WO2014163591A1 - Computer programmable circular external fixator system - Google Patents

Computer programmable circular external fixator system Download PDF

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Publication number
WO2014163591A1
WO2014163591A1 PCT/TR2013/000125 TR2013000125W WO2014163591A1 WO 2014163591 A1 WO2014163591 A1 WO 2014163591A1 TR 2013000125 W TR2013000125 W TR 2013000125W WO 2014163591 A1 WO2014163591 A1 WO 2014163591A1
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WO
WIPO (PCT)
Prior art keywords
ring
external fixator
invention according
sled
circular external
Prior art date
Application number
PCT/TR2013/000125
Other languages
French (fr)
Inventor
Ahmet HARMA
Original Assignee
Harma Ahmet
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 Harma Ahmet filed Critical Harma Ahmet
Priority to PCT/TR2013/000125 priority Critical patent/WO2014163591A1/en
Publication of WO2014163591A1 publication Critical patent/WO2014163591A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/60Surgical 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
    • A61B17/62Ring frames, i.e. devices extending around the bones to be positioned
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/60Surgical 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
    • A61B17/66Alignment, compression or distraction mechanisms

Definitions

  • the invention is a circular external fixator system, which needs less measurement parameters, and can function via softwares that perform measurements and calculations based on the deformity planning method as well as being applicable without any need for softwares by any orthopedic surgeon who have a basic external fixator training.
  • Fixators are the systems wherein wires or pins trans passing bones are connected to an external rigid support. Fixators can be categorized into different groups according to this rigid support's geometry, location or design of its elements.
  • external fixators Devices which implement fragment control and ensure fixation with the help of studs, screws or wires applied externally on bone, by being connected with metal, alloy or composite devices outside, are named external fixators.
  • External fixators are a common treatment method, used in many orthopedic surgical procedures like extremity lengthening, fracture treatment and in cases wherein a bone part should be taken out due to infection or tumor.
  • Today, many orthopedics and traumatology clinics around the world is treating musculosceletal injuries, bone-soft tissue defects, lengthening or shortening procedures and deformity corrections with external fixators. It is possible to make angular and length corrections following the construction of frame with external fixators.
  • Deformity corrections and lengthening procedures can be conducted via computer software in external fixator systems. Calculations are performed and corrections are controlled via computer software that is continuously updated. Since all the plans and calculations may possibly be changed at any stage of the treatment, it is tried to make the new intended correction without the need for any amendments to the external fixators on the patient.
  • TSF Taylor Spatial Frame®
  • Patents named as "orthopedic fixation plate” with European patent number EP 0 948 292 and “orthopedic fixation device” with American patent number 5,702,389 are basically Taylor Spatial Frame® fixators and possess the parallel platform mechanism Stewart Platform with 6 degree of freedom (hexapod array).And the mathematical calculations are performed via computer software based on projective geometry.
  • Taylor Spatial Frame ® consists of two circular ring platforms, one kinetic and one static, connected with each other via 6 rods with changeable lengths, each of which can move with universal hinges on both ends.
  • the software used by the system defines the bone position inside the fixator to the platform by implementing the spatial analysis of guide points measured on radiograms, and ensures the bone parts mobilized by the platform are shaped into the desired and program pre-defined form eventually.
  • Adam Frame ® Another system possessing softwares that perform measurement and calculation based on deformity planning method is Adam Frame ®, which is an external fixator developed with perpendicularly principle (octopod) known also as MimarSinan Platform.
  • octopod perpendicularly principle
  • Any surgeon requires two radiograms on front-back and side planes for necessary measurements while performing the treatment during operation. Measurements on these films can vary according to circumstances such as the distance of X-ray source to the application, and its placement in a way that it can perform shooting perpendicular to the reference ring. Variations can occur between the values defined to software and desired final values in these systems, in which error margins emerge unavoidably. Ultimately, these differences cause such cases as improper implementation of treatment and correction at the end of the program.
  • the invention bringing solutions to the current problems of the state of art, functions with a simpler motion logic compared to hexapod and octopod platforms thanks to the innovation it has brought to ring platforms and rod connection mechanisms.
  • the invention is a circular external fixator system, which needs less measurement parameters, and can function via softwares that perform measurements and calculations based on the deformity planning method as well as being easily applicable without any need for softwares by orthopedic surgeons who have basic external fixator training. Musculoskeletal injuries, bone-soft tissue defects, lengthening and shortening operations, deformity corrections are performed using the invention.
  • the invention has a structure which is functional, light, stable, radiolucent, easily applicable, and easily usable by the patient, with a wide range of mobility.
  • the obtainment of parameters necessary for the software is possible during the operation.
  • Spatial guide point parameters required to be defined for correction process can also be obtained during the operation, depending on the software feature to be used.
  • a faster and more accurate implementation of correction process by the surgeon is facilitated.
  • the invention is an easy to use system with no absolute requirement for repetitional programs, enabling the surgeon to practically repair the remaining shape defects at the end of the program.
  • the number of the radiograms required for bone correction is decreased, protecting the patient from radiation and decreasing the processes for the surgeon.
  • treatment process is implemented via softwares depending on the system used during treatment process and correction operation is made according to program measurements and adjusted day numbers determined.
  • surgeon is obliged to depend on the software and correction implementation prescribed by the program.
  • Implementation of this operation is hard for both hexapod and octopod systems. Because, it is required to make changes in the placement of other rods for the movement of a rod in right and left directions; and this, whilst decreasing the precision of the correction implementation, causes a difficult process for both the surgeon and the patient.
  • the invention enabling simple rod movements depending on the correction operation thanks to the sled mechanism, both facilitates operations for the surgeon and decreases the dependence on softwares during treatment process.
  • the software on the invention can implement the operations with less (4 or 5) parameter usage with the help of measurements obtained ruing operation, whilst current systems require 6 to 8 parameters for decisionmaking of softwares used.
  • the invention on the other hand, possesses high end stability features thanks to the lock mechanism of the correction rods between circular ring platforms. Thanks to the rigid fixation of bone in its optimum position after the correction completed, the invention ensures the maintenance of the bone's position.
  • the invention provides rigid stability of the bone during latency period (generally 10 days following operation and before gradual correction started) and in the necessary period in which gradual correction is completed but osseous union is absent (approximately twelve weeks).
  • the invention provides advantages like reducing complications in early and late period whilst enabling early rehabilitation thanks to a stable anatomical fixation.
  • connection mechanism of the rods of the invention there is two rotation centers while other current systems have only one since they use universal hinges on the both ends of their connection rods. Thus, the movement capability of this new system increases.
  • unique locking mechanisms of the special connection rods of the invention provides rigid stability at the osteotomy or fracture level in any desired position.
  • the invention thanks to its structure, is capable of creating movements in all planes
  • Correction rods and rings of the current invention can be manufactured in small or very small diameters for pediatric usage.
  • Figure 1 View of computer programmable circular external fixator system
  • Figure 2 View of the sled connection element
  • Figure 3 Top view of mobile ring on the invention
  • Figure 4 Top view of reference ring on the invention
  • Figure 5 Base view of sled system on the invention
  • Figure 6 View of mobile ring and first rotation element installed with sled system
  • Figure 7 View of reference ring and first rotation element installed with connection bolt
  • Figure 8 View of pin/wire holder chin apparatus on the invention
  • Figure 10 View of application of the position ruler apparatus to bone using the invention
  • the invention is a computer programmable circular external fixator system, which is used for the correction and treatment of bone (K) deformities and complex fractures in orthopedic surgery; it can be applied by orthopedic surgeons having basic external fixator training without any requirement for a software, and can also function via softwares that perform measurement and calculation based on deformity planning method; providing fixed bone (K) parts with controlled movement, the invention is characterized by a circular mobile ring (2) which have four tangential sled systems (4) existing on the four cardinal directions enabling the movement of correction rod's (3) connection mechanism and also have mobile ring holes (201) between the sled systems (4), a circular reference ring (1) edged by four sides tangentially on the mobile ring's (2) sled system (4) projections and circumferentially placed multiple reference ring holes (101 ) on it and, four correction rods (3) which can lengthen according to application method of fixator, with multiaxial movement capability and is fixed by locking mechanisms.
  • the softwares used by the computer programmable circular external fixator system performs the spatial analysis of 4 or 5 parameters obtained during operation or the measurements obtained from the digital radiograms, and defines the position of bone (K) parts existing in the inner spatial space of the frame to reference ring (1 ), mobile ring (2) and correction rods (3). Finally the bone (K) part connected to the mobile ring (2) is mobilized according to software printout and alignment of the bone (K) can be changed to any desired position.
  • reference ring (1) and the mobile ring (2) on the invention can be manufactured with titanium, composite, aluminum or carbon fiber materials, preferably composite and aluminum have been used.
  • the reference ring (1) and the mobile ring (2) are manufactured from aluminum and composite materials, they are durable against fatigue, and make the platform light. Moreover, they do not cause any problem for bone (K) or fracture imagings with X-Ray or MR (magnetic resonance).
  • the reference ring (1) and the mobile ring (2) on the invention can be manufactured in various diameters, depending on adult or pediatric usage.
  • Correction rods (3) can be manufactured in different dimensions for pediatric applications.
  • Pin/wire holder chin apparatus (9) in the system can be manufactured in different dimensions for pediatric applications.
  • Correction rods (3), reference ring (1) and mobile ring (2) of the invention provides rotation, angulation, translation, and compression and distraction movements and with the
  • the invention carries out this process having with two centers of rotation.
  • the first center of rotation is on the first axis (FA) extending on the first rotation element (301) that provides to rotate of first rotation element (301) around it.
  • correction rods (3) can rotate around the first axis (FA).
  • the other center of the rotation settled on the second axis (SA) which is perpendicular to the first axis (FA). This rotation center ensures correction rod (3) can rotate around the second axis (SA).
  • Reference ring holes (101) and mobile ring holes (201) are used for fixation of wire, pin or screw over the rings via special connection apparatus.
  • a special pin/wire holder chin apparatus (9) can be used which has two tumblers (901) that grasping the sled connection elements (6) over its channel (11).
  • Number of holes (101 ,201) can vary according to reference ring (1) and mobile ring (2) dimensions to be used.
  • Sled system (4) enabling minimal motion changes of rod connections, comprises threaded rod (5) and a sled connection element (6) on threaded rod (5) and correction rods (3) function together with sled systems (4).
  • the sled connection elements (6) comprise a correction rod channel (601), and a threaded rod channel (602) and set-screw hole (603). Fixation of first rotation element (301) to sled system (4) can be accomplished by placing it in the correction rod channel (601) on the sled connection element (6). Rotational movement of first rotation element (301), can be blocked via a set screw (604)over set-screw hole (603). Set screw (604) function is implemented via an Allen screw or a hexagonal edged screwdriver. Provided by this and second rotation element's (302) locking mechanisms, no kinetic part remains with the correction rod (3) and thus, a stable fixation is performed.
  • a set-screw hole (603) is present just under the set screw (604) of the sled connection element (6).
  • the same mechanism is present on the ring connection bolt (8) in which a set screw (802) is present in the slot (801) of ring connection bolt (8) thus tightening of this bolt (8) helps to the secure fixation of the first rotation element (301) while in untightened position it maintains the breaking loose of the first rotation element (301) from the ring connection bolt (8).
  • Four correction rods (3) are connected to the reference ring (1) via a ring connection bolt (8).
  • Fixation of correction rod (3) is accomplished by placement of first rotation element (301), to the channel on the ring connection bolt (8) and locking of the connection is performed by either screw nut (10) or set screw (802) placed in the slot (801) of the ring connection bolt (8).
  • Set screw (802) placing in the slot (801) of the ring connection bolt (8) prevents breaking loose of the first rotation element (301) and when tightening more it helps to lock the rotational movement of the first rotation element (301).
  • channels (11) wherein pin/wire holder chin apparatus (9) are attached, extending at the same direction with sled system (4).
  • Channel (11) enables pin/wire holder chin apparatus (9) fixation with its depth and structure.
  • Channels (11) are cut at opposite locations on mobile ring (2) upper and lower surfaces.
  • Pin/wire holder chin apparatus (9) enables bone (K) fixation with wire, pin or screw when there is a need to fix the bone (K) by crossing the sled system (4).
  • Pin/wire holder chin apparatus (9) has a compression screw (903) which enables its fixation on the channels via tightening the tumblers (901) on its location. Wires or screws that placed in to the pin/wire connection hole (902) are fixed on the pin/wire holder chin apparatus (9) via tightening the set screw (904).
  • the invention uses compass logic and measurements to determine the spatial location of bone (K) between the mobile ring (2) and reference rings (1).
  • North (N), south (S), east (E) and west (W) cardinal points are used to specify sled systems (4) and north-east (NE), northwest (NW), south-east (SE) and south-west (SW) intercardinal points, to specify hole
  • Measuring lines (13) are used on the mobile ring (2) to specify the location of the sled connection element (6) which provides correction rod (3) to move on horizontal axis in the invention.
  • Midpoint of the sled systems (4) is specified by the number zero and measuring lines (13) with increment on both directions are specified with positive and negative numeric values.
  • Position ruler apparatus (stylus) (12) consisting vertical ruler (121) and horizontal ruler (122) is temporarily installed on the holes (101 ,201), which are on the invention to define the coordinates of the bone existing in the spatial space between reference ring (1) and the mobile ring (2).
  • positions of bone (K) existing in the spatial space between the mobile ring (2) and reference ring (1) are obtained via manual measuring.
  • Provisional insertion of the position ruler apparatus (12) in to the holes (101 ,201) is maintained by the transient connection tip (123) of the position ruler apparatus (12) which is fixed with a nut.
  • Horizontal ruler (122) on the position ruler apparatus (12) makes forward - backward motion which measures the distance of bone (K) to the ring.
  • Horizontal ruler (122) also moves up and down that makes the distance measurement possible between the bone (K) ends and the ring level.
  • a second positioning is performed ideally perpendicular (90°) to the first positioning point, For example, SW and NE cardinals are in a perpendicular position when the position ruler apparatus (12) is mounted into a hole (201) in SE direction.
  • Placement of the second position ruler apparatus (12) is performed into the hole (201) in the appropriate region (in case neurovascular structures are at risk of damaged by horizontal ruler (122), region is referred not appropriate). Measurements obtained via vertical ruler (121) and horizontal ruler (122) is recorded to the software application.
  • image intensifier is used during operation.
  • Image intensifier device provides the instant observation of the images with a monitor.
  • Image intensifier monitoring shall not be necessary in case of visible bone (K) ends or osteotomy line is present due to a traumatic open wound or any surgical incision.
  • measurements with position ruler apparatus (12) can be done directly inserting the horizontal ruler's (122) tip on the bone(K).
  • 2mm diameter horizontal ruler (122) is similar with Kirschner wire which is commonly used in orthopedic practice four wire penetrations for each bone (K) segment during measurements, is not extremely interventional.
  • the software used by the invention creates ultimate correcting plan in the desired alignment.
  • This invention can make deformity corrections in two ways which both methods have its original softwares.
  • the above mentioned first method uses manually obtained parameters via special position ruler apparatus (12). More accurate coordinate parameters can be obtained by this method since all measurements are done on the patient during surgery.
  • Other method uses post-operative digital radiographic images which are uploaded to the computer.
  • coordinates of bone (K) parts and reference ring (1) and the mobile ring (2) are defined by signing the reference points on the digital images.
  • Software than define the spatial position of the bone (K) parts, reference ring (1) and mobile ring (2) virtually, and prepares an ultimate correction program for the desired alignment.
  • the most important and unique feature of this invention is its simple and easily understandable working logic. Accordingly any orthopedic surgeon having basic external fixator training can use this device without necessitating any software and can able to correct even complex deformities manually.

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Abstract

The invention is a computer programmable circular external fixator system, used in orthopedic surgery for bone (K) deformity and complex fracture corrections and treatment, functioning with a simple motion logic with less need for measurement parameters, which can function via software's that can perform measurement and computation based on deformity planning method, and as well manually applicable by orthopedic surgeons with basic circular fixator training, with no software requirement and is characterized by a circular mobile ring (2) which have four tangential sled systems (4) existing on the four cardinal directions enabling the movement of correction rod's (3) connection mechanism and also have mobile ring holes (101) between the sled systems (4), rigid circular reference ring (1) edged by four sides tangentially on the mobile ring's (2) sled system (4) projections and circumferentially placed multiple reference ring holes (201) on it, four correction rods (3) which can stretch according to application method of fixator, with a multi axial movement feature and fixed connection with locking mechanisms.

Description

SPECIFICATION
Computer Programmable Circular External Fixator System Technical Field
Functioning with four correction rods and a simpler motion logic compared to hexapod and octopod platforms, thanks to the innovation it has brought to circular platforms and rod connection mechanisms, the invention is a circular external fixator system, which needs less measurement parameters, and can function via softwares that perform measurements and calculations based on the deformity planning method as well as being applicable without any need for softwares by any orthopedic surgeon who have a basic external fixator training.
State of Art
Engineering branches are required in various fields of medical sciences and dentistry, for device manufacturing and development of existing devices with an experimental approach, new osteosynthesis materials or external fixators and their designs, control and improvement of current osteosynthesis materials or external fixators, implementation of difficult or impossible-to-internally-perform tests under laboratory conditions or in virtual environment, theoretical approach for modeling complex structures, development of imaging and signaling processes.
In case of fracture, bone requires an additional support to heal at the right position until the completion of healing. This support is provided via plasters-braces-bandages, internal fixators and external fixators during the healing process. Fixators are the systems wherein wires or pins trans passing bones are connected to an external rigid support. Fixators can be categorized into different groups according to this rigid support's geometry, location or design of its elements.
Devices which implement fragment control and ensure fixation with the help of studs, screws or wires applied externally on bone, by being connected with metal, alloy or composite devices outside, are named external fixators.
External fixators are a common treatment method, used in many orthopedic surgical procedures like extremity lengthening, fracture treatment and in cases wherein a bone part should be taken out due to infection or tumor. Today, many orthopedics and traumatology clinics around the world is treating musculosceletal injuries, bone-soft tissue defects, lengthening or shortening procedures and deformity corrections with external fixators. It is possible to make angular and length corrections following the construction of frame with external fixators.
Deformity corrections and lengthening procedures can be conducted via computer software in external fixator systems. Calculations are performed and corrections are controlled via computer software that is continuously updated. Since all the plans and calculations may possibly be changed at any stage of the treatment, it is tried to make the new intended correction without the need for any amendments to the external fixators on the patient.
Today, the primary external fixator used originally and up to date for this purpose is the fixator known as Taylor Spatial Frame® (TSF).
Patents named as "orthopedic fixation plate" with European patent number EP 0 948 292 and "orthopedic fixation device" with American patent number 5,702,389 are basically Taylor Spatial Frame® fixators and possess the parallel platform mechanism Stewart Platform with 6 degree of freedom (hexapod array).And the mathematical calculations are performed via computer software based on projective geometry.
Taylor Spatial Frame ® consists of two circular ring platforms, one kinetic and one static, connected with each other via 6 rods with changeable lengths, each of which can move with universal hinges on both ends. The software used by the system defines the bone position inside the fixator to the platform by implementing the spatial analysis of guide points measured on radiograms, and ensures the bone parts mobilized by the platform are shaped into the desired and program pre-defined form eventually.
Another system possessing softwares that perform measurement and calculation based on deformity planning method is Adam Frame ®, which is an external fixator developed with perpendicularly principle (octopod) known also as MimarSinan Platform. In Adam
Frame® system too, the connections between upper and lower rings are provided via kinetic rods, the lengths of which can change, as in Taylor Spatial Frame ® system. Its difference from the Taylor Spatial Frame ® is its quality of functioning with 8 connection rods, 4 being axial and 4 diagonal. For this reason, software and parameters used by this system also different. This system can function with less parameter compared to Taylor Spatial Frame ®.
Except for these systems, there are also systems such as Spider Frame ®, Smart Frame ®, TL-HEX ® on the market, using hexapod configuration, i.e., Stewart Platform, which are however intended to be innovated by changing connection rod features. In spite of the fact that the types, multi axial edge hinges or ring adherence methods of the connection rods have been changed, basically, all hexapod systems function with Stewart platform logic. For the connections of the rods, which are used in the corrections of deformities and implement the task of connecting upper and lower rings, to the rings, some sorts of hinges are used on the edges of the rods. In addition to the use of hinges that provide action by connecting two pieces over a pin, which are mostly known as 'universal hinges,' there are also hinges that provide capability of action by using pins between two pieces and a block structure.
However, mechanisms that use rods with universal hinge, can provide a maximum of 90 degrees of motion capability to the rings they are connected, and the fixation of the connected parts is impossible at the end of the motion.
The most important matter of success of these current systems during treatment process is surgeon's sufficient fund of knowledge related to the working mechanism of system.
Projection for plane of movement of bone parts mobilized by the rings with these extremely complex motion systems (either hexapod or octopod) and determination in that way press even the most experienced surgeons. Therefore, the dependence of the results that will be obtained from the corrections to be made via these systems on the skill and knowledge of surgeon and the results of the software is quite high.
Any surgeon requires two radiograms on front-back and side planes for necessary measurements while performing the treatment during operation. Measurements on these films can vary according to circumstances such as the distance of X-ray source to the application, and its placement in a way that it can perform shooting perpendicular to the reference ring. Variations can occur between the values defined to software and desired final values in these systems, in which error margins emerge unavoidably. Ultimately, these differences cause such cases as improper implementation of treatment and correction at the end of the program.
Even the surgeons, who are highly experienced at minimal inconsistencies and have a command of motion logic of these systems, have difficulties in performing manual correction without a new programming even in minimal inconsistencies. Mostly, reshootings, measurements and a new correction programming task are required. Each radiogram causes patient's exposure to radiation, which can be harmful for health.
The invention, bringing solutions to the current problems of the state of art, functions with a simpler motion logic compared to hexapod and octopod platforms thanks to the innovation it has brought to ring platforms and rod connection mechanisms. The invention is a circular external fixator system, which needs less measurement parameters, and can function via softwares that perform measurements and calculations based on the deformity planning method as well as being easily applicable without any need for softwares by orthopedic surgeons who have basic external fixator training. Musculoskeletal injuries, bone-soft tissue defects, lengthening and shortening operations, deformity corrections are performed using the invention.
The invention has a structure which is functional, light, stable, radiolucent, easily applicable, and easily usable by the patient, with a wide range of mobility.
Thanks to the invention, the obtainment of parameters necessary for the software is possible during the operation. Spatial guide point parameters required to be defined for correction process can also be obtained during the operation, depending on the software feature to be used. Thus, a faster and more accurate implementation of correction process by the surgeon is facilitated.
Being suitable for every orthopedic surgeon, the invention is an easy to use system with no absolute requirement for repetitional programs, enabling the surgeon to practically repair the remaining shape defects at the end of the program. Thus, the number of the radiograms required for bone correction is decreased, protecting the patient from radiation and decreasing the processes for the surgeon.
In the current systems, treatment process is implemented via softwares depending on the system used during treatment process and correction operation is made according to program measurements and adjusted day numbers determined. In these treatment systems, surgeon is obliged to depend on the software and correction implementation prescribed by the program. Implementation of this operation is hard for both hexapod and octopod systems. Because, it is required to make changes in the placement of other rods for the movement of a rod in right and left directions; and this, whilst decreasing the precision of the correction implementation, causes a difficult process for both the surgeon and the patient.
The invention, enabling simple rod movements depending on the correction operation thanks to the sled mechanism, both facilitates operations for the surgeon and decreases the dependence on softwares during treatment process. The software on the invention can implement the operations with less (4 or 5) parameter usage with the help of measurements obtained ruing operation, whilst current systems require 6 to 8 parameters for decisionmaking of softwares used.
Current systems do not always enable a stable anatomical fixation, and the instability problem in these systems has not been solved. The invention, on the other hand, possesses high end stability features thanks to the lock mechanism of the correction rods between circular ring platforms. Thanks to the rigid fixation of bone in its optimum position after the correction completed, the invention ensures the maintenance of the bone's position.
Providing stability and elimination of the friction at the osteotomy or fracture level is a must for the union of bone. The invention, thus, provides rigid stability of the bone during latency period (generally 10 days following operation and before gradual correction started) and in the necessary period in which gradual correction is completed but osseous union is absent (approximately twelve weeks).
Thus, the invention provides advantages like reducing complications in early and late period whilst enabling early rehabilitation thanks to a stable anatomical fixation.
In the connection mechanism of the rods of the invention, there is two rotation centers while other current systems have only one since they use universal hinges on the both ends of their connection rods. Thus, the movement capability of this new system increases. In the other hand the unique locking mechanisms of the special connection rods of the invention provides rigid stability at the osteotomy or fracture level in any desired position.
The invention, thanks to its structure, is capable of creating movements in all planes;
translation, angulation (on front-back and right-left planes), rotation (internal or external) and vertical movements (shortening and lengthening), and the combination of all. It also enables controlled dynamization when necessary. All combinations of these complex movement planes can be easily maintained with the simple motion mechanism of mobile ring, regardless of the software.
Correction rods and rings of the current invention can be manufactured in small or very small diameters for pediatric usage.
Brief Description of Graphics
Figure 1 : View of computer programmable circular external fixator system Figure 2: View of the sled connection element Figure 3: Top view of mobile ring on the invention Figure 4: Top view of reference ring on the invention Figure 5: Base view of sled system on the invention
Figure 6: View of mobile ring and first rotation element installed with sled system Figure 7: View of reference ring and first rotation element installed with connection bolt
Figure 8: View of pin/wire holder chin apparatus on the invention
Figure 9: View of position ruler apparatus application on the invention
Figure 10: View of application of the position ruler apparatus to bone using the invention
Figure 11: View of set-screws on the invention
Description of Reference Numbers
1. Reference ring
101. Reference ring holes
2. Mobile ring
201. Mobile ring holes
3. Correction rod
301. First rotation element
302. Second rotation element
4. Sled system
5. Threaded rod
6. Sled connection element
601. Correction rod channel
602. Threaded rod channel
603. Set-screw hole
604. Set-screw
7. Hexagonal screwhead
8. Ring connection bolt
801. Slot
802. Set-screw
9. Pin/wire holder chin apparatus
901. Tumbler
902. Pin/wire hole
903. Compression screw
904. Set-screw
10. Screw nut
11. Channel
12. Position Ruler Apparatus
121. Vertical ruler 122. Horizontal ruler
123. Transient connection tip
13. Measuring lines
14. Grading lines
K. Bone
FA. First Axis
SA. Second Axis
Description of Invention
The invention is a computer programmable circular external fixator system, which is used for the correction and treatment of bone (K) deformities and complex fractures in orthopedic surgery; it can be applied by orthopedic surgeons having basic external fixator training without any requirement for a software, and can also function via softwares that perform measurement and calculation based on deformity planning method; providing fixed bone (K) parts with controlled movement, the invention is characterized by a circular mobile ring (2) which have four tangential sled systems (4) existing on the four cardinal directions enabling the movement of correction rod's (3) connection mechanism and also have mobile ring holes (201) between the sled systems (4), a circular reference ring (1) edged by four sides tangentially on the mobile ring's (2) sled system (4) projections and circumferentially placed multiple reference ring holes (101 ) on it and, four correction rods (3) which can lengthen according to application method of fixator, with multiaxial movement capability and is fixed by locking mechanisms.
The softwares used by the computer programmable circular external fixator system performs the spatial analysis of 4 or 5 parameters obtained during operation or the measurements obtained from the digital radiograms, and defines the position of bone (K) parts existing in the inner spatial space of the frame to reference ring (1 ), mobile ring (2) and correction rods (3). Finally the bone (K) part connected to the mobile ring (2) is mobilized according to software printout and alignment of the bone (K) can be changed to any desired position.
While the reference ring (1) and the mobile ring (2) on the invention can be manufactured with titanium, composite, aluminum or carbon fiber materials, preferably composite and aluminum have been used.
Since the reference ring (1) and the mobile ring (2) are manufactured from aluminum and composite materials, they are durable against fatigue, and make the platform light. Moreover, they do not cause any problem for bone (K) or fracture imagings with X-Ray or MR (magnetic resonance). The reference ring (1) and the mobile ring (2) on the invention can be manufactured in various diameters, depending on adult or pediatric usage.
Correction rods (3) can be manufactured in different dimensions for pediatric applications. Pin/wire holder chin apparatus (9) in the system can be manufactured in different dimensions for pediatric applications.
Correction rods (3), reference ring (1) and mobile ring (2) of the invention provides rotation, angulation, translation, and compression and distraction movements and with the
mobilization of bone (K) parts by these movements any desired alignment of bone (K) parts became possible. The invention carries out this process having with two centers of rotation.The first center of rotation is on the first axis (FA) extending on the first rotation element (301) that provides to rotate of first rotation element (301) around it. Thus, correction rods (3) can rotate around the first axis (FA). The other center of the rotation settled on the second axis (SA) which is perpendicular to the first axis (FA).This rotation center ensures correction rod (3) can rotate around the second axis (SA).
Reference ring holes (101) and mobile ring holes (201) are used for fixation of wire, pin or screw over the rings via special connection apparatus. On the reference ring (1) there are many holes (101) existing circumferentially, for this purpose while on the mobile ring (2) number of holes (201) are limited. When there is a need for using a fixation pin, wire or screw crossing the sled connection elements (6) a special pin/wire holder chin apparatus (9) can be used which has two tumblers (901) that grasping the sled connection elements (6) over its channel (11). Number of holes (101 ,201) can vary according to reference ring (1) and mobile ring (2) dimensions to be used.
The connection of mobile ring (2) with four correction rods (3) is provided with sled system (4). Sled system (4) enabling minimal motion changes of rod connections, comprises threaded rod (5) and a sled connection element (6) on threaded rod (5) and correction rods (3) function together with sled systems (4).
Horizontal movement of sled connection element (6) on threaded rod (5), is provided with rotation of hexagonal screwhead (7). Movement of hexagonal screwhead (7) can be accomplished by hand force or via wrench.
The sled connection elements (6) comprise a correction rod channel (601), and a threaded rod channel (602) and set-screw hole (603). Fixation of first rotation element (301) to sled system (4) can be accomplished by placing it in the correction rod channel (601) on the sled connection element (6). Rotational movement of first rotation element (301), can be blocked via a set screw (604)over set-screw hole (603). Set screw (604) function is implemented via an Allen screw or a hexagonal edged screwdriver. Provided by this and second rotation element's (302) locking mechanisms, no kinetic part remains with the correction rod (3) and thus, a stable fixation is performed.
To avoid breaking loose of the first rotation element (301) from the correction rod channel (601) existing on sled connection element (6), a set-screw hole (603) is present just under the set screw (604) of the sled connection element (6). The same mechanism is present on the ring connection bolt (8) in which a set screw (802) is present in the slot (801) of ring connection bolt (8) thus tightening of this bolt (8) helps to the secure fixation of the first rotation element (301) while in untightened position it maintains the breaking loose of the first rotation element (301) from the ring connection bolt (8). Four correction rods (3) are connected to the reference ring (1) via a ring connection bolt (8). Fixation of correction rod (3) is accomplished by placement of first rotation element (301), to the channel on the ring connection bolt (8) and locking of the connection is performed by either screw nut (10) or set screw (802) placed in the slot (801) of the ring connection bolt (8). Set screw (802) placing in the slot (801) of the ring connection bolt (8) prevents breaking loose of the first rotation element (301) and when tightening more it helps to lock the rotational movement of the first rotation element (301).
On the mobile ring (2), there are channels (11) wherein pin/wire holder chin apparatus (9) are attached, extending at the same direction with sled system (4). Channel (11) enables pin/wire holder chin apparatus (9) fixation with its depth and structure. Channels (11) are cut at opposite locations on mobile ring (2) upper and lower surfaces. Pin/wire holder chin apparatus (9) enables bone (K) fixation with wire, pin or screw when there is a need to fix the bone (K) by crossing the sled system (4). Pin/wire holder chin apparatus (9) has a compression screw (903) which enables its fixation on the channels via tightening the tumblers (901) on its location. Wires or screws that placed in to the pin/wire connection hole (902) are fixed on the pin/wire holder chin apparatus (9) via tightening the set screw (904).
The invention uses compass logic and measurements to determine the spatial location of bone (K) between the mobile ring (2) and reference rings (1). North (N), south (S), east (E) and west (W) cardinal points are used to specify sled systems (4) and north-east (NE), northwest (NW), south-east (SE) and south-west (SW) intercardinal points, to specify hole
(101 ,201 ) layout on the rings.
Measuring lines (13) are used on the mobile ring (2) to specify the location of the sled connection element (6) which provides correction rod (3) to move on horizontal axis in the invention. Midpoint of the sled systems (4) is specified by the number zero and measuring lines (13) with increment on both directions are specified with positive and negative numeric values.
On reference ring (1) and mobile ring (2) 360° grading lines (14) exist, marked by referring to ring centers, for the purpose of bone (K) locating, by using a position ruler apparatus (stylus)(12). Grading lines (14), showing hole (101 ,201) center locations cut on mobile ring (2) and reference ring (1) are shown in a more apparent way.
Coordinate parameters that are indicating the existing location of bone (K) in the spatial space between the reference ring (1) and mobile ring (2) and can be obtained by the position ruler apparatus (12) and the grading lines (14)on the reference ring (1) andthe mobile ring (2). Resultantly the necessary location parameters of the software can be obtained before the patient waked up in the operating room thus additional radiographies are prevented.
Position ruler apparatus (stylus) (12) consisting vertical ruler (121) and horizontal ruler (122) is temporarily installed on the holes (101 ,201), which are on the invention to define the coordinates of the bone existing in the spatial space between reference ring (1) and the mobile ring (2). By virtue of scaling lines which are present on the position ruler apparatus (12), horizontal ruler (122), mobile ring (2) and reference ring (1) coordinates of bone (K) existing in the spatial space between the mobile ring (2) and reference ring (1) are obtained via manual measuring. Provisional insertion of the position ruler apparatus (12) in to the holes (101 ,201) is maintained by the transient connection tip (123) of the position ruler apparatus (12) which is fixed with a nut. Horizontal ruler (122) on the position ruler apparatus (12) makes forward - backward motion which measures the distance of bone (K) to the ring. Horizontal ruler (122) also moves up and down that makes the distance measurement possible between the bone (K) ends and the ring level.
For each ring segment a second positioning is performed ideally perpendicular (90°) to the first positioning point, For example, SW and NE cardinals are in a perpendicular position when the position ruler apparatus (12) is mounted into a hole (201) in SE direction.
Placement of the second position ruler apparatus (12) is performed into the hole (201) in the appropriate region (in case neurovascular structures are at risk of damaged by horizontal ruler (122), region is referred not appropriate). Measurements obtained via vertical ruler (121) and horizontal ruler (122) is recorded to the software application.
For these actions, image intensifier is used during operation. Image intensifier device provides the instant observation of the images with a monitor. Image intensifier monitoring shall not be necessary in case of visible bone (K) ends or osteotomy line is present due to a traumatic open wound or any surgical incision. In such cases, measurements with position ruler apparatus (12) can be done directly inserting the horizontal ruler's (122) tip on the bone(K).
Since 2mm diameter horizontal ruler (122) is similar with Kirschner wire which is commonly used in orthopedic practice four wire penetrations for each bone (K) segment during measurements, is not extremely interventional.
Thus, when the obtained coordinate parameters from the distal and proximal parts of the bone (K) existing in the spatial space between the reference ring (1) and the mobile ring (2) are uploaded to the computer, the software used by the invention creates ultimate correcting plan in the desired alignment.
This invention can make deformity corrections in two ways which both methods have its original softwares. The above mentioned first method uses manually obtained parameters via special position ruler apparatus (12). More accurate coordinate parameters can be obtained by this method since all measurements are done on the patient during surgery. Other method uses post-operative digital radiographic images which are uploaded to the computer. With the software used, coordinates of bone (K) parts and reference ring (1) and the mobile ring (2) are defined by signing the reference points on the digital images. Software than define the spatial position of the bone (K) parts, reference ring (1) and mobile ring (2) virtually, and prepares an ultimate correction program for the desired alignment. Moreover, the most important and unique feature of this invention is its simple and easily understandable working logic. Accordingly any orthopedic surgeon having basic external fixator training can use this device without necessitating any software and can able to correct even complex deformities manually.

Claims

1. The invention is a computer programmable circular external fixator system used in orthopedic surgery for correction of bone (K) deformity and complex fractures and their treatment, and is characterized by a circular mobile ring (2) which have four tangential sled systems (4) existing on the four cardinal directions enabling the movement of correction rod's (3) connection mechanism and also have mobile ring holes (201) between the sled systems (4), a circular reference ring (1) edged by four sides tangentially on the mobile ring's (2) sled system (4) projections and
circumferentially placed multiple reference ring holes (101) on it and, four correction rods (3) which can lengthen according to application method of fixator, with multiaxial movement capability and is fixed by locking mechanisms.
2. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by a mobile ring (2) anda reference ring (1) preferably manufactured by composite and aluminum, while it can be manufactured by materials such as titanium, composite, aluminum, carbon fiber.
3. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by reference ring (1) and mobile ring (2)which can be manufactured in various diameters depending on adult or pediatric usage, and correction rods (3) which can be manufactured in different dimensions.
4. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by two center of rotation that enabling the rotation of the correction rods (3) around the first axis (FA) and the second axis (SA) which is perpendicular the first axis (FA).
5. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by holes (101 ,201 ) used for the fixation of wire, pin, stud or fixing bolts and correction rods (3), plates or other connection elements, located on reference ring (1) and mobile ring (2).
6. The invention according to claim 5 is a computer programmable circular external fixator system, characterized by holes (101 ,201 ), the number of which can change according to reference ring (1) and mobile ring (2) dimensions to be used.
7. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by foursled system (6) comprise athreaded rod (5) and a sled connection element (6) on threaded rod (5) and correction rods (3) function together with sled systems (4).
8. The invention according to claim 7 is a computer programmable circular external fixator system, characterized by a sled connection element (6) comprises a correction rod channel (601) that fixation of first rotation element (301) to sled system (4) can be accomplished by placing it in and a threaded rod channel (602) that ensure connection of threaded rod (5) with sled connection element (6), and a set-screw hole (603) where a set-screw (604) is used to block the rotational movement of first rotation element (301).
9. The invention according to claim 7 is a computer programmable circular external fixator system, characterized by a hexagonal screw head (7) which provides the axial (forward-back)movement of sled connection element (6) on the threaded rod (5) by hexagonal screw head's (7) rotation movement.
10. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by four correction rods (3) that can be fixed on the second axis (SA) by second rotation element's (302) locking mechanism.
11. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by channels (11), cut opposingly on upper and lower surfaces of mobile ring (2), on the same direction with sled system (4), on which pin/wire holder chin apparatus (9) is mounted.
12. The invention according to claim 11 is a computer programmable circular external fixator system, characterized by tumblers (901), providing bone (K) fixation at the regions at the sled line where bone (K) fixation cannot be performed via holes (101 ,201), and, mounted bilaterally on channels (11), and compression screw (903) providing fixation by tightening at the channel (11) placement location and pin/wire holder chin apparatus (9) having a pin/wire hole (902) where parts such as wire, stud, pin are fixed to the bone.
13. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by ring connection bolts (8) havingslots (801) where the movement of the correction rods (3) are blocked by fixation of set-screw (802).
14. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by ring connection bolts (8) having channels where the first rotation element (301) is mounted to the reference ring (1).
15. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by screw nuts (10) on the ring connection bolt (8), performing locking operation on the joint of correction rods (3) with reference ring (1), preventing the rotational movement of first rotation element (301), when tightened.
16. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by mobile ring (2) comprising measuring lines (13) with positive and negative numeric values, of which S, N, W, E axis are indicated by the number zero, to specify the location of sled connection element (6) which provides axial movement of correction rod (3).
17. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by reference ring (1) and mobile ring (2) with 360° grading lines (14), marked by referring to ring centers for the purpose of locating the bone, using range position ruler apparatus (12).
18. The invention according to claim 1 is a computer programmable circular external fixator system, characterized by a vertical ruler (121) to measure the perpendicular distance of bone (K) to rings, and milimetrically horizontal ruler (122) to make forward - backward motion which measures the distance of bone to the reference ring (1), mobile ring (2)and holes (101 ,201) on which position ruler apparatus (12) are mounted including transient connection tip (123) to provide connection.
19. The invention according to claim 1 is a circular external fixator system which can be programmable via a computer and is characterized by grading lines (14) and measuring lines (13) enabling the spatial detection of the bone (K) position and the creation of the final prescription allowing the correction procedure to be performed via a software as well as manually through precision positioning.
PCT/TR2013/000125 2013-04-04 2013-04-04 Computer programmable circular external fixator system WO2014163591A1 (en)

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CN105726108A (en) * 2016-01-29 2016-07-06 湖北工程学院 Bone holder for minimally invasive orthopedic surgery
WO2016193154A1 (en) 2015-05-29 2016-12-08 Université Catholique de Louvain External fixation system
CN108478266A (en) * 2018-03-26 2018-09-04 天津大学 Three branch parallel connection Orthopaedic external fixator of free linking
WO2019040829A1 (en) * 2017-08-24 2019-02-28 Amdt Holdings, Inc. Methods and systems for determining adjustment prescriptions of external fixation devices
CN109745106A (en) * 2019-02-11 2019-05-14 北京工业大学 It is a kind of for ankle foot deformity correction determine turn heart external fixator
CN109745107A (en) * 2019-02-11 2019-05-14 北京工业大学 A kind of three branch parallel connection external fixators that annular is adjusted
CN111481280A (en) * 2020-04-22 2020-08-04 北京工业大学 Y-shaped branched chain external fixator for correcting long bone deformity
CN111956311A (en) * 2020-08-14 2020-11-20 中国人民解放军联勤保障部队第九二0医院 Bridge type external fixing system for fracture reduction
CN113171219A (en) * 2021-04-24 2021-07-27 北京工业大学 Parallel external fixator system for ankle deformity with five-degree-of-freedom correction requirement
CN113303956A (en) * 2021-04-24 2021-08-27 北京工业大学 Parallel external fixator system for correcting monoplane deformity of ankle part
CN113456198A (en) * 2021-06-23 2021-10-01 天津大学 Four-branch-chain six-degree-of-freedom parallel external fixing support
US11337732B2 (en) 2013-09-27 2022-05-24 Orthex, LLC Point and click alignment method for orthopedic surgeons, and surgical and clinical accessories and devices

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Publication number Priority date Publication date Assignee Title
US11337732B2 (en) 2013-09-27 2022-05-24 Orthex, LLC Point and click alignment method for orthopedic surgeons, and surgical and clinical accessories and devices
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CN111481280B (en) * 2020-04-22 2021-03-02 北京工业大学 Y-shaped branched chain external fixator for correcting long bone deformity
CN111956311A (en) * 2020-08-14 2020-11-20 中国人民解放军联勤保障部队第九二0医院 Bridge type external fixing system for fracture reduction
CN113171219A (en) * 2021-04-24 2021-07-27 北京工业大学 Parallel external fixator system for ankle deformity with five-degree-of-freedom correction requirement
CN113303956A (en) * 2021-04-24 2021-08-27 北京工业大学 Parallel external fixator system for correcting monoplane deformity of ankle part
CN113456198A (en) * 2021-06-23 2021-10-01 天津大学 Four-branch-chain six-degree-of-freedom parallel external fixing support

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