Hydroxyapatite tissue filler and its preparation and use

a technology of hydroxyapatite and filler, which is applied in the field of biocompatible compositions, can solve the problems of low immunogenicity of hydroxyapatite, all kinds of complications, and undesired permanent impact of filler materials in tissue,

Inactive Publication Date: 2010-06-03
CAM BIOCERAMICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is discovered recently that the injection of PMMA microspheres causes all kinds of complications in time, to a large extent related to the non-biodegradable properties.
Moreover, it is now believed that the permanent impact of filler materials in tissue is undesired, since the tissue itself is subject to ageing (see e.g. E. Haneke, “Skin rejuvenation without a scalpel. I. Fillers”, J Cosmetic Dermatology; 5: 157-167 (2005); K. De Boulle, “Management of complications after impantation of fillers”, J Cosmetic Dermatology; 3: 2-15 (2004).
Further, hydroxyapatite has very low immunogenicity.
However, the use of foreign body carrier materials renders these injectable hydroxyapatite compositions unattractive.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Gel of Precipitated Amorphous Hydroxyapatite Carrier Particles

[0046]Calcium phosphate (amorphous hydroxyapatite) particles are obtained by precipitation from calcium nitrate and ammonium phosphate. The resulting particles were less than 1 μm in size. After cleaning, a gel-like suspension was obtained.

[0047]In this case, the gel contained, prior to mixing with the augmentation material, 35 wt % carrier particles and 65 wt % water.

[0048]The augmentation particles were produced by spray-drying a slurry of precipitated calcium phosphate, as described above; and then sintered and sieved to obtain particles of 25-45 μm.

[0049]Upon mixing of 14 ml of the gel with 18.84 g augmentation particles a mix of 17.2 wt % carrier particles, 31.9 wt % water and 50.9 wt % augmentation particles was obtained. The weight ratio of augmentation particles to carrier particles was 3:1. Carrier particles and water together formed 70 vol % of the stable suspension.

example 2

Porous Augmentation Particles for Hard Tissue Augmentation

[0050]The gel obtained as described in example 1 was used.

6.25 g of the gel thus obtained was mixed with 1.20 g augmentation particles (80% porous, 1-4 mm hydroxyapatite granulate material (CAM Implants, Leiden, the Netherlands).

[0051]The gel contained 35 wt % carrier particles and 65 wt % water, the mix contained 29.4 wt % carrier particles and 54.5 wt % water and 16.1 wt % augmentation particles. The weight ratio of augmentation particles to carrier particles was 0.5:1.

example 3

Dense Augmentation Particles with a Gel of Calcinated Calcium Phosphate in Water

[0052]Calcium phosphate in spray-dried form was calcinated at about 400° C., and then an average particle size of about 2-3 μm was obtained. After washing, 20 g of these particles were suspended in 100 g water, yielding a gel of 17 wt % carrier particles in 83 wt % water. 3.42 g of the gel was mixed with 4.89 g augmentation particles (dense, 0.5-2 mm HA granulate (CAM Implants). The biocompatible composition thus obtained contained 7.0 wt % carrier particles, 34.2 wt % water and 58.8 wt % hard tissue augmentation particles. The weight ratio of augmentation particles:carrier particles=8:1. The mixture contained 34 vol % of augmentation particles, in terms of the total volume of the composition.

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Abstract

The invention pertains to a biocompatible composition, suitable for use in soft or hard tissue augmentation, wherein the composition is an aqueous suspension containing a carrier fraction of ceramic particles of less than 15 &mgr;m and an augmentation fraction of ceramic particles of at least 20 &mgr;m. The ceramics typically comprise calcium phosphate. The composition is a may be used in soft tissue repair as well as hard bone replacement. It advantageously avoids the need for foreign body materials which are conventionally applied to stabilize augmentation suspensions.

Description

FIELD OF THE INVENTION[0001]The invention pertains to biocompatible compositions containing ceramic particles, in particular hydroxyapatite, for soft and hard tissue augmentation, especially for bone regeneration and treatment of skin contour deficiencies, and for cosmetic use in plastic surgery, in particular for filling soft tissue voids or creating soft tissue augmentation.BACKGROUND OF THE INVENTION[0002]Since long biocompatible materials have been applied in augmenting soft tissue in the practice of plastic and reconstructive surgery. These biomaterials are commonly delivered to the tissue site where augmentation is desired by means of an injectable composition that comprises the biomaterial and a biocompatible fluid, wherein the fluid acts as a lubricant to improve the delivery of the biomaterial suspension.[0003]Since the mid-eighties polymethylmethacrylate (PMMA) has been studied as a soft tissue augmentation device, replacing then popular collagen. The permanent character o...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K47/04A61K8/24A61Q19/00A61K9/14A61L27/00
CPCA61K33/42A61L27/12A61L27/425A61K9/0019
Inventor DE GROOT, KLAAS
Owner CAM BIOCERAMICS
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