Hollow-tube brachytherapy device

• US 5,713,828 A
• Filed: 11/27/1995
• Issued: 02/03/1998
• Est. Priority Date: 11/27/1995
• Status: Expired due to Term

• Current Assignee: International Brachytherapy Company
• Original Assignee: International Brachytherapy Company
• Inventors: Coniglione, Roy
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US08/563,050
• Time in Patent Office: 799 Days
• Field of Search: 600/1, 600/3, 600/6, 600/7, 600/8
• US Class Current: 600/7
• CPC Class Codes: A61K 2121/00 Preparations for use in therapy
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61N 2005/1023 Means for creating a row of seeds, e.g. spacers
• CPC Class Codes: A61N 2005/1024 Seeds
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: G21G 4/08 specially adapted for medical application radiation therapy using radioactive sources A61N5/10
• CPC Class Codes: Y10T 29/49716 Converting
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling
• CPC Class Codes: Y10T 29/4998 Combined manufacture including applying or shaping of fluent material
• CPC Class Codes: Y10T 29/49982 Coating

Abstract

A novel brachytherapy device is formed from a hollow-tube-shaped seed-substrate, allowing the easy association of the device with suture material. This shape minimizes the chance of migration of implanted seeds due to better attachment to tissue. The distribution of the radioactive material on the exterior surface of the tubular device provides a relatively uniform radiation field around the hollow-tube-shaped brachytherapy seed source. Brachytherapy devices are described that are inherently radioactive. Also disclosed are devices that can be rendered radioactive by the transmuting effects of neutron irradiation. Brachytherapy devices are discussed that facilitate medical application and improve safety for patients and medical personnel.

Claims

1. A double-walled tubular brachytherapy device for interstitial implantation of radiation-emitting material within a living body, said double-walled tubular brachytherapy device comprising:

an inner tubular element and an outer tubular element, said inner tubular element and said outer tubular element each having a first end and a second end, said inner tubular element and said outer tubular element being of a substantially equal length and said inner tubular element being substantially centrally disposed within said outer tubular element and spaced apart therefrom over substantially the entire length thereof, said first ends being sealingly joined and said second ends being sealingly joined; and

wherein said inner tubular element comprises a tubular support having a lumen therethrough, an internal surface, and an external surface, said external surface having radiation-emitting material thereon.

2. The double-walled tubular brachytherapy device of claim 1, wherein said inner tubular element comprises a material selected from the group consisting of:

titanium, carbon, stainless-steel, tantalum, hafnium and zirconium.

3. The double-walled tubular brachytherapy device of claim 2, wherein said radiation-emitting material comprises a material selected from the group consisting of:

palladium-103, iridium-192, iodine-125, gold-198, yttrium-90 and phosphorus-32.

4. The double-walled tubular brachytherapy device of claim 3, wherein said radiation-emitting material is a quantity of radiation-emitting material having an activity of between 0.1 and 10,000 millicurie.

5. The double-walled tubular brachytherapy device of claim 4, wherein said radiation-emitting material is an essentially uniform layer of radiation-emitting material.

6. The double-walled tubular brachytherapy device of claim 1, wherein said outer tubular element comprises a material essentially transparent to the radiations emitted by said radiation-emitting material.

7. The double-walled tubular brachytherapy device of claim 6, wherein said outer tubular element comprises a material selected from the group consisting of:

titanium, carbon, stainless-steel, tantalum, hafnium, zirconlure, titanium carbide, titanium nitride, titaninto carbonitride, hafnium nitride, and zirconium nitride.

8. The double-walled tubular brachytherapy device of claim 7, wherein:

said first end of said inner tubular element is sealingly joined to said first end of said outer tubular element; and

said second end of said inner tubular element is sealingly

joined to said second end of said outer tubular element;

wherein said ends are sealingly joined by swaging said ends together and said ends are further joined by laser welding so as to form a sealed device.

9. The double-walled tubular brachytherapy device of claim 1, additionally comprising:

material detectable by radiography disposed as a band on said external surface, said band being essentially centrally located relative to the long axis of said double-walled tubular brachytherapy device, said band having sufficient width and radiopacity to make said double-walled tubular brachytherapy device detectable and its orientation determinable by radiographic examination;

whereby the band permits determination of the presence and orientation of the double-walled tubular brachytherapy device by radiographic examination of a patient receiving brachytherapy with the double-walled tubular brachytherapy device.

10. The double-walled tubular brachytherapy device of claim 9, wherein said inner tubular element comprises a material selected from the group consisting of:

polypropylene, polyethylene terephthalate, nylon, polyurethane, polyphenylene oxide blends, polyphenylsulfone, polysulfone, polyether sulfone, polyphenylene sulfide, phenyletheretherketone, polyetherimide and liquid crystal polymer.

11. The double-walled tubular brachytherapy device of claim 10, wherein:

said outer tubular element is a material essentially transparent to the radiations emitted by said radiation-emitting material and comprises a plastic selected from the group consisting of;

polypropylene, polyethylene terephthalate, nylon, polyurethane, polyphenylene oxide blends, polyphenylsulfone, polysulfone, polyether sulfone, polyphenylene sulfide, phenyletheretherketone, polyetherimide and liquid crystal polymer;

said outer tubular element is fitted over said inner tubular element with said radiographically detectable band deposited thereon and said radiation-emitting material deposited thereon;

said first end of said inner tubular element and said first end of said outer tubular element are sealingly joined; and

said second end of said inner tubular element and said second end of said outer tubular element are sealingly joined;

wherein said ends are sealingly joined by a process selected from the group consisting of;

gluing, heat sealing, ultrasonic welding and solvent welding.

12. A double-walled tubular brachytherapy device of claim 1, wherein:

said inner tubular element has a plurality of perforations;

said outer tubular element has a plurality of perforations;

said outer tubular element is disposed so that said perforations in said outer tubular element are aligned with said perforations of said inner tubular element;

wherein said inner tubular element and said outer tubular element are sealingly engaged, thereby encasing said radiation-emitting material so as to prevent contact between bodily fluids and said radiation-emitting material of said brachytherapy device;

whereby said plurality of perforations permit bodily fluids ready access to said lumen of said double-walled tubular brachytherapy device, and permit tissue growth in and around said double-walled tubular brachytherapy device.

13. A double-walled tubular precursor device adapted to be transmuted into a brachytherapy device, said double-walled tubular precursor device comprising:

an inner tubular element having an inner surface, an outer surface, two open ends and a lumen therethrough, said lumen being continuous with said open ends;

a layer of an isotope on said outer surface of said inner tubular element;

wherein said isotope is selected from the group consisting of;

gold-197, iridium-191, palladium-102, phosphorus-31 and yttrium-89;

wherein said inner tubular element is disposed coaxially relative to an outer tubular element and spaced apart therefrom over substantially the entire length thereof; and

said outer tubular element sealingly encases said isotope so as to provide a sealed double-walled tubular precursor device.

14. A method for converting a double-walled tubular precursor device of claim 13, into a double-walled tubular brachytherapy device, said method comprising:

irradiating said sealed double-walled tubular precursor device with neutrons so as to transmute said isotope to a radiation-emitting isotope,

said neutrons being applied to said double-walled tubular precursor device by a nuclear reactor, or a cyclotron.

15. A method of using a double-walled brachytherapy device having a lumen therethrough, said method comprising:

providing a double-walled tubular brachytherapy device having a pair of coaxial cylindrical walls spaced apart over substantially their entire length, said device having a lumen therethrough;

threadedly inserting through a lumen of said double-walled tubular brachytherapy device a member selected from the group consisting of surgical wire and surgical plastic filament;

fixedly attaching said double-walled tubular brachytherapy device upon said member;

inserting a catheter into a patient at a site where brachytherapy is desired to be delivered by threadedly inserting said catheter through a vessel or by surgically inserting said catheter; and

inserting said double-walled tubular brachytherapy device into said catheter by means of said member.

16. The method of claim 15, additionally comprising:

positioning a plurality of said double-walled tubular brachytherapy devices, each having a lumen therethrough, on said member by threadedly inserting said member through said lumen of each of said double-walled tubular brachytherapy devices;

whereby a plurality of double-walled tubular brachytherapy devices is inserted into said catheter by means of said member.

17. A method of fixedly-locating during surgery a double-walled tubular brachytherapy device having a between therethrough, said method comprising:

providing at least one said double-walled tubular brachytherapy device having walls spaced apart from one another over substantially the entire length of said lumen;

threadedly inserting a surgical fixative through a lumen of said double-walled brachytherapy device;

wherein said surgical fixative is suture material or a rigid surgical fixative rod;

selecting a location where brachytherapy is desired to be delivered, said location being relative to a tumor to be treated, relative to a treatment volume to be irradiated, or relative to other brachytherapy devices; and

surgically attaching said hollow-tube brachytherapy device in a patient at said location by means of said surgical fixative.

18. The method of claim 17, additionally comprising:

positioning a plurality of double-walled tubular brachytherapy devices, each having a between therethrough, on said surgical fixative by threadedly inserting said surgical fixative through said lumen of each of said double-walled tubular brachytherapy devices;

whereby said plurality of double-walled tubular brachytherapy devices is inserted fixedly located relative to said tumor, relative to said volume to be irradiated or relative to said other brachytherapy devices.

19. A method of positioning during surgery, a double-walled tubular brachytherapy device having a lumen therethrough, said method comprising:

providing at least one double-walled tubular brachytherapy device having a lumen therethrough;

selecting a location where brachytherapy is desired to be delivered, said location being relative to a tumor to be treated, relative to a treatment volume to be irradiated, or relative to a previously-applied brachytherapy device;

inserting a double-walled tubular brachytherapy device in the vicinity of said location with a surgical needle; and

positioning said double-walled tubular brachytherapy device at said location with said surgical needle.

20. The method of claim 19, wherein:

a plurality of double-walled tubular brachytherapy devices are inserted at said vicinity of said location with said surgical needle;

whereby said plurality of double-walled tubular brachytherapy devices may be located relative to said tumor, relative to said volume to be irradiated or relative to said other brachytherapy devices.