Pre-filled injection delivery device

• US 6,099,504 A
• Filed: 10/21/1998
• Issued: 08/08/2000
• Est. Priority Date: 10/22/1997
• Status: Expired due to Fees

• Current Assignee: Elan Pharma International Limited (Perrigo Company PLC)
• Original Assignee: Elan Corporation PLC (Perrigo Company PLC)
• Inventors: Lavi, Gilad, Tsals, Izrail, Gross, Joseph
• Primary Examiner(s): Polutta, Mark O.
• Assistant Examiner(s): Hayes, Michael J.
• Application Number:
  US09/176,439
• Time in Patent Office: 657 Days
• Field of Search: 604/93, 604/110, 604/140, 604/141, 604/143, 604/145, 604/148, 604/171, 604/198, 604/200
• US Class Current: 604/140
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• 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 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• 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 5/3272 having projections following labyrinth paths
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A syringe (10) comprises a barrel (11) containing an internal cylindrical body (12) containing a liquid (14) and communicating with a delivery needle (15). The needle (15) is covered before use by a removable sheath (16), and after the sheath (16) is removed, the needle (15) is concealed by a displaceable sleeve (20). In use the sleeve (20) is pressed against the skin by applying pressure while holding the barrel (11). The sleeve (20) is thereby retracted into the barrel (11) allowing the needle (15) to penetrate the skin. The movement of the sleeve (20) also activates a gas generator (17) which expels the liquid (14) from the needle (15). When delivery is complete and the syringe (10) is taken from the skin, a coil spring (22) moves the sleeve (20) back to the starting position again concealing the needle (15). The coil spring (22) is torsionally biased before use and causes a rotational movement of the sleeve (20) relative to the barrel (11) when the sleeve (20) moves into and out of the barrel (11). This rotational movement engages a locking mechanism which prevents further movement of the sleeve (20) and thereby permanently conceals the needle (15).

Claims

1. A syringe comprising:

a) a barrel having a liquid drug reservoir therein, the barrel having a first end and a second end;

b) a delivery needle mounted on the first end of the barrel;

c) a gas generator located at the second end of the barrel, the gas generator in communication with the reservoir when the gas generator is activated;

d) gas generation activation means; and

e) a sleeve moveably mounted on the first end of the barrel from a first position where the tip of the needle is concealed by the sleeve to a second position where the tip of the needle is exposed to a third gas generation activation position,

f) whereby when the sleeve is initially pressed against an injection site, the sleeve moves from the first position to the second position, and the tip of the needle penetrates the injection site, and when the sleeve moves from the second position to the third position, it causes activation of the gas generator which drives a liquid from the reservoir into the injection site through the needle.

2. The syringe of claim 1 wherein the gas generator comprises first and second chambers separated by a deformable membrane.

3. The syringe of claim 2 wherein the gas activation means comprises means for puncturing the deformable membrane.

4. The syringe of claim 2 wherein the first and second chambers house the components of an effervescent couple respectively.

5. The syringe of claim 4 wherein at least one of the components of the couple is a liquid.

6. The syringe of claim 4 wherein the components of the effervescent couple are citric acid and sodium bicarbonate respectively.

7. The syringe of claim 1 wherein the gas activation means is activated by movement of the barrel and sleeve from the first position to the second position.

8. The syringe of claim 1 wherein the sleeve is axially biased towards the first position so that it moves to the first position when no pressure is applied to the barrel.

9. The syringe of claim 8 wherein the sleeve is axially biased by means of a coil spring.

10. The syringe of claim 9 wherein the coil spring is disposed between the sleeve and the barrel.

11. The syringe of claim 5 wherein the sleeve is torsionally biased.

12. The syringe of claim 11 wherein the axial and torsional bias are provided by a compression-extension spring under torsional strain.

13. The syringe of claim 1 further comprising locking means such that when the sleeve returns from the second position to the first position the locking means prevents the sleeve from returning to the second position.

14. The syringe of claim 13 wherein the locking means comprises a pair of co-operating formations disposed on the sleeve and the barrel respectively.

15. The syringe of claim 14 wherein the pair of co-operating formations comprises a slot and a member received in the slot respectively.

16. The syringe of claim 1 wherein the needle extends between about 1-3 mm beyond the first end of the barrel.

17. The syringe of claim 1 wherein the needle extends approximately 1 mm beyond the first end of the barrel.

18. The syringe of claim 1 wherein the gas generator generates a pressure of about 2 atmosphere.

19. A method of injecting liquid drug comprising the following steps:

a) providing a barrel having a liquid drug reservoir therein, a delivery needle mounted on the first end of the barrel,

b) locating a gas generator at the second end of the barrel, the gas generator in communication with the reservoir when the gas generator is activated;

c) moveably mounting a sleeve within the first end of the barrel, the sleeve capable of assuming a first position where the tip of the needle is concealed by the sleeve, a second position where the tip of the needle is revealed, and a third gas generator activation position;

d) placing the sleeve against an injection site;

e) moving the barrel toward the injection site, thereby causing the sleeve to move from the first position to the second position and the tip of the needle to penetrate the injection site; and

f) moving the sleeve to the third position to activate the gas generator thereby driving a liquid from the reservoir into the injection site through the needle.

20. The method of claim 19 further comprising the step of causing the sleeve to return to the first position after moving to the second position.

21. The method of claim 20 further comprising the step of preventing the sleeve from returning to the second position after returning to the first position.

22. The method of claim 19 wherein the gas generator comprises a first chamber and a second chamber separated by a deformable membrane.

23. The method of claim 22 wherein the first and second chambers house the components of an effervescent couple respectively.

24. The method of claim 23 wherein at least one of the components of the couple is a liquid.

25. The method of claim 23 wherein the components of the effervescent couple are citric acid and sodium bicarbonate respectively.

26. The method of claim 22 the gas generator is activated by piercing the membrane.

27. The method of claim 19 wherein the needle penetrates the injection site about 1-3 mm.

28. The method of claim 19 wherein the pressure within the gas generator is about 2 atmosphere.

29. A syringe comprising:

a member having a liquid drug reservoir therein, the member having a first end and a second end;

a delivery needle mounted on the first end of the member;

a gas generator located at the second end of he member, the gas generator in communication with the reservoir when the gas generator is activated; and

a sleeve moveably mounted on the first end of the member from a first position where the tip of the needle is enclosed by the sleeve, to a second position where the tip of the needle is exposed, to a third position where the sleeve activates the gas generator,

whereby when the sleeve is initially pressed against an injection site, the sleeve moves from the first position to the second position, and the tip of the needle penetrates the injection site, and when the sleeve moves from the second position to the third position, it causes activation of the gas generator which drives a liquid from the reservoir into the injection site through the needle.

30. A method of injecting liquid drug comprising the following steps:

a) providing a member having a liquid drug reservoir therein, a delivery needle mounted on the first end of the member,

b) locating a gas generator at the second end of the member, the gas generator in communication with the reservoir when the gas generator is activated;

c) moveably mounting a sleeve within the first end of the member, the sleeve capable of assuming a first position where the tip of the needle is concealed by the sleeve, a second position where the tip of the needle is revealed, and a third position where the gas generator is activated;

d) pressing the sleeve against an injection site, thereby causing the sleeve to move from the first position to the second position and the tip of the needle to penetrate the injection site; and

e) moving the sleeve to the third position to activate the gas generator, thereby driving the liquid from the reservoir into the injection site through the needle.