An extracorporeal positioning system for intramedullary fixation of femoral intertrochanteric fractures

Abstract

This invention discloses an external positioning system for intramedullary fixation of intertrochanteric fractures of the femur, comprising: a main connecting rod for axial fixation along the femoral axis to the lateral thigh; a distal clamp at the distal end of the main connecting rod for clamping and fixing to the distal femoral shaft; a trochanteric apex positioning component connected to the proximal end of the main connecting rod and having a positioning portion for engaging with the apex of the greater trochanter; a secondary connecting rod parallel to and slidably connected to the main connecting rod and lockable at a selected position on the main connecting rod; and a needle guide connected to the proximal end of the secondary connecting rod and having a guide channel for guiding the guide needle into the femoral medullary cavity. This invention effectively reduces the number of intraoperative fluoroscopy sessions, shortens surgical time, reduces patient bleeding and infection risk, reduces radiation exposure for both doctors and patients, and improves surgical precision and safety. Furthermore, each component can be used individually or in combination to adapt to different fracture types and surgical needs.

Description

Technical Field

[0001] This invention belongs to the technical field of medical devices, specifically relating to an external positioning system for intramedullary fixation of intertrochanteric fractures of the femur. Background Technology

[0002] Intertrochanteric fractures of the femur are a common type of hip fracture in the elderly, and intramedullary nailing is currently one of the mainstream treatment methods in clinical practice. In this surgery, the selection of the entry point for the main intramedullary nail is crucial. The ideal entry point is usually located slightly medial to the apex of the greater trochanter of the femur. The accuracy of the entry point directly affects whether the main nail can be successfully placed into the femoral medullary cavity, whether it will cause displacement of the fracture fragments, and whether it will affect the blood supply to the femoral head.

[0003] Currently, the location of the entry point for commonly used intramedullary nailing instruments (such as PFNA and InterTan) relies primarily on the surgeon's anatomical experience and subjective judgment based on fluoroscopic images. Surgeons typically probe the entry point repeatedly by palpating the apex of the greater trochanter and using intraoperative C-arm fluoroscopic images (anteroposterior and lateral views). However, due to potential displacement of the greater trochanter after fracture, soft tissue covering affecting the accuracy of palpation, and the two-dimensional limitations of fluoroscopic images, even experienced surgeons find it difficult to accurately determine the entry point on the first attempt.

[0004] Relying on experience often requires surgeons to adjust the needle insertion point multiple times and perform repeated fluoroscopy verification, leading to prolonged operation time, increased patient bleeding, and a significantly higher X-ray radiation dose for both doctors and patients. The difficulty in locating the needle insertion point is particularly pronounced in obese patients or cases with severe fractures.

[0005] Although there are some auxiliary positioning devices in the existing technology, such as navigation templates and laser locators, they either require preoperative three-dimensional planning, have complex structures that are difficult to adjust flexibly during surgery, or are not compatible with existing standard intramedullary nailing devices, and have not been widely promoted in clinical practice. Summary of the Invention

[0006] The purpose of this invention is to provide an external positioning system for intramedullary fixation of intertrochanteric fractures of the femur, in order to solve the problems in the prior art.

[0007] Therefore, the present invention provides an external positioning system for intramedullary fixation of intertrochanteric fractures of the femur, comprising: The main connecting rod is used to fix it to the lateral thigh along the femoral axis. The distal end of the main connecting rod is provided with a distal clamp, which is used to clamp and fix it to the distal end of the femoral shaft. A trochanter apex positioning element is connected to the proximal end of the main connecting rod and has a positioning part for engaging with the top of the trochanter; A secondary connecting rod is parallel to and slidably connected to the main connecting rod, and can be locked at a selected position on the main connecting rod; The needle guide is connected to the proximal end of the secondary connecting rod and has a guide channel for guiding the guide needle into the femoral medullary cavity.

[0008] In some embodiments, a multi-plane angle positioning device is further included, the multi-plane angle positioning device comprising: A first angle measuring ring and a second angle measuring ring that are perpendicular to each other, both of which are transparent rings and are sealed with half a volume of liquid and air bubbles inside; and A fixed bracket is used to detachably mount the multi-plane angle positioning instrument onto the main connecting rod or the auxiliary connecting rod.

[0009] In some embodiments, the fixing bracket includes a square collar for fitting the multi-plane angle positioning instrument, and two pins disposed below the square collar, at least one of which is provided with a pressure screw for locking.

[0010] In some embodiments, the fixing bracket includes: A square collar and a high-temperature resistant silicone belt disposed below the square collar. One end of the silicone belt is fixed to the square collar, and the other end has multiple holes for fastening to the screw bolts on the other side of the square collar, so as to adapt to the fixing objects with different outer diameters.

[0011] In some embodiments, a multi-plane measuring scale assembly is also included, the multi-plane measuring scale assembly comprising: An X-ray-transmitting straight ruler and an X-ray-transmitting vertical ruler, wherein the straight ruler and the vertical ruler are connected perpendicularly to each other, and the surface of the straight ruler and / or the vertical ruler is embedded with an opaque metal scale mark. And a fixing buckle, used to detachably install the straightedge or ruler onto the secondary connecting rod.

[0012] In some embodiments, the ruler is provided with a metal watchband that can slide along the ruler body for marking the start and end points of measurement under X-ray fluoroscopy.

[0013] In some embodiments, the ridge vertex positioning element includes: The positioning frame body, and a three-dimensional claw structure disposed at the far end of the positioning frame body, the three-dimensional claw structure being used to form a three-point bony engagement with the top of the greater trochanter.

[0014] In some embodiments, the three-dimensional claw structure includes a large leaf foot and two small leaf feet, with the three leaf feet arranged in a triangular pattern. The large leaf foot is connected to a first screw for adjusting the insertion depth.

[0015] In some embodiments, a protruding structure is provided at the proximal end of the main connecting rod, and a longitudinal adjustment hole is provided on the protruding structure. The secondary connecting rod passes through the longitudinal adjustment hole via a connecting crossbeam, and locking nuts are provided at both ends of the connecting crossbeam. The main connecting rod also has a first transverse connecting hole at its near end.

[0016] In some embodiments, the inner wall of the longitudinal adjustment hole is provided with scale markings along the length direction.

[0017] In some embodiments, the secondary connecting rod includes a secondary connecting rod portion, a second transverse connecting hole is provided at the proximal end of the secondary connecting rod portion, a connecting beam is provided on the secondary connecting rod plate near the second transverse connecting rod, and a locking nut is provided on the connecting beam.

[0018] In some embodiments, the needle guide includes: A positioning rod is laterally adjustable to the proximal end of the auxiliary connecting rod. The positioning rod includes a second screw and a plurality of locking nuts connected to the second screw. One end of the screw is provided with a positioning hole. A sleeve is detachably inserted into the positioning hole on the positioning rod, and the internal channel of the sleeve constitutes the guide channel.

[0019] In some embodiments, the sleeve includes a sleeve body, a handle is connected to one side of the sleeve body, and the sleeve body has the internal channel along its length. One end of the sleeve is tapered.

[0020] Beneficial effects: This invention transforms the placement of the needle entry point in intramedullary nailing for intertrochanteric fractures of the femur from a process reliant on repeated trial-and-error based on the surgeon's experience to a mechanically guided approach based on bony anatomical landmarks by incorporating a main connecting rod, a trochanteric apex positioning component, a secondary connecting rod, and a needle entry guide. During the procedure, simply engaging the trochanteric apex positioning component at the top of the greater trochanter and adjusting the positions of the secondary connecting rod and the needle entry guide accurately determines the needle entry point, eliminating the need for multiple fluoroscopic verifications. This reduces the number of X-ray exposures during surgery, shortens the operation time, and minimizes soft tissue damage and bleeding caused by repeated punctures. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram illustrating the use of this application.

[0023] Figure 2 A schematic diagram of the main connecting rod.

[0024] Figure 3 This is a structural schematic diagram of the secondary connecting rod.

[0025] Figure 4 This is a structural schematic diagram of the ridge vertex positioning component.

[0026] Figure 5 This is a schematic diagram of the needle guide component.

[0027] Figure 6 This is a schematic diagram of the structure of a multi-plane angle positioning instrument.

[0028] Figure 7 This is a schematic diagram of one embodiment of the fixed bracket for a multi-plane angle positioning instrument.

[0029] Figure 8 This is a schematic diagram of another embodiment of the fixed bracket for a multi-plane angle positioning instrument.

[0030] Figure 9 This is a schematic diagram of the structure of a multi-plane measuring ruler assembly.

[0031] Figure 10 This is a schematic diagram of the fixing clip structure for a multi-plane measuring ruler assembly.

[0032] In the diagram: 100, main connecting rod; 110, protruding structure; 120, longitudinal adjustment hole; 121, first scale mark; 130, first transverse connecting hole; 200, ridge apex positioning component; 210, positioning frame body; 220, three-dimensional claw structure; 221, leaf foot; 222, first screw; 230, fixing pin; 300, secondary connecting rod; 310, secondary connecting rod section; 311, second scale mark; 320, second transverse connecting hole; 330, connecting beam; 340, locking nut; 400, needle guide component; 410, positioning rod; 411, second screw; 412, locking mechanism. Nut; 413, Positioning hole; 420, Sleeve; 421, Sleeve body; 422, Handle; 423, Internal channel; 500, Multi-plane angle positioning instrument; 510, First angle measuring ring; 520, Second angle measuring ring; 530, Fixing bracket; 531, Square collar; 532, Pin; 533, Pressure screw; 534, Silicone belt; 535, Hole; 536, Screw bolt; 600, Multi-plane measuring ruler assembly; 610, Straight ruler; 620, Vertical ruler; 630, Metal scale markings; 640, Fixing buckle; 650, Metal watchband spindle; 700, Remote clamp. Detailed Implementation

[0033] The invention will be more readily understood by referring to the following detailed description of preferred embodiments and included examples. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the definitions in this specification shall prevail.

[0034] like Figures 1-10 As shown, an external positioning system for intramedullary fixation of intertrochanteric fractures of the femur includes: It includes a main connecting rod 100, a ridge apex positioning component 200, a secondary connecting rod 300, a needle guide component 400, and a distal clamp 700.

[0035] The main connecting rod 100 is a long strip-shaped rod used to fix it to the lateral thigh along the femoral axis. The distal end of the main connecting rod 100 is provided with a distal clamp 700, which is used to clamp and fix it to the distal end of the femoral shaft, thereby maintaining a relatively fixed positional relationship between the main connecting rod 100 and the femoral shaft.

[0036] The trochanteric apex positioning element 200 is connected to the proximal end of the main connecting rod 100. The trochanteric apex positioning element 200 has a positioning part for engaging with the top of the greater trochanter. In use, the positioning part is directly engaged with the bony prominence at the top of the patient's greater trochanter, thereby providing a stable spatial reference point for the entire system based on this anatomical landmark.

[0037] The auxiliary connecting rod 300 is arranged parallel to the main connecting rod 100 and is slidably connected to the main connecting rod 100. The auxiliary connecting rod 300 can move along the axial direction of the main connecting rod 100 and can be locked after moving to a selected position to adapt to the surgical needle insertion position of different patients.

[0038] The needle guide 400 is connected to the proximal end of the secondary connecting rod 300. The needle guide 400 has a guide channel for guiding the guide needle into the femoral medullary cavity. After the surgeon passes the guide needle through the guide channel, the guide needle can be inserted in the predetermined direction.

[0039] In use, firstly, the main connecting rod 100 is fixed to the lateral aspect of the patient's thigh using the distal clamp 700, making the main connecting rod 100 approximately parallel to the femoral shaft axis. Then, the positioning part of the trochanteric apex positioning component 200 is engaged with the apex of the greater trochanter, thereby establishing a spatial coordinate system based on this bony landmark. Next, according to the preoperative planning or intraoperative measurement of the needle insertion point, which is usually located a certain distance medial to the apex of the greater trochanter, the secondary connecting rod 300 is slid along the axial direction of the main connecting rod 100 to adjust it to the appropriate position and lock it. At this point, the end of the guide channel of the needle insertion guide 400 is aligned with the preset needle insertion point. Finally, the guide needle is passed through the guide channel and drilled into the femoral medullary cavity along the direction determined by the channel.

[0040] Based on the above technical solution, a bony benchmark is established through the trochanteric apex positioning component 200, and the needle insertion position is adjusted using the sliding secondary connecting rod 300. The entire system transforms the positioning of the intramedullary nail insertion point from repeated trial and error based on experience to quantitative adjustment based on anatomical landmarks. Therefore, it can reduce the number of intraoperative fluoroscopy sessions, shorten the operation time, and reduce soft tissue damage and bleeding caused by repeated punctures. At the same time, the connection method between the components allows the surgeon to flexibly adjust the system during the operation to adapt to the specific conditions of different patients.

[0041] In one embodiment, such as Figure 6-8 As shown, the external positioning system also includes a multi-plane angle locator 500. The multi-plane angle locator 500 is used to simultaneously measure coronal and sagittal angles during surgery to guide the insertion direction of the guide needle or spiral blade.

[0042] The multi-plane angle locator 500 includes a first angle measuring ring 510, a second angle measuring ring 520, and a fixing bracket 530. Both the first and second angle measuring rings are transparent, high-temperature resistant acrylic rings. The first angle measuring ring 510 has a diameter of 6 cm, and the second angle measuring ring 520 has a diameter of 5 cm. The tube diameter of each ring is 1 cm, and the wall thickness is 0.5 cm. The two measuring rings are joined together perpendicularly. One ring is used to measure the anteroposterior tilt angle in the coronal plane, and the other ring is used to measure the varactuation angle in the sagittal plane. A rectangular column is connected below the two measuring rings. The column is 4 cm high and has a side length of 1 cm.

[0043] Each angle measuring ring is a closed hollow ring, containing half a volume of liquid and an air bubble. The liquids in the two rings are not interconnected. The outer surface of each ring is engraved with angle graduations along the circumference, ranging from 0 degrees to 360 degrees, with 0 degrees and 180 degrees located at the two ends of the horizontal diameter. When the multi-plane angle locator 500 is placed horizontally, the liquid levels in both rings are located at the 0-degree (or 180-degree) horizontal line, and the air bubble is located at the highest point of the ring.

[0044] like Figure 7-8 As shown, the mounting bracket 530 is used to detachably mount the multi-plane angle positioning instrument 500 onto the main connecting rod 100 or the auxiliary connecting rod 300. The upper end of the mounting bracket 530 has a square collar that fits onto the column of the multi-plane angle positioning instrument 500 and is locked in place by screws. The lower end of the mounting bracket 530 has a connection structure that matches the main connecting rod 100 or the auxiliary connecting rod 300; this can be a pin or a snap-fit, to fix the entire angle measuring instrument at the desired measurement position.

[0045] In use, the fixing bracket 530 is installed on the main connecting rod 100 or the auxiliary connecting rod 300, ensuring the multi-plane angle locator 500 is horizontal. Observe the positions of the bubbles in the two angle measuring rings. When the bubble in one ring is at the 0-degree mark, the liquid level of that ring is the horizontal reference. The angle indicated by the bubble in the other ring is the actual angle to be measured. For example, when inserting a femoral neck guide wire, the anteversion angle of the guide wire needs to be determined. After adjusting the multi-plane angle locator 500 to a horizontal position, read the scale value corresponding to the bubble on the second angle measuring ring 520. This value is the current anteversion angle of the guide wire in the sagittal plane. The surgeon can adjust the direction of the needle insertion guide 400 accordingly until the angle indicated by the bubble reaches the required value for the surgery. Because the two rings are perpendicular to each other, the surgeon can simultaneously observe the angle changes in the coronal and sagittal planes without repeatedly switching between anteroposterior and lateral fluoroscopy.

[0046] The Multi-Plane Angle Positioner 500 can simultaneously provide angular references from two orthogonal planes externally. Surgeons can obtain the tilt angle and neck-shaft angle of the guide needle or spiral blade in real time by observing the bubble position, thereby reducing errors in angle estimation based on fluoroscopic images, minimizing the number of repeated fluoroscopic adjustments, and shortening surgical time. Furthermore, this angle positioner employs a mechanical bubble structure, does not rely on electronic components, can withstand high-temperature and high-pressure sterilization, and is convenient and reliable to use.

[0047] In one embodiment, the fixing bracket 530 is used to mount the multi-plane angle positioning instrument 500 on the main connecting rod 100 or the auxiliary connecting rod 300. Depending on the different specifications of the surgical instruments, the fixing bracket 530 can be configured as either a special type or a multi-purpose type.

[0048] In one specific implementation, such as Figure 7As shown, the fixing bracket 530 is a dedicated fixing bracket. This dedicated fixing bracket includes a square collar 531 and two pins 532. The square collar 531 has a height of 5 cm, an outer side length of 2 cm, and an inner side length of 1 cm. The square collar 531 is fitted onto the column of the multi-plane angle positioning instrument 500 and locked in place by screws on the side wall. The two pins 532 are located below the square collar 531, each pin having a height of 3 cm and a width of 0.6 cm. The two pins 532 extend parallel downwards for direct insertion into pre-set insertion holes on the main connecting rod 100 or the auxiliary connecting rod 300. At least one of the pins 532 is equipped with a pressure screw 533, the diameter of which is 0.4 cm. After inserting the pin 532 into the insertion hole, tightening the pressure screw 533 securely locks the fixing bracket 530 onto the target rod. This specialized mounting bracket has a compact structure and a stable connection, and is suitable for connecting rods with standard sockets.

[0049] In another specific implementation, such as Figure 8 As shown, the fixing bracket 530 is a multi-purpose fixing bracket. This multi-purpose fixing bracket also includes a square collar 531, which is mounted on the column of the multi-plane angle locator 500 and has the same dimensions as the dedicated type. Two prongs 532 are located below the square collar 531, each prong being 4 cm high. One prong 532 has a screw bolt 536. The multi-purpose fixing bracket also includes a high-temperature resistant silicone belt 534. One end of the silicone belt 534 is fixed to the lower end of the square collar 531, and the other end has multiple holes 535. The silicone belt 534 is used to wrap around the instrument being fixed, such as Kirschner wires or intramedullary nail aiming arms of different diameters. Then, the holes 535 at the end of the belt are fastened to the screw bolt 536, thereby securing the fixing bracket 530 to the instrument. Because the silicone belt 534 is elastic and has multiple holes 535, it can be adapted to fixing objects of different outer diameters. This multi-purpose fixation bracket requires no pre-set insertion holes and can be flexibly installed on surgical instruments of various shapes and sizes, expanding the application range of the multi-plane angle positioner 500.

[0050] In one embodiment, such as Figure 9-10 As shown, the external positioning system also includes a multi-plane measuring scale assembly 600. The multi-plane measuring scale assembly 600 is used to directly measure bone dimensions, guide pin insertion depth, and distal locking pin length under X-ray fluoroscopy.

[0051] like Figure 9As shown, the multi-plane measuring ruler assembly 600 includes an X-ray-transparent flat ruler 610, an X-ray-transparent vertical ruler 620, and a fixing clip 640. Both the flat ruler 610 and the vertical ruler 620 are made of carbon fiber material, which has a low X-ray absorption rate and therefore hardly shows up in fluoroscopic images, thus not obstructing the observation of bones and instruments.

[0052] The ruler 610 is a rectangular plate structure, 15 cm long, 3 cm wide, and 0.5 cm thick. The upper surface of the ruler 610 is inlaid with metal graduation marks 630, which are made of an X-ray-opaque metal material (such as tungsten or lead) and therefore clearly visible under X-ray fluoroscopy. The ruler 610 has two dumbbell-shaped metal chains 650 that slide along its body. These chains are attached to the frame of the ruler 610 and can slide freely. When measuring the distance between two points under fluoroscopy, the two metal chains 650 are moved to align with the start and end points of the distance to be measured, respectively. The difference in graduations between the two chains is then read on the X-ray image, or a known length of a metal chain 650 can be used as a reference for calculation.

[0053] The ruler 620 is a long, rod-shaped structure, 15 cm long and 0.6 cm wide. Also made of carbon fiber, its surface is inlaid with X-ray-proof metal graduation markings 630. The upper end of the ruler 620 has a threaded connection, which connects vertically to the flat ruler 610 via four screws, forming an L-shaped or T-shaped combination ruler. The flat ruler 610 has four screw holes for mating with the threaded connection of the ruler 620.

[0054] like Figure 10 As shown, the retaining clip 640 is used to detachably mount the straightedge 610 or the vertical ruler 620 to the auxiliary connecting rod 300 or other surgical instruments. The retaining clip 640 includes a clip body, a pressure screw, and a circular through hole. The circular through hole has a diameter of 0.6 cm and is used for the auxiliary connecting rod 300 or other rods to pass through. After tightening the pressure screw, the retaining clip 640 is locked onto the rod, keeping the straightedge 610 or the vertical ruler 620 in a stable position. The retaining clip 640 can be configured as either a dedicated type or a multi-purpose type. The dedicated type retaining clip has a top and bottom edge length of 2 cm, a height of 3 cm, and a clip width of 1 cm, suitable for the standard rods of this system. The multi-purpose fixing buckle has a top side length of 3 cm, a long post height of 3 cm, a short post height of 2 cm, and a buckle width of 2 cm. The short post is equipped with a screw bolt and a high-temperature resistant silicone belt. One end of the silicone belt is fixed to the lower end of the buckle, and the other end has multiple holes for fastening to the screw bolt on the short post, thus adapting to instruments with different outer diameters.

[0055] In use, the fixing clip 640 is installed on the secondary connecting rod 300, and then the straightedge 610 or the vertical ruler 620 is fixed to the clip. Under X-ray fluoroscopy, the metal scale markings 630 on the straightedge 610 and the vertical ruler 620 are clearly visible in the image, and can be used as a length reference to directly read the transverse diameter, anteroposterior diameter of the bone, or the insertion depth of the guide pin. When the distal femoral locking screw is not accurately positioned, the position of the locking screw hole can be marked by moving the metal watch chain axis 650 under fluoroscopy, assisting the surgeon in positioning the locking screw hole and performing blind insertion. Since the straightedge 610 and the vertical ruler 620 are perpendicular to each other, the dimensions of the transverse and sagittal planes can be measured simultaneously without repeated positioning.

[0056] In one embodiment, such as Figure 4 As shown, the trochanteric apex positioning element 200 is used to establish a stable bony connection between the entire system and the top of the greater trochanter.

[0057] The ridge apex positioning component 200 includes a positioning frame body 210 and a three-dimensional claw structure 220. The positioning frame body 210 has a height of 5 cm, and a circular hole with an inner diameter of 0.5 cm, an outer diameter of 1 cm, and a height of 1 cm is provided at its upper end. This circular hole is used to connect the positioning frame crossbeam, which in turn connects to the first transverse connecting hole 130 of the main connecting rod 100.

[0058] A three-dimensional clamping structure 220 is located at the distal end of the positioning frame body 210. The three-dimensional clamping structure 220 includes one large leaf foot and two small leaf feet, arranged in a triangular pattern. The length and width of the large leaf foot are greater than those of the small leaf feet, and a first screw 222 is connected to the large leaf foot. The first screw 222 passes through the positioning frame body 210, and the extension length of the large leaf foot is adjusted by a nut. The two small leaf feet are fixed to the two sides of the distal end of the positioning frame body 210. The three leaf feet work together to clamp onto the bony prominence at the top of the greater trochanter, forming a three-point bony clamping connection. Because the bone surface at the top of the greater trochanter is not completely flat, the triangular three-point distribution allows the positioning element to stably conform to the bone surface. Even if the greater trochanter partially shifts after a fracture, the three leaf feet can still find a stable clamping plane.

[0059] The trochanteric apex positioning component 200 also includes a fixation pin 230. The fixation pin 230 is shaped like a "7," with a length of 6 cm, a width of 5 cm, and a thickness of 0.5 cm. The fixation pin 230 is used to fix the trochanteric apex to the apex of the greater trochanter by tapping with the positioning frame body 210. After the three-dimensional claw structure 220 is engaged with the top of the greater trochanter, the tip of the fixation pin 230 is pressed against the soft tissue or cortical bone of the trochanteric apex, and the other end of the fixation pin 230 is gently tapped with a hammer to allow it to partially penetrate the bone or adhere tightly to the bone surface, thereby temporarily fixing the trochanteric apex positioning component 200 to the bone and preventing displacement of the positioning frame due to touch or traction during surgery.

[0060] The triangular three-dimensional clamp structure 220 can adapt to the irregular bone surface morphology of the greater trochanter, providing stable three-point support. The adjustable first screw 222 on the greater lobule foot allows the surgeon to adjust the clamping depth according to the specific size of the patient's greater trochanter, ensuring stable fixation for patients of different body types. The figure-seven fixing pin 230 further enhances the connection strength between the trochanter apex positioning element 200 and the bone, ensuring that the entire system maintains its reference position during intraoperative procedures.

[0061] In one embodiment, such as Figure 2-3 As shown, the specific structure of the main connecting rod 100 and the auxiliary connecting rod 300 is explained.

[0062] like Figure 2 As shown, a protruding structure 110 is provided at the proximal end of the main connecting rod 100. A longitudinal adjustment hole 120 is provided on the protruding structure 110, with dimensions of 5 cm in length and 0.6 cm in width. A first scale mark 121 is provided along the length direction on the inner wall of the longitudinal adjustment hole 120. The first scale mark 121 is in millimeters and is used to record the sliding position of the secondary connecting rod 300, facilitating the surgeon to reproduce the same adjustment amount during or after surgery.

[0063] A first transverse connecting hole 130 is also provided near the main connecting rod 100. The first transverse connecting hole 130 is 5 cm long and 0.6 cm wide. The first transverse connecting hole 130 is located on one side of the protruding structure 110 and is used to connect the positioning frame beam of the ridge apex positioning member 200. After the positioning frame beam passes through the first transverse connecting hole 130, it is fixed by the locking nuts at both ends. Since the first transverse connecting hole 130 is elongated, the positioning frame beam can move laterally within a certain range within the hole, thereby fine-tuning the transverse position of the ridge apex positioning member 200 relative to the main connecting rod 100.

[0064] like Figure 3 As shown, the auxiliary connecting rod 300 includes an auxiliary connecting rod portion 310. The auxiliary connecting rod portion 310 is 40 cm long, 1.5 cm wide, and 0.5 cm thick. A second transverse connecting hole 320 is provided at the proximal end of the auxiliary connecting rod portion 310. The second transverse connecting hole 320 is 4 cm long and 0.6 cm wide, and is used to connect the positioning rod 410 of the needle guide 400.

[0065] A connecting beam 330 is provided on the secondary connecting rod 310 near the second transverse connecting hole 320. The connecting beam 330 is a circular stud, 4 cm long and 0.6 cm wide. One end of the connecting beam 330 is fixed to the secondary connecting rod 310, and the other end passes through the longitudinal adjustment hole 120 of the main connecting rod 100. Locking nuts 340 are provided at both ends of the connecting beam 330. When the locking nuts 340 are loosened, the connecting beam 330 can slide within the longitudinal adjustment hole 120 and rotate around its own axis, so that the secondary connecting rod 300 can both translate axially along the main connecting rod 100 and make small-angle deflection adjustments relative to the main connecting rod 100. After tightening the locking nuts 340, the connecting beam 330 is clamped on the inner wall of the longitudinal adjustment hole 120, and the position and orientation of the secondary connecting rod 300 are locked.

[0066] The secondary connecting rod 310 has a second scale mark 311 along its length. The second scale mark 311 is located on the upper surface or side of the secondary connecting rod 310, with a scale range of 35 cm, and is used to record the installation position of the needle guide 400 or to measure other surgical-related lengths.

[0067] In one embodiment, such as Figure 5 As shown, the specific structure of the needle guide 400 is described below. The needle guide 400 includes a positioning rod 410 and a sleeve 420. The positioning rod 410 is used to laterally connect the sleeve 420 to the proximal end of the auxiliary connecting rod 300, and can adjust the extension length and direction of the sleeve 420.

[0068] The positioning rod 410 includes a second screw 411 and multiple locking nuts 412 connected to the second screw 411. The second screw 411 is 6 cm long and 0.6 cm wide. One end of the second screw 411 is provided with a positioning hole 413. The positioning hole 413 is a circular ring structure, and the square hole in the middle of the ring has a side length of 1 cm. In use, the second screw 411 is inserted into the second transverse connecting hole 320 of the auxiliary connecting rod 300 and fixed by the locking nuts 412 on both sides. By adjusting the depth of the second screw 411 inserted into the second transverse connecting hole 320, the transverse extension distance of the sleeve 420 relative to the auxiliary connecting rod 300 can be changed.

[0069] The sleeve 420 is detachably inserted into the positioning hole 413 on the positioning rod 410. The sleeve 420 includes a sleeve body 421, which is 3 cm long. A handle 422, which is 3 cm long, is connected to one side of the sleeve body 421. The sleeve body 421 has an internal channel 423 along its length, which is 0.35 cm in diameter. This internal channel 423 forms a guide channel for guiding the guide needle into the femoral medullary cavity.

[0070] One end of the sleeve 420 is tapered 424. Specifically, the distal end of the sleeve 420 is a pointed cone, wider at the top and narrower at the bottom. The square hole in the positioning hole 413 matches the square structure at the upper end of the sleeve 420. After the sleeve 420 is inserted into the positioning hole 413, the pointed end of its tapered 424 points downwards, and the square structure and the square hole cooperate to prevent the sleeve 420 from rotating. The tapered 424 design allows the sleeve 420 to automatically center and remain stable after being inserted into the positioning hole 413, preventing it from shaking under force.

[0071] In use, the second screw 411 of the positioning rod 410 is passed through the second transverse connecting hole 320 of the auxiliary connecting rod 300. After adjusting the extension length, the locking nut 412 is tightened. Then, the sleeve 420 is inserted into the positioning hole 413 from top to bottom, so that the tapered end 424 of the sleeve 420 protrudes below the positioning hole 413. At this time, the guide needle is inserted from the handle 422 end of the sleeve 420, passes through the internal channel 423, and exits from the tapered end 424, thus drilling into the femoral medullary cavity in the direction determined by the sleeve 420.

[0072] In one embodiment, the specific structure of the distal clip 700 is described. The distal clip 700 is disposed at the distal end of the main connecting rod 100. The distal clip 700 is used to fix the distal end of the main connecting rod 100 to the lateral side of the distal end of the femoral shaft, thereby establishing a stable connection between the entire system and the bone of the affected limb together with the proximal trochanter apex positioning member 200.

[0073] The distal clamp 700 includes a clamping rod 710 and a widening joint 720. The clamping rod 710 is 50 cm long, 1.5 cm wide, and 0.5 cm thick. The proximal end of the clamping rod 710 is connected to the distal end of the main connecting rod 100, and the two can be fixed by integral molding or separate connection. The clamping rod 710 extends along the longitudinal axis of the femur, and the widening joint 720 is provided at its distal end.

[0074] The opening joint 720 includes two opening clamping arms. The inner sides of the two clamping arms have anti-slip teeth or elastic pads to enhance clamping stability and prevent excessive pressure on the periosteum. The opening and closing of the opening joint 720 is controlled by an adjusting screw. Rotating the adjusting screw moves the two clamping arms closer or further apart, thereby clamping or releasing the distal femoral shaft. The maximum opening width of the opening joint 720 can accommodate femoral shafts of varying thicknesses, adapting to skeletal differences in adults and children.

[0075] In use, place the main connecting rod 100 along the outer side of the thigh, so that the opening joint 720 of the distal clamp 700 is located on the outer side of the distal femoral shaft. Loosen the adjusting screw to open the two clamping arms, place the distal femoral shaft between the two clamping arms, and then tighten the adjusting screw to clamp the femoral shaft. After clamping, the distal end of the main connecting rod 100 is firmly fixed to the femoral shaft and cannot slide or rotate along the femoral axis.

[0076] An angle adjustment structure can be provided at the connection between the clamping rod 710 of the distal clamp 700 and the main connecting rod 100. This angle adjustment structure includes a ball joint or pivot, allowing the main connecting rod 100 to be adjusted within a small range of angles relative to the clamping rod 710 in the coronal plane. Once adjusted, it is secured with a locking nut. This angle adjustment structure allows the main connecting rod 100 to better adapt to the physiological curvature of the patient's lateral thigh, ensuring that the main connecting rod 100 remains parallel to the femoral shaft axis. When angle adjustment is not required, the main connecting rod 100 and the clamping rod 710 can also be rigidly connected.

[0077] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An external positioning system for intramedullary fixation of intertrochanteric fractures of the femur, characterized in that, include: The main connecting rod is used to fix it to the lateral thigh along the femoral axis. The distal end of the main connecting rod is provided with a distal clamp, which is used to clamp and fix it to the distal end of the femoral shaft. A trochanter apex positioning element is connected to the proximal end of the main connecting rod and has a positioning part for engaging with the top of the trochanter; A secondary connecting rod is parallel to and slidably connected to the main connecting rod, and can be locked at a selected position on the main connecting rod; The needle guide is connected to the proximal end of the secondary connecting rod and has a guide channel for guiding the guide needle into the femoral medullary cavity.

2. The extramedullary positioning system for use with intramedullary fixation of femoral intertrochanteric fractures as described in claim 1 wherein, It also includes a multi-plane angle positioning device, which comprises: A first angle measuring ring and a second angle measuring ring that are perpendicular to each other, both of which are transparent rings and are sealed with half a volume of liquid and air bubbles inside; and A fixed bracket is used to detachably mount the multi-plane angle positioning instrument onto the main connecting rod or the auxiliary connecting rod.

3. The extramedullary positioning system for use with intramedullary fixation of femoral intertrochanteric fractures as described in claim 2, wherein, The fixed bracket includes a square collar for fitting the multi-plane angle positioning instrument, and two pins located below the square collar, with at least one pin having a pressure screw for locking.

4. The extramedullary positioning system for use with intramedullary fixation of femoral intertrochanteric fractures as described in claim 2, wherein, The fixing bracket includes: A square collar and a silicone belt disposed below the square collar. One end of the silicone belt is fixed to the square collar, and the other end has multiple holes for fastening to the screw bolts on the other side of the square collar, so as to adapt to the fixing objects with different outer diameters.

5. The extramedullary positioning system for use with intramedullary fixation of femoral intertrochanteric fractures as described in claim 1 wherein, It also includes a multi-plane measuring ruler assembly, which comprises: An X-ray-transmitting straight ruler and an X-ray-transmitting vertical ruler, wherein the straight ruler and the vertical ruler are connected perpendicularly to each other, and the surface of the straight ruler and / or the vertical ruler is embedded with an opaque metal scale mark. And a fixing buckle, used to detachably install the straightedge or ruler onto the secondary connecting rod; The ruler is equipped with a metal watch chain-like shaft that can slide along the ruler body, used to mark the start and end points of the measurement under X-ray fluoroscopy.

6. The extramedullary positioning system for use with intramedullary fixation of femoral intertrochanteric fractures as described in claim 1 wherein, The ridge vertex positioning element includes: The positioning frame body, and a three-dimensional claw structure disposed at the far end of the positioning frame body, wherein the three-dimensional claw structure is used to form a three-point bony engagement with the top of the greater trochanter; The three-dimensional claw structure includes a large leaf foot and two small leaf feet, with the three leaf feet arranged in a triangular pattern. The large leaf foot is connected to a first screw for adjusting the insertion depth. The trochanter apex positioning component also includes a fixing pin, which is used to be fixed to the tip of the trochanter by being struck by the positioning frame body.

7. The extramedullary positioning system for use with intramedullary fixation of femoral intertrochanteric fractures as described in claim 1 wherein, The main connecting rod has a protruding structure at its near end, and a longitudinal adjustment hole is provided on the protruding structure. The auxiliary connecting rod passes through the longitudinal adjustment hole via a connecting crossbeam, and locking nuts are provided at both ends of the connecting crossbeam. The main connecting rod also has a first transverse connecting hole at its near end.

8. The extramedullary positioning system for use with intramedullary fixation of femoral intertrochanteric fractures of Claim 10, wherein, The inner wall of the longitudinal adjustment hole is provided with a first scale mark along the length direction.

9. The extramedullary positioning system for use with intramedullary fixation of femoral intertrochanteric fractures of Claim 10, wherein, The auxiliary connecting rod includes an auxiliary connecting rod section, a second transverse connecting hole is provided at the proximal end of the auxiliary connecting rod section, the connecting beam is provided on the auxiliary connecting rod plate near the second transverse connecting rod, and the locking nut is provided on the connecting beam; The auxiliary connecting rod is provided with a second scale mark along its length direction.

10. The extramedullary positioning system for use with intramedullary fixation of femoral intertrochanteric fractures of Claim 1, wherein, The needle guiding part comprises: A positioning rod is transversely and adjustably connected to the proximal end of the auxiliary connecting rod, the positioning rod comprises a second screw rod and a plurality of locking nuts connected to the second screw rod, and one end of the screw rod is provided with a positioning hole; A sleeve is detachably inserted into the positioning hole of the positioning rod, and an internal passage of the sleeve constitutes the guiding passage; The sleeve comprises a sleeve main body, one side of the sleeve main body is connected with a handle, and the internal passage is formed along the length direction of the sleeve main body; One end of the sleeve is tapered.

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