Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • 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 or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/72—Intramedullary devices, e.g. pins or nails
  • A61B17/7283—Intramedullary devices, e.g. pins or nails with special cross-section of the nail
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • 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 or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/72—Intramedullary devices, e.g. pins or nails
  • A61B17/7233—Intramedullary devices, e.g. pins or nails with special means of locking the nail to the bone
  • A61B17/7241—Intramedullary devices, e.g. pins or nails with special means of locking the nail to the bone the nail having separate elements through which screws pass
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • 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 or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/74—Devices for the head or neck or trochanter of the femur
  • A61B17/742—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck
  • A61B17/744—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck the longitudinal elements coupled to an intramedullary nail
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • 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 or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/72—Intramedullary devices, e.g. pins or nails
  • A61B17/7233—Intramedullary devices, e.g. pins or nails with special means of locking the nail to the bone

Definitions

• the present invention relates to orthopedic surgical devices, in particular to intramedullary telescopic fixators for surgical placement in a medullary canal of patient's long bones, for example in the tibia, femur, ulna or humerus. More specifically, the present invention relates to an improved system of intramedullary telescopic rotationally stable fixators, which allows the use of an implant for surgical treatment in children with diseases associated with violation of the strength of bone tissue (“bad bone quality”).
• Intramedullary rods have been used for internal fracture fixation for a long time and became a “gold standard” bone fractures treatment.
• the intramedullary rod has the form of a long rod/tube with a specially shaped cross-section and transverse holes at selected places along its length. The rod is placed in the intramedullary canal and fixed with transverse bone screws inserted through the transverse holes of the rod.
• Patent document US6524313B 1 discloses a structure of an intramedullary rod system that consists of a hollow cylinder and a metal rod disposed therein with a possibility of axial movement. On one (distal) end of the cylinder and on one (proximal) end of the rod, there is provided a thread and a locking hole [Fassier F. Fassier-Duval Telescopic IM system TM. Surgical technique / F. Fassier. D. Paley, Pega Medical Inc., 2006. P. 20]. The operation for their installation is less traumatic, as it is performed during one surgical intervention. The metal structure lengthens as the bone grows.
• the system does not provide rotational stability, and therefore the torsional displacement of the bone fragments is possible, which could require additional surgical interventions or additional fixation (external fixator, plate etc.).
• a movable head is mounted on a fixed end of the inner rod, the movable head having an external thread and a through hole for a locking element.
• a free end of the outer tube is provided with a hole along the tube, and an external thread, and on the threaded part, perpendicular to the axis, in the tube there is a through hole for the locking element.
• Patent document WO2021242211 Al also describes a telescopic intramedullary fixation device embodiment for a femoral bone, which has a cylinder-shaped head at one end of the outer tube, the outer diameter of which exceeds the diameter of the tube. Transversal to the axis at an angle of 120- 130 degrees in the mentioned head there is a hole inside which there is a thread for a femoral neck telescopic fixing element.
• a rectangular protrusion on the inner surface of the tube which provides rotational stability of the system, has a fixed position and does not allow intraoperative correction of the length of the tube depending on anatomical parameters of a patient. It is necessary either to produce each intramedullary fixation device individually, or to have a huge assortment of products (typical sizes of fixation devices) both in length and in diameter.
• the angle of the hole in the head for fixing the femoral neck telescopic fixation element is an unchangeable parameter and cannot be changed intraoperatively. It is necessary to use another item of the external tube, which requires a significant expansion of the range of available products necessary for the operation (diameter, length, value of the angle of fixation of a proximal part of a thigh).
• the main technical tasks for the creation of this invention are to eliminate the disadvantages of the existing state of the art, namely to provide a new version of a system of intramedullary telescopic rotationally stable fixators with the following properties:
• the invention provides a kit of elements of an intramedullary telescopic system, which contains: a hollow tube with a mounting end and a free end; a rod configured to be telescopically connected with the tube in such a way that the rod is disposed with its first end in the tube from the side of the free end of the tube with a possibility of axial movement therein; a screw-shaped head configured to be mounted on a second end of the rod, the screw-shaped head having an external thread and a through hole for a locking element; and one of the following elements: an end element with an external thread at one of its ends, configured to be mounted in the tube from the side of the mounting end of the tube, such that the threaded part of the end element is outside the tube, wherein the threaded part has a through hole for a locking element, the through hole provided perpendicular to an axis of the end element; a head for a proximal part of a thigh, configured to be mounted
• the invention provides an intramedullary telescoping system, for assembling of which the elements from the kit are used, and which includes: a hollow tube with a mounting end and a free end; a rod telescopically connected to the tube in such a way that a first end of the rod is disposed in the tube from the side of the free end of the tube with a possibility of axial movement therein; a crew-shaped head mounted on the second end of the rod, the screw-shaped head having an external thread and a through hole for a locking element; and one of the following elements: an end element with an external thread on one of its ends, mounted in the tube from the side of the mounting end of the tube such that the threaded part of the end element is outside the tube, wherein the threaded part has a through a hole for locking element, the through hole provided perpendicular to an axis of the end element; a head for a proximal part of a thigh, mounted on the tube at the mounting end of the tube, where
• the invention provides a tube for the mentioned intramedullary telescopic system, which has a mounting end and a free end, is hollow, and is configured to be telescopically connected with a rod of the intramedullary telescopic system in such a way that the rod is disposed with its first end in the tube from the side of the free end of the tube with a possibility of axial movement therein, wherein the tube is configured to: mount in the tube, from the side of the mounting end of the tube, an end element with an external thread on one of its ends such that the threaded part of the end element is outside the tube, wherein the threaded part is made with a through hole for a locking element, the through hole provided perpendicular to an axis of the end element; or mount on the tube, at the mounting end of the tube, a head for a proximal part of a thigh, wherein the head for the proximal part of the thigh has a cylindrical shape, wherein the head for the
• the invention provides a rod for an intramedullary telescopic system, which is configured to be telescopically connected with a hollow tube of the intramedullary telescopic system in such a way that the rod is disposed with its first end in the tube with a possibility of axial movement therein, and is configured to mount on at its second end a screw -shaped head having an external thread and a through hole for a locking element, and wherein an outer surface of the rod is made with an elongated groove that corresponds in cross-sectional shape and size to an inner surface of a part of a wall of the tube, which is concave forming V-shaped cross-section such that the concave part of the tube wall forms two flat walls at an angle to each other.
• the plane in which the protrusion having V-shaped cross-section is made either coincides with an axis of the locking element after its installation on the mounting end of the tube, or creates an angle with the axis of the locking element after its installation on the mounting end of the tube.
• the concave part of the tube wall is provided along the axis of the tube at the free end of the tube, and the elongated groove is provided along the axis of the rod, such that when the rod is inserted into the tube, the concave part of the tube wall coincides with the elongated groove of the rod, wherein the concave part of the tube wall has a length less than a length of the tube and less than a length of the elongated groove.
• the mounting end of the tube is made with a conical surface such that a diameter of the tube is narrowed at the mounting end.
• the end of the rod has a groove for the locking element such that inserting the locking element simultaneously into the hole of the screw-shaped head and into the groove at the end of the rod leads to mutual locking of the rod and the screw-shaped head.
• the end element is a sleeve, and the end part of the sleeve with the external thread and is a self-tapping screw, wherein preferably the end element is made with a protrusion, and the tube has a corresponding groove for preliminary orientation of the end element relative to the tube, wherein preferably one or more undercuts are made on the end element to secure the end element relative to the tube by crimping the mounting end of the tube.
• the cylinder-shaped head for the proximal part of the thigh has an outer diameter greater than the diameter of the tube, wherein preferably the tube has a groove at the mounting end, and the head for the proximal part of the thigh has a locking pin of an appropriate size for preliminary orientation of the head for the proximal part of the thigh relative to the tube, wherein preferably the head for the proximal part of the thigh has retaining pins and the tube has corresponding holes to ensure securing of the head for the proximal part of the thigh relative to the tube, wherein preferably the hole in the head for the proximal part of the thigh is made across the axis at an angle of 1 10-140 degrees, wherein the kit preferably contains two or more heads for the proximal part of the thigh, with the holes made at different angles, to provide a possibility of selecting a head for the proximal part of the thigh according to a value of said angle,
• the screw-shaped head has an outer diameter greater than the outer diameter of the tube and a diameter of the thread roots, which is preferably equal to the outer diameter of the tube, wherein the screw-shaped head is configured to screw into a bone and preferably is a self-tapping screw.
• the thread inside the hole of the head for the proximal part of the thigh is made along a part or the entire length of the hole and is a cylindrical or conical thread.
• the kit further contains the femoral neck telescopic locking element, which includes an external fixed part which diameter corresponds to the diameter of the hole of the head for the proximal part of the thigh, and which is made with a locking thread, and an internal movable part, which is made with a thread on its outer end, which diameter is greater than the diameter of the movable part, wherein the internal movable part is a self-tapping screw.
• the femoral neck telescopic locking element which includes an external fixed part which diameter corresponds to the diameter of the hole of the head for the proximal part of the thigh, and which is made with a locking thread, and an internal movable part, which is made with a thread on its outer end, which diameter is greater than the diameter of the movable part, wherein the internal movable part is a self-tapping screw.
• all the elements of the kit are made of metal, wherein preferably the concave part of the tube wall is made by plastic deformation of metal of the lube, and the elongated groove of the rod is made by machining metal of the rod.
• the tube and the rod have lengths that are necessary for attachment to bone structures without disturbing a bone growth plate.
• the claimed invention offers a universal kit of elements of an intramedullary telescopic system that can be used in pediatrics. Either an end element or a head for a proximal part of a thigh can be installed on the mounting end of the tube using a special tool.
• the type of the element, which is installed on the mounting end of the tube depends on a zone of application of the implant: a femur or other tubular bones.
• the tube is cut at the free end of the tube, which is intended for receiving the inner rod therein, so as to obtain an estimated length of the implant.
• a V-shaped protrusion is made on the tube, using a special tool on the inner surface of the tube at a certain distance from pre-cut edge at the free end, which is also performed intraoperatively due to plastic deformation of the metal.
• Fig. 1 schematically shows a tube and an end element for assembling an outer part of an intramedullary telescopic system for tubular bones.
• Fig. 2 schematically shows the outer part of the intramedullary assembly telescopic system for tubular bones before the moment of final fixation
• Fig. 3 schematically shows the outer part of the intramedullary assembly telescopic system for tubular bones after final fixation.
• Fig. 4 schematically shows the outer part of the intramedullary telescopic system for tubular bones, in which a V-shaped protrusion is made at the free end of the tube.
• Fig. 5 schematically shows a tube and a head for a proximal part of a thigh for assembling an outer part of an intramedullary telescopic system for a femoral bone.
• Fig. 6 schematically shows the assembly and final mutual fixation of pieces of the outer part of the intramedullary telescopic system for a femoral bone.
• Fig. 7 schematically shows the outer part of the intramedullary telescopic system for femoral bone, in which a V-shaped protrusion is made at the free end of the tube.
• Fig. 8 schematically shows an inner part of the intramedullary telescoping system for a femoral bone, which includes a rod, on an outer surface of which an elongated V-shaped groove is made and a movable screw-shaped head with an external thread is installed.
• Fig. 9 schematically shows the assembly of the outer and inner parts of the intramedullary telescoping system for femoral bone, installation of a femoral neck telescopic fixator, installation of a locking element.
• Fig. 10 schematically shows the assembly of the outer and inner parts of the intramedullary telescopic system for tubular bones, installation of locking elements.
• a universal pediatric telescopic rod which comprises an outer tube 2 having a mounting end and a free end.
• a special tool can be used to install on the mounting end of the outer tube 2, which is made with a conical surface and a hole with an axis transverse to the axis of the tube 2, an end element 1 one end of which is a self-tapping screw provided with an external thread, wherein the threaded part has a through hole 8 for a locking element, which is perpendicular to the axis of the tube 2.
• a protrusion 3 is made on the end element 1 , and the tube 2 has a corresponding groove 4.
• one or more undercuts 5 are made on the end element 1 .
• the end element 1 can be a sleeve. As shown in Fig. 2, the end element 1 is inserted into the mounting end of the tube 2, the protrusion 3 is combined with the groove 4, after which the mounting end of the tube 2 is crimped, as shown in Fig. 3. The material 6 of the tube in the fixation zone 7 is pressed into the undercut 5 and ensures a reliable mutual fixation.
• the tube 2 is cut from the side of the free end to a required length, the sharp edges are processed after cutting, and by the method ofcrimping from the outside in the area 9 closer to the cut free end of the tube 2, a V-shaped protrusion 10 is formed on the inner surface of the tube, as shown in Fig. 4.
• the plane in which the V-shaped protrusion 10 is made on the inner surface of the tube 2 can either coincide with the axis of the hole 8 for the locking element, or, at a surgeon's decision, can create a certain angle in relation to the mentioned axis.
• a special tool can be used to install on the mounting end of the outer tube 2, which is made with the conical surface and the hole with the axis transverse to the axis of the tube 2, a head 1 1 for a proximal part of a thigh, which is for a proximal section of an outer part 20 of a femoral neck telescopic fixator, the head 1 1 being provided with an internal threaded hole at an angle A for installing the femoral neck telescopic fixator.
• Position 19 in Fig. 9 shows an inner part of the femoral neck telescopic fixator, which is configured to screw into the neck of the femur.
• the tube is provided with a notch 4 at the mounting end, and the head 1 1 has a locking pin 13 of an appropriate size.
• the head 1 1 is provided with retaining pins 12, and the tube has corresponding holes 14.
• the head 1 1 for the proximal part of the thigh which is for the outer part 20 of the telescopic fixator, is put on top of the mounting end of the tube 2, as shown in Fig. 6, the locking pin 13 is combined with the notch 4, after which the retaining pins 12 are pressed into the corresponding holes 14 of the tube 2, which ensures reliable mutual fixation.
• the tube 2 is cut from the side of the free end to a desired length, the sharp edges are processed after cutting, and a V-shaped protrusion 10 is formed on the inner surface of the tube 2 in the area 9 closer to the cut free end of the tube 2 by crimping from the outside, as shown in Fig. 7.
• the plane in which the V-shaped protrusion 10 is made on the inner surface of the tube 2 can either coincide with the plane of the hole for installing the femoral neck telescopic locking element, or, at the surgeon’s decision, it can create a certain angle (antetorsion angle) in relation to the mentioned axis.
• the shape and size of the protrusion 10 on the inner surface of the tube 2 in cross-section corresponds to a V-shaped elongated groove 17 on an outer surface of an inner rod 23 shown in Fig. 8.
• the inner rod 23 has the mentioned V-shaped groove 17 almost along its entire length, as shown in Fig. 8.
• a movable screw-shaped head 15 with an external thread is installed, which has an external diameter greater than an external diameter of the tube 2, and a diameter of the thread roots, which is preferably equal to the external diameter of the tube 2.
• the screw-shaped head 15 is a self-tapping screw.
• T he screw-shaped head 15 is configured to screw into a bone while the rod 23 can move in axial direction inside the tube 2.
• the screw-shaped head 15 has, perpendicular to its axis, a through hole 16 for a locking element 21 , and the rod 23 has a corresponding groove 18 for the locking clement 21 on its end. After screwing the screw-shaped head 15 into a bone to a required depth, locking is performed using the locking element 21. Inserting a locking element 21 simultaneously into the hole 16 of the movable screw-shaped head 15 and into the groove 18 on the end of the rod 23 in the locking area 22, as shown in Figs. 9 and 10, leads to mutual locking of the rod 23 and the screw-shaped head 15.
• a locking element 21 is inserted first of all into the hole 8 of the end element 1.
• a locking element 21 is also inserted into the screw-shaped head 15, into the hole 16, it completely blocks the screw-shaped head 15 from rotation and movement.
• the telescopic connection between the elements of the telescopic rod is intended to enable an axial movement of the ends of the elements of the telescopic rod system relative to each other to allow a normal growth of the bone.
• a locking element is a means for securing each end of the telescopic rod assembly to any end of a damaged long bone when the telescopic rod is implanted in the long bone.

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• Health & Medical Sciences (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Neurology (AREA)
• Medical Informatics (AREA)
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• Animal Behavior & Ethology (AREA)
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• Public Health (AREA)
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• Surgical Instruments (AREA)

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• 2023
  • 2023-02-02 EP EP23723096.6A patent/EP4658191A1/de active Pending
  • 2023-02-02 WO PCT/UA2023/000002 patent/WO2024162942A1/en not_active Ceased

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