GB2461743A - Medical device or composition comprising at least two inorganic components - Google Patents

Medical device or composition comprising at least two inorganic components Download PDF

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Publication number
GB2461743A
GB2461743A GB0812734A GB0812734A GB2461743A GB 2461743 A GB2461743 A GB 2461743A GB 0812734 A GB0812734 A GB 0812734A GB 0812734 A GB0812734 A GB 0812734A GB 2461743 A GB2461743 A GB 2461743A
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United Kingdom
Prior art keywords
glass
composition
inorganic components
composition according
inorganic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
GB0812734A
Other versions
GB0812734D0 (en
Inventor
Michael Hall
Malcolm Brown
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smith and Nephew PLC
Smith and Nephew Inc
Original Assignee
Smith and Nephew PLC
Smith and Nephew Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smith and Nephew PLC, Smith and Nephew Inc filed Critical Smith and Nephew PLC
Priority to GB0812734A priority Critical patent/GB2461743A/en
Publication of GB0812734D0 publication Critical patent/GB0812734D0/en
Publication of GB2461743A publication Critical patent/GB2461743A/en
Withdrawn legal-status Critical Current

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Classifications

    • 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
    • A61L27/58—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0092—Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/026—Ceramic or ceramic-like structures, e.g. 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body

Abstract

A device or composition that is at least in part degradable, the composition comprises at least two inorganic components at least one of the components is degradable. In an embodiment a glass structure with a shell made of glass A and a core made of glass B, where glass A degrades slower that glass B is described. Glass A can be a slowly degrading phosphate glass or a silicate glass formulation of the 45S5 Bioglass type. Glass B can be a phosphate- or silicate-based glass. In an embodiment the devices or compositions is of either fibre or particulate form. The compositions and devices may be used in medical devices such as orthopaedic reconstruction and trauma products, for instance implants, pins or plates.

Description

Medical Compositions and Devices The present invention relates to compositions and devices that are at (east in part degradable.
Bioresorbable glass compositions, such as phosphate-based glasses, degrade in-vivo by surface dissolution. These can be used on their own, or as part of composite structures to be implanted.
For example, resorbable glass fibres have been produced to reinforce composites. However, current embodiments of these composites cannot retain their advantageous mechanical properties upon incubation long enough for tissue repair applications, as the surface of the glass starts degrading as soon as water comes into contact with it, effectively destroying the interface of the composite.
The protection of glasses, and glass fibres against moisture, rust, heat or mechanical damage (e.g. abrasion) etc. has been studied in the past. The main process to provide such protection is coating of the glass fibre, with different compounds depending on the applications sought. For example, glass fibres coated with polymers are known.
We have found that polymer-based coatings applied to glasses such as phosphate-based glasses, do not sufficiently retard dissolution of the glass: the initial mechanical properties of the resorbable composites are lost within days of incubation.
According to an aspect of the present invention there is provided a device comprising at least two inorganic components, wherein at least one of the inorganic components is degradable in a medium.
According to an aspect of the present invention there is provided a composition comprising at least two inorganic components, wherein at least one of the inorganic components is degradable in a medi urn.
Each of the inorganic components may be degradable. The inorganic components may have different degradation rates in a medium.
* *. The medium may be a fluid. The fluid may be a liquid. The liquid may be aqueous. The fluid may be a bodily fluid. * *** *
Preferably, the inorganic components are biocompatible.
* * The inorganic component may be a glass material. One or more inorganic components may be * glass materials. The composition may comprise two or more glass components. ***S
*..: The inorganic component may be a ceramic material. One or more inorganic components may be :hh1ceramic materials. The composition may comprise two or more ceramic materials.
The inorganic components may comprise glass and ceramic materials.
Compositions or devices according to the present invention may be in the form of fibres.
Compositions or devices according to the present invention may be in the form of particulates.
Compositions or devices according to the present invention may comprise a first inorganic component surrounded by a second, third, fourth etc inorganic component.
For example, the composition or device may be in the form of a fibre, comprising an inner core of a first inorganic component surrounded by an outer layer (shell) of a second inorganic component.
The composition or device may be a multilayer structure. For example, the composition or device may be in the form of a fibre, comprising an inner core of a first inorganic component surrounded by outer layers of a second, third, fourth etc inorganic component.
According to embodiments of the present invention, there is provided a composition comprising a first glass component and a second glass component, wherein the first and second glass components have different degradation rates in a medium.
According to embodiments of the present invention, there is provided a device comprising a first glass component and a second glass component, wherein the first and second glass components have different degradation rates in a medium.
Embodiments of the invention may comprise a glass structure, preferentially a fibre, with a shell made of glass A, and a core made of glass B, where glass A degrades substantially slower than glass B. The outer shell made of glass A has the function of stopping the early surface dissolution of the fibre, thereby increasing the durability of the structure. The layer of glass A is however thin enough to allow degradation of both glass A and glass B to take place after a determined period of time, so that the whole fibre can be dissolved or resorbed.
Glass A has the primary function of protecting glass B to resist dissolution, so that if incorporated in a composite, the interface can be maintained for a required period of time. Glass A can be, for example, a very slow degrading phosphate glass (potentially containing iron-, calcium-, titanium-, * ,, silicon-oxide, etc.), or a silicate glass formulation of the 45S5 Bioglass� type, or derivative thereof, * to make such a formulation more quickly resorbable than Bioglass� itself. Dissolution rate of glass * A should be lower than 0.00085 mg.cm2.h1 in the fibre form, at 37°c in deionised water.
The fact that the shell of glass A is much thinner than the core of the structure allows for surface-area controlled processes, such as solution ion-exchange, to eventually degrade the shell. Glass A * can also be any resorbable/soluble glass formulation which does not lose any substantial mass over 8 weeks of incubation in simulated body fluid (SBF) or phosphate buffered saline (PBS) at 37°C. *.S*
B has the primary function of giving strength and stiffness to the modified fibre. Glass B can be a phosphate-or silicate-based glass, which will degrade by dissolution when water breaches through the layer of glass A. Glass B should degrade much faster than Glass A, so that the mass Loss of the glass structure resembles Figure 1 or 2, where "I" is the time at which water has breached through the layer of glass A. Preferably, I is 8 to 12 weeks if the glass fibres are used in a composite.
In the fibre form, embodiments of the invention have similarities in structure to optical glass fibres, where shell and core are processed simultaneously. In other forms, such as particulates, the core/shell structure may be in the form of a coated tablet. Fibres can be used on their own, as part of a woven or non-woven mesh, or as reinforcement in a long or short fibre composite, fully resorbable or not. Particulates can be used as a powder, compressed into tablet forms, or as reinforcement in a composite (fully resorbable or not).
Applications can encompass bioresorbable devices and biodegradable commodity objects, which require retention of adequate stiffness and strength for periods of time, but ultimate resorption/degradation to full mechanical properties and mass loss.
Devices and compositions according to embodiments of the present invention may comprise fibres, particulates, any moulded glass shape (for example discs, rods, diamonds, spheres, etc), where the main body of the structure is made of a phosphate-based glass, or any soluble glass formulation, and the shell/outer surface is made of a slower degrading glass than the core.
Embodiments of the present invention may comprise a reverse structure, where the shell is a more rapidly soluble glass, potentially containing actives, or salts, or ions, which are beneficial when released from the structure by dissolution, leaving behind a more durable architecture of slower-degrading glass.
Compositions and devices according to embodiments of the present invention allow the control of the degradation/dissolution of a resorbable glass structure, especially a fibre, over a longer period of time than what would be achieved by standard processing or annealing. They also have the advantage of being fully resorbable, unlike most of the polymer coatings of the prior art.
Used as part of a resorbable composite, the devices/compositions enable the retention of mechanical properties (modulus and strength) over a longer period of time than mono-component glass structures. * **
**. Compositions and devices according to embodiments of the present invention may be used in medical devices such as orthopaedic reconstruction and trauma products, for example implants, pins, plates, or the like. * * * I.. * **** * *.I.
S
*...S'
S

Claims (14)

  1. CLAIMS1. A device or composition comprising at least two inorganic components, wherein at least one of the inorganic components is degradable in a medium.
  2. 2. A device or composition according to claim 1, wherein each of the inorganic components is degradable.
  3. 3. A device or composition according to claim 1 or 2, wherein the inorganic components have different degradation rates in a medium.
  4. 4. A device or composition according to any preceding claim, wherein the medium is a liquid.
  5. 5. A device or composition according to any preceding claim, wherein the inorganic components are biocompatible.
  6. 6. A device or composition according to any preceding claim, wherein at least one inorganic component is a glass material.
  7. 7. A device or composition according to claim 6, wherein one or more inorganic components are glass materials.
  8. 8. A device or composition according to any preceding claim, wherein at least one inorganic component is a ceramic material.
  9. 9. A device or composition according to claim 8, wherein one or more inorganic components are ceramic materials.
  10. 10. A device or composition according to any preceding claim, wherein the device or composition is in the form of fibres.
  11. 11. A device or composition according to any of claims 1 to 9, wherein the device or composition * *. is in the form of particulates. * * * * S.
  12. 12. A device or composition according to any preceding claim comprising a first inorganic component surrounded by one or more other inorganic components.*
  13. 13. A device or composition comprising a first glass component and a second glass component, * wherein the first and second glass components have different degradation rates in a medium.*..:
  14. 14. A device or composition according to claim 13, wherein the first glass component is surrounded by the second glass component.
GB0812734A 2008-07-11 2008-07-11 Medical device or composition comprising at least two inorganic components Withdrawn GB2461743A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GB0812734A GB2461743A (en) 2008-07-11 2008-07-11 Medical device or composition comprising at least two inorganic components

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB0812734A GB2461743A (en) 2008-07-11 2008-07-11 Medical device or composition comprising at least two inorganic components

Publications (2)

Publication Number Publication Date
GB0812734D0 GB0812734D0 (en) 2008-08-20
GB2461743A true GB2461743A (en) 2010-01-20

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GB0812734A Withdrawn GB2461743A (en) 2008-07-11 2008-07-11 Medical device or composition comprising at least two inorganic components

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170360997A1 (en) * 2016-06-16 2017-12-21 The Curators Of The University Of Missouri Inorganic biodegradable substrates for devices and systems

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4737411A (en) * 1986-11-25 1988-04-12 University Of Dayton Controlled pore size ceramics particularly for orthopaedic and dental applications
JPH01275767A (en) * 1988-04-28 1989-11-06 Seiko Epson Corp Production of implant material
US5139424A (en) * 1987-06-15 1992-08-18 Yli Urpo Antti Implant for the replacement of a tooth or a part of the bone tissue
WO2000048552A1 (en) * 1999-02-16 2000-08-24 Nederlandse Organisatie Voor Toegepast-Natuurwetenschappelijk Onderzoek Tno Organoceramics
WO2001031072A1 (en) * 1999-10-28 2001-05-03 Mintek A method of operating a bioleach process with control of redox potential
KR20050075663A (en) * 2004-01-17 2005-07-21 요업기술원 Drug delivery system of ceramic coated by biodegradable and porous silica and process for preparing the same
EP1611906A1 (en) * 2004-06-30 2006-01-04 YLI-URPO, Antti A multilayer material
US20060093645A1 (en) * 2001-01-30 2006-05-04 Janas Victor F Glass scaffolds with controlled resorption rates and methods for making same
WO2007050387A2 (en) * 2005-10-21 2007-05-03 Wake Forest University Health Sciences Keratin bioceramic compositions
WO2007121457A1 (en) * 2006-04-18 2007-10-25 Smith & Nephew, Inc. Composition of biodegradable glass-ceramic
WO2008002682A2 (en) * 2006-06-29 2008-01-03 Orthovita, Inc. Bioactive bone graft substitute
WO2008035088A2 (en) * 2006-09-23 2008-03-27 The University Of Nottingham Degradable composite

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4737411A (en) * 1986-11-25 1988-04-12 University Of Dayton Controlled pore size ceramics particularly for orthopaedic and dental applications
US5139424A (en) * 1987-06-15 1992-08-18 Yli Urpo Antti Implant for the replacement of a tooth or a part of the bone tissue
JPH01275767A (en) * 1988-04-28 1989-11-06 Seiko Epson Corp Production of implant material
WO2000048552A1 (en) * 1999-02-16 2000-08-24 Nederlandse Organisatie Voor Toegepast-Natuurwetenschappelijk Onderzoek Tno Organoceramics
WO2001031072A1 (en) * 1999-10-28 2001-05-03 Mintek A method of operating a bioleach process with control of redox potential
US20060093645A1 (en) * 2001-01-30 2006-05-04 Janas Victor F Glass scaffolds with controlled resorption rates and methods for making same
KR20050075663A (en) * 2004-01-17 2005-07-21 요업기술원 Drug delivery system of ceramic coated by biodegradable and porous silica and process for preparing the same
EP1611906A1 (en) * 2004-06-30 2006-01-04 YLI-URPO, Antti A multilayer material
WO2007050387A2 (en) * 2005-10-21 2007-05-03 Wake Forest University Health Sciences Keratin bioceramic compositions
WO2007121457A1 (en) * 2006-04-18 2007-10-25 Smith & Nephew, Inc. Composition of biodegradable glass-ceramic
WO2008002682A2 (en) * 2006-06-29 2008-01-03 Orthovita, Inc. Bioactive bone graft substitute
WO2008035088A2 (en) * 2006-09-23 2008-03-27 The University Of Nottingham Degradable composite

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170360997A1 (en) * 2016-06-16 2017-12-21 The Curators Of The University Of Missouri Inorganic biodegradable substrates for devices and systems
US11013836B2 (en) * 2016-06-16 2021-05-25 The Curators Of The University Of Missouri Inorganic biodegradable substrates for devices and systems

Also Published As

Publication number Publication date
GB0812734D0 (en) 2008-08-20

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