WO1997037619A1 - Implant intervertebral - Google Patents

Implant intervertebral Download PDF

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Publication number
WO1997037619A1
WO1997037619A1 PCT/CH1996/000127 CH9600127W WO9737619A1 WO 1997037619 A1 WO1997037619 A1 WO 1997037619A1 CH 9600127 W CH9600127 W CH 9600127W WO 9737619 A1 WO9737619 A1 WO 9737619A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant according
perforations
lateral surface
hollow body
implant
Prior art date
Application number
PCT/CH1996/000127
Other languages
German (de)
English (en)
Inventor
Philip Procter
Original Assignee
Synthes Ag Chur
Synthes (U.S.A.)
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 Synthes Ag Chur, Synthes (U.S.A.) filed Critical Synthes Ag Chur
Priority to PCT/CH1996/000127 priority Critical patent/WO1997037619A1/fr
Publication of WO1997037619A1 publication Critical patent/WO1997037619A1/fr

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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/446Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
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    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0069Three-dimensional shapes cylindrical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097Visible markings, e.g. indicia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00179Ceramics or ceramic-like structures

Definitions

  • the invention relates to an intervertebral implant according to the preamble of patent claim 1.
  • intervertebral implants are used in the fusion of vertebral bodies, especially in the area of the lumbar spine.
  • One to two implants are used per intervertebral space.
  • the known implants can be filled with bone graft and similar materials, but do not allow the targeted introduction and distribution of so-called "bone morphogenic proteins” (BMP), contrast agents, or clinically therapeutic agents, semi-fluid bone substitute materials (e.g. bone meal) ) in the intervertebral space.
  • BMP bone morphogenic proteins
  • contrast agents contrast agents
  • clinically therapeutic agents semi-fluid bone substitute materials
  • semi-fluid bone substitute materials e.g. bone meal
  • the invention seeks to remedy this.
  • the invention is based on the problem of creating an intervertebral implant which, after the implant has been introduced into the intervertebral space, is used for the filling and targeted distribution of semi-fluid bone substitute material enriched with so-called "bone morphogenic proteins” (BMP), contrast agents, or clinical therapeutic agents Similar substances (e.g. bone meal) allowed.
  • the advantage can thus be achieved that with a suitable injection tool after the introduction of the hollow implant into the intervertebral space, thanks to its preferably laterally arranged perforations of different sizes, the free spaces between the implants (if two implants are inserted) in a targeted manner as the implants themselves can also be filled with semi-fluid bone substitute.
  • This technique can be used with minimally vasive and open surgical techniques
  • the spiral structure of the implant designed as a rotating body allows it to be rotated and screwed into the intervertebral space during the insertion phase
  • the implant which is designed as a hollow rotating body, is provided on its front surface with a closure cover or with an insertion opening for receiving a tool.
  • Semi-fluid bone meal or similar substances can be introduced into the hollow body both before and after the implantation.
  • the hollow body is furthermore provided with perforations in the form of hole structures which are preferably arranged longitudinally, initially becoming smaller and smaller at the end. The perforations are preferably limited to a longitudinal strip of the lateral surface arranged parallel to the longitudinal axis of the hollow body.
  • Two such longitudinal strips arranged symmetrically to the longitudinal axis are expediently provided, so that they are in the positions 0 ° and 180 ° to the diameter.
  • the position of these longitudinal strips is marked on the front of the implant.
  • the perforations allow targeted delivery of bone replacement material from the hollow body and the rapid ingrowth of the bone into the hollow body.
  • FIG. 1 is a perspective view of the implant according to the invention
  • FIG. 2 shows a longitudinal section through the implant according to the invention according to FIG. 1 with the representation of the injection / exit behavior of the bone replacement mass;
  • FIG. 3 shows a schematic illustration of two implants according to the invention, introduced into the intervertebral space according to FIG. 1.
  • the intervertebral implant shown in FIGS. 1 and 2 consists essentially of an elongated, cylindrical or prismatic hollow body 1 with a longitudinal axis 2, one
  • the outside of the outer surface 5, of the hollow body 1 designed as a rotating body has a three-dimensional, spiral-shaped structure 6 in the form of an external thread and is provided with a number of perforations 7.
  • the external thread has a pitch of at least 2 rr, preferably at least 2.5 mm, and a depth of 0, t
  • the structuring 6 can also consist of longitudinal grooves running parallel to the longitudinal axis 2 or of any other structural elements, such as teeth, perforations, knobs, tips or grooves, which partially cancel out the planarity of the surface.
  • the front wall 3 of the hollow body 1 is provided with an insertion opening 11 for the introduction of preferably semi-fluid bone substitute material 15.
  • the insertion opening 11 is expediently designed in the form of a deep blind hole which is concentric with the longitudinal axis 2 and which runs outwards into a profile (e.g. hexagon profile) in order to permit the inclusion of a drive tool for screwing in the implant.
  • the perforations 7 are restricted to a longitudinal strip 8 of the jacket surface arranged parallel to the longitudinal axis 2. Two such longitudinal strips 8 arranged symmetrically to the longitudinal axis 2 (0 ° and 180 ° position) can also be provided.
  • the longitudinal strip 8 is flattened in comparison to the remaining, unperforated jacket surface 5, preferably by an amount that corresponds at least to the height of the structuring 6 and is a maximum of 4 mm.
  • the flattening is preferably between 1.0 and 3 mm.
  • the average passage area of the perforations 7 is larger in the central area of the lateral surface 5 than in the area of the part of the lateral surface 5 adjacent to the front and rear wall 3, 4.
  • the average passage area of the perforations 7 in the central region of the lateral surface 5 is between 0.8 and 28.0 mm 2 , preferably between 1.8 and 12.0 mm 2 .
  • the average passage area of the perforations 7 is between 0.3 and 19.0 mm 2 , preferably between 0.5 and 7.0 mm 2 .
  • the number of perforations 7 per longitudinal strip 8 is between 3 and 8, preferably between 4 and 6.
  • the front wall 3 has a removable closure cover 9 with the insertion opening 11.
  • the front wall 3 or the closure cover 11 is provided with markings 10 which indicate the position of the longitudinal strips 8 in order to be able to correctly place the perforations 7 of the implant in the intervertebral space.
  • the implant is preferably made of titanium, titanium alloy, ceramic or a biocompatible plastic.
  • the hollow bodies 1 can be screwed into the cleared intervertebral space 16 between two vertebrae by means of a drive instrument indicated by the arrows 12.
  • Two hollow bodies 1 are preferably introduced into the intervertebral space 16.
  • the Hollow body 1 is now aligned on the basis of its markings 10 (FIG. 1) such that the perforations 7 come to lie freely in the horizontal plane (drawing plane of FIG. 3).
  • a filling instrument 14 indicated in FIG. 2 with so-called "bone morphogenic proteins” (BMP), X-ray contrast media, or clinically therapeutic agents, semi-liquid bone substitute material 15 or similar substances (eg bone meal) enriched in the intervertebral space 16 can be injected become.
  • BMP bone morphogenic proteins
  • X-ray contrast media X-ray contrast media
  • clinically therapeutic agents semi-liquid bone substitute material 15 or similar substances (eg bone meal) enriched in the intervertebral space 16 can be injected become.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Neurology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un implant intervertébral se présentant sous forme de corps creux (1) cylindrique allongé ayant un axe longitudinal (2), une paroi avant (3) et une paroi arrière (4). La face extérieure de la surface extérieure (5) du corps creux (1) présente une structure tridimensionnelle (6) et la surface extérieure (5) dudit corps creux (1) est munie de perforations (7). Après introduction de l'implant creux dans l'espace intervertébral, un outil d'injection approprié permet de remplir de manière ciblée avec une matière semi-liquide de substitution osseuse, aussi bien les espaces libres entre les implants (dans le cas où deux implants ont été introduits), que les implants eux-mêmes. Cette technique s'utilise dans des opérations minimalement invasives et dans les opérations ouvertes.
PCT/CH1996/000127 1996-04-10 1996-04-10 Implant intervertebral WO1997037619A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CH1996/000127 WO1997037619A1 (fr) 1996-04-10 1996-04-10 Implant intervertebral

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CH1996/000127 WO1997037619A1 (fr) 1996-04-10 1996-04-10 Implant intervertebral

Publications (1)

Publication Number Publication Date
WO1997037619A1 true WO1997037619A1 (fr) 1997-10-16

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CH1996/000127 WO1997037619A1 (fr) 1996-04-10 1996-04-10 Implant intervertebral

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Country Link
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Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000044317A1 (fr) * 1998-01-23 2000-08-03 Aesculap Ag & Co. Kg Implant intervertebral
WO2001068006A1 (fr) * 2000-03-14 2001-09-20 Sdgi Holdings, Inc. Implant vertebral synthetique filete
WO2002034172A1 (fr) * 2000-10-24 2002-05-02 Sdgi Holdings, Inc. Dispositif de conditionnement de substance osteogenique et procede afferent
WO2002049547A1 (fr) 1999-06-21 2002-06-27 Medicrea Moyen de dilatation et d"interposition
FR2820630A1 (fr) * 2001-02-15 2002-08-16 Karim Benazzouz Dispositif pour vehiculer un substitut osseux ou du ciment au niveau d'une instabilite osseuse, et instrument pour la mise en oeuvre de ce dispositif
FR2841124A1 (fr) * 2002-06-25 2003-12-26 Eurosurgical Cage intersomatique reversible et son dispositif de mise en place entre le corps vertebraux d'une colonne vertebrale
EP1465521A2 (fr) * 2001-11-01 2004-10-13 Lawrence M Boyd Systeme et methode de pretraitement des plaques motrices d'un disque intervertebral
WO2005032435A1 (fr) * 2003-09-30 2005-04-14 Depuy Spine, Inc. Dispositif de fusion vertebrale et procede d'utilisation associe
WO2005102226A1 (fr) * 2004-04-26 2005-11-03 Synthes Gmbh Prothese intervertebrale ou prothese de disque
EP2015827A2 (fr) * 2006-04-27 2009-01-21 Warsaw Orthopedic, Inc. Canule d'administration directionnelle ventilée
WO2009094232A1 (fr) * 2008-01-22 2009-07-30 Warsaw Orthopedic, Inc. Implants du type corps intermédiaire pour procédures d'alignement spinal
EP2306936A2 (fr) * 2008-07-01 2011-04-13 Doctor's Research Group, Inc. Soudure osseuse
WO2011116136A1 (fr) 2010-03-16 2011-09-22 Pinnacle Spine Group, Llc Implants intervertébraux et systèmes et méthodes d'implantation d'un greffon
US8147500B2 (en) 2006-04-20 2012-04-03 Depuy Spine, Inc. Instrumentation kit for delivering viscous bone filler material
AT12828U1 (de) * 2011-05-27 2012-12-15 Sabitzer Ronald J Dr Implantat und einbringvorrichtung zur verwendung mit einem derartigen implantat
US9380932B1 (en) 2011-11-02 2016-07-05 Pinnacle Spine Group, Llc Retractor devices for minimally invasive access to the spine
US10070970B2 (en) 2013-03-14 2018-09-11 Pinnacle Spine Group, Llc Interbody implants and graft delivery systems

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EP0307241A2 (fr) * 1987-09-11 1989-03-15 John W. Brantigan Implant de prothèse chirurgical
EP0353936A1 (fr) * 1987-08-20 1990-02-07 RayMedica, Inc. Prothèse vertébrale contenant une matière thérapeutique
US5015247A (en) * 1988-06-13 1991-05-14 Michelson Gary K Threaded spinal implant
EP0637440A1 (fr) * 1993-08-06 1995-02-08 Advanced Technical Fabrication Implant intersomatique pour colonne vertebrale
US5489308A (en) * 1989-07-06 1996-02-06 Spine-Tech, Inc. Spinal implant
US5505732A (en) * 1988-06-13 1996-04-09 Michelson; Gary K. Apparatus and method of inserting spinal implants

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EP0353936A1 (fr) * 1987-08-20 1990-02-07 RayMedica, Inc. Prothèse vertébrale contenant une matière thérapeutique
EP0307241A2 (fr) * 1987-09-11 1989-03-15 John W. Brantigan Implant de prothèse chirurgical
US5015247A (en) * 1988-06-13 1991-05-14 Michelson Gary K Threaded spinal implant
US5505732A (en) * 1988-06-13 1996-04-09 Michelson; Gary K. Apparatus and method of inserting spinal implants
US5489308A (en) * 1989-07-06 1996-02-06 Spine-Tech, Inc. Spinal implant
EP0637440A1 (fr) * 1993-08-06 1995-02-08 Advanced Technical Fabrication Implant intersomatique pour colonne vertebrale

Cited By (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002535079A (ja) * 1998-01-23 2002-10-22 アエスクラップ アクチェンゲゼルシャフト ウント コンパニー コマンディトゲゼルシャフト 椎間インプラント
WO2000044317A1 (fr) * 1998-01-23 2000-08-03 Aesculap Ag & Co. Kg Implant intervertebral
WO2002049547A1 (fr) 1999-06-21 2002-06-27 Medicrea Moyen de dilatation et d"interposition
WO2001068006A1 (fr) * 2000-03-14 2001-09-20 Sdgi Holdings, Inc. Implant vertebral synthetique filete
AU2001243655B2 (en) * 2000-03-14 2005-04-28 Warsaw Orthopedic, Inc. Synthetic threaded vertebral implant
US8177845B2 (en) 2000-10-24 2012-05-15 Warsaw Orthopedic, Inc. Osteogenic packing device and method
WO2002034172A1 (fr) * 2000-10-24 2002-05-02 Sdgi Holdings, Inc. Dispositif de conditionnement de substance osteogenique et procede afferent
US6780192B2 (en) 2000-10-24 2004-08-24 Sdgi Holdings, Inc. Osteogenic packing device and method
US7550011B2 (en) 2000-10-24 2009-06-23 Warsaw Orthopedic, Inc. Osteogenic packing device and method
FR2820630A1 (fr) * 2001-02-15 2002-08-16 Karim Benazzouz Dispositif pour vehiculer un substitut osseux ou du ciment au niveau d'une instabilite osseuse, et instrument pour la mise en oeuvre de ce dispositif
EP1465521A2 (fr) * 2001-11-01 2004-10-13 Lawrence M Boyd Systeme et methode de pretraitement des plaques motrices d'un disque intervertebral
EP1465521A4 (fr) * 2001-11-01 2008-10-08 Spine Wave Inc Systeme et methode de pretraitement des plaques motrices d'un disque intervertebral
WO2004000176A1 (fr) * 2002-06-25 2003-12-31 Eurosurgical Sa Cage intersomatique reversible et son dispositif de mise en place entre les corps vertebraux d'une colonne vertebrale
FR2841124A1 (fr) * 2002-06-25 2003-12-26 Eurosurgical Cage intersomatique reversible et son dispositif de mise en place entre le corps vertebraux d'une colonne vertebrale
WO2005032435A1 (fr) * 2003-09-30 2005-04-14 Depuy Spine, Inc. Dispositif de fusion vertebrale et procede d'utilisation associe
US7655010B2 (en) 2003-09-30 2010-02-02 Depuy Spine, Inc. Vertebral fusion device and method for using same
US10646353B2 (en) 2004-04-26 2020-05-12 DePuy Synthes Products, Inc. Intervertebral prosthesis or disk prosthesis
US10653532B2 (en) 2004-04-26 2020-05-19 DePuy Synthes Products, Inc. Intervertebral prosthesis or disk prosthesis
US10085851B2 (en) 2004-04-26 2018-10-02 DePuy Synthes Products, Inc. Intervertebral prosthesis or disk prosthesis
US9700432B2 (en) 2004-04-26 2017-07-11 DePuy Synthes Products, Inc. Intervertebral prosthesis or disk prosthesis
US9408719B2 (en) 2004-04-26 2016-08-09 DePuy Synthes Products, Inc. Intervertebral prosthesis or disk prosthesis
WO2005102226A1 (fr) * 2004-04-26 2005-11-03 Synthes Gmbh Prothese intervertebrale ou prothese de disque
US8992618B2 (en) 2004-04-26 2015-03-31 DePuy Synthes Products, LLC Intervertebral prosthesis or disk prosthesis
US9277944B2 (en) 2006-04-20 2016-03-08 DePuy Synthes Products, Inc. Instrumentation kit for delivering viscous bone filler material
US8147500B2 (en) 2006-04-20 2012-04-03 Depuy Spine, Inc. Instrumentation kit for delivering viscous bone filler material
EP2015827A2 (fr) * 2006-04-27 2009-01-21 Warsaw Orthopedic, Inc. Canule d'administration directionnelle ventilée
EP2015827A4 (fr) * 2006-04-27 2009-05-06 Warsaw Orthopedic Inc Canule d'administration directionnelle ventilée
JP2011509746A (ja) * 2008-01-22 2011-03-31 ウォーソー・オーソペディック・インコーポレーテッド 脊椎整列処置用の椎体間インプラント
WO2009094232A1 (fr) * 2008-01-22 2009-07-30 Warsaw Orthopedic, Inc. Implants du type corps intermédiaire pour procédures d'alignement spinal
EP2306936A2 (fr) * 2008-07-01 2011-04-13 Doctor's Research Group, Inc. Soudure osseuse
EP2306936A4 (fr) * 2008-07-01 2013-05-29 Doctor S Res Group Inc Soudure osseuse
WO2011116136A1 (fr) 2010-03-16 2011-09-22 Pinnacle Spine Group, Llc Implants intervertébraux et systèmes et méthodes d'implantation d'un greffon
US9649203B2 (en) 2010-03-16 2017-05-16 Pinnacle Spine Group, Llc Methods of post-filling an intervertebral implant
US9216096B2 (en) 2010-03-16 2015-12-22 Pinnacle Spine Group, Llc Intervertebral implants and related tools
US9788973B2 (en) 2010-03-16 2017-10-17 Pinnacle Spine Group, Llc Spinal implant
EP2547292A4 (fr) * 2010-03-16 2013-09-18 Pinnacle Spine Group Llc Implants intervertébraux et systèmes et méthodes d'implantation d'un greffon
EP2547292A1 (fr) * 2010-03-16 2013-01-23 Pinnacle Spine Group, LLC Implants intervertébraux et systèmes et méthodes d'implantation d'un greffon
AT12828U1 (de) * 2011-05-27 2012-12-15 Sabitzer Ronald J Dr Implantat und einbringvorrichtung zur verwendung mit einem derartigen implantat
US9380932B1 (en) 2011-11-02 2016-07-05 Pinnacle Spine Group, Llc Retractor devices for minimally invasive access to the spine
US10070970B2 (en) 2013-03-14 2018-09-11 Pinnacle Spine Group, Llc Interbody implants and graft delivery systems

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