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

• US 8,801,659 B2
• Filed: 06/01/2009
• Issued: 08/12/2014
• Est. Priority Date: 05/30/2008
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Mudd, Christopher S., Tezel, Ahmet
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US12/994,568
• Publication Number:
  US 20110137286A1
• Time in Patent Office: 1,898 Days
• Field of Search: 604/154, 604/156, 604/187, 604/232, 604/85, 604 87- 92
• US Class Current: 604/85
• 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 for soft tissue comprising:

a cartridge suitable for containing a dermal filler material 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 user-programmable controller coupled to the drive mechanism, where a user-defined injection rate can be set;

a vial, suitable for containing a dilutant for the dermal filler material, fluidly coupled to the cartridge;

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

a plunger actuated by the drive mechanism for forcing the dermal filler material mixed with the dilutant from the cartridge and out of the needle at the user defined injection rate.

2. The device of claim 1 wherein said 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 which is capable of injecting the dermal filler material mixed with the dilutant from the cartridge through a needle having a gauge of between about 23 G to about 34 G.

4. The device of claim 1 which is capable of injecting the dermal filler material mixed with the dilutant through a needle having a gauge of between about 27 G to about 32 G.

5. The device of claim 1 capable of injecting the dermal filler material mixed with the dilutant through a needle having a length of between about ¼

inch (6 mm) to about 2 inches (50 mm).

6. The device of claim 1 capable of injecting the dermal filler material mixed with the dilutant through a needle having a length of between about ½

inch (10 mm) to about 1½

inches (40 mm).

7. The device of claim 1 wherein the cartridge is substantially cylindrical and has an inner diameter of between about 0.25 inch (6.3 mm) to about 1 inch (25 mm).

8. The device of claim 1 wherein the cartridge is substantially cylindrical and has an inner diameter of between about 0.18 inch (4.6 mm) to about 0.35 inch (8.9 mm).

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

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

11. The device of claim 1 which is self-contained.

12. The device of claim 1 wherein the dermal filler material is a hyaluronic acid-based dermal filler that is at least partially crosslinked.

13. The device according to claim 1 further comprising a second motor for agitating the dermal filler material and dilutant mixture in the cartridge.

14. The device according to claim 13 further comprising a weight fitted with the motor.

15. The device of claim 14 wherein the motor causes the weight to spin out of balance which agitates the cartridge to effect the mixing.