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WO2010142550A1 - Procédé de fabrication d'une canule à aiguille dont les propriétés d'écoulement sont améliorées - Google Patents

Procédé de fabrication d'une canule à aiguille dont les propriétés d'écoulement sont améliorées Download PDF

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Publication number
WO2010142550A1
WO2010142550A1 PCT/EP2010/057531 EP2010057531W WO2010142550A1 WO 2010142550 A1 WO2010142550 A1 WO 2010142550A1 EP 2010057531 W EP2010057531 W EP 2010057531W WO 2010142550 A1 WO2010142550 A1 WO 2010142550A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle cannula
cathode
manufacturing
lumen
needle
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/EP2010/057531
Other languages
English (en)
Inventor
Lasse Wengel Christoffersen
Mikael Andersen
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 WO2010142550A1 publication Critical patent/WO2010142550A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
    • C25F—PROCESSES FOR THE ELECTROLYTIC REMOVAL OF MATERIALS FROM OBJECTS; APPARATUS THEREFOR
    • C25F3/00—Electrolytic etching or polishing
    • C25F3/16—Polishing
    • C25F3/22—Polishing of heavy metals
    • C25F3/24—Polishing of heavy metals of iron or steel
    • 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
    • A61M5/329—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 characterised by features of the needle shaft
    • C—CHEMISTRY; METALLURGY
    • C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
    • C25F—PROCESSES FOR THE ELECTROLYTIC REMOVAL OF MATERIALS FROM OBJECTS; APPARATUS THEREFOR
    • C25F7/00—Constructional parts, or assemblies thereof, of cells for electrolytic removal of material from objects; Servicing or operating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals

Definitions

  • the invention relates to a method of manufacturing a needle cannula having improved flow properties and such needle cannula.
  • Needle assemblies are commonly used to either inject substances into or extract substances out of human or animal bodies. Such needle assemblies are typically disposable and are discarded after only one use.
  • a needle cannula which is typically drawn from stainless steel is attached to a hub generally moulded from a suitable polymer.
  • the hub usually carries means for attaching the needle assembly to an injection device.
  • the needle cannula is typically mounted to the hub such that a liquid communication patch can be established between the injection device, through the needle assembly and into the body of the user.
  • the needle cannula is normally made from a stainless-steel tube drawn through progressively smaller dies to make the needle the wanted diameter.
  • the ratio between the outside diameter and the inside diameter is a result of the wall thickness of the stainless tube drawn and the diameter to which it is drawn.
  • the specific dimensions used for a cylindrical needle cannula are given in ISO 9626.
  • a needle cannula having a little outside diameter.
  • injection needles with a very thin needle cannula are very popular among people suffering from diabetes.
  • the outside diameter of a needle cannula is indicated by a "G” followed by a gauge number, which gauge number increases with thinner needles.
  • G30 or G31 the most commonly used injection needles among people suffering from diabetes are G30 or G31.
  • the outside diameter of a G 30 is according to ISO 9626 approximately 0,3 millimetres and of a G 31 approximately 0,26 millimetres.
  • WO 2002/076540 discloses a needle cannula which after is has been drawn is subjected to electro polishing at the tip such that the outside surface becomes conical.
  • the tip inserted into the user during injection can therefore be made smaller than the ISO standard dictates.
  • a G31 needle could e.g. be electro polished at the tip such that the tip becomes that of a G32 needle having an outside diameter of 0,23 mm.
  • Such needle cannula would then have the flow characteristic of a G31 needle, but the pain perception of a G32 needle cannula.
  • Electro polishing a needle cannula on the outside is also disclosed in JP 31-9364 and in US 4,335,718. The latter discloses that it is unwanted to have the liquid etching material flow inside the needle cannula which therefore can be sealed with a suitable mandrel.
  • US 2005/0015062 discloses an injection needle where the inside diameter of the needle cannula is expanded by cutting the narrow lumen with a drill.
  • the flow through a needle cannula is determined by Pouseuilles formula. According to this formula, as explained in US 5,951 ,528, it is preferred to have as large an inside diameter as possible at as short a length as possible in order to maximise the flow through the needle cannula since the ratio of the radius is divided with the length in the formula.
  • Claim 1-2 According to the claimed invention a metallic needle cannula which has been drawn to the preferred diameter is subjected to inside electro polishing by inserting a cathode into the lumen of the needle cannula. By applying an electric current between the cathode and the needle cannula, the latter works as the anode of the cathodic reaction, material is removed from the inside of the needle cannula.
  • the cathode By moving the cathode axially inside the lumen, the area from which material is removed can be controlled.
  • the cathode could e.g. be moved a certain distance into the lumen which would only remove material from within the area swept by the cathode.
  • the liquid acid used for the reaction can be any suitable acid and preferably a phosphoric acid.
  • the liquid acid is flushed into the lumen at a controlled flow speed.
  • the liquid acid can either be sprayed into the lumen from one end and leave the lumen at the same end, or it can flow through the Iu- men from one end to the other end, such that it enters at one end and leaves at the opposite end.
  • the liquid can also be feed through the cathode which is then hollow.
  • the cathode can be made from a metallic material and is preferably partly electrical insulated from the anode such that the cathode reaction only takes place at a limited area of the cathode. This could e.g. be by placing the metallic cathode in a polymeric tube.
  • the tube does not necessarily have to cover the cathode through out the entire periphery, but could be made as bars only partly covering the periphery, in which case it would be preferred to rotate the cathode during the process such that the metallic material inside the lumen is evenly removed. What is important is that direct contact between the inside of the lumen of the cannula and the cathode is avoided.
  • the electro polishing only takes place in a limited area, such as at the vicinity of the insulating tube opening thereby increasing the controllability of the process.
  • the polymeric tube or bars will typically be made from a polymer that is resistant to the acid used, for example PFA, FEP, PVDF, HDPE, PEEK, PES or PEI.
  • the cathode could alternatively be made from a non-metallic material such as a polymeric material, glass or a ceramic material with a hollow area containing a liquid fluid through which the electrical current is transported.
  • the cathode could e.g. be formed as a tube and the liquid acid used could be flushed through the tube. The electric current is in such alternative applied to the liquid.
  • the needle cannula produced by the described process is usually anchored in a hub moulded from a suitable polymeric material. In order to provide the greatest resistance to breaking the needle cannula is anchored at a location where the needle cannula has the largest wall thickness.
  • drug is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle in a con- trolled manner, such as a liquid, solution, gel or fine suspension.
  • a delivery means such as a hollow needle in a con- trolled manner, such as a liquid, solution, gel or fine suspension.
  • Representative drugs includes pharmaceuticals such as peptides, proteins (e.g. insulin, insulin analogues and C- peptide), and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
  • subcutaneous injection is meant to encompass any method of transcutaneous delivery to a subject.
  • injection needle defines a piercing member adapted to penetrate the skin of a subject for the purpose of delivering or removing a liquid.
  • the term “Needle Cannula” is used to describe the actual conduit performing the penetration of the skin during injection.
  • a needle cannula is usually made from a metallic material such as stainless steel and connected to a hub to form an injection needle assembly.
  • the “hub” being the part the needle cannula is mounted to and which carries the connecting means for connecting the needle cannula to an injection apparatus is usually moulded from a suitable thermoplastic material.
  • the "needle assembly” is to be understood as the needle unit itself i.e. comprising a needle cannula mounted in a hub as supplied to the user.
  • Cartridge is the term used to describe the container containing the insulin. Cartridges are usually made from glass but could also be made from any suitable polymer e.g. by moulding or extrusion.
  • a cartridge or ampoule is preferably sealed at one end by a pierceable membrane which can be pierced e.g. by an injection needle. The opposite end is closed by a plunger or piston made from rubber or a suitable polymer. The plunger or piston can be slidable moved inside the cartridge. The space between the pierceable membrane and the movable plunger holds the insulin which is pressed out as the plunger decreased the volume of the space holding the insulin.
  • a flexible reservoir could be used.
  • Figure 1 show the method according to the invention.
  • Figure 2 show another configuration of the method.
  • Figure 3 show another configuration of the method.
  • Figure 4 show another configuration of the method.
  • Figure 5 show the finished needle assembly.
  • distal end in the appended figures is meant to refer to the end of the needle cannula penetrating the patient whereas the term “proximal end” is meant to refer to the opposite end of the needle cannula.
  • Figure 1 and 2 discloses the process of manufacturing the needle cannula 1 according to the invention.
  • the needle cannula 1 which is typically drawn from a tube of stainless steel has a first end 2 and a second end 3. Connecting the two ends 2, 3 is the lumen 4 which is typical cylindrical.
  • a cathode 10 made from a conducting material is inserted into the lumen 4 and an electric current 21 generated in a power supply 20 is applied between the cathode 10 and the needle cannula 1 which works as the anode.
  • Metallic material is thereby removed from the anode (the needle cannula 1) and as the cathode 10 is moved further into the lumen 4 the inside diameter of lumen 4 is increased.
  • the cathode 10 could be electrical insulated by providing it with an insulating tube 1 1 as disclosed in figure 2.
  • the tube 1 1 does not have to cover the entire periphery of the cathode 10 as long as it keeps the metallic component of the cathode 10 away from direct electrical contact with the inside surface of the lumen 4.
  • FIG. 2 discloses that the liquid flow 30 is supplied from a tank 32 containing the suitable liquid 31 which flows through an opening 12 in the cathode 10 and enters the needle cannula 1 at the first end 13 of the cathode 10.
  • the second end 14 of the cathode 10 is connected to the tank 32.
  • the cathode 10 is formed as a solid rod which is insulated e.g. with an insulating tube 1 1.
  • the liquid flow 30 is established by connecting the first end 2 of the needle cannula 1 to the tank 32 containing the suitable liquid 31.
  • the second end 3 of the needle cannula 1 could be connected to the tank 32.
  • the cathode 10 could then be inserted into the correct position in the needle cannula 1 before the cathodic process is started and be moved from that position and towards the second end 3 of the needle cannula 1.
  • the entire cathode 10 is made from a non- metallic material having a through-going opening or lumen 12 through which the liquid 31 flows.
  • the power supply 20 feeds power to an electrode 22 which is submerged in the tank 32 such that the electrical current is transported by the liquid 31 through the hollow cathode 10 and delivered to the anode (the needle cannula 1) at the end of the cathode 10.
  • Figure 5 discloses the needle assembly comprising the needle cannula 1 and a hub 40.
  • the needle cannula 1 is usually glued to the hub 40.
  • a 20 mm long needle cannula is drawn from AISI 304 with an outer diameter of 0,36 mm and an inner diameter of 0,15 mm. Following the ISO 9626 standard this is a G28 needle cannula.
  • the needle cannula is thereafter subjected to inside electro polishing by moving a non- metallic virtual cathode into the lumen thereby increasing the inside diameter to 0,26 mm.
  • the virtual cathode is made from a PP tube having an outside diameter of 0, 14 mm and an inside diameter of 0,08 mm.
  • concentrated phosphoric acid is pumped through the PP tube at a flow rate of 1 to 10 mm 3 /s and at a temperature of 50 0 C.
  • the downstream opening of the PP tube forming the virtual cathode is moved from the proximal opening of the needle cannula to a position 12 mm from this opening at a speed of 12 mm/min.
  • the resulting needle cannula had an inside diameter of 0,15 mm on the distal 8 mm and a diameter of 0,26 mm on the remaining 12 mm.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Electrochemistry (AREA)
  • Materials Engineering (AREA)
  • Metallurgy (AREA)
  • Organic Chemistry (AREA)
  • Vascular Medicine (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)

Abstract

L'invention concerne un procédé de fabrication d'une canule à aiguille (1) par application d'un électropolissage à la lumière interne (4) de la canule à aiguille (1). Une cathode (10) est insérée dans la lumière (4) de la canule à aiguille (1) et un courant électrique (21) est introduit entre la cathode (10) et la canule à aiguille (1) qui fonctionne comme anode. Un acide liquide (31) rince de préférence la lumière interne (4) de la canule à aiguille (1) pendant le procédé.
PCT/EP2010/057531 2009-06-08 2010-05-31 Procédé de fabrication d'une canule à aiguille dont les propriétés d'écoulement sont améliorées Ceased WO2010142550A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP09162136 2009-06-08
EP09162136.7 2009-06-08
US18585109P 2009-06-10 2009-06-10
US61/185,851 2009-06-10

Publications (1)

Publication Number Publication Date
WO2010142550A1 true WO2010142550A1 (fr) 2010-12-16

Family

ID=41347721

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/057531 Ceased WO2010142550A1 (fr) 2009-06-08 2010-05-31 Procédé de fabrication d'une canule à aiguille dont les propriétés d'écoulement sont améliorées

Country Status (1)

Country Link
WO (1) WO2010142550A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4088829A4 (fr) * 2020-11-23 2023-11-01 Chongqing University Procédé de préparation de revêtement super-hydrophobe résistant à l'usure sur la surface d'une aiguille d'échantillonnage

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3326785A (en) * 1962-09-17 1967-06-20 Anocut Eng Co Electrolytic polishing apparatus and method
US4772367A (en) * 1986-05-20 1988-09-20 Poligrat Gmbh Apparatus for and a method of electrochemically polishing pipe inside surfaces
US6660138B2 (en) * 2001-11-28 2003-12-09 Industrial Technology Research Institute Electropolishing process means for an inner surface of a long tube
US20060204535A1 (en) * 2005-02-25 2006-09-14 Johnson Johnnie M Cell-friendly cannula and needle

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3326785A (en) * 1962-09-17 1967-06-20 Anocut Eng Co Electrolytic polishing apparatus and method
US4772367A (en) * 1986-05-20 1988-09-20 Poligrat Gmbh Apparatus for and a method of electrochemically polishing pipe inside surfaces
US6660138B2 (en) * 2001-11-28 2003-12-09 Industrial Technology Research Institute Electropolishing process means for an inner surface of a long tube
US20060204535A1 (en) * 2005-02-25 2006-09-14 Johnson Johnnie M Cell-friendly cannula and needle

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
TOSHIJI KUROBE: "High Speed Slurry Flow Finishing of Inner Wall of Stainless Steel Capillary", INTERNATIONAL JOURNAL OF THE JAPAN SOCIETY FOR PRECISION ENGINEERING, vol. 32, no. 1, March 1998 (1998-03-01)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4088829A4 (fr) * 2020-11-23 2023-11-01 Chongqing University Procédé de préparation de revêtement super-hydrophobe résistant à l'usure sur la surface d'une aiguille d'échantillonnage

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