Source: https://patents.google.com/patent/US9095660B2/en
Timestamp: 2018-07-23 18:36:13
Document Index: 645899119

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

US9095660B2 - Disposable double point injection needle and an insulin injection system comprising a disposable double point injection needle - Google Patents
Disposable double point injection needle and an insulin injection system comprising a disposable double point injection needle Download PDF
US9095660B2
US9095660B2 US13278769 US201113278769A US9095660B2 US 9095660 B2 US9095660 B2 US 9095660B2 US 13278769 US13278769 US 13278769 US 201113278769 A US201113278769 A US 201113278769A US 9095660 B2 US9095660 B2 US 9095660B2
US13278769
US20120277724A1 (en )
A disposable double pointed injection needle has a needle hub to which a thin needle cannula is permanently fastened 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 body. The needle hub is provided with a safety shield guided on the needle hub. The safety shield is urged in a direction away from the needle hub by a spring located between the needle hub and the safety shield. After injection the shield is moved away from the needle hub by the spring and locked in an irreversible position where the safety shield covers the needle cannula and prevents accidental needle stick injuries.
When the movable needle protector is a cylinder-shaped safety
shield surrounding at least the major part of the injection part of the needle cannula when the needle cannula is in an unused state, and which cylinder-shaped safety shield can be longitudinal moved relatively to the needle cannula, such that the safety shield is first moved in the proximal direction when the injection part of the cannula is penetrated into the subcutis layer of a human body, thereby exposing the major part of the injection part to the human body, and which safety shield automatically moves in the distal direction until the cannula is fully surrounded by the safety shield when the injection part of said cannula is removed from the subcutis layer of a human body. it is ensured that the entire injection part of the needle cannula is securely covered at all times during the injection. In a preferred embodiment of the disposable double pointed injection needle according to the invention the safety shield is automatically moved in the distal direction when the injection part of the cannula is removed from the subcutis layer of the human body by a resilient element such as a helical spring. which resilient element is located between the needle hub and the safety shield. and which resilient element is tighten when the injection part of said cannula is penetrated into the subcutis layer of the human body. Such an automatic movement by a spring or another resilient element ensures that the shield is always moved into the position where its covers the injection part of the needle cannula without the need of the user to manually push the shield into this position. Any type of resilient element can be utilized, although it is preferred to use a helical spring. Such a helical spring can be either metallic or made from a polymeric material.
When the safety shield is provided with a number of inwardly
pointed projections guided in guiding tracks provided on the external surface of the needle hub. it is ensured that the shield moves relatively to the needle cannula and the needle hub in a predetermined pattern.
When at least one of the guiding track has at least one elevation
with a steep front preventing the projection from moving backwards in the guiding track when the projection has entered the second or/and the third position, it is ensured that the safety shield can not be moved in the backward direction once an injection has commenced.
Diameter: 0.60 mm 0.50 mm 0.40 mm 0.33 mm 0.30 mm 0.25 mm 0.23 mm
FIG. 5 Shows a sectional view of the top of the safety shield and of the skin-. piercing end of the needle cannula.
The needle hub 4, which is separately shown in FIG. 4, has a distal end 5 and a proximal 35 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.
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 air shot 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 visibly 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.
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. 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.
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.
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 30 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 released, 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.
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.
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.
1. A method of preventing repeated use of a double pointed pen syringe injection needle following injecting of a patient with that needle, the method comprising:
exposing a sharpened end of a double pointed injection needle;
injecting a medication from a medication delivery device through the double pointed needle;
following injecting of a patient, automatically immediately after injection providing a locking visual indication that the needle has been used and cannot be reused, thereby preventing repeated use of the double pointed needle.
2. A method of determining whether a pen syringe needle assembly having a double pointed needle cannula has been previously used, the method comprising:
examining the needle assembly for a locking visual indicator in the form of a sheath around the needle cannula; and
if the sheath is visible, the sheath indicates previous use of the needle assembly, thereby preventing repeated use of the needle assembly.
3. A method of determining whether a pen syringe needle assembly having a double pointed needle cannula has been previously used, the method comprising:
examining the needle assembly for a locked visual indicator in the form of a shield
surrounding the double pointed needle cannula; and
if the shield surrounding the double pointed needle cannula is visible with a color
indicator, the shield confirms that the shield is locked in place and that the pen syringe needle assembly has been previously used.
4. A method of indicating previous use of a pen syringe needle assembly having a double pointed needle, the method comprising:
exposing a sharpened end of a double pointed needle;
following injecting of a patient, automatically activating a locking protective shield providing visual indication that the double pointed needle has been used, thereby minimizing inadvertent sticking of a person with the needle.
US13278769 2000-05-31 2011-10-21 Disposable double point injection needle and an insulin injection system comprising a disposable double point injection needle Active 2022-10-23 US9095660B2 (en)
US20120277724A1 true US20120277724A1 (en) 2012-11-01
US9095660B2 true US9095660B2 (en) 2015-08-04
WO1993000122A1 (en) 1991-06-28 1993-01-07 Inter-Metallic, Inc. Medical safety needle and method
WO1993016746A1 (en) 1992-02-27 1993-09-02 Osborne Barbara J Hypodermic needle shield
JPH06502787A (en) 1990-11-26 1994-03-31
JPH09117507A (en) 1995-10-24 1997-05-06 Terumo Corp Syringe and blood collecting appliance
WO2001064271A1 (en) 2000-03-01 2001-09-07 Disetronic Licensing Ag Needle protecting device for an injection unit
WO2001037898A3 (en) 1999-11-29 2002-01-10 Barker John Combination safety needle assembly and medical apparatus
WO2005035029A1 (en) 2003-10-16 2005-04-21 Tecpharma Licensing Ag Injection device comprising a needle cover
JPH03139363A (en) 1989-07-21 1991-06-13 Comercial Mariae Soc Ltd Safety protection device for injection needle
JPH05337182A (en) 1992-02-06 1993-12-21 Becton Dickinson & Co Safety device for needle
WO1995029721A1 (en) 1994-04-29 1995-11-09 Friend John M Retractable sheath for hypodermic needle
JP2001526095A (en) 1997-12-22 2001-12-18 マレンチェク，ロバート Safety syringe
3rd Party Comments in Inter Partes Reexamination No. 95/000,288 Submitted May 29, 2008.
Becton Dickinson (BD) AutoShield Duo Needle Instructions for Use (IFU), publication date unknown, copyright 2011.
Becton Dickinson (BD) AutoShield Needle Instructions for Use (IFU), publication date unknown, copyright 2008.
Corrected Third Party Respondent's Brief Filed Oct. 9, 2009 in Reexam No. 95/000,288, US Patent No. 6,547,764, Issue Date: Apr. 15, 2003, U.S. Appl. No. 09/870,276, filed May 30, 2010, Inventors: Larsen et al.
English Abstract of JP 3-139363 Filed Jun. 13, 1991.
Machine Translation of JP 2000 167052, Mar. 25, 2003.
Machine Translation of JP 3039310, Jul. 15, 1997.
Notice of Opposition and Response in Opposition of EP Pat. No. 1 448 256, May 3, 2006.
Rebuttal Brief for Appellant/Patent Owner in Response to Examiner's Answer Filed Dec. 17, 2009 in Reexam No. 95/000,288, US Patent No. 6,547,764, Issue Date: Apr. 15, 2003, U.S. Appl. No. 09/870,276, filed May 30, 2010, Inventors: Larsen et al.
Unverified English Language Translation of WO 99/25402, May 27, 1999.
Ypsomed Clickfine AutoProtect Needle Brochure, publication date unknown, cites to Jan. 2012 document.