Disposable Double Point Injection Needle and an Insulin Injection System Comprising a Disposable Double Point Injection Needle

• US 20120277724A1
• Filed: 10/21/2011
• Published: 11/01/2012
• Est. Priority Date: 05/31/2000
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Larsen, Carsten Gerner, Stenholt, Lars, Rex, Jørn, Larsen, Bjørn Gullak, Molin, Anders
• Granted Patent: US 9,095,660 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/3267 Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/59 Aesthetic features, e.g. distraction means to prevent fears of child patients
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/3257 Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3272 having projections following labyrinth paths
• CPC Class Codes: A61M 5/347 rotatable, e.g. bayonet or screw A61M5/344 takes precedence
• CPC Class Codes: A61M 5/349 using adhesive bond or glues

Abstract

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.

Claims

1. An injection needle assembly comprising:

a hub for mounting the assembly to an injection device;

a needle cannula mounted in the hub and having a distal skin piercing end;

cover that conceals the distal end of the needle and is retractable to expose the distal end of the needle and wherein after the shield is exposed to allow an injection with the distal end of the needle cannula, the shield automatically conceals the distal end, automatically irreversibly locks to prevent the distal end from being exposed again, and wherein a visual indicator on the needle assembly automatically visually indicates that the needle has been used following an injection.

2. The needle assembly of claim 1 wherein the needle cannula further comprises a proximal portion that protrudes from the hub in a proximal direction and has a membrane piercing end for piercing a membrane on a cartridge of medicament.

12. The injection needle of claim 1, wherein each indicating area is provided with different colors and/or symbols.

3. A method of preventing inadvertent sticking of a person with an injection needle following injecting of a patient with that needle, the method comprising:

exposing a sharpened end of an injection needle;

injecting a medication from a medication delivery device thru the needle;

after completing the injection,

automatically covering and irreversibly locking the sharpened end of the needle with a shield that prevents the sharpened end from being exposed again; and

—

automatically a visual indication that the needle has been used and cannot be reused, thereby preventing the inadvertent sticking of a person with the needle.

4. An injection needle comprising:

a cannula having a distal and proximal end;

a hub in which the cannula is fastened with the distal end protruding from one end of the hub a the proximal end being exposed at an opposite end so that the proximal end may pierce a cartridge having a pierceable membrane;

a safety shield that is moveable relative to the needle;

wherein the shield is biased in a distal direction to cover the distal end of needle, wherein the shield is moveable in a proximal direction to expose the distal end, and wherein when the shield returns to cover the distal end the shield is automatically and irreversibly locked over the distal end; and

a visual indicator area that automatically shows a visual indication when the shield has been locked over the distal end.

5. The injection needle of claim 4, wherein the shield is guided on the outer surface of the hub.

6. The injection needle of claim 5, wherein the safety shield is provided with a transparent area through which the indicating area is visible at least when the shield is irreversibly locked.

7. The injection needle of claim 6, further comprising an additional indicating area which is visible through the transparent area when the needle is in the unused state.

8. The injection needle of claim 7, wherein the indicating area and the additional indicating area are provided with different colors and/or symbols.

9. The injection needle of claim 4, wherein the shield is guided on an inside surface of the hub.

10. An injection needle according to claim 9, wherein the shield is provided with at least one indicating area and the hub is provided with a transparent area though which the indicating area is visible at least when the shield is irreversible locked.

11. The injection needle of claim 10, wherein the shield is further provided with an additional indicating area which is visible through the transparent area when the needle is in an unused state.

13. A method of determining whether a pen syringe needle assembly having a sheath that covers a needle cannula in the assembly and irreversibly locks, has been previously used, the method comprising:

examining a visual indicating area on the needle assembly; and

based on the examination, determining whether an indicator that indicates previous use is present in the indication area of the needle assembly.

14. A method of determining whether a pen syringe needle assembly having a sheath that covers a needle cannula in the assembly and irreversibly locks has been previously used, the method comprising:

examining a visual indicator area on the needle assembly; and

based on the examination, determining whether a visual indicator that indicates previous use confirms that the sheath that covers a needle cannula is locked in place.

15. A safety injection needle assembly comprising:

an injection needle having an injection part with a first end sharpened for piercing skin and a cartridge part having second end for inserting into a medication holding cartridge of an injection device;

a hub in which the injection needle is mounted;

a slideable safety shield for covering the injection part of the needle, the shield being biased to slide toward and to cover the first end when no external force is applied to the shield;

a lock for irreversibly locking the safety shield in its normally biased position covering the injection part, the lock being activated by sliding the shield from its normally biased position to a position exposing the injection part during an injection; and

a visual indicator indicating that the safety shield is locked in the normally biased position.

16. The double pointed injection needle assembly according to claim 15, wherein the needle hub is provided with at least one indicating area and the safety shield is provided with at least one transparent area through which the indicating area(s) is visible when the safety shield has been irreversible locked in the normally biased position, thereby providing the user with a visual indication when the disposable double pointed injection needle is in a potentially safe position.

17. The double point injection needle assembly according to claim 16, wherein the hub further is provided with at least one additional indicating area that is visible through the transparent area(s) when the injection part of the needle has not been used.

18. The double pointed injection needle assembly according to claim 15, wherein the safety shield is provided with at least one indicating area and that the needle hub is provided with at least one transparent area through which the indicating area(s) is visible when said safety shield has been irreversible locked over the injection part of the needle, thereby providing the user with a visual indication when said disposable double pointed injection needle is in a potentially safe position.

19. The double pointed injection needle assembly according to claim 18, wherein the safety shield further is provided with at least one additional indicating area that is visible through the transparent areas when the needle has not been used to perform an injection.

20. The double pointed injection needle assembly according to claim 17, wherein the indicating areas and the additional indicating areas are provided with different colors.

21. The double pointed injection needle assembly according to claim 17, wherein the indicating areas and the additional indicating areas are provided with different symbols.

22. A safety injection needle assembly comprising:

an elongated cannula having a distal end for injecting a patient;

a hub in which the cannula is mounted;

a moveable safety shield that moves relative to the cannula between a first position exposing the distal end and a second position covering the distal end;

the safety shield being biased toward the second position;

a locking means for irreversibly locking the safety shield in the second position after the shield is initially moved from the second position to the first position and then returned to the second position; and

a visual indicator that shows when the shield is irreversibly locked in the second position, thereby preventing re-use of the needle assembly to administer a second injection after it has been already used to administer a first injection.

23. The safety needle assembly of claim 22, wherein the visual indicator shows a colored surface after the shield is irreversibly locked.

24. The safety needle assembly of claim 22, wherein the visual indicator shows a textured surface after the shield is irreversibly locked.

25. The safety needle assembly of claim 22, wherein the visual indicator shows a shaded surface after the shield is irreversibly locked.

26. A disposable double pointed injection needle comprising:

an elongated cannula having two sharp ends and an outside diameter,

said needle cannula being fastened in a needle hub having a distal end and a proximal end, said proximal end being provided with a fastening mechanism for mounting said needle hub on to a syringe having a cartridge, said needle cannula having an injection part and a cartridge part, the cartridge part for inserting into a cartridge that is covered by said needle hub, the injection part for entering into a human body during injection, the injection part having an overall length short enough to secure subcutaneously injection and the cartridge part having an overall length long enough to extend into the interior of the cartridge when said injection needle is fastened onto said syringe,

wherein said injection needle further is provided with a movable safety shield movable mounted relatively to said needle hub and which movable safety shield surrounds at least most of the injection part of said needle cannula when said needle cannula is in an unused state, and said safety shield can be longitudinal moved relatively to said needle cannula, such that said 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 automatically moved in the distal direction by a resilient element located between said needle hub and said safety shield when the injection part of said cannula is removed from the subcutis layer of the human body, and said safety shield is irreversible locked in a locked safe position where the movable safety shield covers the skin piercing end of the injection part of said needle cannula when the injection part of said cannula is fully removed from the subcutis layer of a human body, and said double pointed disposable injection needle further is provided with means providing the user with a visual indication when said disposable double pointed injection needle is in the safe position.

27. A disposable double pointed injection needle according to claim 26, wherein said needle hub is provided with at least one indicating area and said safety shield is provided with at least one transparent area through which transparent areas the indicating areas is visible when said safety shield has been moved to the irreversible locked position thereby providing the user with a visual indication when said disposable double pointed injection needle is in a potentially safe position.

28. A disposable double pointed injection needle according to claim 27, characterized in that, said hub further is provided with at least one additional indicating area which is visible through the transparent areas when said needle cannula is in the unused state.

29. A disposable double pointed injection needle according to claim 27, characterized in that, said safety shield is provided with at least one indicating area and that said needle hub is provided with at least one transparent area through which transparent areas the indicating areas is visible when said safety shield has been moved to the irreversible locked position thereby providing the user with a visual indication when said disposable double pointed injection needle is in a potentially safe position.

30. A disposable double pointed injection needle according to claim 29, characterized in that, said safety shield further is provided with at least one additional indicating area which is visible through the transparent areas when said needle cannula is in the unused state.

31. A disposable double pointed injection needle according to claim 28, characterized in that, the indicating areas and the additional indicating areas are provided with different colors, different symbols or different colors and different symbols.