WO2013012731A2 - Dispositif orthopédique composite renforcé par des fibres - Google Patents

Dispositif orthopédique composite renforcé par des fibres Download PDF

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Publication number
WO2013012731A2
WO2013012731A2 PCT/US2012/046694 US2012046694W WO2013012731A2 WO 2013012731 A2 WO2013012731 A2 WO 2013012731A2 US 2012046694 W US2012046694 W US 2012046694W WO 2013012731 A2 WO2013012731 A2 WO 2013012731A2
Authority
WO
WIPO (PCT)
Prior art keywords
fixation device
orthopaedic
shaft
plastic
inner core
Prior art date
Application number
PCT/US2012/046694
Other languages
English (en)
Other versions
WO2013012731A3 (fr
Inventor
Sied W. Janna
Henry B. Faber
Nicholas S. Ritchey
Original Assignee
Smith & 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 & Nephew, Inc. filed Critical Smith & Nephew, Inc.
Publication of WO2013012731A2 publication Critical patent/WO2013012731A2/fr
Publication of WO2013012731A3 publication Critical patent/WO2013012731A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/04—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints
    • A61F5/05—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints for immobilising

Definitions

  • Such fixation devices 10 are formed, for example, of multiple layers 12 of a biocompatible plastic, such as polyetheretherketoiie (PEEK), and a reinforcing fiber, such as carbon fiber.
  • PEEK polyetheretherketoiie
  • an orthopaedic fixation device in one general aspect, includes an inner core and a shaft.
  • One of the inner core and the shaft is formed of biocompatible plastic and the other of the inner core and the shaft is formed of metal.
  • the plastic inner core or plastic shaft forming a load-bearing, structural element of the fixation device.
  • the biocompatible plastic includes a multi-layered, fiber-reinforced composite.
  • the composite includes silver fibers.
  • the shaft includes a medicament coating.
  • the shaft defines a channel for a medicament.
  • the fixation device further includes a porous layer covering the channel.
  • the device further includes a
  • the plastic inner core or plastic shaft provides at least 10% of the bending or torsional stiffness properties of the fixation device.
  • the plastic inner core or plastic shaft provides greater than 50% of the bending or torsional stiffness properties of the fixation device.
  • the biocompatible plastic comprises a carbon- fiber, reinforced PEEK.
  • the inner core includes a resorbable fill material that is configured to be resorbed into a body following implantation of the fixation device. The resorption of the fill material decreases stiffness of the fixation device after implantation.
  • the device further includes a RFID element embedded in the fixation device. The RFID element is disposed in a pocket defined within the fixation device.
  • the device further including one or more peaks running along ail or a portion of a length of the fixation device forming a longitudinal ridge that can act to limit rotation of the fixation device in- situ
  • Fig. 1 is a perspective view of a multi-layered, fiber-reinforced composite orthopaedic fixation device.
  • Fig. 2 is a cross-section view of the fixation device of Fig. 1 .
  • Fig. 3 illustrates a fixation device including silver fibers.
  • Fig. 4 is a cross-sectional end view of a fixation device having a fiber-reinforced composite shaft, and a metal core.
  • Fig. 5 is a cross-sectional end view of an alternative embodiment of the fixation device of Fig. 4,
  • Fig. 6 is a cross-sectional end view of an additional alternative embodiment of the fixation device of Fig. 4
  • Fig. 7 is a side view of a fixation device.
  • Fig. 8 is a side view of a distal region of a fixation device.
  • Fig. 9 is a cross-sectional end view of a fixation device.
  • Fig. 10 is a side view of a distal region of a fixation device.
  • one or more layers 12 of the biocompatible plastic can also include silver fibers 16.
  • parallel silver fibers 16 are oriented, for example, about ninety degrees offset from parallel carbon fibers 14 within a layer 12.
  • single element silver fibers are wound with at least one of the multiple layers 12.
  • silver fibers are woven to form a mesh, and the mesh is wound with at least one of the multiple layers 12.
  • silver fiber is partially impregnated in a tape, and the tape is used to form one or more layers 12.
  • silver fibers form part of the first, inner winding layer 12 and also form part of the last, outer layer 12.
  • an orthopaedic implant 20 having an inner body or core 22 and an outer body 24 in the form of, for example, a shaft.
  • the inner body 22 is at least partially geometrically defined by a cannulation 18.
  • the inner body and the outer body may be made from biocompatible metal or polymers.
  • suitable metals may be titanium, titanium alloys, steel, cobalt-chromium alloys, tantalum, magnesium, shape memory alloys, such as Nitonol.
  • suitable polymers may be polyetheretherketones (PEEK), also referred to as polyketones, poly-alpha-hydroxy acids, polycapropactones, polydioxanones, polyesters, polyglycolic acid, polyglycols, polylaetides, polylactie acid, poly-D,L-lactic acid, poly-L,L-lactic acid, polvorthoesters, polyphosphates, polyphosphoesters, poIyphosphonat.es, polysaccharides,
  • PEEK polyetheretherketones
  • the inner body 22 is made of metal and the outer body is made of carbon-fiber, reinforced PEEK having multiple layers 12.
  • the outer body 24 can be formed by the multiple layers 12 without or without the silver fibers 16.
  • the inner body 22 can be formed of a biocompatible polymer and the outer body 24 can be metal.
  • the outer body 24 is depicted as circular but could have other shapes, such as trapezoidal, square, triangular, octagonal, C-shaped, and U-shaped.
  • a metal sleeve 28 formed, for example, of titanium.
  • the sleeve 28 can completely enclose the circumference of the plastic outer body 24, or can extend along only a portion of the circumference of the outer body 24 to adjust the stiffness of the fixation device 20 in a particular area.
  • the elastic modulus and/or the moment of inertia of the fixation device 20 can be adjusted by the selection of the material of the inner body 22, the diameter of the inner body 22 , and the shape of the inner body 22 to hone in on the desired stiffness of the fixation device 20.
  • the metal sleeve 28 can have a selected length and circumference to also adjust the stiffness of the fixation device 20, or the metal sleeve 28 can be excluded.
  • the metal inner body can include a fill material 26, for example, calcium phosphate or calcium sulfate, that is resorbed into the body after implantation providing pathways for blood flow through the fixation device 20.
  • a fill material 26 for example, calcium phosphate or calcium sulfate
  • the resorption of the fill material also acts to decrease the stiffness of the fixation device after implantation. This is significant as the bone should adapt to the decreasing stiffness and thus prevent or significantly reduce stress shielding.
  • the outer body is shaped to allow placement of the fill material 26.
  • the fixation device has a cylindrical inner body 22' and a shaped outer body 24'.
  • Fig. 6 is similar to Fig. 5 but has a hexagonal shaped outer body 24" surrounding a cylindrical inner body 22". Placing the fill material 26 on the outer body rather than the inner body provides an advantage because placement on the outer body has a larger effect on stiffness due to the increased moment of inertia.
  • the fixation device 20 is an intramedullary nail for the long or short bones but other applications are possible.
  • the fixation device may form a hip stern, shoulder stern, a tibial stem, a femoral stern, stems used in revision surgery, finger prosthetics, or a toe prosthesis.
  • the device may also form a bone plate, hip implant, or other devices used, for example, in loiee, shoulder, or hip replacement techniques or surgical procedures.
  • the polymeric inner body 22 or polymeric outer body 24 is a load-bearing, structural element of the fixation device 20 with substantially rigid properties designed to withstand pressures encountered during insertion and retention in the bone.
  • the overall bending stiffness of the fixation device 20 is about 5 300 N m2.
  • the overall torsional stiffness of the fixation device 20 is about 35 600 N m2.
  • the individual stiffness of the fiber-reinforced composite portion and of the metal portion is determined by proper selection of the material's Young's modulus and the structure geometry or moment of inertia to provide adequate load bearing property.
  • the polymeric inner body 22 or polymeric outer body 24 extends substantially the entire length of the fixation device 20.
  • the polymeric outer body has a wall thickness in the range of, for example, about 0.1mm to 9mm, or about 0.1mm to 7.5mm, and the metal inner bod ⁇ ' has a diameter in the range of, for example, about 0.25mm to 15.5mm, or about 2mm to 8mm.
  • the polymeric inner body 22 or the polymeric outer body 24 provides at least 10% of the bending and/or torsional stiffness properties of the fixation device 20, at least 25% of the bending and/or torsional stiffness properties, at least 40% of the bending and/or torsional stiffness properties, and preferably greater than 50% of the bending and/or torsional stiffness properties.
  • the fixation device 10 or 20 can include a medicament coating that enhances blood flow or bone healing, for example, hydroxy apatite, angiogenic factors, BMP, and/or enhances anti-infection properties such as silver and/or an antibiotic dip coating.
  • a medicament coating that enhances blood flow or bone healing, for example, hydroxy apatite, angiogenic factors, BMP, and/or enhances anti-infection properties such as silver and/or an antibiotic dip coating.
  • Calcium phosphate or calcium sulfate can be impregnated in the coating to serve as a bone void tiller.
  • a fixation device 40 can define a channel 42 in its outer surface to, for example, promote blood flow or hold a medicament.
  • the channel 42 has a spiral shape but other shapes are possible.
  • the channel 42 may be straight, C-shaped, U-shaped, T-shaped, or dovetailed.
  • the channel 42 may be formed by thermoforming or machining.
  • all or a portion of the channel 42 is covered by a metal or polymer outer porous layer 44 and, in use, the medicament migrates through the porous layer.
  • the fixation device may have a reduction in cross-section in the area of the layer 44 to maintain its overall shape such that the diameter of the fixation device is not increased.
  • the outer layer 44 is a sponge that is wrapped about the fixation device. The sponge may be soaked in BMP or collagen.
  • the outer layer is monolithic and C-shaped such that it can be expanded for placement over the fixation device but spring back to lock it in place once the layer 44 is located, in another embodiment, the outer layer 44 may be made from two or more components and assembled, for example, by welding, fastening, or mechanical locking, after placement on the fixation device.
  • the outer layer 44 may be located relative to the channel and welded to the outer surface of the fixation device.
  • the outer layer may be formed by selective laser sintering (SLS) such that the layer 44 has controlled porosity.
  • Fig. 7 also illustrates an RFID chip 46 embedded in the fixation device.
  • the RFID chip 46 ma ⁇ ' be inserted in between layers 12 as the fixation device is formed.
  • a pocket is formed by machining or thermoforming, and the RFID 46 is placed in the pocket.
  • a fracture fixation device For most patients, time is of the essence for placement of a fracture fixation device, but for high risk patients, it ma ⁇ ' be advantageous to provide a patient specific solution, even though the patient specific solution may delay surgery due to the time necessary for manufacturing.
  • key patient data is sent to the implant, manufacturer, and the implant manufacturer provides an implant based upon an analysis of the patient data.
  • the manufacturer may create a custom implant based upon the data or ha ve an inventory of implants from which the best match is selected.
  • Patient data may include MRI or X-ray images, bone density information, and comorbidity.
  • magnification generally must also be known.
  • the outer cross-section of the fixation device 10 or 20 can be, for example, circular, trapezoidal, square or triangular.
  • the best matched cross-sectional shape for a given patient can be determined pre-operatively by MRI or X-ray imaging, or various shaped fixation devices can be provided and selected from during surgery. Similarly, the desired bow or bend of the fixation device may be determined. Using bone density, an implant may be selected or manufactured that has a dynamizing slot. Similarly, osteoporotic screws for fixating the implant may be provided by the manufacturer. Based upon comorbidity, such as diabetes, adjunct fixation or medicaments, such as BMP, may be provided.
  • the fixation device can have an increased cross-section 50 around the distal screw hole 52 (Fig. 8) to increase the wall thickness and reduce the risk of a stress riser.
  • the fixation device can have a cross-section with one or more spikes or peaks 60 running along all or part of the length of the fixation device (Fig, 9) to form a longitudinal ridge that can act to limit rotation of the fixation device in-situ.
  • the fixation device can include a chamfer 70 (Fig, 10) at its distal tip 72 to reduce the risk of the fixation device impinging upon the interior wall of the intramedullary canal.
  • the fixation device can define an internal cannulation extending the length of the fixation device.

Landscapes

  • Health & Medical Sciences (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif de fixation orthopédique comprenant un noyau interne et une tige, l'un du noyau interne et de la tige étant constitué d'une matière plastique biocompatible et l'autre du noyau interne et de la tige étant constitué de métal, le noyau interne en matière plastique ou la tige en matière plastique formant un élément structural de support de charge du dispositif de fixation.
PCT/US2012/046694 2011-07-15 2012-07-13 Dispositif orthopédique composite renforcé par des fibres WO2013012731A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161508417P 2011-07-15 2011-07-15
US61/508,417 2011-07-15

Publications (2)

Publication Number Publication Date
WO2013012731A2 true WO2013012731A2 (fr) 2013-01-24
WO2013012731A3 WO2013012731A3 (fr) 2013-04-04

Family

ID=47558682

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2012/046694 WO2013012731A2 (fr) 2011-07-15 2012-07-13 Dispositif orthopédique composite renforcé par des fibres

Country Status (1)

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WO (1) WO2013012731A2 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8721643B2 (en) 2005-08-23 2014-05-13 Smith & Nephew, Inc. Telemetric orthopaedic implant
US9492210B2 (en) 2008-10-15 2016-11-15 Smith & Nephew, Inc. Composite internal fixators
US9849216B2 (en) 2006-03-03 2017-12-26 Smith & Nephew, Inc. Systems and methods for delivering a medicament
US10028776B2 (en) 2010-10-20 2018-07-24 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants
US10525168B2 (en) 2010-10-20 2020-01-07 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications
US10525169B2 (en) 2010-10-20 2020-01-07 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications
US10857261B2 (en) 2010-10-20 2020-12-08 206 Ortho, Inc. Implantable polymer for bone and vascular lesions
US11058796B2 (en) 2010-10-20 2021-07-13 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications
US11207109B2 (en) 2010-10-20 2021-12-28 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications
US11291483B2 (en) 2010-10-20 2022-04-05 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants
US11351261B2 (en) 2010-10-20 2022-06-07 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants
US11484627B2 (en) 2010-10-20 2022-11-01 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5571202A (en) * 1993-01-19 1996-11-05 Mathys Ag Bettlach Shaft for an articulation endoprosthesis
US20040010313A1 (en) * 2000-06-10 2004-01-15 Roger Aston Porous and/or polycrystalline silicon orthopaedic implant
US20080133022A1 (en) * 2006-09-29 2008-06-05 Caylor Edward J Acetabular cup having a wireless communication device
US20100016985A1 (en) * 2008-07-18 2010-01-21 North Carolina State University Processing of biocompatible coating on polymeric implants

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5571202A (en) * 1993-01-19 1996-11-05 Mathys Ag Bettlach Shaft for an articulation endoprosthesis
US20040010313A1 (en) * 2000-06-10 2004-01-15 Roger Aston Porous and/or polycrystalline silicon orthopaedic implant
US20080133022A1 (en) * 2006-09-29 2008-06-05 Caylor Edward J Acetabular cup having a wireless communication device
US20100016985A1 (en) * 2008-07-18 2010-01-21 North Carolina State University Processing of biocompatible coating on polymeric implants

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8721643B2 (en) 2005-08-23 2014-05-13 Smith & Nephew, Inc. Telemetric orthopaedic implant
US9849216B2 (en) 2006-03-03 2017-12-26 Smith & Nephew, Inc. Systems and methods for delivering a medicament
US9492210B2 (en) 2008-10-15 2016-11-15 Smith & Nephew, Inc. Composite internal fixators
US11096726B2 (en) 2008-10-15 2021-08-24 Smith & Nephew, Inc. Composite internal fixators
US10357292B2 (en) 2008-10-15 2019-07-23 Smith & Nephew, Inc. Composite internal fixators
US10857261B2 (en) 2010-10-20 2020-12-08 206 Ortho, Inc. Implantable polymer for bone and vascular lesions
US10525168B2 (en) 2010-10-20 2020-01-07 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications
US10525169B2 (en) 2010-10-20 2020-01-07 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications
US10517654B2 (en) 2010-10-20 2019-12-31 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants
US11058796B2 (en) 2010-10-20 2021-07-13 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications
US10028776B2 (en) 2010-10-20 2018-07-24 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants
US11207109B2 (en) 2010-10-20 2021-12-28 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications
US11291483B2 (en) 2010-10-20 2022-04-05 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants
US11351261B2 (en) 2010-10-20 2022-06-07 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants
US11484627B2 (en) 2010-10-20 2022-11-01 206 Ortho, Inc. Method and apparatus for treating bone fractures, and/or for fortifying and/or augmenting bone, including the provision and use of composite implants, and novel composite structures which may be used for medical and non-medical applications
US11850323B2 (en) 2010-10-20 2023-12-26 206 Ortho, Inc. Implantable polymer for bone and vascular lesions

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Publication number Publication date
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