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WO2025163503A1 - Prothèse de remplacement de corps vertébral - Google Patents

Prothèse de remplacement de corps vertébral

Info

Publication number
WO2025163503A1
WO2025163503A1 PCT/IB2025/050950 IB2025050950W WO2025163503A1 WO 2025163503 A1 WO2025163503 A1 WO 2025163503A1 IB 2025050950 W IB2025050950 W IB 2025050950W WO 2025163503 A1 WO2025163503 A1 WO 2025163503A1
Authority
WO
WIPO (PCT)
Prior art keywords
module
prosthesis
central
contact
modular prosthesis
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/IB2025/050950
Other languages
English (en)
Inventor
Giuseppe Emmanuele UMANA
Matteo GIUNTA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mt Ortho SRL
Original Assignee
Mt Ortho SRL
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 Mt Ortho SRL filed Critical Mt Ortho SRL
Publication of WO2025163503A1 publication Critical patent/WO2025163503A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/4455—Joints 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
    • 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
    • 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
    • A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
    • A61F2002/30607—Kits of prosthetic parts to be assembled in various combinations for forming different prostheses

Definitions

  • the present invention concerns a prosthesis for vertebral body replacement, in particular such prosthesis is implanted in the patient during thoracic corpectomy operations.
  • the corpectomy surgical procedure initially involves the step of removal or excision of the damaged vertebrae and/or intervertebral discs, followed by the placement of a prosthesis adapted to replace the damaged vertebral body, also known as “Vertebral Body Replacement” , to allow the subsequent reconstruction of the part of the spine affected by the damage, restoring its functionality, stability and alignment.
  • vertebral fractures such as vertebral compression fractures and/or fractures related to malignancy or infections
  • causes of vertebral fractures may include falls, sports injuries and motor vehicle accidents
  • the vertebral reconstruction step typical of the corpectomy procedure, involved the use of grafts, such as autografts, allografts and/or bone substitutes.
  • grafts such as autografts, allografts and/or bone substitutes.
  • this surgery often led to complications such as, for example, high rates of pseudoarthrosis and delayed bone consolidation.
  • prostheses made of different materials are preferred, with significant improvements in both clinical and radiographic results.
  • the various materials used for prostheses include, for example, acrylic resin and polymethylmethacrylate (PMMA), ceramics, metals, such as tantalum or carbon, for porous implants, and, nowadays, titanium or non-metallic materials, such as carbon or polyetheretherketone (PEEK), for expandable cage implants, which offer considerable advantages in radiological follow-up, producing fewer artifacts.
  • PMMA acrylic resin and polymethylmethacrylate
  • ceramics such as tantalum or carbon
  • titanium or non-metallic materials such as carbon or polyetheretherketone (PEEK)
  • Such expandable cages for corpectomy procedures provide for filling the metal body with bone grafting material.
  • the surgery proceeds, after the aforementioned filling, with positioning the metal cage in the position previously occupied by the vertebral body and/or the damaged intervertebral discs.
  • This cage therefore has the function of supporting the spine during the progressive growth of the new bone, in and around the cage, which will eventually fuse with the vertebrae below and above the site.
  • the expandable cages have a single modular structure, formed by a cylindrical-shaped main module, which can be telescopically elongated or shortened by means of a threaded shaft and a nut, locking screws, positioned around the adjustment nut, which allow easy locking of the telescopic movement of the structure, and serrated end plates, to prevent movement of the cage after implantation.
  • a further drawback of such expandable cage implants of known type consists in the fact that the type of introduction of bone graft is relevant for the purposes of success of the treatment.
  • the amount and compression that favours fusion of the grafted bone could be insufficient, while a bone graft after cage expansion could alter the pressure on the bone graft, leading to a non-perfect bone fusion.
  • the graft must therefore be evaluated in relation to the risk factors of the individual patient, further lengthening and complicating the phases of diagnosis and preparation for surgery.
  • the task of the present invention is to make a prosthesis for vertebral body replacement that overcomes the limits of the prior art allowing to improve the stability of the implant in the face of the pressure to which the entire spine is subjected.
  • Another object of the present invention is to overcome the need for prior insertion of the bone graft material, leading to a more reliable system of bone growth in the implant, and subsequent fusion.
  • a further object of the invention consists in making a prosthesis having a smaller encumbrance, so as to restrict the surgical access route, and therefore the postoperative discomfort of the patient.
  • a further object of the invention consists in making a prosthesis which is capable of giving the greatest assurances of reliability and safety in use.
  • a still further object of the invention consists in making a prosthesis that is easy to make and economically competitive if compared to the prior art.
  • FIG. 1 is a perspective view of a prosthesis for vertebral body replacement according to the invention in an assembled configuration
  • FIG. 1 is a perspective view of the prosthesis, according to the invention, in disassembled configuration
  • FIG. 3 is a front view of the prosthesis, according to the invention, in disassembled configuration
  • FIG. 4 is a side view of the prosthesis, according to the invention, in disassembled configuration
  • FIG. 5 is a side view of the prosthesis according to the invention in an assembled configuration
  • FIG. 6 is a side view of the prosthesis, according to the invention, in the first step of insertion between two vertebrae of the patient;
  • FIG. 7 is a side view of the prosthesis, according to the invention, in the second step of insertion between two vertebrae of the patient;
  • FIG. 8 is a side view of the prosthesis, according to the invention, in the third step of insertion between two vertebrae of the patient;
  • FIG. 9 is a side view of the prosthesis, according to the invention, in the fourth step of insertion between two vertebrae of the patient;
  • FIG. 10 is a side view of the prosthesis, according to the invention, inserted between two vertebrae of the patient.
  • the prosthesis for vertebral body replacement comprises an upper module 2, called “top”, a lower module 3, called “bottom” , and a central module 4, called “wedge”, where the module closest to the patient's skull is indicated as upper module 2, while the module closest to the patient's coccyx, according to the human body longitudinal axis, is indicated as lower module 4.
  • the invention provides for an assembled configuration in which the central module 4 is inserted between the upper module 2 and the lower module 3, as visible in figures 1 and 5, and a disassembled configuration in which the central module 4 is not totally inserted between the upper module 2 and the lower module 3, as visible in figures 2, 3 and 4.
  • the upper module 2 substantially cylindrical in shape, comprises a substantially flat upper surface 20, configured to contact with the vertebral structure of the patient, a lower surface 21, which in the assembled configuration is in contact with the central module 4, and a lateral surface 22 comprising a hole 100;
  • the lower surface 21 of the upper module 2 is inclined with respect to the upper surface 20
  • the upper surface 30 of the lower module 3 is inclined with respect to the lower surface 31, and the central module 4 has the upper surface 41 and the lower surface 40 not parallel to each other and inclined in a complementary manner with respect to the surfaces 21 and 30, respectively, so as to allow a shape coupling between the central module 4 and the upper module 2 and the lower module 3.
  • said central module has, on a longitudinal vertical plane (i.e. sagittal thinking about the intended use of the prosthesis 1), a wedge-shaped profile.
  • the lower surface 21 of the upper module 2 comprises at least one portion 21’ inclined with respect to the upper surface 20 of the upper module 2 and at least one portion 21” substantially flat and substantially parallel to said upper surface 20.
  • the upper surface 30 of the lower module 3 comprises at least one portion 30’ inclined with respect to the lower surface 31 of the upper lower module 3 and at least one portion 30” substantially flat and substantially parallel to said lower surface 31.
  • At least a portion 21’ of the lower surface 21 of the upper module 2 has an inclination with respect to the upper surface 20 of a value of between 1° and 8°, preferably between 4° and 6°, more preferably substantially equal to 5°.
  • the upper surface 30 of the lower module 3 has an inclination with respect to the lower surface 31 of a value of between 1° and 8°, preferably between 4° and 6°, more preferably substantially equal to 5°.
  • the inclination value of the portion 21’ of the lower surface 21 with respect to the upper surface 20 of the upper module 2 and the inclination value of the portion 30’ of the upper surface 30 with respect to the lower surface 31 of the lower module 3 are substantially the same.
  • the through holes 102, 103 are aligned with the hole 100, of the upper module 3, and with the hole 101, of the lower module 4, respectively, said holes being suitable for receiving a screw for fixing said modules, making the central module 4 solidly coupled with the upper module 2 and the lower module 3.
  • the prosthesis 1 is assembled by first making the central module 4 slip between the upper module 2 and the lower module 3.
  • the first step of insertion of the prosthesis 1 between two vertebrae 700 of the patient provides for the introduction of only the upper 2 and lower 3 modules in contact with each other.
  • the initial surgical access route is smaller than the surgical incisions for the grafting of vertebral prostheses of known art.
  • vertebral prosthesis introduction devices comprise a pressure handle, operable by the surgeon, connected to a lever mechanism to allow the distancing or approach, along a longitudinal vertical plane, of appropriate connection ends of the device with the spinal prosthesis 1.
  • each vertebral prosthesis introduction device is stably coupled with the upper module 2 and the lower module 3 of the prosthesis 1 through, respectively, the holes 221, 321 and 322, 222 present on the lateral surface 22 of the upper module 2 and on the lateral surface 33 of the lower module 3.
  • the holes 222 and 322 are threaded blind holes, while the holes 221 and 321 are interlocking cylindrical blind holes.
  • the presence of an interlocking coupling provided by the holes 221 and 321 prevents possible rotations of the upper module 2 and of the lower module 3 of the prosthesis 1 with respect to the vertebral prosthesis introduction device itself.
  • the upper module 2 and the lower module 3 of the prosthesis 1 are spaced apart, along a longitudinal vertical plane, by means of the vertebral prosthesis insertion devices.
  • the central module 4 of the prosthesis 1 is inserted into the surgical area.
  • the central body 4 is inserted by slipping it between the upper module 2 and the lower module 3.
  • the extension between the upper module 2 and the lower module 3 increases, leading to an increase in the pressure exerted by the vertebrae 700 on the prosthesis 1, and therefore, actually, to an increase in the locking of the prosthesis 1 between the two vertebrae 700.
  • the insertion of the prosthesis 1 between two vertebrae 700 of the patient ends with the central module 4 being interlocked between the upper module 2 and the lower module 3, as illustrated in figure 10, so as to achieve the alignment of the through holes 102, 103 to the hole 100, of the upper module 3, and to the hole 101, of the lower module 4, respectively, and to make the central module 4 solidly coupled and fixed with the upper module 2 and the lower module 3 through a screw housable in said holes, and the subsequent decoupling of the vertebral prosthesis introduction device from the prosthesis 1, as well as the removal of said device from the surgical area.
  • the interlocking and fixing take place both thanks to the pressure exerted by the vertebrae 700 of the patient on the prosthesis 1, specifically on the upper surface 20 of the upper module 2 and on the surface 31 of the lower module 3, and thanks to the presence of the screws through the through holes 102, 103, of the central module 4, and housed in the holes 100 and 101, of the upper module 2 and of the lower module 3, respectively.
  • the upper module 2 and the lower module 3 can be made with different height measurements and the surfaces 21 and 30 with different inclinations to obtain the desired lordosis of the prosthesis 1. These characteristics allow the prosthesis 1 to be easily adapted to the needs of the patient.
  • the hole 100 of the upper module 2 is obtained in a recess 22’, while the hole 101 of said lower module 3 is obtained in a recess 32’, where the recesses 22’, 32’ have a shape complementary to the projecting parts 43, 44 of the central module 4, respectively, to enable a shape coupling.
  • the projecting parts 43, 44 present a substantially cylindrical shape.
  • the upper module 2, the lower module 3 and the central module 4 are made of titanium alloys of titanium or other biocompatible materials suitable for implantation in the human body.
  • the lower surface 21 of the upper module 2, the upper surface 31 of the lower module 3 and the surfaces of the upper 41 and lower 40 module of the central module 4 all have an equal rigidity, thus favouring the sliding of the central module 4, between the upper module 2 and the lower module 3, and obviating the risk of possible relative displacements and/or failures between the modules 2, 3 and 4, since the same modules 2, 3 and 4 are held in contact by the pressure of the vertebral structure of the patient and by the screws of the prosthesis 1, without any suspension or empty space between the relative contact surfaces.
  • the upper surface 20 of the upper module 2 and the lower surface 31 of the lower module 3 comprise a trabecular structure 20’, 31’, respectively, made of titanium or similar alloys, also called “net trabecular” .
  • This structure favours osteo-induction processes, thus avoiding the need to insert bone graft material into the prosthesis, as well as additional anchoring and fixing systems to the patient's bone structure, such as screws and metal bars.
  • the prosthesis 1 according to the present invention thus provides an innovative solution for the stabilization of the spine in that the assembly of the three modules can take place directly at the implantation site allowing the surgeon to use a reduced access route compared to those used in similar cases.
  • prosthesis for vertebral body replacement according to the present invention is susceptible to numerous modifications and variants all falling within the scope of the inventive concept as defined by the appended claims.
  • any materials can be used according to requirements, as long as they are compatible with the specific use, the dimensions and the contingent shapes.

Landscapes

  • 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)

Abstract

La présente invention concerne une prothèse (1) de remplacement de corps vertébral. Selon l'invention, la prothèse (1) comprend un module supérieur (2), un module inférieur (3) et un module central (4) pouvant être assemblés les uns avec les autres et, dans une configuration assemblée de ladite prothèse (1), ledit module supérieur (2) comprend une surface supérieure (20) sensiblement plane, conçue pour venir en contact avec la structure vertébrale (700) du patient, une surface inférieure (21) en contact avec ledit module central (4) et une surface latérale (22) comprenant un trou (100), ledit module inférieur (3) comprend une surface supérieure (30) en contact avec ledit module central (4), une surface inférieure (31) sensiblement plane, conçue pour venir en contact avec la structure vertébrale (700) du patient, et une surface latérale (32) comprenant un trou (101) et ledit module central (4) comprend une surface supérieure (41) en contact avec ladite surface inférieure (21) dudit module supérieur (2), une surface inférieure (40) en contact avec ladite surface supérieure (30) dudit module inférieur (3) et une surface latérale (42) comprenant deux trous traversants (102, 103) à travers deux parties proéminentes (43, 44) de ladite surface latérale (42) et faisant saillie vers ledit module supérieur (2) et ledit module inférieur (3), respectivement, ladite surface inférieure (21) dudit module supérieur (2) étant inclinée par rapport à ladite surface supérieure (20) et ladite surface supérieure (30) dudit module inférieur (3) étant inclinée par rapport à ladite surface inférieure (31) et lesdites surfaces supérieure (41) et inférieure (40) dudit module central (4) n'étant pas parallèles et étant complémentaires des surfaces (21) et (30), respectivement, de manière à permettre un accouplement de forme entre ledit module central (4) et ledit module supérieur (2) et ledit module inférieur (3), ce qui aligne ainsi lesdits trous traversants (102, 103) sur ledit trou, (100) dudit module supérieur (3), et sur ledit trou (101), dudit module inférieur (4), respectivement, conçus pour être fixés avec une vis, ce qui amène ledit module central (4) à être accouplé solidement à la fois audit module supérieur (2) et audit module inférieur (3).
PCT/IB2025/050950 2024-02-02 2025-01-29 Prothèse de remplacement de corps vertébral Pending WO2025163503A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT202400002250 2024-02-02
IT102024000002250 2024-02-02

Publications (1)

Publication Number Publication Date
WO2025163503A1 true WO2025163503A1 (fr) 2025-08-07

Family

ID=91023005

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2025/050950 Pending WO2025163503A1 (fr) 2024-02-02 2025-01-29 Prothèse de remplacement de corps vertébral

Country Status (1)

Country Link
WO (1) WO2025163503A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080103602A1 (en) * 2002-03-21 2008-05-01 Berry Bret M Vertebral body and disc space replacement devices
WO2018007112A1 (fr) * 2016-07-08 2018-01-11 Tfc Médical Implant modulaire pour corporectomie
US20180098861A1 (en) * 2016-09-14 2018-04-12 Globus Medical, Inc. Center lordotic mesh cage

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080103602A1 (en) * 2002-03-21 2008-05-01 Berry Bret M Vertebral body and disc space replacement devices
WO2018007112A1 (fr) * 2016-07-08 2018-01-11 Tfc Médical Implant modulaire pour corporectomie
US20180098861A1 (en) * 2016-09-14 2018-04-12 Globus Medical, Inc. Center lordotic mesh cage

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