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Synthetic biomaterial compound of calcium phosphate phases particularly adapted for supporting bone cell activity

a biomaterial and phase technology, applied in the direction of prosthesis, ceramics, other chemical processes, etc., can solve the problems of bloating performance in vivo, no prior composition developed, and no composition has been demonstrated to participate in the natural bone remodeling process

Inactive Publication Date: 2010-04-20
WARSAW ORTHOPEDIC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a new biomaterial compound that can be used in various bone-related clinical applications. This compound has a unique structure with interconnected micropores and a wide range of physical and chemical properties. It can be formed as a stable powder, pellet, or three-dimensional shape and is resorbable when acted upon by osteoclasts. The compound promotes bone cell growth and can be used to repair large segmental skeletal gaps and non-union fractures in humans and animals. It can also be used to stabilize implantable prostheses and maintain their long-term stability in the host.

Problems solved by technology

Although these different compositions may be used as biocompatible coatings for implants and the like, none of these compositions have been demonstrated to participate in the natural bone remodeling process.
Furthermore, none of the prior compositions developed, can be manipulated to reliably produce a range of films, thicker coatings and bulk ceramic pieces which share a common composition and morphology which leads to similar bloactive performance in vivo and in vitro.
However, despite the osteogenic potential of these artificial materials, none actively participate in the full process of natural bone remodeling.
In addition these analysis techniques are also very time consuming and require highly specialized equipment and training.
Furthermore, the preparation and subsequent examination of bone or dentine slices is neither an easy nor practical method for the assessment of osteoclast activity.
The use of artificial calcium phosphate preparations as substrata for osteoclast cultures has also met with little success.
These results would indicate that functional osteoclasts are difficult to culture in vitro.

Method used

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  • Synthetic biomaterial compound of calcium phosphate phases particularly adapted for supporting bone cell activity
  • Synthetic biomaterial compound of calcium phosphate phases particularly adapted for supporting bone cell activity
  • Synthetic biomaterial compound of calcium phosphate phases particularly adapted for supporting bone cell activity

Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of Ca—P Colloidal Suspension (Sol-Gel)

[0165]The following procedure is based on preparing sufficient sol-gel hydroxyapatite for manufacturing purposes. Solution A comprises a calcium nitrate tetrahydrate and Solution B comprises an ammonium dihydrogen orthophosphate (mono basic). Solution A is mixed with Solution B to produce the desired colloidal suspension. Solution A is prepared by adding 40 mls of doubly distilled water to 4.722 grams of calcium nitrate, Ca(NO3)2. The solution is stirred at moderate speed for sufficient time to dissolve all of the calcium nitrate which is normally in the range of 3 minutes. To this solution, 3 mls of ammonia hydroxide (NH4OH) is added and stirred for approximately another 3 minutes. To this solution is added 37 mls of double distilled water to provide a total solution volume of approximately 80 mls. The solution is stirred for another 7 minutes and covered. The pH of the solution is tested where a pH of about 11 is desired.

[0166]Solu...

example 2

Sintering of Ca—P Products

[0169]The following sintering process may be carried out in standard laboratory furnaces of various sizes, capable of operating at temperatures from ambient up to at least 1100° C., and designed to maintain accurate and stable internal temperatures, particularly between 800° C. and 1100° C., such as Lindberg models 51744 or 894-Blue M. The components prepared by any of the procedures described herein are carefully transferred onto a standard ceramic plate (as is common practice in the Lindberg oven). The ceramic plate is used as a carrier during the sintering process to facilitate easy loading and withdrawal of multiple substrates from the furnace. The furnace temperature is set to the temperature required to achieve the desired ratios of HA:SiTCP. Utilizing a programmable furnace such as the Lindberg model 894-Blue M, the furnace may be programmed to hold the desired temperature, which will normally be selected from the range 800° C. to 1100° C., for a max...

example 3

Preparation of Thin Films

[0171]To create a thin film on a transparent substrate, quartz (amorphous silica) substrates were cleaned using water and chromic acid and subsequently dip coated in the colloidal suspension of Example 1. The substrate needs to be thoroughly cleaned to ensure satisfactory film coverage. In the case of quartz substrates, cleaning is achieved by placing the discs in a glass beaker and supplying chromic acid cleaning solution to the glass beaker to cover all discs. The beaker is then covered. The discs are then sonicated in a water bath for 1 hour. The acid is washed away using tap water for 20 minutes. The residual tap water is removed by three changes of doubly distilled water. After the final change of double distilled water, every single disc is dried with lint-free towel and inspected for flaws in the quartz surface. Any residual particulate on the surface is removed as needed with compressed nitrogen or air. The discs are stored in covered trays in an ase...

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Abstract

The present invention is directed to a synthetic biomaterial compound based on stabilized calcium phosphates and more particularly to the molecular, structural and physical characterization of this compound. The compound comprises calcium, oxygen and phosphorous, wherein at least one of the elements is substituted with an element having an ionic radius of approximately 0.1 to 1.1 Å. The knowledge of the specific molecular and chemical properties of the compound allows for the development of several uses of the compound in various bone-related clinical conditions.

Description

RELATED APPLICATIONS[0001]This application is a continuation-in-part of copending U.S. patent application Ser. No. 09 / 029,872, filed Mar. 2,Jun. 29, 1998, which is a U.S. National Phase Application of PCT / CA96 / 00585, filed Aug. 30, 1996, which is a continuation-in-part of U.S. patent application Ser. No. 08 / 576,238, filed Dec. 21, 1995, now abandoned, which claims the benefit of U.S. Provisional Application Ser. No. 60 / 003,157, filed Sep. 1, 1995, which are each hereby incorporated herein in their entirety by reference. Application Ser. No. 09 / 044,749 claims priority to PCT Application No. PCT / CA98 / 00046, filed on Jan. 29, 1998.FIELD OF THE INVENTION[0002]This invention is directed to a synthetic biomaterial compound based on stabilized calcium phosphates and more particularly to the molecular, structural and physical characterization of this compound. This compound which in the alternative may be referred to as Skelite,™ has applications in the treatment of various bone related cli...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): C04B35/447A61L27/00C04B41/87A61F2/00A61L27/12C04B38/00C23C30/00
CPCA61K35/32A61L27/12A61L27/3821A61L27/3895A61L27/505A61L27/56C04B35/447C04B38/00C23C24/08C23C30/00C04B38/0064C04B38/067A61F2310/00293C04B2111/00836C04B41/87A61L27/00
Inventor PUGH, SYDNEY M.SMITH, TIMOTHY J. N.SAYER, MICHAELLANGSTAFF, SARAH D.
Owner WARSAW ORTHOPEDIC INC
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