Surgery – Radioactive substance applied to body for therapy – Radioactive substance placed within body
Reexamination Certificate
2001-12-13
2004-04-20
Winakur, Eric F. (Department: 3736)
Surgery
Radioactive substance applied to body for therapy
Radioactive substance placed within body
C414S146000
Reexamination Certificate
active
06723037
ABSTRACT:
This application claims a priority based on Japanese Patent Application No.2000-381529 filed on Dec. 15, 2000 and No. 2001-221182 filed on Jul. 23, 2001, the entire contents of which are incorporated herein by reference for all purposes.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to improvements in therapeutic material delivery device (vehicle) for delivering (implanting) a therapeutic material such as a coiled or capsulated radioactive source to an organism for radiotherapy, for example, of a patient suffering prostate cancer.
2. Description of the Related Art
Radiotherapy (brachytherapy) refers to a treatment made by allowing a radioactive beam to radiate to a morbid tissue suffering a prostate cancer, an esophagus cancer, or the like. Radiotherapy includes high-dose, external beam radiation treatment and low-dose close-distance radiation treatment.
It is present practice to employ the latter method as a method for improving a therapeutical effect depending upon a therapeutic site and reducing side effects. In this case, there is practiced a method in which a radioactive source having radioactivity in the form of a sealed radioactive source is implanted (caused to remain) in a diseased part or a part near a morbid part with a delivery needle for the radioactive source, to treat the diseased part. The present invention is applied to the above method using the sealed radioactive source. The radioactive source for use in the present invention is selected from those containing radioactive isotopes that are clinically utilizable, and examples thereof include isotopes of cobalt, phosphorus, strontium, cesium, palladium, yttrium, iridium, rhenium, etc. Particularly preferred are isotopes that radiate &bgr; rays.
The above delivery needle is constituted of an inner needle member having a tubular needle and an outer needle member having a sticking needle formed to have a sharpened forward end, and a plurality of the capsular radioactive sources having radioactivity and having a size of approximately 5 mm are charged into the above outer needle member with tweezers. The above radioactive sources are spaced with spacers formed of a biodegradable substance, and a wax is applied to the forward end of the above sticking needle, so that the above radioactive sources do not come off the sticking needle.
When capsular radioactive sources are implanted in a diseased part with a delivery needle having the above sticking needle, approximately five radioactive sources are charged into one sticking needle as described above and are linearly implanted in the diseased part. In this manner, approximately 25 sticking needles above (corresponding to 125 radioactive sources) are embedded in different implantation positions. In the implantation, the implantation positions are secured while monitoring the positions with an ultrasonic diagnosis apparatus, so that the diseased part is uniformly irradiated with the radioactive sources.
Coiled radioactive sources formed by coiling rod-like or wire-like radioactive sources are recently used in place of capsular radioactive sources. That is because the coiled radioactive sources have a large surface area each and the length of the radioactive sources per piece can be increased as compared with the capsular radioactive sources, so that the number of the radioactive sources required can be decreased. The coiled radioactive sources are therefore less frequently charged into the outer needle member as compared with the capsular radioactive sources. Further, there is the merit of being free from spots that are not irradiated with a radioactive ray (cold spots), since it is not required to insert the spacers.
However, when a conventional inner needle member having a tubular needle and a conventional outer needle member having a sticking needle, which are used for implanting capsular radioactive sources, are used for implanting coiled radioactive sources in a diseased part, the coiled radioactive sources come to be curved, so that the irradiation with a uniform dose of radioactive ray can be no longer possible.
It is therefore required to prepare a medical sticking needle having a three-layered structure formed of an inner needle member through which coiled radioactive sources are to be passed or generally an inner needle member for holding a therapeutic material such as radioactive sources and extruding them forward, a middle needle member for fixing the radioactive sources and an outer needle member that is to be inserted into a diseased part or an intended portion, that is, a therapeutic material delivery device. The present invention relates to improvements in the above delivery device for delivering a therapeutic material such as radioactive sources.
Further, the delivery device may be a therapeutic material delivery device that is formed of an inner needle member for holding a therapeutic material such as radioactive sources and extruding them forward, a cartridge chargeable with the therapeutic material and an outer needle member that is to be inserted into a diseased part or an intended portion. The present invention also relates to improvements in such a delivery device using said cartridge.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a protective tool for a therapeutic material delivery device, which is for preventing wrong or accidental sticking of the outer needle after use and for preventing dissipation of blood adhering to the outer needle, and a delivery device having the tool.
It is another object of the present invention to provide a cartridge for use with a therapeutic material delivery device, which cartridge permits direct calibration of a radioactive source charged therein, and a delivery device having the cartridge.
It is still another object of the present invention to provide a cartridge for use with a therapeutic material delivery device, which cartridge is free from easy breakage of a connector tube connected to an outer needle of the delivery device, and a delivery device having the cartridge.
It is yet another object of the present invention to provide a cartridge for a therapeutic material delivery device, which cartridge permits extrusion of charged radioactive sources to the forward end of an outer needle without any resistance, and a delivery device having the cartridge.
It is further another object of the present invention to provide a cartridge for use with a therapeutic material delivery device, which cartridge permits calibration of the length of radioactive sources charged therein by easy external reading, and a delivery device having the cartridge.
Still further other objects of the present invention will be clear by descriptions to be made hereinafter.
According to the present invention, (1) there is provided a protective tool
68
A or
68
B for a therapeutic material delivery device comprising an outer needle
2
having an outer tubular needle
2
A and an outer needle hub
2
B supporting the outer tubular needle
2
A, the protective tool being to be attached to said outer needle
2
for the protection thereof,
the protective tool comprising a cover
8
′A and a cap
61
or stopper
65
attached to a forward end of said cover for protecting the forward end of the outer tubular needle
2
A,
wherein said cover
8
′A is formed of a plurality of tubes
8
′A
1
,
8
′A
2
,
8
′A
3
, . . . having different diameters that are formed so as to consecutively decrease from a forward place to the outer needle hub
2
B in a backward place, and said tubes are thereby connected such that the cover
8
′A is extendable in the longitudinal direction.
According to the present invention, further, (2) there is provided a protective tool
68
A for a therapeutic material delivery device as recited in the above (1), wherein said cap
61
has an inner tube
61
A formed inside, said inner tube
61
A has, made in a bottom thereof, a hole
62
for inserting and passing said outer tubular needle
2
A, and said inner tube
61
A has, formed in an outer
Hamazaki Kuniharu
Otsuka Tetsuya
Kawasumi Laboratories Inc.
Veniaminov Nikita R
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