IT202000014569A1 - Gabbia intersomatica per stabilizzazione vertebrale - Google Patents

Gabbia intersomatica per stabilizzazione vertebrale Download PDF

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Publication number
IT202000014569A1
IT202000014569A1 IT102020000014569A IT202000014569A IT202000014569A1 IT 202000014569 A1 IT202000014569 A1 IT 202000014569A1 IT 102020000014569 A IT102020000014569 A IT 102020000014569A IT 202000014569 A IT202000014569 A IT 202000014569A IT 202000014569 A1 IT202000014569 A1 IT 202000014569A1
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IT
Italy
Prior art keywords
cage
insert
cage according
intersomatic cage
interbody
Prior art date
Application number
IT102020000014569A
Other languages
English (en)
Inventor
Valerio Vallana
Original Assignee
Sps S R L
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 Sps S R L filed Critical Sps S R L
Priority to IT102020000014569A priority Critical patent/IT202000014569A1/it
Priority to EP21179701.4A priority patent/EP3925576A1/en
Priority to US17/349,979 priority patent/US11679001B2/en
Publication of IT202000014569A1 publication Critical patent/IT202000014569A1/it

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    • 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
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455Joints 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
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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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    • A61F2/4455Joints 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
    • A61F2/447Joints 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 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
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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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Description

DESCRIZIONE dell?invenzione industriale dal titolo:
?Gabbia intersomatica per stabilizzazione vertebrale?
TESTO DELLA DESCRIZIONE
Campo dell'invenzione
La presente invenzione ha per oggetto una gabbia intersomatica per stabilizzazione vertebrale predisposta per essere inserita fra due vertebre contigue allo scopo di distanziarle e mantenerle quindi ad una distanza reciproca tale da ristabilire lo spazio intervertebrale, realizzando la decompressione delle radici nervose e l'accelerazione della fusione intersomatica.
Stato della tecnica
Siffatte gabbie intersomatiche comprendono un corpo di forma generalmente prismatica provvisto di un naso sporgente dall'estremit? anteriore del corpo e destinato ad essere inserito fra due vertebre contigue nel corso dell'inserimento chirurgico della gabbia intersomatica.
Esempi peculiari di gabbie intersomatiche per stabilizzazione vertebrale sono descritti ed illustrati, ad esempio, nelle domande di brevetto italiane n.
102019000023913 e n. 102020000001210 a nome della stessa Richiedente, non pubblicate alla data di deposito o priorit? della presente domanda.
L?applicazione di queste gabbie viene attuata con tecniche chirurgiche invasive che prevedono tipicamente, a seguito dell?inserimento del naso fra le due vertebre, rotazioni alternativamente in senso e nel senso opposto della gabbia, realizzate tramite un apposito strumento manuale, mentre essa viene spinta per potersi incuneare fra le vertebre.
A seguito dell?applicazione la zona intervertebrale ? normalmente soggetta a infiammazioni e in taluni casi anche a infezioni. La ricrescita ossea pu? inoltre risultare insufficiente ed inidonea a inglobare nel tempo in modo efficace la gabbia.
Sintesi dell'invenzione
Lo scopo della presente invenzione ? quello di risolvere i suddetti problemi ed in particolare di rendere disponibile una gabbia intersomatica che consenta di limitare se non addirittura di annullare, a seguito della sua applicazione, le conseguenze cliniche negative per i pazienti.
Secondo l'invenzione questo scopo viene conseguito essenzialmente grazie al fatto che il corpo della gabbia intersomatica comprende un?ossatura rigida esterna definente ampie aperture ed entro la quale ? alloggiato almeno un inserto incorporante sostanze a lento rilascio prolungato scelte nelle classi dei farmaci antiinfiammatori, anti-infezione e promotori di ricrescita ossea.
Preferibilmente l?ossatura ? di titanio o di un analogo materiale biocompatibile, e il corpo contenente i farmaci a rilascio prolungato pu? consistere in un materiale spugnoso o filamentoso o poroso, e anche in materiali ceramici riempiti di nano particelle.
Breve descrizione dei disegni
L'invenzione verr? ora descritta dettagliatamente con riferimento ai disegni annessi, forniti a puro titolo di esempio non limitativo, nei quali:
- la figura 1 ? una vista prospettica frontale della gabbia intersomatica secondo l'invenzione,
- la figura 2 ? una vista prospettica dorsale della gabbia,
- la figura 3 ? una vista in pianta dall'alto della gabbia,
- la figura 4 ? una vista in elevazione laterale della gabbia,
- la figura 5 ? una vista in elevazione frontale della figura 4, e
- la figura 6 ? una vista in elevazione dorsale della figura 4.
Descrizione dettagliata dell'invenzione
Con riferimento alle figure, la gabbia intersomatica secondo l'invenzione consiste in un corpo monolitico 1 di forma generalmente prismatica e pi? precisamente parallelepipeda, avente una faccia superiore 2 ed una faccia inferiore 3 (con riferimento alla posizione impiantata della gabbia nello spazio intervertebrale di un soggetto con colonna vertebrale eretta), e facce laterali 4, 5.
Nella faccia posteriore del corpo 1, indicata con 6, ? formato un recesso 7 per l'introduzione di un attrezzo per l'inserimento chirurgico della gabbia entro lo spazio intervertebrale. Tale strumento, non illustrato, ? configurato per impegnarsi assialmente e torsionalmente con il recesso 7 in modo da poter ruotare il corpo 1 alternativamente in senso destrorso ed in senso sinistrorso o viceversa mentre esso viene contemporaneamente spinto.
Dall'estremit? anteriore del corpo 1, indicata con 8, sporge un naso 9 la cui funzione, durante il procedimento di inserimento della gabbia intersomatica, ? quella di aprire la strada dilatando lo spazio intervertebrale.
La forma del naso 9 ? convenientemente analoga a quella descritta ed illustrata nella gi? citata domanda di brevetto italiano n. 102019000023913 a nome della stessa Richiedente, non pubblicata alla data di deposito o priorit? della presente domanda.
Secondo la caratteristica peculiare dell'invenzione il corpo 1 ? cavo ed ? formato corrispondenza di una o pi? delle sue facce superiore 2, inferiore 3 e laterali 4, 5 da una travatura reticolare che definisce un?ossatura rigida esterna 11 con ampie aperture che pongono in comunicazione la sua cavit? con l?esterno.
La o ciascuna ossatura 11, che nel caso dell?esempio illustrato ? prevista in corrispondenza di tutte le facce 2, 3, 4, 5, ? formata da aste complanari vincolate fra loro e alle facce 7, 8 in modo da costituire una struttura resistente e indeformabile.
Il corpo 1 ? di un materiale biocompatibile, ad esempio titanio, ed ? ad esempio realizzato mediante tecniche additive del tipo sinterizzazione di polveri. Altre tecniche di fabbricazione convenzionali sono naturalmente prospettabili.
Secondo un?altra caratteristica peculiare dell?invenzione entro la cavit? del corpo 1 ? alloggiato un inserto 10 incorporante o imbibito con sostanze farmacologiche a lento rilascio prolungato scelte nelle classi dei farmaci anti-infiammatori, anti-infezione e promotori di ricrescita ossea. L?inserto 10 pu? presentare una struttura spugnosa o filamentosa o porosa, in tal caso ad esempio anch?essa realizzata mediante tecniche additive, o pu? anche essere formato da materiali ceramici riempiti di nano-particelle. Esso pu? essere in un unico pezzo suddiviso in zone distinte per le diverse sostanze farmacologiche, oppure pu? essere formato da settori autonomi e separati, ciascuno incorporante il rispettivo farmaco.
Tipicamente le sostanze farmacologiche possono essere le seguenti:
<? >Promotori di crescita: farmaci anche ad azione multimodale, combinando fattori chemiotattici, mitogenici, morfogenici, metabolici o apoptotici. Tra questi si possono ricordare i BMP (bone morphogenetic proteins) in particolare BMP-2 e BMP-7; i VEGF (vascular endothelial growth factor) che sono stati studiati per promuovere la crescita di vasi sanguigni per la vascolarizzazione dell'osso; fattori di crescita dei fibroblasti. E? anche stato dimostrato che l'uso di statine promuove l'espressione del BMP-2 nel mRNA negli osteoblasti.
? Anti-infezione: principalmente antibiotici ad ampio spettro come la gentamicina e la vancomicina
? Antinfiammatori usuali.
Queste sostanze vengono poi normalmente unite ad eccipienti di vario tipo convenzionale anche atte a favorirne il lento rilascio.
Naturalmente i particolari di costruzione e le forme di realizzazione potranno essere ampiamente variati rispetto a quanto descritto ed illustrato senza per questo uscire dall'ambito dell'invenzione cos? come definita nelle rivendicazioni che seguono.

Claims (5)

RIVENDICAZIONI
1. Gabbia intersomatica per stabilizzazione vertebrale, comprendente un corpo generalmente prismatico (1) avente un naso sporgente (9) e destinato ad essere inserito fra due vertebre contigue per distanziarle nel corso dell'inserimento chirurgico della gabbia, caratterizzata dal fatto che il corpo (1) comprende un?ossatura rigida esterna (11) definente ampie aperture ed entro la quale ? alloggiato almeno un inserto (10) incorporante sostanze a lento rilascio prolungato scelte nelle classi dei farmaci anti-infiammatori, anti-infezione e promotori di ricrescita ossea.
2. Gabbia intersomatica secondo la rivendicazione 1, caratterizzata dal fatto che l?ossatura (11) consiste in una travatura reticolare disposta in corrispondenza di una o pi? delle facce superiore (2), inferiore (3) e laterali (4, 5) del corpo (1).
3. Gabbia intersomatica secondo la rivendicazione 1 o 2, caratterizzata dal fatto che l?ossatura (11) ? di titanio o di un analogo materiale biocompatibile.
4. Gabbia intersomatica secondo una qualsiasi delle rivendicazioni precedenti, caratterizzata dal fatto che detto inserto (10) ? di un materiale spugnoso o filamentoso o poroso.
5. Gabbia intersomatica secondo una qualsiasi delle rivendicazioni 1 a 3, caratterizzata dal fatto che detto inserto (10) ? formato da materiali ceramici riempiti di nano-particelle.
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