CN1264493C - Cartridge for liquid insulin - Google Patents

Cartridge for liquid insulin Download PDF

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Publication number
CN1264493C
CN1264493C CNB028165950A CN02816595A CN1264493C CN 1264493 C CN1264493 C CN 1264493C CN B028165950 A CNB028165950 A CN B028165950A CN 02816595 A CN02816595 A CN 02816595A CN 1264493 C CN1264493 C CN 1264493C
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CN
China
Prior art keywords
cartridge case
insulin
delivery system
plunger
approximately
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Legal status (The legal status 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 status listed.)
Expired - Fee Related
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CNB028165950A
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Chinese (zh)
Other versions
CN1547459A (en
Inventor
拉尔斯·T·克里斯滕森
斯特芬·汉森
拉尔斯·P·克利特莫塞
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Novo Nordisk AS
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Novo Nordisk AS
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Publication of CN1547459A publication Critical patent/CN1547459A/en
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Publication of CN1264493C publication Critical patent/CN1264493C/en
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    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/062—Carpules

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  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (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)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • External Artificial Organs (AREA)

Abstract

A glass cartridge which can be utilized both in an insulin pump system and in an insulin injection system. The glass cartridge contains U200 insulin. In order to obtain a suitable accuracy of the doses delivered by the system, the inside diameter of the cartridge must be in the range 7.45 to 9.32 mm.

Description

The cartridge case that is used for liquid insulin
Technical field
The present invention relates to be used for the agent of pin bottle or the cartridge case of insulin delivery system.These cartridge cases are formed generally as the glass tubing by the plunger sealing at place, an end, this plunger can be squeezed in the pipe and with another end at this pipe the content of pipe be discharged.This another end forms bottleneck, and its outer end can be pierced through by entry needle or intubate, and content is discharged by entry needle or intubate.
Background technology
Glass tubing is well-known for various delivery systems.They are particularly useful for insulin delivery system, and 1.5ml insulin or 3.0ml insulin are housed usually in advance.1.5ml its internal diameter of cartridge case is typically about 6.85mm, and its internal diameter of 3.0ml cartridge case is typically about 9.25mm.These known cartridge cases are filled with the insulin that concentration is 100 ius (IU)/milliliter in advance.Therefore the 1.5ml cartridge case includes 150IU, and 3.0ml includes 300IU.
Common diabetes patient needs every day and injects in its body or injects a certain amount of insulin.Some patients need 100IU every day, in this case suggestion 3.0 cartridge cases.Patient adds this cartridge case in injecting systems or the pumping system, and by entry needle or by be inserted into its intravital intubate with the speed of regulation with injection of insulin or inject in its body.In case cartridge case is drained, then it is abandoned, and new cartridge case is put in the induction system.
Glass for the dress insulin cartridge case for be most preferred material because glass chemically with all be inert on the biology, thereby insulin can be stored in the glass ampoules, and between liquid insulin and glass material, can not occur the reaction.Its extra advantage of glass is that it can carry out heat sterilization.Glass ampoules is gone out by long Production of Glass, these long glass tubings can be cut into littler pipe, the one end thereof fusion, thus keep less opening.The relative open end of pipe is provided with movable plunger, and they are made by rubber or plastics usually.
But be that by its shortcoming of cartridge case that glass is made internal diameter is along with manufacturing process changes.Inside diameter of glass cartridges changes 0.1mm under the situation of the mean inside diameter of about 10mm.But, by classifying glass ampoules or can obtain littler tolerance in advance by the glass technology of looking over one's shoulder.Following table demonstrates common obtainable tolerance at present.
Internal diameter 7 7.5 8 9.25 10 11 12
Tolerance+/- 0.05 0.05 0.06 0.06 0.08 0.09 0.1
These tolerances of this cartridge case are subject matter for a dose accuracy of the insulin of injecting or injecting.The dose accuracy of insulin delivery system is the theme of iso standard 11608-1.This standard code, its degree of accuracy of the dosage in the 0-20IU scope be necessary for+/-1IU, promptly its content of the nominal standard dose of 20IU must be between 19-21IU.This iso standard allow less than the tolerance of the dosage of 20IU+/-1IU in, must be in+/-5% scope and surpass the tolerance of the dosage of 20IU.The most difficult part that satisfies this standard therefore usually at 20IU dosage+/-the degree of accuracy requirement of 1IU.
Major diameter combines with high tolerance and makes that the cross-section variation of glass ampoules is bigger, and bigger tolerance appears in this volume that will cause being carried by this insulin delivery system.But this is not a subject matter when its concentration of insulin has only the 100IU/ milliliter.
Summary of the invention
The eternal purpose of the maker of insulin delivery system is to make their system's miniaturization.But induction system always must comprise a cartridge case.Therefore maker is starved of littler and compacter cartridge case.Yet no one wants to sacrifice the iu quantity that is contained in this cartridge case.A scheme that solves this Gordian difficult problem is to be contained in insulin concentration in the cartridge case by raising.By concentration being increased to the 200IU/ milliliter, thereby the 1.5ml cartridge case can contain 300IU.
Because the area of section of above-mentioned glass ampoules changes greatly, so obviously be difficult to when adopting liquid U200 insulin, meet the ISO11608-1 standard day by day.
In the table of Fig. 1, calculate the displacement degree of accuracy of the glass syringe of different size.Two first row demonstrate the different size and the id tolerance of various cartridge cases.The nominal area of section and the greatest cross-section that calculate these cartridge cases in row 3 and 4 are long-pending.Row 5 have provided insulin concentration.
Calculating in row 6 in order to discharge the 1IU insulin to make the plunger antetheca move forward the into distance of cartridge case. and this motion adopts following formula to calculate according to nominal diameter:
H = V π · R 2
V: volume
R: radius
H: displacement
Its volume of 1IU liquid U200 insulin is 0.005ml, for example its nominal diameter be the antetheca of plunger in the cartridge case of 9.25mm therefore must mobile 0.074mm so that discharge 1IU.
Tolerance on the row 7 expression area of sections is to the influence degree of dose accuracy.As can be seen, for the cartridge case that its nominal diameter is 9.25mm since the tolerance of cartridge case area of section consumed in iso standard, provide+/-tolerance on the IU+/-0.260IU.Calculate tolerance by from the greatest cross-section that demonstrates is long-pending, deducting minimum area of section and this difference be multiply by in a unit displacement shown in the row 6 and multiply by insulin concentration row 4.Shown in the row 8 remaining+/-that inexactness that 0.740IU can be used for insulin delivery system is for example led to the interface of cartridge case is lax.
The tolerance remainder of listing in row 8 is to multiply by the residue tolerance of the inexactness that can be used for insulin delivery system and represent with millimeter in row 9 by discharging the needed displacement of 1IU.
Redescribe and be used for the numeral that its nominal inside diameter is the cartridge case of 9.25mm, the antetheca of plunger must move 20 distances that multiply by 0.074mm, promptly 1.488mm+/-0.055mm (from 1.433 to 1.543mm) so that be in tolerance+/-carry 20IU dosage in the scope of 1IU.
The volume of discharging in these margins of tolerance can adopt following formula to calculate:
V(IU)＝CS·D·IC
V (IU): the volume of representing with IU
CS: the area of section of cartridge case (=π R 2)
D: plunger displacement
IC: insulin concentration
Following table demonstrate when this cartridge case be used in can make plunger with+/-during insulin delivery system that the tolerance of 0.055mm moves forward, for nominal diameter be 9.25mm and tolerance for+/-0.06mm is that internal diameter is the cartridge case of 9.19mm-9.31mm, the area of section that is equivalent to the volume of this cartridge case is 66.33mm 2-68.08mm 2The evacuation volume of measuring with iu.Therefore travelling forward passable distance can be in the scope of 1.433mm to 1.543mm.
1.433mm 1.488mm 1.543mm
66.33mm 2 19.01IU 19.74IU 20.47IU
67.20mm 2 19.26IU 19.99IU 20.74IU
68.08mm 2 19.51IU 20.26IU 21.00IU
Present available mechanical insulin delivery system is because the cause of this mechanical system all has sizable inexactness.Its displacement degree of accuracy of injection device in the past is approximately+/-0.083, the antetheca that this means plunger only with approximately+/-move forward in the margin of tolerance of 0.083mm.When adopting the U200 insulin, according to the form shown in Fig. 1, the maximum of cartridge case permission internal diameter must be less than the internal diameter of nominal 7.5mm cartridge case so that meet the requirement that sets in the ISO11608-1 standard.Internal diameter greater than the cartridge case of 7.5mm all need the displacement degree of accuracy less than+/-0.083mm is so that meet this iso standard.Therefore they be not suitable for being used in a regular insulin system.
So the insulin pump of pump treatment that is used for the diabetes patient is because the existence of motor mechanism has usually than mechanical injection device precise mechanism more, this drives injection device too for motor.But, because the existence of insulin conveying profile continuously, so in insulin pump, needn't have precise mechanism.
In recent years, developed accurately injection device of machinery, its degree of accuracy is higher than known injection device.In fact, these new injection devices can approximately+/-plunger is moved forward in the margin of tolerance of 0.055mm.
Therefore demonstrate, the following tolerance limit that includes liquid U200 insulin and diameter and be nominal 7.5mm cartridge case be 7.45mm to the last tolerance limit of nominal 9.25mm cartridge case be the cartridge case of 9.31mm can be used in the pump and be used in its tolerance+/-0.055mm to+/-the accurate injection device of 0.083mm in, and the requirement that can not run counter to ISO11608-1.
Make medication tube satisfy these requirements.
Internal diameter is that the glass ampoules of 7.45-9.31mm can satisfy the ISO11608-1 standard in the accurate insulin delivery system of the progressive displacement degree of accuracy of plunger in 0.055mm to 0.083mm scope the time under the situation that is filled with liquid U200 insulin in being used in its mechanical mechanism.
Therefore the glass ampoules of its internal diameter in institute's claimed range can be used in insulin pumping system and the insulin-injecting system.
When operating in the lower limit of the internal diameter in 7.45mm to 9.31mm scope, guarantee for example in the scope of 7.45mm to 7.55mm, cartridge case can be done very elongated and have very narrow tolerance, thereby stay maximum allowance for the inaccuracy of insulin delivery system.
Its nominal inside diameter is that the glass ampoules of 7.5mm need be approximately the stroke zone length of 34mm so that hold the volume that is approximately 1.5ml.When including the liquid U200 insulin of 1.5ml, the iu total amount is 300IU, and this will enough be used for three days treatment for most patient.When adopting cartridge case in pumping system, this pump is connected with user's body by intubate usually.Owing to chafing, so advise approximately intubate of change in per three days and position usually in insertion intubate position.Therefore the cartridge case that includes the insulin that is used for minimum three days is preferred.
Because the size in join domain and plunger zone, the entire length of this cartridge case is approximately 52mm.
When operating in the upper limit of the internal diameter in 7.45mm to 9.31mm scope, for example guarantee that in the scope of 9.19mm to 9.31mm this cartridge case can be done very shortly and still leave enough tolerances for the inexactness of this insulin delivery system.Nominal inside diameter is that the glass ampoules of 9.25mm need be approximately the stroke zone length of 23mm so that hold the volume of about 1.5ml, thereby causes being approximately the entire length of 44mm.
Brief description of drawings
With reference to the following drawings and in conjunction with preferred embodiment the present invention is more fully illustrated below, wherein:
Fig. 1 demonstrates the form of the displacement degree of accuracy that is used for different cartridge design;
Fig. 2 demonstrates and comprises the glass ampoules that is needled into according to of the present invention.
For the sake of clarity these accompanying drawings are schematically and are simplified, and they only demonstrate for understanding the requisite details of the present invention, and other details is deleted.Identical on the whole reference number is used for identical or corresponding parts.
Detailed description of preferred embodiments
In Fig. 1, demonstrate the form of the displacement degree of accuracy that is used for different cartridge design.The glass ampoules that accommodates liquid U200 insulin and its nominal diameter and be 7.5-9.25mm for+/-0.083 and+/-displacement leaving space between the 0.055mm, this is used for injection device and is used under the situation of pumping system being necessary and satisfying the ISO11608-1 standard at cartridge case.It can also be seen that in the table from Fig. 1 that adopting nominal diameter is that the displacement degree of accuracy of the insulin delivery system of 9.25mm is necessary for 0.084mm when this cartridge case is equipped with liquid U100 insulin.
With reference to Fig. 2, can limit easily, the term of cartridge case 1 " far-end " refers to the end of carrying conduit 7, by this conduit insulin is discharged, and term " near-end " refers to the opposed end that is carrying plunger 9.
In Fig. 2, disclosed the cartridge case 1 that includes cylindrical wall 2.This cylindrical wall 2 is in far-end 10 places of the cartridge case 10 that ends in the cervical region, and cervical region terminates in the circumferential flange 3, is keeping stinging and flexible thin film 4 by crown cap 5 sealings.In the central part office of thin film 4, crown cap 5 has an opening 6, by this opening thin film 4 is exposed.Hollow pipeline 7 for example entry needle or intubate can pierce through this thin film 4 and is communicated with the inner space with cartridge case 1, and wherein liquid insulin is stored in thin film 4 and fits between the antetheca 8 of the plunger 9 in this cartridge case 1.
Plunger 9 is made by suitable elastomeric material usually, thus it by tight seal on the inboard of cylindrical wall 2.Inside diameter of glass cartridges is represented with D in Fig. 1.
This cartridge case 1 is divided into three zoness of different.The first area is join domain C, it extends to shoulder 12 from the far-end 10 of cartridge case 1.Because the cylindrical wall 2 of cartridge case 1 is reducing at the far-end 10 of cartridge case 1 and the diameter on the part cylindrical wall 2 between the shoulder 12, so plunger 9 can not move the neck area that exceeds shoulder 12 and enter cartridge case 1.Therefore the insulin that is contained in the cervical region of cartridge case 1 can be forced out this cartridge case, therefore falls processed when discarded this cartridge case 1.
Second area is the stroke region S, and it extends to the antetheca 8 of plunger 9 from shoulder 12.The insulin that only is included in the stroke zone can be used for injecting or injecting.
The 3rd zone is plunger zone P, and it extends to the antetheca 8 of plunger 9 from the near-end 11 of cartridge case 1.This plunger zone P is keeping piston 9, and is therefore unavailable for the insulin in being contained in cartridge case 1.
The liquid insulin that is captured between the antetheca 8 of plunger 9 and the fexible film 4 and is positioned at the inside diameter D of cylindrical wall 2 will be forced out by hollow pipeline 7, and this pipeline is inserted among the people who needs insulin at unshowned another place, end when plunger 9 moves forward in cartridge case 1.
Demonstrated certain preferred embodiments in front, but should be emphasized that the present invention is not limited to these embodiments, but can in by the theme that following claim limited, otherwise implement.

Claims (7)

1. glass ampoules that is used for accurate insulin delivery system, (1), described cartridge case, (1) comprises a far-end, (10) and a near-end, (11), both hold the cylindrical wall of the container of liquid insulin by formation, (2) connect, described far-end, (10) be provided with by sealing and fixing at flange, (3) fexible film on, (4) Feng Bi flange, (3), and described near-end, (11) by moving into described cartridge case, (1) plunger, (9) sealing, this cartridge case is contained in liquid insulin and is positioned at fexible film, (4) and plunger, (9) antetheca, (8) in the variable spaces between
It is characterized in that,
Described liquid insulin is the U200 insulin, and the internal diameter of described cylindrical wall (2) is 7.45mm to 9.31mm, thereby described cartridge case (1) can be used in insulin pumping system and the insulin-injecting system.
2. the glass ampoules that is used for accurate insulin delivery system as claimed in claim 1 is characterized in that, the internal diameter of described cartridge case (1) is in the scope of 7.45mm to 7.55mm.
3. the glass ampoules that is used for accurate insulin delivery system as claimed in claim 2 is characterized in that, described cartridge case has three zones: a join domain (C); An one-stroke zone (S) and a plunger zone (P), the length in described stroke zone (S) is approximately 34mm, thus the volume in this stroke zone (S) is approximately 1.5ml.
4. the glass ampoules that is used for accurate insulin delivery system as claimed in claim 3 is characterized in that, the total length of described cartridge case (1) is approximately 52mm.
5. the glass ampoules that is used for accurate insulin delivery system as claimed in claim 1 is characterized in that, the internal diameter of described cartridge case (1) is 9.19mm to 9.31mm.
6. the glass ampoules that is used for accurate insulin delivery system as claimed in claim 5 is characterized in that, described cartridge case has three zones: a join domain (C); An one-stroke zone (S) and a plunger zone (P), the length in described stroke zone (S) is approximately 23mm, thus the volume in this stroke zone (S) is approximately 1.5ml.
7. the glass ampoules that is used for accurate insulin delivery system as claimed in claim 6 is characterized in that, the total length of described cartridge case (1) is approximately 44mm.
CNB028165950A 2001-08-31 2002-08-23 Cartridge for liquid insulin Expired - Fee Related CN1264493C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200101282 2001-08-31
DKPA200101282 2001-08-31

Publications (2)

Publication Number Publication Date
CN1547459A CN1547459A (en) 2004-11-17
CN1264493C true CN1264493C (en) 2006-07-19

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ID=8160689

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CNB028165950A Expired - Fee Related CN1264493C (en) 2001-08-31 2002-08-23 Cartridge for liquid insulin

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EP (1) EP1424984B1 (en)
JP (1) JP2005507682A (en)
KR (1) KR20040029015A (en)
CN (1) CN1264493C (en)
AT (1) ATE300933T1 (en)
AU (1) AU2002325201B2 (en)
CA (1) CA2457943A1 (en)
DE (1) DE60205390T2 (en)
DK (1) DK1424984T3 (en)
ES (1) ES2247366T3 (en)
IL (1) IL159901A0 (en)
PL (1) PL367865A1 (en)
RU (1) RU2299723C2 (en)
WO (1) WO2003017914A1 (en)
ZA (1) ZA200400344B (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008055689A1 (en) * 2006-11-10 2008-05-15 Roche Diagnostics Gmbh Container for receiving medical liquids
US9603995B2 (en) 2013-03-15 2017-03-28 Tandem Diabetes Care. Inc. Device and method for setting therapeutic parameters for an infusion device
WO2016150900A2 (en) * 2015-03-23 2016-09-29 Sanofi-Aventis Deutschland Gmbh Injection device

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3468173D1 (en) * 1983-09-07 1988-02-04 Disetronic Ag Portable infusion apparatus
DE3606163A1 (en) * 1986-02-26 1987-08-27 Hoechst Ag DEVICE FOR APPLICATING MEDICAL SUSPENSIONS
DK503386D0 (en) * 1986-10-20 1986-10-20 Novo Industri As PEPTIME PREPARATIONS
US5334162A (en) * 1993-03-15 1994-08-02 Eli Lilly And Company Cartridge assembly for a lyophilized compound forming a disposable portion of an injector pen and method for same
ZA941881B (en) * 1993-04-02 1995-09-18 Lilly Co Eli Manifold medication injection apparatus and method
GB9511169D0 (en) * 1995-06-02 1995-07-26 Lilly Co Eli Containers for liquid medicaments
US6146361A (en) * 1996-09-26 2000-11-14 Becton Dickinson And Company Medication delivery pen having a 31 gauge needle
AU3247999A (en) * 1998-03-06 1999-09-20 Novo Nordisk A/S Coating system providing low friction
WO2000071191A2 (en) * 1999-04-30 2000-11-30 Eli Lilly And Company Cartridge assembly for medicament suspensions

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Publication number Publication date
RU2299723C2 (en) 2007-05-27
IL159901A0 (en) 2004-06-20
EP1424984B1 (en) 2005-08-03
DE60205390T2 (en) 2006-04-20
WO2003017914A1 (en) 2003-03-06
PL367865A1 (en) 2005-03-07
ES2247366T3 (en) 2006-03-01
ATE300933T1 (en) 2005-08-15
RU2004109579A (en) 2005-03-20
JP2005507682A (en) 2005-03-24
EP1424984A1 (en) 2004-06-09
ZA200400344B (en) 2005-03-30
DK1424984T3 (en) 2005-11-14
CA2457943A1 (en) 2003-03-06
DE60205390D1 (en) 2005-09-08
CN1547459A (en) 2004-11-17
KR20040029015A (en) 2004-04-03
AU2002325201B2 (en) 2007-11-01

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Granted publication date: 20060719

Termination date: 20170823