Surgery – Means for introducing or removing material from body for... – Treating material introduced into body by contact with wound...
Reexamination Certificate
2003-02-04
2004-10-26
Kennedy, Sharon (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into body by contact with wound...
Reexamination Certificate
active
06808506
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a device and a method for delivering or withdrawing a substance through the skin of an animal, including humans, and in particular to a method and device for withdrawing or delivering a substance such as a drug, protein or vaccine to a subject. The invention also relates to a device for enhancing the penetration of one or more dermal-access members.
2. Related Art
The skin is made up of several layers with the upper composite layer being the epithelial layer. The outermost layer of the skin is the stratum corneum that has well known barrier properties to prevent molecules and various substances from entering the body and analytes from exiting the body. The stratum corneum is a complex structure of compacted keratinized cell remnants having a thickness of about 10-30 microns. The stratum corneum forms a waterproof membrane to protect the body from invasion by various substances and the outward migration of various compounds.
The natural impermeability of the stratum corneum prevents the administration of most pharmaceutical agents and other substances through the skin. Numerous methods and devices have been proposed to enhance the permeability of the skin and to increase the diffusion of various substances through the skin in order to be utilized by the body. According to some methods and devices, the delivery of substances through the skin is enhanced by either increasing the permeability of the skin or increasing the force or energy used to direct the substance through the skin.
Other methods of sampling and delivering various substances through the skin include forming micropores or cuts through the stratum corneum. Numerous substances can be effectively administered by piercing the stratum corneum and delivering a substance in or below the stratum corneum. In a similar manner, some substances can be extracted from the body through cuts or pores formed in the stratum corneum. The devices for piercing the stratum corneum generally include a plurality of microneedles or blades having a length to pierce the stratum corneum. Examples of these devices are disclosed in U.S. Pat. No. 5,879,326 to Godshall et al.; U.S. Pat. No. 6,494,865 to Alchas; U.S. Pat. No. 5,997,501 to Gross et al.; U.S. Pat. No. 4,886,499 to Cirelli et al.; U.S. Pat. No. 6,183,434 to Eppstein; U.S. Pat. No. 5,250,023 to Lee et al.; International publication WO 97/48440; U.S. Pat. No. 5,527,288 to Gross et al.; and U.S. Pat. No. 3,595,231 to Pistor. Each of the,foregoing documents is incorporated herein by reference in their entirety.
Some of the above-noted devices include micron-sized needles or blades and can be effective in delivering or sampling substances. However, many of these needles and blades have a length of a few microns to a few hundred microns and typically do not penetrate the skin to a uniform depth. The natural elasticity and resilience of the skin often result in the skin being deformed by the needles rather than pierced. Therefore, when a microneedle array is pressed against the skin, the outermost needles penetrate the skin while the innermost needles do not penetrate the skin or only penetrate to a depth less than the outermost needles.
Moreover, conventional devices have problems with overall height and ease of use. As a result, the prior methods and devices for the sampling and administering of substances have exhibited limited success. Accordingly, a continuing need exists in the industry for an improved device for the sampling and administering of various substances to the body.
SUMMARY OF THE INVENTION
These and other objects are accomplished by a method and device according to the present invention.
A device for delivering or withdrawing a substance, typically a fluid, below the stratum corneum is provided. A body of the device includes a top face, a bottom face spaced from the top face, and a side edge. Typically, a channel is defined within the body. The bottom face includes a first surface area and a second surface area adjacent to and recessed from the first surface area. The bottom face further includes at least one raised protrusion disposed on the second surface area. At least one dermal-access member is provided in each raised protrusion and is in fluid communication with the channel to deliver or withdraw the substance.
Similarly, a method of delivering or withdrawing a substance through at least one layer of the skin of a subject is provided. The method includes the steps of: providing a device having a body having a top face, a bottom face spaced from the top face, and a side edge, the body defining a channel within the body, and at least one dermal-access member coupled to and extending outwardly from said bottom face and being in fluid communication with the channel, wherein the bottom face includes a first surface area and a second surface area adjacent to and recessed from the first surface area, the bottom face further including at least one raised protrusion disposed on the second surface area, at least one dermal-access member installed in at least one raised protrusion; positioning the dermal-access member on a target site of the skin of the subject; applying a pressure against the device sufficient for at least one dermal-access member to penetrate the skin and for the first surface area to contact the skin; and delivering a substance to or withdrawing a substance from the target side of the subject.
In particular, a method and apparatus for delivering a substance, such as a drug, protein or vaccine, into or below the stratum corneum of the skin to a sufficient depth where the substance can be absorbed and utilized by the body is provided.
The device and method according to an embodiment of the present invention are suitable for use in administering various substances, including pharmaceutical and bioactive agents, to a subject, preferably a mammal, and particularly to a human patient. Such substances have biological activity and can be delivered through the body membranes and surfaces, and particularly the skin. Examples include, but are not limited to antibiotics, antiviral agents, analgesics, anesthetics, anorexics, antiarthritics, antidepressants, antihistamines, anti-inflammatory agents, antineoplastic agents, vaccines, including DNA vaccines, and the like. Additional substances that can be delivered to a subject include proteins, peptides and fragments thereof. The proteins and peptides can be naturally occurring, synthesized or produced by recombination.
The device and method may also be used for withdrawing a substance or monitoring the level of a substance in the body. Examples of substances that can be monitored or withdrawn include blood, interstitial fluid or plasma. The withdrawn substances may then be analyzed for various components or properties.
The dermal-access member according to the invention is any member which penetrates the skin of a subject to the desired targeted depth within a predetermined space without passing through it. In most cases, the device will penetrate the skin to a depth of about 0.3-3 mm. Generally, the device is utilized for intradermal administration, for example, with a configuration sufficient to penetrate at a depth of about 1.0-1.7 mm. However, the device can also be used to deliver a substance to a depth of about 0.3 mm or less and at subcutaneous depths of 1.7 mm-3.0 mm depths or greater.
The dermal-access members may comprise conventional injection needles, catheters or microneedles of all known types, employed singularly or in multiple member arrays. The terms “dermal-access member” and “dermal-access members” as used herein are intended to encompass all such needle-like structures. The dermal-access members can include structures smaller than about 28 gauge, typically about 29-50 gauge when such structures are cylindrical in nature. Generally, the dermal access members will be about 30-36 gauge. Non-cylindrical structures encompassed by the term dermal-access member would therefore be of comparable diameter and include pyramid
Fentress James K.
Griggs Julia
Haider M. Ishaq
Lastovich Alexander G.
Martin Frank E.
Anderson, Esq. Chad C.
Becton Dickinson and Company
Becton, Dickinson and Company
Kennedy Sharon
LandOfFree
Device and method for delivering or withdrawing a substance... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Device and method for delivering or withdrawing a substance..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Device and method for delivering or withdrawing a substance... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3285398