Infusion device and method

Abstract

Devices and methods for performing improved percutaneous myocardial revascularization (PMR) procedures. One device includes a preassembled PMR drug delivery catheter and a drug neutralizing vial. The vial assembly allows prepping the PMR catheter by flushing drug through distal needle, and into a vial cavity where the drug is neutralized by a neutralizing agent. One set of devices includes needles having protrusions secured to the distal regions of drug delivery tubes. One needle has outward protruding barbs engaging the inner tube wall while another needle has outward threads which can screw into the tube inner wall. Radiopaque marker bands are also included in the present invention which are asymmetrically distributed on the catheter shaft, allowing a treating physician to determine under fluoroscopy whether the catheter distal region is pointed away or toward the treating physician, as well as determining whether the catheter distal region is rotated toward or away from the treating physician. PMR devices include catheters having dual injection needles, for both injecting a drug into the heart wall and a radiopaque contrast media to mark the already treated sites. One PMR injection device has multiple stops for allowing controlled, variable needle depth penetration with a single distal needle tip.

Description

RELATED CASES [0001] The present application is a continuation of U.S. application Ser. No. 10 / 621,378, which was filed on Jul. 18, 2003, was entitled Infusion Devices and Method and is now U.S. Pat. No. ______. The '378 application is itself a continuation of U.S. Pat. No. 6,616,626, which was filed on Dec. 21, 2000 and shares the same name.FIELD OF THE INVENTION [0002] The present invention is related generally to medical devices. More specifically, the present invention is related to devices and methods associated with delivery of genes or therapeutic substances. BACKGROUND OF THE INVENTION [0003] A number of techniques are available for treating heart disease and diseases of other organs percutaneously. Examples of such techniques include delivery of genes and therapeutic substances, including the delivery of genes and therapeutic substances for percutaneous myocardial revascularization (PMR). This procedure is performed to increase blood perfusion through the myocardium of a pa...

AI Technical Summary

Benefits of technology

The present invention provides improved devices and methods for performing PMR procedures. One device includes a PMR device distal region or hood that can be used to inject a drug or therapeutic substance into the heart wall. The device has a vial for receiving the drug or substance and a needle for preparing the catheter. Another device allows for improved needle attachment to drug delivery tubes. The invention also provides better visualization of the catheter shaft orientation under fluoroscopy and allows for precise, variable depth needle penetration of the heart wall. The invention allows for a single device to be used with multiple, preset, precise penetration depths and can help ensure the safety and effectiveness of PMR procedures.

Problems solved by technology

For example, in some patients, the number of lesions in coronary vessels is so great or the location so remote in the patient vasculature that restoring blood flow to the heart muscle is difficult.

This preparation can be awkward and may leave a container of biologically active material which may require further processing.

In particular, forces may act upon the needle during both the advancement and retraction of the needle within the heart wall, urging the needle undesirably both into and out of the tube.

This may presently be difficult to visualize under fluoroscopy as current marking systems for shafts may make interpretation of the catheter distal region orientation somewhat ambiguous.

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