Microneedle drug delivery device

Details Microneedle drug delivery device Microneedle drug delivery device

1999-12-02

2003-08-26

Mendez, Manuel (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Infrared, visible light, ultraviolet, x-ray or electrical...

C604S272000

Reexamination Certificate

active

06611707

ABSTRACT:

BACKGROUND OF THE INVENTION
A common technique for delivering drugs across or into biological tissue is the use of a needle, such as those used with standard syringes or catheters, to transport drugs across (through) the skin. While effective for this purpose, needles generally cause pain; local damage to the skin at the site of insertion; bleeding, which increases the risk of disease transmission; and a wound sufficiently large to be a site of infection. Needle techniques also generally require administration by one trained in its use. The needle technique also is undesirable for long term, controlled continuous drug delivery.
An alternative delivery technique is the transdermal patch, which usually relies on diffusion of the drug across the skin. However, this method is not useful for many drugs, due to the poor permeability (i.e. effective barrier properties) of the skin. The rate of diffusion depends in part on the size and hydrophilicity of the drug molecules and the concentration gradient across the stratum corneum. Few drugs have the necessary physiochemical properties to be effectively delivered through the skin by passive diffusion. Iontophoresis, electroporation, ultrasound, and heat (so-called active systems) have been used in an attempt to improve the rate of delivery. While providing varying degrees of enhancement, these techniques are not suitable for all types of drugs, failing to provide the desired level of delivery. In some cases, they are also painful and inconvenient or impractical for continuous controlled drug delivery over a period of hours or days.
Attempts have been made to design alternative devices for active transfer of drugs, but there remains a need for better drug delivery devices, which make smaller incisions, deliver drug with greater efficiency (greater drug delivery per quantity applied) and less variability of drug administration, and/or are easier to use.
It is therefore an object of the present invention to provide a microneedle device for relatively painless, controlled, safe, convenient transdermal delivery of a variety of drugs.
SUMMARY OF THE INVENTION
Simple microneedle devices are provided for delivery of drugs across or into biological tissue, particularly the skin. The microneedle devices permit drug delivery at clinically relevant rates across or into skin or other tissue barriers, with minimal or no damage, pain, or irritation to the tissue.
The devices include a plurality of hollow microneedles, which are attached to or integrated into a substrate, and at least one reservoir selectably in communication with the microneedles, wherein the volume or amount of drug to be delivered can be selectively altered. The reservoir contains the drug to be delivered. In one embodiment, the reservoir is formed of a deformable, preferably elastic, material.
The device also can include means for compressing the reservoir to drive the drug from the reservoir through the microneedles. The means can include a plunger or osmotic pump. In one embodiment, the reservoir is a syringe or pump connected to the substrate.
The device also can include a sealing mechanism to contain the drug in one or more of the reservoirs until it is ready to be delivered or mixed with a liquid carrier. In one embodiment, the sealing mechanism is a fracturable barrier interposed between the reservoir and the substrate.
In one embodiment, the device includes a means for providing feedback to the user to indicate that delivery has been initiated and/or completed. An example of the feedback means is a color change.
In another embodiment, the microneedle device further includes a rate control means, such as a semi-permeable membrane, to regulate the rate or extent of drug which flows through the microneedles.
The microneedle devices preferably are provided with means for preventing undesired reuse of or contact with the microneedles. These means can include protective packaging, such as a peelable liner that temporarily covers the tips of the microneedles. The packaging also can be used to shear off the microneedles following their intended use, thereby preventing their reuse.


REFERENCES:
patent: 2893392 (1959-07-01), Wagner et al.
patent: 3034507 (1962-05-01), McConnell et al.
patent: 3086530 (1963-04-01), Groom
patent: 3123212 (1964-03-01), Taylor et al.
patent: 3136314 (1964-06-01), Kravitz
patent: RE25637 (1964-09-01), Kravitz et al.
patent: 3221739 (1965-12-01), Rosenthal
patent: 3221740 (1965-12-01), Rosenthal
patent: 3556080 (1971-01-01), Hein
patent: 3596660 (1971-08-01), Melone
patent: 3675766 (1972-07-01), Rosenthal
patent: 3918449 (1975-11-01), Pistor
patent: 3964482 (1976-06-01), Gerstel et al.
patent: 4109655 (1978-08-01), Chacornac
patent: 4159659 (1979-07-01), Nightingale
patent: 4222392 (1980-09-01), Brennan
patent: 4320758 (1982-03-01), Eckenhoff et al.
patent: 4664651 (1987-05-01), Weinshenker et al.
patent: 4671288 (1987-06-01), Gough
patent: 4703761 (1987-11-01), Rathbone et al.
patent: 4771660 (1988-09-01), Yacowitz
patent: 4798582 (1989-01-01), Sarath et al.
patent: 4921475 (1990-05-01), Sibalis
patent: 4969468 (1990-11-01), Byers et al.
patent: 5035711 (1991-07-01), Aoki et al.
patent: 5279552 (1994-01-01), Magnet
patent: 5335670 (1994-08-01), Fishman
patent: 5364374 (1994-11-01), Morrison et al.
patent: 5383512 (1995-01-01), Jarvis
patent: 5401242 (1995-03-01), Yacowitz
patent: 5457041 (1995-10-01), Ginaven et al.
patent: 5527288 (1996-06-01), Gross et al.
patent: 5582184 (1996-12-01), Erickson et al.
patent: 5591139 (1997-01-01), Lin et al.
patent: 5611806 (1997-03-01), Jang
patent: 5611809 (1997-03-01), Marshall et al.
patent: 5611942 (1997-03-01), Mitsui et al.
patent: 5618295 (1997-04-01), Min
patent: 5658515 (1997-08-01), Lee et al.
patent: 5697901 (1997-12-01), Eriksson
patent: 5801057 (1998-09-01), Smart et al.
patent: 5807375 (1998-09-01), Gross et al.
patent: 5843114 (1998-12-01), Jang
patent: 5848991 (1998-12-01), Gross et al.
patent: 5865786 (1999-02-01), Sibalis et al.
patent: 5879326 (1999-03-01), Godshall et al.
patent: 6080116 (2000-06-01), Erickson et al.
patent: 6132755 (2000-10-01), Eicher et al.
patent: 195 25 607 (1997-01-01), None
patent: 0497620 (1992-08-01), None
patent: 0 652 600 (1995-05-01), None
patent: 7132119 (1995-05-01), None
patent: 7-132119 (1995-05-01), None
patent: 7-196314 (1995-08-01), None
patent: WO 93/17754 (1993-09-01), None
patent: WO 96/37256 (1996-11-01), None
patent: WO 96/40365 (1996-12-01), None
patent: WO 96/41236 (1996-12-01), None
patent: WO 97/07734 (1997-03-01), None
patent: WO 98/00193 (1998-01-01), None
patent: 98/00194 (1998-01-01), None
patent: WO 98/28037 (1998-07-01), None
U.S. patent application Ser. No. 09/095,221, Prausnitz et al., filed Jun. 10, 1998.
U.S. patent application Ser. No. 09/316,229, Allen et al., filed May 21, 1999.
“Single-crystal whiskers,”Biophotonics Int'lp. 64 (Nov./Dec. 1996).
“101 Uses for Tiny Tubules,”Science247 (1990).
Amsden & Goosen, “Transdermal Delivery of Peptide and Protein Drugs: an Overview,”AlChE Journal41(8):1972-97 (1995).
Bronaugh & Maibach,Percutaneous Absorption, Mechanisms—Methodology—Drug Delivery, (Marcel Dekker:New York, 1989).
Brumlik & Martin, “Template Synthesis of Metal Microtubules,”J. Am. Chem. Soc. 113:3174-75 (1991).
Despont, et al., “High-Aspect-Ratio, Ultrathick, Negative-Tone Near-UV Photoresist for MEMS,”Proc. of IEEE 10thAnnual International Workshop on MEMS, Nagoya, Japan, pp. 518-522 (Jan. 26-30, 1997).
Edell, et al., “Factors Influencing the Biocompatibility of Insertable Silicon Microshafts in Cerebral Cortex,”IEEE Transactions on Biomedical Engineering39(6):635-43 (1992).
Frazier, et al., “Two dimensional metallic microelectrode arrays for extracellular stimulation and recording of neurons”,IEEE Proceedings of the Micro Electro Mechanical Systems Conference, pp. 195-200 (1993).
Frazier, et al., “Metallic Microstructures Fabricated Using Photosensitive Polymide Electroplanting Molds,”Journal of Microelectromechanical Systems2:87-97 (1993).
Hadgraft & Guy, eds.,Transdermal Drug Delivery: Developmental Issues and Research Initiativ

Affiliated with

Also associated with

Rating

Microneedle drug delivery device does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Microneedle drug delivery device, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Microneedle drug delivery device will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-3130199