APPARATUS AND METHODS FOR INJECTING HIGH VISCOSITY DERMAL FILLERS

• US 20090240200A1
• Filed: 06/03/2009
• Published: 09/24/2009
• Est. Priority Date: 11/03/2006
• Status: Abandoned Application

• Current Assignee: Aesthetic Sciences Corporation
• Original Assignee: Aesthetic Sciences Corporation
• Inventors: HENEVELD, Scott, SMITH, Stacy R., WALTON, Christian, KRUMME, John F.
• Application Number:
  US12/477,527
• Publication Number:
  US 20090240200A1
• Time in Patent Office: Days
• US Class Current: 604/121
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• 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 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/31513 Piston constructions to improve sealing or sliding

Abstract

A method includes inserting a distal end portion of a needle of a medical injector into a skin of a body. An energy source operatively coupled to the medical injector is actuated such that a dermal filler is conveyed from the medical injector into the skin through the distal end portion of the needle. The distal end portion of the needle is moved within the skin during the actuating.

Claims

1. An apparatus, comprising:

a medicament container having a piston movably disposed therein such that the medicament container is divided into a first portion and a second portion, the first portion configured to contain a medicament;

a needle coupled to the medicament container such that the needle is in fluid communication with the first portion of the medicament container;

an energy source operatively coupled to the piston, the energy source configured to produce a kinetic energy to move the piston within the medicament container such that the medicament having a viscosity of at least 1000 centipoise can be conveyed from the first portion of the medicament container through a distal end of the needle at a flow rate of at least 0.02 cubic centimeters per minute; and

a regulator configured to regulate the flow rate of the medicament through the distal end of the needle.

2. The apparatus of claim 1, wherein the regulator is configured to substantially stop the flow of the medicament and subsequently restart the flow of the medicament during an injection event.

3. The apparatus of claim 1, wherein:

the energy source includes a pressurized fluid, the energy source being configured to convey the pressurized fluid into the second portion of the medicament container; and

the regulator is configured to regulate at least one of a pressure of the pressurized fluid or a flow rate of the pressurized fluid into the second portion of the medicament container.

4. The apparatus of claim 1, wherein at least a portion of the regulator is disposed within a medicament delivery path, the medicament delivery path including at least the first portion of the medicament container and the needle.

5. The apparatus of claim 1, wherein the needle defines a lumen therethrough having a nominal inner diameter of less than approximately 0.140 millimeters.

6. The apparatus of claim 1, wherein the needle has a length of at least 17 millimeters and defines a lumen therethrough having a nominal inner diameter of less than approximately 0.191 millimeters.

7. The apparatus of claim 1, wherein the energy storage member includes a pressurized fluid configured to be conveyed to the second portion of the medicament container to move the piston within the medicament container, a pressure of the pressurized fluid within the second portion of the medicament container being greater than approximately 690 kilopascals.

8. The apparatus of claim 1, wherein the energy storage member includes a pressurized fluid configured to move the piston within the medicament container such that the medicament can be conveyed through the distal end of the needle at a flow rate of at least 0.5 cubic centimeters per minute.

9. The apparatus of claim 1, wherein the medicament has a viscosity of at least 10,000 centipoise.

10. The apparatus of claim 1, wherein the energy storage member includes a pressurized fluid configured to move the piston within the medicament container, the apparatus further comprising:

an adapter configured operatively couple the source of pressurized fluid to the piston such that a pressure of the medicament within the first portion of the medicament container is greater than a pressure of the pressurized fluid from the source of pressurized fluid.

11. The apparatus of claim 1, wherein the energy storage member includes a pressurized fluid configured to move the piston within the medicament container, the apparatus further comprising:

an adapter configured couple the source of pressurized fluid to the medicament container, the adapter including a coupling member configured to engage a flange of the medicament container in at least two circumferential locations.

12. An apparatus, comprising:

a medical injector configured to contain a dermal filler, the medical injector including a needle defining a lumen therethrough having a nominal inner diameter of less than approximately 0.310 millimeters, the needle having a length of at least 17 millimeters;

a pressurized fluid source operatively coupled to the medical injector, a pressurized fluid from the pressurized fluid source having a pressure of at least 345 kilopascals, the pressurized fluid configured to actuate the medical injector such that the dermal filler can be conveyed from the medical injector through the lumen of the needle; and

a regulator configured to regulate the flow rate of the dermal filler through the lumen of the needle.

13. The apparatus of claim 12, wherein the regulator is configured to substantially stop the flow of the dermal filler and subsequently restart the flow of the dermal filler during an injection event.

14. The apparatus of claim 12, wherein the regulator is configured to regulate at least one of a pressure of the pressurized fluid or a flow rate of the pressurized fluid into the medical injector.

15. The apparatus of claim 12, wherein at least a portion of the regulator is disposed within a medicament delivery path.

16. The apparatus of claim 12, wherein at least a portion of the regulator is configured to obstruct a portion of a medicament delivery path.

17. The apparatus of claim 12, wherein the pressurized fluid has a pressure of at least 690 kilopascals.

18. The apparatus of claim 12, wherein the dermal filler has a viscosity of at least 1000 centipoise.

19. The apparatus of claim 12, further comprising:

an adapter configured couple the pressurized fluid source to the medical injector, the adapter including a coupling member configured to engage a flange of the medical injector in at least two circumferential locations.

20. The apparatus of claim 12, further comprising:

an adapter configured couple the pressurized fluid source to the medical injector, the adapter configured to amplify the pressure of the pressurized fluid such that a pressure of the medicament within the medical injector is greater than the pressure of the pressurized fluid from the pressurized fluid source,

the adapter including a coupling member configured to engage a flange of the medical injector, the coupling member configured to substantially surround the circumference of the flange of the medical injector.