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WO2025052335A1 - Broche vertébrale polyaxiale - Google Patents

Broche vertébrale polyaxiale Download PDF

Info

Publication number
WO2025052335A1
WO2025052335A1 PCT/IB2024/058742 IB2024058742W WO2025052335A1 WO 2025052335 A1 WO2025052335 A1 WO 2025052335A1 IB 2024058742 W IB2024058742 W IB 2024058742W WO 2025052335 A1 WO2025052335 A1 WO 2025052335A1
Authority
WO
WIPO (PCT)
Prior art keywords
spinal
elongate aperture
spinal rod
head
fastener
Prior art date
Application number
PCT/IB2024/058742
Other languages
English (en)
Inventor
Uri Arnin
Original Assignee
Premia Spine Ltd.
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 Premia Spine Ltd. filed Critical Premia Spine Ltd.
Publication of WO2025052335A1 publication Critical patent/WO2025052335A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7007—Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads

Definitions

  • the present invention relates generally to surgical devices used in spinal surgery, and particularly to a fusion rod that provides a wide range of polyaxial mounting positions, which is particularly useful between two different levels of vertebra.
  • Spinal fusion may be used to join two or more vertebrae. This procedure can be performed at any level in the spine (cervical, thoracic, lumbar, or sacral) and prevents any movement between the fused vertebrae. Fusion often involves joining vertebrae at two different levels, one level being cephalad, that is, anatomically closer to the head of the person, and the other level being caudal, that is, anatomically closer to the tail bone or feet of the person. For example, fusion may be performed at one or more levels between the LI and SI vertebrae.
  • the TOPS TM device of Premia Spine Ltd. is a non-fusion, posterior arthroplasty system that offers an alternative solution to spinal fusion surgery for patients with moderate to severe lumbar spinal stenosis, degenerative spondylolisthesis and related spinal conditions. The system maintains stability and preserves motion. The implant device replaces bony and soft tissues removed during spinal decompression surgery.
  • the ProMIS TM System is a posterior open or MIS (minimally invasive surgery) fusion system for multiple spine pathologies.
  • spinal rods are often used to connect devices and/or pedicle screws from one vertebral level to another. If a device has been implanted between adjacent vertebrae, and another device is required to be implanted at yet another level adjacent to one of the levels already coupled by a fusion or non-fusion system, the previous spinal rods and devices or pedicle screws must be removed and repositioned, which can be detrimental to the anatomical structure of the spine.
  • the present invention seeks to provide a subwoofer assembly that has a novel construction, as described in detail below.
  • the spider and the surround are directly attached to the same attachment plane.
  • a spinal device including a spinal rod including a head from which extends a shaft, the head having an outer spherical contour and being formed with an internal spherical dome, wherein the internal spherical dome is completely open at a first side, and at a fastener abutment side, which is opposite to the first side, an elongate aperture is formed.
  • FIGs. 1A and IB are simplified posterior (coronal) and sagittal view illustrations, respectively, of spinal devices implanted in a spine, using spinal rods in accordance with a non-limiting embodiment of the invention.
  • Fig. 2 is a simplified posterior (coronal) view of the spinal rod.
  • Figs. 3A, 3B and 3C are sagittal view illustrations of the spinal rod, in different sagittal angles of installation, respectively, in the cephalad, horizontal and caudal sagittal directions.
  • Fig. 4 is a coronal-plane illustration of the spinal rod, in different coronal angles of installation.
  • Fig. 5 is a side-view illustration of the spinal rod.
  • Fig. 6 is a bottom view illustration of the spinal rod.
  • Figs. 7A and 7B are sagittal and axial sectional views, respectively, of the spinal rod coupled to a tulip of a pedicle screw, in accordance with a non-limiting embodiment of the invention.
  • Figs. 1A and IB illustrate spinal devices implanted in a spine, using spinal rods 10, in accordance with a non-limiting embodiment of the invention.
  • Any spinal device which uses bone screws can be used with the invention.
  • a non-limiting example of a spinal device is a non-fusion, posterior arthroplasty device 2, such as the TOPS TM device of Premia Spine Ltd.
  • the posterior arthroplasty device 2 is shown installed between the L4 and L5 vertebrae, by means of a cephalad set of pedicle screws 3 and 4 and a caudal set of pedicle screws 5 and 6, respectively secured to the pedicles or spinal processes or other bone at the L4 and L5 levels.
  • Spinal rods 1 connect the two sets of pedicle screws at the medial and lateral sides of the spine.
  • the spinal rods 1 are secured to the tulips of the pedicle screws with set screws.
  • Another device is required to be implanted at yet another level, such as at the SI level; in the illustrated example, pedicle screws 8 and 9 must be secured to bone at the SI level and spinal rods must be used to couple the set of pedicle screws 5 and 6 to the set of pedicle screws 8 and 9. In the prior art, this would require removing spinal rods 1, and possibly repositioning the set of pedicle screws 5 and 6, which could be detrimental to the anatomical structure of the spine.
  • the present invention provides a novel spinal rod 10 that enables coupling the set of pedicle screws 5 and 6 to the set of pedicle screws 8 and 9 without repositioning the set of pedicle screws 5 and 6, as is explained below.
  • Spinal rod 10 may include a head 12, from which extends a shaft 14.
  • head 12 may be formed with opposing flat faces 16, for grasping with a wrench, for example. Without limitation, the distance F between the flat faces 16 may be in the range of 10-25 mm.
  • Head 12 has an outer spherical contour.
  • head 12 may be formed with an internal spherical dome 18, with a diameter D smaller than the distance F such as but not limited to, 2-3 mm less than distance F.
  • the internal spherical dome 18 is completely open at a first side 20 of spinal rod 10, and at an opposite side 22 (20 and 22 are shown in Fig.
  • an elongate aperture 24 (Fig. 6) is formed.
  • Side 22 is also referred to as fastener abutment side 22 (as explained below with reference to Figs. 7A and 7B).
  • the elongate aperture 24 may have curved ends and straight sides, for example.
  • the longitudinal axis of elongate aperture 24 may be coaxial with shaft 14.
  • the elongate aperture 24 may have a width E, which may be without limitation, in the range of 6-10 mm.
  • the length L of shaft 14 may be without limitation, in the range of 40-60 mm.
  • shaft 14 When side 20 is horizontal (as in Fig. 5), shaft 14 may be tilted from the horizontal by an angle T, which may be without limitation, in the range of 0-10°.
  • the head can pivot around a circle that has a diameter PD, which may be without limitation, in the range of 15-25 mm.
  • the spinal rod is attached to a tulip 30 of pedicle screws 5 or 6 with a set screw 32 (or other suitable threaded fastener 32).
  • the spherical shape of the internal spherical dome allows for a wide range of polyaxial movement.
  • SGI may be 34° and SG2 may be -12°, giving a total range of 46° angular movement.
  • Fig. 4 is a coronal-plane illustration of the spinal rod, in different coronal angles CORI and COR2 of installation.
  • spinal rod 10 when spinal rod 10 is at -12° in the sagittal plane (worst case), the range of movement in the coronal plane may be -34° (COR2) to +28° (CORI). The range is even larger at higher positive sagittal angles.
  • Figs. 7A and 7B are sagittal and axial sectional views respectively of the spinal rod 10 coupled to tulip 30 of pedicle screw 5 or 6. It is seen that set screw 32 mates with a threaded fastener 36 of the pedicle screw assembly. Fastener 36 passes through elongate aperture 24.
  • the overall height Hl from the top of set screw 32 to the bottom of tulip 30 may be without limitation, in the range of 18-32 mm.
  • the height H2 from the top of set screw 32 to the top of tulip 30 may be without limitation, in the range of 6-10 mm.
  • set screw 32 abuts against fastener abutment side 22.
  • the set screw 32 In the sagittal plane (Fig. 7A) the set screw 32 abuts against fastener abutment side 22 on only one side of elongate aperture 24; in the axial plane (Fig. 7B) set screw 32 abuts against fastener abutment side 22 on both sides of elongate aperture 24.
  • set screw 32 abuts against fastener abutment side 22 depends on the angular orientation of head 12.
  • pedicle screws 8 and 9 may be secured to bone at the SI level without removing and repositioning pedicle screws 5 and 6.
  • the surgeon simply removes the existing set screws from pedicle screws 5 and 6, and places the head 12 of spinal rod 10 on the corresponding pedicle screw 5 or 6, swivels the spinal rod 10 angularly so that one end of shaft 14 can be secured to pedicle screw 8 or 9, and tightens the set screw on head 12 at the chosen angular orientation.
  • the procedure is quick and easy.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Neurology (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Un dispositif vertébral comprend une broche vertébrale (10) présentant une tête (12) à partir de laquelle s'étend une tige (14). La tête (12) présente un contour sphérique externe et est formée avec un dôme sphérique interne (18). Le dôme sphérique interne (18) est complètement ouvert au niveau d'un premier côté (20), et une ouverture allongée (24) est formée au niveau d'un côté de butée de fixation (22), qui est opposé au premier côté (20).
PCT/IB2024/058742 2023-09-10 2024-09-09 Broche vertébrale polyaxiale WO2025052335A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363581664P 2023-09-10 2023-09-10
US63/581,664 2023-09-10

Publications (1)

Publication Number Publication Date
WO2025052335A1 true WO2025052335A1 (fr) 2025-03-13

Family

ID=93037025

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2024/058742 WO2025052335A1 (fr) 2023-09-10 2024-09-09 Broche vertébrale polyaxiale

Country Status (1)

Country Link
WO (1) WO2025052335A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100030224A1 (en) * 2008-02-26 2010-02-04 Spartek Medical, Inc. Surgical tool and method for connecting a dynamic bone anchor and dynamic vertical rod
US20100036420A1 (en) * 2004-03-31 2010-02-11 Depuy Spine, Inc. Head-to-head connector spinal fixation system
US20150150602A1 (en) * 2013-10-14 2015-06-04 Dennis P. Devito Assembly for treating an isthmic fracture

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100036420A1 (en) * 2004-03-31 2010-02-11 Depuy Spine, Inc. Head-to-head connector spinal fixation system
US20100030224A1 (en) * 2008-02-26 2010-02-04 Spartek Medical, Inc. Surgical tool and method for connecting a dynamic bone anchor and dynamic vertical rod
US20150150602A1 (en) * 2013-10-14 2015-06-04 Dennis P. Devito Assembly for treating an isthmic fracture

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