Adjustment tool for support device and support device

Abstract

The adjustment tool of the present invention is intended for use with a support device. The adjustment tool includes a first adjustment shaft (34), a second adjustment shaft (35), and a third adjustment shaft (41), and a beam (33) that can be adjusted for rotational movement in at least one direction by at least one of the adjustment shafts (34, 35, and / or 41). The first adjustment shaft (34) is attached to the beam (33), the second adjustment shaft (35) is attached to the first adjustment shaft (34), and the third adjustment shaft (41) is attached to the second adjustment shaft (35). The adjustment tool also includes a pair of mounting arms (36). One mounting arm is movable laterally along the beam on one side of the first adjustment shaft, and the other mounting arm is movable laterally along the beam on the other side of the first adjustment shaft. The support device of the present invention includes positioning and supported components. The support device is connected on the one hand to its lateral support arms and on the other hand to the adjustment tool which is connected to the component to be supported, for example a support device for positioning a patient for surgery such as correction of a bone dislocation or intramedullary nailing of the tibia.

Description

[Technical Field]

[0001] The present invention relates to an adjustment tool and its use for the mutual positioning of components of a mechanical device, in particular a support device. The present invention also relates to such a support device. [Background technology]

[0002] Workholding, positioning, and support devices are used to create safety points for workpieces or tasks that allow support during operation to improve accuracy and precision. Components within such devices should be securely positioned in specific positions, locations, and / or orientations so that the device can support the task in question. Such support devices exist for very different types of tasks and are then designed for both position, location, and support, or either one or the other. Positioning of components can, for example, ensure the geometric stability of the support device so that it is in the correct position and orientation for operation.

[0003] The positioning components of a support or positioning device consist of movable and / or rotating arms and shafts held together by screws or pins, and sometimes clamps and surfaces. These parts ensure that the components are precisely positioned and remain in the same position throughout the entire movement. The surfaces, arms, and shafts provide support, the pins and screws allow for precise positioning, and the clamps, for example, allow the support device or its components to be removed or their position adjusted.

[0004] Surgical positioning is the placement of a patient in a specific position during surgery. The goal of selecting and adjusting a specific surgical position is to maintain patient safety while allowing access to the surgical site. Often, patients must be placed in an awkward position to gain access to the surgical site.

[0005] For example, the lithotomy position is a common position for surgical procedures and medical examinations involving the pelvis and lower abdomen, as well as a common position for childbirth in the Western world. In the Trendelenburg position, the patient is placed supine, or lying face-down, at a 15-30 degree angle with the feet elevated above the head. The reverse Trendelenburg position also involves tilting the body back, but with the head elevated. In particular, intramedullary nailing of the tibial ligament can be performed with the patient lying supine on a radiolucent table or fracture table.

[0006] To position a patient for surgery, different positioning and support devices are used. These devices are adjusted to each individual patient, as a natural consequence of people of different sizes. Thus, the support devices have components that are adjusted with respect to their height and location as well as their mutual distance and position, and they can be extended or shortened in different directions, such as vertically and horizontally or at an angle, with the necessary adjustment depending on the length and dimensional proportions of the actual person to be fixed in position, e.g., for surgery.

[0007] Additionally, adjustable components of devices used for surgical positioning include arms, shafts, screws, pins, etc. Specific positioning accessories and the entire device must be designed to achieve a specific position and provide patient safety and support. Each such device has various ancillary equipment and accessories, such as components used to elevate the legs from the operating table surface for gynecological, urological, and orthopedic procedures.

[0008] One such orthopedic procedure used to treat tibia fractures is intramedullary nailing, which involves inserting a metal nail into the medullary cavity of the tibia.

[0009] Tibial fractures are common injuries, especially in young and middle-aged adults. Fractures can be caused by falls, accidents, or a strong blow to the leg. Treatment for tibial fractures generally involves repositioning, or repositioning the ends of the bone in place at the fracture site.

[0010] Intramedullary nailing is the most common method for treating tibial fractures. The nail is placed into the medullary canal through the tendons under the patella. Once the nail is in place, screws are inserted into each end to hold the bone in the desired position.

[0011] The function of intramedullary nailing of the tibia is to align the bone parts separated by the fracture so that the two ends of the bone at the fracture site of the tibia are in a straight line and the tibia can ossify in the correct position.

[0012] Traditionally, intramedullary nails are inserted into the bone from the top of the tibia, and studies have shown that a significant number of patients experience pain in the anterior knee after the procedure, known as anterior knee pain.

[0013] Furthermore, a surgical technique still commonly used involves placing the patient's leg at an angle greater than 90 degrees relative to the circular support. Additionally, the leg is pulled diagonally forward and downward to align the two ends of the injured tibia. This procedure can pinch the nerve behind the knee, increasing the risk of nerve injury. When using a wedge pillow, an assistant, i.e., another surgeon, is required to hold the leg in place. The assistant's role in this procedure is to maintain the necessary traction on the leg to prevent movement while the two ends of the bone are aligned and a space is drilled in the bone for the insertion of the intramedullary nail.

[0014] Two versions of intramedullary nailing of the tibia are known. The first method uses a traction table designed for this procedure, but it poses numerous challenges. For example, surgical preparation is time-consuming and imaging is difficult. If the patient is not positioned correctly, nerve damage may occur, and this method requires the surgeon to work in an ergonomically demanding position. The second method involves intramedullary nailing on a standard operating table using a wedge pillow designed for intramedullary nailing of the tibia. The problem with this procedure is that the leg moves continuously, requiring a second orthopedic surgeon or trauma specialist to support the leg during the procedure. Additionally, this wedge pillow procedure, which allows for significant leg movement, is prone to tissue and vascular damage in the calf muscles.

[0015] A commonly used surgical technique involves drilling a needle into the heel bone and attaching it to a traction device, as the heel bone area contains important nerve structures and soft tissues that are vulnerable to injury.

[0016] CN110537964 is cited as prior art, which discloses an apparatus for intramedullary nailing of the tibia, in which the length of the bone can be adjusted by a needle penetrating the bone.

[0017] The object of the present invention is to provide an auxiliary element to be used as an adjustment element in a support device to facilitate the adjustment of components in the support device that are to be adjusted in general with respect to height and location, as well as mutual distance and position.

[0018] A particular object of the present invention is to provide an apparatus that allows for a safer and more patient-friendly tibial intramedullary nailing procedure. [Prior art documents] [Patent documents]

[0019] [Patent Document 1] Chinese Patent Application Publication No. 110537964 Summary of the Invention

[0020] The adjustment tool of the present invention is intended for use with a support device. The adjustment tool includes a first adjustment shaft, a second adjustment shaft, and a third adjustment shaft, and a beam that can be adjusted for rotational movement in at least one direction by at least one of the adjustment shafts. The first adjustment shaft is attached to the beam, the second adjustment shaft is attached to the first adjustment shaft, and the third adjustment shaft is attached to the second adjustment shaft. The adjustment tool also includes a pair of mounting arms. One mounting arm is movable laterally along the beam on one side of the first adjustment shaft, and the other mounting arm is movable laterally along the beam on the other side of the first adjustment shaft.

[0021] The support device of the present invention has a component to be positioned and supported. The support device has an adjustment tool coupled to its lateral support arms on one hand and to the component to be supported on the other hand. The adjustment tool includes a first adjustment shaft, a second adjustment shaft, and a third adjustment shaft, and a beam that can be adjusted for rotational movement in at least one direction by at least one of the adjustment shafts. The first adjustment shaft is attached to the beam, the second adjustment shaft is attached to the first adjustment shaft, and the third adjustment shaft is attached to the second adjustment shaft. The adjustment tool also includes a pair of mounting arms. One mounting arm is movable laterally along the beam on one side of the first adjustment shaft, and the other mounting arm is movable laterally along the beam on the other side of the first adjustment shaft.

[0022] In particular, the support device is a support device for positioning a patient for surgery such as correction of a bone dislocation or intramedullary nailing of the tibia.

[0023] The support device of the present invention for correcting bone dislocation or intramedullary nailing of the tibia includes a framework frame consisting of a vertical support and longitudinal and lateral horizontal supports. The support device further includes a retractor needle that is passed through the tibia and a guide slidably coupled to the longitudinal horizontal support of the support device. The guide includes a first finder for adjusting the position of the retractor needle laterally relative to the upper articular surface of the tibia and a second finder for adjusting the position of the retractor needle vertically and passing the retractor needle through the tibia in the lateral direction of the tibia. The first mounting arm is configured to be attached to one end of the frame and to the end of the retractor needle that is passed laterally through the tibia using the guide. The support device further includes an adjustment tool coupled to the horizontal support slidably mounted between some of the longitudinal supports within the frame at the other end of the frame other than the first mounting arm. The adjustment tool includes first, second, and third adjustment shafts and a beam that can be adjusted for rotational movement in at least one direction by at least one of the adjustment shafts. The first adjusting shaft is attached to the beam, the second adjusting shaft is attached to the first adjusting shaft, and the third adjusting shaft is attached to the second adjusting shaft. The adjustment tool further includes a pair of mounting arms, one of which is movable laterally along the beam on one side of the first adjusting shaft, and the other of which is movable laterally along the beam on the other side of the first adjusting shaft.

[0024] Preferred embodiments of the invention have the features described below as disclosed in the dependent claims.

[0025] The terms positioning and location as used in the context of the present invention include any kind of displacement, such as axial, circumferential, rotational and linear movement to place a component in a desired position.

[0026] In a preferred embodiment, the first adjustment shaft, the second adjustment shaft and the third adjustment shaft are perpendicular to each other.

[0027] The rotational movement includes a first rotation of the beam around its midpoint in a horizontal plane. In other words, a rotation of the beam around a vertical axis in the horizontal plane. The rotational movement can also include a second rotation of the beam around its midpoint in a vertical plane. In other words, a rotation of the beam around a vertical axis in the vertical plane. Furthermore, the rotational movement can include a third rotation of the beam, which is an angular rotation along an arc defined by the distance between the third adjustment shaft and the beam and the radius of curvature. In other words, as the third adjustment shaft is rotated back and forth, there is a circular motion of the beam that follows a back and forth circular path.

[0028] The first adjusting shaft, the second adjusting shaft, and the third adjusting shaft can be rotated relative to one another simultaneously or separately by locking screws within each adjusting shaft.

[0029] There is a first locking screw for the first rotation and a second locking screw for the second rotation. The first locking screw holds the first adjusting shaft in place, but for added security, there may be a set screw fastened to the second adjusting shaft to further securely hold the first adjusting shaft in place. There is a third locking screw for adjusting angular rotation. A fourth locking screw extends perpendicular to the first adjusting shaft to secure the first adjusting shaft to the beam.

[0030] When the locking screws are loosened simultaneously, a combined type of rotation is achieved for adjustment. For example, when the first and second locking screws are loosened simultaneously, the beam may move in a reference plane other than the horizontal or vertical plane. Therefore, adjustment can be achieved by two or three locking screws simultaneously.

[0031] The adjustment tool can be used with various types of support devices. In some applications, only one or two types of rotational movement of the beam are required to achieve useful adjustment of the components within the support device.

[0032] When the adjustment tool of the present invention is used in a support device for positioning a patient for surgery such as correction of a bone dislocation or intramedullary nailing of the tibia, three types of adjustments, namely, a first type of rotational adjustment about its midpoint in the horizontal plane, a second type of rotational adjustment about its midpoint in the vertical plane, and angular rotation performed as a circular movement of the beam, are usually required for accurate adjustment and are preferably performed simultaneously. However, even in such cases, only one or two types of rotational adjustment may be sufficient, and this is determined on a case-by-case basis depending, for example, on the size and dimensional proportions of the patient.

[0033] The third adjustment shaft can be a two-piece shaft, the parts of which are fastened together by a screw. The third adjustment shaft preferably has the form of a mounting ring that surrounds the support arm of the support device. The two-piece design allows the adjustment tool to be removed from and reattached to the support arm.

[0034] The support mounting arms of the adjustment tool are movable laterally along the beam on either side of the first adjustment shaft. A fifth locking screw secures the support mounting arms in a selected location on the beam.

[0035] Lateral movement of the support mounting arms is effected along at least one groove in the beam by means of a sliding screw which holds the support mounting arms in position within the beam and allows them to slide along at least one groove by means of a ball at the end of the sliding screw.

[0036] The support mounting arms have means for coupling them to another component of the support device, such as a thumbscrew, and in the case of a surgical device, the means for coupling the support mounting arms to another component of the support device, such as a retractor needle, further comprises a fastening plate through which the thumbscrew passes.

[0037] The adjustment tool can be used with different types of support devices by coupling a third adjustment shaft to its support arm and by coupling the support mounting arm to another component of the support device for support purposes.

[0038] The support device of the present invention for the correction of bone dislocations or for intramedullary nailing of the tibia is suitable for both of these types of surgery.

[0039] If the support device is specifically intended for intramedullary nailing of the tibia, the adjustment tool is not necessary and can therefore be removed, and instead a second mounting arm can be fastened to the frame so that, instead of the support mounting arm, it can be attached to the end of a retractor needle passed laterally through the tibia using a guide. This can be done, for example, if adjustment using such a second mounting arm is easier than using an adjustment tool.

[0040] However, it is preferred to use an adjustment tool to correct bone dislocations.

[0041] The support device for correcting bone malalignment or intramedullary nailing of the tibia includes a first mounting arm for a traction needle on the lower part of the tibia. The first mounting arm is attached to a lateral support slidably mounted between some of the longitudinal supports in the frame. The lateral support slidably mounted between the longitudinal supports is slid along the longitudinal supports by a guide carriage, such as a traction carriage.

[0042] The longitudinal horizontal support usually consists of an upper support and a lower support, in which case the lower support preferably serves as a sliding rail for the guide carriage.

[0043] The device for intramedullary nailing of the tibia also includes a second mounting arm for the upper tibia traction needle, which is fixedly (i.e., non-movably) attached to a lateral support mounted between the two vertical supports within the frame.

[0044] The lateral supports can be rotated forward and backward, meaning that the mounting arms attached to them can be rotated to a forward or backward position.

[0045] The guide comprises a first finder having an attachment means attached thereto and a second finder having an attachment means attached thereto for passing retraction needles through the lower and upper parts of the tibia respectively.

[0046] The vertical height adjustment part is connected to the guide, and the vertical height adjustment part is attached at its upper part to a separate attachment element in the same attachment means or guide and at its lower part to a second attachment means, and the first finder and the second finder are in the same guide at different adjustable heights.

[0047] All mounting arms, the first mounting arm, the support mounting arm and possibly the second mounting arm, are attached to the lateral support by a ring that surrounds them. The ring has threaded holes into which screws can be fastened at the bottom of the grooves to hold the mounting arms in place.

[0048] The device according to the present invention for intramedullary nailing of the tibia, which may be referred to as a tibial traction and repositioning device, has been developed for "suprapatellar" (i.e., performed below the kneecap) intramedullary nailing of the tibia in adult patients.

[0049] The tibial traction and repositioning device of the present invention positions the knee at an angle of approximately 5 to 10 degrees, thereby avoiding compression of the back of the leg and preventing damage to the patient's nerves in the "flexion" behind the knee. The device has needle attachment arms on the upper and lower parts of the tibia. The needle attachment arm on the lower part of the tibia is on a sliding rail, so that the end of the tibia can be aligned by pulling the lower attachment mechanism. The needle attachment arm on the upper part of the tibia does not move longitudinally of the device.

[0050] Due to its versatile functionality, the adjustment tool is designed to facilitate corrective tibial osteotomies, i.e., corrective surgeries of the tibia, as well as the connection of external anchoring devices to the tibia, i.e., external fixation devices for stabilizing and aligning fractured bones. Such fixation devices can be externally adjusted to ensure that the bone remains in an optimal position during surgery and / or healing. The adjustment tool of the present invention can be used as a further improvement by connecting the distal end, i.e., the ankle end, of the tibial traction and repositioning device or device for correcting bone dislocation of the present invention to a horizontal support.

[0051] The adjustment tool of the present invention provides a substantial improvement in achieving accurate results in osteotomies where correction of mid-tibial dislocations or dislocations that do not reach the articular surface is performed. By using the adjustment element of the present invention, the correct correction of angular and rotational disorders can be achieved according to an action plan performed after magnetic resonance imaging or native X-ray examination.

[0052] The essential function of the adjustment tool is that the support mounting arms can simultaneously move laterally along the beam to which they are fastened, allowing the beam to be rotated in different directions. Additionally, the correct bone length can be achieved by using a guide carriage that slides along the lower support. All of these adjustments can be locked in the desired position for surgery, allowing the procedure to be performed by a single surgeon.

[0053] The adjustment tool of the present invention can also be used in devices for the correction of congenital bone dislocations. Even in high tibial osteotomies (HTO) of the upper tibia, the device of the present invention offers significant improvements over conventional methods for intramedullary nailing of the tibia. Using the device of the present invention, the correction of bone dislocations is significantly easier because the foot can be stabilized in place for surgery and the adjustment tool can be gradually adjusted according to a grade scale, which allows the patient to directly see how much the distal end of the tibia must be rotated to place it in the correct position.

[0054] The adjustment tool of the present invention can also be used in an apparatus for performing a rotational osteotomy, in which malrotation of the tibia is corrected. In a rotational osteotomy, the tibia is completely cut and the correct position is achieved by rotating the tibia in the appropriate direction. In such a procedure, the adjustment tool of the present invention offers a significant advantage because the tibia is fastened to the apparatus at both the proximal and distal ends, so it is not shortened during cutting. With the distal axis of the adjustment tool rotated 30 degrees, very precise malrotation can be achieved by using the adjustment tool of the present invention within the apparatus.

[0055] In one embodiment of the present invention, the tibia is attached to the tibial traction and repositioning device by means of thin needles that are drilled into the bone from the side of the tibia, from the top and bottom of the fractured tibia. An advantage of the novel device is that the needles are drilled into already damaged bone, so that intact bone, nerves, and tissue are not unnecessarily damaged.

[0056] One embodiment of the medical-technical device according to the invention allows for safer and more cost-effective intramedullary nailing of the tibia. Conventionally, intramedullary nailing of the tibia on a pillow requires an additional surgeon to perform the procedure in order to provide sufficient traction to the leg and hold it in place during the procedure.

[0057] The invention is explained in more detail below by means of embodiments and associated figures, as well as the use of the embodiments. [Brief explanation of the drawings]

[0058] [Figure 1] FIG. 2 illustrates an adjustment element of the present invention. [Figure 2] 1 shows an example of a support device of the invention in the form of an inventive device for correcting bone dislocations or for intramedullary nailing of the tibia. [Figure 3] FIG. 3 is a detailed view of a portion of FIG. 2. DETAILED DESCRIPTION OF THE INVENTION

[0059] 1 shows an adjustment tool of the present invention, which comprises a beam 33 that can be adjusted for different types or combinations of rotations.

[0060] The first adjusting shaft 34 is coupled to the beam 33 for rotation of the beam about its midpoint in a horizontal plane, i.e., about a vertical axis in the horizontal plane. This rotation is referred to herein as the first rotation. The beam 33 passes through the first adjusting shaft 34. At the top of the first adjusting shaft 34 is a first locking screw 37 for adjusting the first rotation by loosening the first locking screw 37. By using the grade scale marked on it, the shaft 34 can be rotated in both the left and right directions.

[0061] The second adjusting shaft 35 is coupled to the first adjusting shaft 34 to rotate the beam 33 about a vertical axis in the vertical plane, i.e., about its midpoint in the vertical plane. This rotation is referred to herein as the second rotation. A second locking screw 38 at the end of the second adjusting shaft 35 can be loosened to adjust the second rotation of the beam 33. Also, by using the grade scale marked on it as an aid, the shaft 35 can be rotated in both the left and right directions.

[0062] A set screw 39 fastened to the second adjusting shaft 35 can be used as additional security to hold the first adjusting shaft 34 in place.

[0063] A fourth lock screw 40 extends perpendicular to the first adjustment shaft 34 and secures the first adjustment shaft 34 to the axis 33 .

[0064] When screws 39 and 40 are on top of each other, the shafts do not rotate relative to each other. In Figure 1, it can be seen that adjustment shaft 34 is rotated approximately 30 degrees to the left relative to adjustment shaft 35.

[0065] The third adjusting shaft 41 is used to rotate the entire adjusting tool by moving the second adjusting shaft 35 back and forth (or up and down, depending on how you look at it). This causes the angular rotation of the beam about the third adjusting shaft 41 to be a circular movement along an arc. There is a third locking screw 42 to adjust the rotation of the third adjusting shaft 41, i.e., to effect the angular rotation. Also, by using a marked grade scale as an aid, the shaft 41 can be rotated in both directions, left and right.

[0066] The third adjusting shaft 41 is a two-part shaft, the parts of which are fastened together by a screw 43. The third adjusting shaft 41 has the form of a mounting ring that surrounds the lateral support arm of the support device for installation. A third locking screw 42 also attaches the third adjusting shaft 41 to the support arm of the support device of the present invention.

[0067] The first adjusting shaft 34, the second adjusting shaft 35, and the third adjusting shaft 41 are perpendicular to one another. Figure 1 is seen as a perspective view from above. The third adjusting shaft 41 can be rotated to cause a circular movement of the beam 33, so that it is perpendicular to the first adjusting shaft 34 as well as the second adjusting shaft 35.

[0068] A pair of support mounting arms 36 are located on either side of the first adjustment shaft 34, allowing for laterally movable support mounting arms 36 along the beam 33. In FIG. 2, the lower ends of the support mounting arms 36 are configured to surround the shaft 33. Alternatively, they may be at the ends of arms or slots for inward movement. A fifth locking screw 44 secures the mounting arms 36 in a selected location on the beam 33.

[0069] Lateral movement of the mounting arms 36 is effected along at least one groove 45 in the beam 33 by means of a sliding screw 46 which holds the support mounting arms 36 in position within the beam 33 and allows them to slide along at least one groove 45 by means of a ball at the end of the sliding screw 46.

[0070] The mounting arm 36 has means, such as a thumbscrew 47, for coupling to another component of the support device, for example, a retractor needle of a device for correcting a bone dislocation or for intramedullary nailing of the tibia. The means for coupling the support mounting arm 36 to another component of the support device further comprises a fastening plate 48 through which the thumbscrew passes.

[0071] 2 shows an example of a support device of the present invention in the form of a traction and repositioning device of the present invention for intramedullary nailing of the tibia, which is for the correction of bone dislocations or tibial traction and repositioning for intramedullary nailing of the tibia, where an intramedullary nail is inserted into the tibia.

[0072] Tibial fractures sustained by trauma in patients are treated by inserting an intramedullary nail into the tibia, which is then left in place if tibia repair is required, when the bone is broken into two or more pieces and the fracture does not extend to the articular surface.

[0073] The patient (not shown) lies supine on an operating table (not shown) throughout the procedure. The patient is anesthetized for the procedure. The patient is then draped with a sterile cover, leaving the leg to be operated on exposed.

[0074] The device according to the present invention has a rectangular base 1. The base 1 is a bottom plate, which is a rectangular plate with an open center to enable imaging from above relative to the leg without any metal in the imaging area. The purpose of the base 1, i.e., the bottom plate, is to stabilize the device and prevent it from being pressed against the soft mattress of the operating table. A vertical support 2 can be attached to the base 1.

[0075] Two upper supports 4 are attached to four vertical supports 2 at each corner of the base 1 by knurled head screws 19, approximately at tibia height when the knee is raised to an angle of about 10 degrees. The two upper supports 4 are attached to either side of the base 1 by extending across its longitudinal sides. In addition, two lower supports 3, also extending across the longitudinal sides of the base 1, are joined at approximately ankle height.

[0076] The lateral supports 5, 5', 5" and 6 are attached to the vertical supports 2, for example by screws 15, at approximately ankle height, and are connected to the other two sides of the base 1 by extending over the short sides of the base 1. The device further comprises a lateral support 6' between the lower supports 3, which moves on a guide carriage 8, such as a tow carriage, along the lower supports 3. The lower supports 3 are therefore constructed to function as sliding rails for the guide carriage 8 and to support the device.

[0077] The vertical supports 2, upper supports 4, lower supports 3 and lateral supports 5, 5', 5", 6 and 6' may be, for example, guides, pipes or rods, or corresponding supports or shafts.

[0078] In FIG. 2, the lowest lateral supports 5' and 5" are at a height somewhat lower than the lower support 3, and lateral support 5 and lateral support 6 are at a height somewhat higher than the lower support 3. For explanatory purposes, lateral support 6 is depicted discontinuously in FIG. 2 to make it easier to see how the first mounting arm 24 is attached to it, as will be explained later in the text. Lateral support 6 is a control shaft, the function of which will be explained below. In FIG. 2, lateral supports 5, 5', 5" and 6 are attached to the vertical support 2 by fastening screws 15 or another attachment method. The purpose of the holes (unnumbered) in the vertical support 2 is to lighten the weight of the vertical support 2, since it is heavy. The lateral supports 5, 5', 5" and 6 are in their fixed positions, and lateral support 6' moves along the lower support 3 as described above.

[0079] The device according to the invention is placed under the leg to be operated on, with the patient lying on his back, with the leg to be operated on facing the shaft 5 on the device.

[0080] After this, the operated leg must still be placed precisely or more precisely in position on the device to stabilize the fractured bone.

[0081] For stabilization, so-called traction needles are drilled laterally through the tibia, both at the top of the tibia, near the patella, below the patella, and at the bottom of the tibia, at the ankle. The drilling of the traction needles through the tibia is carried out by a guide attached to the upper support 4. The guide 21 moves along the other upper support 4.

[0082] The retractor needles are removed after surgery before the surgical wound is closed. However, before drilling the retractor needles, it must be ensured that the guide 21 for drilling the retractor needles is correctly positioned relative to the bone both vertically and laterally. The position of the guide 21 is confirmed with an X-ray machine and adjusted if necessary.

[0083] The guide 21 moves unhindered within the upper support 4 from the ankle to the knee and comprises separate lateral arms 11, 13 of different heights which act as finders for positioning the retraction needle. These lateral arms 11, 13 are directional and are not intended to rotate, therefore their shape is preferably other than circular, for example square, so as to better lock them in the lateral direction with the sleeve to prevent rotation.

[0084] Positioning of the first towing needle The guide 21 comprises a first sleeve 25 through which a first lateral arm 11 passes laterally relative to the upper support 4, the end of which indicates the retractor 20 in position A, where its lateral position is adjusted. When the retractor 20 is in position A within the sleeve 30 at the end of the lateral arm 11, it is marked as 20A. The lateral arm 11 serves as an upper finder for the subsequent installation of the retractor 20. The purpose of the lateral arm 11, i.e., the upper finder, is to adjust the lateral position of the guide 21, which is done by X-raying from above. The actual drilling of the retractor 20 through the tibia has not yet taken place at position A.

[0085] The guide 21 has a second sleeve (not visible on the other side of the guide 21) that passes through the height adjustment part 12, the second sleeve being at the top of the height adjustment part 12. The height adjustment part 12 can be a bar or the like. At the bottom of the height adjustment part 12 there is a third sleeve 10 through which the height adjustment part 12 of the guide 21 passes. This allows the height adjustment part 12 to combine the lower finder with the upper finder (i.e. the lateral arms 11 and 13).

[0086] The second lateral arm 13 passes through the sleeve 10 laterally relative to the upper support 4, and to this second lateral arm 13 the retractor needle 20 is now attached by means of a connecting piece 31 with a sleeve 23. In other words, the retractor needle is transferred from the lateral arm 11 to the lateral arm 13. The lateral arm 13 serves as a lower finder for the retractor needle 20, the same as was used previously to ascertain where the retractor needle 20 is located relative to the upper articular surface of the tibia, i.e., its position in the lateral direction has been ascertained, and then it has been transferred into the sleeve 23 of the lateral arm 13.

[0087] Thus, after lateral adjustment of the guide 21, once it has first been ensured by x-ray that the retractor needle 20 is at the correct height by lateral x-ray, this same retractor needle 20 is drilled through the sleeve 23 of the lower finder and further through either the upper or lower part of the tibia.

[0088] It is further emphasized that the leg is first x-rayed from above to ensure that the retractor needle 20 does not penetrate the joint and remains below the joint surface before transferring the retractor needle 20 from the upper finder to the lower finder, which are positioned on top of each other when viewed from above, and the finders are aligned on top of each other when the device is viewed from the side.

[0089] Once the position of the guide 21 is assured and correctly positioned, drilling of the retractor needle 20 through the bone is performed, typically to expose an equal area on each side of the leg.

[0090] To drill the bone, the retraction needle 20 is attached to a separate hand drill (not shown) before being drilled through the sleeve 23 into the tibia, i.e., once the guide 21, and therefore the sleeve 23, is set to the correct height relative to the tibia by using the height adjustment 12. An X-ray from above shows how close the needle is to the articular surface.

[0091] When the retractor needle 20 is at position B drilled into the bone, it is marked as 20B. Thus, position B represents the retractor needle 20B at position B drilled inside the bone. The order in which the needles 20 are positioned is not important, but it is more common to position the retractor needle at the top of the tibia first. Therefore, in this embodiment, it was assumed that the retractor needle 20 was drilled into the top of the tibia first.

[0092] The upper thigh traction needles 20 are attached at their ends, for example by thumbscrews 16' and clamps 14', to the first attachment arms 24 intended for them, at a small angle of about 10 degrees to the leg. The first attachment arms 24 are then attached to the fixed lateral supports 6 by rings 27, which pass through the rings 27. Alternatively, the lower ends of the first attachment arms 24 may be configured, for example, bent, around the lateral supports 6.

[0093] The first attachment arm 24 is attached to the lateral support 6 by a ring 27, allowing them to rotate back and forth. The attachment arm 24 rotates with the lateral support 6 when the screw 18 is loose. Thus, the first attachment arm 24 can be rotated to a rearward position that is out of the way when the patient is wearing the traction needle.

[0094] The first mounting arm 24 also moves slightly laterally along the lateral support 6 when the installed knurled head screw 32 is loosened.

[0095] On the outer surface of the lateral support 6 there is a groove 7 which remains on the inside or outside of the device at the end of the knee, i.e. at the end of the upper thigh.

[0096] The purpose of groove 7 is to allow a clamping screw, such as knurled head screw 32, to lock first attachment arm 24 in a position close enough to the skin to attach retractor needle 20 to first attachment arm 24. In other words, attachment arm 24 is first positioned close to the skin and then locked by knurled head screw 32 in lateral groove 7 on the outer surface of lateral support 6. Groove 7 prevents rotation of first attachment arm 24 because a portion of the clamping screw is at the bottom of groove 7. Without groove 7, tightening first attachment arm 24 against the rounded surface of lateral support 6 would allow first attachment arm 24 to rotate.

[0097] Positioning the second tow needle In this embodiment, the second retractor needle is positioned relative to the lower part of the tibia using the same guide 21 that the first retractor needle 20 was positioned relative to the upper part of the tibia.

[0098] When the longitudinal position of the second towing needle is adjusted in the upper finder 11, as was done with the first towing needle, the second towing needle is positioned at the end of the lateral arm 13, which functions as the lower finder, by means of the connecting piece 31 and the sleeve 23 therein.

[0099] The drilling of the second retractor needle through the bottom of the tibia at the ankle is performed in the same manner as the drilling of the first retractor needle 20 into the top of the tibia.

[0100] Since FIG. 2 is assumed to show a first retractor needle 20 drilled into the upper part of the tibia, the second retractor needle is not given its own reference number, but if the question were to position the second retractor needle, FIG. 2 would be exactly equivalent, except that the first retractor needle 20 would be replaced by the second retractor needle.

[0101] The transtibial traction needles are attached at both their upper ends to supporting attachment arms 36 intended for them, for example by means of thumb screws 47 and clamps or fastening plates 48. The support attachment arms 36 are part of the adjustment element of the invention, which is presented in more detail in FIG.

[0102] The adjustment tool is attached to a lateral support 6' which moves the legs at a small angle of about 10 degrees.

[0103] The adjustment tool is detachable and can be removed from the device, and instead of attaching the retraction needle to attachment arm 36 , the transtibial retraction needle can be attached to second support attachment arm 22 .

[0104] In that case, the transtibial traction needles are attached at their ends, for example by thumbscrews 16 and clamps 14, to second attachment arms 22 intended for them, which are attached to the moving lateral supports 6', with the legs at a small angle of about 10 degrees.

[0105] The second mounting arm 22 is attached to the lateral support 6' by a ring 27, allowing them to rotate back and forth. The second mounting arm 22 rotates together with the lateral support 6' when the screw 28 is loosened. Therefore, the second mounting arm 22 can be rotated to a rearward position that does not get in the way when the patient is wearing the traction needle. Therefore, the forward and backward movement of the second mounting arm 22 can be adjusted with the screw 17, thereby rotating the lateral support 6'.

[0106] The second mounting arm 22 also moves somewhat laterally along the lateral support 6' when the knurled head screw 32 is loosened.

[0107] To position the traction needle, i.e., the lower leg traction needle, the second attachment arm 22 is first placed close to the skin and then locked to the lateral support 6', which moves along the lower support 3, in a groove 7 on the outer surface of the lateral support 6', by means of a knurled head screw 32. At the ankle end, i.e., the lower leg end, the groove remains facing outwards from the device.

[0108] Once the retractor needle is positioned, screw 17 is rotated to a forward position and locked with knurled head screw 32 .

[0109] Some additional highlights are disclosed below.

[0110] Generally speaking, if the knurled head screw 32 is loose, the first and second mounting arms 22 and 24 and the support mounting arms 36 can simultaneously move laterally on the shaft 6 or 6' when the towing needle 20 is already attached to the first and second mounting arms 22 and 24 or the first and second mounting arms 24 and the support mounting arms 36. The rods 6, 6' and the first and second mounting arms 22, 24 and the support mounting arms 36 must not move forward or backward under any circumstances after the towing needle 20 is attached. If the knurled head screw 32 is loose and the thread is no longer in the groove 7, the first and second mounting arms 22, 24 and the support mounting arms 36 can freely rotate about the shaft 6, 6', but this should not happen.

[0111] The purpose of the long upper supports 4 at the top of the device is to stabilize the device. They can also be used to support the leg, for example, by using an X-ray drape during the actual intramedullary nailing procedure or when positioning the retractor needle at the very beginning of the procedure. Supporting with an X-ray drape means that the drape can be positioned so that both ends of the drape are attached to the upper supports 4 with, for example, a drape forceps. One end of the drape is on one upper support 4, and the other end of the drape is on the other upper support 4. In this way, the leg can be placed on one or more drapes, and therefore no support is required, for example, when positioning the retractor needle.

[0112] The upper support 4 is intentionally slightly higher than the attachment arm of the retractor needle when in the normal anterior position so that the upper support 4 does not interfere with radiography when imaging laterally relative to the leg.

[0113] The guide 21, used at the beginning of the procedure, is also attached to the upper support 4. The guide 21 slides unimpeded on the upper support 4 from the knee to the ankle. The guide 21 is always attached to the outermost, longest upper support 4 relative to the leg being operated on. The retractor needle is drilled into the tibia through the sleeve of the guide 21, which is why the guide 21 is always positioned within the outermost upper support 4. The guide 21 has two functions: an upper finder 11 and a lower finder 13. The upper finder 11 includes a lateral rod 30 with a hollow end, allowing the retractor needle to be placed at the end of the rod. The upper finder 11 indicates how far the retractor needle is from the joint surface using an X-ray machine, i.e., the X-ray is taken from above the leg. The lower finder 13 is used to view the exact height of the retractor needle from a lateral perspective relative to the leg using an X-ray machine. The lower finder 13 also includes a guide sleeve 23 through which the same retractor needle originally used in the upper finder is drilled through the bone. The lower finder also includes a height adjustment 12, e.g., a vertical rod, that allows the height of the sleeve relative to the bone to be adjusted. These two features, i.e., the upper finder and the lower finder, are clearly aligned with each other when the entity is viewed from above.

[0114] The upper support 4 can be removed from the device once the intramedullary nail is positioned in the tibia, but this is not required. The device can be constructed so that the upper support 4 does not get in the way when the fastening screws are placed in the nail.

[0115] In addition to stabilizing the device, the long lower support 3 also functions as a sliding rail for the guide carriage 8, or traction carriage, at the ankle. The carriage allows the appropriate amount of traction force to be applied to the leg to align the bone ends, and locks the guide carriage 8 to the lower support 3, preventing it from moving independently.

[0116] The lower lateral supports 5' and 5" are so-called fixed lateral supports and can be removed if necessary, but their purpose is to stabilize the device. The first mounting arms 24 of all two retractor needles are attached to the upper lateral support 6. Also, the lateral support 6 of the first mounting arm 24 has a milled groove on both ends, which means that the lateral support 6 can be rotated to a rearward position when the retractor needle is positioned in the patient's body using the finder 13. Once the retractor needle is positioned, the lateral support 6 is rotated to a forward position and locked in place with a knurled head screw 18, preventing the first mounting arm 24 from swinging.

[0117] The guide carriage 8 (i.e., traction carriage) moves unimpeded on the lower supports 3 from the ankle to the knee. The guide carriage 8 includes a bushing / sleeve (not numbered) through which each of the lower supports 3 passes, and the sleeve has some type of locking screw (not numbered) that can lock the guide carriage 8 in a desired position on the lower supports 3. The upper part of the lower sleeve through which the lower supports 3 pass has a separate attachment mechanism for the lateral support of the traction needle's attachment arm, which is attached to the lower sleeve. The first attachment arm 24 of the ankle traction needle functions in the same way as for the knee attachment, i.e., the first attachment arm 24 can be locked in a forward position, and the lateral support 6 has a groove 7 so that the first attachment arm 24 of the traction needle can be moved laterally and locked in a desired position within the groove 7 with a knurled head screw.

[0118] The upper support 4 is typically positioned approximately 5-7 cm higher than the traction needles, which are drilled through the tibia and attached to the first and second mounting arms 22 and 24, or to the first and support mounting arms 36 for the traction needles. The thickness of the human tibia is relatively constant in adult patients, and the needles are usually drilled through the center of the bone, so leg size is irrelevant. Therefore, the upper support 4 never interferes with imaging. The ankle is at the same height as the second mounting arm 22 or the support mounting arm 36.

[0119] The lateral support 6' is moved along the lower support 3 to allow the leg to be tractioned and positioned, and the leg is placed in a fixed position on the lower support 3 where it is correctly tractioned. For this purpose, the second attachment arm 22 or support attachment arm 36 for the traction needle on the lower part of the tibia is on a sliding rail by the lateral support 6', so that by pulling on the lower attachment mechanism, the end of the tibia can be aligned.

[0120] The leg is placed under longitudinal traction and laterally repositioned by aligning the bone ends at the fracture site, for example, by using an X-ray dressing. X-ray dressings are nonwoven fabrics with small metal threads inside. The purpose of the metal threads in the fabric (when used in surgeries that place the fabric inside a person's body) is to make it possible to locate the fabric by X-ray imaging, since otherwise, it would be practically impossible to find a blood-stained fabric. The fabric is approximately 40 cm long and, when unfolded, approximately 30 cm wide. The fabric can also be used to assist in attaching the traction needle by placing the fabric laterally on the upper support 4 so that the leg is supported by the fabric. Therefore, there is no need to support the leg when positioning the needle, and the leg remains in place better.

[0121] The holes in the rings 27 of the lateral support 6' and the first and second mounting arms 22, 24 are threaded, so that the support mounting arms 36 can be held in place by the knurled screws 32 when they are tightened into the bottom of their grooves; when the knurled screws are loosened, the first and second mounting arms 22, 24, or the first and second mounting arms 24, 24, and the support mounting arms 36 can again be moved simultaneously. This also prevents the mounting arms 22, 24, 36 from rotating downward due to the weight of the legs, because the screws 32 are in the grooves and not against a rounded surface. Similarly, the ring 27 of the lateral support 6 is provided with a knurled screw, not shown in FIG. 1, that is used for tightening in a corresponding manner.

[0122] FIG. 3 is a detailed view of a portion of FIG.

[0123] Once the retractor needle 20 is in place, the actual intramedullary nailing is performed: The surgeon then makes an incision above the patella, through which the instruments used to make the incision are inserted below the patella and into the inside of the tibia.

[0124] A tissue protector is first placed under the patella, which prevents instruments from damaging tissue and other critical areas not related to the surgery itself. All instruments required for the procedure, except for the intramedullary nail, are inserted into the tibia through the tissue protector.

[0125] Next, drill an entrance opening into the bone with a slightly larger drill bit to a depth of approximately 4 cm longitudinally of the bone.

[0126] A guide wire is then inserted into the bone, reaching down to the ankle. The guide wire is approximately 2 to 3 mm thick. This is because the drill bit used to drill the bone marrow is hollow, preventing the guide wire from penetrating and damaging the tissue at the fracture site.

[0127] After this, the bone is gradually drilled from the inside, or "reamed," by changing the drill bit to a 1.5 mm larger one after each drilling, until there is enough space for the intramedullary nail. The intramedullary nail is then inserted into the bone with the aid of a guide wire.

[0128] When the intramedullary nail is inside the bone, the guide wire is removed and the upper horizontal support 4 is optionally removed from the side of the device.

[0129] The intramedullary nail is then secured inside the patient with a screw. The upper support 4 is then optionally removed, after which the legs can be removed from the first and second attachment arms 22, 24 for the traction needle or the support attachment arm 36, and the needle is cut from one side closest to the skin and pulled out of the patient with flat-nose pliers.

[0130] After these procedures, the incision is closed and covered with a wound dressing.

Claims

1. An adjustment tool for a support device, said adjustment tool comprising a first adjustment shaft (34), a second adjustment shaft (35) and a third adjustment shaft (41) and a beam (33) whose rotational movement in at least one direction can be adjusted by at least one of said adjustment shafts (34, 35 and / or 41), The first adjusting shaft (34) is attached to the beam (33); The second adjusting shaft (35) is attached to the first adjusting shaft (34), the third adjusting shaft (41) is attached to the second adjusting shaft (34), and the adjusting tool comprises: a pair of mounting arms (36) on either side of the first adjustment shaft (34) that are laterally movable along the beam (33); Further provided with Adjustment tool.

2. 2. The adjustment tool of claim 1, wherein the first adjustment shaft (34), the second adjustment shaft (35), and the third adjustment shaft (41) are perpendicular to each other.

3. 3. The adjustment tool according to claim 1 or 2, wherein the first adjustment shaft (34), the second adjustment shaft (35), and the third adjustment shaft (41) can be rotated relative to one another simultaneously or separately by lock screws (37, 38, and 42) within the respective adjustment shafts (34, 35, and 41).

4. 4. An adjustment tool according to any one of claims 1 to 3, wherein the rotational movement comprises a first rotation of the beam (33) about its midpoint in a horizontal plane, whereby a first lock screw (37) for the first rotational adjustment is present in the first adjustment shaft (34).

5. 5. An adjustment tool according to any one of claims 1 to 4, wherein the rotational movement includes a second rotation of the beam (33) about its midpoint in a vertical plane, whereby a second lock screw (38) for the second rotational adjustment is present in the second adjustment shaft (35).

6. 6. The adjustment tool of claim 1, wherein the rotational movement includes a third rotation of the beam (33), which is an angular rotation along an arc defined by the distance between the third adjustment shaft (35) and the beam (33), whereby a third lock screw (42) for the third rotational adjustment is present in the third adjustment shaft (35).

7. 7. An adjustment tool according to any one of claims 1 to 6, further comprising a set screw (39) fastened to the second adjustment shaft (35) to hold the first adjustment shaft (34) in place for added security.

8. 8. An adjustment tool according to any one of claims 1 to 7, further comprising a fourth lock screw (40) that passes vertically through the first adjustment shaft (34) and secures it to the beam (33).

9. 9. Adjusting tool according to any one of claims 1 to 8, wherein the third adjusting shaft (41) is a two-part shaft, the parts being fixed together by means of a screw (43).

10. 10. The adjustment tool of claim 1, wherein the mounting arms (36) are laterally movable along the beam (33) on either side of the first adjustment shaft (34) and have a fifth lock screw (44) for fixing the mounting arms (36) in a selected location on the beam (33).

11. 11. An adjustment tool according to any one of claims 1 to 10, wherein the lateral movement of the mounting arms (36) is effected along at least one groove (45) in the beam (33) by means of a sliding screw (46) which holds the mounting arms (36) in position in the beam (33) and allows them to slide along the at least one groove (45) by means of a ball at the end of the sliding screw (46).

12. 12. Adjusting tool according to any one of the preceding claims, wherein the third adjusting shaft (41) has the form of a mounting ring that surrounds a support arm of a support device.

13. 13. An adjustment tool according to any one of the preceding claims, wherein the mounting arms (36) have means for connecting them to another component of the support device, such as a thumbscrew.

14. 14. The adjustment tool of claim 13, wherein the means for coupling the mounting arm (36) to another component of the support apparatus further comprises a fastening plate (48) through which the thumbscrew (47) passes.

15. A support device having a positioning and supported component, said support device having an adjustment tool according to any one of claims 1 to 14, which is coupled on the one hand to its lateral support arms and on the other hand to its component, said adjustment tool comprising a first adjustment shaft (34), a second adjustment shaft (35) and a third adjustment shaft (41) and a beam (33) whose rotational movement in at least one direction can be adjusted by at least one of the adjustment shafts (34, 35 and / or 41), The first adjusting shaft (34) is attached to the beam (33); The second adjusting shaft (35) is attached to the first adjusting shaft (34), the third adjusting shaft (41) is attached to the second adjusting shaft (34), and the adjusting tool comprises: a pair of mounting arms (36) on either side of the first adjustment shaft (34) that are laterally movable along the beam (33); Further provided with Support device.

16. The support device of claim 15, wherein the support device is for positioning a patient for surgery such as correction of a bone dislocation or intramedullary nailing of the tibial bone.

17. 17. A support device according to claim 16 for correction of bone dislocation or intramedullary nailing of the tibia, said support device comprising: a framework frame consisting of vertical supports (2) and longitudinal horizontal supports (3, 4) and lateral horizontal supports (5, 5', 5", 6, 6'); a traction needle (20) that is passed through the tibia; a guide (21) slidably coupled to the longitudinal horizontal support (4) of the support device, said guide (21) comprising: a first finder (11) for adjusting the position of the traction needle (20) in the lateral direction relative to the articular surface of the upper part of the tibia; a second finder (13) for adjusting the position of the retractor needle (20) in the vertical direction and for passing the retractor needle (20) through the tibia in the lateral direction of the tibia; a guide (21) comprising: Equipped with a support device, wherein the first attachment arm (24) is configured to be attached to one end of the frame and to an end of the traction needle (20) that is passed laterally through the tibia using the guide (21); 15. An adjustment tool according to any one of claims 1 to 14, coupled at the other end of the frame other than the first mounting arm (24) to a horizontal support (6') slidably mounted between some of the longitudinal supports in the frame. The adjustment tool further comprises: a first adjusting shaft (34), a second adjusting shaft (35), and a third adjusting shaft (41); and a beam (33) whose rotational movement in at least one direction can be adjusted by at least one of said adjusting shafts (34, 35, and / or 41); Equipped with The first adjusting shaft (34) is attached to the beam (33); The second adjusting shaft (35) is attached to the first adjusting shaft (34), the third adjusting shaft (41) is attached to the second adjusting shaft (34), and the adjusting tool comprises: a pair of mounting arms (36) on either side of the first adjustment shaft (34) that are laterally movable along the beam (33); Further provided with A support device comprising:

18. 18. The device according to claim 17, wherein when the device is used as a device for intramedullary nailing of the tibia, the device further comprises a second mounting arm (22) configured to be attached to the frame so that, instead of the support mounting arm (36), it can be attached to the end of the traction needle (20) that has been passed laterally through the tibia by using the guide (21), and the third adjustment shaft (41) is a two-part shaft, the parts being fixed to each other by a screw (43) to allow easy removal of the adjustment element.

19. 19. Apparatus according to claim 17 or 18, wherein the transverse supports (6') slidably mounted between the longitudinal supports slide along the longitudinal supports by means of guide carriages (8), the longitudinal horizontal supports consisting of upper supports (4) and lower supports (3), the lower supports (3) acting as sliding rails for the guide carriages (8).

20. 20. The device according to claim 19, wherein the angular rotation of the beam (33) can be performed by the guide carriage (8) via the slidable lateral support (6') fastened to the third adjusting shaft (41).

21. 21. Apparatus according to any one of claims 17 to 20, wherein the lateral supports (6', 6) are configured to rotate forward and backward, meaning that the mounting arms (36, 22 and 24, respectively) attached to the lateral supports (6', 6) can be rotated to a forward and backward position.

22. 22. Apparatus according to any one of claims 14 to 21, wherein the mounting arms (36, 22, 24) are attached to the transverse supports (6' and 6 respectively) by means of rings (27, 27') surrounding them or by having ends which surround the transverse supports (6' and 6 respectively), the rings (27, 27') or ends being provided with threaded holes into which screws (44, 32) can be fastened into the bottoms of grooves to hold the mounting arms (36, 22, 24) in place.

Images