WO2022229974A1 - Système de variation d'espace entre des segments osseux - Google Patents

Système de variation d'espace entre des segments osseux Download PDF

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Publication number
WO2022229974A1
WO2022229974A1 PCT/IN2022/050367 IN2022050367W WO2022229974A1 WO 2022229974 A1 WO2022229974 A1 WO 2022229974A1 IN 2022050367 W IN2022050367 W IN 2022050367W WO 2022229974 A1 WO2022229974 A1 WO 2022229974A1
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WO
WIPO (PCT)
Prior art keywords
bone
distractor
housing
rotational
rotation
Prior art date
Application number
PCT/IN2022/050367
Other languages
English (en)
Inventor
Rohan Milind Deshpande
Ayush Sanjay Gaikwad
Original Assignee
Rohan Milind Deshpande
Ayush Sanjay Gaikwad
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 Rohan Milind Deshpande, Ayush Sanjay Gaikwad filed Critical Rohan Milind Deshpande
Publication of WO2022229974A1 publication Critical patent/WO2022229974A1/fr

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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
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8004—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with means for distracting or compressing the bone or bones
    • 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
    • A61B17/72—Intramedullary pins, nails or other devices
    • 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
    • A61B2017/681—Alignment, compression, or distraction mechanisms

Definitions

  • Present invention in general relates to the field of biomedical engineering and more particularly to a system for varying gap between bone segments.
  • Distraction osteogenesis is an orthopedic surgical technique used for skeletal reconstruction.
  • segments of the fractured bone are distracted apart relative to each other generally at a rate of 1 mm/day.
  • New bone generates in the gap. Initially, it is soft and gets consolidated (hardened) over time. With daily increments in the gap between bones, new bone keeps on generating in the increased gap, with the overall length of bone increasing.
  • the medical conditions with congenital and acquired skeletal defects and bone loss in fractures are treatable with distraction osteogenesis.
  • the medical devices used for bone distraction are of two types first are external fixators and the second are implantable bone distraction devices.
  • External fixators are the most widely used devices for the procedure but are very cumbersome for the patient, prone to pin site infections on multiple sites, and heavy to carry for months on the body. The most prominent reason for its use is reliability and affordability.
  • implantable devices are more comfortable offering a better quality of life to patients, however, it has limitations of weight-bearing, bone distraction force, structural strength, and importantly size and cost.
  • Most implantable bone devices fit in the intramedullary cavity of bone as orthopedic nails. Generally, congenital skeletal defects are treated, at a young age (pediatric patient). Most patients at this age don’t have an intramedullary cavity big enough to fit bone distraction nails. Another concept for such scenarios is plating over bone and making the plate distractable to facilitate bone distraction.
  • US 20190133650A1 discloses an intra-corporal telescopic osteodistraction device, an extra-corporal force producing device, a method for bone lengthening and a bone lengthening arrangement.
  • This document talks about an intra-corporal telescopic osteodistraction device for locking the length of the bone and for providing axial, torsional and bending stability; an extra-corporal force producing device, for producing a force for extension causing a lengthening of the intra-corporal device and the bone; a method for bone lengthening and a bone lengthening arrangement utilizing the devices mentioned therein.
  • WO 2015/184397 Al discloses an extra medullary bone lengthener and use thereof that is an internal device that does not require nailing.
  • This document talks a telescoping plate that attaches to the upper and lower portions of the bone via screws; a small motor affixed on or within the plate.
  • This motor controlled remotely, will controllably lengthen the plate, thus lengthening the bone.
  • the bone will be cut (osteotomy) then the plate will be applied to both ends and fixed to each end with screws.
  • the motor will be controlled from outside by a remote control which will allow the plate to expand causing lengthening of the attached bone.
  • US 20110004246A1 discloses internal osteodistraction device.
  • an internal osteodistraction device which includes two fixing points for attachment to a bone in such a way that the distance between the fixing points can be increased in a controlled manner, and a magnetostrictive element which produces a reciprocating mechanical motion in a changing magnetic field.
  • the magnetostrictive element is configured for taking up solely a compressive or tensile force, such that the magnetostrictive element pushes a unidirectional movement permitting element which allows for an increase in the distance between the fixing points, and as the magnetostrictive element is in the process of returning to its original length, a second unidirectional movement permitting element allows the magnetostrictive element to resume its original length without changing a distance between the fixing points of the distraction device.
  • the primary object of the present invention is to provide a system to distract and/or compress bone segment/s.
  • Another object of the present invention is to vary the gap between the bone segments by varying the gap between the parts of the bone plate which are fixed (in rigid connection) to different bone segments.
  • Yet another object of the present invention is to provide an operable means which when operated should result in precisely varying (increase or decrease as intended) the gap between the bone segments fixed (in rigid connection) to the bone plate. Yet another object of the present invention is to maintain the set gap between those bone segments.
  • the present invention provides a system for varying gap between bone segments.
  • the disclosed system enables efficient cure and/or management of skeletal deformities and/or bone fractures, by bone distraction, bone fracture compression and bone transport.
  • a system for varying gap between bone segments comprising a bone distraction plate and a driving shaft
  • the bone distraction plate comprising: a housing configured to connect to the bone segment and accommodate at least a portion of a rotational to linear motion converter mechanism; at least one rotational to linear motion converter mechanism comprising a power screw and a distractor wherein the distractor linearly displace relative to the housing upon rotation of the power screw and has a configuration to connect to another bone segment; and at least one transmission unit comprising a driver and a driven having non-parallel axes of rotation wherein the driven is operatively connected to the power screw to transmit rotation, wherein the transmission unit and the rotational to linear motion converter mechanism are arranged to displace the distractor linearly relative to the housing by rotating the driver around the axis; a first end of the driving shaft detachably operatively connects to the driver to provide rotation in one of an arrangement comprising: a second end of the driving shaft is extracorporeal provided with rotational motion manually or by a power tool; and an implant rotates
  • the driven of the transmission unit is arranged to rotate upon rotation of the driver.
  • the transmission unit is configured to perform torque multiplication.
  • the transmission unit is configured to perform torque multiplication and rotational motion transmission at an angle in at least one stage.
  • the rotational to linear motion mechanism comprises: the power screw characterized by external threads and arranged to receive rotational motion from the driven by operative connection; and the distractor characterized by internal threads interfacing with external threads of the power screw; wherein the rotation of the power screw linearly displaces the distractor relative to the housing by transferring motion with the threaded interface.
  • the housing comprises a limiter to limit the axial displacement of the distractor relative to the housing by obstructing a protruding portion.
  • the housing comprises at least a non-circular portion of bore interfacing with the non-circular portion of the distractor to restrict the distractor from rotating relative to the housing.
  • the bone distraction plate is configured to distract or compress the bone segments of one of a tibia, fibula, femur, ulna, radius, and humerus.
  • FIG. 1 shows exploded view of a bone distraction plate, with cut sectional view of a housing and a distractor
  • Fig. 2 shows the assembled the bone distraction plate of Fig. 1 further connected with a driving shaft
  • Fig. 3 shows distracted the bone distraction plate of Fig. 2 by operating it
  • Fig. 4 shows distracted the bone distraction plate implanted in body for bone lengthening
  • Fig. 5 shows distracted the bone distraction plate implanted in body for bone transport.
  • the systems, methods, and examples provided herein are only illustrative and not intended to be limiting.
  • the present invention can be understood as a system for treating skeletal deformities and bone fractures, especially of bone like the tibia, fibula, femur, humerus, ulna, radius.
  • a bone distraction plate is configured to connect to a bone segment on a first end.
  • a driving shaft detachably operatively connects to a driver of a transmission unit of the bone plate on a first end. When the driving shaft is rotated, it transmits that motion to the transmission unit fitted inside the bone distraction plate.
  • the transmission unit further transmits that motion to a rotational to linear motion convertor mechanism.
  • the linearly displacing part (second end of bone distraction plate) of the rotational to linear motion convertor mechanism is fixed (in rigid connection) with another bone segment (directly or indirectly).
  • the linearly displacing part displaces, the bone segment fixed (in rigid connection) to it also displaces, resulting in varying the gap between the bone segments.
  • the present invention provides a system that is for varying gap between bone segments.
  • the system comprises a bone distraction plate which when operated increases or decreases a gap between the parts of the bone distraction plate that are fixed (in rigid connection) with different bone segments (directly or indirectly) hence varying a gap between the bone segments.
  • a driving shaft is provided to operate the bone distraction plate.
  • Figure 1 shows a driving shaft (210) and the exploded view of a bone distraction plate (100) comprising a housing (110), a transmission unit (120), and a rotational to linear motion converter mechanism (130), with sectional view of the housing (110) and a distractor (133).
  • the housing (110) is configured to attach with the bone segment (310) by a bone screws (340) via a holes (111).
  • the housing (110) has a one bore (112) to accommodate the transmission unit (120) and a bore (113) to accommodate a portion of the rotational to linear motion converter mechanism (130).
  • a limiter (114) is a part of the housing (110) that fits in the housing (110).
  • the limiter (114) can be monolithic with the housing (110). In this preferred embodiment, the limiter (114) is made separate from the housing (110) for ease in the assembly of the distractor (133).
  • the bore (113) is non-circular in at least a portion (115).
  • the housing (110) has a hole (116) to access a driver (121) of the transmission unit
  • the transmission unit (120) comprises the driver (121) and a driven (123) arranged such that rotation or the driver (121) around an axis (122) rotates the driven (123) around an axis (124), wherein a output rotation obtained at the driven (123) is torque multiplied.
  • the axes (122) (124) are non-parallel, preferably at an angle between 30 to 150 degrees (210 to 330 degrees if measured from the other side).
  • the preferred embodiment shows the right angle between axes (122) (124).
  • the axes (122) (124) are non-intersecting.
  • the transmission unit (120) does torque multiplication and angular motion transmission unit in at least one stage.
  • the driver (121) is configured to detachably connect with the driving shaft (210) for operative connection.
  • the rotational to linear motion converter mechanism (130) comprises an input part and an output part arranged such that rotation of the input part around the axis linearly displaces the output part relative to the housing (110).
  • the input part is a power screw (131) having external self-locking threads (132) preferably shaped buttress, trapezoidal, acme, or square.
  • the output part is the distractor (133) having a bore (134) with internal threads (135) in a portion (as in a nut).
  • the threads (135) are self- locking and preferably buttress, trapezoidal, acme, or square.
  • the distractor (133) is further configured to fix a second bone segment (320) with the bone screws (340) via a bone screw holes (138).
  • the internal threads (135) of the distractor (133) engage with the external threads (132) of the power screw (131).
  • At least a portion of the distractor (133) linearly displaces/slides in the bore (113).
  • a portion of the distractor (133) is non-circular radially (136).
  • the distractor (133) also has a protruding portion (137) that limits axial/linear displacement of the distractor (133) relative to the housing (110) when the protruding portion (137) abuts the limiter (114), and the limiter (114) causes obstruction.
  • the driving shaft (210) has two ends wherein a first end (211) is configured to detachably operatively connect with the driver (121), such that rotation of the driving shaft (210) rotates the driver (121) around the axis (122).
  • Figure 2 shows a complete construction of the bone distraction plate (100) with sectional view of the housing (110), and the distractor (133).
  • the transmission unit (120) is accommodated in the bore (112), where the driver (121) is accessible from the hole (116), from where the driving shaft (210) is detachably connected to the driver (121), wherein rotation of the driving shaft (210) rotates the driver (121) around the axis (122).
  • the driven (123) is operatively connected to the power screw (131), such that the rotation of the driven (123) rotates the power screw (131).
  • the power screw (131) is further in threaded connection with the distractor (133) (the external threads (132) of power screw (131) interface with the internal threads (135) of distractor (133)).
  • the radially non-circular portion (136) of the distractor (133) interfaces with the radially non-circular portion (115) of the bore (113), such that the distractor (133) cannot rotate relative to the housing (110).
  • the distractor (133) is telescopically slide able (able to displace linearly) in the bore (113).
  • the limiter (114) limits the linear displacement of the distractor (133) relative to the housing (110) by obstructing the protruding portion (137) of the distractor (133), by abutment.
  • the driver (121) is configured to get detachably connected with the driving shaft (210) for operative connection, by which it (121) shall receive rotation.
  • Figure 3 shows the distractor (133) of the bone distraction plate (100) displaced relative to the housing (110), wherein the driving shaft (210) is detachably connected with the driver (121).
  • the driving shaft (210) When the driving shaft (210) is rotated around the axis (122), it transmits (provides) rotational motion and power to the driver (121) which further rotates the driven (123).
  • the transmission unit (120) transmits rotational motion and power given to the driver (121) at an angle and multiplies torque.
  • the output rotational motion and power of the transmission unit (120) is fetch-able at the driven (123).
  • the driven (123) as being operatively connected with the power screw (131) rotates it.
  • the power screw (131) being in threaded connection with the distractor (133) (as the external threads (132) of the power screw (131) interface with the internal threads (135) of the distractor (133)) and the distractor (133) not being able to rotate relative to the the housing (110), the distractor (133) gets linearly displaced relative to the housing (110).
  • the figure 4 shows the bone distraction plate (100) used for bone lengthening, wherein the housing (110) connects to the bone segment (310) by the bone screws (340), and the distractor (133) connects to another bone segment (320) by the bone screws (340). The distance between these two bone segments (310) (320) is adjusted using the bone distraction plate (100).
  • the figure also shows an implant (220 implanted under a skin (360) (the implant (220) is Intracorporeal (350)).
  • the implant (220) comprises the driving shaft (210) that operatively connects detachably to the driver (121) on first end (211) and on the second end (212) to an actuator of the implant (220).
  • the actuator When the actuator is actuated it rotates the driving shaft (210), further rotating the driver (121) which further operates the bone distraction plate (100).
  • the distractor (133) slides out of the bore (113), as the bone segment (320) is connected to the distractor (133) it also displaces, increasing the gap between bone segments (310) (320) causing bone distraction.
  • the figure 5 shows the bone distraction plate (100) used for bone transport, wherein the housing (110) connects to the bone segment (310) by the bone screws (340), and the distractor (133) connects to another bone segment (320) by the bone screws (340).
  • the connection is such that the intramedullary cavity remains vacant.
  • Bone segment (310) and a bone segment (330) are fixed by an intramedullary nailing. So all forces coming on limbs while carrying out daily activities are taken by the the intramedullary nail (230).
  • the bone distraction plate (100) does bone distraction only. This enables to prioritize the design of the bone distraction plate (100) for distracting bones. While the patient does not need to compromise mobility.
  • the driving shaft (210) is detachably operatively coupled to the driver (121 ) on the first end (211 ) and the second end (212) comes is extracorporeal (370) (out of the body).
  • the driver (121) is rotated that further operates the bone distraction plate (100) increasing the gap between bone segments (310) (320). New bone gets generated in the gap between bone segments (310) (320) with incremental distraction.
  • a knob for leverage or a power tool can be attached to it and used.
  • the driving shaft (210) can be removed after distraction phase as it is detachably connected to the driver (121) and the bone distraction plate (100) is preferably kept inside the body (in Intracorporeal region (350)) until the newly generated bone consolidates and can be removed later.
  • the bone distraction plate (100) of the system is preferably implanted on the bone/s like tibia, femur, humerus, ulna, and radius.
  • the bone distraction plate (100) can also be used for bone compression for fracture management by decreasing the gap between bone segments.
  • the driver (121) should be rotated in other direction so that the distractor (133) slides in the housing (110).
  • the bone distraction plate (100) has motion translation mechanism (the transmission unit (120) and the rotational to linear motion convertor mechanism (130)) fitted inside and the input rotation motion to driving shaft is provided by other separate means (by a power tool, implant with actuator or manually).
  • This enables the bone distraction plate (100) to have complete mechanical construction decreasing complexity hence reducing risk of failure and increasing reliability.
  • Complete mechanical construction gives more robustness to the bone distraction plate (100), hence it can handle more forces and abuse compared to devices fitted with complex integral drive system and electronics. For distracting more than two bone segments plurality of transmission and rotational to linear mechanism can be used.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (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

La présente invention concerne un système permettant de faire varier l'espace entre des segments osseux comprenant une plaque de distraction osseuse et un arbre d'entraînement. La plaque de distraction osseuse comprend un boîtier configuré pour être connecté à un segment osseux et recevoir au moins une partie d'un mécanisme de conversion de mouvement rotatif en mouvement linéaire. Le mécanisme de conversion de mouvement rotatif en mouvement linéaire comprend une ou plusieurs vis électriques et un distracteur, le distracteur étant déplacé linéairement par rapport au boîtier lors de la rotation de la vis et ayant une configuration pour se connecter à un autre segment osseux. Le boîtier comprend également au moins une unité de transmission comprenant un dispositif d'entraînement et un entraînement ayant des axes de rotation non parallèles, l'entraînement étant connecté fonctionnellement à la vis électrique pour transmettre la rotation. L'unité de transmission et le mécanisme de conversion de mouvement rotatif en mouvement linéaire sont agencés pour déplacer le distracteur de manière linéaire par rapport au boîtier en faisant tourner le dispositif d'entraînement autour de l'axe.
PCT/IN2022/050367 2021-04-26 2022-04-17 Système de variation d'espace entre des segments osseux WO2022229974A1 (fr)

Applications Claiming Priority (2)

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IN202121019026 2021-04-26
IN202121019026 2021-04-26

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060241767A1 (en) * 2005-04-22 2006-10-26 Doty Keith L Spinal disc prosthesis and methods of use
WO2017203097A1 (fr) * 2016-05-27 2017-11-30 Synoste Oy Dispositif d'ostéodistraction télescopique intracorporel, dispositif de production d'une force extracorporelle, procédé d'allongement des os et configuration d'allongement des os

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060241767A1 (en) * 2005-04-22 2006-10-26 Doty Keith L Spinal disc prosthesis and methods of use
WO2017203097A1 (fr) * 2016-05-27 2017-11-30 Synoste Oy Dispositif d'ostéodistraction télescopique intracorporel, dispositif de production d'une force extracorporelle, procédé d'allongement des os et configuration d'allongement des os

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
KONSTANTIN HORAS ET AL.: "A novel intramedullary callus distraction system for the treatment of femoral bone defects", STRATEGIES IN TRAUMA AND LIMB RECONSTRUCTION, vol. 11, 24 May 2016 (2016-05-24), pages 113 - 121, XP055897847, DOI: 10.1007/s11751-016-0255-5 *

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