Process of making a molded device

• US 6,331,266 B1
• Filed: 09/29/1999
• Issued: 12/18/2001
• Est. Priority Date: 09/29/1999
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Monahan, Larry A., Powell, Kenneth G., Sage, Burton H. Jr.
• Primary Examiner(s): Tentoni, Leo B.
• Application Number:
  US09/408,450
• Time in Patent Office: 811 Days
• Field of Search: 264/219, 264/313, 264/320, 264/322, 264/328.1, 264/328.16, 264/337, 264/338
• US Class Current: 264/313
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B29C 2045/0094 injection moulding of small-sized articles, e.g. microarticles, ultra thin articles
• CPC Class Codes: B29C 33/405 Elastomers, e.g. rubber B29C33/50 takes precedence
• CPC Class Codes: B29C 33/424 Moulding surfaces provided with means for marking or patterning for injection moulding B29C45/372
• CPC Class Codes: B29C 45/372 provided with means for marking or patterning, e.g. numbering articles
• CPC Class Codes: B29K 2883/00 Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as mould material
• CPC Class Codes: B29L 2031/7544 Injection needles, syringes
• CPC Class Codes: B29L 2031/756 Microarticles, nanoarticles
• CPC Class Codes: B81B 2201/055 Microneedles
• CPC Class Codes: B81C 1/00111 Tips, pillars, i.e. raised structures microneedles A61M37/0015
• CPC Class Codes: B81C 2201/034 Moulding

Abstract

A device, preferably a micro-device, is molded from a plastic material by injection molding, compression molding or embossing. A microabrader can be molded having microneedles for abrading the stratum corneum of the skin to form an abraded site in the tissue for enhancing drug delivery. The micro-device is molded using a mold assembly having a silicon molding surface. The silicon molding surface can include a recess corresponding to the desired shape and length of the microneedles. The silicon molding surface enables micron and submicron size features to be molded from polymeric materials without the polymeric material adhering to the mold surface. Micro-devices having molded features having micron and submicron dimensions can be rapidly produced without the use of a release agent.

Claims

1. A method of making a molded device comprising a plurality of micron or sub-micron size structural features, said method comprising the steps of:

providing a mold assembly having a mold section with a recess defining a mold cavity and having a silicon mold member disposed in said mold cavity, said silicon mold member having a mold surface with a contoured surface defining an impression of said device and said structural features facing said mold cavity;

introducing a plastic material into said mold cavity to fill said mold cavity and said contoured surface in said silicon mold member to form said molded device having a body and molded surface corresponding to said contoured surface and said structural features;

and removing said molded device from said mold section.

2. The method of claim 1, wherein said molded device has structural features which are a plurality of needles, about 5 to 250 microns in length.

3. The method of claim 2, wherein said needles are hollow.

4. The method of claim 1, wherein said silicon mold member releases said device from the mold surface and said molding is in the absence of a release agent, whereby said molded device is substantially clean and sterile.

5. The method of claim 1, wherein said mold cavity has a plurality of side walls and a bottom surface, and said silicon mold member is bonded to said bottom surface.

6. The method of claim 5, wherein said silicon mold member has an outer peripheral edge corresponding to the shape of said mold cavity, wherein said silicon mold member substantially covers said bottom surface of said mold cavity.

7. The method of claim 6, wherein said mold surface of said silicon mold member is substantially flat.

8. The method of claim 7, wherein said structural features comprise recesses which are provided in said mold surface and are spaced apart uniformly to form rows and columns, each of said recesses having a depth of about 5 to about 250 microns and said recesses being spaced to provide a density of about 4 to about 100 of said recesses per mm².

9. The method of claim 1, wherein said polymeric material is selected from the group consisting of polycarbonates, polyethylenes, polypropylene, polystyrene, polyesters and polyamides.

10. The method of claim 1, wherein said contoured surface of said silicon mold member has structural features comprising at least one recess, peak or ridge with at least one dimension ranging from about 0.5 micron to about 500 microns .

11. The method of claim 1, wherein said mold assembly includes an inlet in communication with said mold cavity, and said introducing step comprises injecting said plastic material through said inlet to said mold cavity.

12. The method of claim 1, wherein said introducing step comprises injecting a hot thermoplastic material into said mold cavity.

13. The method of claim 1, wherein said introducing step comprises introducing a thermoplastic material into said cavity and heating and compressing said thermoplastic material to mold said device.

14. The method of claim 1, wherein said introducing step comprises positioning a thermoplastic substrate on said mold cavity and pressing said mold assembly against said substrate to form said molded device.

22. The method of claim 1, wherein said structural features are selected from the group consisting of one or more channels, conduits, capillaries, needles, points, recesses and combinations thereof.

24. The method of claim 7, wherein said mold surface having at least one structural feature includes a plurality of spaced apart recesses, said recesses being spaced to provide a density of about 4 to about 100 of said recesses per mm².

15. A method of injection molding a device, said method comprising the steps of:

providing a mold assembly having a mold section with a recess defining a mold cavity, said recess having at least one side wall and a bottom wall, and a silicon mold member coupled to said mold section within said recess, said silicon mold member having a contoured mold surface facing said mold cavity and having at least one structural feature of about 5 to about 250 microns in at least one dimension;

closing said mold cavity and injecting a hot polymeric material into said mold cavity to substantially fill said mold cavity and to form a molded device, without said polymeric material adhering to said silicon mold member; and

cooling the mold assembly and removing said molded device from said mold cavity, said molded device having a surface corresponding to said mold surface.

16. The method of claim 15, wherein said molded device is molded substantially in the absence of a release agent on said silicon mold member or said mold surface.

17. The method of claim 15, wherein said silicon mold member has an outer peripheral edge corresponding to the shape of said mold cavity, wherein said silicon mold member substantially covers said bottom wall of said mold cavity.

18. The method of claim 15, wherein said mold surface having at least one structural feature includes a plurality of spaced apart recesses forming rows and columns, said recesses being spaced to provide a density of about 4 to about 100 of said recesses per mm².

19. The method of claim 15, wherein said polymeric material is selected from the group consisting of polycarbonates, polyethylenes, polypropylene, polystyrene, polyesters and polyamides.

20. The method of claim 15, wherein said molded device is a microneedle device.

21. The method of claim 15, wherein said contoured surface of said silicon mold member and having at least one structural feature has as said structural feature at least one recess, peak or ridge with at least one dimension ranging from about 0.5 micron to about 500 microns.

23. The method of claim 15, wherein said structural features are selected from the group consisting of one or more channels, conduits, capillaries, needles, points, recesses and combinations thereof.