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WO2011116112A2 - Fabrication de biotuteurs en verre poreux par des procédés sol-gel et faisant appel à une éponge polymère - Google Patents

Fabrication de biotuteurs en verre poreux par des procédés sol-gel et faisant appel à une éponge polymère Download PDF

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Publication number
WO2011116112A2
WO2011116112A2 PCT/US2011/028695 US2011028695W WO2011116112A2 WO 2011116112 A2 WO2011116112 A2 WO 2011116112A2 US 2011028695 W US2011028695 W US 2011028695W WO 2011116112 A2 WO2011116112 A2 WO 2011116112A2
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WIPO (PCT)
Prior art keywords
sponge
scaffold
temperature
glass
slurry composition
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Ceased
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PCT/US2011/028695
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English (en)
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WO2011116112A3 (fr
Inventor
Himanshu Jain
Shaojie Wang
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Lehigh University
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Lehigh University
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Publication of WO2011116112A3 publication Critical patent/WO2011116112A3/fr
Priority to US13/617,293 priority Critical patent/US9321675B2/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C03—GLASS; MINERAL OR SLAG WOOL
    • C03B—MANUFACTURE, SHAPING, OR SUPPLEMENTARY PROCESSES
    • C03B19/00—Other methods of shaping glass
    • C03B19/12—Other methods of shaping glass by liquid-phase reaction processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/10—Ceramics or glasses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • C—CHEMISTRY; METALLURGY
    • C01—INORGANIC CHEMISTRY
    • C01B—NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C
    • C01B33/00—Silicon; Compounds thereof
    • C01B33/113—Silicon oxides; Hydrates thereof
    • C01B33/12—Silica; Hydrates thereof, e.g. lepidoic silicic acid
    • C01B33/16—Preparation of silica xerogels
    • C—CHEMISTRY; METALLURGY
    • C01—INORGANIC CHEMISTRY
    • C01B—NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C
    • C01B33/00—Silicon; Compounds thereof
    • C01B33/113—Silicon oxides; Hydrates thereof
    • C01B33/12—Silica; Hydrates thereof, e.g. lepidoic silicic acid
    • C01B33/16—Preparation of silica xerogels
    • C01B33/166—Preparation of silica xerogels by acidification of silicate in the presence of an inert organic phase

Definitions

  • Bioactive materials such as bioactive ceramics (“bioceramics”) and bioactive glass (“BG”), are of interest for numerous biomedical applications. These materials make direct interfacial bond with the host tissue, in contrast to conventional bio-inert materials like titanium and cobalt-chrome alloys that cause scar tissue formation. Therefore, bioactive glass and bioceramics have been developed as implants to replace hard tissues of the musculo- skeletal system, such as bones and teeth.
  • known conventional bioceramics and bulk bioactive glass do not degrade efficiently, and are expected to remain in the human body for a long time.
  • bioscaffolds and methods of making the bioscaffolds.
  • the bioscaffolds are biocompatible and include nanopores, macropores and/or combinations thereof.
  • the methods provided herein utilize sponges as templates for a glass and/or glass-ceramic precursor material, and hold the precursor material in a desired shape prior to converting the precursor material to a glass, ceramic, or glass-ceramic scaffold.
  • the methods and resulting bioscaffolds described herein integrate a sol-gel process with sponge replication methods to fabricate porous scaffolds having high specific surface area and well controlled macropore sizes over a broad range suitable for many applications, such as hard tissue engineering
  • a method for producing a biocompatible scaffold includes : a) providing a slurry composition, the slurry composition comprising at least one glass precursor material; b) providing a sponge template; c) infiltrating the sponge template with the slurry; d) optionally removing excess slurry from the sponge template; and e) heating the sponge template to a temperature and for a time sufficient to convert the slurry composition into a scaffold comprising at least one of a glass, ceramic, glass-ceramic, or any combination thereof.
  • the scaffold produced comprises a series of interconnected macropores, and further comprises nanopores.
  • Figure 1 is a flow diagram of exemplary methods for providing bioactive glass scaffold by a sol-gel process and polymer sponge replication method.
  • Figure 2 is a scanning electron micrograph of an interconnected porous bioactive glass scaffold.
  • Figure 3 illustrates nanopore size distribution in accordance with an exemplary bio scaffold herein.
  • Figure 4 illustrates various surface area of exemplary scaffolds prepared from the mixture of acid-catalyzed and basic-catalyzed sol-gel particles listed in Table 1.
  • Figure 5 illustrates pore size distribution of exemplary scaffolds prepared from the mixture of acid-catalyzed and basic-catalyzed sol-gel particles listed in Table 1.
  • bioscaffolds and methods of making the bioscaffolds.
  • the bioscaffolds are biocompatible, and include interconnected and discrete pores, such as macropores, nanopores, and combinations thereof.
  • the methods provided herein utilize sponges or sponge-like apparatus as template for a glass and/or glass-ceramic precursor material in a desired shape prior to converting the precursor material to a glass or glass-ceramic article.
  • bioscaffolds that include superior high surface area, nano-macroporous porosity.
  • the bioscaffolds are made by methods that include a sol-gel process combined with polymer sponge replication methods.
  • the formation of a desired 3D bioscaffold structure was demonstrated in 70 mol SiO 2 -30 mol CaO glass composition as an example, in which porosity and other features were substantially uniform across the sample article.
  • the porosity and structure includes open, interconnected macropores with an average pore size of between from about 300 to about 600 ⁇ .
  • the interconnected macropores in such an exemplary bioscaffold are desirable for tissue ingrowth and vascularization when the bioscaffold is placed inside a living organism ("in vivo").
  • the exemplary bioscaffold made by methods herein preferably further includes nanopores.
  • the nanopores co-exist with the macropores, but need not all be interconnected to one another.
  • the nanopores provide a high specific surface area (high being, for example, greater than or equal to about 150 m 2 /g). Such high specific surface area is desirable for enhancing the bioscaffold' s degradation rate, such as in vivo.
  • These exemplary bioscaffolds, having interconnected macropores and coexisting interconnected and/or isolated nanopores hold promise for applications in hard tissue engineering.
  • isolated macropores can be present as well.
  • new methods are provided for fabricating high surface area nano-macro porous glass scaffold with interconnected macropores.
  • pore includes any open channel, as well as any open holes in the scaffold material.
  • macropore or “macroporous” means that the pore has an average diameter of greater than Attorney Docket No. : 137590.04502 about ⁇ .
  • nanopore or “nanoporous” means that the pore has an average diameter of smaller than about lOOnm.
  • interconnected means that there is a communicable connection between at least some of the pores.
  • sponge means any media made of porous material and having absorptive properties, such as absorption of liquid-based solutions and compositions. This includes, but is not limited to, foams, natural sponges, as well as man-made sponges made from natural or synthetic materials such as animal sponge (e.g. sea sponges), cellulose or other natural fibrous materials, as well as sponges made from polymers such as polyurethane, polyethers, polyester, among others.
  • the scaffolds provided herein can be used in hard tissue engineering, among other uses.
  • progenitor cells harvested from a subject's body are seeded and grown on a scaffold to produce a "loaded scaffold.”
  • the loaded scaffold is then implanted into a subject animal or human to replace diseased tissue.
  • the scaffold is placed in a subject's body, where the scaffold becomes loaded as the subject's own tissues contact the scaffold and interact with it.
  • the bioscaffold provides a three dimensional (3D) structure for the regeneration of natural tissue either in vitro or in vivo.
  • the scaffold preferably degrades gradually over time, and eventually is eliminated or replaced by natural tissue.
  • the scaffolds include open, interconnected macropores.
  • the pores have an average diameter preferably larger than about 300 ⁇ , with the interconnecting portions having an average diameter of at least about 100 ⁇ . More preferably, the interconnecting portions have an average diameter of at least about 200 ⁇ . Most preferably, the interconnecting portions have an average diameter of at least about 300 ⁇ .
  • Such interconnected macropores are desirable for tissue ingrowth and vascularization (blood vessel formation).
  • nanopores are also provided in the scaffold. Such nanopores enhance bioactivity and provide a desirably high specific surface area (e.g. > about 120-200 m 2 /g). Such a high surface area is desirable for enhancing the degradation rate of the scaffold structures.
  • the interconnected nanopores for high surface area also make the scaffolds provided herein useful for other purposes such as drug delivery, ambient or high temperature filtration, and catalyst support.
  • the bioscaffold not only provides a 3D structure for the regeneration of natural tissue, but also degrades gradually and, eventually be replaced by the natural tissue completely.
  • the bioscaffold is useful for applications in hard tissue engineering.
  • the scaffold includes a series of open, interconnected macropores having an average diameter size from about 300 ⁇ to about 600 ⁇ , which sizes are desirable and compatible for tissue ingrowth and vascularization.
  • the scaffold further includes nanopores that coexist with (but need not be interconnected with) the macropores.
  • the nanopores enhance bioactivity and provide high specific surface area, such as about 120 to about 200m 2 /g, which is desirable for, among other things, enhancing the degradation rate of the scaffold when implanted inside the body.
  • methods are provided for the formation of a bioscaffold having a desired 3D structure and interconnected macropores, as well as coexisting nanopores.
  • the exemplary methods herein produce exemplary bioscaffolds having a very high specific surface area to impart desirable properties such as biodegradability, as well as desirable interconnected macropores that are large enough and prevalent enough to allow vascularization when used in vivo, for example. Additionally, in examples where the macropores have sizes ranging from 300-600 ⁇ and are highly interconnected, those features are desirable for tissue ingrowth and vascularization. Further, using our methods, scaffolds with complex shapes and different macropore patterns can be easily fabricated, since the macrostructure of the scaffold is the positive replication of the polymer sponge templates.
  • sponge as a template to hold the precursor materials prior to heating, and during heating and glass formation, provides the advantage of 3D shape control.
  • scaffolds having complex shapes, as well as varying sizes and densities and patterns of macropores can be easily fabricated, since the macrostructure of the scaffold is the positive replication of the polymer sponge template.
  • the method utilizes 70mol S1O2 and 30mol CaO glass composition (also known as "70S30C”) as a precursor material.
  • 70S30C 30mol CaO glass composition
  • bioscaffolds comprising other compositions can be easily fabricated by starting with a gel and/or powder of an appropriate precursor composition.
  • the 70S30C gel particles are fabricated by the sol-gel process. Briefly, calcium nitrate tetrahydrate (Ca(N0 3 )2.4H 2 0) is dissolved in 0.05N acetic acid solution, to which tetramethylorthosilicate (TMOS) is added. In some sol gel process examples, 0.003N Attorney Docket No. : 137590.04502 ammonia solution is used instead of acetic acid. However, the inventors have observed that bioscaffolds prepared with ammonia solution usually result in relatively lower surface area.
  • TMOS tetramethylorthosilicate
  • the molar ratio of TMOS to Ca(N0 3 )2.4H 2 0 is 7:3, although the ratio can be altered to accomplish a desired result in accordance with the inventions herein. After vigorous stirring, samples are aged at 40°C to produce gelled samples.
  • the gelled samples were then dried, crushed and sieved through 225 size mesh to form a powder.
  • the resulting powder is further ground for 3 hours in an attrition mill.
  • the colloidal gel glass slurry was dried again to yield a fine dried xerogel powder.
  • a new slurry was then prepared by adding 25 wt of this dried xerogel powder to 75 wt aqueous medium, containing 1 wt binder and 0.5 wt dispersant.
  • the slurry was stirred vigorously to ensure substantial homogeneity before infiltrating with a polyurethane (PU) sponge that includes about 60 pores per inch. The excessive slurry was squeezed out.
  • PU polyurethane
  • the as -coated slurry-infiltrated sponge was dried at 40 C in an oven. Then, the samples were heated at l°C/min up to about 600°C to decompose the PU of the sponge. Next, the resulting article was heated to 700°C at a rate of 2°C/min and sintered for 2 hours, before cooling down to room temperature.
  • the sponge was a polyurethane foam sponge material available as a standard catalog item from The Filter Factory, Inc. of San Ynez, California, and identified as "Bulk reticulated polyurethane foam fan filter media" catalog number RF .5R-60. That commercially available foam sponge material was characterized as polyurethane having about 60 pores per inch. A small rectangular section of that sponge material was compressed by squeezing before placing it in the slurry composition in a container. Soaking was allowed for about 5 minutes. Excess slurry was removed by squeezing the soaked sponge. The sponge was then dried as described herein, before heating to a temperature and time sufficient to convert the slurry composition to a glass material in the form of a scaffold having dimensions of about 1 cm by 1 cm by 0.3 cm.
  • Figure 1 illustrates a flow chart of the methods used.
  • Figure 2 shows a scanning electron micrograph of an interconnected porous bioactive glass scaffold.
  • Figure 3 illustrates nanopore size distribution in accordance with an exemplary bio scaffold herein.
  • Figure 4 illustrates various surface area of exemplary scaffolds prepared from the mixture of acid-catalyzed and basic-catalyzed sol-gel particles listed in Table 1.
  • Figure 5 illustrates additional pore size distributions of scaffolds prepared from the mixture of acid-catalyzed and basic-catalyzed sol-gel particles listed in Table 1.
  • Bioscaffolds having varying levels and patterns of porosity can be provided by starting with a precursor gel and/or powder of appropriate composition. Surface area of the resulting scaffolds can be selectively changed and controlled, such as by using a basic or acidic solution as catalyst.
  • a basic or acidic solution as catalyst.
  • 0.003N ammonia solution or some other basic solution like sodium hydroxide solution
  • acidic solution like hydrochloric acid and nitric acid
  • acetic acid can be used instead of acetic acid as a catalyst for the gelation of solution.
  • basic solutions make surface area of xerogel powders small, while acid solutions create xerogels with high specific surface area.
  • scaffolds prepared with ammonia solution resulted in relatively lower surface area than scaffolds prepared using acetic acid.
  • nanopore distribution is selectively variable, as illustrated in Fig. 2, Fig. 4, and Fig. 5.
  • Optimal nanopore distribution and optimal pore sizes will vary depending upon such factors as specific tissue (bones, teeth structures, and other structural members) to be repaired or replaced, its location in body, the age of the patient, the nature of the injury, and other factors.
  • scaffolds fabricated by various techniques including 3D printing, freeze casting, polymer sponge replication method, using conventional ceramic and/or glassy materials were never sufficiently biodegradable.
  • scaffolds made from sol-gel materials were nanoporous, but in all such cases any macropores or interconnected macropores "throats" were too small, barely achieving 100 ⁇ size.
  • previous methods of fabricating sol-gel derived scaffolds by others have relied on the use of hydrofluoric acid to accelerate gelation in order to freeze the rapidly evolving macrostructure. Residual fluorine ions from such methods have shown to impart potentially cyto-toxic effects.
  • Nanopores are the result of the sol-gel process.
  • the alkoxide chemical such as TMOS hydrolyzes and poly-condensates into nano-particles.
  • Addition of catalyst controls the transition of the sol into a gel.
  • the dry gel includes these weakly connected nano-particles.
  • the nanopores are the interstitial space between these nano-particles.
  • the hydrolysis and poly-condensation process can be varied resulting in different size and texture of the nano-particles.
  • the scaffold made of these particles yield various surface area and nanopore size. Simply put, the size of the nanopores can be controlled by choosing appropriate acid or basic catalysis condition.
  • TMOS TMOS
  • TEOS calcium nitrate
  • other chemical equivalents compatible with the sol-gel process can be used.
  • the use of such chemicals to synthesize nanoporous materials was exclusively through sol-gel process.
  • various other chemical compositions can be easily synthesized by mixing these or similar precursors in different molar ratio.
  • the exemplary proof-of-concept utilized a 70S30C composition because that composition has been shown to be bioactive. Nonetheless, the methods herein can be easily applied to other compositions in a sol-gel process, followed by sponge replication methods herein to yield scaffolds for use in other material science applications.
  • the inclusion of nanopores makes the scaffold significantly more biodegradable, as well as more bioactive.
  • the scaffolds further include macropores with size ranging from about 300 to about 600 ⁇ , the macropores being highly interconnected, which is desirable and beneficial for tissue ingrowth and vascularization.
  • the scaffolds with complex shape and different macropores can be easily fabricated, since the macrostructure of the scaffold is the positive replication of the polymer sponge templates.
  • the scaffold can be used in hard tissue engineering.
  • the exemplary scaffolds described herein made from 70S30C alone may not be suitable for use in in-vivo, load-bearing applications.
  • embodiments that are suitable for load bearing applications are contemplated through selection and control of precursors of glassy and/or ceramic materials and the levels and types of porosity, as well as control and design of shapes and dimensions of scaffolds.
  • the selection of the sponge template for such features as pore size, pore interconnections, sponge material type, and shapes will determine many features of the positive replication that becomes the scaffold upon heating and conversion of a composition absorbed into and onto the sponge, followed by thermal degradation of the sponge template.
  • the infiltrated sponge after soaking, spraying, injecting, or otherwise infiltrating the sponge with slurry, the infiltrated sponge can be evaluated for slurry content, and slurry content amounts adjusted by the user. Evaluating can be by weighing, for example, and comparing sponge weight before infiltration to post-infiltration weight. To accomplish a desired slurry composition that will yield the desired scaffold having a desired density, any excess slurry can optionally be removed by wringing, squeezing, compressing, using centrifugal or centripetal forces, drying the sponge, and combinations thereof.
  • bioscaffolds prepared by the present methods such as 1) improving the mechanical properties of the bioscaffold through selection of materials and the method steps, as well as the template; 2) tailoring the surface areas to meet various requirements on degradation rate of the scaffold, such as by increasing or decreasing the nanoporosity through selection of acids, bases, and catalysts as described herein, and 3) further control of macroporosity and nanoporosity through variation of materials and methods herein.
  • an advantage of the methods herein is that bioscaffolds can be produced having various sizes of nanopores and with selectively variable surface areas. Those features can be provided and controlled easily by mixing the acid-catalyzed high-surface area powder(s) with the basic-catalyzed low-surface area powder in appropriate preselected ratio(s).
  • scaffolds prepared by various mass ratio of acid-catalyzed and basic-catalyzed powder are listed in Table 1.
  • Fig. 3 shows the overall surface area of these bioscaffolds, which is linearly proportional to the ratio of acid-catalyzed and basic-catalyzed powders.
  • the average nanopore size can be controlled in this way too (as shown in Fig. 4). Therefore, surface area and nanopore size of bioscaffold can be easily tailored continuously. Such control allows for tailoring of the degradation rate of resulting scaffolds for various applications.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Materials Engineering (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Manufacturing & Machinery (AREA)
  • Ceramic Engineering (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne des tuteurs biocompatibles et leurs procédés de fabrication. Lesdits procédés permettent d'obtenir un tuteur en verre bioactif nanomacroporeux interconnecté de qualité présentant une grande surface active, en combinant un procédé sol-gel et des procédés de réplication impliquant une éponge polymère. La fabrication d'un biotuteur macroporeux uniformément nanoporeux et interconnecté est illustrée par un exemple utilisant un matériau de départ comprenant une composition de verre constituée de 70 % en moles de SiO2 et de 30 % en moles de CaO. Le biotuteur comprend une série de macropores ouverts et interconnectés d'une taille de 300 à 600 µm, comme nécessaire en vue d'une pénétration et d'une vascularisation tissulaires. Dans le même temps, des nanopores également présents permettent d'avoir une grande surface spécifique (>150 m²/g), ce qui est nécessaire pour améliorer la vitesse de dégradation de la structure. Ces biotuteurs se montrent très prometteurs dans le domaine de l'ingénierie des tissus durs.
PCT/US2011/028695 2010-03-16 2011-03-16 Fabrication de biotuteurs en verre poreux par des procédés sol-gel et faisant appel à une éponge polymère Ceased WO2011116112A2 (fr)

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US13/617,293 US9321675B2 (en) 2010-03-16 2012-09-14 Fabrication of porous glass bioscaffolds by sol-gel and polymer sponge methods

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101278099B1 (ko) 2012-01-31 2013-06-24 고려대학교 산학협력단 다공성 생체세라믹 입자의 제조방법 및 이에 의해 제조된 다공성 입자
CN105288725A (zh) * 2015-11-23 2016-02-03 海安南京大学高新技术研究院 一种纳米氧化锆多孔组织工程支架及其制备方法
CN107308499A (zh) * 2017-04-19 2017-11-03 上海师范大学 纳米生物玻璃/高分子三维多孔材料及其制备方法和应用
CN110227178A (zh) * 2019-07-30 2019-09-13 广东工业大学 一种生物陶瓷支架及其应用

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* Cited by examiner, † Cited by third party
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CN108892145B (zh) * 2018-07-17 2020-07-03 佛山今兰生物科技有限公司 一种SiO2基生物活性组织修复材料的量化生产方法

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US6993406B1 (en) * 2003-04-24 2006-01-31 Sandia Corporation Method for making a bio-compatible scaffold
US7758803B2 (en) * 2006-01-11 2010-07-20 Jiang Chang Resorbable macroporous bioactive glass scaffold and method of manufacture
CA2673379C (fr) * 2006-12-21 2015-02-24 Numat As Echafaudage d'oxyde metallique

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101278099B1 (ko) 2012-01-31 2013-06-24 고려대학교 산학협력단 다공성 생체세라믹 입자의 제조방법 및 이에 의해 제조된 다공성 입자
CN105288725A (zh) * 2015-11-23 2016-02-03 海安南京大学高新技术研究院 一种纳米氧化锆多孔组织工程支架及其制备方法
CN107308499A (zh) * 2017-04-19 2017-11-03 上海师范大学 纳米生物玻璃/高分子三维多孔材料及其制备方法和应用
CN110227178A (zh) * 2019-07-30 2019-09-13 广东工业大学 一种生物陶瓷支架及其应用

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