This application is the national phase under 35 U.S.C. §371 of PCT International Application No. PCT/NL01/00647 which has an International filing date of Sept. 3, 2001, which designated the United States of America.
The invention relates to a row of radioactive seeds and non-radioactive spacers arranged with a predetermined pitch, in which the number of spacers can be zero, for a brachytherapeutic treatment of an animal body with radioactive radiation, which seeds have elongated shapes.
Such a row is known from Dutch patent application 1012697 and American patent application Ser. No. 09/377,382.
Therein is disclosed a device for composing a row of radioactive seeds and non-radioactive spacers, in which the number of spacers can be zero, for a brachytherapeutic treatment of tissue with radioactive radiation. The seeds disclosed therein have an elongated shape. By means of the device disclosed in the above mentioned patent applications the row of radioactive seeds and non-radioactive spacers is entered into a hollow needle with an open end which open end has been temporarily closed with a plug of wax. After the row of radioactive seeds and non-radioactive spacers has been entered into the hollow needle the relevant needle is subsequently inserted in the body comprising the tissue to be irradiated. After the needle with the row of radioactive seeds and non-radioactive spacers has been entered into or near to the tissue to be irradiated a plunger causes the row of radioactive seeds and non-radioactive spacers to remain at its place and the hollow needle is retracted. By retracting the plug of wax is pushed against the row of radioactive seeds and non-radioactive spacers and subsequently the plug releases from the open end of the hollow needle. On further retraction of the hollow needle the complete row of radioactive seeds and non-radioactive spacers is placed in or near to the tissue to be irradiated. Finally, the hollow needle and the plunger are removed from the body. In this way it is achieved that the row of radioactive seeds and non-radioactive spacers with a predetermined pitch has been placed in the body.
The disclosed manner of inserting a row of radioactive seeds and non-radioactive spacers has a disadvantage in that after the row has been inserted into the body or near to the tissue to be irradiated there is no physical relation anymore between the inserted seeds and spacers other than through the tissue of the body. That may have as a consequence that upon movements of the body in which the row of radioactive seeds and non-radioactive spacers has been inserted the radioactive seeds and non-radioactive spacers may move through the body/the tissue to be irradiated and as a consequence of such movement irradiate other tissue. That may be disadvantageous for the therapeutic treatment since the distribution of radioactive seeds and non-radioactive spacers has been calculated with great accuracy in order to reach an optimal result in respect of the irradiation of the tissue to be irradiated. This is the more important because in general not one but a number or even a great number of rows of radioactive seeds and non-radioactive spacers each arranged with a predetermined pitch, is inserted in order to irradiate the tissue, often cancerous tissue and spare the urethra.
In the context of the present invention, the term “spacer” is defined as an element which substantially has the same form and substantially the same dimensions as the seed, but, contrary to a seed, is not radioactive.
There is a need for rows of radioactive seeds and non-radioactive spacers, arranged with a predetermined pitch, in which the number of spacers can be zero, for brachytherapeutic treatment of tissue with radioactive radiation in which better care can be taken that the mutual spatial arrangements of radioactive seeds and non-radioactive spacers upon movement of the body cannot mutually change places after insertion of the row into the body.
This object is achieved according to the invention in that connectors are present between successive seeds, which connectors have substantially elongated shapes with two ends, in that at least one end of each connector is provided with an introversion in a longitudinal direction of the connector, in that the introversion has a shape complementary to the shape of a seed and in the longitudinal direction of the connector has a dimension which at most is equal to half the length of a seed.
Thereby it is achieved that the physical coherence is present between successive seeds of a row of radioactive seeds and non-radioactive spacers. The seeds have been coupled to each other “mechanically” in the form of a flexible “chain”. Contrary to a normal chain the seeds and the connectors are not fixed together which on the one hand ensures a certain degree of flexibility and on the other hand is not necessary since the tissue to be irradiated and the body, respectively exercise sufficient pressure to cause the seeds to remain pressed into the introversions.
As such U.S. Pat. No. 4,815,449 discloses a row of radioactive seeds and non-radioactive spacers arranged with a predetermined pitch, in which the number of spacers can be zero, for a brachytherapeutic treatment of tissue with radioactive radiation, which seeds have elongated shapes. The relevant seeds and spacers are surrounded by elongated cylindrical elements one cross-end of which is provided with a projection and an other cross-end of which is provided with an introversion. The projections have shapes complementary to those of the introversions. Identical elements thus achieved can be connected together into a row of elements. The row of elements come into being in that way has a large degree of stiffness, that is, is not flexible, and is provided with a sharp tip at the end that is being driven into the body. In this way the elements connected together form a needle with a sharp tip. After insertion of the row of radioactive seeds and non-radioactive spacers, which are present in the elements of the needle thus formed, the relevant needle with the sharp tip remains in the body. A disadvantage thereof is that movements of the body and/or the tissue in which the row of radioactive seeds and non-radioactive spacers, engineered as a needle, has been inserted upon movements on the one hand can be hindered because the needle thus formed is not flexible, that is behaves as a stiff elongated element in the body and on the other side that one of the ends of that stiff element is provided with a sharp tip. Upon movements that sharp tip can easily cause damage to the tissue about the tip causing traumatic tissue reaction. A further disadvantage is that the material from which the cover of the seeds and spacers has been manufactured must be of sufficient stiffness to be able to form a stiff needle. That limits the choice of materials suited for this purpose.
International Patent Application WO 99/59675 discloses a “spacer” element for treating prostate cancer, using an implant of radioactive seeds. The “spacer” element according to WO 99/59675 has a generally cylindrical exterior form and comprises a central section and two cup-like end sections. It is configured in such a way that it fits within a conventional needle, which is loaded with an alternating succession of radioactive seeds and “spacer” elements (with the meaning of WO 99/59675), for subsequent positioning in the prostate. It should be noted that with the “spacer” element according to International Patent Application WO 99/59675 a different element, i.e. a connecting element between two seeds, is meant which differs from the above defined term “spacer” according to the present invention.
International Patent Application WO 00/09211 discloses radioactive seeds provided with “gripping” ends. Such an end fits in a cavity in a bio-absorbable “spacer” according to WO 00/09211. Subsequent seeds are linked together by means of ‘spacers’ according to WO 00/09211 before being loaded in an injection needle, so as to remain connected to each other. It should be noted that with the “spacer” element according to International Patent Application WO 00/09211 a different element is meant which differs from the above defined term “spacer” according to the present invention. The “spacers” according to WO 00/09211 can have different lengths.
The preferred embodiment of a row according to the invention is characterised in that seeds and spacers have identical form and measurements and in that each end of each connector is provided with an introversion in longitudinal direction of the connector and in that each introversion is shaped complementary to the shape of a seed and in a longitudinal direction of the connector has dimensions smaller than half the length of a seed.
Thereby it is achieved that the row can be composed alternately comprising a seed or spacer and a connector. The calculated and desired radiation pattern is achieved by distributing seeds and spacers along the row in the rate calculated and coupling the seeds and spacers by means of the connectors.
A further preferred embodiment of a row according to the invention is characterised in that one or more spacers comprise connectors one end of which is provided with an introversion and an other end of which is provided with a projection having a shape identical to the shape as from an end of a seed.
Thereby it is achieved that on composing an arranged row of radioactive seeds and non-radioactive spacers only one action will be necessary to add one non-radioactive spacer to an already existing row in which the last element of the row is provided with an introversion and that subsequently through adding of this particular spacer the row again ends with an introversion such that either again such a spacer can be fitted or a seed can be fitted.
The invention also relates to a connector for forming a row as disclosed hereinbefore.
A particular embodiment of a connector according to the invention is characterised in that cross-sectional dimensions of an introversion are fractionally smaller than cross-sectional dimensions of a seed, in that the connector is manufactured of somewhat flexible material and in that at least over part of the length of an introversion and going from the end at which the introversion is present a slit has been provided which in a direction perpendicular to a longitudinal direction of the connector stretches from the outside of the connector to the introversion.
Thereby it is achieved that a mechanical clamping takes place of a radioactive seed and a non-radioactive spacer, respectively, which have been put in the relevant introversion.
Further scope of the applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.
The invention will now further be described with reference to the accompanying drawings, which are given by way of illustration only, and thus are not limitative of the present invention, and in which:
Referring to
In case connector 2 is provided with a continuous slit 7 or with two non-continuous slits at the location of the slit parts 7A and 7B the introversions 5 and 6 are somewhat flexible as a result of the presence of the slit and slits, respectively. In that case the diameter of the introversions 5 and 6 is fractionally smaller than the diameter D of a seed or a spacer. As a consequence, there is advantageously a slight degree of clamping which is favourable for the physical coherence of the row of radioactive seeds and non-radioactive spacers arranged with connectors 2. In the case of neither a continuous slit 7 nor two separate slits at the location of the slit parts 7A and 7B the shapes of the introversions 5 and 6 are not flexible. In that case the inner diameters of the introversions 5 and 6 should be fractionally larger than the diameter D of the radioactive seeds and non-radioactive spacers respectively, such as shown in
The choice to apply a slit 7 or two slits at the locations of the slit parts 7A and 7B is amongst others dependent upon the flexibility of the bio-absorbable material from which connector 2 has been manufactured. The stiffer the relevant material, the more need for slits 7.
The total length of connector 2 is indicated by Z. The lengths of introversions 5 and 6 are smaller than the length of a seed 1, preferably, but not necessarily, smaller than half the length of a seed 1. Preferably, but not necessarily, the lengths of the introversions 5 and 6 are equal. That has as an advantage that in composing an arranged row of radioactive seeds and non-radioactive spacers the orientation of the connector 2 in a row does not play a role. Logistically that produces advantages since in the processing of the connectors 2, such as in filling apparatus appropriate for composing an arranged row of radioactive seeds and non-radioactive spacers the orientation of the connector 2 does not have to be looked at.
In
Reference numeral 61 refers to the same course of things sketched in relation to the adding of a spacer 67 to an already existing row, the last connector of which has been indicated by reference numeral 66. Similarly to the description hereinbefore relating to a radioactive seed 64 the movement of a plunger 62 links up a connector 63 to a non-radioactive spacer 67 to a unit 68 which is brought into connection with the element 66 by the plunger 62.
In
Reference numeral 76 indicates which actions are taken when two or more subsequent spacers of the model shown in
After the foregoing many possibilities for executing the invention will be obvious for the person skilled in the art. All these embodiments are considered to embody the invention which has been put under protection according to the accompanying claims.
Number | Date | Country | Kind |
---|---|---|---|
1016101 | Sep 2000 | NL | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/NL01/00647 | 9/3/2001 | WO | 00 | 3/5/2003 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO02/20089 | 3/14/2002 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
4697575 | Horowitz | Oct 1987 | A |
4784116 | Russell et al. | Nov 1988 | A |
4815499 | Johnson | Mar 1989 | A |
5713828 | Coniglione | Feb 1998 | A |
5738663 | Lopez | Apr 1998 | A |
6010446 | Grimm | Jan 2000 | A |
6200258 | Slater et al. | Mar 2001 | B1 |
6264599 | Slater et al. | Jul 2001 | B1 |
6273851 | Slater et al. | Aug 2001 | B1 |
6283911 | Keren | Sep 2001 | B1 |
6450939 | Grimm | Sep 2002 | B1 |
6497647 | Tucker | Dec 2002 | B1 |
6709381 | Munro, III | Mar 2004 | B1 |
Number | Date | Country |
---|---|---|
WO 9959675 | Nov 1999 | WO |
WO 0009211 | Feb 2000 | WO |
Number | Date | Country | |
---|---|---|---|
20040054249 A1 | Mar 2004 | US |