EP3820389A2 - An external fixator having an alignment device - Google Patents

An external fixator having an alignment device

Info

Publication number
EP3820389A2
EP3820389A2 EP19846126.1A EP19846126A EP3820389A2 EP 3820389 A2 EP3820389 A2 EP 3820389A2 EP 19846126 A EP19846126 A EP 19846126A EP 3820389 A2 EP3820389 A2 EP 3820389A2
Authority
EP
European Patent Office
Prior art keywords
bone
alignment device
external fixator
connection
alignment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19846126.1A
Other languages
German (de)
French (fr)
Other versions
EP3820389A4 (en
Inventor
Teyfik DEMIR
Fatih SOYLEMEZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tobb Ekonomi Ve Teknoloji Universitesi
Original Assignee
Tobb Ekonomi Ve Teknoloji Universitesi
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 Tobb Ekonomi Ve Teknoloji Universitesi filed Critical Tobb Ekonomi Ve Teknoloji Universitesi
Publication of EP3820389A2 publication Critical patent/EP3820389A2/en
Publication of EP3820389A4 publication Critical patent/EP3820389A4/en
Pending legal-status Critical Current

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
    • A61B17/60—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
    • A61B17/68—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

Definitions

  • the present invention relates to an external fixator having an alignment device which is used for therapeutic purposes in surgical operations of bone fractures and which enables to use external fixation and internal bone joining and alignment together during the treatment of the fractured bone.
  • Bones are rigid and firm structures that support body movements and allow the surrounding tissues to adhere.
  • the bones having a length greater than the thickness are classified as long bones.
  • the longest bone in the human skeletal structure is the femur (thigh) bone.
  • the state when the bone loses its original form and is fractured into a plurality of pieces due to any impact, pressure and trauma, and sometimes due to diseases such as bone resorption, bone tumors, and“osteogenesis imperfecta” is called a bone fracture.
  • one of the methods of closed reduction, plaster cast, external fixation, open reduction, fixation via plate-screw or intramedullary nailing is used to treat the fracture.
  • the femur bone is one of the most robust and large bones of the body.
  • the femur bone starts from the hip joint and extends up to the knee joint.
  • healing is generally achieved by using indirect reduction techniques and fixation without opening the fracture line in order not to deform blood build up.
  • Implants such as intramedullary nails, various plates and external fixators are used for fractures of long bones such as femur.
  • Intramedullary nail is generally the first choice for fractures of long bones such as femur, humerus and tibia.
  • external fixation method can also be used to prevent malunion of the bone. In the current applications, external fixation method is frequently used for long bone fractures.
  • External fixators provide ease in wound care in case of open fractures; however pin site (nail site) infection and limitation of movement in the knee joint are among the major disadvantages of the external fixator.
  • External fixation is a method of fixing the bones from outside of the body.
  • the fixator is attached to the bone from outside of the body by nails or wires. These nails pass through the skin and sometimes through the muscles to connect the external fixator to the bone. Two or more nails are placed in order to hold the fractured bone in place and connect it to the fixator.
  • External fixation treatment method is also used for treatment of bone infections, bone nonunion and malunion, and for bone lengthening.
  • the biggest problem encountered in the external fixation method is the difficulty of locating the bone and the hole on the bone from outside of the body during fixation of the fractured bone. For this reason, bone and hole detection are carried out by using methods like laser, navigation system and ultrasound. In this case, the operation time is prolonged and complications may occur during the operation with the said methods.
  • the intramedullary nailing method which is used in long bone fractures, is based on the principle of placing the cylindrical intramedullary nail into the medullary canal in the bones and fixing it with screws in complete bone fractures.
  • intramedullary nailing method There are types of intramedullary nailing method, namely locked and unlocked. Locked intramedullary nailing method is suitable for anatomical and biomechanical structure of femur bone and it is a treatment method applied with high rates of union and low rates of complications.
  • the intramedullary nailing method the medullary canal (bone marrow) on the fractured bone is discharged and the intramedullary nail is placed along the canal so as to hold the bone in a linear position.
  • Intramedullary nails are mainly designed to enable load bearing and to minimize the movement in the fracture site. Standard intramedullary nails cannot contact the cortex sufficiently and therefore cannot provide the desired stability. The intramedullary nailing method prevents the rotational movement of the bone and ensures that it remains in a linear position.
  • the reduction process (the process of overlapping the axes of the medullary canal of the fractured bone fragments) cannot be carried out under suitable conditions since it is performed in a closed manner without seeing.
  • the nail changes shape according to the angle of the canal.
  • Different apparatuses are used to locate the distal lock screw.
  • the insertion of the screw to ensure locking without seeing takes a long time.
  • the rotation of the bone is prevented but it is not possible to align it linearly or bone union occurs in different directions.
  • surface friction problems are encountered when inserting an intramedullary nail in bone fractures.
  • United States patent document no. US5429640A an application in the state of the art, with a priority date of 27.11.1992, disclose a bone fixation system.
  • an internal screw which is used such that the bone will be fixed from the inner region and the fracture will be aligned.
  • Fixing bolts for other region fractures can be inserted by means of the holes formed on the screw disclosed in the said document. It is stated that the hole regions and diameters thereof can be adjusted to suit different needs.
  • the said document discloses use of an internal screw and bone alignment by forming spaces on the screw for mounting of external parts.
  • this state-of-the-art document does not include an external bone fixation system such as the external fixator of the present invention.
  • a bone alignment device is inserted into the medullary canal within the fractured bone to render the fractured fragments concentric.
  • external fixation of the bone is ensured by means of the external fixator.
  • the alignment device inserted into the bone is connected at one end to the external fixator and the other end is exposed to prevent surface friction. In this case, malunion is prevented during bone healing.
  • United States patent document no. US20120209266A1 an application in the state of the art, with a priority date of 11.02.2011, discloses an external fixation system.
  • the lower part is angularly aligned to enable the screw connection for the elbow in the said document.
  • Three screws are used for the upper connection and the height and tension adjustment is provided by the moveable system.
  • the invention of the said document provides an external fixation system for fixing the deformed bone externally.
  • a bone alignment device is inserted into the medullary canal within the fractured bone to render the fractured fragments concentric.
  • external fixation of the bone is ensured by means of the external fixator.
  • the alignment device inserted into the bone is connected at one end to the external fixator and the other end is exposed to prevent surface friction. In this case, malunion is prevented during bone healing.
  • the external fixator having an alignment device disclosed in the present invention enables the deformed bone to be internally aligned and externally fixed.
  • the alignment device in the external fixator having an alignment device enables the fractured bone fragments to be aligned concentrically while at the same time fixing the bone from outside of the bone.
  • the alignment device inserted into the bone is connected at one end to the external fixator and the other end is exposed to prevent surface friction. In this case, malunion is prevented during bone healing.
  • the object of the present invention is to provide an external fixator having an alignment device which enables to align the fractured bone fragments concentrically by means of the alignment device passed through the medullary canal within the fractured bone.
  • Another object of the present invention is to provide an external fixator having an alignment device that enables the fractured bone fragments, which are aligned internally by means of the alignment device, to be fixed from outside in a linear position.
  • a further object of the present invention is to provide an external fixator having an alignment device which prevents surface friction during internal alignment of the fractured bone fragments.
  • Another object of the present invention is to provide an external fixator having an alignment device which, while aligning the bone internally by means of the alignment device, also enables compression via distal locking.
  • a further object of the present invention is to provide an external fixator having an alignment device which, when concentrically aligning the bone from the inside, prevents rotation of the fractured bone fragments by locking from one end of the alignment device.
  • Another object of the present invention is to provide an external fixator having an alignment device which, in addition to the internal alignment and the external fixation of the bone, prevents bone malunion.
  • An external fixator having an alignment device which is developed to fulfill the objects of the present invention and defined in Claim 1 and the other claims dependent thereon is generally comprised of an alignment device and an external fixator.
  • the alignment device is placed in the medullary canal within the bone depending on the position and geometry of the bone.
  • the alignment device is arranged in the medullary canal such that the center axes of the alignment holes coincide with the connection holes.
  • the alignment device is inserted into the medullary canal and aligns the bone or the bone fragments concentrically.
  • the schanz screws are inserted into the connection regions in the external fixator.
  • the schanz screws which are passed through the connection regions, are inserted from one end of the external fixator into the connection hole in the connection end of the alignment device.
  • the schanz screws which are passed through the connection holes of the alignment device, are fitted into the alignment hole in the bone.
  • the alignment device connected to the bone and the external fixator at the connection end thereof enables the bone to be aligned concentrically and allows to adjust the length of the bone by being connected to the external fixator.
  • the alignment device is inserted into the medullary canal from one end thereof together with the external fixator and fixed to the bone, thereby preventing the bone from rotating and getting deformed (crooked) during the alignment thereof.
  • Figure 1 is a perspective view of the external fixator having an alignment device placed on the bone.
  • Figure 2 is a front view of the external fixator having an alignment device placed on the bone.
  • Figure 3 is a perspective exploded view of the external fixator having an alignment device.
  • Figure 4 is a perspective exploded view of the external fixator having an alignment device rom another angle.
  • Figure 5 is a perspective view of the external fixator having an alignment device.
  • Figure 6 is an enlarged view of one end of the external fixator having an alignment device when placed on the bone.
  • Figure 7 is an enlarged view of one end of the external fixator having an alignment device when placed on the bone from another angle.
  • Figure 8 is an enlarged view of one end of the external fixator having an alignment device.
  • Figure 9 is an enlarged view of one end of the external fixator having an alignment device from another angle.
  • An external fixator having an alignment device
  • An external fixator having an alignment device (1) which is used for therapeutic purposes in surgical operations of bone (A) fractures, and which enables to use external fixation and internal bone joining and alignment together during the treatment of the fractured bone (A), essentially comprising
  • At least one external fixator (2) which comprises at least one connection region (2.2) and at least one schanz screw (2.3), is mounted to the bone (A) through a plurality of connection regions (2.2) by means of schanz screws (2.3), and which enables the fractured bone (A) fragments, to which it is mounted, to be moved close to each other when the connection regions (2.2) are moved close to each other and the fractured bone fragments (A) to be moved away from each other when the connection regions (2.2) are moved away each other, at least one alignment device (3), which comprises at least one free end (3.2) and at least one connection end (3.3), and which
  • the external fixator having an alignment device (1) which is the subject matter of the present application is used in surgical operations for treatment of fractured bones.
  • the external fixator having an alignment device (1) enables the use of external fixation and internal bone (A) joining and alignment together during treatment of the fractured bone (A).
  • the external fixator having an alignment device (1) comprises an external fixator (2) and an alignment device (3).
  • the external fixator having an alignment device (1) enables external fixation of the bone (A) by means of the external fixator (2) and the internal alignment by means of the alignment device (3).
  • the external fixator (2) in the external fixator having an alignment device (1) enables fixation of fractured bone (A) fragments from the outside of the bone (A).
  • the external fixator (2) comprises an aligning bar (2.1), a connection region (2.2) and a schanz screw (2.3).
  • the external fixator (2) is mounted to the bone (A) through a plurality of connection regions (2.2) via schanz screws (2.3).
  • the external fixator (2) enables the fractured bone (A) fragments, to which it is mounted, to be moved close to each other when the connection regions (2.2) are moved close to each other and the fractured bone fragments (A) to be moved away from each other when the connection regions (2.2) are moved away each other.
  • the external fixator (2) is used in cases of fractured bones or bone lengthening processes.
  • connection regions (2.2) provided in the external fixator (2) is preferably in the geometric form of a bar, and one or more connection regions (2.2) are placed thereon.
  • the connection regions (2.2) are preferably located on both ends of the aligning bar (2.1) to fix the two ends of the fractured bone (A) to each other.
  • the connection regions (2.2) can move linearly on the aligning bar (2.1) and can be positioned with respect to the position of the fractured bone (A).
  • the external fixator (2) performs the fixation process as the schanz screws (2.3) passed through the connection regions
  • alignment holes (C) are drilled on the bone (A) at preferred positions.
  • the alignment holes (C) are provided depending on the number of the schanz screws (2.3) to be inserted into the bone (A).
  • the schanz screws (2.3) are fitted into the alignment holes (C) upon passing through the connection regions (2.2) in order to fix the fractured bone (A) at both ends thereof.
  • the alignment device (3) in the external fixator having an alignment device (1) is passed through the fractured bone (A) to hold the fractured fragments together and align them.
  • the alignment device (3) comprises an inclined region (3.1), a free end (3.2) and a connection end (3.3).
  • the alignment device (3) is connected from its connection end (3.3) to a connection region (2.2) of the external fixator (2) by means of one or more schanz screws (2.3) such that its free end (3.2) is exposed.
  • the alignment device (3) is inserted into the medullary canal (B) in the bone (A) to enable the fractured bone (A) fragments to be aligned concentrically.
  • the alignment device (3) When inserted into the medullary canal (B), the alignment device (3) enables the bone (A) to be parallel with the external fixator (2).
  • the alignment device (3) is preferably in a geometric form of a cylindrical bar.
  • the geometric form of the alignment device (3) is adjusted to be suitable to the geometric form of the bone (A) to which it will be applied.
  • the alignment device (3) comprises an inclined region (3.1) and a free end (3.2).
  • the alignment device (3) is used by being inserted into the medullary canal (B) of the bone (A).
  • the inclined region (3.1) is formed depending on the geometric form of the bone (A) into which the alignment device (3) will be inserted.
  • the inclined region (3.1) prevents the alignment device (3) from being subjected to surface friction when it is inserted into the medullary canal (B) of the bone (A).
  • the inclined region (3.1) has a similar geometry to the geometric form of the medullary canal (B).
  • the alignment device (3) is inserted into the bone (A) from the connection end (3.3) via schanz screws (2.3).
  • the schanz screws (2.3) are inserted into the alignment device (3) together with the bone (A) after the alignment device (3) is placed in the medullary canal (B).
  • the alignment device (3) is connected at one end thereof to the bone (A) and the external fixator (2) via schanz screws (2.3). While the alignment device (3) is connected to the bone (A) and the external fixator (2) at its connection end (3.3), the free end (3.2) thereof remains free and exposed in the medullary canal (B).
  • connection end (3.3) of the alignment device (3) is located at the inclined region (3.1) or the free end (3.2).
  • the alignment device (3) is connected to the bone (A) and the external fixator (2) from the inclined region (3.1) or the free end (3.2) via the connection end (3.3).
  • the connection end (3.3) is located on the inclined region (3.1) ( Figure 3).
  • the region on which the connection end (3.3) will be located is preferably adjusted depending on the medullary canal (B) in which the alignment device (3) will be placed.
  • the alignment device (3) is inserted into the medullary canal (B) to enable the fractured bone (A) fragments to be held together concentrically.
  • the alignment device (3) attaches to the bone (A) within the medullary canal (B) and can remain fixed due to the friction of the surface.
  • the alignment device (3) can remain fixed in the medullary canal (B) and enables alignment of the fractured fragments of the bone (A).
  • connection holes (3.3) enables the alignment device (3) to be connected to the external fixator (2) and the bone (A).
  • connection hole (3.3.1) preferably has a circular geometric form.
  • the connection hole (3.3.1) enables the schanz screws (2.3) to be passed through the alignment device (3).
  • the schanz screws (2.3) that are passed through the connection holes (3.3.1) are fixed to the bone (A).
  • the alignment device (3) is placed within the medullary canal (B) such that the connection holes (3.3.1) and the center axes of the alignment holes (C) in the bone (A) coincide with each other.
  • the alignment device (3) enables the fractured bone (A) fragments to be aligned concentrically, while the external fixator (2) enables the distance between the bone (A) fragments to be adjusted thereby fixing the bone (A).
  • the alignment device (3) is inserted into the medullary canal (B) from one end thereof together with the external fixator (2) and fixed to the bone (A), thereby preventing the bone (A) from rotating and getting deformed (crooked) during the alignment thereof.
  • the alignment device (3) is placed in the medullary canal (B) within the bone (A) depending on the position and geometry of the bone (A).
  • the alignment device (3) is arranged in the medullary canal (B) such that the center axes of the alignment holes (C) coincide with the connection holes (3.3.1).
  • the alignment device (3) is inserted into the medullary canal (B) and aligns the bone (A) or the bone (A) fragments concentrically.
  • the schanz screws (2.3) are inserted into the connection regions (2.2) in the external fixator (2).
  • the alignment device (3) After the alignment device (3) is inserted into the medullary canal (B), the schanz screws (2.3), which are passed through the connection regions (2.2), are inserted from one end of the external fixator (2) into the connection hole (3.3.1) at the connection end (3.3) of the alignment device (3).
  • the schanz screws (2.3), which are passed through the connection holes (3.3.1) of the alignment device (3), are fitted into the alignment hole (C) in the bone (A).
  • the alignment device (3) connected to the bone (A) and the external fixator (2) at the connection end (3.3) thereof enables the bone (A) to be aligned concentrically and allows to adjust the length of the bone (A) by being connected to the external fixator (2).
  • the alignment device (3) is inserted into the medullary canal (B) from one end thereof together with the external fixator (2) and fixed to the bone (A), thereby preventing the bone (A) from rotating and getting deformed (crooked) during the alignment thereof.

Abstract

The present invention relates to an external fixator having an alignment device (1) which is used for therapeutic purposes in surgical operations of bone (A) fractures and which enables to use external fixation and internal bone (A) joining and alignment together during the treatment of the fractured bone (A).

Description

AN EXTERNAL FIXATOR HAVING AN ALIGNMENT DEVICE
Field of the Invention
The present invention relates to an external fixator having an alignment device which is used for therapeutic purposes in surgical operations of bone fractures and which enables to use external fixation and internal bone joining and alignment together during the treatment of the fractured bone.
Background of the Invention
Bones are rigid and firm structures that support body movements and allow the surrounding tissues to adhere. In the skeletal structure, the bones having a length greater than the thickness are classified as long bones. The longest bone in the human skeletal structure is the femur (thigh) bone. The state when the bone loses its original form and is fractured into a plurality of pieces due to any impact, pressure and trauma, and sometimes due to diseases such as bone resorption, bone tumors, and“osteogenesis imperfecta” is called a bone fracture. Depending on the structure of the fracture; one of the methods of closed reduction, plaster cast, external fixation, open reduction, fixation via plate-screw or intramedullary nailing is used to treat the fracture. The femur bone is one of the most robust and large bones of the body. The femur bone starts from the hip joint and extends up to the knee joint. In femoral bone fractures, healing is generally achieved by using indirect reduction techniques and fixation without opening the fracture line in order not to deform blood build up. Implants such as intramedullary nails, various plates and external fixators are used for fractures of long bones such as femur. Intramedullary nail is generally the first choice for fractures of long bones such as femur, humerus and tibia. On the other hand, external fixation method can also be used to prevent malunion of the bone. In the current applications, external fixation method is frequently used for long bone fractures. External fixators provide ease in wound care in case of open fractures; however pin site (nail site) infection and limitation of movement in the knee joint are among the major disadvantages of the external fixator. External fixation is a method of fixing the bones from outside of the body. The fixator is attached to the bone from outside of the body by nails or wires. These nails pass through the skin and sometimes through the muscles to connect the external fixator to the bone. Two or more nails are placed in order to hold the fractured bone in place and connect it to the fixator. External fixation treatment method is also used for treatment of bone infections, bone nonunion and malunion, and for bone lengthening. The biggest problem encountered in the external fixation method is the difficulty of locating the bone and the hole on the bone from outside of the body during fixation of the fractured bone. For this reason, bone and hole detection are carried out by using methods like laser, navigation system and ultrasound. In this case, the operation time is prolonged and complications may occur during the operation with the said methods.
In the state of the art, the intramedullary nailing method, which is used in long bone fractures, is based on the principle of placing the cylindrical intramedullary nail into the medullary canal in the bones and fixing it with screws in complete bone fractures. There are types of intramedullary nailing method, namely locked and unlocked. Locked intramedullary nailing method is suitable for anatomical and biomechanical structure of femur bone and it is a treatment method applied with high rates of union and low rates of complications. In the intramedullary nailing method, the medullary canal (bone marrow) on the fractured bone is discharged and the intramedullary nail is placed along the canal so as to hold the bone in a linear position. In addition, the addition of locking screws to modern nailing systems has extended the indications for this procedure, including severely broken fractures and distal and proximal body fractures. For these reasons, closed locked intramedullary nailing is the preferred treatment method for femoral fractures. Intramedullary nails are mainly designed to enable load bearing and to minimize the movement in the fracture site. Standard intramedullary nails cannot contact the cortex sufficiently and therefore cannot provide the desired stability. The intramedullary nailing method prevents the rotational movement of the bone and ensures that it remains in a linear position. However, in some applications, the reduction process (the process of overlapping the axes of the medullary canal of the fractured bone fragments) cannot be carried out under suitable conditions since it is performed in a closed manner without seeing. In the systems used in distal locking, as the nail enters the canal, the nail changes shape according to the angle of the canal. Different apparatuses are used to locate the distal lock screw. The insertion of the screw to ensure locking without seeing takes a long time. However, in the nailing method, the rotation of the bone is prevented but it is not possible to align it linearly or bone union occurs in different directions. In the current applications, surface friction problems are encountered when inserting an intramedullary nail in bone fractures. In the state of the art, there is a need for an implantation method that enables compression by distal locking with the fixator, easy distal locking and prevention of surface friction.
United States patent document no. US5429640A, an application in the state of the art, with a priority date of 27.11.1992, disclose a bone fixation system. In the design of the said document, there is provided an internal screw which is used such that the bone will be fixed from the inner region and the fracture will be aligned. Fixing bolts for other region fractures can be inserted by means of the holes formed on the screw disclosed in the said document. It is stated that the hole regions and diameters thereof can be adjusted to suit different needs. The said document discloses use of an internal screw and bone alignment by forming spaces on the screw for mounting of external parts. However, this state-of-the-art document does not include an external bone fixation system such as the external fixator of the present invention. In the invention of the present application, a bone alignment device is inserted into the medullary canal within the fractured bone to render the fractured fragments concentric. In addition to enabling concentric alignment of the bones, external fixation of the bone is ensured by means of the external fixator. In the present invention, the alignment device inserted into the bone is connected at one end to the external fixator and the other end is exposed to prevent surface friction. In this case, malunion is prevented during bone healing.
United States patent document no. US20120209266A1, an application in the state of the art, with a priority date of 11.02.2011, discloses an external fixation system. The lower part is angularly aligned to enable the screw connection for the elbow in the said document. Three screws are used for the upper connection and the height and tension adjustment is provided by the moveable system. The invention of the said document provides an external fixation system for fixing the deformed bone externally. However, there is no alignment device for joining the fractured bone from the inside. In the invention of the present application, a bone alignment device is inserted into the medullary canal within the fractured bone to render the fractured fragments concentric. In addition to enabling concentric alignment of the bones, external fixation of the bone is ensured by means of the external fixator. In the present invention, the alignment device inserted into the bone is connected at one end to the external fixator and the other end is exposed to prevent surface friction. In this case, malunion is prevented during bone healing.
The external fixator having an alignment device disclosed in the present invention enables the deformed bone to be internally aligned and externally fixed. The alignment device in the external fixator having an alignment device enables the fractured bone fragments to be aligned concentrically while at the same time fixing the bone from outside of the bone. In the present invention, the alignment device inserted into the bone is connected at one end to the external fixator and the other end is exposed to prevent surface friction. In this case, malunion is prevented during bone healing.
In the state of the art, there is no explanation regarding the technical features and the technical effects provided by the invention of the present application. In the current applications, there is no external fixator having an alignment device which enables the fractured bones to be aligned concentrically with the device placed internally into the medullary canal and at the same time enables to fix the bone from outside of the bone, and prevents any deformity (malunion) during union of the bone by preventing surface friction within the bone.
Objects of the Invention
The object of the present invention is to provide an external fixator having an alignment device which enables to align the fractured bone fragments concentrically by means of the alignment device passed through the medullary canal within the fractured bone.
Another object of the present invention is to provide an external fixator having an alignment device that enables the fractured bone fragments, which are aligned internally by means of the alignment device, to be fixed from outside in a linear position.
A further object of the present invention is to provide an external fixator having an alignment device which prevents surface friction during internal alignment of the fractured bone fragments.
Another object of the present invention is to provide an external fixator having an alignment device which, while aligning the bone internally by means of the alignment device, also enables compression via distal locking.
A further object of the present invention is to provide an external fixator having an alignment device which, when concentrically aligning the bone from the inside, prevents rotation of the fractured bone fragments by locking from one end of the alignment device. Another object of the present invention is to provide an external fixator having an alignment device which, in addition to the internal alignment and the external fixation of the bone, prevents bone malunion.
Summary of the Invention
An external fixator having an alignment device, which is developed to fulfill the objects of the present invention and defined in Claim 1 and the other claims dependent thereon is generally comprised of an alignment device and an external fixator. The alignment device is placed in the medullary canal within the bone depending on the position and geometry of the bone. The alignment device is arranged in the medullary canal such that the center axes of the alignment holes coincide with the connection holes. The alignment device is inserted into the medullary canal and aligns the bone or the bone fragments concentrically. On the other hand, the schanz screws are inserted into the connection regions in the external fixator. After the alignment device is inserted into the medullary canal, the schanz screws, which are passed through the connection regions, are inserted from one end of the external fixator into the connection hole in the connection end of the alignment device. The schanz screws, which are passed through the connection holes of the alignment device, are fitted into the alignment hole in the bone. In this case, the alignment device connected to the bone and the external fixator at the connection end thereof enables the bone to be aligned concentrically and allows to adjust the length of the bone by being connected to the external fixator. The alignment device is inserted into the medullary canal from one end thereof together with the external fixator and fixed to the bone, thereby preventing the bone from rotating and getting deformed (crooked) during the alignment thereof.
Detailed Description of the Invention An external fixator having an alignment device developed to fulfill the objects of the present invention is illustrated in the accompanying figures wherein,
Figure 1 is a perspective view of the external fixator having an alignment device placed on the bone.
Figure 2 is a front view of the external fixator having an alignment device placed on the bone.
Figure 3 is a perspective exploded view of the external fixator having an alignment device.
Figure 4 is a perspective exploded view of the external fixator having an alignment device rom another angle.
Figure 5 is a perspective view of the external fixator having an alignment device. Figure 6 is an enlarged view of one end of the external fixator having an alignment device when placed on the bone.
Figure 7 is an enlarged view of one end of the external fixator having an alignment device when placed on the bone from another angle.
Figure 8 is an enlarged view of one end of the external fixator having an alignment device.
Figure 9 is an enlarged view of one end of the external fixator having an alignment device from another angle.
The components in the figures are given reference numbers as follows:
1. An external fixator having an alignment device
2. External fixator
2.1. Aligning bar
2.2. Connection region
2.3. Schanz screw
3. Alignment device
3.1. Inclined region
3.2. Free end 3.3. Connection end
3.3.1. Connection hole
A. Bone
B. Medullary canal
C. Alignment hole
An external fixator having an alignment device (1), which is used for therapeutic purposes in surgical operations of bone (A) fractures, and which enables to use external fixation and internal bone joining and alignment together during the treatment of the fractured bone (A), essentially comprising
at least one external fixator (2) which comprises at least one connection region (2.2) and at least one schanz screw (2.3), is mounted to the bone (A) through a plurality of connection regions (2.2) by means of schanz screws (2.3), and which enables the fractured bone (A) fragments, to which it is mounted, to be moved close to each other when the connection regions (2.2) are moved close to each other and the fractured bone fragments (A) to be moved away from each other when the connection regions (2.2) are moved away each other, at least one alignment device (3), which comprises at least one free end (3.2) and at least one connection end (3.3), and which
• is connected from its connection end (3.3) to a connection region (2.2) of the external fixator (2) by means of one or more schanz screws (2.3) such that its free end (3.2) is exposed,
• is inserted into the medullary canal (B) in the bone (A) to enable the fractured bone (A) fragments to be aligned concentrically,
• enables the bone (A) to be parallel with the external fixator (2) when inserted into the medullary canal (B).
The external fixator having an alignment device (1) which is the subject matter of the present application is used in surgical operations for treatment of fractured bones. The external fixator having an alignment device (1) enables the use of external fixation and internal bone (A) joining and alignment together during treatment of the fractured bone (A). The external fixator having an alignment device (1) comprises an external fixator (2) and an alignment device (3). The external fixator having an alignment device (1) enables external fixation of the bone (A) by means of the external fixator (2) and the internal alignment by means of the alignment device (3).
In one embodiment of the present invention, the external fixator (2) in the external fixator having an alignment device (1) enables fixation of fractured bone (A) fragments from the outside of the bone (A). The external fixator (2) comprises an aligning bar (2.1), a connection region (2.2) and a schanz screw (2.3). The external fixator (2) is mounted to the bone (A) through a plurality of connection regions (2.2) via schanz screws (2.3). The external fixator (2) enables the fractured bone (A) fragments, to which it is mounted, to be moved close to each other when the connection regions (2.2) are moved close to each other and the fractured bone fragments (A) to be moved away from each other when the connection regions (2.2) are moved away each other. The external fixator (2) is used in cases of fractured bones or bone lengthening processes. The aligning bar
(2.1) provided in the external fixator (2) is preferably in the geometric form of a bar, and one or more connection regions (2.2) are placed thereon. The connection regions (2.2) are preferably located on both ends of the aligning bar (2.1) to fix the two ends of the fractured bone (A) to each other. The connection regions (2.2) can move linearly on the aligning bar (2.1) and can be positioned with respect to the position of the fractured bone (A).
In one embodiment of the present invention, the external fixator (2) performs the fixation process as the schanz screws (2.3) passed through the connection regions
(2.2) are mounted to the bone (A) (Figures 1-2). In order to insert the schanz screws (2.3) into the bone (A), alignment holes (C) are drilled on the bone (A) at preferred positions. The alignment holes (C) are provided depending on the number of the schanz screws (2.3) to be inserted into the bone (A). The schanz screws (2.3) are fitted into the alignment holes (C) upon passing through the connection regions (2.2) in order to fix the fractured bone (A) at both ends thereof. The schanz screws (2.3), which are passed through the connection region (2.2) located at one end of the external fixator (2), are also passed through one end of the alignment device (3) that ensures the alignment of the bone (A) from the inside and are fixed to the bone (A) by (Figures 3-4).
In one embodiment of the present invention, the alignment device (3) in the external fixator having an alignment device (1) is passed through the fractured bone (A) to hold the fractured fragments together and align them. The alignment device (3) comprises an inclined region (3.1), a free end (3.2) and a connection end (3.3). The alignment device (3) is connected from its connection end (3.3) to a connection region (2.2) of the external fixator (2) by means of one or more schanz screws (2.3) such that its free end (3.2) is exposed. The alignment device (3) is inserted into the medullary canal (B) in the bone (A) to enable the fractured bone (A) fragments to be aligned concentrically. When inserted into the medullary canal (B), the alignment device (3) enables the bone (A) to be parallel with the external fixator (2). The alignment device (3) is preferably in a geometric form of a cylindrical bar. The geometric form of the alignment device (3) is adjusted to be suitable to the geometric form of the bone (A) to which it will be applied.
In one embodiment of the present invention, the alignment device (3) comprises an inclined region (3.1) and a free end (3.2). The alignment device (3) is used by being inserted into the medullary canal (B) of the bone (A). The inclined region (3.1) is formed depending on the geometric form of the bone (A) into which the alignment device (3) will be inserted. The inclined region (3.1) prevents the alignment device (3) from being subjected to surface friction when it is inserted into the medullary canal (B) of the bone (A). At the same time, the inclined region (3.1) has a similar geometry to the geometric form of the medullary canal (B). The alignment device (3) is inserted into the bone (A) from the connection end (3.3) via schanz screws (2.3). The schanz screws (2.3) are inserted into the alignment device (3) together with the bone (A) after the alignment device (3) is placed in the medullary canal (B). The alignment device (3) is connected at one end thereof to the bone (A) and the external fixator (2) via schanz screws (2.3). While the alignment device (3) is connected to the bone (A) and the external fixator (2) at its connection end (3.3), the free end (3.2) thereof remains free and exposed in the medullary canal (B).
In one embodiment of the present invention, the connection end (3.3) of the alignment device (3) is located at the inclined region (3.1) or the free end (3.2). The alignment device (3) is connected to the bone (A) and the external fixator (2) from the inclined region (3.1) or the free end (3.2) via the connection end (3.3). In this embodiment of the invention, the connection end (3.3) is located on the inclined region (3.1) (Figure 3). The region on which the connection end (3.3) will be located is preferably adjusted depending on the medullary canal (B) in which the alignment device (3) will be placed. The alignment device (3) is inserted into the medullary canal (B) to enable the fractured bone (A) fragments to be held together concentrically. The alignment device (3) attaches to the bone (A) within the medullary canal (B) and can remain fixed due to the friction of the surface. As a result of connection of the alignment device (3) from a single connection end
(3.3), the alignment device (3) can remain fixed in the medullary canal (B) and enables alignment of the fractured fragments of the bone (A). The connection end
(3.3) enables the alignment device (3) to be connected to the external fixator (2) and the bone (A). There is one or more connection holes (3.3.1) provided at the connection end (3.3). The connection hole (3.3.1) preferably has a circular geometric form. The connection hole (3.3.1) enables the schanz screws (2.3) to be passed through the alignment device (3). The schanz screws (2.3) that are passed through the connection holes (3.3.1) are fixed to the bone (A). The alignment device (3) is placed within the medullary canal (B) such that the connection holes (3.3.1) and the center axes of the alignment holes (C) in the bone (A) coincide with each other. The alignment device (3) enables the fractured bone (A) fragments to be aligned concentrically, while the external fixator (2) enables the distance between the bone (A) fragments to be adjusted thereby fixing the bone (A). The alignment device (3) is inserted into the medullary canal (B) from one end thereof together with the external fixator (2) and fixed to the bone (A), thereby preventing the bone (A) from rotating and getting deformed (crooked) during the alignment thereof.
Use of the external fixator having an alignment device (1) provided in this embodiment of the invention is performed as follows: The alignment device (3) is placed in the medullary canal (B) within the bone (A) depending on the position and geometry of the bone (A). The alignment device (3) is arranged in the medullary canal (B) such that the center axes of the alignment holes (C) coincide with the connection holes (3.3.1). The alignment device (3) is inserted into the medullary canal (B) and aligns the bone (A) or the bone (A) fragments concentrically. On the other hand, the schanz screws (2.3) are inserted into the connection regions (2.2) in the external fixator (2). After the alignment device (3) is inserted into the medullary canal (B), the schanz screws (2.3), which are passed through the connection regions (2.2), are inserted from one end of the external fixator (2) into the connection hole (3.3.1) at the connection end (3.3) of the alignment device (3). The schanz screws (2.3), which are passed through the connection holes (3.3.1) of the alignment device (3), are fitted into the alignment hole (C) in the bone (A). In this case, the alignment device (3) connected to the bone (A) and the external fixator (2) at the connection end (3.3) thereof enables the bone (A) to be aligned concentrically and allows to adjust the length of the bone (A) by being connected to the external fixator (2). The alignment device (3) is inserted into the medullary canal (B) from one end thereof together with the external fixator (2) and fixed to the bone (A), thereby preventing the bone (A) from rotating and getting deformed (crooked) during the alignment thereof.

Claims

1. An external fixator having an alignment device (1), which is used for therapeutic purposes in surgical operations of bone (A) fractures, and which enables to use external fixation and internal bone joining and alignment together during the treatment of the fractured bone (A), essentially comprising
at least one external fixator (2), which comprises at least one connection region (2.2) and at least one schanz screw (2.3), is mounted to the bone (A) through a plurality of connection regions (2.2) by means of schanz screws (2.3), and enables the fractured bone (A) fragments, to which it is mounted, to be moved close to each other when the connection regions (2.2) are moved close to each other and the fractured bone fragments (A) to be moved away from each other when the connection regions (2.2) are moved away each other; and characterized by
at least one alignment device (3), which comprises at least one free end (3.2) and at least one connection end (3.3), and which
• is connected from its connection end (3.3) to a connection region (2.2) of the external fixator (2) by means of one or more schanz screws (2.3) such that its free end (3.2) is exposed,
• is inserted into the medullary canal (B) in the bone (A) to enable the fractured bone (A) fragments to be aligned concentrically,
• enables the bone (A) to be parallel with the external fixator (2) when inserted into the medullary canal (B).
2. External fixator having an alignment device (1) according to Claim 1, characterized by the alignment device (3) which comprises an inclined region (3.1) and is connected from its connection end (3.3) to a connection region (2.2) of the external fixator (2) by means of one or more schanz screws (2.3) such that its free end (3.2) is exposed.
3. External fixator having an alignment device (1) according to Claim 1, characterized by the alignment device (3), whose geometric form is adjusted to be suitable to the geometric form of the bone (A) to which it will be applied, and which comprises an inclined region (3.1) and a free end (3.2).
4. External fixator having an alignment device (1) according to Claim 2, characterized by the inclined region (3.1), which is formed depending on the geometric from of the bone (A) in which the alignment device (3) will be placed, and which prevents the alignment device (3) from being subjected to surface friction when placed into the medullary canal (B) of the bone (A).
5. External fixator having an alignment device (1) according to Claim 1, characterized by the alignment device (3) which is inserted into the bone (A) from its connection end (3.3) via schanz screws (2.3), and whose free end
(3.2) remains exposed inside the medullary canal (B) when it is being connected to the bone (A) and the external fixator (2) from its connection end
(3.3).
6. External fixator having an alignment device (1) according to Claim 1, characterized by the connection end (3.3) which enables the alignment device (3) to be connected to the bone (A) and the external fixator (2) from the inclined region (3.1) or the free end (3.2).
7. External fixator having an alignment device (1) according to Claim 1, characterized by the connection end (3.3), which is located at the inclined region (3.1) of the alignment device (3), and the region at which it will be located is adjusted depending on the medullary canal (B) in which the alignment device (3) will be placed.
8. External fixator having an alignment device (1) according to Claim 1, characterized by the alignment device (3), which attaches to the bone (A) within the medullary canal (B) and can remain fixed due to the friction of the surface.
9. External fixator having an alignment device (1) according to Claim 1, characterized by the alignment device (3), which, as a result of connection thereof from a single connection end (3.3), can remain fixed in the medullary canal (B) and enables alignment of the fractured fragments of the bone (A).
10. External fixator having an alignment device (1) according to Claim 1, characterized by the connection end (3.3), which includes one or more connection holes (3.3.1) thereon, and enables the alignment device (3) to be connected to the external fixator (2) and the bone (A).
11. External fixator having an alignment device (1) according to Claim 10, characterized by the connection hole (3.3.1) which enables insertion of the schanz screws (2.3) to the alignment device (3).
12. External fixator having an alignment device (1) according to Claim 1, characterized by the alignment device (3), which is inserted into the medullary canal (B) from one end thereof together with the external fixator (2) and fixed to the bone (A), thereby preventing the bone (A) from rotating and getting deformed (crooked) during the alignment thereof.
EP19846126.1A 2018-07-09 2019-07-05 An external fixator having an alignment device Pending EP3820389A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2018/09776A TR201809776A2 (en) 2018-07-09 2018-07-09 EXTERNAL FIXER WITH ALIGNMENT APPARATUS
PCT/TR2019/050530 WO2020032891A2 (en) 2018-07-09 2019-07-05 An external fixator having an alignment device

Publications (2)

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EP3820389A2 true EP3820389A2 (en) 2021-05-19
EP3820389A4 EP3820389A4 (en) 2022-03-23

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Publication number Priority date Publication date Assignee Title
CH668692A5 (en) * 1984-11-30 1989-01-31 Synthes Ag Bone pin alignment instrument - has lockable head pivoting in all directions
DE4328015A1 (en) * 1993-08-20 1995-02-23 Alumedica Aluminium Bearbeit Device for treating bones
PT809472E (en) * 1995-10-21 2002-08-30 Pennig Dietmar CAVITY OF INTRAMEDULAR CAVITY FOR THE STRETCHING OF FEMUR
US6706046B2 (en) * 2000-02-01 2004-03-16 Hand Innovations, Inc. Intramedullary fixation device for metaphyseal long bone fractures and methods of using the same
SI24067A (en) * 2012-05-23 2013-11-29 dr. Vane AntoliÄŤ Improved modular side device with an intramedular pin for guiding a bone during its lengthening
CN106859757B (en) * 2015-12-14 2018-07-06 重庆医科大学附属永川医院 A kind of bone handling device for shin bone large segmental bone defect

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WO2020032891A2 (en) 2020-02-13
EP3820389A4 (en) 2022-03-23
TR201809776A2 (en) 2018-08-27

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