Source: https://patents.google.com/patent/WO2003017915A1/en
Timestamp: 2018-09-26 03:47:43
Document Index: 375722630

Matched Legal Cases: ['art 11', 'art 11', 'arts 12', 'art 11', 'art 11', 'art 12', 'art 11', 'art 12', 'art 15', 'art 11']

WO2003017915A1 - A cartridge and a medical delivery system accommodating such a cartridge - Google Patents
A cartridge and a medical delivery system accommodating such a cartridge Download PDF
WO2003017915A1
WO2003017915A1 PCT/DK2002/000554 DK0200554W WO03017915A1 WO 2003017915 A1 WO2003017915 A1 WO 2003017915A1 DK 0200554 W DK0200554 W DK 0200554W WO 03017915 A1 WO03017915 A1 WO 03017915A1
PCT/DK2002/000554
Lars Thougaard Kristensen
Lars Korsbjerg Nielsen
Morten Baek Jensen
A cartridge having a distal end provided with a mechanical coding. The coding has the form of a circular protrusion where the circular outer diameter is dedicated a specific concentration of insulin contained in the cartridge. The distal end of the cartridge is fitted in to a circular contour in the housing. The outer diameter of the protrusion on the distal end of the cartridge is chosen as a larger diameter for a higher concentration of insulin. In this way only a cartridge containing the correct concentration or a lower concentration fits into a delivery system designed for a specific concentration of insulin.
A cartridge and a medical delivery system accommodating such a cartridge
The Technical field of the invention:
The invention relates to ampoules or cartridges for medical delivery systems. Such cartridges are commonly shaped as a glass or plastic tube being at one end closed by a piston, which may be pressed into the tube to expel the content of the tube at the other end of the tube. This other end is often formed as a bottleneck, the outer end of which may be pierced by a conduit such as an injection needle or a catheter through which the content is expelled.
The invention furthermore relates to a medical delivery system accommodating such a cartridge.
Cartridges are widely known for various medical delivery systems. They are especially used for insulin delivery systems, and are usually supplied pre-filled with either 1 ,5 ml of insulin or 3,0 ml of insulin.
The typical diabetes patient will require a certain amount of insulin either injected or infused into their body every day. The patient loads a cartridge containing the insulin into either an injection system or a pump system and injects or infuses the insulin into their body at a prescribed rate, either through an injection needle or through a catheter having one end inserted into their body. The injection needle or the catheter is at the other end connected to the car- tridge. Once the cartridge is empty it is disposed of and a new cartridge is loaded into the delivery system.
Glass is the most preferred material for cartridges containing insulin, however cartridges moulded from plastic such as shown in WO 98.56438 is on the verge of a break through.
A prior art glass cartridge is disclosed in EP 0 549 694. This glass cartridge has an adapter mounted on the distal end of the glass cartridge. The adapter has a bore for receiving the neck part of the glass cartridge, which neck part is closed of by a metal cover. The inner wall of the bore is provided with gripping elements for gripping behind the edge of the metal cover when the neck part is mounted in the bore.
Traditionally, cartridges containing fluid medication have been used with medical delivery systems worldwide for invasive delivery of various types of fluid medicines. However, in typical medical delivery systems a cartridge is simply inserted into the delivery system without the system having any method of determining if the medicament contained in the cartridge is the correct type of medication for that specific delivery system. The user must manually check the cartridge to make sure that the medication is the correct one. This is quit important, since the administration of a incorrect kind of medication or of an incorrect dosage could result in injury or death.
In order to overcome the drawbacks of the prior art it is here suggested to provide the cartridge with a mechanical coding according to claim 1 , which mechanical coding has to fit into a specific contour in the medical delivery system in order to allow correct mounting of the cartridge in the medical delivery system.
Explanation of the claims:
By providing the cartridge with a mechanical coding it is ensured that the specific cartridge will only fit into a medical delivery system having a cartridge receiving part with a contour conforming to the shape of the mechanical coding of the cartridge.
In some medical delivery systems however, the conduit delivering the medication into the body of the patient are connected directly to the cartridge. The connecting part of the conduit, which are usually referred to as the conduit connector can then be made with an interior contour, which fits over the specific contour of the mechanical coding of the cartridge.
The shape of the contour of the cartridge and the corresponding part of the medical delivery system or the conduit connector can be any geometrical shape wanted, e.g. triangular, square or any other polygon. In this way the manufacture of the medicament can ensure that a specific medicament contained in a cartridge having a mechanical coding only can be dispensed from a specific medical delivery system and/or through a specific conduit.
The mechanical coding can either be moulded as an integral part of the cartridge, or it can be added to the cartridge in the form of e.g. an adapter, a sleeve or a jacket connected to the cartridge. The mechanical coding could also be provided as a part of the cartridge sealing.
The mechanical coding could also be provided as one or more depressions provided either in the cartridge or in the adapter. The medical delivery system would then be provided with a stud, which has to fit into the depression or depressions in order to allow the cartridge to be connected to the medical delivery system.
When the mechanical coding is made as one or more protrusions extending radial outwards from the outer cartridge surface, which is cylindrical, the cartridge can perform like a key while the cartridge receiving part of the medical delivery system or the conduit connector receiving the cartridge can perform as a key hole.
Instead of providing the outer cartridge surface with the mechanical coding, an adapter carry- ing the mechanical coding can be mounted on the cartridge at its distal end. This solution is to be preferred for glass cartridges.
When the mechanical coding is made as one or more protrusions extending radial outwards from the outer adapter surface, which is cylindrical, the outer adapter mounted on the car- tridge can perform like a key while the cartridge receiving part of the medical delivery system or the conduit connector receiving the cartridge can perform as a key hole.
By letting the protrusion or protrusions located on the outer surface of the cartridge or the adapter form a substantial circular protrusion, the outer surface of either the cartridge or the adapter can be made rotational symmetrical.
The protrusions can be formed as one circular protrusion covering substantially 360 degrees of the outer surface, or as a number of individual protrusions preferably located along a circle on the outer periphery of the outer surface of the cartridge or the adapter, such that the outer surface is rotational symmetrical, hence the location of the cartridge or the adapter in relation to the cartridge receiving part of the medical delivery system or the conduit connector receiving the cartridge is of importance.
The mating key hole of the cartridge receiving part of the medical delivery system or the conduit connector needs in its simplest form just be a hole having an inside contour conforming to the outside diameter of the circular protrusion.
Cartridges can then be made to fit specific delivery systems simply by mating the outside di- ameter of the circular protrusion with the inside contour of the cartridge receiving part of the medical delivery system or with the inside contour of the conduit connector.
The circular protrusion can either be made as one or a few protrusions substantially covering 360 degrees of the outer cartridge surface or the outer adapter surface, or it can be made as a number of raised islands located along the outer cartridge surface or the outer adapter surface. The number of raised island can vary from one and up.
The diameter of the circular protrusion can be utilized to indicate a parameter of the medicament contained in the specific cartridge. The parameter could e.g. be the type of medicament or it could be the concentration of the medicament.
When the cartridge contains insulin for treating diabetes it is to be preferred that the specific diameter of the circular protrusion is dedicated a specific concentration of insulin. Most insulin sold today has a concentration of 100 International Units (IU) pr. millilitre of insulin. Re- cently insulin with a concentration of 200 IU pr. ml. has emerged.
If a patient by accident loads a cartridge containing insulin with a concentration of 200 IU pr. ml. into a medical delivery system which are designed for use with insulin having a concentration of 100 IU pr. ml the patient will inject twice the number of International Units needed while the medical delivery systems normally are designed to expel a given quantity of insulin. The consequences of this could be fatal. It is therefore of the outmost importance that cartridges containing insulin with a concentration of 200 IU pr. ml are effectively prevented from being used in medical delivery systems designed to handle insulin with 100 IU pr. ml.
This is done by providing cartridges containing insulin with a concentration of 200 IU pr. ml. with a circular protrusion with a larger diameter than a cartridge containing insulin with only 100 IU pr. ml. When at the same time the inside contour of the cartridge receiving part of the medical delivery system or the conduit connector for a 100 I U pr. ml system is made to fit the diameter of the circular protrusion of the adapter of a cartridge containing insulin with a 100 IU pr. ml, it is ensured that a cartridge containing insulin with a concentration of 200 IU pr. ml can not be used in such a delivery system while the diameter of the circular protrusion of this cartridge is to large to fit into the inside contour of the cartridge receiving part of the medical delivery system or the conduit connector of a 100 IU pr. ml system.
This system can be expanded to also encompass insulin with even higher concentrations, such as 300 or 400 IU pr. ml simply by moulding the circular protrusions carried on the cartridges of these higher concentrations with larger diameters, such that the circular protrusion of a cartridge containing insulin with a specific concentration do not fit into the cartridge receiving part of a medical delivery system and/or into a conduit connector for a medical deliv- ery system designed for a lower concentration of insulin.
When using cartridges with circular protrusions with larger diameters for higher concentrations of insulin it will however be possible for a patient to fit a cartridge containing insulin with a lower concentration into the cartridge receiving part of a medical delivery system and/or into a conduit connector of system designed for a higher concentration of insulin. The result of this is that the patient does not get insulin enough for the correct treatment, which is a major inconvenience for that individual patient, but which is not a fatal incident, and which the patient will discover next time the blood glucose level is measured.
It is furthermore an object of the present invention to provide a medical delivery system accommodating a cartridge carrying a mechanical coding.
Such a medical delivery system is described in claim 9, as having a housing for accommodating a cartridge containing a fluid medicament, which housing in at least a part of the hous- ing has a contour with an inside shape conforming to the outside shape of the mechanical coding, such that only cartridges containing a fluid medicament suitable for the specific medical delivery system can be received in the specific medical system.
In some medical delivery systems, the conduit delivering the fluent medicament is connected directly to the cartridge by use of a conduit connector located at one end of the conduit. This conduit connector will then have a contour conforming to the mechanical coding on the outer cartridge surface or the adapter surface, such that only cartridges containing a fluid medicament suitable for the specific medical delivery system can be connected to the conduit of that specific medical delivery system.
The medicament contained in the cartridge is preferably insulin, the mechanical coding is a circular protrusion and the specific outside diameter of the circular protrusion is dedicated a specific concentration of insulin and the outside diameter is chosen as a larger diameter for a higher concentration.
In this way it is ensured that only insulin with concentrations suitable for or lower than the insulin concentration a specific insulin delivery system or conduit is designed for can actually be used in that specific insulin delivery system or with that specific conduit.
In the present context, the term "Medical delivery system" is taken to mean any system for invasive bringing a fluid medicament into a human body. The most commonly used medical delivery system is an injection system or an infusion system. In an injection system a predetermined quantity of the medicament are brought into the human body at one time through a conduit such as an injection needle temporarily inserted in the body. In an infusion system a quantity of the medicament is pumped via a pump system into the human body at a small constant rate through a conduit such as a catheter constantly inserted in the human body.
Although the wording "human body" is used through out this application, the medical delivery system could as well be used on any other mammal body without dispersing from the scope of the claims. It is to be understood that the wording "protrusion", refers to an element or a part that protrudes from a surface disregarding the form or the shape of the element or the part, while the term "circular protrusion" refers to a part which continuously protrudes from a circular surface substantially at all 360 degrees round the surface. The circular protrusion can however be made from a number of raised points located at a circle at the periphery of the surface without dispersing from the scope of the claims.
In the present context, the term "Conduit connector" is taken to mean a part or an element which is connected to the conduit or moulded as an integral part of the conduit, and which can be connected directly to either the cartridge, to the adapter or to the medical delivery system.
Figure 1 Shows an adapter mounted on a cartridge.
Figure 2 Shows the adapter of figure 1 seen from above
Figure 3 Shows an adapter with two circular protrusions protruding from the outer adapter surface.
Figure 4 Shows an adapter with a number of raised islands protruding forming the outer adapter surface.
Figure 5 Shows an adapter where the protrusion has the same width as the extension of the outer adapter surface.
Figure 6 Shows an adapter, which can be horizontally mounted on the cartridge. The figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out. Throughout, the same reference numerals are used for identical or corresponding parts.
Detailed Description of Embodiment:
Initially it may be convenient to define that, the term "distal end" of the cartridge 2 or the adapter 1 is meant to refer to the end carrying the conduit through which the medicine is expelled, whereas the term "proximal end" is meant to refer to the opposite end.
Figure 1 shows the adapter 1 mounted on a cartridge 2. The cartridge 2 is closed of by a metal cover 3 which are folded over the bottleneck of the cartridge 2 and beaded at the lower edge. The adapter 1 has a distal end surface 4, a proximal end surface 5 and an outer adapter surface 6 there between. The adapter 1 further has a longitudinal bore conforming the outer diameter of the metal cover 3. The adapter 1 is mounted on the cartridge 2 simply by pushing the adapter 1 over the metal cover 3. This is possible since the inside bore of the adapter has a diameter larger than the outside diameter of the metal cover 3. The inside surface 7 of this bore is provided with a number of gripping elements 8, usually there are three such gripping elements 8 located with a 120 degrees displacement. The diameter formed by these three gripping elements 8 are smaller than the diameter of the metal cover 3, such that the gripping elements 8 will grip behind the beaded end of the metal cover 3 when the adapterl is mounted on the cartridge 2.
The outer adapter surface 6 is provided with one or more protrusions 9, which protrusion 9 extends radial outwards from the outer adapter surface. The protrusion 9 can as shown in figure 2 have a circular form covering 360 degrees of the outer adapter surface 6.
The circular protrusion 9 has an outer diameter, which can be different from one adapter 1 to another adapter 1 as indicated with dotted lines 10.
The cartridge receiving part 11 is provided with a circular bore 13, which receives the adapter 1 when the cartridge 2 is mounted in the cartridge receiving part 11. For other types of cartridge receiving parts 12 indicated with dotted lines, the bore 14 could have a different diameter. Referring to figure 1 and 6, a specific outside diameter of the circular protrusion 9, 10 is dedicated to a specific concentration of the insulin contained in the cartridge 2. The cartridge 2 containing the lowest concentration is provided with an adapter 1 having only a small outside diameter of the circular protrusion 9, while the larger concentrations are provided with an adapter 1 having a larger diameter of the circular protrusion 10.
The same is the case for the diameter of the bore of the cartridge receiving part 11. The cartridge receiving part 11 on a medical delivery system designed for low concentrations has the smallest diameter of the bore 13, while the cartridge receiving part 12 on a medical delivery system for handling larger concentrations has a larger bore 14.
As illustrated in figure 6 a cartridge receiving part 11 on a medical delivery system designed for 100 I U pr. ml can only receive the adapter 1 of an cartridge 2 containing insulin with a 100 IU pr. ml. concentration, which is indicated by the outside diameter of the circular protrusion 9, while the cartridge receiving part 12 on a system designed for 200 IU pr. ml. can receive both the adapter 1 of a cartridge 2 containing insulin with a concentration of 100 IU pr. ml and the adapter 1 of a cartridge 2 containing insulin with a concentration of 200 IU pr. ml, indicated by a circular protrusion 10 having a larger outside diameter.
Although the 100 IU cartridge 2 of figure 6 is described as being a cartridge 2 with an adapter 1 mounted thereto, it could as well be a cartridge 2 moulded from plastic with the protrusion 9 moulded as an integral part of the cartridge 2.
The cartridge receiving part 15 of medical delivery system designed for 300 IU pr. ml is able of handle both the previous mentioned adapters 1 having circular protrusions 9, 10 as well as an adapter of a cartridge having a circular protrusion 16 with an even larger diameter containing insulin with a concentration of 300 IU pr. ml.
Figure 3 to 5 show different configurations of adapters 1. The adapter 1 of figure 3 is provided with two protrusions 9, 17 both covering 360 degrees of the outer surface 6. The first protrusion 9 is shown as having a width W. The adapter 1 shown in figure 4 is provided with a number of protrusions 18 which are shaped as a number of raised points, and which raised points are provided on a circle covering substantially 360 degrees of the outer surface 6 of the adapter 1.
The circular protrusion or protrusions can have a width W that equals the longitudinal extension of the outer adapter surface 6 as shown in figure 5, in which case there in fact is no protrusions but simply a relatively large diameter D of the entire outer adapter surface 6.
The circular protrusion 9 shown in figure 3 is located in a specific distance L from the distal end surface 4. Instead of providing the circular protrusion 9 with different diameters, the general idea of the present invention could also be realised by providing the circular protrusion 9 in different distances L from the distal end surface 4 for different insulin concentrations. It is apparent that only one circular protrusion 9 is needed in this case. The distance L could e.g. be chosen as a little distance for an insulin with a concentration of 200 IU pr. ml. and a greater distance for an insulin with a concentration of 100 IU pr. ml. The cartridge receiving part 11 , 12 of the medical delivery system could then be made with an inside located neck or shoulder with a narrow diameter preventing the cartridge 2 containing insulin with a concentration on 200 IU pr. ml. to fully enter the cartridge receiving part of a medical deliver system designed for insulin with a concentration on 100 IU pr. ml.
1. A cartridge containing a fluid medicament, which cartridge comprises a distal end, a proximal end and an outer cartridge surface there between,
the cartridge carries a mechanical coding at the distal end.
2. A cartridge according to claim 1 , characterized in that, the outer cartridge surface is cylindrical and that the mechanical coding is one or more protrusions extending radial outwards from the distal end of the outer cartridge surface.
3. A cartridge according to claim 1 , characterized in that said distal end is provided with a an adapter comprising a distal end surface, a proximal end surface and an outer adapter surface there between, and which outer adapter surface carries the mechanical coding.
4. A cartπdge according to claim 3, characterized in that, the outer adapter surface is substantial cylindrical and that the mechanical coding is one or more protrusions extending radial outwards from the outer adapter surface.
5. A cartridge according to claim 2 or 4, characterized in that, the protrusion or protrusions together form at least one substantially circular protrusion.
6. A cartridge according to claim 5, characterized in that, the outer diameter of the circular protrusion indicates a parameter of the medicament contained in the cartridge.
7. A cartridge according to claim 6, characterized in that, the medicament is insulin and that a specific diameter of the circular protrusion is dedicated a specific concentration of the insulin.
8. A cartridge according to claim 7, characterized in that, the larger concentration has the larger diameter.
9. A medical delivery system comprising a housing for accommodating a cartridge containing a fluid medicament according to anyone of the claims 1-8, characterized in that
the mechanical coding on the outer cartridge surface or the outer adapter surface is received in a contour in the housing or in a part of the housing, which contour has an inside shape conforming to the outside shape of the mechanical coding.
10. A medical delivery system comprising a housing for accommodating a cartridge containing a fluid medicament according to anyone of the claims 1-8,
the fluid medicament contained in the cartridge is delivered into a human body through a conduit having a first end mounted onto the cartridge or the adapter and a second end in- serted into the human body, the first end of the conduit having a contour, conforming to the outside shape of the mechanical coding carried on the outer cartridge surface or the outer adapter surface.
11. A medical delivery system according to claim 9 or 10, characterized in that, the medica- ment contained in the cartridge is insulin, the mechanical coding is a substantially circular protrusion and that a specific outside diameter of the circular protrusion is dedicated a specific concentration of insulin and which outside diameter is chosen as a larger diameter for a higher concentration.
PCT/DK2002/000554 2001-08-27 2002-08-23 A cartridge and a medical delivery system accommodating such a cartridge WO2003017915A1 (en)
DKPA200101268 2001-08-27
KR20047002461A KR20040027934A (en) 2001-08-27 2002-08-23 A cartridge and a medical delivery system accommodating such a cartridge
CA 2457949 CA2457949A1 (en) 2001-08-27 2002-08-23 A cartridge and a medical delivery system accommodating such a cartridge
DE2002613253 DE60213253D1 (en) 2001-08-27 2002-08-23 A cartridge and a medical delivery system houses the such a cartridge
EP20020758184 EP1423079B1 (en) 2001-08-27 2002-08-23 A cartridge and a medical delivery system accommodating such a cartridge
JP2003522438A JP4224702B2 (en) 2001-08-27 2002-08-23 Medical delivery system accommodating a cartridge and the cartridge
DE2002613253 DE60213253T2 (en) 2001-08-27 2002-08-23 A cartridge and a medical delivery system houses the such a cartridge
WO2003017915A1 true true WO2003017915A1 (en) 2003-03-06
ID=8160683
PCT/DK2002/000554 WO2003017915A1 (en) 2001-08-27 2002-08-23 A cartridge and a medical delivery system accommodating such a cartridge
US (4) US20030078195A1 (en)
EP (1) EP1423079B1 (en)
JP (1) JP4224702B2 (en)
KR (1) KR20040027934A (en)
CN (1) CN1278666C (en)
CA (1) CA2457949A1 (en)
DE (2) DE60213253T2 (en)
RU (1) RU2318492C2 (en)
WO (1) WO2003017915A1 (en)
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