Electroformed Needle Cannula

Patent metadata

Field	Value
Publication number	US-2018085533-A1
Application number	US-201615562432-A
Country	US
Kind code	A1
Filing date	Mar 15, 2016
Priority date	Apr 1, 2015
Publication date	Mar 29, 2018
Grant date	—

Abstract

Disclosed herein is a method of electroforming a needle cannula ( 100 ) for an injection device, wherein the electroforming method is performed in an electroforming system ( 1 ) comprising a cathode ( 10 ), an anode ( 60 ) and an electrolyte ( 50 ) with dissolved metal ions, wherein the method comprises providing a permanent mandrel ( 10 ), wherein the mandrel is configured to constitute the cathode. The mandrel ( 10 ) comprises a forming portion ( 20 ) having a forming surface ( 21, 22, 23, 24, 25, 26 ) adapted to form an inner surface of the needle cannula ( 100 ), wherein the forming portion ( 20 ) comprises a cylindrical axis (A), a longitudinal extension, a first proximal end ( 16 ) and a second distal end ( 17 ). The method further comprises electrodepositing a metal or metal alloy on the forming surface ( 21, 22, 23, 24, 25, 26 ) of the mandrel, where the electrodeposited metal or metal alloy is corresponding to the metal ions dissolved in the electrolyte ( 50 ), and whereby the electrodeposited metal or metal alloy is forming a needle cannula ( 100 ) on the mandrel ( 10 ), and separating the mandrel ( 10 ) from the formed needle cannula ( 100 ) by moving the mandrel ( 10 ) and the electroformed needle cannula relative to each other. Further disclosed is a method of producing different cannula features as composite structures ( 301, 302, 303, 304, 305 ) and interlock structures ( 105, 106, 107, 152, 153 ).

First claim

1 . A method of electroforming a needle cannula for an injection device, wherein the electroforming method is performed in an electroforming system comprising a cathode, an anode and an electrolyte with dissolved metal ions, wherein the method comprises:
providing a permanent mandrel, wherein the mandrel is configured to constitute the cathode, wherein the mandrel is having a forming portion with a forming surface adapted to form the inner surface of the needle cannula, wherein the mandrel comprises a cylindrical axis, a longitudinal extension, a first proximal end and a second distal end, electrodepositing a metal or metal alloy on the forming surface of the mandrel, where the electrodeposited metal or metal alloy is corresponding to the metal ions dissolved in the electrolyte, and whereby the electrodeposited metal or metal alloy is forming a needle cannula on the mandrel, separating the mandrel from the formed needle cannula by moving the mandrel and the electroformed needle cannula relative to each other, wherein the system for electroforming comprises a first, and a second electrolyte, wherein the first electrolyte comprises a first solution of metal ions, wherein the second electrolyte comprises a second solution of metal ions, wherein the method further comprises: electrodepositing a first layer of metal or metal alloy corresponding to the metal ions of the first solution onto the mandrel, electrodepositing a second layer of metal or metal alloy corresponding to the metal ions of the second solution onto the mandrel and/or the first metal or metal alloy.

2 . A method of electroforming a needle cannula according to claim 1 , wherein the method further comprises
forming a composite structure, by electrodeposition of the second layer onto the first layer.

3 . A method of electroforming a needle cannula according to claim 1 , wherein the method further comprises:
electrodepositing a third layer of metal or metal alloy onto the second layer of metal or metal alloy, wherein the metal of the third layer corresponds to the metal ions of the first solution or a third electrolyte comprising a third solution of metal ions, and thereby forming a composite structure, where the second layer is substantially covered by the first and the third layer.

4 . A method of electroforming a needle cannula according to claim 1 , wherein the first layer of metal or metal alloy and the second layer of metal or metal alloy is electrodeposited at the needle cannula tip, and thereby reinforces the formed tip in order to reduce the tendency of hooking.

5 . An electroformed needle cannula for an injection device, obtainable by a method according to claim 1 , wherein the cannula comprises:
a first layer of metal or metal alloy, and a second layer of metal or metal alloy, wherein the second layer reinforces the cannula tip.

6 . An electroformed needle cannula for an injection device, obtainable by a method according to claim 1 , wherein the cannula comprises:
a first layer of metal or metal alloy, and a second layer of metal or metal alloy, wherein the outer surface of the needle cannula is covered by the second layer.

7 . An electroformed needle cannula according to claim 6 , wherein the second layer is a biocompatible outer layer.

8 . An electroformed needle cannula for an injection device, wherein the needle cannula is formed by a method according to claim 1 , wherein the cannula comprises:
a first biocompatible layer of metal or metal alloy, a second layer of metal or metal alloy, and a third biocompatible layer of metal or metal alloy.

9 . A needle cannula according to claim 8 , wherein the second layer is covered by the first and the third layer.

10 . A method of electroforming a needle cannula for an injection device, wherein the electroforming method is performed in an electroforming system comprising a cathode, an anode and an electrolyte with dissolved metal ions, wherein the method comprises:
providing a permanent mandrel, wherein the mandrel is configured to constitute the cathode, wherein the mandrel is having a forming portion with a forming surface adapted to form the inner surface of the needle cannula, wherein the mandrel comprises a cylindrical axis, a longitudinal extension, a first proximal end and a second distal end, electrodepositing a metal or metal alloy on the forming surface of the mandrel, where the electrodeposited metal or metal alloy is corresponding to the metal ions dissolved in the electrolyte, and whereby the electrodeposited metal or metal alloy is forming a needle cannula on the mandrel, separating the mandrel from the formed needle cannula by moving the mandrel and the electroformed needle cannula relative to each other, forming an interlock structure.

11 . A method of electroforming a needle cannula according to claim 10 , wherein the electroforming system further comprises a holding device comprising a local anode, wherein the local anode is adapted to locally increase the deposition rate, and wherein the method further comprises:
positioning the local anode at a desired position relative to the mandrel, electroforming a needle cannula, wherein the electrodeposition rate is increased at an area in the proximity of local anode, and thereby forms an interlock structure on the needle cannula.

12 . A method of electroforming a needle cannula according to claim 10 further comprising:
depositing a conducting material on the forming surface of the mandrel, and thereby creating an interlock forming structure to form an interlock structure on the needle cannula,
forming a needle cannula with an interlock structure, and
separating the needle cannula and the interlock forming structure from the mandrel.

13 . A method of electroforming a needle cannula according to claim 12 further comprising:
removing the interlock forming structure from the needle cannula.

14 . A method of electroforming a needle cannula according to claim 10 further comprising:
depositing a polymer on the forming surface of the mandrel, and thereby creating an interlock forming structure to form an interlock structure on the needle cannula,
coating the deposited polymer with a conducting film,
forming a needle cannula with an interlock structure,
separating the needle cannula and the interlock forming structure from the mandrel, and
removing the interlock forming structure from the needle cannula.

15 . An electroformed needle cannula for an injection device obtainable by the method according to claim 10 , wherein the cannula comprises:
an interlock structure adapted to mate with a corresponding structure of a needle hub, and thereby allowing a cannula to snap fit, when inserted into a needle hub, wherein the interlock structure forms a protrusion on the outer surface of the needle cannula.

Assignees

• Novo Nordisk As

Inventors

• Trosborg Jacqueline

Classifications

• A61M5/329 Primary

  characterised by features of the needle shaft · CPC title

• A61M5/3286

  Needle tip design, e.g. for improved penetration · CPC title

• A61M2207/00

  Methods of manufacture, assembly or production · CPC title

• C25D1/00

  Electroforming · CPC title

• C25D1/02 Primary

  Tubes; Rings; Hollow bodies · CPC title