Surgery – Radioactive substance applied to body for therapy – Radioactive substance placed within body
Reexamination Certificate
1999-08-17
2001-06-26
Lacyk, John P. (Department: 3736)
Surgery
Radioactive substance applied to body for therapy
Radioactive substance placed within body
Reexamination Certificate
active
06251060
ABSTRACT:
The invention relates to a method for temporarily inserting at least one radioactive source in an animal body comprising providing a channel in said body by means of a hollow open needle, inserting a flexible closed end sheath in the hollow open needle, retracting the hollow open needle over the flexible closed end sheath while maintaining the flexible closed end sheath in position in the channel in the body, fixing the flexible closed end sheath relative to the body by means of a fixing element, inserting into the sheath a radiation device having at least one radioactive source and after a period of time retracting the radiation device from the flexible closed end sheath.
The invention also relates to an apparatus for temporarily inserting at least one radioactive source in an animal body comprising a hollow open needle for providing a channel into the body, a flexible closed end sheath for insertion into the channel through the hollow open needle, the hollow open needle being retractable over the flexible closed end sheath, a fixing element for fixing the flexible closed end sheath relative to said body, a radiation device insertable into the flexible closed end sheath, the radiation device having at least one radioactive source therein.
BACKGROUND OF THE INVENTION
In the process of brachytherapy a radioactive source is brought to the vicinity of cancerous tissue for irradiating that cancerous tissue with radioactive radiation. Numerous proposals have been made for devices to carry out such processes. Such processes are e.g. known as manual low dose rate brachytherapy using wires, seeds, pellets, tubes and high dose rate or remote afterloading HDR brachytherapy. In LDR and HDR brachytherapy one or more low and high, respectively, intensity radioactive sources are fixed at a distal end of a so-called guide wire, i.e. remote afterloading. For certain types of cancer e.g. prostate cancer or breast cancer, more than one time spaced apart dose of radiation is required to be effective. Those doses are given over a period of several days. A patient has to be hospitalized during that period. Each time a dose is to be delivered during that period needles are placed into the body of the patient and treatment started. It is also known to have the needles remain in the body. Especially HDR brachytherapy needs only a few minutes or less for one dose. Thus for a patient such method means a long time in the hospital for a few short time treatments. Patients perceive such a method as being quite burdensome.
It is known in brachytherapy to insert a number of needles in a body semi-permanently for the total duration of the treatment. In that case a number of needles is inserted into the body, usually by means of a template, and fixed relative to the body by means of a fixing element. The template may also function as a fixing element. Each of the needles then is provided with a coupling. All needles stick out of the body for a certain distance and are provided with a coupling. Through the couplings so-called guide tubes or transfer tubes can be connected to the needles. As is well known in brachytherapy a so-called afterloader machine may be used to control the transport of the radiation source from the machine to the needles through the guide tubes or transfer tubes. An afterloader machine therefore is provided with an indexer device. The guide tubes or transfer tubes with ends thereof coupled to the fixing element are in turn coupled at opposite ends to the indexer. As is well known from afterloader brachytherapy machines manufactured and sold by e.g. Nucletron B.V. from the Netherlands a radioactive source at a distal tip of a so-called guide wire is transported under control of the machine from a safe in the machine through the indexer into a guide tube and through the guide tube into a corresponding needle. After a certain period the guide wire with the radioactive source is retracted into the afterloader machine. In case a further irradiation is to take place from another needle, the indexer is controlled such that a further guide tube is connected to receive the guide wire with the radioactive source at the tip. And so on until all required irradiations have taken place from the various needles. Then the needles are disconnected from the guide tubes. The patient then is “free” to walk around with a set of needles in his or her body until the next treatment has to take place. It is known to use plastic needles that have a small amount of flexibility instead of inflexible metal needles. The above description relates also to such flexible plastic needles.
During the periods that no treatment is taking place the patient is free in theory to walk around, however, in practice the set of needles sticking out of the body prevents the patient to feel really free. In any case it is not possible for such a patient to leave the hospital and return only for a next treatment.
BRIEF DESCRIPTION OF THE INVENTION
An object of the invention is to provide a method for temporarily inserting at least one radioactive source in a body by use of a radiation device which comprises a hollow closed end needle, said hollow closed end needle being provided with at least one radioactive source in it. The hollow closed end needle is inserted into a flexible closed end sheath, in which the hollow closed end needle is detachably connected to a fixing element and in which after a period of time the hollow closed end needle is disconnected from the fixing element and removed from the flexible closed end sheath.
A further object of the invention is to provide a method in which said at least one radioactive element is semi-permanently positioned in said hollow closed end needle.
A further object of the invention is to provide an apparatus for temporarily inserting at least one radioactive source in an animal body comprising a hollow open needle for defining a channel into the body, a flexible closed end sheath for insertion into the channel through the hollow open needle, the hollow open needle being retractable over the flexible closed end sheath. A fixing element is provided for fixing the flexible closed end sheath relative to the body. A radiation device is insertable into the flexible closed end sheath. The radiation device comprises at least one radioactive source and a hollow closed end needle. At least one radioactive source is positionable inside the hollow closed end needle and means are present for detachably connecting the needle to the fixing element.
A further object of the invention is to provide such a system in which the at least one radioactive element is semi-permanently positioned in the hollow closed end needle.
Thereby it is achieved that for a single patient a set of needles with radioactive sources is available for more than one treatment in which the radioactive sources are positioned in the needles in the configuration for that particular patient. The needles with the radioactive sources in them can then be stored until the next treatment takes place.
A further object of the invention is for the fixing element to comprise a breathable tape that is adhereable to the body.
A still further object of the invention is that the flexible closed end sheath is collapsible under pressures present in the channel in the body.
A still further object of the invention is to provide a part near or at a distal end of the flexible closed end sheath that is not collapsible under pressures present in the channel in said body.
Thereby it is achieved that the non-collapsible part acts as an anchoring device for the closed end sheath in the body.
A still further object of the invention is that a radiopaque marker is present in a distal end of the flexible closed end sheath.
It is a still further object of the invention to provide the hollow closed end needle with a coupling device slideable along the hollow closed end needle for fixing the needle to the fixing element.
It is a further object of the invention to provide a coupling device as fastenable upon said hollow closed end needle.
Thereby it is achieved that the
Adrianus Koster Albert Dirk
Hooft Eric Van't
Johnson Lu Anne
Schot Hans Martin
Birch & Stewart Kolasch & Birch, LLP
Cadugan Joseph A.
Lacyk John P.
Nucletron B.V.
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