Injection device for soft-tissue augmentation fillers, bioactive agents and other biocompatible materials in liquid or gel form

• US 10,279,162 B2
• Filed: 12/01/2016
• Issued: 05/07/2019
• Est. Priority Date: 05/30/2008
• Status: Active Grant

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Mudd, Christopher S., Tezel, Ahmet
• Primary Examiner(s): Schmidt, Emily L
• Application Number:
  US15/366,824
• Publication Number:
  US 20170080154A1
• Time in Patent Office: 887 Days
• CPC Class Codes: A61B 5/150129 by cooling
• CPC Class Codes: A61M 2005/2006 Having specific accessories
• 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 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/31588 electrically driven
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/049 Toxic
• CPC Class Codes: A61M 2202/09 Body tissue
• CPC Class Codes: A61M 2202/20 Pathogenic agents
• CPC Class Codes: A61M 2205/19 Constructional features of carpules, syringes or blisters
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/36 related to heating or cooling
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/586 Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/6045 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61M 2205/6063 : Optical identification systems
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2205/8212 : with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2205/8237 : Charging means
• CPC Class Codes: A61M 2205/8243 : by induction
• CPC Class Codes: A61M 2210/04 : Skin
• CPC Class Codes: A61M 39/24 : Check- or non-return valves
• CPC Class Codes: A61M 5/19 : having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• 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 5/2053 : Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• 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 5/2448 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/31575 : using scaling up or down transmissions, e.g. gearbox
• CPC Class Codes: A61M 5/422 : Desensitising skin
• CPC Class Codes: A61M 5/427 : Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion

Abstract

Described herein are injection devices capable of automatically injecting substances into the soft tissue of a patient. The devices can inject low to high viscosity materials at predetermined, user selected injection rates, allowing the operator more control than a traditional syringe. The devices can allow mixing of more than one substance and/or reconstitution of a solid substance for injection. The injection devices described herein can allow the operator to easily inject one or more low to high viscosity liquid or gel soft-tissue augmentation fillers, one or more drugs, one or more other biocompatible materials, or combinations thereof.

Claims

1. A hand-held injection device comprising:

a cartridge containing a dermal filler and couplable to a needle;

a shell structured to contain the cartridge;

a motorized drive mechanism;

a power source for activating the drive mechanism;

a vial, containing a dilutant, fluidly coupled to the cartridge;

a one-way valve;

a pump for directing the dilutant through the one-way valve and into the cartridge to be mixed with the dermal filler; and

a plunger actuated by the drive mechanism for forcing the dermal filler mixed with the dilutant from the cartridge and out of the needle.

2. The device of claim 1, further comprising a user-programmable controller coupled to the drive mechanism, where a user defined injection rate can be set at a rate between about 0.001 ml/sec and about 1 ml/sec.

3. The device of claim 1, wherein the power source is a battery contained in the shell.

4. The device of claim 1, requiring no external power source to operate.

5. The device of claim 1, further comprising a motor for agitating a mixture of the dermal filler and the dilutant in the cartridge.

6. The device of claim 5, further comprising a weight fitted with the motor, wherein the motor is configured to cause the weight to spin out of balance to agitate the cartridge to effect mixing of the dermal filler and the dilutant.

7. The device of claim 1, wherein the cartridge is substantially cylindrical and the vial is coupled to a lateral side of the cartridge.

8. The device of claim 1, wherein the shell comprises a first opening through which the cartridge is configured to be loaded and a second opening, separate from the first opening, through which the vial is configured to be loaded.

9. The device of claim 1, wherein the shell is elongate and configured to be held by an operator in a similar manner to that of a writing instrument.

10. The device of claim 1, wherein the shell comprises a U-shaped appendage configured to receive a finger of an operator, the shell further comprising an injection button disposed on a top side of the shell.

11. The device of claim 10, wherein the top side of the shell comprises a depression configured to accommodate the finger, the depression being disposed between the injection button and the U-shaped appendage.

12. The device of claim 1, wherein the shell has a pistol-grip style design in which the shell has a longitudinal body and a grip extending from a lateral side of the longitudinal body.

13. The device of claim 1, wherein the pump is an electronically powered component.

14. A hand-held injection device comprising:

a cartridge containing a dermal filler, the cartridge being substantially cylindrical and having a distal end configured to couple to a needle and a proximal end opposite to the distal end;

an outer shell configured to contain the cartridge and be held by an operator;

a vial containing a dilutant having a lower viscosity than the dermal filler, the vial being fluidly coupled to the cartridge at a lateral side thereof between the proximal end and the distal end;

a one-way valve disposed between the vial and the cartridge and configured to direct the dilutant into the cartridge to be mixed with the dermal filler;

a plunger disposed in the cartridge and configured to move through the cartridge to force a mixture of the dermal filler and the dilutant from the cartridge and out of the needle;

a motorized drive mechanism comprising a first motor and one or more gears, the motorized drive mechanism being coupled to the plunger through the distal end of the cartridge; and

a power source configured to activate the motorized drive mechanism.

15. The hand-held injection device of claim 14, further comprising a second motor fitted with an out of balance weight and configured to spin the out of balance weight to agitate the mixture in the cartridge through vibration of the cartridge.

16. The device of claim 14, further comprising a user-programmable controller coupled to the motorized drive mechanism and configured to be set at a user defined injection rate.

17. A hand-held injection device comprising:

a cartridge containing a dermal filler and configured to couple to a needle;

a shell configured to contain the cartridge;

a vial containing a dilutant and configured to fluidly couple to the cartridge;

a one-way valve configured to direct the dilutant into the cartridge to be mixed with the dermal filler;

a pump configured to direct the dilutant through the one-way valve;

a plunger configured to move through the cartridge to force a mixture of the dermal filler and the dilutant from the cartridge and out of the needle;

a motorized drive mechanism comprising a first motor and configured to couple to the plunger; and

a second motor configured to agitate the mixture in the cartridge.

18. The hand-held injection device of claim 17, wherein the second motor is fitted with an out of balance weight and configured to spin the out of balance weight to agitate the mixture in the cartridge through vibration of the cartridge.

19. The device of claim 17, further comprising a power source configured to activate the motorized drive mechanism.

20. The device of claim 17, further comprising a user-programmable controller coupled to the motorized drive mechanism and configured to be set at a user defined injection rate.