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Local concentration management systemRelated Patent Categories: Surgery, Controlled Release Therapeutic Device Or SystemLocal concentration management system description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070167932, Local concentration management system. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] This invention relates generally to drug delivery devices and methods of use relating to same, and more particularly relates to a device suitable for delivery of highly concentrated agent formulations. BACKGROUND OF THE INVENTION [0002] Precise and accurate delivery of drugs or therapeutic agents to a specific treatment site within a subject represents a substantial challenge in the design of drug delivery systems. Site-specific drug delivery can be particularly challenging when the drug is to be delivered to the subject long-term, e.g., over several hours to several days, weeks or months. [0003] One approach to long-term site-specific drug delivery involves the use of implantable delivery systems, e.g., biodegradable or osmotically-driven drug delivery devices (see e.g., U.S. Pat. Nos. 5,607,696, 5,609,885, and 5,783,213. While these implantable systems avoid the need for repeated injections often associated with long-term drug therapy administration, they have a number of limitations. First, the treatment sites which they can access are limited. Second, sites to which drug delivery is required can be fragile, sensitive or inaccessible and thus often not amenable to insertion of an implant. Third, the size of the delivery device can be impractical for long-term treatment regimes as the reservoir of the device that holds the drug either needs to be large enough to hold sufficient quantities of drug for the course of treatment or, alternatively, allow re-filling with drug during the course of the treatment. The latter is especially troubling as manipulating, re-filling and re-positioning these implantable devices can have serious consequences, e.g., increased risk of infection, patient discomfort, and increased costs. [0004] Difficulty in delivery of drugs or agents to inaccessible locations of the body has been addressed in part by the use of catheters attached to drug delivery devices. For example, the distal end of such a catheter can be positioned at the desired site of delivery in the body, with the catheter acting as a conduit for the drug or desired agent from the drug delivery device. This configuration allows access to previously inaccessible sites, but these devices face many of the same issues as the traditional drug delivery devices, such as catheter size and toxicity at the delivery site. [0005] An alternative approach is to provide formulations having high concentrations of drug, such that delivery of small amounts of formulation are sufficient to provide for a desired therapeutic effect. The total amount of formulation required for long-term therapy is thus substantially decreased, thus minimizing the size requirements for the reservoir of the device used to accomplish delivery. While this approach has met with some success, there are still serious limitations for certain therapeutics and for chronic delivery. For example, formulations with high concentrations of drug can be toxic to cells at the delivery site, or can result in irritation, inflammation, and tissue damage at the delivery site. Often formulating drugs at such high concentrations requires the use of very high or very low pH solutions, which alone can cause adverse side effects, particularly at the delivery site. [0006] There is thus a need in the field for drug delivery devices which allow the use of a smaller drug reservoir and highly concentrated drug formulations, and that provide for safe delivery to a treatment site for long-term therapy. SUMMARY OF THE INVENTION [0007] The present invention provides a local concentration management system for delivering a highly concentrated therapeutic agent formulation. The system comprises a device comprising an elongate body defining a lumen between its proximal and distal end, and further comprising a diffuser element, a dilutor element, or both. The diffuser element, which is selectively permeable to the agent, is operatively associated with the elongate body so that agent flows through the elongate body, and into and through the diffuser element to exit the system. The dilutor element can be operatively associated with the system so as to be in fluid communication with the elongate body lumen, a diffusion space defined by a diffuser element inner wall, or both. The dilutor element is selectively water permeable, but substantially impermeable to agent, thus providing for dilution of the agent during transit through the system. [0008] In various embodiment, the diffuser element can be associated with the elongate body in a variety of configurations, including attachment along the elongate body, attachment at the distal end of the elongate body (e.g., in the form of a "cup" or "hat"), and/or attachment to a separate structure that keeps the elongate body and diffuser element in a defined association (e.g., attachment to a drug delivery device). The elongate body can be provided within the body of a drug delivery device (e.g., the elongate body serves as the drug delivery device exit outlet or orifice) or is an extension of a drug delivery device orifice as a permanently or removably attached element. [0009] In further embodiments, the dilutor element is associated with the elongate body, the diffuser element, or both in a variety of configurations. For example, the dilutor element can be provided as a portion of the elongate body wall so that an inner wall of the dilutor element is in fluid communication with the elongate body inner lumen, thus providing for ingress of water into the inner lumen and dilution of formulation as is passes through the elongate body. In another embodiment, the dilutor element is positioned within the diffuser element, to provide for ingress of water during the course of diffusion of formulation out of the device. In another embodiment, the dilutor element and the diffuser element are provided as a single element, such that the same element provides for both ingress of water from the environment of use and diffusion of agent out of the device. [0010] In one aspect, the device is provided in connection with a drug delivery device to comprise a drug delivery system whereby the drug delivery device and the device are in fluid communication. Such a drug delivery system thus comprises; a drug delivery device; and a device comprising a catheter comprising an elongate body with an inner lumen and a diffuser element, with the elongate body and the diffuser element associated so that a formulation flows through the elongate body and out through the diffuser element. Alternatively, the device comprises a catheter operatively associated with a dilutor element positioned so as to provide for fluid communication between the elongate body inner lumen and an inner wall of the dilutor element such that formulation that flows through the elongate body inner lumen is diluted by water that enters the lumen via the dilutor element prior to exit from the device In another embodiment, the device comprises a catheter operatively associated with both a diffuser element and a dilutor element, which elements may be provided as separate elements or combined as a single element. [0011] The drug delivery device may be completely or partially implantable, or may be retained at a site external to the body with at least a distal portion of the catheter implanted to direct the agent to the desired delivery site within the body. An exemplary drug delivery device for use in the system is configured to have at least one compartment for storing the formulation, e.g., a reservoir. [0012] In another aspect, the present invention provides a method for delivery of a drug or therapeutic agent to a treatment site in a subject by implanting at least the distal end of a device of the invention at a desired delivery site and introducing an agent into the elongate body inner lumen to provide for delivery to a delivery site. By providing for diffusion of the agent over a greater surface area at the delivery site, and optionally dilution via the dilutor element during flow of formulation prior to delivery, the device helps to reduce side effects that may be caused by delivery of a concentrated agent to a site. [0013] In other aspects, the invention provides a method for diluting the concentration of an agent exiting a device by implanting at least a distal portion of a local concentration management device at a delivery site in a subject, and introducing a formulation comprising an agent at a first concentration into the inlet of the elongate body. The introduced agent flows through the elongate body passageway, out the local concentration management device and to the delivery site in the subject, such that the agent in the formulation at the delivery site is diluted to a second concentration that is less than the first agent concentration. In related embodiments, the local concentration management device comprises a dilutor element, and the agent formulation is diluted during transit through the device. (e.g., the agent in the formulation is diluted from a first, higher concentration to a second, lower concentration prior to exit at the delivery site). [0014] In another aspect, the invention features a method for dispersing a drug delivery stream by implanting at least a distal portion of a local concentration management device at a delivery site in a subject, and introducing a formulation comprising an agent at a first concentration into the inlet of the elongate body. The introduced agent flows through the elongate body passageway, out the local concentration management device and to the delivery site in the subject in a pattern that is disperse relative to a delivery pathway through the device. The dispersed agent formulation is thus diluted to second, lower concentration within fluids at the delivery site. [0015] A primary object of the invention is to provide a device that can control the local concentration of agent at a desired delivery site. [0016] Another object of the invention is to provide a device that can be used to deliver formulations comprising high concentrations of a drug or other agent with minimal detriment to the surrounding tissue. [0017] It is another object of the invention to provide a mechanism by which the delivery of drug will be over a greater surface area compared to conventional devices. [0018] Another object of the invention is to provide a drug delivery system that can be readily handled, implanted and adapted for use in accurate, consistent and reliable delivery of drug at a particularly low volume rate, e.g., microliter or submicroliter quantities of a formulation per day. [0019] It is yet another object of the invention to provide a drug delivery system compatible for use with a highly concentrated drug formulation so that a smaller volume of drug is required to provide a therapeutic effect, thereby reducing the volume of formulation that must be stored in the drug delivery device. This permits reduction in size of the entire drug delivery device, thus increasing comfort and mobility for the patient. [0020] It is another object of the invention to provide a device that is suitable for delivery of drug to a distal delivery site within a subject, particularly sites that are highly sensitive or fragile, e.g., the spinal cord. [0021] Another object of the invention is to provide a device that can be used with a variety of drug delivery devices. Continue reading about Local concentration management system... Full patent description for Local concentration management system Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Local concentration management system 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. Start now! - Receive info on patent apps like Local concentration management system or other areas of interest. ### Previous Patent Application: Catheter connector assemblies and methods for attaching a catheter and luer assembly Next Patent Application: Method of treating tissue with radio frequency vascular electrode array Industry Class: Surgery ### FreshPatents.com Support Thank you for viewing the Local concentration management system patent info. 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