WO2022200467A1 - Système pour guider la croissance de la colonne vertébrale - Google Patents

Système pour guider la croissance de la colonne vertébrale Download PDF

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Publication number
WO2022200467A1
WO2022200467A1 PCT/EP2022/057691 EP2022057691W WO2022200467A1 WO 2022200467 A1 WO2022200467 A1 WO 2022200467A1 EP 2022057691 W EP2022057691 W EP 2022057691W WO 2022200467 A1 WO2022200467 A1 WO 2022200467A1
Authority
WO
WIPO (PCT)
Prior art keywords
connector
support member
elongated support
guiding portion
transverse opening
Prior art date
Application number
PCT/EP2022/057691
Other languages
English (en)
Inventor
Alex Kristian ROTH
Remco Johannes Petrus DOODKORTE
Damian Phillip HEINZ
Paulus Cornelis Petronella Hubertus WILLEMS
Original Assignee
Universiteit Maastricht
Academisch Ziekenhuis Maastricht
Dsm Ip Assets B.V.
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 Universiteit Maastricht, Academisch Ziekenhuis Maastricht, Dsm Ip Assets B.V. filed Critical Universiteit Maastricht
Publication of WO2022200467A1 publication Critical patent/WO2022200467A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • 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 ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • 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 ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • 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 ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7053—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant with parts attached to bones or to each other by flexible wires, straps, sutures or cables
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated

Definitions

  • This disclosure relates to a system to guide the growth of the spinal column.
  • the disclosure further relates to a connector.
  • the system can be used to treat for example scoliosis which is a three- dimensional deformity of the spine that can occur due to neuromuscular or syndromic pathology, spinal degeneration, congenital disorders, but most commonly in an idiopathic manner.
  • Scoliosis can occur at various ages, but when scoliosis arises at young age such as for example below the age of 10, it is referred to as early onset scoliosis.
  • the treatment of this spinal deformity is normally non-surgical by exercises and bracing of the spine. However, when the curve progresses and thereby hinders organ function, such as the lung capacity, surgical correction of the spine is necessary. It is imperative to maintain spinal growth in these patients in order to accompany lung development.
  • the system is configured to guide the growth of the spinal column, wherein the system comprises:
  • - at least one connector comprising a guiding portion having a bearing surface for receiving the elongated support member, a bone connecting portion designed to secure the connector to a vertebra, and between the bone connecting portion and the guiding portion at least one transverse opening extending transversely to the longitudinal center line of the connector; and - at least one cable configured to extend around an outer surface of the elongated support member and through the transverse opening for securing the elongated support member to the guiding portion of the connector such that relative sliding movement of the elongated support member, such as in its elongated direction, over the bearing surface is permitted with respect to the connector, wherein the at least one transverse opening is designed to hold the cable extending through the transverse opening at a distance with respect to the longitudinal center line of the connector.
  • This system provides an improved growth-guidance construct which may be particularly advantageous for treating early onset scoliosis in a relatively user- friendly manner or as an additional semi-rigid fixation for the treatment of degenerative scoliosis.
  • This system is user-friendly from a surgeon’s perspective as the securing step of the elongated support member to the connector is relatively easy and/or fast by using a cable.
  • the system may also provide improvements from a patient’s perspective as an incision in the patient required for the system is relatively small. The system may therefore allow percutaneous surgery and reduce surgical invasiveness. The system may also reduce associated risks of neurological damage and epidural bleeding.
  • the system may also allow sliding of the elongated support member over the bearing surface, while maintaining the desired orientation of the elongated support member with respect to the (growing) spine.
  • the system is configured such that the elongated support member is slidable against the bearing surface in its elongated direction and may be substantially constrained from movement in other directions by the bearing surface and/or the at least one cable.
  • the system may also be applied as a semi-rigid fixation in an addition to a standard spinal fusion construct for treating degenerative scoliosis in patients.
  • one or two levels of bilateral fixation of the system may be added to at least one of the outer sections of the standard spinal fusion construct seen in the longitudinal direction of the standard spinal fusion construct, preferably cranially.
  • An elongated support member of the standard spinal fusion construct may be used to provide the system as defined in this disclosure.
  • the connector of this disclosure comprises a guiding portion having a bearing surface for receiving an elongated support member, a bone connecting portion designed to secure the connector to a vertebra, and between the bone connecting portion and the guiding portion at least one transverse opening extending transversely to the longitudinal center line of the connector; wherein the at least one transverse opening is designed to hold a cable extending through the transverse opening at a distance with respect to the longitudinal center line of the connector.
  • the cable used to secure the elongated support member to the connector secured to a vertebra may be knotted using a sliding knot for securing the elongated support member to the connector.
  • the sliding knot may have two strands, wherein these two strands are guided for fixation through the transverse opening. Without any means to separate the strands in the transverse opening the risk of entwinement is relatively high. Entwinement of the strands reduces the likelihood of a successful connection of the elongated support member to the connector, e.g.
  • the transverse opening is configured to prevent that a cable extending through the transverse opening and securing the elongated support member to the connector is able to coincide with or to cross the longitudinal center line of the connector.
  • the at least one transverse opening of the connector is designed to hold a first strand of a cable extending through the transverse opening at a distance with respect to the longitudinal center line of the connector for example on a first side of the transverse opening, whereas the second strand is also held at a distance with respect to the longitudinal center line of the connector for example on a second side of the transverse opening opposite to the first side.
  • the connector may be configured to provide a desired and predetermined connection of the elongated support member thereto, i.e. a semi-rigid fixation between the connector and the elongated support member.
  • the connector itself may require a relatively small incision in a patient for insertion in a percutaneous surgical procedure with minimal surgical invasiveness.
  • This connector can also be used to provide an additional semi-rigid fixation for the treatment of degenerative scoliosis in combination with a standard spinal fusion construct, wherein seen in the longitudinal direction of the standard spinal fusion construct at least one end section of its elongated support member is connected to at least one connector as disclosed in this disclosure.
  • the connector may comprise a central bore coinciding with the longitudinal center line of the connector.
  • a central bore through the connector allows, by using a tool extending through the central bore, an accurate positioning of the connector with respect to the vertebra, for example its pedicle, and the tool may also facilitate a user-friendly fixation of the bone connecting portion of the connector into the vertebra with minimal surgical invasiveness.
  • the at least one transverse opening of the connector being designed to hold the cable extending through the transverse opening at a distance with respect to the longitudinal center line of the connector, there is further no risk that the tool is hindered by the cable or that the cable is hindered by the tool during insertion of the connector in the vertebra.
  • the bone connecting portion may be designed as a bone connecting portion of a pedicle screw to provide a reliable and strong fixation of the connector in the vertebra, i.e. the pedicle.
  • the transverse opening comprises two partially connected opening portions wherein the opening portions are connected in a communicating manner by an open bridging portion which crosses the longitudinal center line of the connector, preferably the transverse opening has a cross section resembling the outline of a capital B.
  • the open bridging portion has a reduced height seen in the direction of the longitudinal center line of the connector compared to the height of the opening portions.
  • the two opening portions provide a clear indicator for a user how to arrange the strands of a cable in the transverse opening, i.e. one strand in the first opening portion and the other strand in the second opening portion.
  • the transverse opening of the connector is adapted for using a sliding knot connection as discussed above.
  • the two opening portions may be two symmetrical opening portions.
  • the bearing surface of the guiding portion may be a flat surface or a substantially flat surface. Such a flat surface facilitates a less rigid fixation which facilitates preventing the occurrence of auto-fusion, in particular when used with a sliding knot.
  • the bearing surface may be shaped as a groove, wherein the groove-like bearing surface is adapted to receive a portion of the elongated support member.
  • the groove may have complementary shape to the elongated support member.
  • the groove has for example the shape of a partial circle or a partial ellipse in its cross-section. The groove may provide that the elongated support member is slidable against the bearing surface in its elongated direction and that the elongated support member is substantially constrained from movement in other directions when secured to the connector by the at least one cable.
  • the bone connecting portion of the connector preferably may be designed as one of the group of pins, tacks, stakes, nails, and screws.
  • the guiding portion is a top portion of the connector which is located above vertebra if the connector is secured to the vertebra by the bone connection portion of the connector.
  • the top end surface of the guiding portion (and of the connector) is the bearing surface.
  • Figure 1 shows diagrammatic view of an embodiment of a system to guide the growth of the spinal column
  • Figures 2A-C show various diagrammatic views of the steps of securing an elongated support member to a connector to obtain the system as shown in figure 1 ;
  • Figure 3 shows two views of a detachably connectable guiding portion of the connector also shown in figures 1-2c;
  • Figure 4 shows two views of a different embodiment of a detachably connectable guiding portion of the connector.
  • a system 100 to guide the growth of the spinal column comprises an elongated support member 3 extending mainly in a elongated direction indicated by arrow P1 , and two identical spaced apart connectors 1 for supporting the elongated support member 3.
  • the elongated support member 3 is also known as a spinal rod.
  • Each connector 1 comprises a guiding portion 5 having a bearing surface 7 for receiving the elongated support member 3.
  • the connector 1 further comprises a bone connecting portion 9 designed to secure the connector to a vertebra (not shown). As can been in figure 1 the bone connecting portion 9 is only partially shown.
  • the bone connecting portion 9 is designed as a bone connecting portion of a pedicle screw.
  • the connector 1 further comprises between the bone connecting portion 9 and the guiding portion 5 at least one transverse opening 25 extending transversely to the longitudinal center line (indicated with dotted lines in Figs. 1, 2a, 2b) of the connector 1.
  • the system 100 also comprises two cables 21 , wherein each cable 21 is configured to extend around a portion of an outer surface of the elongated support member 3 and through the transverse opening 25 of one of the connectors 1 for securing the elongated support member 3 to the guiding portion 5 of the connector 1 such that relative sliding movement in the direction indicated by the arrow P1 of the elongated support member in its elongated direction over the bearing surface 7 is permitted with respect to the stationary connectors 1.
  • Each of the connectors is stationary secured to a vertebra.
  • each connector extends substantially in a direction transverse to the elongated support member, i.e. the longitudinal center line of the elongated support member extending in a direction indicated by arrow P1 , extends substantially transversely to the longitudinal center line of the connector 1 indicated by the dotted lines.
  • Each transverse opening 25 in the connector 1 is designed to hold the cable 21 extending through the transverse opening 23 at a distance with respect to the longitudinal center line of the connector 1.
  • Each transverse opening 25 extends transversely to the longitudinal center line of the connector 1 and extends substantially transversely to the elongated direction (P1) of the elongated support member 3.
  • Figs. 2a-c show how to obtain the system 100 shown in Fig. 1.
  • Figs. 2a- c shows how the configuration of the connector 1 facilitates to provide a desired semi rigid connection of the elongated support member 3 to the (stationary) connector 1 permitting sliding in the desired direction P1 for guiding growth of the spinal column (not shown) and allowing percutaneous surgery with minimal surgical invasiveness.
  • the connector 1 comprises the guiding portion 5 having the bearing surface 7 for receiving the elongated support member 3, the bone connecting portion 9 (partially shown in Fig. 2a-c) designed to secure the connector 1 to a vertebra (not shown), and between the bone connecting portion 9 and the guiding portion 5 the transverse opening 25 extending transversely to the longitudinal center line of the connector 1.
  • the transverse opening 25 is designed to hold the cable 21 extending through the transverse opening 25 at a distance with respect to the longitudinal center line of the connector 1 (see Fig. 2b).
  • the connector 1 further comprises a central bore 31 (Fig. 2a) coinciding with the longitudinal center line of the connector 1 , i.e. the longitudinal center line of the central bore 31 corresponds with the longitudinal center line of the connector.
  • the central bore 31 extends through the connector 1 completely.
  • the central bore 31 allows by using an external tool 200 inserted in the central bore 31 and extending through the central bore 31 an accurate positioning of the connector 1 with respect to the vertebra.
  • the transverse opening 25 comprises two partially connected opening portions 25a, 25b (Fig.
  • the opening portions 25a, 25b are connected in a communicating manner by an open bridging portion 25c which crosses the longitudinal center line of the connector 1.
  • the transverse opening 25 has a cross section resembling the shape of a capital B.
  • the open bridging portion 25c has a reduced height seen in the direction of the longitudinal center line of the connector 1 compared to the height of the opening portions 25a, b.
  • the two opening portions 25a, b provide a clear indicator for a user how to arrange the strands 21a, 21b of the cable 21 in the transverse opening 25, i.e. one strand 21a in the first opening portion 25a and the other strand 21b in the second opening portion 25b.
  • the transverse opening 25 of the connector 1 is adapted for using a cable 21 with a sliding knot 21c as shown in Figs. 1 , 2B, 2C for securing the elongated support member 3 to the connector 1.
  • the two opening portions 25a, b are two symmetrical opening portions.
  • the transverse opening 25 has a cable guiding section 25d above the open bridging portion 25c between opening portions 25a, 25b.
  • This guiding section 25d has a design such that a cable 21 , or one of its strands 21a, 21b, is guided automatically to one of the two opening portions 25a, 25b.
  • This design prevents that a cable 21 can be arranged for securing the elongated support member 3 in the open bridging portion 25c, i.e. provides automatic guidance for a user for positioning the cable 21 or its strands 21a, 21b in a correct manner in the opening portions 25a, 25b.
  • edges of the connector defining the transverse opening see for example edge 26 indicated in fig. 2a, are designed to prevent that the cable is abraded during use, for example these edges 26 are rounded.
  • the cable 21 is a round braided cable made from ultra-high molecular weight polyethylene.
  • Figure 3 shows details of the guiding portion 5.
  • the guiding portion 5 has a bearing surface 7 being a flat surface or a substantially flat surface. Such a flat surface facilitates a less rigid fixation of the elongated support member 3 to the stationary connector 1.
  • the guiding portion 5 is connectable to the connector 1.
  • the connector 1 has a first fastening portion 35, in fig. 2A an upper cavity 35 on its top end surface 37, and the guiding portion 5 has a second fastening portion 39, in Fig. 2A a projection 39 mating with the cavity for connecting the guiding portion 5 to the connector 1.
  • the guiding portion 5 may be detachably connected to the connector 1. Before insertion of the connector 1 in a patient or after securing the connector 1 in the vertebra the guiding portion 5 is connected to the connector 1.
  • the guiding portion 5 or at least the bearing surface 7 is substantially made from a first material facilitating sliding of the at least one elongated support member, such as for example a biocompatible polymer such as polyethylene which provides an excellent sliding surface with minimal wear and minimal wear particle generation.
  • the connector 1 and/or the elongated support member 3 is substantially made from a second material which is different from the first material, such as for example a biocompatible metal.
  • the connector 1 without the guiding portion 5 is an integral one-piece connector, preferably the connector 1 is substantially made of one material.
  • the guiding portion 5 also has a central bore 41 for the tool 200, wherein the central bore extends completely through the guiding portion 5 and coincides with the center line of the guiding portion 5.
  • the center line of the guiding portion 5 is the center line of the central bore 41.
  • the central bore 31 extends between the guiding portion 5 and the opposite end of the connector seen in its longitudinal direction, i.e. the direction of the longitudinal center line of the connector.
  • FIG 4 two views are shown of an alternative embodiment of a guiding portion 5’, wherein the main difference with the guiding portion 5 shown in figure 3 is that the upper surface comprises a groove 43 as a bearing surface.
  • the groove 43 is of complementary shape to the elongated support member 3, such that the groove 43 is adapted to receive a portion of the elongated support member 3 therein for providing more support to the elongated support member 3 without affecting its sliding capacity in a direction indicated by the arrow P1 , i.e. its elongated direction.
  • the groove 43 also contributes to hold the elongated support member 3 in a desired orientation with respect to the guiding portion 5’ and the connector 1.
  • the elongated support member 3 has a cylindrical shape, such that the groove 43 has the shape of a partial circle in its cross-section (as can be seen in the lower drawing of figure 4) to provide maximum sliding capacity for the elongated support member 3 in the direction indicated by the arrow P1 , while the elongated support member 3 is restricted in moving in a direction extending traverse to the direction indicated by the arrow P1 and traverse to the center line of the guiding portion 5’.
  • the guiding portion 5’ also has a central bore 4T for the tool 200, i.e. a central bore 4T as the central bore 41 of the guiding portion 5 shown in figure 3.
  • the transverse opening may comprises two closed transverse openings which are separated from each other, wherein in the section of the connector separating the two closed transverse openings from each other the longitudinal center line of the connector extends.
  • the two space apart closed transverse openings may extend parallel with respect to each other.
  • a method for guiding the growth of the spinal column comprises the following steps:
  • the transverse opening is designed to hold the cable extending through the transverse opening at a distance with respect to the longitudinal center line of the connector.
  • the method may use a knotted cable using a sliding knot for securing the elongated support member to the connector to reduce surgical invasiveness.
  • the elongated support member is secured to each connector by a single double looped knotted cable.
  • the sliding knot has two strands, wherein these two strands are guided for fixation through the transverse opening in a separated way, wherein each strand is located in the transverse opening at a distance from the longitudinal center line of the connector. These two distances may be substantially identical such that a first strand may be located or positioned on a first side of the transverse opening and the second strand may located or positioned on a second side of the transverse opening opposite to the first side.
  • the connector may comprise a central bore coinciding with the longitudinal center line of the connector.
  • a central bore through the connector allows by using a tool extending through the central bore an accurate positioning of the connector with respect to the vertebra, for example its pedicle, and the tool may facilitate a user- friendly fixation of the bone connecting portion of the connector into the vertebra with minimal surgical invasiveness.

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  • 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

L'invention concerne un système pour guider la croissance de la colonne vertébrale, le système comprenant au moins un élément de support allongé et au moins un raccord comprenant une partie de guidage présentant une surface d'appui pour l'élément de support allongé, une partie de raccord à l'os conçue pour fixer le raccord à une vertèbre, et entre la partie de raccord à l'os et la partie de guidage au moins une ouverture transversale s'étendant transversalement à la ligne centrale longitudinale du raccord.
PCT/EP2022/057691 2021-03-24 2022-03-23 Système pour guider la croissance de la colonne vertébrale WO2022200467A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP21164648 2021-03-24
EP21164648.4 2021-03-24

Publications (1)

Publication Number Publication Date
WO2022200467A1 true WO2022200467A1 (fr) 2022-09-29

Family

ID=75203235

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2022/057691 WO2022200467A1 (fr) 2021-03-24 2022-03-23 Système pour guider la croissance de la colonne vertébrale

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WO (1) WO2022200467A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4805602A (en) * 1986-11-03 1989-02-21 Danninger Medical Technology Transpedicular screw and rod system
US5242446A (en) * 1992-01-02 1993-09-07 Acromed Corporation Connector for a spinal column corrective device
US20010034522A1 (en) * 1992-08-12 2001-10-25 Synthes (U.S.A.) Spinal column fixation device
FR2937531A1 (fr) * 2008-10-23 2010-04-30 Lotfi Miladi Systeme d'osteosynthese rachidienne
EP2337512B1 (fr) 2008-09-12 2012-03-14 Synthes GmbH Système de fixation de stabilisation et de guidage de colonne vertébrale

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4805602A (en) * 1986-11-03 1989-02-21 Danninger Medical Technology Transpedicular screw and rod system
US5242446A (en) * 1992-01-02 1993-09-07 Acromed Corporation Connector for a spinal column corrective device
US20010034522A1 (en) * 1992-08-12 2001-10-25 Synthes (U.S.A.) Spinal column fixation device
EP2337512B1 (fr) 2008-09-12 2012-03-14 Synthes GmbH Système de fixation de stabilisation et de guidage de colonne vertébrale
FR2937531A1 (fr) * 2008-10-23 2010-04-30 Lotfi Miladi Systeme d'osteosynthese rachidienne

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