages the coding according to the invention offers diabetics.
Although the coding is shown and described as being carried by a circumferential edge coding along a linear or curved edge is within the scope of this application.

Claims

Claims
1. Method for code marking of a device containing a medicine, characterised in that the code is provided as irregularities, notches or projections, placed along an edge formed by two surfaces meeting each other under an angle larger than 180° so that the code can be read by following said edge by a finger nail.
2. A Method according to claim 1 , characterised in that the irregularities are notches cut into said edge an mainly perpendicular to this edge.
3. A method according to claim 1 or 2, characterised in that the edge is the circumferential circular edge formed between a cylindrical surface of a needle hub receiving stud on a syringe and the end surface of said stud.
4. A method according to claim 3, characterised in that the needle receiving stud is mounted as a code top on a cartridge and is mounted on the syringe with this cartridge.
5. A method according to anyone of the preceding claims, characterised in that the code contains a certain sequence of irregularities which sequence defines a start point for the code.
PCT/DK2001/000495 2000-08-03 2001-07-13 Coding on medical device WO2002011664A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001279585A AU2001279585A1 (en) 2000-08-03 2001-07-13 Coding on medical device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200001165 2000-08-03
DKPA200001165 2000-08-03

Publications (1)

Publication Number Publication Date
WO2002011664A1 true WO2002011664A1 (en) 2002-02-14

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ID=8159635

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK2001/000495 WO2002011664A1 (en) 2000-08-03 2001-07-13 Coding on medical device

Country Status (2)

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AU (1) AU2001279585A1 (en)
WO (1) WO2002011664A1 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007060156A1 (en) * 2005-11-22 2007-05-31 Novo Nordisk A/S System of different shaped injection devices
WO2010084084A1 (en) * 2009-01-23 2010-07-29 Sanofi-Aventis Deutschland Gmbh Medicament identification system for multi-dose injection devices
WO2011131781A1 (en) * 2010-04-23 2011-10-27 Sanofi-Aventis Deutschland Gmbh Coded keying insert for a medicament cartridge

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2224383A (en) * 1988-09-30 1990-05-02 Carol Martin Indicating medical prescriptions
GB2315357A (en) * 1996-07-16 1998-01-28 Philip Frank French Items labelled with barcodes
US5730292A (en) * 1996-08-23 1998-03-24 Jones; Terry Lee Method and apparatus for identifying insulin vials
WO1999047062A1 (en) * 1998-03-17 1999-09-23 The Cleveland Clinic Foundation A syringe labeling system
US6106930A (en) * 1996-11-13 2000-08-22 Isis Pharmaceuticals Inc. Preparation consisting of a surface-adhering, film-like or wafer-like administration form
US6247400B1 (en) * 1998-09-17 2001-06-19 Caretec Gmbh Apparatus for producing elevations which can be detected in a tactile manner

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2224383A (en) * 1988-09-30 1990-05-02 Carol Martin Indicating medical prescriptions
GB2315357A (en) * 1996-07-16 1998-01-28 Philip Frank French Items labelled with barcodes
US5730292A (en) * 1996-08-23 1998-03-24 Jones; Terry Lee Method and apparatus for identifying insulin vials
US6106930A (en) * 1996-11-13 2000-08-22 Isis Pharmaceuticals Inc. Preparation consisting of a surface-adhering, film-like or wafer-like administration form
WO1999047062A1 (en) * 1998-03-17 1999-09-23 The Cleveland Clinic Foundation A syringe labeling system
US6247400B1 (en) * 1998-09-17 2001-06-19 Caretec Gmbh Apparatus for producing elevations which can be detected in a tactile manner

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007060156A1 (en) * 2005-11-22 2007-05-31 Novo Nordisk A/S System of different shaped injection devices
WO2010084084A1 (en) * 2009-01-23 2010-07-29 Sanofi-Aventis Deutschland Gmbh Medicament identification system for multi-dose injection devices
WO2011131781A1 (en) * 2010-04-23 2011-10-27 Sanofi-Aventis Deutschland Gmbh Coded keying insert for a medicament cartridge
US9072845B2 (en) 2010-04-23 2015-07-07 Sanofi-Aventis Deutschland Gmbh Coded keying insert for medicament cartridge

Also Published As

Publication number Publication date
AU2001279585A1 (en) 2002-02-18

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