WO2004026111B1 - Flexible and/or elastic brachytherapy seed or strand - Google Patents

Flexible and/or elastic brachytherapy seed or strand

Info

Publication number
WO2004026111B1
WO2004026111B1 PCT/US2003/029673 US0329673W WO2004026111B1 WO 2004026111 B1 WO2004026111 B1 WO 2004026111B1 US 0329673 W US0329673 W US 0329673W WO 2004026111 B1 WO2004026111 B1 WO 2004026111B1
Authority
WO
WIPO (PCT)
Prior art keywords
strand
seed
group
millimeters
brachytherapy
Prior art date
Application number
PCT/US2003/029673
Other languages
French (fr)
Other versions
WO2004026111A3 (en
WO2004026111A2 (en
Inventor
Edward J Kaplan
Original Assignee
Microspherix Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32475685&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2004026111(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Microspherix Llc filed Critical Microspherix Llc
Priority to EP03749783A priority Critical patent/EP1545705A4/en
Priority to JP2004538328A priority patent/JP2006500115A/en
Priority to AU2003267309A priority patent/AU2003267309A1/en
Publication of WO2004026111A2 publication Critical patent/WO2004026111A2/en
Publication of WO2004026111A3 publication Critical patent/WO2004026111A3/en
Publication of WO2004026111B1 publication Critical patent/WO2004026111B1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/06Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/061Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/064Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/0038Radiosensitizing, i.e. administration of pharmaceutical agents that enhance the effect of radiotherapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6957Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a device or a kit, e.g. stents or microdevices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/04X-ray contrast preparations
    • A61K49/0409Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is not a halogenated organic compound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/12Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
    • A61K51/1282Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02Inorganic materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18Materials at least partially X-ray or laser opaque
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1007Arrangements or means for the introduction of sources into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1027Interstitial radiation therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966Radiopaque markers visible in an X-ray image
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/44Radioisotopes, radionuclides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/45Mixtures of two or more drugs, e.g. synergistic mixtures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N2005/1019Sources therefor
    • A61N2005/1023Means for creating a row of seeds, e.g. spacers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N2005/1019Sources therefor
    • A61N2005/1024Seeds

Abstract

A flexible or elastic brachytherapy strand (10) that includes an imaging marker (30) and/or a therapeutic, diagnostic or prophylactic agent (14) such as a drug (14) in a biocompatible carrier that can be delivered to a subject upon implantation needle. Strands (10) can be formed as chains or continuous arrays of seeds up to 50 centimeters or more, with or without spacer material (20) flaccid, rigid, or flexible.

Claims

AMENDED CLAIMS
[received by the International Bureau on 12 July 2004 (12.07.04); original claims 1-26 replaced by amended claims 1-30]
We claim:
1. A brachytherapy strand or seed for implantation into a subject comprising
(a) a non-radionuclide imaging marker, and
(b) a biocompatible carrier. wherein the strand or seed is elastic, and has a size and shape suitable for passing through the bore of a needle having an interior diameter of less than about 2.7 millimeters (10 gauge).
2. The strand or seed of claim 1 formed of a synthetic polymer.
3. The strand or seed of claim 1 formed of an inorganic material.
4. The strand or seed of claim 1 formed of a natural material selected from the group consisting of proteins, peptides, polysaccharides, lipi s, and combinations thereof.
5. The strand or seed of claim 1 formed of a shape memory material. β- The strand or seed of claim 1 further comprising a therapeutic, prophylactic or diagnostic agent.
7. The strand or seed of claim 1 further comprising conduits, cavities or pores along the length of the strand.
©. Thø stra d or seed of claim 7 further comprising a portal for external access using a needle or other introducer instrument for purposes of filling the conduits, cavities or pores with therapeutic or diagnostic agents after implantation.
9. The strand or seed of claim 1 further comprising a radioactive agent.
10. The strand or seed of claim 1 wherein the imaging marker is detectable by X-ray, fluorescence, infrared; ultrasound, magnetic detection, or MRΪ.
11. The strand or seed of claim 1 , wherein the size and shape is suitable for passing through the bore of a needle having an interior diameter of less than about 1.4 millimeters (15 gauge).
44
12. The strand or seed of claim 1 , wherein the strand or seed is shaped into a cylinder having a diameter of between about 0.5 to 3 millimeters and a length of 4 to 500 millimeters.
44A
13. The strand of claim 1 , wherein the strand comprises seeds strung on or formed as a strand of between about 0.5 and 3 mm diameter and a length of between one and 50 cm,
14. The strand or seed of claim 1 , wherein the carrier is biodegradable.
15. The strand or seed of claiml further comprising a material selected from the group consisting of ferromagnetic microspheres, oxygen, hemoglobin, synthetic hemoglobin-like substances and drugs for enhancing oxygen perfusion.
16. The strand of claim 1 , further comprising seeds.
17. The strand of claim 15, wherein the seeds are formed of a material selected from the group consisting of non-polymeric or inorganic materials and polymers.
18. The strand or seed of claim 9 further comprising a means of tracing the radioactive agent
19. The strand or seed of claim 1 further comprising a radiosensitizing agent.
20. The strand or seed of claim 1 wherein the imaging marker is a radiopaque marker comprising a substance selected from the group consisting of platinum, iridium,, rheniums, gold, tantal n3 bis u hs indium, tungsten, silver, and radiopaque polymers.
21. The strand or seed of claim 1 further comprising hairs coating the external surface of the brachytherapy strand for enhancement of adhesive potential.
22. The strand or seed of claim 1 further comprising polymeric anchoring structures.
23. The strand or seed of claim 22 wherein the anchoring structures are shape memory polymeric anchoring structures or electroactive polymeric anchoring structures.
24. The strand or seed of claim 3 wherein the inorganic material is selected from the group consisting of silicon, coral, fullerene, bioceramic, and hydroxyapatite.
45
25. The strand or seed of claim 1 wherein the strand or seed is formed of a composite of an inorganic material and a polymer.
26. The strand or seed of claim 6, comprising one or more areas comprising a therapeutic, prophylactic or diagnostic agent and one ore more areas comprising spacers.
27. The strand of claim 1 , wherein the strand forms a mesh or lattice.
28. A method of making a brachytherapy strand or seed for implantation into a subject comprising mixing a biocompatible elastic carrier with a non-radioactive imaging agent to form a brachytherapy strand or seed.
29- A method for adrninisteriπg a therapeutically active component to a target tissue in a subject, the method comprising implanting a brachytherapy strand or seed comprising
(a) a non-radionuclide imaging marker, and
(b) a biocompatible carrier, wherein the strand or seed is elastic, and has a size and shape suitable for passing through the bore of a needle having an interior diameter of less than about 2.7 millimeters (10 gauge). 30. The method of claim 30, wherein the target tissue is a diseased tissue selected from the group consisting of prostate, breast and tongue.
46
PCT/US2003/029673 2000-11-16 2003-09-19 Flexible and/or elastic brachytherapy seed or strand WO2004026111A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP03749783A EP1545705A4 (en) 2000-11-16 2003-09-19 Flexible and/or elastic brachytherapy seed or strand
JP2004538328A JP2006500115A (en) 2000-11-16 2003-09-19 Flexible and / or elastic seeds or strands for brachytherapy
AU2003267309A AU2003267309A1 (en) 2000-11-16 2003-09-19 Flexible and/or elastic brachytherapy seed or strand

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US24912800P 2000-11-16 2000-11-16
US41205002P 2002-09-19 2002-09-19
US60/412,050 2002-09-19

Publications (3)

Publication Number Publication Date
WO2004026111A2 WO2004026111A2 (en) 2004-04-01
WO2004026111A3 WO2004026111A3 (en) 2004-07-01
WO2004026111B1 true WO2004026111B1 (en) 2004-08-26

Family

ID=32475685

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/029673 WO2004026111A2 (en) 2000-11-16 2003-09-19 Flexible and/or elastic brachytherapy seed or strand

Country Status (5)

Country Link
US (7) US7776310B2 (en)
EP (1) EP1545705A4 (en)
JP (1) JP2006500115A (en)
AU (1) AU2003267309A1 (en)
WO (1) WO2004026111A2 (en)

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US8821835B2 (en) 2014-09-02
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US20100261946A1 (en) 2010-10-14
US20150238661A1 (en) 2015-08-27
AU2003267309A1 (en) 2004-04-08
US7776310B2 (en) 2010-08-17
EP1545705A4 (en) 2010-04-28
WO2004026111A3 (en) 2004-07-01
US20170216499A1 (en) 2017-08-03
EP1545705A2 (en) 2005-06-29
US10493181B2 (en) 2019-12-03
US20040109823A1 (en) 2004-06-10
US20200093968A1 (en) 2020-03-26
AU2003267309A8 (en) 2004-04-08
US10994058B2 (en) 2021-05-04
US20150010470A1 (en) 2015-01-08
US9636401B2 (en) 2017-05-02
US9636402B2 (en) 2017-05-02
US20130280168A1 (en) 2013-10-24
WO2004026111A2 (en) 2004-04-01
US20180050134A2 (en) 2018-02-22
US8470294B2 (en) 2013-06-25

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