US2009124996A1PendingUtilityA1

Apparatus and methods for injecting high viscosity dermal fillers

51
Assignee: HENEVELD SCOTTPriority: Nov 3, 2006Filed: May 2, 2008Published: May 14, 2009
Est. expiryNov 3, 2026(~0.3 yrs left)· nominal 20-yr term from priority
A61F 2/0059A61M 5/002A61M 5/1452A61M 5/2053A61M 5/3129A61M 5/31511A61M 5/31513A61M 2005/3128
51
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Claims

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

exact text as granted — not AI-modified
1 . A method, comprising
 inserting a distal end portion of a needle of a medical injector into a skin of a body;   actuating an energy source operatively coupled to the medical injector such that a dermal filler is conveyed from the medical injector 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 energy source includes a pressurized fluid; and   the actuating includes conveying the pressurized fluid to the medical injector such that the dermal filler is conveyed from the medical injector 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 medical injector 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 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 , wherein the actuating is performed at a first time after the inserting, the method 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 such 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 such 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. 
   
   
       11 . A method, comprising:
 inserting a distal end portion of a needle of a medical injector into a skin of a body;   actuating a non-manually-powered machine operatively coupled to the medical injector such that a dermal filler is conveyed from the medical injector 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.   
   
   
       12 . The method of  claim 11 , wherein:
 the non-manually-powered machine includes a pressurized fluid; and   the actuating includes conveying the pressurized fluid to the medical injector such that the dermal filler is conveyed from the medical injector through the distal end portion of the needle.   
   
   
       13 . 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.   
   
   
       14 . The method of  claim 11 , further comprising:
 moving a valve body within a medicament flow path defined within the medical injector such that a flow rate of the dermal filler through the distal end portion of the needle is regulated.   
   
   
       15 . 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.   
   
   
       16 . The method of  claim 11 , wherein the skin is any one of facial skin or skin of a neck region of the body. 
   
   
       17 . 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 from the medical injector into the skin through the distal end portion of the needle.   
   
   
       18 . 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.   
   
   
       19 . The apparatus of  claim 18 , 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. 
   
   
       20 . The apparatus of  claim 18 , 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.   
   
   
       21 . The apparatus of  claim 18 , 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. 
   
   
       22 . The apparatus of  claim 18 , wherein the needle defines a lumen therethrough having a nominal inner diameter of less than approximately 0.191 millimeters. 
   
   
       23 . The apparatus of  claim 18 , wherein the needle defines a lumen therethrough having a nominal inner diameter of less than approximately 0.140 millimeters. 
   
   
       24 . The apparatus of  claim 18 , 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. 
   
   
       25 . The apparatus of  claim 18 , wherein the energy source 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 345 kilopascals. 
   
   
       26 . The apparatus of  claim 18 , 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. 
   
   
       27 . The apparatus of  claim 18 , 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. 
   
   
       28 . The apparatus of  claim 18 , wherein the medicament has a viscosity of at least 10,000 centipoise. 
   
   
       29 . The apparatus of  claim 18 , 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.   
   
   
       30 . The apparatus of  claim 18 , 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.   
   
   
       31 . 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.   
   
   
       32 . The apparatus of  claim 31 , 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. 
   
   
       33 . The apparatus of  claim 31 , 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. 
   
   
       34 . The apparatus of  claim 31 , wherein at least a portion of the regulator is disposed within a medicament delivery path. 
   
   
       35 . The apparatus of  claim 31 , wherein at least a portion of the regulator is configured to obstruct a portion of a medicament delivery path. 
   
   
       36 . The apparatus of  claim 31 , wherein the pressurized fluid has a pressure of at least 690 kilopascals. 
   
   
       37 . The apparatus of  claim 31 , wherein the dermal filler has a viscosity of at least 1000 centipoise. 
   
   
       38 . The apparatus of  claim 31 , 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.   
   
   
       39 . The apparatus of  claim 31 , 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.

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