Substance delivery via a rotating microabrading surface

• US 7,166,086 B2
• Filed: 08/27/2003
• Issued: 01/23/2007
• Est. Priority Date: 08/29/2002
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Martin, Frank E., Haider, M. Ishaq, Alarcon, Jason B., Erskine, Timothy J., Mikszta, John A., Lastovich, Alexander G., Dekker, John P. III, O'Connor, Scott A.
• Primary Examiner(s): Lucchesi; Nicholas
• Assistant Examiner(s): Stigell; Theodore J.
• Application Number:
  US10/649,134
• Publication Number:
  US 20040143211A1
• Time in Patent Office: 1,245 Days
• Field of Search: 604 46- 48, 604/174, 604/500, 604289-290, 606185-186, 606167-173, 606176-183, 601/19
• US Class Current: 604/46
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

A method and device for the delivery of a substance into skin via the rotational movement of a microabrader device reduces the effects of operator variability. The method includes applying a substance to an area of a patient'"'"'s skin through the rotational movement of microprotrusions which may be imparted by a spring device present in the microabrader device or the motion of the operator through the handle of the microabrader device. The device may further include system and methods for monitoring pressure of the device against the skin and thereby promote consistency between applications and control of penetration depth. The delivered substance may be placed on the microprotrusions and a reconstituting liquid included in the microabrader device.

Claims

1. A method for delivering substance into skin via an abrasion device comprising the steps of:

providing an abrader having a plurality of microprotrusion arrays, each array having a plurality of frustoconical protrusions, each protrusion having at least one scraping edge, wherein the frustroconical protrusions within each individual array have aligned scraping edges and each array is positioned within the abrader such that the scraping edges of each array are not aligned with the scraping edges of another array;

positioning the abrader device at a delivery site on the skin of a patient;

applying a substance to the skin of a patient at the delivery site; and

,

mechanically rotating the protrusions of the abrader device against the skin with sufficient force to disrupt and substantially penetrate the stratum corneum of the skin, thereby creating intersecting furrows in the skin by the rotation of scraping edges of the abrader.

2. The method according to claim 1, wherein the mechanical rotation of the protrusions forms an abraded area that increases the permeability of the skin to the substance and permits transfer of the substance through the abraded area into the skin.

3. The method according to claim 1, further comprising the step of providing a housing that surrounds the mechanically rotating protrusions, where the housing, which remains stationary during the rotation of the protrusions, keeps the skin of a patient, at the delivery site, taunt.

4. The method according to claim 3, wherein the housing holds the patient'"'"'s skin at the delivery site in place as the protrusions of the abrader device are rotated against the skin to be treated.

5. The method according to claim 1, further comprising the step of monitoring the force with which the protrusions on the abrader device is applied against the skin.

6. The method according to claim 1, wherein the substance is applied on the skin of the patient at the delivery site before the abrader device is positioned at the delivery site.

7. The method according to claim 1, wherein the substance is applied on the skin of the patient at the delivery site simultaneously as the abrader device is positioned at the delivery site.

8. The method according to claim 1, wherein the substance is pre-applied or coated on the protrusions before the abrader device is mechanically rotated.

9. The method according to claim 1, wherein the rotation of the array of microprotrusions forms circular furrows, and some of the furrows intersect other furrows thereby increasing the amount of surface area through which the substance can be absorbed.

10. The method according to claim 1, wherein the mechanical rotation of the protrusions is about an axis substantially perpendicular to the skin.

11. The method according to claim 10, further comprising the step of translating said protrusions along said axis while rotating said protrusions about said axis, thereby disrupting the skin with both a rotating and translating motion.

12. A method for delivering substance into skin via a microabrader device comprising the steps of:

positioning the microabrader device at a delivery site on the skin of a patient, said microabrader device having a support and a plurality of microprotrusion arrays, each array having a plurality of frustoconical microprotrusions coupled to the support where each of said microprotrusions having at least one scraping edge and a length to abrade the stratum corneum wherein the frustroconical protrusions within each individual array have aligned scraping edges and each array is positioned within the abrader such that the scraping edges of each array are not aligned with the scraping edges of another array; and

rotating the microabrader device against the skin at the delivery site with sufficient force so that the plurality of microprotrusions disrupt and penetrate the stratum corneum substantially without piercing the stratum corneum thereby creating intersecting furrows in the skin by the rotation of scraping edges of the abrader and allowing a substance to be delivered into the skin of a patient at the delivery site.

13. The method according to claim 12, wherein the rotating step is accomplished by mechanically rotating the microabrader device.

14. The method according to claim 13, wherein the rotating step abrades a localized area of skin thereby increasing the resultant efficiency of drug or vaccine delivery.

15. The method according to claim 12, wherein the rotation of the protrusions is about an axis substantially perpendicular to the skin.

16. A method for delivering substance into skin via an abrasion device comprising the steps of:

providing an abrader having a plurality of microprotrusion arrays, each array having a plurality of frustroconical protrusions with at least one scraing edge wherein the frustroconical protrusions within each individual array have aligned scraping edges and each array is positioned within the abrader such that the scraping edges of each array are not aligned with the scraping edges of another array;

positioning the abrader device at a delivery site on the skin of a patient;

applying a substance to the skin of a patient at the delivery site; and

,

mechanically rotating the protrusions of the abrader device against the skin with sufficient force to disrupt and substantially penetrate the stratum corneum of the skin, wherein the rotation is about an axis substantially perpendicular to the skin, thereby creating intersecting furrows in the skin by the rotation of scraping edges of the abrader.

17. The method according to claim 16, wherein the mechanical rotation of the protrusions forms an abraded area that increases the permeability of the skin to the substance and permits transfer of the substance through the abraded area into the skin.

18. The method according to claim 16, further comprising the step of providing a housing that surrounds the mechanically rotating protrusions, where the housing, which remains stationary during the rotation of the protrusions, keeps the skin of a patient, at the delivery site, taunt.

19. The method according to claim 18, wherein the housing holds the patient'"'"'s skin at the delivery site in place as the protrusions of the abrader device are rotated against the skin to be treated.

20. The method according to claim 16, further comprising the step of monitoring the force with which the protrusions on the abrader device is applied against the skin.

21. The method according to claim 16, further comprising the step of translating said protrusions along said axis while rotating said protrusions about said axis, thereby disrupting the skin with both a rotating and translating motion.

22. The method according to claim 21, further comprising the step of providing a housing that surrounds the mechanically rotating and translating protrusions, wherein the housing, which remains stationary during the rotation and translation of the protrusions, keeps the skin of a patient, at the delivery site, taunt.

23. The method according to claim 21, further comprising the step of monitoring the force with which the protrusions on the abrader device is applied against the skin.

24. The method according to claim 21, wherein the housing holds the patient'"'"'s skin at the delivery site in place as the protrusions of the abrader device are rotated against the skin to be treated.