Source: http://www.google.com/patents/US20020004648?ie=ISO-8859-1
Timestamp: 2015-05-26 06:32:34
Document Index: 28882882

Matched Legal Cases: ['art 8', 'art 9', 'art 9', 'art 27', 'art 28', 'art 27', 'art 27', 'art 27', 'art 28', 'art 27', 'art 28', 'arts 27', 'art 27', 'art 28', 'art 28', 'art 27', 'art 28', 'art 8', 'art 8', 'art 8', 'art 27', 'art 28', 'art 27']

Patent US20020004648 - Disposable double pointed injection needle, and an insulin injection system ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA disposable double pointed injection needle has a needle hub to which a thin needle cannula is permanently fasten and which needle hub can be mounted on to a syringe comprising a dose setting and injection mechanism and a cartridge containing a liquid medicine to be injected subcutaneously into a human...http://www.google.com/patents/US20020004648?utm_source=gb-gplus-sharePatent US20020004648 - Disposable double pointed injection needle, and an insulin injection system comprising a disposable double pointed injection needleAdvanced Patent SearchPublication numberUS20020004648 A1Publication typeApplicationApplication numberUS 09/870,276Publication dateJan 10, 2002Filing dateMay 30, 2001Priority dateMay 31, 2000Also published asUS6547764, US8075522, US20030139705, US20050171485, US20120277724Publication number09870276, 870276, US 2002/0004648 A1, US 2002/004648 A1, US 20020004648 A1, US 20020004648A1, US 2002004648 A1, US 2002004648A1, US-A1-20020004648, US-A1-2002004648, US2002/0004648A1, US2002/004648A1, US20020004648 A1, US20020004648A1, US2002004648 A1, US2002004648A1InventorsCarsten Larsen, Lars Stenholt, Anders Molin, Jorn Rex, Bjorn LarsenOriginal AssigneeLarsen Carsten Gerner, Lars Stenholt, Anders Molin, Jorn Rex, Larsen Bjorn GullakExport CitationBiBTeX, EndNote, RefManReferenced by (38), Classifications (18), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetDisposable double pointed injection needle, and an insulin injection system comprising a disposable double pointed injection needle
BRIEF DESCRIPTION OF THE DRAWINGS [0052] The invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which: [0053]FIG. 1 Shows an exploded view of the disposable double pointed injection needle according to the invention. [0054]FIG. 2 Shows a sectional view of the disposable double pointed injection needle according to the invention. [0055]FIG. 3 Shows a sectional view of the safety shield according to an embodiment of the invention. [0056]FIG. 4 Shows a sectional view of the needle hub according to an embodiment of the invention. [0057]FIG. 5 Shows a sectional view of the top of the safety shield and of the skinpiercing end of the needle cannula. [0058]FIG. 6 Shows a perspective view of the needle hub according to an embodiment of the invention. [0059]FIG. 7 Shows a perspective view of the disposable double pointed injection needle with the visual indication showing that the disposable double pointed injection needle is in an unlocked position. [0060]FIG. 8 Shows a perspective view of the disposable double pointed injection needle with the visual indication showing that the disposable double pointed injection needle is in a locked position.
[0061] 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 [0062] Initially it may be convenient to define that, the term “distal end” of the disposable double pointed injection needle according to the invention is meant to refer to the end 2 penetrating into the human body 11, whereas the term “proximal end” is meant to refer to the opposite end 3 entering into the cartridge 12. [0063]FIG. 1 and 2 shows the disposable double pointed injection needle according to the invention. The injection needle comprises of five main parts: a needle cannula 1, a needle hub 4, a safety shield 10, a resilient element 21 and a container 13. [0064] The needle cannula 1 is elongated and both ends 2, 3 are sharpened usually by being cut in an oblique cut. The needle cannula 1 is firmly fastened in a needle hub 4. The distal part of the needle cannula 1 extending from the fastening point in the needle hub 4 is referred to as the injection part 8, and the part extending in the proximal direction from its fastening point in the needle hub 4 is referred to as the cartridge part 9. [0065] The needle hub 4, which is separately shown in FIG. 4, has a distal end 5 and a proximal end 6. The proximal end 6 is on the interior surface provided with a thread 7, which fits over an external thread on the cartridge 12 or on a not shown syringe carrying the cartridge 12. In this way the disposable double pointed injection needle can easily be connected and disconnected to the cartridge 12 or the syringe carrying the cartridge 12. The needle hub 4 can be provided with a not shown cover covering the cartridge part 9 of the needle cannula 1. This not shown cover can be connected to the needle hub 4 by a hinge, such that the cover can be opened prior to connecting the needle hub 4 to a syringe, and closed when the needle hub 4 has been disconnected from a syringe. [0066] The needle hub 4 has at the distal end 5 a centrally located hub tower 15 surrounded by a circular well 14 through which a channel 16 reaching all the way through the needle hub 4 to the proximal end 6 is formed. The needle cannula 1 is under manufacturing placed in this channel 16, and the channel is filled with glue or other material, which can firmly fasten the needle cannula 1 to the needle hub 4. The glue used could e.g. be ordinary glue for gluing metal to a polymeric material, or it could be glue which is harden by use of UV light. Instead of using glue, the material of the hub 4 could be melted to fasten the needle cannula 1 to the hub 4. The height of the hub tower 15 and the length of the channel 16 can vary depending on the type of the disposable double pointed injection needle. A longer channel 16 gives a better control over the sideways movements of the needle cannula 1 during manufacturing. If wanted the hub tower 15 can have a height such that the distal end of the hub tower 15 aligns the distal top surface 17 of the needle hub 4. The depth of the well 14 is chosen such that the well 14 can support a resilient element in the form of a helical spring 21 which is located between the needle hub 4 and the safety shield 10 pressing the safety shield 10 away from the needle hub 4. [0067] The needle hub 4 is on the outside surface provided with a number of tracks 18 into which tracks 18 a number of projections 22 located on the safety shield 10 fits. At the proximal end 6, the needle hub 4 is provided with a number of outward pointing ribs 19, which interacts with a number of inwardly pointing ribs 20 located on the inside surface of the container 13. [0068] The safety shield 10, which is shown in FIG. 3 is guided on the outside surface of the needle hub 4 as shown in FIG. 2. The safety shield 10 is on the inside surface provided with a number of inwardly pointing projections 22. Each of these projections 22 can, as shown, be carried on a resilient arm 23 formed as an integral part of the safety shield 10. The projections 22 can however be moulded directly on the inside surface of the safety shield in which case they would not be visible from outside the safety shield 10, as shown in FIG. 7 and FIG. 8. The safety shield 10 is formed as a cup or a hat and closed on all sides except the proximal side, which fits over the needle hub 4. At the distal end, the safety shield 10 is provided with a bore 25 large enough for the needle cannula 1 to pass through. [0069] When the safety shield 10 is located on the needle hub 4 and the disposable double pointed injection needle is in its initial position, the skin-piercing end 2 of the needle cannula 1 could be located a little above the safety shield 10 as shown in FIG. 2. Prior to each injection, the user must perform a so-called airshot in order to press any air contained in the cartridge 12 out through the needle cannula 1. When doing this, it is somewhat important that the user can visible inspect that all the air is pressed out and only fluent medicine is expelled from the needle cannula 1. Due to this the skin-piercing end 2 of the needle cannula 1 must be visible. One way of making the skin-piercing end 2 of the needle cannula 1 visible is by making the needle cannula 1 long enough to extend a little beyond the safety shield 10, although having the skin-piercing end 2 of the needle cannula 1 align the top surface of the safety shield 10 would be sufficient. Another solution could be to make the needle cannula 1 short enough to be within the boundaries of the safety shield 10 and make the safety shield 10 transparent or partly transparent. Yet another solution could be to keep the needle cannula 1 short enough to be within the boundaries of the safety shield 10 and to cut away a fraction 26 of the top of the safety shield 10 making the skin-piercing end 2 of the needle cannula 1 partly visible, as indicated with dashed lines in FIG. 5. [0070] The hub 4 is on the outside provided with a number of tracks 18, which is best seen in FIG. 4 and in FIG. 6. Each track 18 has a first part 27 being substantially parallel to the needle cannula 1 and open at the top surface of the needle hub 4. A second part 28 of the track 18 is connected to the first part 27 at an acute angle and extends in the direction towards the distal end 5 of the needle hub 4. When the safety shield 10 is mounted over the needle hub 4, the projection 22 is passed into the first part 27 of the track 18. This first part 27 of the track 18 is provided with an elevation 29 having a sloping front allowing the projection 22 to pass over the elevation 29 and a step backside preventing the projection 22 from moving out of the track 18 once located there. [0071] If wanted the second part 28 of the track 18 could be the part parallel to the needle cannula 1, the first part 27 would then be connected to the second part at an acute angle. [0072] A certain degree of resiliency between the projections 22 and the tracks 18 is desired. Such a resiliency can be obtained either by providing the safety shield 10 with resilient arms 23 carrying the projections, or by making the bottom of the tracks 18 resilient e.g. by only connecting the bottom of the tracks 18 to the needle hub 4 in some areas. [0073] During injection, as shown in FIG. 2, the safety shield 10 is pressed back against the force of the helical spring 21 by the skin of a human body 11. When the needle cannula 1 is fully inserted into the subcutaneous layer of the human body, the projection 22 enters into the second part 28 of the track 18. The two parts 27, 28 of the track 18 is separated from each other by yet an elevation 30, which elevation 30 has a steep backside preventing the projection 22 form sliding back into the first part 27 of the track 18 once the projection 22 has entered into the second part 28 of the track 18. When the needle cannula 1 is removed from the subcutaneous layer of the user, the projection 22 will slide along the second part 28 of the track 18, and once the needle cannula 1 is fully retracted from the user the projection 22 will drop into a hole or well 31 where it will be permanently locked. [0074] While commencing the injection the projection 22 is located in the first part 27 of the track 18 between the first elevation 29 and the second elevation 30, as indicated in FIG. 2, where the position of the track 18 is indicated with dashed lines. The front of the second elevation has a sloping surface, which the projection 22 has to climb before entering the second part 28. The slope of this front is chosen such that the user must overcome a certain force before the projection 22 reaches the top of the elevation. For people suffering from needle anxiety it is preferred to locate the skin-piercing end 2 of the needle cannula 1 out of sight i.e. inside the boundaries of the safety shield 10, and to maximize the force a user has to apply before the safety shield 10 starts to move. Making the slope of the front of the second elevation 30 steep can maximize this force. By doing so a certain force applied by the user has to be build up before the safety shield 10 starts to move, the movement will then be rather sudden once the force is release, which is done when the projection 22 has started to be lifted over the elevation 30. The sudden release of the build up force will result in a very rapid insertion of the skin-piercing end 2 of the needle cannula 1 into the subcutaneous layer of the human body. [0075] The most distal end of the safety shield 10 could be moulded with a textured outside surface in order to increase the friction between the skin of the human body and the surface of the safety shield 10 during injection. [0076] When the injection needle is in the initial position ready to be inserted into the human body the safety shield 10 surrounds at least the major part of the injection part 8 of the needle cannula 1, leaving only the tip of the skin piercing end 2 of the needle cannula 1 free to be inspected when an air-shot is performed, as shown in FIG. 2. Once the needle cannula 1 is fully inserted into the human body, the major part of the injection part 8 is exposed to the human body. The only part of the injection part 8 of the needle cannula 1 not being exposed to the human body is the part lying between the fastening point in the needle hub 4 and the top surface of the safety shield 10. The length of this part depends on the height of the hub tower 15 and the wall thickness of the top surface of the safety shield 10. [0077] In order to provide the user with a clear visible indication that the injection needle has been used, the safety shield 10 can be provided with at least one transparent area 32, which in its simplest form could be a hole in the safety shield 10. Through this transparent area 32 the user can see a first area 33 on the outside surface of the needle hub 4. Since the first part 27 of the tracks 18 is located at an acute angle to the second part 28, the safety shield 10 will rotate some degrees-depended upon the angle-relatively to the needle hub 4 when an injection is performed. This rotation will bring the transparent area 32 to a second area 34 also located on the outside surface of the needle hub 4. [0078] If more than one transparent area 32 are provided, a corresponding numbers of first areas 33 and second areas 34 can be provided, such that a first area 33 is visible through each transparent area 32 prior to use, and that a second area 34 is visible through each transparent area 32 when the shield 10 is irreversible locked in the third position after use. [0079] When the injection needle is in the initial position ready to be inserted into the human body, the projection 22 is located in the first part 27 of the track 18. In this position the first area 33 on the outside surface of the hub 4 is visible through the transparent area 32 of the safety shield 10. After the injection, the projection 22 is located in the hole or well 31, and the transparent area 32 of the safety shield 10 is dislocated such that the second area 34 is now visible through the transparent area 32. [0080] Since the colour of the first area 33 indicates that the disposable double pointed injection needle is ready for use, this colour is usually green, black, blue or white. The second area 34 indicating that the disposable double pointed injection needle has been used will typically be red, orange or yellow. However it could be possible to indicate that the safety needle is in a potential unsafe position by colouring the first area 33 in a colour indicating danger, and henceforth colour the second area 34 in a colour indicating that the safety needle is in a potentially safe position. Instead of colouring the areas 33, 34 symbols or letters indicating the state of the disposable double pointed injection needle could be used. The colours, symbols or letters can be applied to the outside surface of the needle hub using inks, coatings or mouldings. The areas 33, 34 could be moulded with a depressed or textured surface in order to enhance the adherence of the colour. [0081] The disposable double pointed injection needle is delivered ready to use either in a sterile peel bag or in a container 13. The container 13 fully houses the needle hub 4, the needle cannula 1, the helical spring 21 and the safety shield 10 before use. The proximal end of the container 13 constitutes a peripheral surface 24 onto which a not shown pealable barrier is fastened. The barrier could be a sheet made of paper or from a polymeric or metallic sheet, and is preferably glued, melted or welded on to the surface 24. The barrier is impermeable by germs such that the inside of the container is kept sterile until the barrier is broken. Although the barrier is impermeable to germs and the like, it is possible to sterilize the interior of the sheath e.g. with steam. [0082] The proximal end of the container 13 is on the inside surface provided with a number of inwardly pointing ribs 20, which interacts with s similar number of outwardly pointing ribs 19 located on the proximal end 6 of the needle hub 4. If the fastening mechanism located on the inside surface of the needle hub 4 is a thread 7 as shown in FIG. 2, this thread 7 has to be screwed onto the thread of the cartridge 12 or the not shown syringe in order to connect these two parts. This is done by rotating the container 13 containing the disposable double pointed injection needle. When the rotational force emerging when the container 13 is rotated relatively to the cartridge 12 or the not shown syringe is transferred directly to the needle hub 4, the rotational force is prevented from damaging the tracks 18 and the projections 22. [0083] Instead of delivering the disposable double pointed injection needle to the consumer in a separate container, the safety shield 10 itself could be used as a sterile confinement simply by prolonging the safety shield 10 in the proximal direction such that the safety shield 10 fully surrounds the needle hub 4 when the safety shield 10 is in its ready-to-use position shown in FIG. 2. The proximal end of the safety shield 10 would then have to be sealed by a pealable barrier, and the hole 25 through which the needle cannula 1 passes during injection would also have to be sealed by a pealable barrier or by a drop a soft material which can be penetrated by the needle cannula 1 e.g. silicone. The resilient arms 23 carrying the projections 22 could then be made such that the surface of the safety shield 10 was not penetrated as shown in FIG. 7 and in FIG. 8. [0084] 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. Referenced byCiting PatentFiling datePublication dateApplicantTitleUS6986760Jul 9, 2002Jan 17, 2006Becton, Dickinson And CompanyPen needle and safety shield systemUS7182734Aug 8, 2002Feb 27, 2007Becton, Dickinson And CompanyRetracting needle safety deviceUS7258678Mar 7, 2003Aug 21, 2007Becton, Dickinson And CompanyRetractable safety needleUS7497847Nov 3, 2003Mar 3, 2009Becton, Dickinson And CompanySafety shield system for a syringeUS7540858 *Jan 23, 2007Jun 2, 2009Becton, Dickinson And CompanyRetracting safety pen needleUS7553293Nov 1, 2004Jun 30, 2009Novo Nordisk A/SSafety needle assemblyUS7815611Aug 31, 2007Oct 19, 2010Becton, Dickinson And CompanyPen needle and safety shield systemUS8235950Feb 3, 2005Aug 7, 2012Salvus Technology GmbHSafety needleUS8282609Feb 9, 2004Oct 9, 2012Salvus Technology LimitedSafety needleUS8287492Dec 9, 2010Oct 16, 2012Stat Medical DevicesPen needle tipUS8343094Jul 15, 2010Jan 1, 2013Shaw Thomas JUniversal syringe with retractable needleUS8597255Nov 24, 2008Dec 3, 2013Salvus Technology LimitedSafety needleUS8636688Sep 11, 2012Jan 28, 2014Retractable Technologies, Inc.Universal syringe with retractable needleUS8764706Feb 4, 2010Jul 1, 2014Becton, Dickinson And CompanyDisposable pen needle with re-use prevention featuresUS8827961May 21, 2009Sep 9, 2014West Pharmaceutical Services, Inc.Safety needleUS8834415Aug 1, 2012Sep 16, 2014Stat Medical Devices, Inc.Pen needle tipUS8961470Feb 16, 2012Feb 24, 2015Steven SchragaPen needle with safety shield systemUS20130006179 *Feb 10, 2011Jan 3, 2013Terumo Kabushiki KaishaInjection needle assembly and drug injection apparatusUS20130085457 *Sep 19, 2012Apr 4, 2013Becton Dickinson France, S.A.S.Syringe Having a Spring Action Plunger RodUS20130231614 *Mar 23, 2011Sep 5, 2013John David CrossDedicated Needle AssemblyUS20130245562 *Nov 28, 2011Sep 19, 2013Sanofi-Aventis Deutschland GmbhAutomatic Delivery Device with Triggering MechanismEP1447108A1 *Apr 7, 2003Aug 18, 2004Douglas Arthur EmmottA safety accessory for needlesEP2344223A1 *Aug 17, 2009Jul 20, 2011Becton, Dickinson and CompanySafety pen needle assemblyEP2514450A1 *Apr 21, 2011Oct 24, 2012Sanofi-Aventis Deutschland GmbHMedicated module with automatic reservoir engagement and magnetic lock mechanismEP2552518A1 *Mar 31, 2011Feb 6, 2013Enable Injections, LLCMedical fluid injection device and systemWO2003015855A1 *Aug 8, 2002Feb 27, 2003Becton Dickinson CoRetracting needle safety deviceWO2003066141A1 *Aug 6, 2002Aug 14, 2003Becton Dickinson CoPen needle and safety shield systemWO2004071560A1 *Feb 9, 2004Aug 26, 2004Douglas Arthur EmmottA safety needleWO2005044349A1 *Oct 15, 2004May 19, 2005Becton Dickinson CoSafety shield system for a syringeWO2005051466A1 *Nov 18, 2004Jun 9, 2005Philip Richard Damian AgiusSafety needleWO2005079441A2 *Feb 17, 2005Sep 1, 2005Childrens Hosp Medical CenterInjection device for administering a vaccineWO2006091201A1 *Mar 8, 2005Aug 31, 2006Becton Dickinson CoSafety shield system for a syringeWO2006131832A1 *Apr 20, 2006Dec 14, 2006Becton Dickinson FranceProtection device for protecting an injection needleWO2009102624A1 *Feb 6, 2009Aug 20, 2009Retractable Technologies IncSyringe with recessed nose and protective guard for use with frontal attachmentsWO2010090735A1 *Feb 4, 2010Aug 12, 2010Becton, Dickinson And CompanyDisposable pen needle with re-use prevention featuresWO2011117284A1 *Mar 23, 2011Sep 29, 2011Sanofi-Aventis Deutschland GmbhMedicated module with user selectionWO2011117287A1 *Mar 23, 2011Sep 29, 2011Sanofi-Aventis Deutschland GmbhMedicated module with automatic reservoir engagementWO2012072563A1 *Nov 28, 2011Jun 7, 2012Sanofi-Aventis Deutschland GmbhMedicated module with automatic reservoir engagement* Cited by examinerClassifications U.S. Classification604/195, 128/919, 604/241, 604/198International ClassificationA61M5/24, A61M5/32, A61M5/34Cooperative ClassificationA61M5/24, A61M2005/3267, A61M2205/59, A61M2205/583, A61M5/3257, A61M5/349, A61M5/326, A61M5/3272, A61M5/347European ClassificationA61M5/32C2H2F, A61M5/32C2H5LLegal EventsDateCodeEventDescriptionSep 17, 2014FPAYFee paymentYear of fee payment: 12Dec 6, 2011FPB1Expired due to reexamination which canceled all claimsOct 14, 2010FPAYFee paymentYear of fee payment: 8Nov 6, 2007RRRequest for reexamination filedEffective date: 20070924Oct 4, 2006FPAYFee paymentYear of fee payment: 4Sep 4, 2001ASAssignmentOwner name: NOVO NORDISK A/S, DENMARKFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LARSEN, CARSTEN GERNER;STENHOLT, LARS;MOLIN, ANDERS;AND OTHERS;REEL/FRAME:012141/0522;SIGNING DATES FROM 20010713 TO 20010731Owner name: NOVO NORDISK A/S NOVO ALLE DK-2880 BAGSVAERD DENMAOwner name: NOVO NORDISK A/S NOVO ALLE DK-2880 BAGSVAERD DENMAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LARSEN, CARSTEN GERNER;STENHOLT, LARS;MOLIN, ANDERS;AND OTHERS;REEL/FRAME:012141/0522;SIGNING DATES FROM 20010713 TO 20010731Owner name: NOVO NORDISK A/S NOVO ALLEDK-2880 BAGSVAERD, (1) /Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LARSEN, CARSTEN GERNER /AR;REEL/FRAME:012141/0522;SIGNING DATES FROM 20010713 TO 20010731RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services