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US20020020646A1 - Needle magazine - Google Patents

Needle magazine Download PDF

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Publication number
US20020020646A1
US20020020646A1 US09/875,715 US87571501A US2002020646A1 US 20020020646 A1 US20020020646 A1 US 20020020646A1 US 87571501 A US87571501 A US 87571501A US 2002020646 A1 US2002020646 A1 US 2002020646A1
Authority
US
United States
Prior art keywords
needle
shell
magazine
magazine according
injection device
Prior art date
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.)
Abandoned
Application number
US09/875,715
Other languages
English (en)
Inventor
Lars Groth
Niels Hvid
Carsten Larsen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novo Nordisk AS
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to US09/875,715 priority Critical patent/US20020020646A1/en
Assigned to NOVO NORDISK A/S reassignment NOVO NORDISK A/S ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LARSEN, CARSTEN GERNER, HVID, NIELS, GROTH, LARS MORCH
Publication of US20020020646A1 publication Critical patent/US20020020646A1/en
Abandoned legal-status Critical Current

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Images

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
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • 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
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • A61M2005/004—Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
    • 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
    • A61M5/008—Racks for supporting syringes or needles
    • 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
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion

Definitions

  • the invention relates to a needle magazine for storing and dispensing a plurality of needle assemblies for use on an injection device.
  • Medical injection devices are used to deliver selected doses of medication to patients. Some medication, such as insulin is self-administered. The typical diabetes patient will require injections of insulin several times during the course of the day. In order to prevent infections it is recommended to use a sterile needle assembly for each injection. Needle assemblies are often delivered in magazines where each magazine contains only one needle assembly in a sterile compartment. Such a magazine is described in U.S. Pat. No. 5,971,966. Using a needle assembly of this kind requires the patient to open the magazine and to fasten the needle assembly on to the injection device prior to each injection. The storage of sterile needle assemblies of this type and the final disposable of used needle assemblies present a problem, since new sterile needle assemblies are often carried loosely in purses or briefcases, and used needle assemblies are often disposed of unsafely.
  • the prior art magazine is attached to the injection device by fitting the entire magazine into an open end of the removable cap of a pencil-shaped injection device. Due to the dimensions of a pencil-shaped injection device only five needle assemblies can be contained in the magazine. An ordinary disposable injection device usually contains 300 IU of insulin. For many diabetes patients this is sufficient for 10 to 20 injections, therefore one magazine of needle assemblies are not enough for the lifetime of one disposable injection device, which is very inconvenient.
  • a needle magazine for storing and dispensing a plurality of needle assemblies for use on an injection device having a housing accommodating a cartridge containing medicine for a number of dosed injections and which needle magazine can be carried on the injection device, which needle magazine comprises;
  • a plurality of confinements each containing a needle assembly having a first distal end, which is sharpened for piercing the skin of the user and an opposite proximal end and a side wall there between, which confinements each has a first distal surface and an opposite proximal surface,
  • each needle assembly means for supporting each needle assembly in an upright position, having the first distal end pointing towards the first distal surface and the opposite proximal end pointing towards the opposite proximal surface
  • the shell can be rotated in order to index the needle assemblies and to position one of the needle assemblies above the cartridge, and that
  • the shell can be activated for bringing the proximal end of the positioned needle assembly into contact with the cartridge, and the distal end of the needle assembly into a position where the distal end of the needle assembly is located outside the magazine, whereby the medicine can be injected.
  • the needle assemblies in the needle magazine are confined in separate, sterile confinements. These confinements are connected in a side-by-side relation.
  • one needle assembly is positioned above the cartridge containing the medicine to be expelled.
  • the shell impacts the hub of the needle assembly while the distal end of the needle unit passes through the distal surface of the confinement.
  • the proximal end of the needle is forced to pass through the proximal surface of the confinement and further into the cartridge, where it pierces the elastomeric seal.
  • the shell is brought back to the original position and can be rotated which brings the next needle assembly in position above the cartridge.
  • the magazine can either be a loose part, which is connected to the injection device; in this case the entire magazine is disposed off when all the needle assemblies in the magazine are used.
  • the magazine could also be made as an integral part of the injection device, is this case the injection device including the needle magazine is disposed off when all the needle assemblies in the magazine is used, or when all the medicine contained in the cartridge is used.
  • the shell connecting the confinement can be shifted between a first position where the needle assembly is fully confined inside the confinement and a second position in which the positioned needle assembly penetrates the distal surface and the proximal surface, it is ensured that the sterile barrier is penetrated.
  • the magazine has means locking the shell in the second position against the force of a spring, and that the means can be released whereby the shell travels back into the first position under influence of the spring, it is ensured that the shell in an easy way can be shifted between the parked position and the injection position.
  • the means supporting the needle assemblies in an upright position is either connected to a hub located on the side wall of each needle assembly inside the confinement or supporting the hub from outside the confinement, it is ensured that the needle assemblies are held in the correct upright position at all times.
  • the means can either be a number of arms provided on the shell as disclosed in claim 6 , which arms is made up from several parts connected together through a number of film-hinges allowing the arm to flex as disclosed in claim 7 , or the means for supporting the needle assemblies could, as disclosed in claim 8 , be a number of circular walls projecting from the shell
  • the confinements is a plurality of cavities each having the form of a circular segment, which segments together forms a full circle, it is ensured that shell has a circular appearance.
  • Each circular segment must be able to fit over the cartridge, when the shell is pushed backward against the injection device prior to an injection.
  • each confinement is a bag, and that a plurality of such bags each containing one needle assembly is connected together.
  • the needle assemblies can be provided packed in sterile bags. These bags are preferably connected together to form a string.
  • the magazine has means preventing the shell from being rotated in one rotational direction, it is ensured that the shell cannot be rotated backwards in order to reuse the needle assemblies.
  • the means preferably being a number of pawls located on the housing of the magazine and which pawls engage a pawl wheel, preferably a star-shaped pawl wheel, on the interior surface of the shell.
  • the magazine has means preventing the shell from rotating more than approximately 360 degrees, it is ensured that the shell is limited to one full rotation, thereby preventing reuse of the needle assemblies once the content of the magazine is used once.
  • FIG. 1 Shows a schematically top-view of the needle magazine according to the invention.
  • FIG. 2 Shows a view along the line A-A in FIG. 1 with the shell in the parked position.
  • FIG. 3 Shows a view along the line A-A in FIG. 1 with the shell in the injection position.
  • FIG. 4 Shows a view along the line B-B in FIG. 1 with the shell in the injection position.
  • FIG. 5 Shows a schematically top-view of the needle magazine according to another embodiment of the invention.
  • FIG. 6 Shows a view along line C-C in FIG. 5 with the shell in the parking position.
  • FIG. 7 Shows a view along the line C-C in FIG. 5 with the shell in the injection position.
  • FIG. 8 Shows a view along the line D-D in FIG. 5 with the shell in the injection position.
  • FIG. 1 shows a top-view of the needle magazine 1 according to the invention.
  • Each needle assembly consist of a needle cannula 2 and a hub 3 .
  • Each hub 3 is connected to a circular wall 20 surrounding the centre-axis of the shell 5 through a thin arm 6 , which arm is made flexible by a number of film-hinges 7 .
  • FIG. 2 shows a view along line A-A in FIG. 1 with the shell 5 in the parked position.
  • the magazine 1 is shown and explained as being integral with the injection device 8 , which device 8 contains a cartridge 9 , but the magazine 1 could as well be a loose part comprising a shell 5 and a housing, which housing then could be connected to the injection device 8 e.g. by a thread connection.
  • the magazine is on the top covered by a cover 33 that snaps around the magazine 1 .
  • A, preferably helical, spring 11 is located in an enclosure 17 along the centre-axis of the injection device 8 . This spring 11 urges the shell 5 in a direction away from the injection device 8 , but is retained locked on to the injection device 8 by a circumferentially snap-coupling, made up by a hook-shaped part 12 formed in the shell 5 which is prevented from further forward movement by another hook-shaped part 13 provided in the injection device 8 .
  • Each needle assembly is captured in a sterile confinement 14 , which has an upper surface 15 and a bottom surface 16 .
  • Both surfaces 15 , 16 comprise of a sterile barrier e.g. a polymeric film, a metallic film of simply a paper sheet, which can be penetrated by the needle cannula 2 as later explained.
  • Both the upper surface 15 and the bottom surface 16 can be composed of other materials, as long as the part of the surfaces 15 , 16 located right below and right above the needle cannula 2 is made from a material which can easily be penetrated by the very thin needle cannula 2 .
  • the upper surface 15 of the shell 5 can be provided with a hole 10 only allowing passage of the needle cannula 2 . If so wanted the bottom surface can be provided with a similar hole allowing passage of the cartridge 9 .
  • the wall 18 surrounding the enclosure 17 has on the outside a somewhat star-shaped appearance with a number of peaks 19 equalling the number of needles 2 .
  • the shell 5 is around the centre-axis provided with a circular wall 20 fully surrounding the centre-axis.
  • This wall 20 has an identical star-shaped appearance at least on a part of the inside surface with a number of indentations 21 equalling, or being a product of, the number of needle assemblies.
  • the enclosure 17 is on top of the wall 18 closed by a rim 23 having a smaller diameter than the enclosure 17 .
  • a centrally located stud 26 provided on the shell 5 projects through this smaller diameter and into the enclosure 17 .
  • the stud 26 is inside the enclosure 17 provided with a protrusion 25 .
  • the injection device 8 is also provided with a similar protrusion 24 , as shown in FIG. 1. These protrusions 24 , 25 abut each other when the shell has been rotated approximately 360 degrees, thereby preventing the user from reusing the used needle assemblies.
  • FIG. 3 and FIG. 4 both shows the magazine 1 in the injection position.
  • the distal part of the needle cannula 2 passes through the upper surface 15
  • the proximal part of the needle cannula 2 passes through the bottom surface 16 and further through the elastomeric barrier in the cartridge 9 .
  • the hook-shaped part 12 is arrested by a third hook-shaped part 27 , which holds the shell 5 in the injection position until the shell is manually released.
  • the arm 6 carrying the hub 3 is bended in the film-hinges 7 , and the hub 3 is squeezed in between the cartridge 9 and the upper surface 15 .
  • the distal part of the needle cannula 2 projects through the hole 10 outside the boundaries of the shell 5 and the proximal end of the needle cannula 2 projects through the elastomeric barrier of the cartridge 9 and into the cartridge 9 .
  • the needle cannula 2 When the shell 5 is released after the injection and moves forward under influence of the spring, the needle cannula 2 is first retained in the cartridge 9 due to the friction between the elastomeric barrier of the cartridge 9 and the needle cannula 2 .
  • the design of the film-hinges 7 prevents the needle cannula 2 from moving further backwards, and the needle assembly will end up located in the middle of the magazine 1 , as shown in FIG. 2.
  • a stop preventing the needle cannula from moving backwards out of the shell 5 could be provided.
  • the shell 5 can be manually rotated until the next needle assembly is indexed above the cartridge 9 .
  • the correct position being when the next peak 19 drops into the next indentation 21 .
  • the pawl 22 prevents the shell 5 from being rotated backwards.
  • Torsion means that rotates the shell 5 a few degrees when the shell 5 is released could be provided. This would render it impossible to use the same needle cannula 2 again, since the shell 5 and thereby the used needle cannula 2 cannot be rotated backwards.
  • the magazine 1 is disposed of.
  • both the injection device and the magazine is disposed off.
  • FIGS. 5 - 8 The embodiment of the invention shown in FIGS. 5 - 8 works in the same way as previous described, and the same numerals are used for the same items. The only difference being the confinement containing the needle assemblies.
  • each needle assembly is confined in a bag 29 , having a sterile interior, which bag 29 is made out of an impermeable material e.g. a polymeric material.
  • a number of such bags 29 are connected together on a string 30 .
  • the string 30 connecting the bags 29 could be a separate string 30 , as shown in FIG. 5, or the string 30 could be made up from the material forming the bags 29 .
  • the string 30 of bags 29 is supported by an inner wall 31 and an outer wall 32 provided on the inside surface of the shell 5 . These two walls are located with a distance approximately equal to the diameter of the hub 3 . In this way the hub 3 located inside the bag 29 is supported holding the needle cannula 2 in an upright position by the walls 31 , 32 .
  • the bag 29 In the injection position the bag 29 is folded together and the hub 3 is squeezed between the cartridge 9 and the upper surface 15 .
  • the bag 29 is fastened to the hub 3 e.g. by welding.
  • the bag 29 is secured to the shell 5 e.g. by having a part of the film from which the bag 29 is made secured in a recess 34 provided on the inside surface of the shell 5 .
  • a loose ring 35 could be forced into the recess 34 for securing the bag-material onto the shell 5 .
  • the needle cannula 2 When the shell 5 is released after the injection and moves forward, the needle cannula 2 is first retained in the cartridge 9 due to friction between the elastomeric barrier of the cartridge 9 and the needle cannula 2 .
  • the bag 29 both being secured to the shell 5 and to the hub 3 prevents the needle cannula 2 from moving further backwards, and the needle assembly will end up located in the middle of the magazine 1 , as shown in FIG. 6.

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  • Health & Medical Sciences (AREA)
  • Diabetes (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)
US09/875,715 2000-06-09 2001-06-06 Needle magazine Abandoned US20020020646A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US09/875,715 US20020020646A1 (en) 2000-06-09 2001-06-06 Needle magazine

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DKPA200000891 2000-06-09
DKPA200000891 2000-06-09
US21285900P 2000-06-20 2000-06-20
US09/875,715 US20020020646A1 (en) 2000-06-09 2001-06-06 Needle magazine

Publications (1)

Publication Number Publication Date
US20020020646A1 true US20020020646A1 (en) 2002-02-21

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Family Applications (1)

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US09/875,715 Abandoned US20020020646A1 (en) 2000-06-09 2001-06-06 Needle magazine

Country Status (3)

Country Link
US (1) US20020020646A1 (fr)
AU (1) AU5824001A (fr)
WO (1) WO2001093927A1 (fr)

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US9261476B2 (en) 2004-05-20 2016-02-16 Sanofi Sa Printable hydrogel for biosensors
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9351680B2 (en) 2003-10-14 2016-05-31 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a variable user interface
US9375169B2 (en) 2009-01-30 2016-06-28 Sanofi-Aventis Deutschland Gmbh Cam drive for managing disposable penetrating member actions with a single motor and motor and control system
US9427514B2 (en) 2010-08-16 2016-08-30 Becton, Dickinson And Company Needle changing apparatus
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9561000B2 (en) 2003-12-31 2017-02-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US9560993B2 (en) 2001-11-21 2017-02-07 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
WO2017189164A1 (fr) * 2016-04-28 2017-11-02 Becton, Dickinson And Company Magasin pour aiguilles de stylo
WO2017189163A1 (fr) * 2016-04-28 2017-11-02 Becton, Dickinson And Company Chargeur d'aiguilles de stylo
WO2017189166A1 (fr) * 2016-04-28 2017-11-02 Becton, Dickinson And Company Magasin d'aiguilles de stylo
WO2017189165A1 (fr) * 2016-04-28 2017-11-02 Becton, Dickinson And Company Magasin d'aiguilles de stylo
US9820684B2 (en) 2004-06-03 2017-11-21 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US9849247B2 (en) * 2010-02-01 2017-12-26 Becton, Dickinson And Company Low dose prefilled drug delivery device and method
US20190001049A1 (en) * 2015-07-28 2019-01-03 Health Robotics S.R.L. Container for Closing Caps for Syringes
US20190053465A1 (en) * 2016-02-11 2019-02-21 Somark Innovations Group Pty Ltd Systems and methods for attaching identification information to an animal
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US10980936B2 (en) 2016-04-28 2021-04-20 Becton, Dickinson And Company Pen needle magazine
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US11020540B2 (en) 2016-04-28 2021-06-01 Becton, Dickinson And Company Pen needle magazine
US11207470B2 (en) 2016-04-28 2021-12-28 Becton, Dickinson And Company Pen needle exchange system
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