U.S. patent application number 10/230428 was filed with the patent office on 2003-04-24 for cartridge and medical delivery system accommodating such cartridge.
Invention is credited to Jensen, Morten Baek, Kristensen, Lars Thougaard, Nielsen, Lars Korsbjerg, Steengaard, Kim.
Application Number | 20030078195 10/230428 |
Document ID | / |
Family ID | 8160683 |
Filed Date | 2003-04-24 |
United States Patent
Application |
20030078195 |
Kind Code |
A1 |
Kristensen, Lars Thougaard ;
et al. |
April 24, 2003 |
Cartridge and medical delivery system accommodating such
cartridge
Abstract
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.
Inventors: |
Kristensen, Lars Thougaard;
(Vesko, DK) ; Nielsen, Lars Korsbjerg; (Birkerod,
DK) ; Steengaard, Kim; (Birkerod, DK) ;
Jensen, Morten Baek; (Naerum, DK) |
Correspondence
Address: |
Reza Green, Esq.
Novo Nordisk of North America, Inc.
Suite 6400
405 Lexington Avenue
New York
NY
10174-6401
US
|
Family ID: |
8160683 |
Appl. No.: |
10/230428 |
Filed: |
August 23, 2002 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60317307 |
Sep 5, 2001 |
|
|
|
Current U.S.
Class: |
604/201 ;
514/5.9; 604/189 |
Current CPC
Class: |
A61M 5/14566 20130101;
A61M 2205/6045 20130101; A61J 2205/40 20130101; A61M 5/1452
20130101; A61M 5/24 20130101 |
Class at
Publication: |
514/3 ;
604/189 |
International
Class: |
A61K 038/28; A61M
005/00 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 27, 2001 |
PA |
2001 01268 |
Claims
We claim:
1. A cartridge containing a fluid medicament, which cartridge
comprises a distal end, a proximal end and an outer cartridge
surface there between, characterized in that 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 cartridge 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 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 claim 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 claim 8, characterized in that, 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 inserted 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 10, characterized
in that, the medicament 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.
Description
CROSS REFERENCE OF RELATED APPLICATION
[0001] This application claims the benefit of priority under 35
U.S.C. .sctn.119 of U.S. Provisional Application No. 60/317,307,
filed on Sep. 5, 2001 and Danish Application PA 2001 01268, filed
on Aug. 27, 2001; the contents of both are hereby fully
incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. The Technical Field of the Invention
[0003] 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.
[0004] 2. Description of Related Art
[0005] 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.
[0006] 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 cartridge. Once the cartridge is empty it is
disposed of and a new cartridge is loaded into the delivery
system.
[0007] 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.
[0008] 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.
SUMMARY OF THE INVENTION
[0009] 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.
[0010] In order to overcome the drawbacks of the prior art it is
here suggested to provide the cartridge with a mechanical coding
that 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.
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] 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.
[0016] 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.
[0017] 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.
[0018] Instead of providing the outer cartridge surface with the
mechanical coding, an adapter carrying the mechanical coding can be
mounted on the cartridge at its distal end. This solution is to be
preferred for glass cartridges.
[0019] 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
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.
[0020] 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.
[0021] 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.
[0022] 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.
[0023] Cartridges can then be made to fit specific delivery systems
simply by mating the outside diameter 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.
[0024] 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.
[0025] 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.
[0026] 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. Recently insulin with a
concentration of 200 IU pr. ml. has emerged.
[0027] 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.
[0028] 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.
[0029] 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 IU 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.
[0030] 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 delivery system designed for a lower concentration of
insulin.
[0031] 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.
[0032] It is furthermore an object of the present invention to
provide a medical delivery system accommodating a cartridge
carrying a mechanical coding.
[0033] 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 housing 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.
[0034] 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.
[0035] 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.
[0036] 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.
[0037] Definitions
[0038] 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.
[0039] 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.
[0040] 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.
[0041] 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0042] The invention will be explained more fully below in
connection with a preferred embodiment and with reference to the
drawings in which:
[0043] FIG. 1 Shows an adapter mounted on a cartridge.
[0044] FIG. 2 Shows the adapter of FIG. 1 seen from above
[0045] FIG. 3 Shows an adapter with two circular protrusions
protruding from the outer adapter surface.
[0046] FIG. 4 Shows an adapter with a number of raised islands
protruding forming the outer adapter surface.
[0047] FIG. 5 Shows an adapter where the protrusion has the same
width as the extension of the outer adapter surface.
[0048] FIG. 6 Shows an adapter, which can be horizontally mounted
on the cartridge.
[0049] 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 THE INVENTION
[0050] 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.
[0051] FIG. 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 adapter 1 is mounted on the cartridge 2.
[0052] 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 FIG. 2 have
a circular form covering 360 degrees of the outer adapter surface
6.
[0053] 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.
[0054] 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.
[0055] Referring to FIGS. 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.
[0056] 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.
[0057] As illustrated in FIG. 6 a cartridge receiving part 11 on a
medical delivery system designed for 100 IU 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.
[0058] Although the 100 IU cartridge 2 of FIG. 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.
[0059] 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.
[0060] FIGS. 3 to 5 show different configurations of adapters 1.
The adapter 1 of FIG. 3 is provided with two protrusions 9, 17 both
covering 360 degrees of the outer surface 6.
[0061] The first protrusion 9 is shown as having a width W. The
adapter 1 shown in FIG. 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.
[0062] The circular protrusion or protrusions can have a width W
that equals the longitudinal extension of the outer adapter surface
6 as shown in FIG. 5, in which case there in fact is no protrusions
but simply a relatively large diameter D of the entire outer
adapter surface 6.
[0063] The circular protrusion 9 shown in FIG. 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.
[0064] Some preferred embodiments have been shown in the foregoing,
but it should be stressed that the invention is not limited to
these, but may be embodied in other ways within the subject matter
defined in the following claims.
* * * * *