Device for fracture reduction fixation and navigation and use method thereof

Abstract

The invention discloses a device for fracture reduction fixation and navigation and a using method thereof, and particularly relates to the technical field of medical instruments, the device comprises a screw rod and first spherical parts arranged on the screw rod, and the adjacent first spherical parts are connected through a connecting kit; the fixing frame comprises a base and a fixing seat fixedly connected with the base, and the fixing seat is provided with a through mounting groove used for guiding the implanting direction of the steel nail; the screw penetrates through the base and is in threaded connection with a second spherical part and a positioning part which are used for clamping the base, a first ball socket matched with the second spherical part is formed in one side of the base, a spherical-crown-shaped protrusion is arranged on the other side of the base, and a second ball socket matched with the spherical-crown-shaped protrusion is formed in the positioning part. Through cooperation of the second spherical part, the first ball socket, the spherical-crown-shaped protrusion and the second ball socket and superposition of the three ball centers, multi-degree-of-freedom universal adjustment of the fixing frame is achieved, traction reduction, mechanical fixing and physical navigation functions are integrated, the operation process is simplified, and single-person operation can be achieved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a device for fracture reduction, fixation and navigation, and a method of using the same. Background Technology

[0002] Fractures, especially those of long bones in the limbs (such as the femur), are among the most common traumas in orthopedic clinics. For cases accompanied by severe soft tissue injury, open fractures, or poor local conditions, external fixation is the preferred and irreplaceable treatment option. Traditional external fixation techniques, such as the Ilizarov circular external fixator or unilateral external fixator, work by implanting steel pins at the proximal and distal ends of the fracture and connecting them to an external rigid support structure to create a stable biomechanical system. This maintains the alignment of the fracture ends, creating conditions conducive to fracture healing.

[0003] However, existing external fixation techniques have significant limitations in clinical application. First, the functions of existing devices are relatively simple, mostly used only for fixation, while precise reduction of fractures requires independent instruments such as traction beds and bone clamps. The reduction and fixation operations are separated, making the process complex and time-consuming. Second, complex structures, such as the Ilizarov ring frame, consist of multiple rings, rods, and numerous hinges, resulting in limited adjustment dimensions. Especially when dealing with complex fractures with multiple dimensions of displacement such as shortening, angulation, and rotation, it is difficult to achieve flexible and rapid omnidirectional adjustment. Surgeons often need to perform tedious combination adjustments and even repeated disassembly and assembly, which not only increases surgical trauma and infection risks but also places extremely high demands on the surgeon's experience.

[0004] To address the problems of separation of reduction and fixation functions and limited adjustment dimensions in the existing technologies, this invention provides a device and its method of use for fracture reduction, fixation and navigation. This device integrates three major functions: universal traction reduction, mechanical fixation and physical navigation, in order to simplify the surgical procedure, achieve multi-dimensional adjustment, reduce soft tissue damage and improve the accuracy of fracture reduction. Summary of the Invention

[0005] In order to overcome the above-mentioned defects of the prior art, embodiments of the present invention provide a device and a method of using it for fracture reduction, fixation and navigation, so as to solve the problems mentioned in the background art.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a device for fracture reduction, fixation, and navigation, comprising: At least two support rods, each support rod comprising: a screw and a first spherical member threadedly connected to the outer surface of the screw, wherein two adjacent first spherical members are fixedly connected by a connecting kit; At least one set of fixing frames, the fixing frames including: a base and a fixing seat fixedly connected to the base, the fixing seat having a through mounting groove for guiding the direction of steel nail insertion; The screw passes through the base, and the outer surface of the screw is threaded with a second spherical component and a positioning component for clamping the base. The outer surface of the second spherical component is spherical. The base has a first spherical recess that matches the second spherical component on the side facing the second spherical component. The first spherical recess is fitted over the outside of the second spherical component. The base has a crown-shaped protrusion on the side facing the positioning component. The positioning component has a second spherical recess that matches the crown-shaped protrusion on the side facing the base. The second spherical recess is fitted over the crown-shaped protrusion. The centerline of the screw coincides with the centerline of the second spherical component and the centerline of the positioning component along the extension direction of the screw, respectively; the center of the second spherical component, the center of the first socket, and the center of the second socket coincide with the center of the second socket.

[0007] Furthermore, the connecting kit includes two mating clamps, which are connected by at least two locking screws. Each of the two clamps has a spherical crown-shaped clamping groove that matches the first spherical component on its side that is close to each other. The depth of the spherical crown-shaped clamping groove is less than the radius of the first spherical component. The two mating spherical crown-shaped clamping grooves are fitted onto the first spherical component.

[0008] Furthermore, both the outer surfaces of the first spherical component and the outer surfaces of the second spherical component are provided with insertion holes for assisting rotation.

[0009] Furthermore, each of the aforementioned fixtures has at least two spherical clamping grooves.

[0010] Furthermore, the center of the spherical protrusion has a through-hole adjustment groove, which connects the first ball socket and the second ball socket. The screw passes through the adjustment groove, and the diameter of the adjustment groove is larger than the diameter of the screw.

[0011] Furthermore, the outer surfaces of the first spherical component, the second spherical component, and the crown-shaped protrusion are all roughened.

[0012] Furthermore, the fixing base is C-shaped or semi-circular, the mounting groove is opened along the arc direction of the fixing base, and the opening direction of the mounting groove points to the center direction of the fixing base.

[0013] A method of using a device for fracture reduction, fixation, and navigation, comprising the aforementioned device for fracture reduction, fixation, and navigation; and further comprising the following steps: Traction reduction: By adjusting the relative angle of two adjacent support rods through the connecting kit, the support rods can drive the proximal and distal ends of the fracture to perform multi-dimensional traction, thereby completing the reduction of the fracture. Adjusting the fixation frame angle: Rotate the positioning member and / or the second spherical member to loosen the base from the positioning member and the second spherical member, so that the crown-shaped protrusion of the base rotates in the second spherical socket, while the first spherical socket of the base rotates around the second spherical member, adjusting the fixation frame to a preset angle so that the fixation frame matches the fracture anatomy. Locking the angle of the fixing frame: Rotate the positioning member and / or the second spherical member to make the positioning member and the second spherical member move relative to each other along the screw axis and clamp the base, thereby locking the angle of the fixing frame; Implantation of steel nails for fixation: Using the mounting slot on the fixation base as a guide, steel nails are implanted into the fracture ends to complete the fixation of the fracture.

[0014] Furthermore, in the step of adjusting the angle of the fixing frame, a tool is inserted into the insertion hole on the outer surface of the second spherical component to assist in rotating the second spherical component, so as to loosen or clamp the base.

[0015] Furthermore, in the traction reset step, by tightening the locking screws on the connecting kit, the two clamps clamp the first spherical member, locking the rotation angle of the first spherical member within the connecting kit.

[0016] The technical effects and advantages of this invention are as follows: 1. Compared with existing technologies, by setting up a second spherical component, a first ball socket on the base, a spherical crown protrusion, and a second ball socket on the positioning component, with the three ball centers coinciding, a multi-degree-of-freedom universal adjustment of the fixation frame is achieved. This can flexibly cope with concurrent deformities such as shortening, angularity, and rotation, and in some cases, it can replace a large traction bed. It effectively solves the problems of separation of repositioning and fixation functions and limited adjustment dimensions proposed in the background technology. It integrates the three major functions of universal traction repositioning, mechanical fixation, and physical navigation into one, avoiding the cumbersome instrument changes during surgery, significantly simplifying the surgical procedure, and enabling single-person operation.

[0017] 2. Compared with existing technologies, the design of the connecting kit, which uses a spherical clamping groove with a depth less than the radius of the first spherical component, allows the first spherical component to rotate omnidirectionally when loosened, and generates a stable clamping force through spherical contact when tightened, thus balancing adjustment flexibility and locking stability. The outer surface of the second spherical component has an insertion hole, which facilitates the insertion of tools to assist rotation and reduces the difficulty of operation. The outer surface of each spherical component is made into a rough surface, which enhances the friction during clamping and improves the reliability of locking. The fixing seat is C-shaped or semi-circular, with the mounting groove pointing towards the center, providing a precise needle insertion path for steel nail implantation and improving the safety and accuracy of the surgery. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the overall structure of the present invention. Figure 1 .

[0019] Figure 2 This is a schematic diagram of the overall structure of the present invention. Figure 2 .

[0020] Figure 3 This is a schematic diagram of the support rod of the present invention.

[0021] Figure 4 This is a schematic diagram of the connection kit of the present invention.

[0022] Figure 5 This is a schematic diagram of the spherical crown-shaped protrusion structure of the fixing frame of the present invention.

[0023] Figure 6 This is a schematic diagram of the structure of the first ball socket of the fixing frame of the present invention.

[0024] Figure 7 This is a schematic diagram of the second ball socket structure of the positioning component of the present invention.

[0025] Figure 8 This is a schematic diagram of the structure of the first spherical socket fitting the crown-shaped protrusion and the second spherical socket fitting the second spherical component of the present invention.

[0026] Figure 9 This is a schematic diagram of the structure of the present invention, in which a threaded steel nail is installed on a fixed base.

[0027] Figure 10 This is a schematic diagram of the structure of the unthreaded steel nail of the present invention installed on the fixed base.

[0028] The reference numerals in the attached drawings are as follows: 100, support rod; 110, screw; 120, first spherical component; 200, connecting kit; 210, clamp; 211, spherical crown-shaped clamping groove; 220, locking screw; 300, fixing frame; 310, base; 311, first ball socket; 312, spherical crown-shaped protrusion; 313, adjusting through groove; 320, fixing seat; 321, mounting groove; 400, second spherical component; 410, insertion hole; 500, positioning component; 510, second ball socket. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0030] As attached Figure 1-8The device shown is for fracture reduction, fixation, and navigation, comprising: at least two support rods 100 and at least one set of fixation frames 300. The support rod 100 includes: a screw 110 and a first spherical member 120 threadedly connected to the outer surface of the screw 110, with adjacent first spherical members 120 fixedly connected by a connecting kit 200; in a preferred embodiment, as shown in the attached... Figure 1-8 As shown, the connecting kit 200 includes two mating clamps 210. The two clamps 210 are connected by at least two locking screws 220. Each of the two clamps 210 has a spherical crown-shaped clamping groove 211 that matches the first spherical member 120 on its side that is close to each other. The depth of the spherical crown-shaped clamping groove 211 is less than the radius of the first spherical member 120. The two mating spherical crown-shaped clamping grooves 211 are together sleeved on the first spherical member 120, that is, the two clamps 210 together wrap around and clamp the first spherical member 120. The spherical crown-shaped clamping groove 211 refers to a spherical crown-shaped groove formed by cutting a sphere with a plane. Its depth is less than the depth of a hemisphere, so that when two opposing spherical crown-shaped clamping grooves 211 are closed, a partially enclosed clamping space is formed around the first spherical member 120. This structure allows the first spherical member 120 to rotate omnidirectionally in the loosened state, and in the locked state, clamping and fixing are achieved through friction generated by the contact between the spherical surface of the first spherical member 120 and the spherical crown-shaped clamping groove 211 of the clamp 210. When the locking screw 220 is tightened, the two clamps 210 clamp the first spherical member 120, and the rotation angle of the first spherical member 120 within the connecting kit 200 is locked; when loosened, the first spherical member 120 can rotate omnidirectionally within the spherical crown-shaped clamping groove 211. In a preferred embodiment, as shown in the attached... Figure 1-8 As shown, each clamp 210 has at least two spherical clamping grooves 211 to connect multiple support rods 100 or construct a multi-ring structure.

[0031] The fixing frame 300 includes: a base 310 and a fixing seat 320 fixedly connected to the base 310. The fixing seat 320 has a through mounting groove 321 for guiding the direction of steel nail insertion. In a preferred embodiment, as shown in the attached figure... Figure 1-8 As shown, the mounting base 320 is C-shaped or semi-circular, and the mounting groove 321 is opened along the arc direction of the mounting base 320, with the opening direction of the mounting groove 321 pointing towards the center of the mounting base 320; thus, the mounting groove 321 serves a physical navigation function; wherein, as Figure 9 and Figure 10 As shown, the steel nails in the mounting slot 321 are divided into threaded and unthreaded types.

[0032] The screw 110 passes through the base 310. A second spherical member 400 and a positioning member 500 are threaded onto the outer surface of the screw 110. The second spherical member 400 and the positioning member 500 are located on opposite sides of the base 310, respectively, for clamping the base 310. The outer surface of the second spherical member 400 is spherical. A first ball socket 311, matching the second spherical member 400, is formed on the side of the base 310 facing the second spherical member 400. The first ball socket 311 is fitted onto the second spherical member 400. The second spherical member 400 is external to the first spherical socket 311, and can rotate omnidirectionally within it. The base 310 has a crown-shaped protrusion 312 on the side facing the positioning member 500, and the positioning member 500 has a second spherical socket 510 on the side facing the base 310 that matches the crown-shaped protrusion 312. The second spherical socket 510 is fitted onto the outside of the crown-shaped protrusion 312, allowing the crown-shaped protrusion 312 to rotate omnidirectionally within the second spherical socket 510. In a preferred embodiment, as shown in the attached... Figure 1-8 As shown, the center of the spherical protrusion 312 is provided with a through adjustment groove 313, which connects the first ball socket 311 and the second ball socket 510. The screw 110 passes through the adjustment groove 313. The diameter of the adjustment groove 313 is larger than the diameter of the screw 110 so that the base 310 does not interfere with the screw 110 when adjusting the angle. In the clamping state: the center line of the screw 110 coincides with the center line of the second spherical member 400 and the center line of the positioning member 500 along the extension direction of the screw 110; the center of the second spherical member 400, the center of the first ball socket 311, and the center of the second ball socket 510 coincide; this design of coinciding ball centers ensures that the relative position of the fixing frame 300 with the screw 110 remains stable when it rotates around the ball center, that is, when the positioning member 500 and the second spherical member 400 move relative to each other along the axial direction of the support rod 100 and clamp the base 310, the angle of the fixing frame 300 is locked; when the positioning member 500 and the second spherical member 400 release the base 310, the fixing frame 300 can rotate omnidirectionally around the ball center, so the overall structure is reliable.

[0033] In a preferred embodiment, as shown in the appendix Figure 1-8 As shown, the outer surfaces of the first spherical member 120, the second spherical member 400, and the crown-shaped protrusion 312 are all roughened to enhance the frictional force between them and the corresponding components, such as the frictional clamping force between the first spherical member 120 and the connecting kit 200, thereby enhancing clamping stability.

[0034] In a preferred embodiment, as shown in the appendix Figure 1-8As shown, both the outer surfaces of the first spherical component 120 and the second spherical component 400 are provided with insertion holes 410 for assisting rotation; tools can be inserted into these insertion holes 410 to assist in rotating the first spherical component 120 and the second spherical component 400, facilitating one-handed operation; the first spherical component 120 and the second spherical component 400 are of the same specifications to increase overall versatility, that is, the two mating spherical crown-shaped clamping grooves 211 can also be fitted onto the second spherical component 400, thereby improving practicality; In this application, a spherical crown-shaped protrusion is a structure formed by cutting a sphere with a plane, where the outer surface is part of the sphere. To facilitate the passage of the screw 110, the spherical crown-shaped protrusion 312 has a through-hole adjustment groove 313 at its center. The adjustment groove 313 axially passes through the base 310, so that when viewed in cross-section, the outer contour of the spherical crown-shaped protrusion 312 has a shape similar to an isosceles trapezoid with rounded edges, where the rounded edges correspond to the arc segments of the original sphere, and the straight edges correspond to the plane formed by the cutting plane. Therefore, the angle between the screw 110 and the fixing frame 300 can be adjusted using the adjustment groove 313; for example, the angle between the centerline of the support rod 100 and the centerline of the adjustment groove 313 does not exceed 30°, which is sufficient for normal use.

[0035] As attached Figure 1-8 As shown, a method of using a device for fracture reduction, fixation, and navigation includes a device for fracture reduction, fixation, and navigation; and further includes the following steps: S1: Traction Reduction: By adjusting the relative angle of the two adjacent support rods 100 through the connecting kit 200, the support rods 100 drive the proximal and distal ends of the fracture to perform multi-dimensional traction, thereby completing the reduction of the fracture; More specifically, in this step, the locking screw 220 is loosened, so that the two clamps 210 release the first spherical member 120. After adjusting the support rod 100 to the required angle, the locking screw 220 on the connecting kit 200 is tightened, so that the two clamps 210 clamp the first spherical member 120, locking the rotation angle of the first spherical member 120 within the connecting kit 200.

[0036] S2: Adjust the angle of the fixation frame 300: Rotate the positioning member 500 and / or the second spherical member 400 to loosen the base 310 from the positioning member 500 and the second spherical member 400, so that the spherical crown protrusion 312 of the base 310 rotates in the second spherical socket 510, while the first spherical socket 311 of the base 310 rotates around the second spherical member 400, and adjust the fixation frame 300 to the preset angle so that the fixation frame 300 matches the fracture anatomical shape; in this step, by inserting a tool into the insertion hole 410 on the outer surface of the second spherical member 400, the second spherical member 400 is rotated to loosen or clamp the base 310.

[0037] S3: Locking the angle of the fixing bracket 300: Rotate the positioning member 500 and / or the second spherical member 400 so that the positioning member 500 and the second spherical member 400 move relative to each other along the axial direction of the screw 110 and clamp the base 310, locking the angle of the fixing bracket 300; since the three spherical centers coincide, the relative position of the fixing bracket 300 and the support rod 100 remains stable after locking.

[0038] S4: Implantation of steel nails for fixation: Using the mounting groove 321 on the fixation base 320 as a guide, steel nails are implanted into the fracture ends to complete the fracture fixation. The opening direction of the mounting groove 321 points towards the center of the fixation base 320, providing a precise needle insertion path for the steel nail implantation.

[0039] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0040] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A device for fracture reduction, fixation, and navigation, characterized in that, include: At least two support rods (100), each support rod (100) comprising: a screw (110) and a first spherical member (120) threaded to the outer surface of the screw (110), wherein two adjacent first spherical members (120) are fixedly connected by a connecting kit (200); At least one set of fixing brackets (300), the fixing brackets (300) include: a base (310) and a fixing seat (320) fixedly connected to the base (310), the fixing seat (320) having a through mounting groove (321) for guiding the direction of steel nail implantation. The screw (110) passes through the base (310). The outer surface of the screw (110) is threaded with a second spherical part (400) and a positioning part (500) for clamping the base (310). The outer surface of the second spherical part (400) is spherical. The base (310) has a first ball socket (311) that matches the second spherical part (400) on the side facing the second spherical part (400). The first ball socket (311) is sleeved on the outside of the second spherical part (400). The base (310) has a crown-shaped protrusion (312) on the side facing the positioning part (500). The positioning part (500) has a second ball socket (510) that matches the crown-shaped protrusion (312) on the side facing the base (310). The second ball socket (510) is sleeved on the outside of the crown-shaped protrusion (312). The centerline of the screw (110) coincides with the centerline of the second spherical member (400) and the centerline of the positioning member (500) along the extension direction of the screw (110); the center of the second spherical member (400), the center of the first ball socket (311), and the center of the second ball socket (510) coincide.

2. The device for fracture reduction, fixation, and navigation according to claim 1, characterized in that: The connecting kit (200) includes two mating clamps (210), which are connected by at least two locking screws (220). Each of the two clamps (210) has a spherical crown-shaped clamping groove (211) that matches the first spherical member (120) on one side that is close to each other. The depth of the spherical crown-shaped clamping groove (211) is less than the radius of the first spherical member (120). The two mating spherical crown-shaped clamping grooves (211) are fitted onto the first spherical member (120).

3. The device for fracture reduction, fixation, and navigation according to claim 2, characterized in that: Both the outer surfaces of the first spherical member (120) and the second spherical member (400) are provided with insertion holes (410) for assisting rotation.

4. The device for fracture reduction, fixation, and navigation according to claim 2, characterized in that: Each of the clamps (210) has at least two spherical clamping grooves (211).

5. The device for fracture reduction, fixation, and navigation according to claim 1, characterized in that: The center of the spherical protrusion (312) is provided with a through-hole adjustment groove (313), which connects the first ball socket (311) and the second ball socket (510). The screw (110) passes through the adjustment groove (313), and the diameter of the adjustment groove (313) is larger than the diameter of the screw (110).

6. The device for fracture reduction, fixation, and navigation according to claim 1, characterized in that: The outer surfaces of the first spherical member (120), the second spherical member (400), and the crown-shaped protrusion (312) are all roughened.

7. The device for fracture reduction, fixation, and navigation according to claim 1, characterized in that: The fixing seat (320) is C-shaped or semi-circular, and the mounting groove (321) is opened along the arc direction of the fixing seat (320), and the opening direction of the mounting groove (321) points to the center direction of the fixing seat (320).

8. A method of using a device for fracture reduction, fixation, and navigation, comprising the device for fracture reduction, fixation, and navigation as described in any one of claims 1-7; characterized in that: Includes the following steps: Traction reduction: The relative angle of the two adjacent support rods (100) is adjusted by the connecting kit (200) so that the support rods (100) can drive the proximal and distal ends of the fracture to perform multi-dimensional traction and complete the reduction of the fracture. Adjust the angle of the fixation frame (300): Rotate the positioning member (500) and / or the second spherical member (400) to loosen the base (310) from the positioning member (500) and the second spherical member (400), so that the spherical crown protrusion (312) of the base (310) rotates in the second ball socket (510), while the first ball socket (311) of the base (310) rotates around the second spherical member (400), and adjust the fixation frame (300) to a preset angle so that the fixation frame (300) matches the fracture anatomy. Locking the angle of the fixing bracket (300): Rotate the positioning member (500) and / or the second spherical member (400) so that the positioning member (500) and the second spherical member (400) move relative to each other along the axial direction of the screw (110) and clamp the base (310), thereby locking the angle of the fixing bracket (300); Implantation of steel nails for fixation: Using the mounting groove (321) on the fixation seat (320) as a guide, steel nails are implanted into the fracture ends to complete the fixation of the fracture.

9. A method of using the device for fracture reduction, fixation, and navigation according to claim 8, characterized in that: In the step of adjusting the angle of the fixing bracket (300), a tool is inserted into the insertion hole (410) on the outer surface of the second spherical member (400) to assist in rotating the second spherical member (400) so as to loosen or clamp the base (310).

10. A method of using the device for fracture reduction, fixation, and navigation according to claim 8, characterized in that: In the traction reset step, by tightening the locking screw (220) on the connecting kit (200), the two clamps (210) clamp the first spherical piece (120) and lock the rotation angle of the first spherical piece (120) within the connecting kit (200).

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