# US 2014/0194852 A1 · Micron-sized gold, kit comprising said gold and its use as a non-toxic immune suppressor

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- Number: US 2014/0194852 A1
- Document ID: US20140194852A1
- Status: Published application
- Kind: A1
- Application number: 14/150,297
- Filed: 2014-01-08
- Published: 2014-07-10
- Earliest claimed: 2013-01-09
- Assignees: Berlock ApS
- Applicants: Berlock Aps
- Inventors: Gorm DANSCHER
- Web page: https://patentgrep.com/patent/US20140194852A1

## CPC

- A61K 33/242: Gold; Compounds thereof
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61L 27/306: {Other specific inorganic materials not covered by A61L27/303 - A61L27/32}
- A61L 27/32: Phosphorus-containing materials, e.g. apatite
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/06: Antipsoriatics
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 37/02: Immunomodulators
- C08L 5/08: Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
- A61L 2300/102: Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
- A61L 2300/802: Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
- A61L 2420/04: Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS 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 (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## Abstract

Sterile micron-sized gold particles contained in capped vials, a kit of part including the vial and a liquid capable of suspending the particles, as well as their preparation, medical devices or medicaments prepared by their preparation as well as uses thereof in treating inflammation. Also, gold coated implants preferably for use in combination with the medical devices.

## Claims

### Claim 1

A kit comprising a capped vial and a liquid contained in a syringe, said capped vial being penetrateable by the syringe,
wherein the capped vial comprises solid micron-sized gold,
wherein the biggest dimension of the micron-sized solid gold particles or gold flakes is in the range of 20 μm to 75 μm, and at least one glass bead,
wherein the liquid is compatible with the human body and is capable of maintaining the micron sized gold particles in suspension for at least one minute at a temperature of approximately 25° C.

### Claim 2 (depends on 1)

A kit according to claim 1, wherein the viscosity of the liquid is in the range of 1-110 cP.

### Claim 3 (depends on 1)

A kit according to claim 1, wherein the micron-sized gold is shaped as particles or flakes.

### Claim 4 (depends on 1)

A kit according to claim 1, wherein the capped vial comprises between 2.5 and 10 mg micron-sized solid gold particles or gold flakes.

### Claim 5 (depends on 1)

Kit according to any of the claim 1, wherein the liquid is medical grade hyaluronic acid.

### Claim 6

Medical device, for the treatment of inflammatory diseases, said medical device being obtainable by a method comprising the steps of
providing a capped vial comprising solid micron-sized gold particles or gold flakes and at least one glass bead having a diameter of 3-8 mm,
injecting a liquid which is inert to the human body and which liquid is capable of maintaining the micron sized gold particles or gold flakes in suspension for at least 1 minutes,
agitating the mixture of solid micron-sized gold particles or gold flakes glass bead(s) and the injected liquid to provide a suspension, whereby the glass beads facilitates efficient distribution of the micron-sized solid gold particles or gold flakes in the suspension,
aspirating the suspension into the syringe, whereby the medical device is provided said medical device being the solid micron-sized gold particles in suspension.

### Claim 7 (depends on 6)

Medical device according to claim 6, wherein the liquid has a viscosity in the range of of 1-110 cP.

### Claim 8 (depends on 6)

Medical device according to claim 6, wherein the liquid is medical grade hyaluronic acid.

### Claim 9

Capped vial comprising solid micron-sized gold particles or gold flakes and at least one glass bead, wherein the smallest diameter of the micron-sized solid gold particles is above 20 μm.

### Claim 10 (depends on 9)

Capped vial according to claim 9, wherein the capped vial comprises between 5 and 10 mg micron-sized solid gold particles or gold flakes.

### Claim 11 (depends on 6)

Medical device according to claim 6 for use in the treatment of inflammatory diseases.

### Claim 12 (depends on 11)

Medical device according to claim 11, wherein the inflammatory disease is selected from the group consisting of arthrose, multiple sclerosis, Alzheimers disease, psoriasis, eczema, autoimmune diseases and inflammation related conditions, wounds, as well as cosmetic conditions such as wrinkles.

### Claim 13 (depends on 6)

A method for treating an inflammatory disease comprising the steps of administering one dose of a medical device according to claim 6 into a location in need of treatment or preventative treatment.

### Claim 14 (depends on 6)

A method for improving long term mechanical fixation and suppression of release of toxic metals from a gold coated implant comprising the steps of
administering one dose of a medical device according to claim 6 prior to or simultaneously with delivery of the implant in the human at the interface between the bone tissue and the implant.

### Claim 15 (depends on 14)

A method according to claim 14, wherein the implant has an anchor part and a non-anchor part and wherein the anchor part of the implant is coated with a dotted or patchy gold layer covering no more than 70% of the total surface area of the anchor part.

### Claim 16 (depends on 13)

Method according to any of the claim 13, wherein the location is selected from the vicinity of a joint, intra-articularly, subcutaneously, intra-sclerally the urinary bladder, injuries/trauma caused by a lesion or eczema and along a sutured wound.

### Claim 17

Gold coated implant for human or animal use said implant having an anchor part to be in contact with bone tissue said anchor part having dotted gold deposits and a gilded non-anchor part in contact with adjacent tissue.

### Claim 18 (depends on 17)

Gold coated implant for human or animal use according to claim 17, wherein the surface of the implant is coated with gold dots.

### Claim 19 (depends on 17)

Gold coated implant for human or animal use according to claim 17, wherein the anchor part of the implant is coated with a dotted or patchy gold layer covering no more than 70% of the total surface area of the anchor part.

### Claim 20 (depends on 17)

Gold coated implant for human or animal use according to claim 17, wherein the anchor part is coated with a gold layer covering not more than 50% of the total surface of the anchor part.

### Claim 21 (depends on 17)

Gold coated implant for human or animal use according to claim 17, wherein the layer of gold has a thickness in the range of 50-500 nm.

### Claim 22 (depends on 17)

Gold coated implant according to claim 17, wherein the gold coating is obtained by a method comprising the steps of
a. immersing the implant in a strong alkaline solution
b. cleaning the implant by cathodic polarization to produce a hydrogen gas at the surface of the implant comprising sodium hydroxide,
c. immersing the implant in a weak acid solution
d. applying a layer of gold to the implant by partly immersing the implant into a weak acid gold bath comprising gold cyanide; and/or
e. applying points of gold particles or flakes to the surface of the implant, and
f. rinsing the implant between each step of a-d.

### Claim 23

A method for improving long termed mechanical fixation of a gold coated implant, comprising the steps of
applying a dose of a micron sized gold particle or flake, wherein the biggest dimension of micron-sized solid gold particle or flake is in the range 20 μm to 75 μm, to an inflicted tissue; and
inserting the gold coated implant, wherein the implant has a gold dotted anchor part to be in contact with bone tissue and a non-anchor part to be facing adjacent tissue which is gilded.

### Claim 24 (depends on 23)

The method according to claim 23, wherein the dose is prepared by a method comprising the steps of
providing a capped vial comprising solid micron-sized gold particles or gold flakes and at least one glass bead having a diameter of 3-8 mm,
injecting hyaluronic acid into the capped vial,
agitating the mixture of solid micron-sized gold particles or gold flakes glass bead(s) and the injected hyaluronic acid to provide a suspension, whereby the glass beads facilitates efficient distribution of the micron-sized solid gold particles or gold flakes in the suspension,
aspirating the suspension into the syringe, whereby the dose is provided said dose comprising the solid micron-sized gold particles in suspension.

### Claim 25 (depends on 1)

A method for improving therapy for the treatment and prevention of inflammatory diseases, wherein the improvement comprises
delivering to a human or animal in need of such treatment a gold coated implant according to claim 1 to an inflicted area, wherein the implant having at least one part of its surface to be in contact with bone and the remaining surface to be facing adjacent tissue characterised in that the remaining surface to be facing adjacent tissue has a larger total area covered in gold than the at least one part of the surface to be in contact with bone; and
applying a dose of a gold particle or flake to an inflicted tissue, where the biggest dimension of micron-sized solid gold particles or flakes is in the range of 20 microns to 75 microns.

### Claim 26 (depends on 25)

The method according to claim 25 where the dose of gold is applied prior to or simultaneously with delivering the gold coated implant.

### Claim 27 (depends on 25)

The method according to claim 25, wherein the disease is rheumatoid arthritis.

### Claim 28 (depends on 1)

A kit according to claim 1, wherein the viscosity of the liquid is in the range of 15-50 cP at a temperature of approximately 25° C.

### Claim 29 (depends on 6)

Medical device according to claim 6, wherein the liquid has a viscosity in the range of 15-110 cP at a temperature of approximately 25° C.
