WO2022168057A1 - Système et dispositifs de réduction de fracture fermée, de correction de malformation et de fixation d'os - Google Patents

Système et dispositifs de réduction de fracture fermée, de correction de malformation et de fixation d'os Download PDF

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Publication number
WO2022168057A1
WO2022168057A1 PCT/IB2022/051092 IB2022051092W WO2022168057A1 WO 2022168057 A1 WO2022168057 A1 WO 2022168057A1 IB 2022051092 W IB2022051092 W IB 2022051092W WO 2022168057 A1 WO2022168057 A1 WO 2022168057A1
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WIPO (PCT)
Prior art keywords
bone
reduction
arm
pin
correction
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PCT/IB2022/051092
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English (en)
Inventor
Kiran Antony NELSON SALDANHA
Yogesh Rao NARAYAN KALE
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Nelson Saldanha Kiran Antony
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Application filed by Nelson Saldanha Kiran Antony filed Critical Nelson Saldanha Kiran Antony
Publication of WO2022168057A1 publication Critical patent/WO2022168057A1/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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64—Devices extending alongside the bones to be positioned
    • A61B17/6416—Devices extending alongside the bones to be positioned with non-continuous, e.g. hinged, pin-clamp connecting element
    • 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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64—Devices extending alongside the bones to be positioned
    • A61B17/6466—Devices extending alongside the bones to be positioned with pin-clamps movable along a solid connecting rod
    • 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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64—Devices extending alongside the bones to be positioned
    • A61B17/6466—Devices extending alongside the bones to be positioned with pin-clamps movable along a solid connecting rod
    • A61B17/6483—Devices extending alongside the bones to be positioned with pin-clamps movable along a solid connecting rod the connecting rod having a non-circular section
    • 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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/66—Alignment, compression or distraction mechanisms

Definitions

  • This invention generally relates to the field of medical devices and specifically to the reduction of fractures.
  • the purpose is to prevent or reduce later deformity, to encourage healing and normal use of the bone and/or joint and limb, and to reduce pain.
  • the need for fracture reduction or reduction of a bone dislocation is dependent on the severity and location of the injury. Dependent on the situation, even minor injuries can prove to be fatal and disabling if the restoration of the bone to its correct position is not performed carefully and accurately.
  • Reduction can be performed either directly or indirectly.
  • Direct reduction In direct reduction, the fracture site is opened, and the bone fragments are bought together under direct vision. Internal fixation devices such as plates and screws are then used to stabilize the fragments. This method of reduction is called ‘anatomical’ as the bone is brought to its original position with good contact between fractured fragments.
  • the limitation of direct reduction is that the soft tissue surrounding the fracture is compromised due to the invasive nature of the method which in turn delays the healing process.
  • Also known as open reduction direct reduction is done as a surgical procedure for fractures that cannot be reduced or held in reduced position by closed reduction.
  • Indirect reduction In indirect or closed reduction, the soft tissue envelope around the fracture is kept intact while manipulating the limb and/or bone segments using traction or external devices. Incision of the skin over the fracture and exposure of the fracture is not performed or required. Bone can be immobilized in the reduced position using casts and splints but when the fracture is unstable, it is stabilized using internal fixation or external fixation devices.
  • the present invention enables external manipulation of bone segments to reduce the fracture.
  • the device utilizes transcutaneous bone screws (4) which are inserted into bone segments at a distance from fracture site and held by Versatile multi -pin clamps (3).
  • a Reduction arm (1) is attached to the Versatile multi-pin clamps (3) in order to manipulate the bone segments in six degrees of freedom and accurately reduce the fracture.
  • Six degrees of freedom refers to movement relative to three orthogonally opposed axis (x,y and z) and rotation about each of these three axis. In practice, six degrees of freedom for fracture reduction can be resolved into:
  • the present invention consists of Reduction arm (1), Stabilization arm (2) and Versatile multi-pin clamps (3).
  • Transcutaneous bone screws hereinafter referred to as pins (4) are inserted into the fractured bone segments.
  • pins (4) are attached to two Versatile multi-pin clamps (3) the upper one connecting to the upper or proximal segment, and the lower one connecting to the lower or distal segment.
  • the Reduction arm (1) and Stabilization arm (2) can be attached to the Versatile multi-pin clamp (3) using any of the four hexagonal anchoring points (48) on the clamp.
  • Reduction arm (1) has a central body (5) that has mechanisms for controlled correction of angulation, translation, and rotation.
  • the proximal and distal halves (6) of Reduction arm identical to each other, are mounted on the proximal and distal central body extensions (7). They have two mechanisms each for quick adjustment and one mechanism each for gradual adjustment of overall working length of Reduction arm (1).
  • First stage quick length adjustment mechanism involves two concentric cylindrical tubes, outer cylindrical tube (8) and inner cylindrical tube (9), each having two flat surfaces on their inner and outer aspects, sliding against each other enabling adjustment of overall length of the Reduction arm.
  • the two tubes can be locked to each other using a locking screw (10).
  • the two flat surfaces on the outer aspect of inner cylindrical tube (9) articulate with the two flat surfaces on the inner aspect of the outer cylindrical tube (8) preventing any rotation occurring between the two tubes.
  • the two flat surfaces on the inner aspect the inner cylindrical tube (9) articulate with the two flat surfaces on the outer aspect of the central body extension (7) preventing any rotation between them.
  • the central body extension (7) has a threaded hollow core (11) that articulates with the threads of a long-cannulated screw (12).
  • the head (13) of the long- cannulated screw is held in place between the stopper (14) of the inner cylindrical tube and a mounted stopper (15), thus engaging the inner cylindrical tube (9).
  • the cannulation in the long- cannulated screw (12) has a hexagonal cross section that engages with a hexagonal driver (16).
  • the head (17) of hexagonal driver is held in place between the stopper (18) of the outer cylindrical tube and an end cap (19), thus engaging the outer cylindrical tube (8).
  • Gradual adjustment of the overall working length of the Reduction arm (1) is performed by turning the hexagonal driver (16) which then turns the long-cannulated screw (12) which then engages the inner cylindrical tube (9) enabling it to slide against the central body extension (7).
  • a second stage quick length adjustment can be performed using a short sliding cylinder (20) around the outer cylindrical tube (8) enabling further adjustment to the overall working length of the Reduction arm (1).
  • the short sliding cylinder (20) has two flat surfaces on its inner aspect that articulate with the two flat surfaces on the outer aspect of the outer cylindrical tube (8) preventing any rotation between them.
  • the Reduction arm (1) has two identical extensions (26), one from the proximal and distal halves (6) of the Reduction arm.
  • One end of the reduction arm extension (26) is attached to one of the half cylinders (23) and the other end has a hexagonal connector (27) that provides attachment to one of the hexagonal anchoring points (48) on the Versatile multi-pin clamp (3).
  • the height of the reduction arm extension (26) i.e. distance between the Reduction arm (1) and the bone can be adjusted and locked using a locking screw (28) to match the radius of the arc of the curved rail (41) of rotation correction mechanism (35) so that the correction of rotation occurs around the long axis of the bone.
  • Reduction arm extension (26) also has a hinge joint (29) that allows rotation of the Reduction arm (1) around the axis of the bone to any desired plane to correct translation and angulation in that plane.
  • the hinge joint (29) of the reduction arm extension has radial serrations for locking which can be locked using a locking screw (30).
  • the ball joint (31) consists of an inner ball with a threaded rod (31a) and an outer ball(3 lb) with a spherical washer(31c) around it.
  • the threaded rod of the inner ball (31a) is attached to the hinge joint (29) and the outer ball (31b) is attached to the hexagonal connector (27).
  • the ball joint (31) enables connection of the Reduction arm (1) to the Versatile multi-pin clamp (3) irrespective of its position or orientation and also enables Reduction arm (1) to be brought to neutral position (straightened) before it can be realigned to a new plane either by rotating around its own axis or by rotating around the axis of bone.
  • An alternative to the ball joint (31) is to use a triple hinge connector (63) that has three lockable hinge joints (66) in three axes orthogonal to each other (x,y,z) allowing six degrees of freedom to connect the Reduction arm (1) to the Versatile multi-pin clamp (3) irrespective of its position or orientation.
  • the hinge joints (66) of the triple hinge connector (63) have radial serrations for locking.
  • Triple hinge connector (63) has a hexagonal connector (65) at one end to attach to one of the four anchoring points (48) on the Versatile multi-pin clamp (3).
  • the lockable sliding base plate (64) at the other end can be detached and the hinge joint (66) at that end can be connected directly to the hinge joint (29) of the reduction arm extension.
  • the central body (5) of the Reduction arm is enclosed in a casing (33) that houses a translation correction mechanism (34) and a rotation correction mechanism (35).
  • the angulation correction mechanism (36) attached to one end of the casing (33), has a hinge joint (37) that can be adjusted using a driver (38).
  • the hinge (37) of the angulation correction mechanism (36) should be aligned to the transverse bisector of the angle of fracture so that any correction of angulation at the fracture does not introduce a translation at the fracture. This can be achieved using the first and second stage quick length adjustment and gradual length adjustment mechanisms of the Reduction arm (1).
  • the translation correction mechanism (34) moves on a rail (39) in the casing that can be adjusted using a driver (40).
  • the rotation correction mechanism (35) moves on a curved rail (41) in the casing that can be adjusted using a driver (42).
  • the curved rail (41) has an arc with a fixed radius to which the distance between the Reduction arm ( 1 ) and bone should be matched using the height adjustment mechanism (28) so that rotation occurs around the long axis of the bone.
  • the Reduction arm (1) can be moved to reorient it to a new desired plane either by rotating it around its own axis using the articulation between the two half cylinders (23) and short sliding cylinder (20) or by rotating it around the axis of the bone using the hinge joints (29) of the reduction arm extension (26).
  • the purpose of the two-way mechanism of changing planes is to enable the device to be conveniently positioned, allowing adequate Xray exposure of the limb and providing access to internal fixation.
  • the Reduction arm (1) must be first brought to neutral position (straightened) before moving it to a new plane which is enabled by the ball joints (31) on the reduction arm extensions (26). During this maneuver of bringing the Reduction arm (1) to neutral and moving it to a new plane, bone segments are temporarily stabilized and the correction already achieved is maintained by the Stabilization arm (2).
  • the Stabilization arm (2) has a stabilization rod (43) that can be connected to one of the hexagonal anchoring points (48) on the Versatile multipin clamp (3) using a hexagonal connector (44).
  • the stabilizing rod (43) is secured at either end with clam-shell clamps (45). There is a lockable ball joint (46) between the clam-shell clamp (45) and the hexagonal connector (44).
  • the ball joint (46) of the stabilizing arm is designed similar to the ball joint (31) of the reduction arm extension. It enables the Stabilization arm (2) to be connected to the proximal and distal Versatile multi-pin clamps (3) irrespective of their orientation.
  • the Versatile multi-pin clamp (3) has a body (47) that provides four hexagonal anchoring points (48) for attachment of the hexagonal connector (27) of the Reduction arm, hexagonal connector (44) of the Stabilization arm and hexagonal connector (65) of the triple hinge connector (63).
  • Pins (4) are held by three types of pin holders (49a, 49b & 49c) that attach to the rails (50) on two sides of the body (47) of the multi-pin clamp.
  • the pin holders (49a, 49b & 49c) can slide on the rails (50) to any desired position and can be locked to the serrations (51) under the rails (50) using a locking screw (52).
  • Variable angle (49a) and fixed angle (49b) pin holders are inclined at an angle to the body (47) of the multi-pin clamp whereas straight (49c) pin holder is in the same plane as the body (47) of multi-pin clamp.
  • Variable angle pin holder (49a) has a lockable ball joint (53) to allow variable angle orientation of the pins.
  • the ball joint (53) of the variable angle pin holder has similar design to the ball joint (31) of the reduction arm extension.
  • a body extension (55) and a rail extension (56) enable attachment of additional pins if necessary.
  • Body extension (55) can be attached to an anchoring slot (57) on the side of the body (47) of the multi-pin clamp.
  • Body extension (55) has a rail (58) for attachment of pin holders (49a, 49b & 49c) and has a ridge (59) for attachment of rail extension (56).
  • the Multi -planar rail fixator (60).
  • the multi-planar rail (61) has a square cross section with four rails (62) on its four surfaces.
  • Versatile multi-pin clamps (3) can be connected to multi-planar rail (61) using a triple hinge connector (63).
  • a lockable sliding base plate (64) on one end of the triple hinge connector (63) provides attachment to one of the four rails (62) on the multi-planar rail (61).
  • Other end of triple hinge connector (63) has a hexagonal connector (65) that can be attached to one of the four anchoring points (48) on the Versatile multi-pin clamp (3).
  • the triple hinge connector (63) has three lockable hinge joints (66) in three axes orthogonal to each other (x,y,z) allowing six degrees of freedom so that the multi-planar rail (61) can be connected to the Versatile multi-pin clamp (3) irrespective of its position and orientation.
  • the hinge joints (66) of the triple hinge connector (63) have radial serrations for locking. Additional pins (4) can be inserted into bone segments and connected directly to the multi -planar rail (61) through lockable rail multi -pin clamp (67).
  • An external fixator of bone needs to have six degrees of freedom of movement to be able to correct displaced bone fragments and reduce the fracture.
  • the different displacements that can occur in a fractured long bone are: distraction or overlapping of bone segments, rotation around the longitudinal axis of bone, translation in various planes and angulation in various planes.
  • the prior art devices are unable to use the previously inserted bone pins of fracture reduction device for definitive fixation.
  • a definitive external fixator needs to be attached using new bone pins that need to be inserted into the bone in a particular orientation to enable connection to the definitive fixator.
  • External fixators can be divided into either circular (ring) fixators or monolateral fixators.
  • Circular external fixators may allow six degrees of freedom for reduction of fracture but their bulky nature limits access to the bone for subsequent application of internal fixation.
  • Ilizarov type of circular external fixators require repeated changes of correction devices such as hinges, translation blocks and rotation blocks.
  • Hexapod type of circular fixators based on Stewart platform require computer based mathematical algorithms to calculate the corrections. These features of circular external fixators make them impractical for use as intra-operative fracture reduction devices. Both Ilizarov and Hexapod type circular external fixators can be used for intraoperative correction of deformity but conversion to internal fixation after application of circular fixator is usually difficult due to limited access to the bone.
  • Monolateral external fixation devices are mostly used to stabilize the bones after reducing the fracture by direct hand manipulation of the limb by the surgeon. Few monolateral external fixators have adjustment features that drive certain degrees of freedom, typically compression or distraction and, at times, a single revolution about an axis. Translation and angulation in all planes cannot be independently corrected in a controlled manner. At times, correction of either translation or angulation results in unintended secondary displacement in another plane or loss of reduction in another plane. Most of these devices need to be mounted in a particular orientation to the bone to achieve correction, necessitating placement of transcutaneous bone screws in particular orientation, limiting access to the bone for subsequent internal fixation. The lack of full six degrees of freedom for correction of displacement of bone segments precludes the use of monolateral external fixators for intra-operative deformity correction and internal fixation.
  • US6328737 Bl describes a fracture reduction device comprising linear adjustment means for linearly reducing a fractured bone in three directions, and angular adjustment mechanism for angularly reducing a fractured bone about three independent axes.
  • the adjustment mechanism is such that adjustment in each direction and about each axis is independent of the others.
  • the present invention can be used to move the whole segment of the bone which allows full correction of translation and angulation.
  • the present invention can be used for any bone.
  • US7282052 B2 discloses a unilateral external fixator device that allows for gross manipulation and fine adjustment of deformities in six degrees of freedom.
  • the device may comprise a Strut assembly and two compound movable joints, one at each end of the strut assembly.
  • the device enables six degrees of freedom for correction of deformity
  • the device actually enables correction of translation and rotation around two orthogonal axes. Therefore, a deformity in an oblique plane needs to be corrected using composite movements around the three orthogonal axes.
  • the present invention allows for correction of deformity in a given plane by moving the device to the plane of deformity without losing the correction already achieved in the previous plane.
  • the pin holding clamp in this invention allows for fixed angle parallel pin placement in the bone whereas the present invention enables variable angle and variable position of pin placement. This flexibility of pin placement allows placement of bone pins in any location giving access to internal fixation devices.
  • US9456849 B2 provides an external fixation connection rod having articulatable joints that can be attached to external supports.
  • the fixation connection rod includes a telescopic rod and connecting mechanisms for coupling the joints of the connection rod to the external supports, and the connecting mechanisms are operable to substantially lock the orientation of the joints.
  • US20070225704 Al deals with a device for electromechanically and/or electro-pneumatically positioning a fractured bone having a first clamping unit, a second clamping unit, and one of: (i) a translation component for relative translational movement of one clamping unit with respect to the other; (ii) an angulation component for relative angulational movement of one clamping unit with respect to the other; and (iii) a rotational component for relative rotational movement of one clamping unit with respect to the other.
  • This device has motors that are electromechanically driven to correct deformity. Once the device is attached to the bone pins it cannot be moved to another plane. Therefore, correction of all deformities in all planes is not possible.
  • the present invention has motors that are mechanically driven by the operator and the device itself can be moved to any desired plane without losing the correction already achieved. Correction of rotation as well as translation in some planes is not possible.
  • US6001097A discloses a reducing apparatus which allows each displacement which has been affected to be analyzed and precisely measured. It includes three telescopic bars disposed along the axes x, y and z, connected to one another by joining pieces which are movable in relation to the telescopic bars.
  • This device enables correction of deformity around three orthogonal axes.
  • the present invention overcomes this problem by correcting deformity in one plane and then moving the device to a new desired plane without losing the correction already achieved.
  • US20130110110A1 discloses a modular-design Poly axial External Fixator for fixating bones strong enough to hold the bones in their intended position.
  • the fixator uses two or more preloaded pins or Kirschner-wires or non-preloaded screws.
  • the PEF uses non-linear Kirschner- wires anchorage using external loading cages mounted in each arm of a polyaxial hinged external fixator. The hinges and the cages offer a high degree of configuration flexibility and modularity.
  • This device enables correction of deformity in some planes using the polyaxial joints but there is no provision to correct deformities in oblique plane without losing the correction already achieved.
  • the present invention overcomes this problem by correcting deformity in one plane and then moving the device to a new desired plane without losing the correction already achieved.
  • US9155561 B2 describes external fixation systems for correcting bone deformities in adjacent bones or fragments thereof.
  • the systems herein include first and second elongate rods that translate with respect to one another via rotation of an actuation member at an end of one of the rods.
  • At least one housing is coupled along a length of one of the rods.
  • the at least one housing includes at least one pin clamping member for clamping an end of a fixation pin therein.
  • This device enables greater flexibility of pin placement attached to a mini rail but the flexibility is only possible by altering the angle of fixation of bone pins.
  • the actual position of bone pins in relation to other pins in the clamp cannot be changed.
  • the present invention enables flexible placement of bone pins by enabling variable angle as well as variable position of bone pins in relation to other pins in the clamp.
  • US6102911 A discloses an orthopaedic apparatus, particularly for the surgical correction of angular and longitudinal defects of the bones of limbs, of the femur and tibia type, comprising a longitudinal rod externally positionable substantially parallel to a bone for correction, a first clamp movably anchored to the rod for supporting drilling guides for screws insertable in a proximal portion of the bone, and at least one second clamp movably anchored to the rod for supporting drilling guides for screws insertable in a distal portion of the bone.
  • This device enables correction of longitudinal and angular deformities in two orthogonal planes. It does not enable angular and translation deformities in any other plane. It also does not enable correction of rotation. In contrast the present invention enables correction of all deformities in all planes.
  • US4628922 A deals with a fracture reduction apparatus comprising a first holder for holding first set of bone fixation pins, and a second holder for holding a second set of bone fixation pins, the fixation pins being located with the site of the fracture intermediate them.
  • Each of the holders is rotatable about a respective set of three orthogonal axes, the three axes of each set intersecting one another at a respective point located in the bone.
  • This device enables correction of angular deformities in two orthogonal planes. It does not enable angular and translation deformities in any other plane. It also does not enable flexibility for the placement of bone pins. In contrast the present invention enables correction of all deformities in all planes and flexibility for the placement of bone pins.
  • US8303588 B2 deals with an external skeletal fixation device including first and second pin clamp units fixedly holding rodlike members inserted, respectively, into a first part and a second part of a bone on the opposite sides, respectively, of a virtual hinge point corresponding to a center of rotational angulation, a center on opposite sides of a fracture site of the bone or a part of the osteotomy site for deformity correction are turned, or a center about which a joint turn.
  • This device enables skeletal stabilisation of fractured bone segments but does not enable controlled correction of various components of deformity using drivers.
  • the present invention enables controlled correction of all various components deformities in different planes using drivers to drive deformity correction.
  • US6277118 Bl teaches an external fixator for securing a bone through a first bone screw connected to a first portion of the bone and a second bone screw connected to a second portion of the bone, clamping assemblies and an angular correction module connecting the assemblies.
  • the said module includes a first and second element coupled to allow articulation of the first clamping assembly relative to the second about a center of rotation.
  • This device enables correction of angulation deformities but does not enable correction of translation.
  • the present invention enables controlled correction of angulation, translation and rotation to achieve complete reduction of fracture.
  • US20040133199 Al relates to an external fixation device comprising an extendible central body and clamps for bone screws, said central body comprising two parts telescoping slidable one on the other, said parts including a first portion of elongate shape formed integrally with a second end portion of substantially cylindrical shape, said first portions of the parts being slidably coupled to each other characterized in that it further comprises a plate, a recess on the surface of the interconnected elements and having its contour shape matching the plate, and means for releasably securing the plate in the recess.
  • EP1021992 A2 discloses a fixing device comprising: a bar, a turret-like support having an outer casing movably mounted on said bar, an articulated joint for supporting surgical element, a single locking device for securing the outer casing to the bar and locking the angular position of the articulated joint comprising a cam movably supported by the outer casing and placed between the bar and the articulated joint.
  • This device enables correction of angulation deformities using an articulated joint but it does not enable controlled correction of translation and rotation.
  • the present invention enables controlled correction of angulation, translation and rotation to achieve complete reduction of fracture.
  • US Patent 6565564 relates to a simple external bone fixator assembly which allows surgeons to assembly onto a bone fixation rod at an intermediate location along the length of the rod.
  • the invention also consists of a bone pin locking assembly for use with standard bone fixation road and bone pines.
  • the rod clamp is a single piece construction, having a jaw capable of loosely capturing the bone fixation rod when the surgeon presses the jaw onto the rod and the assembly may be rigidly fixed to the rod using a bolt which tightens the jaw onto the rod.
  • This aforementioned invention comprises a clamp that can hold multiple pins but these pins have to be parallel to each other for its functioning.
  • the clamp in present invention allows for each pin to be placed in variable positions using a sliding mechanism and in multiple directions using variable angle fixation mechanism.
  • US Patent 4624249 relates to an external fixator having specialized pin holders which are slidably, but fixably disposed within hollow spacing members of the external fixation frame.
  • the spacing members are externally threaded to receive nuts which fix the pin holders and the members are slotted to receive transfixion pins which are fixed in the pin holders by the means of set screws(6).
  • the aforementioned invention is a bone external fixation device and is not designed to achieve reduction of bone fragments. Controlled correction of angulation, translation and rotation between the fractured bone fragments cannot be performed using this device. In contrast, the present invention allows for reduction of bone fragments by controlled correction of angulation, translation and rotation.
  • US8758343 B2 provides an apparatus for engaging bone fixation elements in a bone fixation frame.
  • the apparatus may include first and second clamp structures which may be configured to engage first and second bone fixation elements, respectively.
  • the first clamp structure may have a first spherically contoured bearing surface.
  • the second clamp structure may have a second spherically contoured bearing surface which may be seated in sliding contact with the first bearing surface.
  • This device enables stabilisation of fracture after achieving reduction by other means. It does not enable the operator to correct deformity and achieve reduction. In contrast our invention enables correction of deformities to achieve reduction and also enables stabilisation of fracture.
  • This aforementioned invention is for a clamp that can hold two pins inserted into the bone. The clamp can be then attached to a connecting rod in variable orientation. The two pins can only be inserted in a fixed angle.
  • the present invention allows for each individual pin to be attached in variable positions using a sliding mechanism and in multiple directions using variable angle fixation mechanism.
  • US Patent 11716176 consists of a device for electromechanically and/or electro-pneumatically positioning a fractured bone having a first clamping unit adapted for attachment to the bone by at least one first bone fastener, a second clamping unit adapted for attachment to the bone by at least one second bone fastener, and at least one of: (i) a translation component operatively driven by a translational driver for relative translational movement of one clamping unit with respect to the other along a translational axis; (ii) an angulation component operatively driven by an angulational driver for relative angulational movement of one clamping unit with respect to the other along an articulation axis; and (iii) a rotational component operatively driven by a rotational driver for relative rotational movement of one clamping unit with respect to the other along a rotational axis. Comments on US Patent 11716176
  • the aforementioned invention has motors that are electromechanically driven to correct deformity. Once the device is attached to the bone pins it cannot be moved to another plane. Therefore, correction of all deformities in all planes is not possible.
  • the present invention has motors that are mechanically driven by the operator and the device itself can be moved to any desired plane without losing the correction already achieved.
  • US Patent 09495204 talks about an external fixator for securing a bone through a first bone screw(6) connected to a first portion of the bone and a second bone screw(6) connected to a second portion of the bone.
  • the external fixator includes a first bone screw clamping assembly for receiving the first bone screw and a second bone screw clamping assembly for receiving the second bone screw.
  • the external fixator additionally includes an angular correction module connecting the first and second bone screw clamping assemblies.
  • the angular correction module includes a first element and a second element coupled to allow articulation of the first bone screw clamping assembly relative to the second bone screw clamping assembly about a center of rotation spaced from the module.
  • the aforementioned invention enables correction of angulation deformities but does not enable correction of translation and rotation.
  • the present invention enables controlled correction of angulation, translation and rotation to achieve complete reduction of fracture.
  • the main object of the invention is aimed at bringing the segments of fractured bone back to their normal morphology.
  • a further object of the invention is to keep the soft tissue envelope intact to preserve the biological environment.
  • a further object of the invention is to achieve accurate and controlled correction of all displacements of bone. • A further object of the invention is to be able to apply bone pins in any position and in any orientation to provide access to internal fixation after reduction.
  • a further object of the invention is to be able to apply the device to the bone in a way that it does not hinder optimum X-ray imaging of the bone.
  • a further object of the invention is to be able to convert to definitive fixation after fracture reduction by applying definitive external fixator directly to the bone pins and clamps that have been already applied to the bone during process of fracture reduction.
  • a further object of the invention is to be able to use it for intra-operative deformity correction of bone which can then be stabilized with internal fixation.
  • Bone pins transcutaneous bone screws
  • Versatile multi-pin clamp (3) to optimise access for subsequent internal fixation.
  • Reduction arm (1) and Stabilization (2) arms can be connected to Versatile multi-pin clamps (3) in such a way that they do not hinder optimum X-ray imaging and access for internal fixation, irrespective of the position and orientation of the Versatile multi-pin clamps (3).
  • Reduction arm (1) enables controlled independent correction of length (distraction and compression), rotation, angulation and translation in all planes.
  • Reduction arm (1) can be re-oriented to any new plane in order to drive further correction in that new plane. This is performed by locking the Stabilization arm (2) to maintain the correction already achieved while moving the Reduction arm (1) to re-orient it to a new plane. This process can be repeated any number of times without any unintended secondary displacement.
  • Step 1 Reduction arm (1) attached to the proximal and distal Versatile multi-pin clamps (3) is used to correct displacements of bone segments.
  • the quick length adjustment mechanisms of the proximal and distal halves (6) of reduction arm and lockable ball joint (31) enable the Reduction arm (1) to be connected to the Versatile multi -pin clamps (3) irrespective of their position and orientation. Compression or distraction between segments is performed using the quick and gradual length adjustment features in the proximal and distal halves (6) of the Reduction arm. Rotation between the bone segment is corrected using the rotation correction mechanism (35) in the central body (5).
  • the height of the reduction arm extension (26) should be adjusted using the height adjustment mechanism (28) to match the radius of the arc of the curved rail (41) of rotation correction mechanism (35) so that the correction of rotation occurs around the long axis of the bone.
  • Translation and angulation in the plane parallel to the Reduction arm ( 1 ) can be corrected using translation correction mechanism (34) and angulation correction mechanism (35) in the central body (5).
  • Step 2 Stabilization arm (2), attached to the other side of the Versatile multi-pin clamps (3) is then engaged by locking the clam shell clamps (45) and ball joints (46) of the stabilization arm to maintain the correction achieved so far.
  • Step 3 The Reduction arm (1) is then brought to neutral position (straightened) by unlocking the ball joints (31) on the reduction arm extensions (26).
  • the Reduction arm (1) is then moved to a new plane where there is residual displacement (translation and/or angulation) either by rotating it around its own axis using the articulation between the two half cylinders (23) and short sliding cylinder (20) or by rotating it around the axis of the bone using the hinge joints (29) of the reduction arm extension (26).
  • the Reduction arm (1) is fixed in the new plane by locking the ball joints (31) on the reduction arm extensions (26).
  • Step 3 can also be executed in the same way when a triple hinge connector (63) is used instead of the ball joint (31).
  • Three lockable hinge joints (66) in three axes orthogonal to each other (x,y,z) are unlocked to allow movement of Reduction arm(l) to a new desired plane and locked to fix the Reduction arm (1) in the new plane.
  • Step 4 Stabilization arm (2), is disengaged by unlocking the clam shell clamps (45) and ball joints (46) of the stabilization arm. Residual displacement (translation and/or angulation) in the new plane can be corrected using the translation correction mechanism (34) and angulation correction mechanism (35) in the central body (5) of the Reduction arm.
  • the Versatile multi-pin clamp (3) enables bone pins to be inserted in variable positions and at variable angles.
  • Pins (4) are held by pin holders (49a, 49b & 49c) that can slide to any desired position and attach to the rails (50) on two sides of the body (47) of the multi-pin clamp.
  • a body extension (55) and a rail extension (56) enable attachment of additional pins if necessary.
  • the reduction device can be moved to any desired plane even after the fracture is reduced without losing the reduction.
  • definitive fixation after fracture reduction can be performed simply by connecting a Multi-planar rail fixator (60) directly to the Versatile multi-pin clamps (3).
  • This feature enables conversion to definitive external fixation using the bone pins (4) that have been already inserted and attached to the Versatile multi-pin clamps (3) during the process of fracture reduction. This is made possible by using the locking triple hinge connector (63) between the multi-planar rail (61) and Versatile multi-pin clamps (3).
  • the axes of three locking hinge joints (66) on the triple hinge connector are oriented orthogonally to each other(x,y,z) which enables six degrees of freedom so that the multi-planar rail (61) can be connected to the Versatile multipin clamps (3) irrespective of its position and orientation.
  • the prior art devices are unable to connect to the previously inserted bone pins for fracture reduction and therefore, they need insertion of new bone pins in particular orientation to enable connection.
  • Figure 1 represent three-dimensional view and line diagram of assembly of reduction device consisting of proximal and distal versatile multi-pin clamps (3) attached to Stabilization arm (2) on one side and Reduction arm (1) on the other side.
  • Figure 2 represent three-dimensional view and line diagram of the Reduction arm consisting of central body (5), proximal and distal halves (6) and reduction arm extensions (26).
  • Figure 3 represent three-dimensional exploded view and line diagram of one half (6) of reduction arm and reduction arm extension (26).
  • Figure 4 represent cross section and line diagram of one half (6) of reduction arm and reduction arm extension (26).
  • Figure 5 represent three-dimensional view and line diagram of reduction arm extension (26).
  • Figure 6 represent three-dimensional view and line diagram of central body (5) of Reduction arm viewed from the side of rotation correction mechanism (35).
  • Figure 7 represent three-dimensional view and line diagram of central body (5) of Reduction arm viewed from the side of translation correction mechanism (34).
  • Figure 8 represent three-dimensional view and line diagram of central body (5) of Reduction arm without the casing (33).
  • Figure 9 represent three-dimensional view and line diagram of the Stabilization arm (2) and its components.
  • Figure 10 represent three-dimensional view and line diagram of versatile multi-pin clamp (3) with its body (47), two pin holders (49a & 49b) and bone pins (4).
  • Figure 11 represent three-dimensional view and line diagram of body (47) of versatile multi-pin clamp (3).
  • Figure 12 represent three-dimensional view and line diagram of versatile multi -pin clamp (3) with its body (47), body extension (55) and three types of pin holders (49a, 49b, & 49c) viewed from the top.
  • Figure 13 represent three-dimensional view and line diagram of versatile multi -pin clamp (3) with its body (47), body extension (55), rail extension (56) and pin holders (49a & 49b) viewed from the bottom.
  • Figure 14 represent three-dimensional view and line diagram of assembly of Multiplanar rail fixator (60) attached to the proximal and distal versatile multi-pin clamps (3) with triple hinge connectors (63). Numbered list of components
  • Locking screw for the hinge joint in the Reduction arm extension Lockable ball joint of the Reduction arm extension consisting of inner ball with a threaded rod- 31a, outer ball- 31b and spherical washer- 31c Circular locking nut for the ball joint of the Reduction arm extension Casing of the central body of Reduction arm Translation correction mechanism Rotation correction mechanism Angulation correction mechanism Hinge for the angulation correction mechanism Driver for the angulation correction mechanism Rail for the translation correction mechanism Driver for the translation correction mechanism Curved rail for the rotation correction mechanism Driver for the rotation correction mechanism Stabilizing rod Hexagonal connector of the Stabilizing arm Clam-shell clamp of the Stabilizing arm Lockable ball joint of the Stabilizing arm Body of the Versatile multi-pin clamp Hexagonal anchoring points on the versatile multi-pin clamp Three types of pin holders.
  • the Fracture Reduction and Deformity Correction Device comprises of the following units:
  • Central body (5) of the reduction arm This has the translation correction mechanism (34), rotation correction mechanism (35) and angulation correction mechanism (36) enabling correction of translation, rotation and angulation of bone segments.
  • the proximal and distal halves (6) of Reduction arm These have two mechanisms each for quick adjustment and one mechanism each for gradual adjustment of overall working length of Reduction arm.
  • a short sliding cylinder (20) and two half cylinders (23) around it enables rotation of the Reduction arm (1) around its own axis so that it can be aligned into any desired plane.
  • Reduction arm extensions (26) They have height adjustment mechanism (28) to adjust the distance between the Reduction arm and the bone.
  • a lockable hinge joint (29) enables rotation of the Reduction arm (1) around the axis of the bone to any desired plane.
  • a lockable ball joint (31) with hexagonal connector (27) enables connection of Reduction arm (1) to Versatile multi -pin clamp (3) irrespective of its position or orientation.
  • Stabilization rods (43) are rods of various lengths with a circular cross section that can be used to provisionally stabilize the bone segments when the Reduction arm ( 1 ) needs to be moved to a new desired plane by rotating around its own axis or around the axis of the bone.
  • a lockable ball joint (46) between the clam-shell clamp (45) and the hexagonal connector (44) enables the stabilization arm to be connected to the proximal and distal Versatile multipin clamps (3) irrespective of their position or orientation.
  • Body of the Multi-pin clamp (47): It has four hexagonal anchoring points (48) to provide attachment for Reduction arm (1), Stabilizing arm (2) and Multiplanar rail fixator (60). It has rails (50) on two sides and anchoring slots (57) on other two sides. The rails (50) provide attachment to pin holders (49a, 49b & 49c) that can be locked to the serrations (51) under the rails. The anchoring slots provide attachment to body extension (55).
  • Pin holder Three types of pin holders (49a, 49b & 49c) can slide to any desired position on the rails (50) on two sides of the body (47) of the multi-pin clamp and can be locked to the serrations (51) under the rails (50). Variable angle(49a) and fixed angle(49b) pin holders are inclined at an angle to the body (47) of the multi-pin clamp whereas straight(49c) pin holder is in the same plane as the body (47) of multi -pin clamp. Variable angle pin holder(49a) has a lockable ball joint (53) to allow variable angle orientation of the pins.
  • Body extension (55) It has a rail (58) for attachment of pin holders (49a, 49b & 49c) and has a ridge (59) for attachment of rail extension (56). It can be attached to an anchoring slot (57) on the side of the body (47) of the multi-pin clamp.
  • Rail extension (56) It has a rail for attachment of additional pins if necessary. It can be attached to the ridge (59) on the side of the body extension (55).
  • Multi-planar rail (61) This has a square cross section with four rails (62) on its four surfaces to which Versatile multi-pin clamp (3) can be connected using a triple hinge connector (63).
  • Triple hinge connector (63) This has a lockable sliding base plate (64) on one end which can be attached to one of the four rails (62) on the multi -planar rail (61). It has a hexagonal connector
  • the hinge joints (66) of the triple hinge connector (63) have radial serrations for locking. It can also be used to connect the Reduction arm (1) to Versatile multipin clamp (3) by detaching the lockable sliding base plate (64) and attaching the hinge joint

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (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 et des dispositifs pour une réduction de fracture fermée, une correction de malformation et une fixation d'os. Par conséquent, l'invention concerne un système, une méthode, un procédé et un appareil pour permettre la réduction d'une fracture, la correction d'une malformation et la stabilisation d'os : des broches osseuses (vis osseuses transcutanées) (4) pouvant être insérées dans des segments osseux dans n'importe quelle position et dans n'importe quelle orientation à l'aide d'une pince à broches multiples polyvalente (3) pour optimiser l'accès pour une fixation interne ultérieure, et un bras de réduction (1) et des bras de stabilisation (2) peuvent être connectés à des pinces à broches multiples polyvalentes (3) de manière à ne pas gêner l'imagerie par rayons X optimale et l'accès à la fixation interne indépendamment de la position et de l'orientation des pinces à broches multiples polyvalentes (3). Le bras de réduction (1) permet une correction indépendante contrôlée de la longueur, de la rotation, de l'angulation et de la translation dans tous les plans et peut être réorienté vers n'importe quel nouveau plan afin d'entraîner une correction supplémentaire dans ce nouveau plan.
PCT/IB2022/051092 2021-02-08 2022-02-08 Système et dispositifs de réduction de fracture fermée, de correction de malformation et de fixation d'os WO2022168057A1 (fr)

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Citations (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4624249A (en) 1984-12-04 1986-11-25 Medicuba Orthopedic external fixing apparatus
US4628922A (en) 1984-09-28 1986-12-16 University College London Fracture reduction apparatus
DE19522114A1 (de) * 1995-06-19 1997-01-23 Christof Kaufmann Unilateraler Fixateur externe: ein mechanisches Rahmensystem zur Reponierung von Knochenfragmenten, bestehend aus den Implantaten, deren Enden nach außerhalb des Körpers zeigen, dort mechanisch gefaßt und durch einen gemeinsamen Traversenstab miteinander fest verbunden werden
US6001097A (en) 1996-01-18 1999-12-14 Jaquet Orthopedie S.A. Fracture reducing apparatus
EP1021992A2 (fr) 1999-01-21 2000-07-26 Medicalplastic S.r.L. Fixateur externe pour l'orthopédie et la traumatologie
US6102911A (en) 1997-02-13 2000-08-15 Orthofix S.R.L. Orthopaedic apparatus, particularly for the surgical correction of bone deformities
US6277118B1 (en) 2000-01-31 2001-08-21 Electro-Biology, Inc. External fixator including an angular correction module and related method
US6328737B1 (en) 1997-04-11 2001-12-11 Keel University Fracture reduction device
US20020026190A1 (en) * 1999-10-21 2002-02-28 Walulik Stephen B. Clamp assembly for an external fixation system
US6565564B2 (en) 2000-12-14 2003-05-20 Synthes U.S.A. Multi-pin clamp and rod attachment
US20040133199A1 (en) 2001-03-05 2004-07-08 Michele Coati External fixation device for reducing bone fractures
WO2006102166A2 (fr) * 2005-03-18 2006-09-28 Ron Anthon Olsen Attelle reglable pour osteosynthese
US20070225704A1 (en) 2006-03-23 2007-09-27 Ziran Bruce H Electromechanically driven external fixator and methods of use
US7282052B2 (en) 2002-09-17 2007-10-16 Ebi, L.P. Unilateral fixator
WO2010029406A1 (fr) * 2008-09-11 2010-03-18 Orthofix S.R.L. Dispositif orthopédique à appliquer à l'extérieur d'un os
US8303588B2 (en) 2005-03-03 2012-11-06 Kozo Nakamura External skeletal fixation device
US20130110110A1 (en) 2010-07-07 2013-05-02 Gabriel Waisman Polyaxial external fixator and method of using the same
US8758343B2 (en) 2005-04-27 2014-06-24 DePuy Synthes Products, LLC Bone fixation apparatus
US20140276816A1 (en) * 2013-03-15 2014-09-18 Biomet C.V. Polyaxial pivot housing for external fixation system
US9155561B2 (en) 2013-03-06 2015-10-13 Stryker Trauma Sa Mini-rail external fixator
US9456849B2 (en) 2008-02-12 2016-10-04 Texas Scottish Rite Hospital For Children Fast adjust external fixation connection rod
US9495204B2 (en) 2014-01-06 2016-11-15 International Business Machines Corporation Constructing a logical tree topology in a parallel computer

Patent Citations (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4628922A (en) 1984-09-28 1986-12-16 University College London Fracture reduction apparatus
US4624249A (en) 1984-12-04 1986-11-25 Medicuba Orthopedic external fixing apparatus
DE19522114A1 (de) * 1995-06-19 1997-01-23 Christof Kaufmann Unilateraler Fixateur externe: ein mechanisches Rahmensystem zur Reponierung von Knochenfragmenten, bestehend aus den Implantaten, deren Enden nach außerhalb des Körpers zeigen, dort mechanisch gefaßt und durch einen gemeinsamen Traversenstab miteinander fest verbunden werden
US6001097A (en) 1996-01-18 1999-12-14 Jaquet Orthopedie S.A. Fracture reducing apparatus
US6102911A (en) 1997-02-13 2000-08-15 Orthofix S.R.L. Orthopaedic apparatus, particularly for the surgical correction of bone deformities
US6328737B1 (en) 1997-04-11 2001-12-11 Keel University Fracture reduction device
EP1021992A2 (fr) 1999-01-21 2000-07-26 Medicalplastic S.r.L. Fixateur externe pour l'orthopédie et la traumatologie
US20020026190A1 (en) * 1999-10-21 2002-02-28 Walulik Stephen B. Clamp assembly for an external fixation system
US6277118B1 (en) 2000-01-31 2001-08-21 Electro-Biology, Inc. External fixator including an angular correction module and related method
US6565564B2 (en) 2000-12-14 2003-05-20 Synthes U.S.A. Multi-pin clamp and rod attachment
US20040133199A1 (en) 2001-03-05 2004-07-08 Michele Coati External fixation device for reducing bone fractures
US7282052B2 (en) 2002-09-17 2007-10-16 Ebi, L.P. Unilateral fixator
US8303588B2 (en) 2005-03-03 2012-11-06 Kozo Nakamura External skeletal fixation device
WO2006102166A2 (fr) * 2005-03-18 2006-09-28 Ron Anthon Olsen Attelle reglable pour osteosynthese
US8758343B2 (en) 2005-04-27 2014-06-24 DePuy Synthes Products, LLC Bone fixation apparatus
US20070225704A1 (en) 2006-03-23 2007-09-27 Ziran Bruce H Electromechanically driven external fixator and methods of use
US9456849B2 (en) 2008-02-12 2016-10-04 Texas Scottish Rite Hospital For Children Fast adjust external fixation connection rod
WO2010029406A1 (fr) * 2008-09-11 2010-03-18 Orthofix S.R.L. Dispositif orthopédique à appliquer à l'extérieur d'un os
US20130110110A1 (en) 2010-07-07 2013-05-02 Gabriel Waisman Polyaxial external fixator and method of using the same
US9155561B2 (en) 2013-03-06 2015-10-13 Stryker Trauma Sa Mini-rail external fixator
US20140276816A1 (en) * 2013-03-15 2014-09-18 Biomet C.V. Polyaxial pivot housing for external fixation system
US9495204B2 (en) 2014-01-06 2016-11-15 International Business Machines Corporation Constructing a logical tree topology in a parallel computer

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