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Needle Guide Templates for Implantable Drug Pumps

IP.com Disclosure Number: IPCOM000229489D
Publication Date: 2013-Jul-31
Document File: 4 page(s) / 293K

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7044932: PATENT

Abstract

Implanted drug infusion pumps used for administering drugs into the cerebrospinal fluid associated with the brain and spinal cord tend to be referred to as intrathecal drug pumps or, more generally, therapeutic delivery devices or systems. These intrathecal pumps can be used to treat a number of indications including, for example, long-term, chronic pain and spasticity, among other things. Such pumps are surgically implanted within a patient’s body (i.e., subcutaneously), and tend to be configured to dispense a therapeutic drug over an extended time period by releasing pre-determined, metered amounts of the drug through a catheter into the intrathecal space. Because these pumps can remain within a patient’s body for several (e.g., 5-7) years, they are designed to be refilled while still implanted within the patient's body. In order to refill an implanted intrathecal pump, a needle or syringe guide template, also known as a needle guide form or index, and, more generally, a needle guide, lead, or director, is often used to locate a septum of the pump for refilling the pump. See, for example, Implantable Drug Pump Access Template, U.S. Patent No. 7,044,932. The present disclosure relates to needle guide templates, and describes several needle guide templates suitable for use with currently available intrathecal drug pumps.

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Needle Guide Templates for Implantable Drug Pumps

Implanted drug infusion pumps used for administering drugs into the cerebrospinal fluid associated with the brain and spinal cord tend to be referred to as intrathecal drug pumps or, more generally, therapeutic delivery devices or systems.  These intrathecal pumps can be used to treat a number of indications including, for example, long-term, chronic pain and spasticity, among other things.  Such pumps are surgically implanted within a patient’s body (i.e., subcutaneously), and tend to be configured to dispense a therapeutic drug over an extended time period by releasing pre-determined, metered amounts of the drug through a catheter into the intrathecal space.

Because these pumps can remain within a patient’s body for several (e.g., 5-7) years, they are designed to be refilled while still implanted within the patient's body. In order to refill an implanted intrathecal pump, a needle or syringe guide template, also known as a needle guide form or index, and, more generally, a needle guide, lead, or director, is often used to locate a septum of the pump.  See, for example, Implantable Drug Pump Access Template, U.S. Patent No. 7,044,932.

In general, these templates aid or facilitate emptying and refilling a generally corresponding intrathecal pump without requiring removal of the pump from a patient’s body by locating or identifying the point or location of the body where the syringe or needle needs to be inserted. The pump can be located by palpation with gloved fingers and, thereafter, the template can be aligned over the implanted pump such that a hole or aperture in the template is aligned with the pump septum.   Septa of some pumps protrude or raise a portion of the patient’s skin, or include some other palpable identifier to assist a technician in locating same and thus facilitate piercing the pump septum (e.g., by way of inserting a needle of a syringe therethrough).  The most popular implanted drug pump, the Medtronic® SynchroMed® II (shown in Figure 2), has a septum that is difficult to feel by palpation, so care providers tend to palpate to find the outside diameter of the pump.  In other embodiments, the pump may include one or more palpable identifiers (other than the septum itself) that function as reference points to enable a technician to ascertain the location of a desired needle insertion point (e.g., a septum into a drug reservoir of the pump).  Once the template is aligned with the pump, a syringe needle (e.g., a non-coring Huber style needle), a hypodermic needle, a catheter, or the like may be passed through the template aperture, through the skin of a patient, and into the pump septum. A desired amount of drug (typically in fluid form) is percutaneously injected into the pump, or alternatively, removed or pulled from the pump.  Examples of medical fluids that can be loaded into and administered by such pumps include, but are not limited to, intrathecal mo...