Source: https://patents.google.com/patent/EP1449555B1/en
Timestamp: 2019-03-24 18:00:14
Document Index: 170024975

Matched Legal Cases: ['art 6', 'art 7', 'art 6', 'art 7', 'art 6', 'art 7', 'art 6', 'art 7', 'art 7', 'art 6', 'art 7', 'art 6']

EP1449555B1 - Needle cannula - Google Patents
Needle cannula Download PDF
EP1449555B1
EP1449555B1 EP04012277A EP04012277A EP1449555B1 EP 1449555 B1 EP1449555 B1 EP 1449555B1 EP 04012277 A EP04012277 A EP 04012277A EP 04012277 A EP04012277 A EP 04012277A EP 1449555 B1 EP1449555 B1 EP 1449555B1
EP04012277A
EP1449555A1 (en
2001-03-23 Priority to DK200100483 priority Critical
2001-03-23 Priority to DKPA200100483 priority
2002-03-15 Application filed by Novo Nordisk AS, Nipro Corp filed Critical Novo Nordisk AS
2002-03-15 Priority to EP02704635A priority patent/EP1331958B1/en
2004-08-25 Publication of EP1449555A1 publication Critical patent/EP1449555A1/en
2006-06-21 Publication of EP1449555B1 publication Critical patent/EP1449555B1/en
The invention relates to an elongated tubular needle cannula for injecting a fluid drug into a human body. A needle assembly accroding to the preamble of claim 1 is disclosed in FR-A-2086899.
A catheter for a spinal anaesthesia procedure is disclosed in US 5.002.535. This know catheter has an outside diameter at the skin piercing distal end which is smaller than the outside diameter at the opposite proximal end in order to provide a strong catheter which only makes a small hole in the dura mater when the catheter is removed thereby preventing leakage of cerebrospinal fluid from the spinal cord. The various diameters of the disclosed catheter is shown in the following table:
Outside diameter (mm) 0,45 - 0,63 0,63 - 1,25
Inside diameter (mm) 0,25 - 0,43 0,43 - 1,05
When injecting a drug into a human being, either as intramuscular injection or as subcutaneously injection, the injection needle used has a needle cannula with a substantially smaller diameter than the diameter of the disclosed catheter. Injection needles available today all have a needle cannula with both a uniform outside diameter and a uniform outside diameter, due to the fact that a needle cannula is drawn from a tube. Such a prior art needle cannula is illustrated in figure 1.
The outside diameter of a needle cannula is indicated by a "G" followed by a gauge number, which gauge number increases with thinner needles. At the present, the most commonly used injection needles among people suffering from diabetes are G30 or G31. Thus the outside diameter of a G 30 is approximately 0,3 millimetres and of a G 31 approximately 0,26 millimetres
Injection needles for insulin delivery pens are disclosed in US 5.462.535. These known injection needles comprises a very thin G 30 needle cannula firmly fastened in a hub for removable mounting the injection needle onto one of the many insulin delivery pens available today.
The transition zone could in some cases be viewed as a transition point, but since the tapered appearance of the needle cannula is preferably made by dipping the needle cannula in a bath containing a metal eroding substance such as an acid as will be explained later, the area where the two elongated portions meets has more the configuration of a belt or zone than that of a point. The belt or zone is usually located in a distance of 1/4 to 2/3 of the length of the needle cannula inward from the skin piercing distal end.
When the skin piercing distal end has an outside diameter equal to or smaller than a G 31 needle, the opposite proximal end has an outside diameter equal to or larger than a G 30 needle, and the longitudinal lumen has an uniform inside diameter equal to or larger than the inside diameter of a G 30 needle, it is ensured that the needle cannula operates as a G 30, or larger, needle cannula, while the pain perception is that of a G 31, or smaller, needle cannula.
When the skin piercing distal end has an outside diameter equal to or smaller than a G 32 needle, the opposite proximal end has an outside diameter equal to or larger than a G 31 needle, and the longitudinal lumen has an uniform inside diameter equal to or larger than the inside diameter of a G 31 needle, it is ensured that the needle cannula operates as a G 31, or larger, needle cannula, while the pain perception is that of a G 32, or smaller, needle cannula
When the difference in the outside diameter between the distal end and the proximal is 5 % or more, it is ensured that the difference approximately follows the steps defined in the ISO 9626 standard.
When both the skin piercing distal end and the opposite proximal end is sharpened, the needle cannula is especially suitable for an injection pen provided with a cartridge containing the fluid to be injected, and where a barrier in the cartridge must be penetrated by the proximal end of the needle cannula in order to provide access to the fluid contained in the cartridge.
A method of manufacturing a needle cannula having a reduced tip end must be both simple and economic to use in a large-scale production.
Such a method comprises the step of dipping at least a part of said needle cannula adjacent to and including the distal end into a metal eroding substance such as an acid containing bath for a controlled period of time, thereby removing a part of the needle cannula material.
When the first elongated tubular portion extending from the peripheral transition zone to the skin piercing distal end of said needle cannula is dipped in a bath containing a metal eroding substance, such as an acid for a controlled period of time leaving the second tubular portion extending from the peripheral transition zone to the opposite proximal end out of the metal eroding bath, a needle cannula suitable for use in a needle assembly for an injection pen is manufactured.
A use of the needle cannula according to the invention either in a disposable syringe or in an injection needle assembly will be very attractive to people who has to inject them self several times every day, such as people suffering from diabetes.
The needle cannula can be used in a disposable syringe comprising a barrel and plunger and wherein the needle cannula is permanently fastened to the barrel of the disposable syringe, or in an injection needle assembly comprising the needle cannula and a needle hub and wherein the needle cannula is permanently fastened in the needle hub.
When the needle hub comprises a base and an annular sleeve extending from the base, the annular sleeve having means for removable mounting the hub onto a syringe, and the needle cannula being fastened in the base such that the first elongated tubular portion of the needle cannula extends from the base in a direction away from the sleeve, and the second tubular portion extends in the opposite direction and the second tubular portion is surrounded by the sleeve, it is ensured that the needle assembly is particular suitable for use on an injection pen.
Initially it may be convenient to define that the term "distal end" of the needle cannula according to invention is meant to refer to the end, which is forced to penetrate the skin of the human body when injecting a fluid, whereas the term "proximal end" is meant to refer to the opposite end of the needle cannula which in use points away from the human body.
It is to be understood that the wording "outside diameter at the skin piercing distal end", refers to the outside diameter of the most distal end of the needle cannula. This most distal end is however often cut in an oblique shape to facilitate the penetration of the skin of the human body, which makes its difficult exactly to measure the outside diameter at the most distal end. It is therefore sometimes necessary to measure the diameter right before the oblique cut, which diameter then falls within the definition of the diameter of the distal end. The same is the case if the opposite proximal end has an oblique cut, then the outside diameter of the opposite proximal end could be the diameter adjacent the oblique cut.
Although the wording "human body" is used throughout this application, the needle cannula could as well be used on any mammal body without dispersing from the scope of the claims.
It is to be understood that the wording "injection pen", merely refers to an injection device having an oblong or elongated shape, somewhat like a pen for writing. Although such pens usually have a tubular cross-section, modern writing pens often have a different cross-section such as triangular, rectangular or square. A pen shaped housing can in a similar way have a large variety of different cross-sections.
Designated metric size 0,25 mm 0,23 mm 0,20 mm
Minimum outside diameter 0,254 mm 0,229 mm 0,203 mm
Maximum outside diameter 0,267 mm 0,241 mm 0,216 mm
Minimum inside diameter 0,114 mm 0,089 mm 0,089 mm
Shows a sectional side view of a prior art needle cannula.
Shows a sectional view of an exemplary needle cannula
Shows a sectional view of a needle cannula according to the invention.
Shows a view of a needle cannula mounted on a disposable syringe.
Shows a view of a needle cannula according to the invention mounted in a hub.
Shows a view of a needle cannula mounted in a hub.
Shows a view of a needle cannula according to the invention dipped in an acid containing bath.
Figure 1 show a needle cannula 1 made up from an elongated tube, which is drawn until the desired diameter is obtained. Both the outside diameter of the needle cannula 1 and the inside diameter of the needle cannula 1 are approximately uniform throughout the entire length of the tube making up the needle cannula 1. The inside cylindrical and longitudinal lumen 3 of the needle cannula 1 is therefore parallel with the outside surface 2 of the needle cannula 1.
As shown in figure 2 the outside surface 2 of the needle cannula 1 can be made to taper towards the distal end 4, such that the outside diameter of the distal 4 end is smaller than the outside diameter of the proximal end 5. At the same time the inside cylindrical and longitudinal lumen 3 continues to have a uniform diameter.
The following table indicates the outside diameter of the proximal end 5 and of the skin piercing distal end 4 of a needle cannula 1 according to the present invention as they appear in the ISO 9626 standard. The minimum inside diameter of the lumen 3 is also indicated in the table. The tolerances for these numbers is usually +/- 0,01 mm on the actual outside diameter.
Conical gauges G30 G31 G31 ----- G32 G32 ----- G33
Diameter, proximal end 0,298 - 0,320 mm 0,254 - 0,267 mm 0,229 - 0,241 mm
Diameter, distal end 0,254 - 0,267 mm 0,229 - 0,241 mm 0,203 - 0,216 mm
Min Diam., inside lumen 0,133 mm 0,114 mm 0,089 mm
As shown on figure 3 the needle cannula needs not to be conical tapered along the entire length. Instead the outside sidewall of the needle cannula 1 can be divided into two elongated tubular portions 6, 7 interfacing each other in a peripheral transitions zone 8. The first part 6 extends from the distal skin-piercing end 4 to the peripheral transition zone 8, while the second part 7 extends from the proximal end to the peripheral transitions zone 8. The first part 6 is conically tapered from the peripheral transitions zone 8 towards the skin piercing distal end 4, while the second part 7 has approximately the same uniform diameter from the peripheral transitions zone 8 to the proximal end 5. The inside diameter of the longitudinal lumen 3 is uniform along the entire length of the needle cannula.
The needle cannula 1 shown in figure 2 and figure 3 is preferably manufactured by dipping the distal end of the needle cannula 1 into an acid containing bath, as will be described later. Alternatively the tapered second part 6 could med manufactured by it self and welded on to the first part 7 .
Figure 4 and 5 shows the needle cannula 1 permanently fastened in a needle hub 13, 14, which needle hub 13, 14 have means for removable mounting the needle hub 12 onto a syringe.
Figure 4 show a traditional needle assembly for intramuscular injection of a fluid. The needle cannula 1 is fastened in the needle hub 13 such that the proximal end 5 of the needle cannula 1 connects to the cylindrical opening 15 in the needle hub 13 into which opening 15 the tip of a not shown hypodermic syringe is pushed when mounting the needle hub 1 onto a hypodermic syringe.
The needle cannula 1 shown in figure 2, which is tapered along the entire length of the needle cannula 1 is particular suitable for this type of needle assembly.
Figure 5 shows a needle assembly for use on a pen system where an injection pen is provided with a cartridge containing the fluid to be injected, and where a barrier in the cartridge must be penetrated in order to provide access to the fluid contained in the cartridge. The needle cannula 1 of the needle assembly is divided into a first part 6, which penetrates into the skin of a human being, and a second part 7, which penetrates into the cartridge containing the fluid, when the needle assembly is mounted on the injection pen. The skirt 16 surrounding the cylindrical opening 15 into which opening 15 the injection pen is inserted, usually carries means, such as a thread, for holding the needle assembly on to the injection pen.
The needle cannula 1 shown in figure 3 is particular suitable for this type of needle assembly, since the second part 7 of the needle cannula 1 has a uniform diameter larger than the diameter of the first part 6. This provides a second part 7, which is more reluctant to bending than the first part 6. This is to be preferred since the second part of 7 the needle cannula 1 has to penetrate the barrier of the cartridge.
No matter which of the needle hubs 13, 14 are used, the needle cannula 1 must be located in the needle hub 13, 14 such that the needle cannula 1 has a relatively large diameter at the junction 17 between the needle cannula 1 and the needle hub 13, 14. When bending the needle cannula 1 during injection, the largest torque will be exerted right at this junction 17. It is therefore important that the needle cannula 1 has a relatively large diameter and thereby a large resistant against bending at the junction 17. This could e.g. be provided if the peripheral transition zone 8 of the needle cannula 1 shown in figure 3 is located right at the junction 17 between the needle cannula 1 and the needle hub 14.
Figure 6 shows the needle cannula 1 permanently fastened to a disposable syringe 9. The disposable syringe 9 comprises a barrel 10 containing the fluid to be injected and a plunger 11, which is moved forward in order to press the fluid trough the lumen 3 of the needle cannula 1. A removable needle cover 12 can cover the needle cannula 1 when the syringe 9 is not in use.
A preferred method of manufacturing a metallic needle cannula according to the invention is shown in figure 7. The part of the metallic needle cannula 1 which diameter is intended to be reduced is dipped in a bath containing a metal eroding substance such as an acid. In order to increase the removal of material from the needle cannula 1 electrical wires 19 can apply a current between the needle cannula 1 and the container 18 containing the acid, or a not shown cathode which is dipped in the bath, such that the needle cannula 1 works as the anode of an electrolytic process.
An injection needle assembly comprising
a needle cannula (1) with a lumen (3) extendmg through said needle cannula (1) from a skin piercing distal end (4) to an opposite proximal end (5) along a longitudinal axis of the needle cannula (1),
which longitudinal lumen (3) is cylindrical and has approximately the same uniform inside diameter through the needle cannula (1) from the skin piercing distal end (4) to the opposite proximal end (5),
wherein a first elongated portion (6) of the needle cannula (1)has a conical tapered outside over at least a part of the length which conical taper terminates at the skin piercing distal end (4), and a second elongated portion (7) of the needle cannula (1) has an outside diameter equal to or larger than the largest diameter of the first elongated portion (6), characterized by
a needle hub (14) comprising a base and an annular sleeve (16) extending from the base, the annular sleeve (16) having means for removable mounting the hub (14) onto a syringe, wherein
the needle cannula (1) is fastened in the base such that the first elongated portion (6) extends from the base in a direction away from the sleeve (16) and the second elongated portion (7) extends in the opposite direction, the second portion (7) being at least partly surrounded by the sleeve (16).
An injection needle assembly according to claim 1, characterized in that, the two elongated tubular portions (6,7) of the needle cannula (1) interfaces each other in a peripheral transition zone (8), which penpheral transition zone (8) is concealed in the base of the hub (14) such that the first elongated tubular portion (6) is conically tapered from the base of the hub (14) to the skin piercing distal end (4), and the second portion (7) has approximately the same uniform outside diameter from the base of the hub (14) to the opposite proximal end (5) of said cannula (1)
An injection needle assembly according to claim 1 or 2, characterized in that the skin piercing distal end (4) has an outside diameter equal to or smaller than a G 31 needle, the opposite proximal end (5) has an outside diameter equal to or larger than a G 30 needle, and the longitudinal lumen (3) has an uniform inside diameter equal to or larger than the inside diameter of a G 30 needle.
An injection needle assembly according to claim 1 or 2, characterized in that the skin piercing distal end (4) has an outside diameter equal to or smaller than a G 32 needle, the opposite proximal end (5) has an outside diameter equal to or larger than a G 31 needle, and the longitudinal lumen (3) has an uniform inside diameter equal to or larger than the inside diameter of a G 31 needle.
An injection needle assembly according to anyone of the preceding claims, characterized in that, the distal end (4) is approximately 5 % or more small in outside diameter than the proximal end (5).
An injection needle assembly according to anyone of the preceding claims, charactenzed in that both the skin piercing distal end (4) and the opposite proximal end (5) is sharpened.
EP04012277A 2001-03-23 2002-03-15 Needle cannula Active EP1449555B1 (en)
EP02704635A EP1331958B1 (en) 2001-03-23 2002-03-15 Needle cannula
DK04012277T DK1449555T3 (en) 2001-03-23 2002-03-15 Needle cannula
EP02704635A Division EP1331958B1 (en) 2001-03-23 2002-03-15 Needle cannula
EP1449555A1 EP1449555A1 (en) 2004-08-25
EP1449555B1 true EP1449555B1 (en) 2006-06-21
EP04012277A Active EP1449555B1 (en) 2001-03-23 2002-03-15 Needle cannula
EP02704635A Active EP1331958B1 (en) 2001-03-23 2002-03-15 Needle cannula
AT (2) AT275426T (en)
AU (1) AU2002238403B2 (en)
DE (2) DE60212691T2 (en)
ES (2) ES2227430T3 (en)
IL (2) IL157945D0 (en)
PL (1) PL203322B1 (en)
PT (2) PT1331958E (en)
TW (1) TW574044B (en)
ZA (1) ZA200307272B (en)
EP2209801B1 (en) * 2007-10-16 2013-01-16 Pharmacyclics, Inc. Manufacture, compositions and uses of coagulationfactor viia modulator
CN105188814A (en) * 2013-03-07 2015-12-23 泰尔茂株式会社 Method for producing needle-equipped outer tube, and needle-equipped outer tube
2002-03-15 PL PL363867A patent/PL203322B1/en unknown
2002-03-15 ES ES02704635T patent/ES2227430T3/en active Active
2002-03-15 DE DE60212691T patent/DE60212691T2/en active Active
2002-03-15 DK DK04012277T patent/DK1449555T3/en active
2002-03-15 DE DE60201165T patent/DE60201165T2/en active Active
2002-03-15 PT PT02704635T patent/PT1331958E/en unknown
2002-03-15 IL IL15794502A patent/IL157945D0/en unknown
2002-03-15 AU AU2002238403A patent/AU2002238403B2/en not_active Ceased
2002-03-15 EP EP04012277A patent/EP1449555B1/en active Active
2002-03-15 AT AT02704635T patent/AT275426T/en unknown
2002-03-15 EP EP02704635A patent/EP1331958B1/en active Active
2002-03-15 ES ES04012277T patent/ES2268539T3/en active Active
2002-03-15 RU RU2003131188/14A patent/RU2288746C2/en not_active IP Right Cessation
2002-03-15 KR KR1020037012391A patent/KR100841727B1/en active IP Right Grant
2002-03-15 WO PCT/DK2002/000175 patent/WO2002076540A1/en active IP Right Grant
2002-03-15 CA CA2441582A patent/CA2441582C/en not_active Expired - Fee Related
2002-03-15 AT AT04012277T patent/AT330652T/en unknown
2002-03-15 JP JP2002575050A patent/JP3590401B2/en active Active
2002-03-15 CN CNB028071417A patent/CN1285390C/en active IP Right Grant
2002-03-15 PT PT04012277T patent/PT1449555E/en unknown
2002-03-18 US US10/100,493 patent/US20030009137A1/en not_active Abandoned
2002-03-21 TW TW91105487A patent/TW574044B/en not_active IP Right Cessation
2003-06-16 US US10/462,203 patent/US20040025556A1/en not_active Abandoned
2003-09-16 IL IL157945A patent/IL157945A/en active IP Right Grant
2003-09-17 ZA ZA200307272A patent/ZA200307272B/en unknown
2003-09-18 US US10/665,268 patent/US20040064109A1/en not_active Abandoned
2006-06-15 US US11/453,383 patent/US20060247583A1/en not_active Abandoned
AT275426T (en) 2004-09-15
RU2288746C2 (en) 2006-12-10
JP3590401B2 (en) 2004-11-17
DE60201165T2 (en) 2005-09-22
DE60212691D1 (en) 2006-08-03
US20060247583A1 (en) 2006-11-02
PL203322B1 (en) 2009-09-30
PT1331958E (en) 2005-02-28
AT330652T (en) 2006-07-15
KR20040012736A (en) 2004-02-11
US20040064109A1 (en) 2004-04-01
ES2227430T3 (en) 2005-04-01
IL157945A (en) 2009-09-22
TW574044B (en) 2004-02-01
US20030009137A1 (en) 2003-01-09
DE60212691T2 (en) 2007-06-28
US20040025556A1 (en) 2004-02-12
RU2003131188A (en) 2005-04-10
PT1449555E (en) 2006-11-30
ES2268539T3 (en) 2007-03-16
CN1498123A (en) 2004-05-19
JP2004518516A (en) 2004-06-24
AU2002238403B2 (en) 2006-07-20
KR100841727B1 (en) 2008-06-27
EP1331958B1 (en) 2004-09-08
EP1331958A1 (en) 2003-08-06
DK1449555T3 (en) 2006-10-09
EP1449555A1 (en) 2004-08-25
PL363867A1 (en) 2004-11-29
CA2441582A1 (en) 2002-10-03
CN1285390C (en) 2006-11-22
DE60201165D1 (en) 2004-10-14
WO2002076540A1 (en) 2002-10-03
CA2441582C (en) 2010-06-08
IL157945D0 (en) 2004-03-28
ZA200307272B (en) 2004-09-17
DE60217892T2 (en) 2007-10-31 Automatic syringe with a needle, which punches out any nuclear
DE60015996T2 (en) 2005-11-10 Retractable needle assembly
Ref document number: 1331958
Free format text: NEEDLE CANNULA
Ref document number: 60212691
Ref document number: 2268539
Ref document number: 330652