Methods and apparatuses for forming microprojection arrays

• US 20030199810A1
• Filed: 11/27/2002
• Published: 10/23/2003
• Est. Priority Date: 11/30/2001
• Status: Abandoned Application

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wright, Cedric Thomas, Keenan, Richard Lamar, Trautman, Joseph Creagan, Chan, Keith T.
• Application Number:
  US10/305,641
• Publication Number:
  US 20030199810A1
• Time in Patent Office: Days
• US Class Current: 604/46
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• 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: B21D 22/02 Stamping using rigid devices or tools
• CPC Class Codes: B81B 1/008 Microtips

Abstract

A method for producing a device for piercing a body surface is disclosed. A sheet (200) is provided having opposite first and second faces. A plurality of microprojections (304) and openings (302) are formed through the first and second faces of the sheet (200). The first face of the sheet (200) is positioned adjacent a die (402) having a plurality of cavities (404) corresponding to the plurality of microprojections (304) of the sheet (200) in such a way that each of the microprojections (304) of the sheet (200) is positioned adjacent a corresponding cavity (404) of the die (402). An elastomeric material (410) is then forced against a second face of the sheet (200) and into the cavities (404) of the die (402) to deflect the microprojections (304) of the sheet (200) into the cavities (404) of the die (402). To aid bending of the microprojection (304) along its base (904), embodiments of the device may include a hole (902) through the microprojection (304), a groove (1202) in one face of the microprojection (304), or a notch (1104) in a side edge of the microprojection (304). In further embodiments, one sheet (200a) may be stacked with another sheet (200b) so that the openings (302a, 302b) of the sheets (200a, 200b) forming the device (1400) are generally in alignment with the opening of a top sheet (200a) of the stack with the microprojections (304b) of the sheets (200b) beneath the top sheet (200a) outwardly extending through the opening (302a) of the top sheet (200a) in the stack.

Claims

1. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die.

2. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die;

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die; and

reducing the force on at least a portion of the elastomeric material thereby causing the retraction of at least a portion of the elastomeric material from the cavities of the die.

3. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

providing a block having a bore therethrough;

positioning the block adjacent the second face of the sheet so that at least a portion of the plurality of microprojections and openings of the sheet are positioned within the bore of the block;

providing a piston which is sized to fit within the bore of the block;

disposing an elastomeric material in the bore of the block; and

biasing the piston into the bore of the block to force the elastomeric material against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die.

4. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

wherein the elastomeric material is biased against the second face of the sheet with a force sufficient to bend at least a portion of the microprojections of the sheet into the cavities of the die to an angle of at least 45 degrees from a plane of the sheet.

5. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

wherein the elastomeric material is biased against the second face of the sheet with a force sufficient to bend at least a portion of the microprojections of the sheet into the cavities of the die to an angle of at least 60 degrees from a plane of the sheet.

6. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

wherein the elastomeric material is biased against the second face of the sheet with a force sufficient to bend at least a portion of the microprojections of the sheet into the cavities of the die to an angle of at least 90 degrees from a plane of the sheet.

7. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

wherein the elastomeric material is biased against the second face of the sheet with a force sufficient to bend at least a portion of the microprojections of the sheet into the cavities of the die to an angle between about 1 degree to about 90 degrees relative to the a plane of the sheet and all of the microprojections are bent to substantially the same angle.

8. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming, by an etching process, a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die.

9. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

wherein the cavities of the die each have a depth greater than a length of the associated corresponding microprojection of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die.

10. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

wherein the outer perimeter of each opening of the sheet is located inside of the outer perimeter of the adjacent cavity of the die;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die.

11. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die;

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

the elastomeric material being forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die; and

wherein each of the microprojections of the sheet has a base positioned adjacent an inwardly extending lip of the corresponding adjacent cavity of the die so that during the bending of the microprojections, the base of each microprojection is bent against the inwardly extending lip of the corresponding adjacent cavity of the die.

12. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die;

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

the elastomeric material being forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die; and

wherein each of the microprojections of the sheet has a base positioned adjacent an inwardly extending lip of the corresponding adjacent cavity of the die so that during the bending of the microprojections, the base of each microprojection is bent against the inwardly extending lip of the corresponding adjacent cavity of the die and each microprojection is bent into a shape corresponding to the contour of the inwardly extending lip of the corresponding cavity of the die.

13. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

forcing an elastomeric material, said elastomeric material being selected from the group consisting of silicone rubber, butyl rubber and polyurethane, against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die.

14. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

each microprojection having a base;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die, the base of each microprojection having an opening to facilitate bending of the microprojection along the base.

15. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

each microprojection having a base;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die, the base of each microprojection having a groove to facilitate bending of the microprojection along the base.

16. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

each microprojection having a base;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die, the base of each microprojection having an a notch along at least one side of the microprojection to facilitate bending of the microprojection along the base.

17. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die;

providing a cover plate having a plurality of openings therethrough which correspond in size, shape and location to the plurality of cavities in the die;

placing the cover plate on the second face of the sheet; and

forcing an elastomeric material against the cover plate and against the microprojections formed in the sheet;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die.

18. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

providing a block having a bore therethrough;

positioning the block adjacent the second face of the sheet so that at least a portion of the plurality of microprojections and openings of the sheet are positioned within the bore of the block;

providing a piston which is sized to fit within the bore of the block;

disposing an elastomeric material in the bore of the block;

said elastomeric material shaped to fit within the bore; and

biasing the piston into the bore of the block to force the elastomeric material against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die.

19. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

said elastomeric material having a durometer hardness of 20A to about 100A as determined by the ASTM Test Method D2240-00, the elastomeric material being forced into the cavities of the die, causing the microprojections of the sheet to be bent into the cavities of the die.

20. A method for producing a device for piercing a body surface, the method comprising the steps of:

providing a sheet having opposite first and second faces;

forming a plurality of microprojections and openings through the first and the second faces of the sheet;

providing a die having a plurality of cavities corresponding to the plurality of microprojections of the sheet;

the die being comprised of a base plate and one or more forming plates;

wherein each forming plate contains a plurality of openings therethrough and wherein the openings in each the forming plates are correspondingly located so that when the forming plates are aligned and disposed on the base plate, the openings also align and form said cavities;

positioning the first face of the sheet against the die so that each of the microprojections of the sheet is positioned adjacent a corresponding cavity of the die; and

forcing an elastomeric material against the second face of the sheet and against the microprojections formed therein;

wherein the elastomeric material is forced into the cavities of the die causing the microprojections of the sheet to be bent into the cavities of the die.

21. A device for piercing a body surface, comprising:

a sheet having an opening therethrough and a microprojection located along a periphery of the opening; and

the microprojection having an opening therethrough positioned at a base of the microprojection, the base being located adjacent the periphery of the opening.

22. A device for piercing a body surface, comprising:

a sheet having an opening therethrough and an outwardly extending microprojection located along a periphery of the opening; and

the microprojection having an opening therethrough positioned at a base of the microprojection, the base being located adjacent the periphery of the opening.

23. A device for piercing a body surface, comprising:

a sheet having an opening therethrough and a microprojection located along a periphery of the opening; and

the microprojection having an opening therethrough positioned at a base of the microprojection, the opening being generally centered along an axis of the base, the base being located adjacent the periphery of the opening.

24. A device for piercing a body surface, comprising:

a sheet having an opening therethrough and one or more downwardly extending microprojections located along a periphery of the opening; and

one or more of the microprojections having a groove in one face of the microprojection, the groove extending along a base of the microprojection, the base being located adjacent the periphery of the opening.

25. A device for piercing a body surface, comprising:

a sheet having an opening therethrough and one ore more microprojections located along a periphery of the opening; and

the microprojection having a side edge outwardly extending from the periphery of the opening and a notch in the side edge positioned adjacent a base of the microprojection, the base being located adjacent the periphery of the opening.

26. A device for piercing a body surface, comprising:

a stack of sheets including a top sheet, each of the sheets having an opening therethrough and one or more microprojections located along a periphery of the opening and outwardly extending from the respective sheet; and

the openings of the sheets in the stack being generally in alignment with the opening of the top sheet and the microprojections of the sheets beneath the top sheet outwardly extending through the openings of the top sheet.

27. A device for piercing a body surface, comprising:

a stack of two sheets including a top sheet, each of the sheets having an opening therethrough and one or more microprojections located along a periphery of the opening and outwardly extending from the respective sheet; and

the openings of the sheets in the stack being generally in alignment with the opening of the top sheet and the microprojections of the sheets beneath the top sheet outwardly extending through the openings of the top sheet.

28. A device for piercing a body surface, comprising:

a stack of sheets including a top sheet, each of the sheets having an opening therethrough and one or more microprojections located along a periphery of the opening and outwardly extending from the respective sheet;

the openings of the sheets in the stack being generally in alignment with the opening of the top sheet and the microprojections of the sheets beneath the top sheet outwardly extending through the openings of the top sheet; and

wherein at least one of the microprojections of at least one of the sheets has a hole therethrough positioned at a base of the respective microprojection located adjacent the periphery of the opening of the respective sheet.

29. A device for piercing a body surface, comprising:

a stack of sheets including a top sheet, each of the sheets having an opening therethrough and one or more microprojections located along a periphery of the opening and outwardly extending from the respective sheet;

the openings of the sheets in the stack being generally in alignment with the opening of the top sheet and the microprojections of the sheets beneath the top sheet outwardly extending through the openings of the top sheet; and

wherein the one or more microprojections of the top sheet each have a length less than each of the one or more microprojections of the other sheets of the stack.

30. A device for piercing a body surface, comprising:

a stack of sheets including a top sheet, each of the sheets having an opening therethrough and one or more microprojections located along a periphery of the opening and outwardly extending from the respective sheet;

the openings of the sheets in the stack being generally in alignment with the opening of the top sheet and the microprojections of the sheets beneath the top sheet outwardly extending through the openings of the top sheet; and

wherein the microprojections of the sheets are spaced apart from each other.

31. A device for piercing a body surface, comprising:

a pair of sheets each having an opening therethrough and a microprojection located along a periphery of the opening and outwardly extending from the respective sheet; and

the sheets being positioned adjacent one another such that peripheries of the openings of sheets are generally aligned with one another and the microprojection of one of the sheets extends through the opening of the other sheet.

32. A device for piercing a body surface, comprising:

a pair of sheets each having an opening therethrough and a microprojection located along a periphery of the opening and outwardly extending from the respective sheet;

the sheets being positioned adjacent one another such that peripheries of the openings of sheets are generally aligned with one another and the microprojection of one of the sheets extends through the opening of the other sheet; and

wherein the microprojections of each of the sheets are positioned in different locations around the periphery of the openings.

33. A device for piercing a body surface, comprising:

a pair of sheets each having an opening therethrough and a microprojection located along a periphery of the opening and outwardly extending from the respective sheet;

the sheets being positioned adjacent one another such that peripheries of the openings of sheets are generally aligned with one another and the microprojection of one of the sheets extends through the opening of the other sheet; and

wherein the microprojections of the one sheet are located at one end of the openings and the microprojections of the other sheet are located at the opposite end of the openings.