APPARATUS AND METHODS FOR INJECTING HIGH VISCOSITY DERMAL FILLERS

• US 20100324531A1
• Filed: 08/30/2010
• Published: 12/23/2010
• Est. Priority Date: 11/03/2006
• Status: Active Grant

• Current Assignee: Nordson Corporation
• Original Assignee: Nordson Corporation
• Inventors: Walton, Christian, Smith, Stacy R., Heneveld, Scott, Krumme, John F.
• Granted Patent: US 8,343,132 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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. A method, comprising

receiving a syringe pre-filled by a dermal filler supplier such that a first portion of the syringe contains a dermal filler, the syringe having a piston movably disposed therein such that the syringe is divided into the first portion and a second portion, the first portion of the syringe being coupled to a needle;

coupling the second portion of the syringe to a non-manual energy source via a hand piece such that the first portion of the syringe is unconstrained by the hand piece, the coupling including disposing a push rod of the hand piece within the second portion of the syringe such that the push rod is adjacent the piston of the syringe;

inserting a distal end portion of a needle into a skin of a body;

actuating the non-manual energy source such that a gas having a first pressure is supplied to the hand piece, the hand piece configured to amplify the first pressure such that the dermal filler is conveyed from the first portion of the syringe at a second pressure higher than the first pressure, the dermal filler conveyed into the skin through the distal end portion of the needle; and

moving the distal end portion of the needle within the skin during the actuating.

2. The method of claim 1, wherein the inserting includes inserting the distal end portion of the needle into a subcutaneous tissue of the skin.

3. The method of claim 1, wherein:

the non-manual energy source includes a pressurized fluid; and

the actuating includes conveying the pressurized fluid to the hand piece such that the dermal filler is conveyed from the first portion of the syringe through the distal end portion of the needle.

4. The method of claim 1, further comprising:

regulating a flow rate of the dermal filler through the distal end portion of the needle during the actuating.

5. The method of claim 1, further comprising:

moving a valve body within a medicament flow path defined within the syringe such that a flow rate of the dermal filler through the distal end portion of the needle is regulated.

6. The method of claim 1, further comprising:

regulating the non-manual energy source such that a flow rate of the dermal filler through the distal end portion of the needle is at least 0.02 cubic centimeters per minute.

7. The method of claim 1, further comprising:

regulating a flow rate of the dermal filler through the distal end portion of the needle at a first time after the moving, without removing the needle from the skin between the inserting and the regulating, such that the flow rate of the dermal filler is substantially zero;

moving the distal end portion of the needle within the skin when the flow rate of the dermal filler is substantially zero; and

regulating a flow rate of the dermal filler through the distal end portion of the needle at a second time after the first time, without removing the needle from the skin between the regulating at the first time and the regulating at the second time such that the flow rate of the dermal filler is greater than zero.

8. The method of claim 1, wherein:

the inserting includes inserting the distal end portion of the needle into the skin in a distal direction; and

the moving includes moving the distal end portion of the needle in a proximal direction.

9. The method of claim 1, wherein:

the moving includes moving the needle from a first location within the skin to a second location within the skin, the first location spaced apart from the second location by at least 4 millimeters.

10. The method of claim 1, wherein the skin is any one of facial skin or skin of a neck region of the body.

17. The method of claim 1, wherein the syringe is a rigid syringe.

18. The method of claim 1, wherein the coupling includes disposing a flange of the syringe within a coupling portion of the hand piece such that the first portion of the syringe is visible to a user.

19. The method of claim 1, wherein the inserting includes inserting the needle at an angle relative to a surface of the skin of not greater than between approximately 5 degrees and approximately 35 degrees.

30. The method of claim 1, wherein the hand piece is configured to amplify the first pressure such that the second pressure is greater than 100 pounds per square inch.

31. The method of claim 1, wherein the hand piece is configured to amplify the first pressure such that the second pressure is greater than 150 pounds per square inch.

32. The method of claim 1, wherein the hand piece is configured to amplify the first pressure such that the second pressure is approximately 250 pounds per square inch.

11. A method, comprising:

coupling a proximal end portion of a syringe to a non-manually-powered machine using a hand piece such that a distal end portion of the syringe and a central portion of the syringe are unconstrained, at least the distal end portion configured to contain a dermal filler, the distal end portion coupled to a needle;

inserting a distal end portion of a needle into a skin of a body; and

actuating the non-manually-powered machine operatively coupled to the hand piece such that a gas having a first pressure is supplied to the hand piece, the hand piece configured to amplify the first pressure such that the dermal filler is conveyed from the distal portion of the syringe at a second pressure higher than the first pressure into the skin through the distal end portion of the needle, the second pressure being approximately 250 pounds per square inch.

12. The method of claim 11, further comprising:

regulating a flow rate of the dermal filler through the distal end portion of the needle during the actuating.

13. The method of claim 11, further comprising:

moving a valve body within a medicament flow path such that a flow rate of the dermal filler through the distal end portion of the needle is regulated.

14. The method of claim 11, wherein:

the inserting includes inserting the distal end portion of the needle into the skin in a distal direction; and

the moving includes moving the distal end portion of the needle in a proximal direction.

15. The method of claim 11, wherein the skin is any one of facial skin or skin of a neck region of the body.

16. The method of claim 11, wherein

the actuating includes actuating the non-manually-powered machine such that at least 0.5 cubic centimeters of the dermal filler is conveyed into the skin through the distal end portion of the needle.

20. The method of claim 11, further comprising:

moving the distal end portion of the needle within the skin during the actuating.

21. The method of claim 11, wherein the coupling includes disposing a flange of the syringe within a coupling portion of the hand piece such that the distal end portion of the syringe and the central portion of the syringe are unobstructed by the hand piece.

22. The method of claim 11, wherein the coupling is performed such that the distal end portion of the syringe can be manipulated by a user.

23. The method of claim 11, wherein the inserting includes inserting the needle at an angle relative to a surface of the skin not greater than between approximately 5 degrees and approximately 35 degrees.

24. The method of claim 11, wherein the inserting includes inserting the needle at an angle relative to a surface of the skin of approximately 20 degrees.

25. The method of claim 11, wherein:

the dermal filler has a viscosity of at least 1000 centipoise; and

the hand piece is configured to amplify the first pressure such that the dermal filler is conveyed from the first portion of the syringe at a flow rate of at least 0.02 cubic centimeters per minute.

33. The method of claim 11, wherein:

the syringe has a piston movably disposed therein; and

the coupling includes disposing a push rod of the hand piece within the proximal end portion of the syringe such that the push rod is in contact with the piston of the syringe.

26. A method, comprising:

coupling a proximal end portion of a syringe to a hand piece such that a push rod of the hand piece is disposed adjacent a piston within the syringe and such that the syringe and the hand piece collectively define a range of minimum insertion angles relative to a surface of a skin of a body between approximately 5 degrees and approximately 35 degrees;

inserting a distal end portion of a needle coupled to the syringe into the skin of the body at an angle relative to the surface of the skin; and

actuating a pneumatic energy source operatively coupled to the syringe via the hand piece such that the hand piece receives a gas having a gas pressure from the pneumatic energy source, and amplifying the gas pressure via the hand piece such that a pressure of the dermal filler within the syringe is higher than the gas pressure and is approximately 250 pounds per square inch, such that a dermal filler is conveyed from the syringe into the skin through the distal end portion of the needle.

27. The method of claim 26, wherein:

the dermal filler has a viscosity of at least 1000 centipoise; and

the amplifying includes amplifying the first pressure such that the dermal filler is conveyed from the first portion of the syringe at a flow rate of at least 0.02 cubic centimeters per minute.

28. The method of claim 26, comprising:

moving the distal end portion of the needle within the skin during the actuating.

29. The method of claim 26, wherein:

the coupling includes coupling a flange of the syringe to the hand piece such that at least a central portion of the syringe and a distal end portion of the syringe are exposed.

34. 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;

a non-manual 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.