Microneedles, Microneedle Arrays, Methods for Making, and Transdermal and/or Intradermal Applications

• US 20100121307A1
• Filed: 11/02/2009
• Published: 05/13/2010
• Est. Priority Date: 08/24/2007
• Status: Abandoned Application

• Current Assignee: Microfabrica Incorporated (Technoprobe S.P.A.)
• Original Assignee: Microfabrica Incorporated (Technoprobe S.P.A.)
• Inventors: Nielsen, Kirk G., Cohen, Adam L., Lockard, Michael S., Arat, Vacit
• Application Number:
  US12/611,108
• Publication Number:
  US 20100121307A1
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• 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

Abstract

Embodiments are directed to microneedle array devices for intradermal and/or transdermal interaction with the body of patient to provide therapeutic, diagnostic or preventative treatment wherein portions of the devices may be formed by multi-layer, multi-material electrochemical fabrication methods and wherein individual microneedles may include valve elements or other elements for controlling interaction (e.g. fluid flow). In some embodiments needles are retractable and extendable from a surface of the device. In some embodiments, interaction occurs automatically with movement across the skin of the patient while in other embodiments interaction is controlled by an operator (e.g. doctor, nurse, technician, or patient).

Claims

1. A device for the intradermal and/or transdermal dispensing of a drug into a body of a patient through a desired delivery area, comprising:

a. a handle

b. a cylindrical body having one or more apertures extending from an interior region to an exterior region wherein the cylindrical body and the handle are joined to one another such that relative rotation between the handle and body may occur,

c. a plurality of needles extending outward from the one or more apertures, wherein the needles and cylindrical body are configured to provide a desired penetration depth into a surface of a delivery area when the cylindrical body is rolled over the delivery area as the handle is translated relative to the delivery area;

wherein the device further includes at least one element taken from the group of elements consisting of;

(1) at least a portion of some of the needles are formed from a multi-layer, multi-material fabrication process where each of the multiple layers are formed from the deposition of at least one structural material and at least one sacrificial material, a trimming (e.g. planarization) of the at least one structural material and the at least one sacrificial material to set a boundary level for the layer, and wherein after formation of a plurality of layers, the sacrificial material is removed from the plurality of layers;

(2) the needles include penetration stops located proximally relative to more distal apertures in the needles such that the distance between the apertures and the penetration stops defines a desired delivery depth for the drug below surface of the delivery area;

(3) the outer surface of the cylindrical body is covered with a membrane that inhibits flow of the drug from the needles except in those locations where the needles have been made to extend through the membrane by contact with the delivery area;

(4) the outer surface of the cylindrical body is covered with a compressible membrane that inhibits flow of the drug from the needles except in those locations where the needles have been made to extend through the membrane by compression of the membrane against the delivery area;

(5) the distal ends of the needles are made to extend from an interior position relative to the apertures in the cylindrical body via one or more bulges in one or more tracks along which with the needles move as the cylindrical body rotates with respect to the handle wherein the bulge or bulges correspond to a location along the perimeter of the cylindrical body that is intended to be in contact with a delivery area during a drug delivery;

(6) a drug is held within the cylindrical body within pores of a flexible porous medium and is forced from selected needles by squeezing the porous medium adjacent the selected needles;

(7) selected needles are extended from selected apertures via fluid pressure exerted by the drug on bases of the selected needles;

(8) a non-rotating inter conformable structure is held with the cylindrical structure wherein the conformable structure includes a recess which acts as a reservoir for the drug and which is configured and located so that it is positioned adjacent to only a portion of the needles and in particular that portion of the needles that are located in a desired dispensing position and wherein other portions of the conformable structure act to inhibit other needles from dispensing the drug;

(9) the distal ends of the needles are made to extend from an interior position relative to the apertures in the cylindrical body such that they extend beyond the outer surface of the cylindrical body for penetration into the tissue through the delivery area when the cylindrical body is in contact with the delivery area;

(10) a plurality of normally closed valves (i.e. when no dispensing is to occur) which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area;

(11) a plurality of normally closed valves (i.e. when no dispensing is to occur) which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves are made to open by a plurality of trigger mechanisms being depressed as the cylindrical body is pressed against the delivery area;

(12) a plurality of normally closed valves (i.e. when no dispensing is to occur) which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves comprise valve seats that seal the exit ports of the needles when trigger mechanisms are not sufficiently depressed;

(13) a plurality of normally closed valves (i.e. when no dispensing is to occur) which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves comprise valve seats that seal the fluid entry ports of the needles when trigger mechanisms are not sufficiently depressed;

(14) the plurality of needles are held within the cylindrical body and are made to extend from the cylindrical body in a region of the cylindrical body that is in contact with the delivery area prior to dispensing the drug and after dispensing the drug are made to retract back into the cylindrical body.

4. The device of claim 1 wherein the device comprises at least two of the elements.

5. The device of claim 1 wherein the device comprises at least two of the elements.

2. A device for the intradermal and/or interdermal interaction with a body of a patient, comprising:

a. a handle

b. a smooth body having one or more apertures extending from an interior region to an exterior region wherein the smooth body and the handle are functionally connected to one another such that the smoothed body extends beyond a surface of a body of the handle,

c. a plurality of needles which are extendible from the smooth body and retractable into the smooth body via the one or more apertures such that upon extension a desired intradermal or interdermal interaction can occur via passages within the needles and such that upon retraction the smooth body may be translated or rotated along the surface of the delivery area, wherein the needles and smooth body are configured to provide a desired penetration depth of the needles into a surface of the delivery area when the needles are extended;

wherein the device further includes an element taken from the group of elements consisting of;

(1) at least a portion of some of the needles are formed from a multi-layer, multi-material fabrication process where each of the multiple layers is formed from the deposition of at least one structural material and at least one sacrificial material, a trimming (e.g. planarization) of the at least one structural material and the at least one sacrificial material sets a boundary level for the layer, and wherein after formation of a plurality of layers the sacrificial material is removed from the plurality of layers;

(2) the needles include penetration stops that are located proximally from more distal apertures such that the distance between the apertures and the penetration stops defines a desired interaction depth within the tissue;

(3) the outer surface of the smooth body is covered with a membrane that inhibits interaction between the tissue and the needles except in those locations where the needles have been made to extend through the membrane by contact with the delivery area;

(4) the outer surface of the smooth body is covered with a compressible membrane that inhibits interaction between the needles and the tissue except in those locations where the needles have been made to extend through the membrane by compression of the membrane against the delivery area;

(5) the distal ends of the needles are made to extend from an interior position relative to the apertures in the smooth body via a bulge in one or more tracks along which with the needles move as the smooth body rotates with respect to handle wherein the bulge or bulges correspond to a location along the perimeter of the smooth body that are intended to be in contact with a delivery area an interaction;

(6) a drug is held within the smooth body within pores of a flexible porous medium and is forced from selected needles during an interaction by squeezing the porous medium adjacent the selected needles;

(7) selected needles are extended from selected apertures via fluid pressure exerted by a drug on bases of the selected needles wherein the drug is to be dispensed during an interaction;

(8) a non-rotating conformable structure is held within the smooth structure wherein the conformable structure includes a recess which acts as a reservoir for a drug to be dispensed during an interaction and which is configured and located so that the conformable structure is positioned adjacent to only a portion of the needles and in particular that portion of the needles that are located in a desired dispensing position and wherein other portions of the conformable structure act to inhibit other needles from dispensing the drug;

(9) the distal ends of the needles are made to extend from an interior position relative to the apertures in the smooth body such that they extend beyond the outer surface of the smooth body for penetration into the tissue through the delivery area when the smooth body is in contact with the delivery area;

(10) a plurality of normally closed valves which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein the direction of fluid flow is selected from the group consisting of outward flow and an inward flow;

(11) a plurality of normally closed valves which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves are made to open by a plurality of trigger mechanisms being depressed as the smooth body is pressed against the delivery area, wherein the direction of fluid flow is selected from the group consisting of outward flow and an inward flow;

(12) a plurality of normally closed valves which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves comprise valve seats that seal the exit ports of the needles when trigger mechanisms are not sufficiently depressed, wherein the direction of fluid flow is selected from the group consisting of outward flow and an inward flow;

(13) a plurality of normally closed valves which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves comprise valve seats that seal the fluid entry ports of the needles when trigger mechanisms are not sufficiently depressed, wherein the direction of fluid flow is selected from the group consisting of outward flow and an inward flow;

(14) the plurality of needles are held within the cylindrical body and are made to extend from the cylindrical body in a region of the smooth body that is in contact with the delivery area prior to interaction between the needles and the tissue and after interaction are made to retract back into the smooth body;

(15) the interaction comprises directing radiation down one or more the plurality of needles;

(16) the interaction comprises reading an electrical signal from one or more of the needles;

(17) the interaction comprises applying a voltage to one or more of the needles;

(18) the interaction comprises a diagnostic procedure;

(19) the interaction comprises a preventative treatment; and

(20) the interaction comprises a therapeutic treatment.

6. The device of claim 2 wherein the device comprises at least two of the elements.

7. The device of claim 2 wherein the device comprises at least two of the elements.

8. The device of claim 2 wherein the smooth body is configured to roll relative to the handle when contacted to the skin of a patient.

9. The device of claim 8 wherein the interaction occurs via operator control.

10. The device of claim 8 wherein the interaction occurs automatically as rolling occurs.

11. The device of claim 8 wherein the interaction is prompted by signals from the device that can be detected by an operator.

12. The device of claim 2 wherein the smooth body is configured to slide along the skin of the patient.

13. The device of claim 12 wherein the interaction occurs via operator control.

14. The device of claim 12 wherein the interaction occurs automatically as rolling occurs.

15. The device of claim 12 wherein the interaction is prompted by signals from the device that can be detected by an operator.

3. A method for supplying therapeutic or preventative treatment to a body of a patient, comprising:

(A) applying the surface of a device to the skin of a patient in a desired working area;

(B) extending a plurality of microneedles from the surface of the device through the skin to a desired interaction area;

(C) providing a therapeutic treatment, a preventative treatment to the patent via an interaction wherein the interaction is selected from the group comprising;

(1) delivering antibiotics;

(2) delivering of antipruritic agent;

(3) delivering of anti-inflammatory agent;

(4) delivering of an analgesic;

(5) treating an abscess;

(6) removal of a lesion;

(7) providing a treatment to relieve edema;

(8) delivering depilatory agents to the roots of unwanted hairs;

(9) removing tattoos via dye delivery;

(10) delivering hair re-growth agents;

(11) providing a treatment for hyperhydrosis;

(12) delivery of insulin;

(13) delivery of a vaccine;

(14) delivery of a growth hormone;

(15) delivery of an anti-osteoporosis drug;

(16) delivery a chemotherapy agent;

(17) delivery of a thrombolytic agent;

(18) delivery of a blood pressure regulation drug;

(19) delivery of an addiction therapy drug;

(20) delivery of nanoparticles;

(21) delivery of nanoparticles for use in a cancer treatment;

(22) performing allergy testing;

(23) delivery of radioactive drugs;

(24) delivery of a drug with a narrow therapeutic range; and

(12) providing an in vivo sensing of a body fluid for detection of the presence of a substance of interest.

16. The method of claim 3 wherein the device comprises an element taken from the group of elements consisting of:

(1) at least a portion of some of the needles are formed from a multi-layer, multi-material fabrication process where each of the multiple layers is formed from the deposition of at least one structural material and at least one sacrificial material, a trimming (e.g. planarization) of the at least one structural material and the at least one sacrificial material sets a boundary level for the layer, and wherein after formation of a plurality of layers the sacrificial material is removed from the plurality of layers;

(2) the needles include penetration stops that are located proximally from more distal apertures such that the distance between the apertures and the penetration stops defines a desired interaction depth within the tissue;

(3) the outer surface of the smooth body is covered with a membrane that inhibits interaction between the tissue and the needles except in those locations where the needles have been made to extend through the membrane by contact with the delivery area;

(4) the outer surface of the smooth body is covered with a compressible membrane that inhibits interaction between the needles and the tissue except in those locations where the needles have been made to extend through the membrane by compression of the membrane against the delivery area;

(5) the distal ends of the needles are made to extend from an interior position relative to the apertures in the smooth body via a bulge in one or more tracks along which with the needles move as the smooth body rotates with respect to handle wherein the bulge or bulges correspond to a location along the perimeter of the smooth body that are intended to be in contact with a delivery area an interaction;

(6) a drug is held within the smooth body within pores of a flexible porous medium and is forced from selected needles during an interaction by squeezing the porous medium adjacent the selected needles;

(7) selected needles are extended from selected apertures via fluid pressure exerted by a drug on bases of the selected needles wherein the drug is to be dispensed during an interaction;

(8) a non-rotating conformable structure is held within the smooth structure wherein the conformable structure includes a recess which acts as a reservoir for a drug to be dispensed during an interaction and which is configured and located so that the conformable structure is positioned adjacent to only a portion of the needles and in particular that portion of the needles that are located in a desired dispensing position and wherein other portions of the conformable structure act to inhibit other needles from dispensing the drug;

(9) the distal ends of the needles are made to extend from an interior position relative to the apertures in the smooth body such that they extend beyond the outer surface of the smooth body for penetration into the tissue through the delivery area when the smooth body is in contact with the delivery area;

(10) a plurality of normally closed valves which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein the direction of fluid flow is selected from the group consisting of outward flow and an inward flow;

(11) a plurality of normally closed valves which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves are made to open by a plurality of trigger mechanisms being depressed as the smooth body is pressed against the delivery area, wherein the direction of fluid flow is selected from the group consisting of outward flow and an inward flow;

(12) a plurality of normally closed valves which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves comprise valve seats that seal the exit ports of the needles when trigger mechanisms are not sufficiently depressed, wherein the direction of fluid flow is selected from the group consisting of outward flow and an inward flow;

(13) a plurality of normally closed valves which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves comprise valve seats that seal the fluid entry ports of the needles when trigger mechanisms are not sufficiently depressed, wherein the direction of fluid flow is selected from the group consisting of outward flow and an inward flow;

(14) the plurality of needles are held within the cylindrical body and are made to extend from the cylindrical body in a region of the smooth body that is in contact with the delivery area prior to interaction between the needles and the tissue and after interaction are made to retract back into the smooth body;

(15) the interaction comprises directing radiation down one or more the plurality of needles;

(16) the interaction comprises reading an electrical signal from one or more of the needles;

(17) the interaction comprises applying a voltage to one or more of the needles;

(18) the interaction comprises a diagnostic procedure;

(19) the interaction comprises a preventative treatment; and

(20) the interaction comprises a therapeutic treatment.

17. The method of claim 16 wherein the device comprises at least two of the elements.

18. The method of claim 3 wherein the smooth body is configured to roll relative to the handle when contacted to the skin of a patient.

19. The device of claim 18 wherein the interaction occurs via operator control.

20. The device of claim 18 wherein the interaction occurs automatically as rolling occurs.

21. The device of claim 18 wherein the interaction is prompted by signals from the device that can be detected by an operator.

22. The device of claim 3 wherein the smooth body is configured to slide along the skin of the patient.

23. The device of claim 22 wherein the interaction occurs via operator control.

24. The device of claim 22 wherein the interaction occurs automatically as rolling occurs.

25. The device of claim 22 wherein the interaction is prompted by signals from the device that can be detected by an operator.