Setting of hardenable bone substitute

• US 10,294,107 B2
• Filed: 02/20/2014
• Issued: 05/21/2019
• Est. Priority Date: 02/20/2013
• Status: Active Grant

• Current Assignee: Bone Support AB (BONESUPPORT HOLDING AB)
• Original Assignee: Bone Support AB (BONESUPPORT HOLDING AB)
• Inventors: Ehrenborg, Kristina Caroline Victoria, Sandell, Veronica Rebecca, Liden, Eva Christina
• Primary Examiner(s): Westerberg, Nissa M
• Application Number:
  US14/768,649
• Publication Number:
  US 20160015856A1
• Time in Patent Office: 1,916 Days
• Field of Search: None
• CPC Class Codes: A61K 31/7036 having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/42 Phosphorus; Compounds thereof
• CPC Class Codes: A61K 38/14 Peptides containing saccharide radicals; Derivatives thereof , e.g. bleomycin, phleomycin, muramylpeptides or vancomycin
• CPC Class Codes: A61K 49/04 X-ray contrast preparations
• CPC Class Codes: A61K 49/0433 containing an organic halogenated X-ray contrast-enhancing agent
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/112 Phosphorus-containing compounds, e.g. phosphates, phosphonates
• CPC Class Codes: A61L 2300/202 with halogen atoms, e.g. triclosan, povidone-iodine
• CPC Class Codes: A61L 2300/40 characterised by a specific therapeutic activity or mode of action
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/428 Vitamins, e.g. tocopherol, riboflavin
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/025 Other specific inorganic materials not covered by A61L27/04 - A61L27/12
• CPC Class Codes: A61L 27/10 : Ceramics or glasses
• CPC Class Codes: A61L 27/12 : Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/3608 : Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/3616 : Blood, e.g. platelet-rich plasma
• CPC Class Codes: A61L 27/365 : Bones
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61P 19/08 : for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: C01B 25/327 : After-treatment increasing the phosphate content of ores C01B25/32

Abstract

The invention relates to hardenable ceramic bone substitute compositions having improved setting, powders for such compositions and methods for their manufacture and use in medical treatment. More specifically the invention relates to hardenable bone substitute powder and hardenable bone substitute paste with improved setting properties, comprising calcium sulfate and heat-treated hydroxyapatite (passivated HA), which bone substitute is suitable for treatment of disorders of supportive tissue such as bone loss, bone fracture, bone trauma and osteomyelitis.

Claims

1. A method for preparing a composition consisting of a sintered, micronized, and passivated crystalline hydroxyapatite powder (pHA) including the steps of:

a) providing a powder consisting of sintered and micronized crystalline hydroxyapatite (raw HA powder) with the chemical formula (Ca₁₀(PO₄)₆(OH)₂), wherein the raw HA powder has a crystalline content of >

90%, a particle size below 200 μ

m (D(v,0.99)), and a specific surface area below 20 m²/g (BET),

b) heating the composition consisting of the raw HA powder to a temperature between 300 and 900°

C. for between 10 minutes and 10 hours to obtain the composition consisting of the sintered, micronized, and passivated crystalline hydroxyapatite powder (pHA).

2. A method according to claim 1, wherein the heating step b) comprises heating composition consisting of the sintered and micronized crystalline hydroxyapatite (raw HA) powder to a temperature between 300 and 600°

C. for 1 to 4 hours.

3. A method according to claim 1, wherein providing the powder consisting of sintered and micronized crystalline hydroxyapatite (raw HA powder) in step a) comprises producing the raw powder by:

1) sintering hydroxyapatite at a temperature above 900°

C., and

2) micronizing the sintered hydroxyapatite (HA) to obtain said raw HA powder.

4. A method according to claim 3, comprising sintering hydroxyapatite at a temperature between 900 and 1350°

C.

5. A method according to claim 1, wherein the raw HA powder has a crystalline content of 95% or more.

6. A method according to claim 1, wherein the raw HA powder has a crystalline content of 99%.

7. A method according to claim 1, wherein the raw HA powder has a particle size of less than 50 μ

m (D(v,0.99)).

8. A method according to claim 1, wherein the raw HA powder has a specific surface area below 10 m²/g (BET).