Fiducial marker for use in stereotactic radiosurgery and process of production

Patent metadata

Field	Value
Publication number	US-10071173-B2
Application number	US-201615564786-A
Country	US
Kind code	B2
Filing date	Apr 5, 2016
Priority date	Apr 7, 2015
Publication date	Sep 11, 2018
Grant date	Sep 11, 2018

Abstract

Composition in the form of a shaped device, for use as a fiducial marker in tissues in the animal body, in radiotherapy and/or radiosurgery, characterized in that it comprises:—a core consisting of a colloidal dispersion of metal nanoparticles and/or oxides or metal salts having X-ray-contrast properties, where said nanoparticles are stabilized with surfactants, polymers or capping agents in a liquid vehicle, and—a polymeric casing that encapsulates the core, said device having a minimum size of not less than 500 microns and a maximum size not greater than 3000 microns.

First claim

The invention claimed is:

1. A composition in the form of a shaped device, for use as a fiducial marker in tissues in an animal body, in radiotherapy and/or radiosurgery, comprising:
a core consisting of a colloidal dispersion of components selected from the group consisting of metal nanoparticles, metal oxides, and metal salts having X-ray-contrast properties, where said components are stabilized with surfactants, polymers or capping agents in a liquid vehicle, and
a polymeric casing that encapsulates the core,
said shaped device having a minimum size of not less than 500 microns and a maximum size not greater than 3000 microns, wherein said polymeric casing comprises an encapsulating polymeric material selected from silicone elastomers, polydimethylsiloxane, or a combination thereof.

2. The composition according to claim 1 , wherein one component is he nanoparticles, wherein said nanoparticles include colloidal gold with size from 50 to 200 nm.

3. The composition according to claim 1 , wherein said nanoparticles are coated with 4-2-hydroxyethyl-1-piperazinylethanesulphonic acid.

4. The composition according to claim 1 , wherein said liquid vehicle is selected from the group consisting of water, glycerol, dimethyl sulphoxide, dimethylformamide and ethylene glycol or their aqueous solutions.

5. The composition according to claim 1 , wherein said liquid vehicle is glycerol.

6. The composition according to claim 1 , wherein said colloidal dispersion comprises said nanoparticles at a concentration from 50 to 800 mg/ml in the liquid vehicle.

7. A method of stereotactic radiosurgery carried out on body tissues comprising:
providing a composition and
implanting said composition in said body tissue as a fiducial marker,
wherein the composition is in the form of a shaped device, for use as a fiducial marker in tissues in an animal body, in radiotherapy and/or radiosurgery, comprising:
a core consisting of a colloidal dispersion of components selected from the group consisting of metal nanoparticles, metal oxides, and metal salts having X-ray-contrast properties, where said components are stabilized with surfactants, polymers or capping agents in a liquid vehicle, and
a polymeric casing that encapsulates the core,
said shaped device having a minimum size of not less than 500 microns and a maximum size not greater than 3000 microns, wherein said polymeric casing comprises an encapsulating polymeric material selected from silicone elastomers, polydimethylsiloxane, or a combination thereof.

8. A process for production of a composition in the form of a shaped device, for use as a fiducial marker in tissues in an animal body, in radiotherapy and/or radiosurgery, comprising:
a core consisting of a colloidal dispersion of components selected from the group consisting of metal nanoparticles, metal oxides, and metal salts having X-ray-contrast properties, where said components are stabilized with surfactants, polymers or capping agents in a liquid vehicle, and
a polymeric casing that encapsulates the core,
said shaped device having a minimum size of not less than 500 microns and a maximum size not greater than 3000 microns, wherein said polymeric casing comprises an encapsulating polymeric material selected from silicone elastomers, polydimethylsiloxane, or a combination thereof,
wherein the colloidal dispersion of components comprises a dispersion of nanoparticles, and
wherein said composition is shaped by moulding of a solution of the encapsulating polymeric material, introducing said dispersion of nanoparticles in volume from 0.01 to 100 μl into said moulded solution and polymerizing said encapsulating polymeric material in a mould.

9. A process for production of a composition comprising the steps of:
moulding of a hollow polymeric body of an encapsulating polymeric material,
introduction into a cavity of said hollow polymeric body of a vehicle selected from water, glycerol, dimethyl sulphoxide, dimethylformamide or ethylene glycol or their aqueous solutions,
polymerization of the encapsulating polymeric material, and
insertion of a colloidal dispersion of nanoparticles in a liquid vehicle so as to replace the vehicle previously introduced in said cavity,
wherein the composition is in the form of a shaped device, for use as a fiducial marker in tissues in an animal body, in radiotherapy and/or radiosurgery, the composition comprising:
a core consisting of a colloidal dispersion of components selected from the group consisting of metal nanoparticles, metal oxides, and metal salts having X-ray-contrast properties, where said components are stabilized with surfactants, polymers or capping agents in the liquid vehicle, and
a polymeric casing that encapsulates the core,
said shaped device having a minimum size of not less than 500 microns and a maximum size not greater than 3000 microns, wherein said polymeric casing comprises the encapsulating polymeric material selected from silicone elastomers, polydimethylsiloxane, or a combination thereof.

Assignees

• Fondazione St Italiano Tecnologia
• Fondazione Istituto Italiano Di Tech

Inventors

• Maiorano Gabriele
• Mele Elisa
• Athanasiou Athanasia
• Pompa Pier Paolo

Classifications

• A61B90/39

  Markers, e.g. radio-opaque or breast lesions markers · CPC title

• A61B2090/3954

  magnetic, e.g. NMR or MRI · CPC title

• A61B2090/3966

  Radiopaque markers visible in an X-ray image · CPC title

• A61B2090/3908

  Soft tissue, e.g. breast tissue · CPC title

• A61K49/04 Primary

  X-ray contrast preparations · CPC title