ITBO20100597A1 - INTERVERTEBRAL DISC THERDESIS - Google Patents
INTERVERTEBRAL DISC THERDESIS Download PDFInfo
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- ITBO20100597A1 ITBO20100597A1 IT000597A ITBO20100597A ITBO20100597A1 IT BO20100597 A1 ITBO20100597 A1 IT BO20100597A1 IT 000597 A IT000597 A IT 000597A IT BO20100597 A ITBO20100597 A IT BO20100597A IT BO20100597 A1 ITBO20100597 A1 IT BO20100597A1
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- Italy
- Prior art keywords
- component
- seat
- prosthesis according
- stem
- aforementioned
- Prior art date
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- 229910052751 metal Inorganic materials 0.000 claims description 14
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- JUPQTSLXMOCDHR-UHFFFAOYSA-N benzene-1,4-diol;bis(4-fluorophenyl)methanone Chemical compound OC1=CC=C(O)C=C1.C1=CC(F)=CC=C1C(=O)C1=CC=C(F)C=C1 JUPQTSLXMOCDHR-UHFFFAOYSA-N 0.000 claims description 9
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- 206010061246 Intervertebral disc degeneration Diseases 0.000 description 1
- 208000007466 Male Infertility Diseases 0.000 description 1
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- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
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- 210000000988 bone and bone Anatomy 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
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- 230000003412 degenerative effect Effects 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 229910052588 hydroxylapatite Inorganic materials 0.000 description 1
- 208000021600 intervertebral disc degenerative disease Diseases 0.000 description 1
- 239000007769 metal material Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 238000002601 radiography Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
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- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (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)
Description
PROTESI DISCALE INTERVERTEBRALE INTERVERTEBRAL DISC PROSTHESIS
DESCRIZIONE DELL’INVENZIONE DESCRIPTION OF THE INVENTION
L’invenzione s’inserisce nell’ambito delle protesi discali per gli impianti intervertebrali. The invention fits into the field of disc prostheses for intervertebral implants.
Nel disco intervertebrale l'annulus fibrosus, o anello fibroso, racchiude al suo interno il nucleo polposo. In un disco intervertebrale sano, il nucleo polposo asseconda il movimento biomeccanico della colonna vertebrale ed il disco sopporta il carico e le forze di compressione a cui à ̈ costantemente soggetta la colonna vertebrale. Purtroppo i dischi intervertebrali sono soggetti a fenomeni degenerativi, in particolare a livello lombare, a causa del maggior carico che devono sopportare. In the intervertebral disc, the annulus fibrosus, or fibrous ring, encloses the nucleus pulposus. In a healthy intervertebral disc, the nucleus pulposus supports the biomechanical movement of the vertebral column and the disc bears the load and compressive forces to which the vertebral column is constantly subjected. Unfortunately, the intervertebral discs are subject to degenerative phenomena, particularly at the lumbar level, due to the greater load they have to bear.
Fino ad alcuni anni fa l’unico trattamento per le patologie del disco era l’artrodesi vertebrale, un’operazione chirurgica mediante la quale si asporta il disco intervertebrale degenerato e incapace di sostenere detto carico e si ottiene, con varie tecniche, una fusione ossea fra le due vertebre interessate dal disco degenerato. Questo trattamento chirurgico solleva il paziente dal dolore ma determina la perdita di movimento fra le due vertebre, che risultano così fissate rigidamente fra di loro. Ciò può condurre, nel tempo, a un sovraccarico funzionale dei due dischi vicini a quello rimosso che possono sviluppare una patologia riscontrabile biomeccanicamente e tramite radiografia. In una percentuale non trascurabile dei casi, a tale patologia si associa anche una sintomatologia tale da richiedere ulteriori interventi di artrodesi anche sulle vertebre vicine con conseguente perdita di mobilità di un ulteriore settore della colonna vertebrale. Until a few years ago, the only treatment for disc pathologies was vertebral arthrodesis, a surgical operation through which the degenerated intervertebral disc unable to support said load is removed and is obtained, with various techniques, a bone fusion between the two vertebrae affected by the degenerated disc. This surgical treatment relieves the patient of pain but causes the loss of movement between the two vertebrae, which are thus rigidly fixed to each other. This can lead, over time, to a functional overload of the two discs close to the removed one which can develop a pathology detectable biomechanically and by radiography. In a non negligible percentage of cases, this pathology is also associated with symptoms such as to require further arthrodesis interventions also on the neighboring vertebrae with consequent loss of mobility of a further sector of the vertebral column.
Le protesi discali intervertebrali sono state proposte in tempi relativamente recenti come alternativa all'artrodesi nel trattamento della discopatia degenerativa quando la patologia riscontrata non necessita del blocco delle due vertebre adiacenti al disco degenerato. Intervertebral disc prostheses have been proposed relatively recently as an alternative to arthrodesis in the treatment of degenerative disc disease when the pathology found does not require blocking of the two vertebrae adjacent to the degenerated disc.
L’intervento d’impianto di tali protesi discali in sostituzione del disco intervertebrale o del nucleo polposo à ̈ preferito all’artrodesi poiché consente il movimento biomeccanico delle due vertebre interessate dall’impianto. Tali protesi discali sono state studiate per alleviare il mal di schiena e assecondare i movimenti della colonna vertebrale e tipicamente comprendono uno snodo sferico che consente il citato movimento biomeccanico. Pertanto le protesi comprendono due componenti: l’uno provvisto di una sede e l’altro provvisto di una parte conformata per impegnarsi con la sede per individuare congiuntamente a quest’ultima lo snodo sferico. Tipicamente tale parte à ̈ costituita da una porzione di una sfera (nel seguito riferita brevemente come “porzione sferica†) The implantation of these disc prostheses to replace the intervertebral disc or nucleus pulposus is preferred to arthrodesis as it allows the biomechanical movement of the two vertebrae involved in the implant. These disc prostheses have been designed to relieve back pain and support the movements of the spine and typically include a ball joint that allows the aforementioned biomechanical movement. Therefore, the prostheses include two components: one provided with a seat and the other provided with a part shaped to engage with the seat to identify the ball joint together with the latter. Typically this part consists of a portion of a sphere (hereinafter referred to briefly as `` spherical portion '')
Una tipologia di protesi discale à ̈ la cosiddetta “protesi discale totale†che sostituisce interamente il disco intervertebrale degenerato e richiede la rimozione sia del nucleo polposo sia dell’anello fibroso. Dette protesi, devono pertanto essere in grado di sopportare le compressioni a cui viene sottoposto il disco intervertebrale sostituito oltre ad assecondare il movimento biomeccanico delle vertebre interessate all’impianto. A livello lombare o sacrale, dove le vertebre devono sostenere un peso maggiore, le dimensioni delle protesi discali totali sono tali da consentire il loro impianto solo tramite una via di accesso chirurgica anteriore che può comportare notevoli complicanze fra cui la sterilità maschile. One type of disc prosthesis is the so-called â € œtotal disc prosthesisâ € which completely replaces the degenerated intervertebral disc and requires the removal of both the nucleus pulposus and the fibrous ring. These prostheses must therefore be able to withstand the compressions to which the replaced intervertebral disc is subjected as well as to support the biomechanical movement of the vertebrae involved in the implant. At the lumbar or sacral level, where the vertebrae have to support a greater weight, the dimensions of the total disc prostheses are such as to allow their implantation only through an anterior surgical access route which can lead to significant complications including male infertility.
Una prima categoria di protesi discali totali à ̈ costituita da protesi composte da due componenti metallici in cui in cui quello superiore à ̈ provvisto di un primo lato, destinato a contraffacciare il piatto vertebrale inferiore di una prima vertebra, e di un secondo lato, opposto al primo lato, in cui à ̈ prevista una sede. Il componente inferiore presenta un primo lato destinato a contraffacciare il piatto vertebrale superiore di una seconda vertebra, adiacente ed inferiore alla prima vertebra, ed un secondo lato, opposto al primo lato, provvisto di una porzione sferica per impegnarsi con la sede del componente superiore individuando congiuntamente a quest’ultima uno snodo sferico. A first category of total disc prostheses consists of prostheses composed of two metal components in which the upper one is provided with a first side, intended to counter the lower vertebral plate of a first vertebra, and a second side, opposite on the first side, where there is a seat. The lower component has a first side intended to counter face the upper vertebral plate of a second vertebra, adjacent and lower to the first vertebra, and a second side, opposite the first side, provided with a spherical portion to engage with the seat of the upper component, identifying together with the latter a spherical joint.
Per impiantare la protesi, i due componenti devono essere pre-assemblati in modo che la porzione sferica si impegni nella sede realizzando il citato snodo sferico. Per la tipologia stessa di materiale utilizzato, vale a dire un metallo compatibile con gli impianti, questa protesi discale presenta una bassa frizione delle parti sede e porzione sferica che definiscono lo snodo sferico. Per contro tale protesi non possiede caratteristiche di elasticità e quindi non à ̈ in grado di ammortizzare gli shock assiali di compressione, a cui à ̈ sottoposta la colonna vertebrale, agenti sulle vertebre. To implant the prosthesis, the two components must be pre-assembled so that the spherical portion engages in the seat creating the aforementioned ball joint. Due to the type of material used, that is to say a metal compatible with the implants, this disc prosthesis has a low friction of the seat and spherical portion that define the spherical joint. On the other hand, this prosthesis does not have elasticity characteristics and therefore is not able to cushion the axial compression shocks to which the spinal column is subjected, acting on the vertebrae.
In una seconda categoria di protesi discali totali, quest’ultime sono costituite da tre componenti, uno inferiore, uno intermedio ed uno superiore. Il componente inferiore à ̈ metallico ed à ̈ provvisto di un primo lato, destinato a contraffacciare il piatto vertebrale superiore di una prima vertebra, e di un secondo lato, opposto al primo lato, comprendente un alloggiamento. Il componente superiore à ̈ metallico, à ̈ sostanzialmente identico al e svolge la stessa funzione del componente superiore delle protesi a due componenti: esso pertanto prevede una sede. Il componente intermedio à ̈ realizzato in materiale plastico, tipicamente HDPE. Esso à ̈ destinato ad essere interposto fra il componente superiore e quello inferiore, ad essere supportato dall’alloggiamento del componente inferiore e prevede superiormente una porzione sferica conformata per impegnarsi con la sede del componente superiore per individuare congiuntamente a quest’ultima uno snodo sferico. In a second category of total disc prostheses, the latter are made up of three components, one lower, one intermediate and one upper. The lower component is metallic and is provided with a first side, intended to counter the upper vertebral plate of a first vertebra, and a second side, opposite the first side, comprising a housing. The upper component is metallic, it is substantially identical to and performs the same function as the upper component of two-component prostheses: it therefore has a seat. The intermediate component is made of plastic material, typically HDPE. It is intended to be interposed between the upper and lower components, to be supported by the housing of the lower component and has a spherical portion at the top that is shaped to engage with the seat of the upper component to identify a joint jointly with the latter. spherical.
Per impiantare la protesi discale, essa viene pre-assemblata in modo che il componente intermedio sia ricevuto e supportato dall’alloggiamento del componente inferiore e la porzione sferica si impegni nella sede realizzando il citato snodo sferico. To implant the disc prosthesis, it is pre-assembled so that the intermediate component is received and supported by the housing of the lower component and the spherical portion engages in the seat creating the aforementioned ball joint.
In virtù del componente intermedio in HDPE, le protesi discali a tre componenti presentano un’elasticità paragonabile a quella del disco intervertebrale sano e quindi sono teoricamente in grado di assorbire elasticamente shock assiali di compressione agenti sulle vertebre. Thanks to the intermediate component in HDPE, the three-component disc prostheses have an elasticity comparable to that of the healthy intervertebral disc and therefore are theoretically able to elastically absorb axial compression shocks acting on the vertebrae.
Purtroppo, soprattutto a livello lombare o sacrale, dove il carico à ̈ maggiore, si possono avere delle forze di compressione agenti sulle vertebre interessate dall’impianto tali da deformare, almeno temporaneamente, la porzione sferica. Tale deformazione comporta una diminuzione della superficie di contatto della porzione sferica con la sede nello snodo e l’usura asimmetrica della porzione sferica a seguito della frizione dello snodo sferico. Esiste quindi il rischio che nel lungo periodo tale usura possa comportare il blocco dello snodo sferico e quindi la perdita di movimento delle vertebre interessate dall’impianto con le stesse conseguenze negative relative all’artrodesi descritte in precedenza. Unfortunately, especially at the lumbar or sacral level, where the load is greater, there may be compression forces acting on the vertebrae affected by the implant such as to deform, at least temporarily, the spherical portion. This deformation results in a decrease in the contact surface of the spherical portion with the seat in the joint and asymmetrical wear of the spherical portion as a result of the friction of the spherical joint. There is therefore the risk that in the long term this wear could lead to the blockage of the ball joint and therefore the loss of movement of the vertebrae affected by the implant with the same negative consequences relating to the arthrodesis described above.
La sostituzione del disco intervertebrale con una protesi discale totale à ̈ una tecnica piuttosto recente e non vi sono ancora sufficienti informazioni di ritorno relative a eventuali complicanze nel lungo periodo. Pertanto à ̈ il singolo chirurgo che sceglie se utilizzare una protesi discale a due o a tre componenti a seconda che dia rispettivamente una maggiore importanza all’affidabilità nel tempo dello snodo sferico o alla capacità di assorbire elasticamente le forze di compressione e gli shock assiali a cui sono sottoposte le vertebre. Poiché l’impianto di una protesi discale totale comporta notevoli rischi di complicanze connesse all’approccio chirurgico anteriore, sono state proposte delle protesi discali aventi dimensioni ridotte e tali da consentirne l’impianto per una via di accesso chirurgico posteriore. Tali protesi discali, dette di nucleo, sostituiscono solo il nucleo polposo del disco intervertebrale e pertanto devono sopportare compressioni inferiori rispetto alle protesi discali totali. Le protesi discali di nucleo attualmente utilizzate sono tipicamente costituite da tre componenti sagomati in maniera sostanzialmente analoga ai componenti della protesi discale totale a tre componenti con la differenza di essere realizzate interamente in PEEK. Nonostante le dimensioni ridotte, il PEEK conferisce alle protesi discali di nucleo una sufficiente resistenza alla compressione. Tale resistenza, a parità di dimensioni della protesi, non à ̈ ottenibile con altri materiali plastici, come l’HDPE. D’altro canto l’elasticità di tali protesi di nucleo dovuta al PEEK à ̈ inferiore a quella del nucleo polposo sano. Inoltre le protesi discali di nucleo sono comunque soggette a deformazione e usura della porzione sferica, sebbene in misura minore rispetto alle protesi discali totali a tre componenti in cui il componente intermedio à ̈ in HDPE. Pertanto anche le protesi discali di nucleo presentano il rischio di blocco dello snodo sferico. Replacing the intervertebral disc with a total disc prosthesis is a fairly recent technique and there is not yet enough feedback on any long-term complications. Therefore it is the individual surgeon who chooses whether to use a two or three-component disc prosthesis depending on whether he gives greater importance to the reliability of the ball joint over time or to the ability to elastically absorb compression forces and axial shocks. which the vertebrae are subjected to. Since the implantation of a total disc prosthesis involves considerable risks of complications related to the anterior surgical approach, disc prostheses have been proposed with reduced dimensions and such as to allow their implantation through a posterior surgical approach. These disc prostheses, called nucleus, replace only the pulpy nucleus of the intervertebral disc and therefore have to withstand lower compressions than total disc prostheses. The core disc prostheses currently used are typically made up of three components shaped in a manner substantially similar to the components of the three-component total disc prosthesis with the difference that they are made entirely of PEEK. Despite its small size, PEEK gives core disc prostheses sufficient compressive strength. This resistance, with the same size of the prosthesis, cannot be obtained with other plastic materials, such as HDPE. On the other hand, the elasticity of these core prostheses due to PEEK is lower than that of the healthy nucleus pulposus. Furthermore, core disc prostheses are still subject to deformation and wear of the spherical portion, although to a lesser extent than total three-component disc prostheses in which the intermediate component is made of HDPE. Therefore, even core disc prostheses present the risk of locking the ball joint.
Lo scopo della presente invenzione consiste nel ridurre e/o eliminare i sopra citati svantaggi relativi alle protesi discali note. The object of the present invention is to reduce and / or eliminate the aforementioned disadvantages relating to known disc prostheses.
Gli scopi suindicati vengono ottenuti con una protesi discale intervertebrale, comprendente: − un componente inferiore provvisto di un primo lato destinato a contraffacciare il piatto vertebrale superiore di una prima vertebra; The aforementioned purposes are achieved with an intervertebral disc prosthesis, comprising: ∠’a lower component provided with a first side intended to counter face the upper vertebral plate of a first vertebra;
− un componente superiore provvisto di: un primo lato destinato a contraffacciare il piatto vertebrale inferiore di una seconda vertebra adiacente e superiore a detta prima vertebra; e un secondo lato, opposto a detto primo lato, comprendente una sede; ∠’an upper component equipped with: a first side intended to counter the lower vertebral plate of a second vertebra adjacent and superior to said first vertebra; and a second side, opposite said first side, comprising a seat;
− un componente intermedio destinato ad essere interposto fra il componente inferiore e il componente superiore e provvisto superiormente di una parte conformata per impegnarsi con la sede per individuare congiuntamente alla sede uno snodo sferico; ∠’an intermediate component intended to be interposed between the lower component and the upper component and provided at the top with a shaped part to engage with the seat to identify a ball joint jointly with the seat;
caratterizzata dal fatto di comprendere ulteriormente: characterized by further understanding:
− mezzi elastici destinati ad essere interposti funzionalmente fra il componente inferiore ed il componente intermedio per reagire elasticamente a forze di compressione agenti lungo la colonna vertebrale una volta che la citata protesi à ̈ stata impiantata fra le citate prima e seconda vertebra. - elastic means intended to be functionally interposed between the lower component and the intermediate component to react elastically to compression forces acting along the spine once the aforementioned prosthesis has been implanted between the aforementioned first and second vertebrae.
Detti mezzi elastici consentono di ottenere una protesi discale con un’elasticità paragonabile a quella del nucleo polposo sano e permettono di utilizzare per la produzione dei componenti intermedio e superiore dei materiali aventi caratteristiche di maggiore rigidità , indeformabilità e resistenza all’usura rispetto a quelli attualmente impiegati nelle protesi di tipo noto. Said elastic means allow to obtain a disc prosthesis with an elasticity comparable to that of the healthy nucleus pulposus and allow to use for the production of the intermediate and superior components of materials having characteristics of greater rigidity, non-deformability and resistance to wear compared to those currently used in known types of prostheses.
Preferibilmente tali materiali sono materiali metallici. Pertanto risultano minimizzati i fenomeni di deformazione ed usura dovuti alla compressione delle vertebre ed alla frizione dello snodo, in particolare la citata usura asimmetrica. Di conseguenza lo snodo sferico della protesi proposta risulta affidabile anche nel lungo periodo. Preferably these materials are metallic materials. Therefore the deformation and wear phenomena due to the compression of the vertebrae and the friction of the joint are minimized, in particular the aforementioned asymmetrical wear. Consequently, the ball joint of the proposed prosthesis is reliable even in the long term.
Sono quindi preferite le protesi secondo l’invenzione in cui la parte del componente intermedio conformata per impegnarsi con la sede e la sede stessa sono provvisti di uno strato di metallo in corrispondenza delle relative superfici destinate a contattarsi mutuamente. Preferibilmente detta parte del componente intermedio à ̈ interamente in metallo. Quando il componente superiore e il componente intermedio sono in metallo, il rischio di usura delle superfici di contatto dello snodo sferico risulta ulteriormente diminuito. Prostheses according to the invention are therefore preferred in which the part of the intermediate component shaped to engage with the seat and the seat itself are provided with a layer of metal in correspondence with the relative surfaces intended to mutually contact each other. Preferably, said part of the intermediate component is entirely made of metal. When the upper component and the intermediate component are made of metal, the risk of wear of the contact surfaces of the ball joint is further reduced.
Sono inoltre preferite le protesi secondo l’invenzione in cui anche il componente inferiore à ̈ in metallo poiché presentano una maggiore resistenza alla compressione. Prostheses according to the invention are also preferred in which the lower component is also made of metal since they have a greater resistance to compression.
Ovviamente il metallo usato per la produzione di tali protesi à ̈ compatibile con gli impianti. Il titanio à ̈ particolarmente preferibile poiché fornisce meno artefatti nelle radiografie. Obviously the metal used for the production of these prostheses is compatible with the implants. Titanium is particularly preferable as it provides fewer artifacts on radiographs.
Analogamente all’arte nota, detta parte del componente intermedio impegnabile nella sede può essere conformata come una porzione di una sfera e la protesi secondo l’invenzione può essere pre-assemblata posizionando i mezzi elastici sul componente inferiore in modo tale da essere supportati da quest’ultimo. Il componente intermedio deve essere poi supportato dai mezzi elastici e la relativa parte deve essere impegnata con la sede per individuare congiuntamente a questa ultima lo snodo sferico. Similarly to the known art, said part of the intermediate component that can be engaged in the seat can be shaped as a portion of a sphere and the prosthesis according to the invention can be pre-assembled by positioning the elastic means on the lower component in such a way as to be supported from the latter. The intermediate component must then be supported by the elastic means and the relative part must be engaged with the seat to identify the spherical joint together with the latter.
Le caratteristiche dell’invenzione saranno rese evidenti nella seguente descrizione di una preferita forma di realizzazione della protesi discale, in accordo con quanto riportato nelle rivendicazioni e con l’ausilio delle allegate tavole di disegno, nelle quali: The characteristics of the invention will be made clear in the following description of a preferred embodiment of the disc prosthesis, in accordance with what is reported in the claims and with the aid of the attached drawing tables, in which:
le Figg.1 e 2 sono viste in prospettiva in esploso rispettivamente dall’alto e dal basso di una forma di realizzazione della protesi discale proposta; Figs.1 and 2 are exploded perspective views respectively from above and from below of an embodiment of the proposed disc prosthesis;
la Fig.3 Ã ̈ una vista frontale della protesi discale delle Fig.1 e 2 assemblata; Fig.3 is a front view of the assembled disc prosthesis of Fig.1 and 2;
la Fig.4 Ã ̈ una sezione di Fig.3 secondo il piano IV-IV di Fig.3; Fig.4 is a section of Fig.3 according to the IV-IV plane of Fig.3;
la Fig.5 Ã ̈ una vista laterale della protesi discale di Fig.1 assemblata; Fig.5 is a side view of the assembled disc prosthesis of Fig.1;
la Fig.6 Ã ̈ una sezione di Fig.5 secondo il piano VI-VI di Fig.5; e Fig.6 is a section of Fig.5 according to the VI-VI plane of Fig.5; And
la Fig.7 à ̈ un’ulteriore vista frontale della protesi discale assemblata di Fig.1. Fig.7 is a further front view of the assembled disc prosthesis of Fig.1.
Ai fini della presente descrizione, i medesimi riferimenti numerici nelle figure sottintenderanno caratteristiche simili a meno che non sia altrimenti indicato. For the purposes of the present description, the same numerical references in the figures will imply similar characteristics unless otherwise indicated.
Con riferimento alle allegate figure, la protesi discale intervertebrale 1 secondo l’invenzione comprende un componente inferiore, uno superiore, uno intermedio e mezzi elastici. Il componente inferiore 20 à ̈ provvisto di un primo lato 21 destinato a contraffacciare il piatto vertebrale superiore di una prima vertebra. Il componente superiore 10 à ̈ provvisto di un primo lato 11, destinato a contraffacciare il piatto vertebrale inferiore di una seconda vertebra adiacente e superiore a detta prima vertebra, e un secondo lato 12, opposto a detto primo lato 11, comprendente una sede 15. Il componente intermedio 30 à ̈ destinato ad essere interposto fra il componente inferiore 10 e il componente superiore 20 ed à ̈ provvisto superiormente di una parte 35 conformata per impegnarsi con la sede 15 per individuare congiuntamente alla sede 15 uno snodo sferico. I mezzi elastici 40 sono destinati ad essere interposti funzionalmente fra il componente inferiore 20 ed il componente intermedio 30 per reagire elasticamente a forze di compressione agenti lungo la colonna vertebrale una volta che la citata protesi à ̈ stata impiantata fra le citate prima e seconda vertebra. With reference to the attached figures, the intervertebral disc prosthesis 1 according to the invention comprises a lower, an upper, an intermediate component and elastic means. The lower component 20 is provided with a first side 21 intended to counter face the upper vertebral plate of a first vertebra. The upper component 10 is provided with a first side 11, intended to face the lower vertebral plate of a second vertebra adjacent and superior to said first vertebra, and a second side 12, opposite to said first side 11, comprising a seat 15. The intermediate component 30 is intended to be interposed between the lower component 10 and the upper component 20 and is provided at the top with a part 35 shaped to engage with the seat 15 to identify a spherical joint together with the seat 15. The elastic means 40 are intended to be functionally interposed between the lower component 20 and the intermediate component 30 to react elastically to compression forces acting along the vertebral column once the aforementioned prosthesis has been implanted between the aforementioned first and second vertebrae.
In determinate posizioni della colonna vertebrale ed in funzione della tipologia di mezzi elastici utilizzati per assemblare la protesi, gli shock dovuti alla forza di compressione agente sulle vertebre interessate dall’impianto potrebbero anche comportare una deformazione permanente dei mezzi elastici. Pertanto sono preferite le protesi discali in cui il componente inferiore 20 à ̈ provvisto di un finecorsa 28, 29 disposto per limitare l’escursione dei mezzi elastici 40 per evitare una deformazione permanente dei mezzi elastici 40. In certain positions of the spinal column and depending on the type of elastic means used to assemble the prosthesis, the shocks due to the compressive force acting on the vertebrae affected by the implant could also lead to permanent deformation of the elastic means. Therefore, disc prostheses are preferred in which the lower component 20 is provided with a limit switch 28, 29 arranged to limit the excursion of the elastic means 40 to avoid permanent deformation of the elastic means 40.
Il fine corsa, secondo una forma di realizzazione non mostrata, può riscontrare un apposita protuberanza presente sul secondo lato 12 del componente superiore. The limit switch, according to an embodiment not shown, may have a suitable protuberance present on the second side 12 of the upper component.
Vantaggiosamente, come nella forma di realizzazione mostrata, il finecorsa 28, 29 Ã ̈ disposto per riscontrare il componente intermedio 30 quando i mezzi elastici raggiungono la massima escursione consentita. Advantageously, as in the embodiment shown, the limit switch 28, 29 is arranged to abut the intermediate component 30 when the elastic means reach the maximum allowed excursion.
A tale scopo il componente intermedio 30 può comprendere: un cappello 36 provvisto di una calotta conformante la citata parte 35 conformata per impegnarsi con la sede 15; e un gambo 33 che si origina dalla parete inferiore del cappello 36, mentre il componente inferiore 20 comprende su di un secondo lato 22, opposto al relativo primo lato 11, un alloggiamento 24 per ricevere congiuntamente i mezzi elastici 40 ed il gambo 33 (Fig.1). For this purpose, the intermediate component 30 can comprise: a cap 36 provided with a cap conforming the aforementioned part 35 shaped to engage with the seat 15; and a stem 33 that originates from the lower wall of the cap 36, while the lower component 20 comprises on a second side 22, opposite the relative first side 11, a housing 24 for jointly receiving the elastic means 40 and the stem 33 (Fig .1).
Quando il fondo dell’alloggiamento 24 definisce il citato finecorsa 28 per riscontrare il gambo 33, il componente inferiore 20 può riscontrare il gambo 33 riscontrandone la relativa superficie di contatto inferiore 38. When the bottom of the housing 24 defines the aforementioned limit switch 28 to abut the shank 33, the lower component 20 can abut the shank 33 by finding its relative lower contact surface 38.
Quando il cappello 36 à ̈ provvisto di una superficie di contatto anulare periferica 39 prevista in corrispondenza della parete inferiore del cappello 36, il componente inferiore 20 comprende sul secondo lato 22 e il citato finecorsa 29, il quale à ̈ anulare, concentrico ed esterno all’alloggiamento 24 per riscontrare la superficie di contatto anulare periferica 39 del cappello 36. When the cap 36 is provided with a peripheral annular contact surface 39 provided in correspondence with the lower wall of the cap 36, the lower component 20 comprises on the second side 22 and the aforementioned limit switch 29, which is annular, concentric and external to the € ™ housing 24 to abut the peripheral annular contact surface 39 of the cap 36.
Nella protesi mostrata, il componente intermedio 30 à ̈ conformato come un fungo e presenta sia un gambo 33 provvisto di superficie di contatto inferiore 38 che un cappello 36 provvisto inferiormente della citata superficie di contatto anulare periferica 39. Pertanto esso può riscontrare contemporaneamente il componente inferiore 20 in due finecorsa diversi; vale a dire sia il finecorsa 28 previsto nella parete di fondo dell’alloggiamento 24 e che il citato finecorsa anulare 29. In tal modo il componente intermedio 30 riscontra il componente inferiore 20 su di una superficie maggiore rispetto ad un singolo finecorsa 28, 29 diminuendo la pressione agente sui singoli finecorsa 28 e 29. In the prosthesis shown, the intermediate component 30 is shaped like a mushroom and has both a shank 33 provided with a lower contact surface 38 and a cap 36 provided at the bottom with the aforementioned peripheral annular contact surface 39. Therefore it can simultaneously meet the lower component 20 in two different limit switches; that is to say both the limit switch 28 provided in the bottom wall of the housing 24 and the aforementioned annular limit switch 29. In this way the intermediate component 30 encounters the lower component 20 on a larger surface than a single limit switch 28, 29 decreasing the pressure acting on the single limit switches 28 and 29.
Com’à ̈ mostrato nelle Fig. 4 e 6, una volta pre-assemblata la protesi 1, i mezzi elastici 40 supportano il componente intermedio 30. Quando la protesi 1 assemblata viene impiantata, le forze di compressione agenti sulle vertebre deformano i mezzi elastici, comprimendoli. Tipicamente i mezzi elastici 40 saranno predisposti per essere parzialmente compressi quando il paziente à ̈ in posizione eretta e non à ̈ sottoposto a sforzi ed il carico agente sulle vertebre interessate dall’impianto à ̈ dato sostanzialmente dal peso della parte del corpo sovrastante le vertebre. As shown in Figs. 4 and 6, once the prosthesis 1 has been pre-assembled, the elastic means 40 support the intermediate component 30. When the assembled prosthesis 1 is implanted, the compressive forces acting on the vertebrae deform the means rubber bands, compressing them. Typically, the elastic means 40 will be designed to be partially compressed when the patient is in an upright position and is not subjected to strain and the load acting on the vertebrae affected by the implant is substantially given by the weight of the part of the body overlying the vertebrae. .
A seguito di un shock assiale, per un breve periodo un carico maggiore grava su dette vertebre comprime ulteriormente i mezzi elastici 40 e l’estremità superiore 42 dei mezzi elastici si avvicina al componente inferiore effettuando un’escursione F. Il componente intermedio 30, supportato dai mezzi elastici, si avvicina al componente inferiore 20 fino a che riscontra il finecorsa 28, 29. In tal modo i mezzi elastici 40 non possono essere compressi ulteriormente e vengono salvaguardati da una deformazione permanente. La resistenza della protesi discale intervertebrale 1 à ̈ data dalla natura dei materiali di cui sono composti i suoi componenti inferiore, intermedio e superiore 10, 30, 20. Risultano perciò vantaggiose le protesi in cui detti componenti 10, 30, 20 sono in metallo. Following an axial shock, for a short period a greater load weighs on said vertebrae further compresses the elastic means 40 and the upper end 42 of the elastic means approaches the lower component making an excursion F. The intermediate component 30 supported by the elastic means, it approaches the lower component 20 until it encounters the limit switch 28, 29. In this way the elastic means 40 cannot be further compressed and are protected from permanent deformation. The resistance of the intervertebral disc prosthesis 1 is given by the nature of the materials of which its lower, intermediate and upper components 10, 30, 20 are made. Therefore, prostheses in which said components 10, 30, 20 are made of metal are advantageous.
Una volta rilasciato, almeno parzialmente, tale carico maggiore, la reazione dei mezzi elastici 40 sarà diretta a far sollevare la relativa estremità superiore 42 e di conseguenza il componente intermedio e 30 verrà allontanato dal componente inferiore 20. Tali mezzi elastici 40 fungono quindi da “shock assorber†in quanto sono in grado di ammortizzare le forze di compressione agenti sulle vertebre consentendo al componente intermedio di poter oscillare verticalmente. Once this greater load has been released, at least partially, the reaction of the elastic means 40 will be directed to raise the relative upper end 42 and consequently the intermediate component e 30 will be moved away from the lower component 20. These elastic means 40 therefore act as â € œshock absorbâ € as they are able to cushion the compressive forces acting on the vertebrae allowing the intermediate component to be able to oscillate vertically.
Preferibilmente detti mezzi elastici 40 sono in PEEK di grado medicale. Essi possono comprendere almeno una molla, che preferibilmente à ̈ conformata come una molla a tazza 45 provvista di un foro passante assiale 43. Preferably said elastic means 40 are made of medical grade PEEK. They can comprise at least one spring, which is preferably shaped like a cup spring 45 provided with an axial through hole 43.
Vantaggiosamente il componente intermedio 30 à ̈ conformato come un fungo il cui gambo 33 à ̈ impegnabile nel foro passante 43 della molla a tazza 45 ed il cui cappello 36, una volta impegnato il gambo 33 nel foro passante 43 della molla a tazza 45, à ̈ destinato a riscontrare, con la relativa parete inferiore da cui si origina il gambo 33, l’estremità superiore 42 della molla a tazza 45. Il componente inferiore 10, la molla a tazza 45 ed il gambo 33 sono predisposti in modo tale che, una volta assemblata la protesi con il gambo 33 impegnato nel foro passante 43, la molla a tazza 45 supporti il componente intermedio 30. Advantageously, the intermediate component 30 is shaped like a mushroom whose stem 33 can be engaged in the through hole 43 of the cup spring 45 and whose cap 36, once the stem 33 is engaged in the through hole 43 of the cup spring 45, is It is intended to meet, with the relative lower wall from which stem 33 originates, the upper end 42 of the cup spring 45. The lower component 10, the cup spring 45 and the stem 33 are arranged in such a way that once the prosthesis has been assembled with the stem 33 engaged in the through hole 43, the cup spring 45 supports the intermediate component 30.
Sono preferite le protesi 1 secondo l’invenzione, in cui il fondo dell’alloggiamento 24 à ̈ provvisto di una sede centrale incassata, cosicché resti individuata una prima parete anulare 25, rialzata ed esterna alla sede centrale incassata, che riceve in appoggio la molla a tazza 45, ed una seconda parete, interna alla sede centrale incassata, che definisce il citato finecorsa 28 per riscontrare il gambo 33. The prostheses 1 according to the invention are preferred, in which the bottom of the housing 24 is provided with a central recessed seat, so that a first annular wall 25 remains identified, raised and external to the recessed central seat, which I support the cup spring 45, and a second wall, inside the recessed central seat, which defines the aforementioned limit switch 28 to abut the stem 33.
Preferibilmente detti mezzi elastici 40 sono in PEEK di grado medicale. Essi possono comprendere almeno una molla, che preferibilmente à ̈ conformata come una molla a tazza 45. Preferably said elastic means 40 are made of medical grade PEEK. They may comprise at least one spring, which is preferably shaped like a cup spring 45.
Quando la molla a tazza 45 à ̈ disposta con la concavità rivolta verso il componente inferiore 20 può supportare il componente intermedio 30 più facilmente. When the cup spring 45 is arranged with the concavity facing the lower component 20 it can support the intermediate component 30 more easily.
Nel caso in cui sia presente un'unica molla a tazza 45, come nella forma di realizzazione illustrata nelle Fig. 1-7, tale molla 45 potrà avere una forma piuttosto tozza con un elevato valore di spessore S. In tal modo à ̈ possibile ottenere una sufficiente elasticità della protesi 1 anche con un valore di forza di compressione agente sulle vertebre elevato. In the event that a single cup spring 45 is present, as in the embodiment illustrated in Figs. 1-7, this spring 45 may have a rather squat shape with a high thickness value S. In this way it is possible obtain a sufficient elasticity of the prosthesis 1 even with a high compressive force acting on the vertebrae.
La protesi discale 1 proposta può essere una protesi discale totale destinata a essere impiantata in sostituzione di un disco intervertebrale per una via di accesso chirurgico anteriore. In tal caso i mezzi elastici 40 possono anche non comprendere una molla a tazza 45 e/o non essere in PEEK. Infatti, anche con mezzi elastici 40 conformati in altro modo e/o in altri materiali, si possono ottenere protesi discali totali aventi una elasticità paragonabile a quella del nucleo polposo, in particolare se à ̈ destinata a essere impiantata in una posizione della colonna vertebrale in cui il peso da sostenere à ̈ minore. The proposed disc prosthesis 1 may be a total disc prosthesis intended to be implanted to replace an intervertebral disc for an anterior surgical approach. In this case, the elastic means 40 may also not comprise a cup spring 45 and / or may not be made of PEEK. In fact, even with elastic means 40 shaped in another way and / or in other materials, it is possible to obtain total disc prostheses having an elasticity comparable to that of the nucleus pulposus, in particular if it is intended to be implanted in a position of the vertebral column in where the weight to be supported is less.
Vantaggiosamente la protesi discale 1 secondo l’invenzione à ̈ dimensionata per sostituire il nucleo polposo di un disco intervertebrale e pertanto consente l’impianto tramite una via di accesso chirurgico posteriore. Le dimensioni ridotte di tale protesi discale di nucleo, legate alla compressione che la protesi di nucleo deve sopportare, possono essere vantaggiosamente ottenute con forma di realizzazione delle Figg.1 -7, in cui la protesi discale 1 comprende componenti inferiori e superiori 20, 10 in metallo; mezzi elastici 40 in PEEK, conformati come una molla a tazza 45; e un componente intermedio 30, interamente in metallo, conformato a forma di fungo come precedentemente descritto con il gambo 33 impegnabile nel foro passante della molla a tazza 45. In particolare, in tale forma di realizzazione di protesi discale 1 di nucleo mostrata nelle figura 1-7, la molla a tazza 45 in PEEK garantisce una flessione F di 0.3 mm se sottoposta ad una forza di compressione di 120 kg Fig. 6. Inoltre la struttura metallica della protesi discale 1 di nucleo, una volta assemblata, garantisce un carico di rottura analogo a quello delle vertebre e pari a 300 kg. Preferibilmente i componenti della protesi discale sono conformati in modo da ottenere, in pianta, uno snodo sferico disposto centralmente con un centro di rotazione che, una volta impiantata la protesi, deve essere più vicino alla vertebra inferiore che a quella superiore. Come visibile nelle Figg. 3-7 i primi lati 11, 21 e i secondi lati 12, 22, dei componenti inferiori e superiore presentano dell’inclinazione tali da consentire al componente superiore 20 di inclinarsi in tutte le direzioni di almeno 4°, preferibilmente 4,5°, rispetto al componente inferiore 10. Nella Fig. 7 la protesi discale 1 presenta una delle possibili inclinazioni del componente superiore 10 rispetto a quell’inferiore 20. Advantageously, the disc prosthesis 1 according to the invention is sized to replace the nucleus pulposus of an intervertebral disc and therefore allows implantation via a posterior surgical access route. The reduced dimensions of this core disc prosthesis, linked to the compression that the core prosthesis must withstand, can be advantageously obtained with the embodiment of Figs. 1-7, in which the disc prosthesis 1 comprises lower and upper components 20, 10 metal; elastic means 40 of PEEK, shaped like a cup spring 45; and an intermediate component 30, entirely in metal, shaped in the shape of a mushroom as previously described with the stem 33 engageable in the through hole of the cup spring 45. In particular, in this embodiment of the core disc prosthesis 1 shown in Figure 1 -7, the PEEK cup spring 45 guarantees a flexion F of 0.3 mm when subjected to a compression force of 120 kg Fig. 6. Furthermore, the metal structure of the disc core prosthesis 1, once assembled, guarantees a load of break similar to that of the vertebrae and equal to 300 kg. Preferably, the components of the disc prosthesis are shaped in such a way as to obtain, in plan view, a spherical joint arranged centrally with a center of rotation which, once the prosthesis is implanted, must be closer to the lower vertebra than to the upper one. As can be seen in Figs. 3-7 the first sides 11, 21 and the second sides 12, 22, of the lower and upper components have an inclination such as to allow the upper component 20 to incline in all directions by at least 4 °, preferably 4.5 °, with respect to the lower component 10. In Fig. 7 the disc prosthesis 1 has one of the possible inclinations of the upper component 10 with respect to the lower one 20.
Vantaggiosamente, la protesi discale 1 comprende una pluralità di denti di ancoraggio 14 che, una volta penetrati nei piatti vertebrali, evitano spostamenti di detta protesi 1. Tali denti possono essere disposti sul primo lato 21 del componente inferiore 10 e sul primo lato del componente superiore 20. Advantageously, the disc prosthesis 1 comprises a plurality of anchoring teeth 14 which, once penetrated into the vertebral plates, avoid displacements of said prosthesis 1. These teeth can be arranged on the first side 21 of the lower component 10 and on the first side of the upper component. 20.
Le superfici a contatto con i piatti vertebrali, sui primi lati 11 e 21 dei componenti inferiori 20 e superiori 10, possono comprendere delle composizioni o sostanze destinate a facilitare la fusione di tali componenti con le vertebre. Ad esempio, la protesi 1 può comprendere uno strato d’idrossiapatite su detti primi lati 11 e 21. The surfaces in contact with the vertebral plates, on the first sides 11 and 21 of the lower 20 and upper 10 components, may comprise compositions or substances intended to facilitate the fusion of these components with the vertebrae. For example, the prosthesis 1 can comprise a layer of hydroxyapatite on said first sides 11 and 21.
S’intende che quanto sopra à ̈ stato descritto a titolo esemplificativo e non limitativo, per cui eventuali varianti di natura pratico-applicativa s’intendono rientranti nell’ambito protettivo dell’invenzione come sopra descritto e nel seguito rivendicato. It is understood that what above has been described by way of non-limiting example, therefore any variants of a practical-applicative nature are intended to fall within the protective scope of the invention as described above and claimed hereinafter.
Claims (13)
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WO2021113174A2 (en) | 2019-12-04 | 2021-06-10 | Bray Jr Robert S | Artificial disc replacement device and methods and instruments for implanting same |
US11938035B2 (en) | 2019-12-04 | 2024-03-26 | Robert S. Bray, Jr. | Artificial disc replacement device |
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