Surgery – Instruments – Internal pressure applicator
Reexamination Certificate
2000-03-06
2001-07-31
Truong, Kevin (Department: 3731)
Surgery
Instruments
Internal pressure applicator
C600S003000
Reexamination Certificate
active
06267775
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical devices for positioning radioactive treatment sources in body vessels of patients. In particular, the present invention is a radially compressible and self-expandable device for centering radioactive treatment sources in body vessels.
DESCRIPTION OF THE RELATED ART
Medical devices configured for radiation treatments of stenosis (constricted regions) in blood flow-supporting and other vessels of a patient are generally known and disclosed, for example, in European Patent Publication No. 0 633 041 and German Patent Registration No. G 91 02 312.2. In general. the devices shown in these publications include an elongated flexible catheter tube with a radially expandable support structure such as a self-expandable stent or one or two inflatable balloons on its distal end. The devices are percutaneously inserted into the vessel and transluminally directed to the treatment site. After the support structure is located adjacent to the treatment site it is radially expanded to generally center the catheter tube within the vessel. A radioactive source is then inserted into and directed through the catheter tube until it is located at the treatment site. Following the treatment the radioactive source is withdrawn through the catheter. The support structure is then radially compressed or collapsed and the catheter tube withdrawn.
The intensity of radiation applied to the body tissues by sources typically used in these treatments varies nonlinearly with the distance of the source from the tissue (i.e., the intensity~d
2
). To uniformly treat the tissue, it is therefore important for the radioactive source to be radially centered within the vessel at the treatment site. When used to treat linear vessel sections, the known support structures are generally capable of centering the radiation source to achieve a relatively uniform distribution of radiation at the treatment site. However, when these support structures are positioned at treatment sites in curved vessel sections, the catheter tube can be bent to a radius of curvature which is different than the curvature of the vessel section. Portions of the catheter tube, and therefore the radioactive source when positioned in the tube during treatment, will therefore be closer to one side of the vessel than the other. As a result, the dose of radiation applied to the treatment site may not be uniform.
It is evident that there is a continuing need for improved support structures for use in connection with radiation treatments of stenosis. In particular, there is a need for support structures capable of relatively accurately centering the radioactive source at treatment sites in curved vessel portions. The support structure should be capable of being accurately positioned, and relatively easily inserted and withdrawn. A device of this type which enables radiation treatments while allowing significant perfusion (flow) of blood through the vessel would be particularly advantageous.
SUMMARY OF THE INVENTION
The present invention is a medical device including a radioactive source within a support structure for treating a body vessel. The support structure of the device is capable of relatively accurately centering the source within a curved portion of a body vessel during radioactive treatments of stenosis. The support structure can be relatively easily positioned and withdrawn from the vessel, and allows blood perfusion during the treatments.
The support structure is an axially flexible member formed from a plurality of filaments which are helically wound and interwoven in a braided configuration. The support structure includes a plurality of spaced unconstricted regions and a plurality of spaced constricted regions. The unconstricted regions are radially compressible and self-expandable from a positioning diameter when the device is in a positioning state to a vessel-engaging, treatment diameter which is greater than the positioning diameter when the device is in a treatment state. The constricted regions are concentric with the unconstricted regions and have a diameter which is less than the treatment diameter of the unconstricted regions when the device is in the treatment state. The radioactive source is supported within the constricted regions of the support structure when the device is in the treatment state.
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pate
Clerc Claude O.
Stinson Jon S.
Crompton Seager & Tufte LLC
Schneider (USA) Inc.
Truong Kevin
LandOfFree
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