WO2008018096A1 - Dispositif d'espacement intervertébral avec applicateur - Google Patents

Dispositif d'espacement intervertébral avec applicateur Download PDF

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Publication number
WO2008018096A1
WO2008018096A1 PCT/IT2006/000611 IT2006000611W WO2008018096A1 WO 2008018096 A1 WO2008018096 A1 WO 2008018096A1 IT 2006000611 W IT2006000611 W IT 2006000611W WO 2008018096 A1 WO2008018096 A1 WO 2008018096A1
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WO
WIPO (PCT)
Prior art keywords
spacer
plates
intervertebral
membrane
applicator device
Prior art date
Application number
PCT/IT2006/000611
Other languages
English (en)
Inventor
Radames Binotto
Original Assignee
Radames Binotto
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 Radames Binotto filed Critical Radames Binotto
Priority to PCT/IT2006/000611 priority Critical patent/WO2008018096A1/fr
Priority to EP06796262A priority patent/EP2049049A1/fr
Publication of WO2008018096A1 publication Critical patent/WO2008018096A1/fr

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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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/441—Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30461—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30462—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30565—Special structural features of bone or joint prostheses not otherwise provided for having spring elements
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • A61F2002/30583—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid filled with hardenable fluid, e.g. curable in-situ
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30617—Visible markings for adjusting, locating or measuring
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0085—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof hardenable in situ, e.g. epoxy resins
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia

Definitions

  • the present patent relates to the field of medical devices for spinal neurosurgery, neurotraumatology and orthopaedics, and in particular concerns a new intervertebral spacer and related applicator device.
  • Intervertebral spacers are known for interosseus positioning, used in the treatment of vertebral pathologies, of degenerative or traumatic origin for example, and having the purpose of restoring or correcting the connection between the vertebrae of the spinal column at one or more levels, also stimulating cervical fusion.
  • a first problem common to the spacers currently used is due to the occlusion, by the spacer, of the haversian canals via which the bone tissue is nourished. This results in undesired high intraoperative morbidity.
  • spacers generally have low mechanical strength and are able to provide only a limited degree of intersomatic fusion.
  • Spacers provided with holes are known, which reduce the risk of occlusion of the haversian vessels and guarantee a greater degree of fusion.
  • primary immobilisation meaning the initial position at the time of the operation
  • secondary immobilisation meaning the intersomatic fusion which guarantees that the implant remains correctly positioned also in the long term.
  • the operation for implant of the known intervertebral spacers usually entails an anterior approach, i.e. the surgical incision is made on the anterior part of the patient's body and the operation therefore also involves the internal organs, the vascular and visceral structures, with consequent serious risks for the patient.
  • the object of the new spacer with applicator device is to allow the surgeon to operate on the patient with a posterolateral approach, thus limiting the invasive nature of the operation and consequent risks.
  • a further object of the new spacer with applicator is to guide the surgeon to correct positioning and implanting in the intervertebral space(s).
  • a further object of the present invention is to have initially reduced dimensions with respect to the known intervertebral spacers, the spacer then being able to adapt to the intervertebral space in which it is implanted.
  • a further object of the present invention is to permit stable initial positioning, i.e. primary immobilisation.
  • a further object is to permit a high degree of spinal intersomatic fusion, i.e. guarantee secondary immobilisation, not obstructing the growth of the bone trabeculae.
  • a further object of the present invention is not to require the use of connection plates or vertebrae fixing screws, particularly in the case of implant on two or more levels.
  • a further object of the present invention is to limit the invasiveness of the operation.
  • a further object is to obtain mechanical strength comparable to that of the vertebrae.
  • the new intervertebral spacer suitable for insertion with posterolateral approach, by means of applicator device, in the anterior intervertebral space, i.e. between two vertebrae, and in which the opposite sides facing the two vertebrae comprise protrusions or teeth suitable for permitting and guaranteeing primary and secondary immobilisation of the spacer.
  • the new spacer can vary its thickness, for example as a result of injection inside it of specific substances as described and claimed below, so as to adapt to and be constrained in a stable manner in the intervertebral space.
  • the new spacer comprises two opposite plates, provided with said protruding parts for immobilisation, which, if not subject to any external stress, tend to position themselves on substantially parallel planes.
  • Said plates have a preferably bean-shaped form, i.e. a substantially curvilinear profile suitable for being inserted and positioned in the anterior intervertebral space and where said profile has at least one concave part which is positioned facing towards the spinal cord.
  • one or more holes are preferably obtained for the passage of cells and to permit growth of the bone trabeculae inside them, thus favouring secondary immobilisation of the spacer and fusion with the adjacent bodies.
  • at least one membrane and/or other shock absorbing body will be positioned and constrained, having the function of spacing the two plates, countering the relative movements between the plates and delimiting an empty space between the plates, inside which cementing or similar substances can then be injected, for example substances suitable for stimulating bone re- growth, i.e. fusion, or plastic substances suitable for favouring shock absorption of the spacer.
  • one or more springs acting as shock absorbers and spacers can be positioned between said plates, where said springs are made of Nitinol, for example, a nickel-titanium shape memory alloy.
  • the new intervertebral spacer can be conveniently positioned by means of an applicator device comprising a variously shaped hollow tubular element suitable for being gripped by the surgeon during application and having, at one end, a connection element for the fitting of said spacer.
  • Said applicator device furthermore comprises at least one element with the function of indicating the position of the spacer.
  • Said indicator element integral with -said tubular element, has a preferably flat shape and lies on a plane parallel to the main plane on which said spacer lies, constrained at the end of the tubular element. The form, dimensions and actual spatial arrangement of the spacer are also illustrated on it, so that during the spacer implant operation the surgeon always knows and can therefore control the position of the spacer.
  • Said applicator device also comprises seats, hooks or holes for the passage of at least one thread, for example a suture thread which, fixed both to the applicator device and to the spacer, ensures assembly of the applicator on the spacer during the connection operation.
  • Said membrane is also extendible, i.e. it permits variation of the relative distance between the two plates.
  • said membrane can be a balloon, for example, where the substance injected inside it causes swelling of the membrane, therefore moving the plates away from each other.
  • said membrane can be a concertina-type membrane.
  • the latter has for example a thickness of approximately 4-8 mm and can therefore be inserted in the intervertebral space with minimum difficulty on the part of the surgeon, who operates on the patient with posterolateral approach, also requiring smaller surgical incisions than at present.
  • the surgeon inserts a needle/catheter through a duct inside said tubular element of the applicator device, bringing it out of the opposite end, i.e. where the spacer is positioned, and puncturing said membrane.
  • Said membrane can be provided with a valve through which said substances are injected. Via said needle, it is therefore possible to inject between said plates, i.e. in the space delimited by said membrane, the cementing and/or adhesive substance and/or the diversified stem cells or other types of material in gel or liquid form.
  • the distance between the plates is increased, i.e. the overall thickness of the spacer is increased, even up to 15 mm for example, thus adapting perfectly to the intervertebral space.
  • the overall diameter or thickness of the spacer depends on the dimensions of said membrane used, which can be sized according to the dimensions of the intervertebral space.
  • Nitinol springs will be positioned and retained between said plates; said springs will be initially compressed, therefore keeping the plates close to each other.
  • the increase in temperature causes expansion of the springs, which consequently move the plates apart.
  • the cementing substance also has the function of stimulating bone or cartilaginous fusion, without obstructing growth of the bone trabeculae. Said substance injected, furthermore, reaches and fills the interstices between the new spacer and the vertebrae between which the spacer is inserted, ensuring that the new spacer and the vertebrae are joined.
  • the material used for construction of the new spacer is biocompatible, i.e. it integrates perfectly with the human tissue, and has mechanical characteristics similar to those of the adjacent vertebrae.
  • said plates will be made preferably of plastic polymeric material, for example caprolactone or its derivatives and/or fine metal materials.
  • Said membrane is made for example of silicone or similar medical plastic materials, natural or synthetic polymers, also latest generation materials, with the possibility of insertion of differentiated cellular material suitable for activating bone growth and/or the growth of cartilage or other.
  • hydroxylapatite mixed with plasma and gelatins of various origins and growth factors ceramic bioglass suitable for bone fusion mixed with gelatins of various origins and growth factors, metal implantology products, elastic medical plastic silicone materials, synthetic and natural polymers, tissues, resins, polyethylene with the possibility of injection of cells suitable for colonising and transforming the supporting material.
  • Figure 1 shows a three-dimensional view of the spacer (S) with plates
  • Figure 2 shows an exploded view of the spacer e (S) and the connection end (Al) of the applicator device (A).
  • Figure 3 shows a three-dimensional view of the applicator device (A).
  • Figure 4 shows schematically the position of the spacer (S) with respect to the vertebrae (V).
  • Figure 5 shows a three-dimensional view of the spacer (S) with balloon membrane (M), while figure 6 shows aUhree-dimensional view of a further possible embodiment of the new spacer (S) with concertina membrane (M).
  • Figures 7a 3 7b, 7c schematise the process for implanting the new spacer
  • FIG. 8 shows an exploded view of the spacer (S) with membrane (M) and non-compressed springs (T).
  • the new intervertebral spacer (S), suitable for insertion by means of applicator device (A) in the intervertebral space, comprises on the opposite sides (Sv) facing the vertebrae one or more protrusions or teeth (D) suitable for permitting and guaranteeing primary and secondary immobilisation of the spacer (S).
  • the new spacer (S) can vary its thickness, as a result of injection inside it of specific substances and/or due to the expansion of springs (T), made for example of Nitinol and appropriately positioned inside the spacer (S).
  • the new spacer (S) comprises two opposite plates (Pi, Ps), bean-shaped for example, i.e. with substantially curvilinear profile with at least one concave part (Ll) which is positioned facing towards the spinal cord (L), as in figure 4.
  • One or more holes (B) are furthermore preferably obtained on one or both of said plates (Pi, Ps) for the passage of cells and to permit growth of the bone trabeculae inside them, thus favouring secondary immobilisation of the spacer and fusion with the adjacent bodies. It is envisaged that between said two plates (Pi, Ps) at least one membrane (M) and/or springs (T) and/or other shock absorbing body and spacer will be positioned and constrained, having the function of spacing the two plates (Pi, Ps), countering the relative movements thereof, and delimiting an empty space between the plates (Pi, Ps) inside which the cementing substances can then be injected.
  • said membrane (M) is extendible, i.e. it is possible to increase/reduce the height extension of its surface by increasing/reducing the distance between said plates (Pi, Ps).
  • said membrane (M) has a concertina or balloon- shaped lateral wall (Ml).
  • the new intervertebral spacer (S) is positioned by means of an applicator device (A) comprising a tubular element (A2) suitable for being gripped by the surgeon during application and having, at one end, a connection element (Al) for said spacer (S).
  • Said tubular element (A2) is preferably at least partly curvilinear to facilitate insertion and positioning of the spacer (S).
  • Said connection element (Al) comprises for example one or more protrusions (A3) suitable for being inserted in corresponding seats (P3) obtained on one or both of said plates (Pi, Ps).
  • Said applicator device (A) also comprises an element (N) with the function of indicating the position of the spacer (S) and where said indicator element (N) is integral with said tubular element (A2).
  • Said indicator element (N) has a flat shape and lies on a plane parallel to the main plane on which said spacer (S) lies, fitted to the connection element (Al).
  • Said indicator element (N) furthermore bears, for example as a relief, engraving or drawing (R), the form, dimensions and actual spatial arrangement of the plates (Pi, Ps) of the spacer (S) fixed at the end of said tubular element (A2), so that the surgeon, during the operation for implant of the spacer (S) 5 always knows_ and can therefore control the position thereof.
  • Said applicator device (N) and said plates (Pi, Ps) also comprise seats, hooks or holes (Gp, Fp, Ga, Fa) for the passage of at least one suture thread (F) which, fixed both to the applicator device (A) and to the spacer (S), ensures their assembly, particularly during the connection operation.
  • said thread (F) is kept tensioned by being retained at least at one end by means of at least one stop (Fl) inserted in a seat (Ga) obtained on said indicator element (N).
  • the thread (F) is furthermore inserted in holes (Fa) obtained on said connection element (Al), in seats (Gp) positioned on the outer faces of said plates (Pi, Ps), in through holes (Fp) obtained on said plates (Pi, Ps) and therefore envelops and retains said plktes (Pi, Ps) on said applicator device (A) and in a suitable position.
  • Said thread (F) can also be partially inserted in the duct (A4) inside said tubular element (A2).
  • the extendible concertina or balloon-shaped wall (Ml) of said membrane (M) permits variation of the relative distance between the two plates (Pi, Ps).
  • the surgeon After appropriately positioning the spacer (S), the surgeon inserts a needle or a catheter through the inner duct (A4) of said tubular element (A2) of the applicator device (A), brings it out of the opposite end, i.e. where the spacer (S) is positioned, and punctures said membrane (M).
  • the distance between the plates (Pi, Ps) is increased, i.e. the overall thickness of the spacer (S) is increased, even up to 15 mm, hence it adapts perfectly to the intervertebral space.
  • said plates (Pi, Ps) will move away from one another due to the expansion of Nitinol springs (T), positioned and retained between the plates (Pi, Ps), as shown in figure 8. Said increase in distance between the plates (Pi, Ps), furthermore, causes said protrusions (A3) of the connection element (Al) to come out of the corresponding seats (P3) on the plates (Pi, Ps), thus causing the release of said connection element (Al) from the spacer (S).
  • the applicator device (A) can therefore be extracted, while the spacer remains anchored in a stable manner in the required position in the intervertebral space.
  • Said plates (Pi, Ps) comprise, on their inner face, protrusions (C) for positioning and housing said membrane (M), which fit into holes (M2) obtained in corresponding positions on said membrane (M) and where said holes (M2) also permit passage of the cementing substances and organic fluids to stimulate bone and cartilaginous fusion.
  • Said springs (T) can also be constrained -to said protrusions (C) of said plates (Pi, Ps) and therefore also have the function of ensuring assembly of the spacer (S), retaining said plates (Pi, Ps) and countering the relative movements thereof.
  • said membrane (M) can be constrained to one or both of said plates (Pi, Ps) in another way, for example by gluing or by slotting in.
  • said teeth (D) can be positioned directly on said membrane
  • Said membrane (M) is preferably made of elastic material, for example silicone, nylon or derivatives, polyethylene or derivatives, etc.
  • said teeth (D) are made of rigid material, such as plastic polymeric material, for example caprolactone or its derivatives and/or metallic materials such as titanium, medical steel, etc.
  • said applicator (A) is a needle or thread guide or cannula needle, i.e. comprising an internal duct for the injection of substances.
  • said applicator (A) will comprise a connection element (Al) for connection to said spacer (S), suitable for permitting release of the spacer (S) once it has been appropriately positioned in the intervertebral space.
  • said applicator (A) will comprise a connection element (Al) with slot or thread coupling or other release devices.
  • the spacer (S) produced as above can have extremely compact dimensions and can therefore be inserted in the intervertebral space also percutaneously as well as surgically.
  • the spacer (S), adequately closed as in figure 7a, can be inserted in the intervertebral space by means of a needle (G) which is removed after positioning of the spacer (S) (figure 7b).
  • the teeth (D) positioned on said membrane (M) block the spacer (S) between the vertebrae and the applicator (A) can be removed.
  • the new interosseous spacer (S) can also be wholly or partly coated in carbon or pyrolytic carbon.

Landscapes

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

Abstract

La présente invention concerne un nouveau dispositif d'espacement intervertébral (S) destiné à un positionnement interosseux convenant à une insertion entre deux vertèbres (V), qui comprend une membrane extensible (M) formant un espace interne adapté pour être rempli entièrement ou partiellement avec des ciments, et dans lequel ladite membrane (M) peut augmenter/réduire son extension, s'adaptant en forme et/ou en dimensions à l'espace intervertébral. Le nouveau dispositif d'espacement (S) comprend un ou plusieurs éléments saillants ou dents (D) positionnés sur une surface ou sur les deux surfacs (Sv) opposées desdites vertèbres (V).
PCT/IT2006/000611 2006-08-08 2006-08-08 Dispositif d'espacement intervertébral avec applicateur WO2008018096A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/IT2006/000611 WO2008018096A1 (fr) 2006-08-08 2006-08-08 Dispositif d'espacement intervertébral avec applicateur
EP06796262A EP2049049A1 (fr) 2006-08-08 2006-08-08 Dispositif d'espacement intervertébral avec applicateur

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2006/000611 WO2008018096A1 (fr) 2006-08-08 2006-08-08 Dispositif d'espacement intervertébral avec applicateur

Publications (1)

Publication Number Publication Date
WO2008018096A1 true WO2008018096A1 (fr) 2008-02-14

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IT2006/000611 WO2008018096A1 (fr) 2006-08-08 2006-08-08 Dispositif d'espacement intervertébral avec applicateur

Country Status (2)

Country Link
EP (1) EP2049049A1 (fr)
WO (1) WO2008018096A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000044319A1 (fr) * 1999-01-27 2000-08-03 Disc-O-Tech Medical Technologies, Ltd. Espaceur extensible intervertebral
WO2002017825A2 (fr) * 2000-08-28 2002-03-07 Disc Dynamics, Inc. Prothese de disque intervertebral
US6387130B1 (en) * 1999-04-16 2002-05-14 Nuvasive, Inc. Segmented linked intervertebral implant systems
US20040093087A1 (en) * 2002-11-05 2004-05-13 Ferree Bret A. Fluid-filled artificial disc replacement (ADR)
US20040230309A1 (en) * 2003-02-14 2004-11-18 Depuy Spine, Inc. In-situ formed intervertebral fusion device and method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000044319A1 (fr) * 1999-01-27 2000-08-03 Disc-O-Tech Medical Technologies, Ltd. Espaceur extensible intervertebral
US6387130B1 (en) * 1999-04-16 2002-05-14 Nuvasive, Inc. Segmented linked intervertebral implant systems
WO2002017825A2 (fr) * 2000-08-28 2002-03-07 Disc Dynamics, Inc. Prothese de disque intervertebral
US20040093087A1 (en) * 2002-11-05 2004-05-13 Ferree Bret A. Fluid-filled artificial disc replacement (ADR)
US20040230309A1 (en) * 2003-02-14 2004-11-18 Depuy Spine, Inc. In-situ formed intervertebral fusion device and method

Also Published As

Publication number Publication date
EP2049049A1 (fr) 2009-04-22

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