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WO2016016419A1 - Tube d'aiguille et procédé de production d'aiguilles d'injection - Google Patents

Tube d'aiguille et procédé de production d'aiguilles d'injection Download PDF

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Publication number
WO2016016419A1
WO2016016419A1 PCT/EP2015/067634 EP2015067634W WO2016016419A1 WO 2016016419 A1 WO2016016419 A1 WO 2016016419A1 EP 2015067634 W EP2015067634 W EP 2015067634W WO 2016016419 A1 WO2016016419 A1 WO 2016016419A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
needle tube
sharpened tip
end portion
injection
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.)
Ceased
Application number
PCT/EP2015/067634
Other languages
English (en)
Inventor
Leif Engmann Kristensen
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
Novo Nordisk AS
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 Novo Nordisk AS filed Critical Novo Nordisk AS
Publication of WO2016016419A1 publication Critical patent/WO2016016419A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21G—MAKING NEEDLES, PINS OR NAILS OF METAL
    • B21G1/00—Making needles used for performing operations
    • B21G1/08—Making needles used for performing operations of hollow needles or needles with hollow end, e.g. hypodermic needles, larding-needles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B24—GRINDING; POLISHING
    • B24B—MACHINES, DEVICES, OR PROCESSES FOR GRINDING OR POLISHING; DRESSING OR CONDITIONING OF ABRADING SURFACES; FEEDING OF GRINDING, POLISHING, OR LAPPING AGENTS
    • B24B19/00—Single-purpose machines or devices for particular grinding operations not covered by any other main group
    • B24B19/16—Single-purpose machines or devices for particular grinding operations not covered by any other main group for grinding sharp-pointed workpieces, e.g. needles, pens, fish hooks, tweezers or record player styli
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B24—GRINDING; POLISHING
    • B24B—MACHINES, DEVICES, OR PROCESSES FOR GRINDING OR POLISHING; DRESSING OR CONDITIONING OF ABRADING SURFACES; FEEDING OF GRINDING, POLISHING, OR LAPPING AGENTS
    • B24B3/00—Sharpening cutting edges, e.g. of tools; Accessories therefor, e.g. for holding the tools
    • B24B3/60—Sharpening cutting edges, e.g. of tools; Accessories therefor, e.g. for holding the tools of tools not covered by the preceding subgroups
    • B24B3/605—Sharpening cutting edges, e.g. of tools; Accessories therefor, e.g. for holding the tools of tools not covered by the preceding subgroups of surgical or dental instruments

Definitions

  • the present invention relates to methods of producing injection needles for use in medical needle assemblies such as pen needle assemblies.
  • Injection needles are widely used in the medical area to deliver medicaments to specific body sites. For example, within the treatment of diabetes mellitus pen needle assemblies are oftentimes used with injection pens for subcutaneous administration of various glucose regulating agents.
  • a pen needle assembly includes an injection needle and a needle hub having means for attachment to an injection pen. The injection needle is typically fixed to the needle hub so as to enable skin penetration by the one needle end and penetration of a cartridge septum by the other needle end.
  • pen needle assemblies In the diabetes care segment one important characteristic of pen needle assemblies is the length of the front needle which is the portion of the injection needle that is inserted into the skin to deliver the given agent.
  • front needle assemblies offer front needle lengths in the range of 4mm-12mm with the smaller lengths becoming increasingly preferred.
  • the resistance to flow through the injection needle is i.a. proportional to the length of the needle and inversely proportional to the inner diameter to the fourth power.
  • a high needle gauge is thus not preferable from an effort perspective.
  • One compromising solution to this apparent paradox is to use a split needle arrangement comprising a separate skin penetrating needle with a high needle gauge and a back needle with a smaller needle gauge. The medicament will thus flow a shorter distance through a small lumen, whereby the flow resistance is reduced while the desired small outer dimension of the skin inserted needle portion is maintained.
  • US 8,608,710 (Becton Dickinson & Company) discloses a serial arrangement of two needle cannulas with different needle gauges in a pen needle assembly. The thinner of the needles is adapted to enter the body of the user, while the other is adapted to establish fluid access to a medicament container. Both needles are separate elements that are fixed to a needle hub.
  • the skin pene- trating needle is a separate needle element which is of approximately half the length of a conventional injection needle.
  • Conventional injection needles as used in most state of the art pen needle assemblies have a length in the range of 14mm-16mm. These injection needles are processed by grinding the patient dedicated end so as to minimise discomfort during needle insertion and the container dedicated end so as to allow easy penetration of the con- tainer septum. This is done on grinding machinery which is designed to handle needle tubes of 14mm-16mm, and for which it may be difficult or impossible to handle needle tubes of half that length.
  • a method of manufacturing injection needles comprising step (i) grinding a first end portion of a needle tube to produce a first sharpened tip, step (ii) grinding a second end portion of the needle tube, opposite the first end portion, to produce a second sharpened tip, and step (iii) dividing the needle tube be- tween the first sharpened tip and the second sharpened tip, thereby providing two injection needles.
  • Step (ii) may be carried out simultaneously with or subsequent to step (i), but, importantly, step (iii) is carried out subsequent to both step (i) and step (ii) to allow the needle tube to be ground completely before division.
  • a 14mm needle tube may be ground on existing grinding machinery and then divided afterwards to provide two injection needles suitable for use as needle elements in respective needle assemblies.
  • the needle tube may be divided a predetermined distance from the first sharpened tip to provide desired needle lengths.
  • the needle tube may be divided midway, or substantially midway, between the first sharpened tip and the second sharpened tip.
  • two injection needles of equal, or substantially equal, lengths are provided which can both be used in the production of a specific needle assembly model.
  • the needle tube may be divided such that the one injection needle is noticeably longer than the other, enabling use of the two injection needles in the production of different needle assembly models.
  • the needle tube may extend along a longitudinal axis between the first end portion and the second end portion, and step (iii) may comprise dividing, e.g.
  • step (iii) may comprise dividing the needle tube at an angle to the longitudinal axis differing from 90°. For example, by cutting the needle tube at an acute angle to the longitudinal axis, which acute angle is in the range [25°; 30°], needle ends may be obtained which are particularly suitable as back needle ends for easy penetration of reser- voir closures, such as e.g. self-sealing rubber septa.
  • the present method is thus also applicable in general to produce injection needles of conventional lengths in a manner which eliminates, or at least reduces, the need for separate, dedicated back needle processing steps, ensuring a less costly manufacturing.
  • the first end portion and the second end portion may be ground identically, e.g. to provide for the establishment of identical skin penetrating needle portions. This enables use of both injection needles in the same type of needle assembly and may enable a faster and more cost efficient mass production of the injection needles.
  • step (i) and step (ii) may provide sharpened tips of different configurations.
  • at least one of the first sharpened tip and the second sharpened tip may be multi-bevelled, e.g. produced by three or more grinds resulting in three or more distinct bevels, to provide for easy and painless penetration of a user's skin.
  • the needle tube may be provided as a separated piece of a longer tube. Accordingly, a tubing may initially be divided into a plurality of needle tubes, whereafter at least some of said needle tubes undergo the manufacturing steps described above.
  • the plurality of needle tubes thus initially provided may be of equal length or of a limited number of different lengths, depending on the desired production set-up.
  • a method of manufacturing an injection needle assembly comprising arranging an injection needle produced by a method as described in the above in connection with the first aspect of the invention in a retaining portion of a needle hub such that (a) the injection needle protrudes from the retaining portion in a distal direction, and (b) the injection needle is in fluid communication with a hollow piercing member extending from the retaining portion in a proximal direction.
  • a needle manufactured according to the above described first aspect of the inven- tion is coupled to a needle hub to provide a complete needle assembly which can be attached to a needle mount of an injection pen.
  • a method of manufacturing an injection needle assembly comprising arranging an injection needle produced by a method as described in the above in connection with the first aspect of the invention in a retaining por- tion of a needle hub such that (a) the injection needle protrudes from the retaining portion in a distal direction, and (b) the injection needle is in fluid communication with a coupling por- tion of the needle hub, which coupling portion is adapted to receive a hollow piercing member.
  • a needle manufactured according to the above described first aspect of the invention is coupled to a needle hub which is further capable of receiving a second piercing ele- ment for the provision of a complete needle assembly.
  • a needle tube comprising a first end portion comprising a first sharpened tip and a second end portion comprising a second sharpened tip, wherein the first sharpened tip and the second sharpened tip have identical configuration.
  • This intermediate product may e.g. be placed on a shelf for a time period, allowing the manufacturer to prepare multiple double-ended injection needles, while postponing a decision on where and/or how to divide them. This may, for example, be beneficial in case the specific types of needle assemblies for which the injection needles are intended are yet to be decided on.
  • the first sharpened tip and the second sharpened tip each comprises three distinct bevels.
  • end portions are "ground identically" or when sharpened tips or ends have “identical configuration” this means that the respective end portions or tips have been processed to obtain the same shape.
  • the shape is independent of the angular orientation of the processed end portion about the longitudinal axis.
  • each of these bevels is at a respective angle of incli- nation to each of the other two bevels and to a first imaginary plane containing the longitudinal axis.
  • the second sharpened tip then has three distinct bevels which are each at the same respective angles to the other bevels and to a second imaginary plane containing the longitudinal axis than the corresponding bevel of the first sharpened tip.
  • the second imaginary plane need not be angularly aligned with the first imaginary plane.
  • proximal refers to a portion, position or direction opposite or away from the insertion site
  • distal refers to a portion, position or direction close to or towards the insertion site.
  • reference to a certain aspect or a certain embodiment e.g.
  • an aspect signifies that a particular feature, structure, or characteristic described in connection with the respective aspect or embodiment is included in, or inherent of, at least that one aspect or embodiment of the invention, but not necessarily in/of all aspects or embodiments of the inven- tion. It is emphasized, however, that any combination of the various features, structures and/or characteristics described in relation to the invention is encompassed by the invention unless expressly stated herein or clearly contradicted by context.
  • Figs. 1 is a cross sectional view of a conventional pen needle assembly
  • Fig. 2a is a side view of an unmodified needle tube to be processed in accordance with the present invention
  • Fig. 2b is a side view of the needle tube following the initial process steps
  • Fig. 2c is a side view of the final result of the processing
  • Fig. 2d is an enlargement of section Q of Fig. 2c, showing the needle tube divided perpendicularly to its longitudinal axis
  • Figs. 2e and 2f are views similar to that of Fig. 2d, showing exemplary other separation angles for the needle tube
  • Fig. 3 is a cross sectional view of a needle assembly including an injection needle produced by the method according to the present invention.
  • Fig. 1 is a cross sectional view of a typical pen needle assembly 10 of the prior art.
  • the pen needle assembly 10 comprises a needle hub 1 1 with a central retaining portion 12 to which an injection needle 15 is securely fixed, and an internally threaded collar 13 for engagement with a mating thread on a needle mount of a pen injector (not shown).
  • the injection needle 15 comprises a sharpened front needle portion 16 adapted for insertion through a human skin barrier and a sharpened back needle portion 17 adapted for penetration of a septum of a drug containing cartridge.
  • the needle hub 1 1 further has an abutment surface 14 for abutment with a skin portion surrounding the insertion site.
  • Fig. 2a is a side view of a needle tube 1 to be processed in accordance with the present invention.
  • the needle tube 1 is a hollow cylindrical structure extending longitudinally between a first end portion 2 and a second end portion 3.
  • Fig. 2b is a side view of the needle tube 1 following the initial process steps, showing a first sharpened tip 4 at the first end portion 2 and a second sharpened tip 5 at the second end portion 3.
  • the sharpened tips 4, 5 have been produced identically by grinding in a manner conventionally known in the art of injection needle manufacturing.
  • Fig. 2c is a close-up view of section Q of Fig. 2c, showing the ends of the needle tube 1 , which are established by cutting at a right angle, CH, to the longitudinal axis.
  • Figs. 2e and 2f show in a similar way the ends of respective needle tubes having been cut at different exemplary acute angles, a 2 and a 3 , to the longitudinal axis.
  • a 3 may equal 28°, whereby the produced injection needles are automatically provided with a tip which is suitable for penetration of e.g. a rubber septum of a drug cartridge (not shown).
  • a tip which is suitable for penetration of e.g. a rubber septum of a drug cartridge (not shown).
  • the produced injection needles are of a conventional length and intended for use in pen needle assemblies of the prior art type shown in Fig. 1 .
  • Fig. 3 is a cross sectional view of a pen needle assembly 20 incorporating an injection nee- die 6 manufactured according to the present invention.
  • the pen needle assembly 20 comprises a needle hub 21 of plastic having an integrated back cannula 27 pointed for penetration of a cartridge septum.
  • the injection needle 6 is attached to a central retaining portion 22, by gluing, press-fitting, or other ways of attachment known in the art, such that a tight fluid communication is provided between the proximal end portion of the back cannula 27 and the sharpened tip 4.
  • the needle hub 21 further has an internally threaded collar 23 for secure engagement with a needle mount of an injection device (not shown) and a distally oriented abutment surface 24 for abutment with a skin portion of a user.
  • the back cannula 27 is molded with the remaining portion of the needle hub 21 and has a larger lumen as well as a larger outer diameter than the injection needle 6.
  • the pen needle assembly 20 is thus both relatively inexpensive to manufacture and offers a reduced flow resistance compared with the conventional pen needle assembly 10 illustrated in Fig. 1.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Surgery (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un procédé de fabrication d'aiguilles d'injection pour utilisation dans des ensembles d'aiguille à stylo. Le procédé comprend l'usinage d'une première partie d'extrémité (2) d'un tube d'aiguille (1) pour produire une première pointe acérée (4), l'usinage d'une deuxième partie d'extrémité (3) du tube d'aiguille (1) pour produire une deuxième pointe acérée (5), et la division du tube d'aiguille (1) entre la première pointe acérée (4) et la deuxième pointe acérée (5), de manière à produire deux aiguilles d'injection (6, 7). L'invention concerne en outre un tube d'aiguille.
PCT/EP2015/067634 2014-07-31 2015-07-31 Tube d'aiguille et procédé de production d'aiguilles d'injection Ceased WO2016016419A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14179238 2014-07-31
EP14179238.2 2014-07-31

Publications (1)

Publication Number Publication Date
WO2016016419A1 true WO2016016419A1 (fr) 2016-02-04

Family

ID=51260672

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2015/067634 Ceased WO2016016419A1 (fr) 2014-07-31 2015-07-31 Tube d'aiguille et procédé de production d'aiguilles d'injection

Country Status (1)

Country Link
WO (1) WO2016016419A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1812450A1 (de) * 1967-12-07 1969-07-03 Qualitex Dunod & Cie Verfahren und Einrichtung zum Schleifen von Injektionsnadeln
US6015338A (en) * 1997-08-28 2000-01-18 Norton Company Abrasive tool for grinding needles
US8608710B2 (en) * 2010-12-09 2013-12-17 Becton Dickinson & Company Pen needle assembly with different gauge needle cannulas
EP2740417A1 (fr) * 2011-08-05 2014-06-11 Kabushiki Kaisha Iken Kougyo Procédé de fabrication d'une aiguille de suture sans chas

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1812450A1 (de) * 1967-12-07 1969-07-03 Qualitex Dunod & Cie Verfahren und Einrichtung zum Schleifen von Injektionsnadeln
US6015338A (en) * 1997-08-28 2000-01-18 Norton Company Abrasive tool for grinding needles
US8608710B2 (en) * 2010-12-09 2013-12-17 Becton Dickinson & Company Pen needle assembly with different gauge needle cannulas
EP2740417A1 (fr) * 2011-08-05 2014-06-11 Kabushiki Kaisha Iken Kougyo Procédé de fabrication d'une aiguille de suture sans chas

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