CA2689890A1 - Method of manufacturing an intracutaneous microneedle array - Google Patents

Method of manufacturing an intracutaneous microneedle array Download PDF

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Publication number
CA2689890A1
CA2689890A1 CA2689890A CA2689890A CA2689890A1 CA 2689890 A1 CA2689890 A1 CA 2689890A1 CA 2689890 A CA2689890 A CA 2689890A CA 2689890 A CA2689890 A CA 2689890A CA 2689890 A1 CA2689890 A1 CA 2689890A1
Authority
CA
Canada
Prior art keywords
microneedle array
photoresist material
plastic material
mold
mask layer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA2689890A
Other languages
French (fr)
Other versions
CA2689890C (en
Inventor
Faiz F. Sherman
Vadim Vladimirovich Yuzhakov
Vladimir Gartstein
Grover David Owens
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Corium Inc
Original Assignee
Corium International, Inc.
Faiz F. Sherman
Vadim Vladimirovich Yuzhakov
Vladimir Gartstein
Grover David Owens
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Corium International, Inc., Faiz F. Sherman, Vadim Vladimirovich Yuzhakov, Vladimir Gartstein, Grover David Owens filed Critical Corium International, Inc.
Priority claimed from CA002591168A external-priority patent/CA2591168C/en
Publication of CA2689890A1 publication Critical patent/CA2689890A1/en
Application granted granted Critical
Publication of CA2689890C publication Critical patent/CA2689890C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C51/00—Shaping by thermoforming, i.e. shaping sheets or sheet like preforms after heating, e.g. shaping sheets in matched moulds or by deep-drawing; Apparatus therefor
    • B29C51/08—Deep drawing or matched-mould forming, i.e. using mechanical means only
    • B29C51/082—Deep drawing or matched-mould forming, i.e. using mechanical means only by shaping between complementary mould parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B26—HAND CUTTING TOOLS; CUTTING; SEVERING
    • B26F—PERFORATING; PUNCHING; CUTTING-OUT; STAMPING-OUT; SEVERING BY MEANS OTHER THAN CUTTING
    • B26F1/00—Perforating; Punching; Cutting-out; Stamping-out; Apparatus therefor
    • B26F1/24—Perforating by needles or pins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/0033—Moulds or cores; Details thereof or accessories therefor constructed for making articles provided with holes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/42—Moulds or cores; Details thereof or accessories therefor characterised by the shape of the moulding surface, e.g. ribs or grooves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C37/00—Component parts, details, accessories or auxiliary operations, not covered by group B29C33/00 or B29C35/00
    • B29C37/0053—Moulding articles characterised by the shape of the surface, e.g. ribs, high polish
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/17—Component parts, details or accessories; Auxiliary operations
    • B29C45/26—Moulds
    • B29C45/2628—Moulds with mould parts forming holes in or through the moulded article, e.g. for bearing cages
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C51/00—Shaping by thermoforming, i.e. shaping sheets or sheet like preforms after heating, e.g. shaping sheets in matched moulds or by deep-drawing; Apparatus therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B81—MICROSTRUCTURAL TECHNOLOGY
    • B81C—PROCESSES OR APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OR TREATMENT OF MICROSTRUCTURAL DEVICES OR SYSTEMS
    • B81C1/00—Manufacture or treatment of devices or systems in or on a substrate
    • B81C1/00015—Manufacture or treatment of devices or systems in or on a substrate for manufacturing microsystems
    • B81C1/00023—Manufacture or treatment of devices or systems in or on a substrate for manufacturing microsystems without movable or flexible elements
    • B81C1/00111—Tips, pillars, i.e. raised structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0053—Methods for producing microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C59/00—Surface shaping of articles, e.g. embossing; Apparatus therefor
    • B29C59/02—Surface shaping of articles, e.g. embossing; Apparatus therefor by mechanical means, e.g. pressing
    • B29C59/022—Surface shaping of articles, e.g. embossing; Apparatus therefor by mechanical means, e.g. pressing characterised by the disposition or the configuration, e.g. dimensions, of the embossments or the shaping tools therefor
    • B29C2059/023—Microembossing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7544—Injection needles, syringes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/756—Microarticles, nanoarticles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B81—MICROSTRUCTURAL TECHNOLOGY
    • B81B—MICROSTRUCTURAL DEVICES OR SYSTEMS, e.g. MICROMECHANICAL DEVICES
    • B81B2201/00—Specific applications of microelectromechanical systems
    • B81B2201/05—Microfluidics
    • B81B2201/055—Microneedles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B81—MICROSTRUCTURAL TECHNOLOGY
    • B81C—PROCESSES OR APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OR TREATMENT OF MICROSTRUCTURAL DEVICES OR SYSTEMS
    • B81C2201/00—Manufacture or treatment of microstructural devices or systems
    • B81C2201/03—Processes for manufacturing substrate-free structures
    • B81C2201/036—Hot embossing

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Manufacturing & Machinery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Medical Informatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Analytical Chemistry (AREA)
  • Dermatology (AREA)
  • Microelectronics & Electronic Packaging (AREA)
  • Forests & Forestry (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

A microneedle array is manufactured using a mold preparation procedure that begins try placing an optical mask over a layer of PMMA material, exposing the PMMA
material to x-rays, then developing using a photoresist process. The remaining PMMA material is then electroplated with metal. Once the metal has reached an appropriate thickness, it is detached to become a metal mold that is used in a microembossing procedure, in which the metal mold is pressed against a heated layer of plastic material. Once the mold is pressed down to its proper distance, the plastic material is cooled until solidified, and the mold is then detached, thereby leaving behind an array of microneedles. If the microneedles are hollow, then an additional procedure is used to create through-holes all the way through the underlying substrate material using laser optical means.

Claims (5)

1. A method for preparing a mold for manufacturing a microneedle array, characterized by the steps of: providing a photoresist material, in contact with a temporary substrate; placing a mask layer upon said photoresist material, said mask layer having a predetermined pattern, at least a portion of said mask layer comprising a material that prevents high energy radiation from passing therethrough;
exposing said combination photoresist material/mask layer to high energy radiation;
removing said mask layer, and chemically developing exposed portions of said photo-resist material, thereby removing portions of the photoresist material and leaving behind a pattern of said photoresist material that represents a three-dimensional structure emulating a plurality of microneedles that are to be later formed;
electroplating said patterned photoresist material with a metallic substance; and detaching said metallic substance from said patterned photoresist material, said metallic substance thereby forming a microneedle array mold.
2. The method as recited in claim 1, wherein said photoresist material comprises polymethylmethacrylate (PMMA); or wherein said mask layer comprises gold; or wherein said electroplating metallic substrate comprises nickel.
3. The method as recited in claim 1, including the step of chemically coating said patterned photoresist material before the step of electroplating to aid in later detachment of the metallic substance from the patterned photoresist material.
4. The method as recited in claim 1, including the step of a microembossing procedure, comprising: placing a plastic material upon a temperature-controlled surface and, by use of said temperature-controlled surface, heating said plastic material to substantially its elastic working temperature, said plastic material having a first substantially planar surface touching said temperature-controlled surface and a second substantially planar surface on its opposite side;
pressing said microneedle array mold against the second substantially planar surface of said plastic material, thereby forming a three-dimensional pattern comprising a microneedle array in said plastic material; by use of said temperature-controlled surface, cooling said patterned plastic material below its deformable temperature; and de-molding, by removing said microneedle array mold from contact with said patterned plastic material, thereby leaving behind a plastic microneedle array; and preferably: wherein said plastic material comprises a biocompatible polymer.
5. The method as recited in claim 1, including the step of providing a vacuum during the molding process; or including the step of forming a fluid-holding chamber on the second substantially planar surface side of said patterned microneedle array.
CA2689890A 1999-06-09 2000-06-07 Method of manufacturing an intracutaneous microneedle array Expired - Fee Related CA2689890C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/328,946 1999-06-09
US09/328,946 US6312612B1 (en) 1999-06-09 1999-06-09 Apparatus and method for manufacturing an intracutaneous microneedle array
CA002591168A CA2591168C (en) 1999-06-09 2000-06-07 Method of manufacturing an intracutaneous microneedle array

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA002591168A Division CA2591168C (en) 1999-06-09 2000-06-07 Method of manufacturing an intracutaneous microneedle array

Publications (2)

Publication Number Publication Date
CA2689890A1 true CA2689890A1 (en) 2000-12-14
CA2689890C CA2689890C (en) 2012-09-04

Family

ID=23283160

Family Applications (2)

Application Number Title Priority Date Filing Date
CA002376283A Expired - Fee Related CA2376283C (en) 1999-06-09 2000-06-07 Method of manufacturing an intracutaneous microneedle array
CA2689890A Expired - Fee Related CA2689890C (en) 1999-06-09 2000-06-07 Method of manufacturing an intracutaneous microneedle array

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA002376283A Expired - Fee Related CA2376283C (en) 1999-06-09 2000-06-07 Method of manufacturing an intracutaneous microneedle array

Country Status (7)

Country Link
US (3) US6312612B1 (en)
EP (1) EP1183064B1 (en)
JP (1) JP4436992B2 (en)
AU (1) AU5727900A (en)
CA (2) CA2376283C (en)
TW (1) TW512067B (en)
WO (1) WO2000074764A1 (en)

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