Miniature x-ray catheter with retractable needles or suction...

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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C604S164010, C604S156000, C604S103030, C606S002000

Reexamination Certificate

active

06551278

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to a miniaturized x-ray having a x-ray source catheter that generates x-rays while minimizing risk of exposure to the x-rays. Retractable needles are provided to anchor the x-ray source at a desired site or to deliver therapeutic or diagnostic agents.
BACKGROUND OF THE INVENTION
Traditionally, x-rays have been used in the medical industry to view bone, tissue and teeth. X-rays have also been used to treat cancerous and precancerous conditions by exposing a patient to x-rays using an external x-ray source. Treatment of cancer with x-rays presents many well documented side effects, many of which are due to the broad exposure of the patient to the therapeutic x-rays.
Minimally invasive endoscopic techniques have been developed and are used to treat a variety of conditions. Endoluminal procedures are procedures performed with an endoscope, a tubular device into a lumen of which may be inserted a variety of rigid or flexible tools to treat or diagnose a patient's condition. Endoscopes can be either rigid or flexible, and are chosen according to the desired application.
The desire for improved minimally invasive medical devices and techniques have led to the development of miniaturized x-ray devices that may be used in the treatment or prevention of a variety of medical conditions. International Publication No. WO 98/48899 describes a miniature x-ray unit having an anode and cathode separated by a vacuum gap positioned inside a metal housing. The anode includes abase portion and a projecting portion. The x-ray unit is insulated and connected to a coaxial cable which, in turn, is connected to the power source. An x-ray window surrounds the projecting portion of the anode and the cathode so that the x-rays can exit the unit. The x-ray unit is sized for intra-vascular insertion, and may be used, inter alia, in vascular brachytherapy of coronary arteries, particularly after balloon angioplasty.
International Publication No. WO 97/07740 describes an x-ray catheter having a catheter shaft with an x-ray unit attached to the distal end of the catheter shaft. The x-ray unit comprises an anode and a cathode coupled to an insulator to define a vacuum chamber. The x-ray unit is coupled to a voltage source via a coaxial cable. The x-ray unit can have a diameter of less than 4 mm and a length of less than about 15 mm, and can be used in conjunction with coronary angioplasty to prevent restenosis.
U.S. Pat. No. 5,795,339 describes a catheter-advancement actuated needle retraction system is disclosed herein. The invention includes a generally hollow barrel that houses a needle hub, which can include a flashback chamber. A needle is affixed to the distal end of the needle hub and is aligned to extend through an opening in the distal end of the barrel. The needle extends through a catheter hub and catheter affixed to the catheter hub. A spring is disposed in the barrel lumen to cooperate with the needle hub to urge the needle hub toward the proximal end of the barrel. A latch actuator is releasably engaged with the catheter hub. A latch, which cooperates with the latch actuator, is movable between one position, which maintains the needle hub adjacent to the distal end of the barrel, and a second position allowing the spring to urge the needle hub to the proximal end of the barrel. A mechanism may be provided to cushion the needle hub as it contacts the proximal end of the barrel by the force of the spring.
U.S. Pat. No. 5,865,806 describes a one step catheter advancement automatic needle retraction system. It comprises a generally hollow barrel, a needle hub which can include a flashback chamber disposed in the barrel, a secondary flashback chamber disposed in the barrel, a biasing mechanism for retracting the needle into the barrel and a clip associated with the secondary flashback chamber for engaging a catheter hub. The needle hub in conjunction with the secondary flashback chamber retains the needle in the extended position against the force of the biasing mechanism until the catheter has been advanced a certain distance from the distal end of the barrel.
U. S. Pat. No. 5,718,688 describes a catheter placement unit comprising a catheter having an axial bore, a catheter hub at one end of the catheter, an introducing needle having a pointed tip for introducing the catheter into a desired position in a patient's body, and a needle hub on the needle remote from the tip for mounting the needle so that it extends through the catheter bore for introduction of the catheter into the patient's body and so that it can subsequently be withdrawn from the catheter bore leaving the catheter in position in the patient's body. The unit includes a needle tip protector on the needle for shielding the needle tip when the needle has been withdrawn from the catheter bore. The needle tip protector includes a locking device which is initially in an unlocked position permitting withdrawal of the needle from the catheter bore but which is arranged to be placed in a locked position, in which the locking device engages the outer surface of the needle, by withdrawal of the needle from the catheter bore so as to lock the needle tip protector on the needle in the shielding position. The locking device retains the catheter hub on the needle when the locking device is in the unlocked position and releases the catheter hub from the needle when the locking device is in the locked position. Separation of the catheter from the needle is therefore prevented until the needle has been drawn from the catheter bore to trigger shielding of the needle tip.
U.S. Pat. No. 5,704,914 describes a catheter assembly is which includes a flexible catheter, a hub attached to the catheter which defines a lumen and an adjoining flash back chamber which communicate with the catheter, and a flexible resilient diaphragm attached to the hub through which a hypodermic needle such as a catheter introducer needle can be passed. The diaphragm prevents a liquid, such as blood, which has been introduced into the hub lumen from flowing past the diaphragm and beyond the hub when the diaphragm is unpenetrated. A hollow tubular body may also be included to which a cannulated catheter needle can be either stationarily or movably attached. The body is removably attached to the hub behind the diaphragm. If movably attached to the body, the needle has a retracted position fully recessed within the body for safe storage and an advanced operative position extending through the diaphragm, hub and catheter. A needle occluding member may also be provided to prevent a liquid such as blood from flowing through the needle into the body. The member may be a movable guide wire or a stationary obturator member. A liquid outlet port can be provided on the side of the hub and a multi-position stop cock can be mounted on the hub to direct liquid flow from the catheter to the side port while blocking flow toward the diaphragm and vise versa.
U.S. Pat. No. 5,782,740 describes a rapid exchange type intravascular catheter suitable for maintaining patency of a body lumen for a period of time sufficient to permit delivery of a radiation source to the body lumen. The catheter utilizes a reinforcing mandrel to improve the pushability and strength of the catheter as it tracks along a guide wire, and permits blood flow through an inflatable member while radiation therapy is being provided.
U.S. Pat. No. 5,816,999 describes the provision of ionizing radiation from an extracorporeal source to the interior of an internal body cavity or lumen and the dispersion of this radiation across a desired area of diseased tissue. It consists of an extracorporeal radiation source, a flexible catheter containing at least one hollow conduit for the transportation of the radiation along a curved path, an entrance portion to the catheter for the capture of the radiation, and an x-ray dispersive closure cap at the distal end of the catheter for the dispersion of the radiation within the body cavity or lumen and onto a specific area of tissue. It c

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