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  Device and method for delivering or withdrawing a substance through the skinUSPTO Application #: 20070244448Title: Device and method for delivering or withdrawing a substance through the skin Abstract: An apparatus for delivering or withdrawing a fluid through at least one layer of the skin is provided. A device includes a body having a top face, a bottom face, a side edge and at least one channel. The bottom face includes a first surface area and a second surface area adjacent to and recessed at a first distance from the first surface area. The bottom face further includes at least one raised protrusion disposed on the second surface area. The protrusion has a height from the first surface greater than the first distance. At least one dermal-access member is provided in the protrusion and is in fluid communication with the channel to deliver or withdraw the fluid. (end of abstract)
Agent: David W. Highet, Vp And ChiefIPCounsel Becton, Dickinson And Company - Franklin Lakes, NJ, US Inventors: Alexander G. Lastovich, James K. Fentress, Julia Griggs, Ronald J. Pettis, Diane Sutter, Frank E. Martin, M. Ishaq Haider USPTO Applicaton #: 20070244448 - Class: 604264000 (USPTO) Related Patent Categories: Surgery, Means For Introducing Or Removing Material From Body For Therapeutic Purposes (e.g., Medicating, Irrigating, Aspirating, Etc.), Treating Material Introduced Into Or Removed From Body Orifice, Or Inserted Or Removed Subcutaneously Other Than By Diffusing Through Skin, Material Introduced Or Removed Through Conduit, Holder, Or Implantable Reservoir Inserted In Body, Body Inserted Tubular Conduit Structure (e.g., Needles, Cannulas, Nozzles, Trocars, Catheters, Etc.) The Patent Description & Claims data below is from USPTO Patent Application 20070244448. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation of U.S. patent Application Ser. No. 10/951,208 filed on Sep. 27, 2004 which is a continuation of U.S. patent application Ser. No. 10/357,502 filed on Feb. 4, 2003, now U.S. Pat. No. 6,808,506 on Oct. 26, 2004 which claimed priority to the following U.S. Provisional Patent Applications, identified by application No. and filing date: No. 60/353,194, filed Feb. 4, 2002; No. 60/397,038, filed Jul. 22, 2002; No. 60/407,284, filed Sep. 3, 2002; No. 60/420,233, filed Oct. 23, 2002; No. 60/377,649 filed May 6, 2002; and No. 60/389,881, filed Jun. 20, 2002. This application is also related to U.S. application Ser. No. 10/951,217, filed Sep. 27, 2004, which has issued as U.S. Pat. No. 7,083,592 on Aug. 1, 2006. The contents of each of the foregoing documents are incorporated herein by reference in their entirety. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] 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. [0004] 2. Related Art [0005] 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. [0006] 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. [0007] 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. [0008] 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. [0009] 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 [0010] These and other objects are accomplished by a method and device according to the present invention. [0011] 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. [0012] 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 the 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. [0013] 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. [0014] 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. [0015] 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. [0016] 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. [0017] 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 pyramidal, rectangular, octagonal, wedged, triangular, hexagonal, cylindrical, tapered and other geometrical shapes and arrangements. For example, the dermal-access members can be microtubes, lancets and the like. Any suitable delivery mechanism can be provided for delivering the substance to the penetrated skin. [0018] By varying the targeted depth of delivery of substances by the dermal-access members, pharmacokinetic and pharmacodynamic (PK/PD) behavior of the drug or substance can be tailored to the desired clinical application most appropriate for a particular patient's condition. The targeted depth of delivery of substances by the dermal-access members may be controlled manually by the practitioner, with or without the assistance of an indicator mechanism to indicate when the desired depth is reached. Preferably however, the device has structural mechanisms for controlling skin penetration to the desired depth. This is most typically accomplished by means of a widened area or hub associated with the shaft of the dermal-access member that may take the form of a backing structure or platform to which the dermal-access members are attached. The length of dermal-access members may be varied during the fabrication process and can be produced at less than 3 mm in length. The dermal-access members are typically sharp and of a very small gauge, to further reduce pain and other sensation when the dermal-access members are seated in the patient. The invention may include a single-lumen dermal-access member or multiple dermal-access members assembled or fabricated in linear arrays or two- or three-dimensional arrays to increase the rate of delivery or the amount of substance delivered in a given period of time. Dermal-access members may be incorporated into a variety of devices such as holders and housings that may also serve to limit the depth of penetration. The dermal-access members of the invention may also incorporate or be in fluid communication with reservoirs to contain the substance prior to delivery or pumps or other means for delivering the substance into the patient under pressure. Alternatively, the dermal-access members may be linked externally to such additional components. [0019] The device may include a luer type or other connection port for connection to a fluid delivery system such as a syringe, a pump, or a pen. In such an embodiment, the device may use a length of tubing for feeding a low dead volume body through an opening in the body. [0020] Any suitable mechanism for delivering a fluid to the dermal-access members can be used. For example, a luer connection can be secured directly to the device for delivering a fluid from tubing or directly from a syringe secured to the luer connection. Furthermore, the device or portions of the device can be incorporated into an applicator that applies the device to a patient in a consistent manner, for example, at a consistent pressure, velocity and dose. [0021] As an option, a removable shield can protect the device and particularly, the dermal-access members until use. Continue reading... Full patent description for Device and method for delivering or withdrawing a substance through the skin Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Device and method for delivering or withdrawing a substance through the skin patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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