Low volume accurate injector

• US 9,452,261 B2
• Filed: 05/08/2011
• Issued: 09/27/2016
• Est. Priority Date: 05/10/2010
• Status: Active Grant

• Current Assignee: West Pharma. Services IL, Ltd. (West Pharmaceutical Services Incorporated)
• Original Assignee: Medimop Medical Projects Ltd. (West Pharmaceutical Services Incorporated)
• Inventors: Alon, Ruth
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Stiles, Amber
• Application Number:
  US13/643,470
• Publication Number:
  US 20130041346A1
• Time in Patent Office: 1,969 Days
• Field of Search: 604/93.01, 604/117, 604/118, 604121-122, 604124-125, 604/131, 604/156, 604/181, 604/187, 604200-201, 604207-212, 604/214, 604217-218, 604/232, 604/244, 604/246, 604/264, 604/272, 604/506
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/2411 from the front
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2005/31588 electrically driven
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• 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 5/3146 Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: A61M 5/3156 using volume steps only adjustable in discrete intervals, i.e. individually distinct intervals
• CPC Class Codes: A61M 5/31575 using scaling up or down transmissions, e.g. gearbox
• 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 5/484 Regulating injection pressure
• CPC Class Codes: A61M 5/488 Limiting injection pressure

Abstract

Substance-administration apparatus (20) is provided, including a housing (22), and a needle (80), couplable to the housing (22), having a skin-insertion portion 0.3-2.5 mm in length and an outer diameter less than 0.23 mm. A dosage regulator (60) regulates a dosage of substance injected in a single injection through the needle (80). Dosage is selectable by a setting of the dosage regulator (60) as one of a plurality of selectable dosages. At least one dosage is less than or equal to 10 ul. An injection driver (54), activatable by a user, drives the substance through the needle (80). A motor coupled to the injection driver (54) is actuated by the dosage regulator (60) in a pulsatile manner to produce brief periods of high pressure in the apparatus (20) that expel a predetermined volume of the substance through the needle (80) at a controlled rate. Other applications are also described.

Claims

1. A substance-administration apparatus, comprising:

a housing;

a needle, couplable to the housing, having a skin-insertion portion 0.3-2.5 mm in length and an outer diameter that is less than 0.23 mm;

a dosage regulator coupled to the housing, which regulates a dosage of a substance expelled in a single injection through the needle, a single dosage from a plurality of selectable dosages being selectable by a user, the plurality of selectable dosages including at least one dosage that is less than or equal to 10 ul;

an electromechanical motor automatically actuated by the dosage regulator in a pulsatile manner, the motor being drivingly coupled to a rotator, which rotates about a central axis thereof;

an injection driver for driving the substance through the needle, the injection driver having a rotatable gear system drivingly coupled to the rotator;

wherein actuation of the motor in the pulsatile manner rotates the rotator and the coupled gear system in the pulsatile manner, to, in turn, drive the injection driver in the pulsatile manner to automatically produce a series of bursts of pressure in the housing that expel the single selected dosage of the substance through the needle at a controlled rate.

2. The apparatus according to claim 1, wherein the skin-insertion portion is 1-2.5 mm in length.

3. The apparatus according to claim 1, wherein the apparatus is generally cylindrical.

4. The apparatus according to claim 1, wherein the plurality of selectable dosages includes at least one dosage that is greater than 10 ul.

5. The apparatus according to claim 1, wherein the plurality of selectable dosages does not include any dosages that are greater than 50 ul.

6. The apparatus according to claim 1, wherein the at least one dosage is 5-10 ul.

7. The apparatus according to claim 1, wherein the at least one dosage is 1-5 ul.

8. The apparatus according to claim 1, wherein the outer diameter of the needle is less than 0.21 mm.

9. The apparatus according to claim 1, wherein the outer diameter of the needle is between 0.15 mm and 0.23 mm.

10. The apparatus according to claim 1, wherein the substance includes a viscous substance, and wherein the dosage regulator is configured to regulate the dosage of the viscous substance injected in the single injection through the needle.

11. The apparatus according to claim 1, wherein the apparatus comprises the substance, and wherein the substance comprises a depilatory agent.

12. The apparatus according to any one of claims 1-11, further comprising a cartridge, pre-filled with the substance, couplable to the housing, for providing the substance in a plurality of injections.

13. The apparatus according to claim 12, wherein the needle is couplable to the housing by being couplable to the cartridge, and wherein the needle and the cartridge are couplable to the housing by the user, prior to use of the apparatus.

14. The apparatus according to claim 12, wherein the cartridge is pre-filled with powder of botulinum toxin, and the injection driver is movable in a reverse direction to draw solution into the cartridge and facilitate suspension of the powder after receipt of the cartridge in the housing.

15. A substance-administration method, comprising:

selecting a single dosage of a substance by selecting one of a plurality of selectable dosages from a substance-administration apparatus comprising;

a housing, a needle couplable to the housing, a dosage regulator coupled to the housing which regulates the dosage of the substance from one of the plurality of selectable dosages including at least one dosage that is less than or equal to 10 ul, an electromechanical motor automatically actuated by the dosage regulator in a pulsatile manner, the motor being drivingly coupled to a rotator, which rotates about a central axis thereof, an injection driver for driving the substance through the needle, the injection driver having a rotatable gear system drivingly coupled to the rotator, wherein actuation of the motor in the pulsatile manner rotates the rotator and the coupled gear system in the pulsatile manner, to, in turn, drive the injection driver in the pulsatile manner to automatically produce a series of bursts of pressure in the housing that expel the single selected dosage of the substance through the needle at a controlled rate;

inserting the needle into skin of a subject to a depth of 0.3-2.5 mm, the needle having an outer diameter that is less than 0.23 mm;

expelling the single selected dosage of the substance through the needle at a controlled rate by automatically producing the series of bursts of pressure in the device; and

administering the selected dosage of the substance through the needle.

16. The method according to claim 15, wherein inserting the needle comprises inserting the needle to a depth of 1-2.5 mm.

17. The method according to claim 15, wherein the plurality of selectable dosages further includes at least one dosage that is greater than 10 ul, and wherein selecting comprises selecting the at least one dosage that is greater than 10 ul.

18. The method according to claim 15, wherein the plurality of selectable dosages does not include any dosages that are greater than 50 ul, and wherein selecting comprises selecting a dosage from the plurality of selectable dosages that does not include any dosages that are greater than 50 ul.

19. The method according to claim 15, wherein the at least one dosage is 5-10 ul, and wherein selecting comprises selecting the at least one dosage that is 5-10 ul.

20. The method according to claim 15, wherein the at least one dosage is 1-5 ul, and wherein selecting comprises selecting the at least one dosage that is 1-5 ul.

21. The method according to claim 15, wherein the outer diameter of the needle is less than 0.21 mm, and wherein inserting the needle comprises inserting the needle that has an outer diameter that is less than 0.21 mm.

22. The method according to claim 15, wherein the substance includes a depilatory agent, and wherein administering the substance comprises administering the depilatory agent.

23. The method according to claim 15, wherein the substance includes a viscous substance, and wherein administering the substance comprises administering the viscous substance.

24. The method according to any one of claims 15-23, further comprising coupling to the needle a cartridge that is pre-filled with the substance, and providing the substance from the cartridge in a plurality of injections.

25. The method according to claim 24, wherein the cartridge is pre-filled with powder of botulinum toxin, and wherein the method further comprises suspending the powder prior to the providing the substance from the cartridge in the plurality of injections.

26. The method according to any one of claims 15-23, wherein inserting the needle in the skin comprises inserting the needle in at least one site selected from the group consisting of:

skin of a face of the subject and skin of a neck of the subject.

27. The method according to claim 26, wherein inserting the needle in the at least one selected site comprises inserting the needle and administering the substance at at least 5 sites.

28. The method according to claim 26, wherein inserting the needle in the at least one selected site comprises inserting the needle at two sites separated by less than 1 mm.