A fracture external fixation brace capable of applying stress stimulation

Abstract

The present invention discloses a fracture external fixation brace capable of applying stress stimulation, comprising an upper fixing component and a lower fixing component, wherein the upper fixing component and the lower fixing component are respectively used to be mounted on the outside of the fracture, and the upper fixing component and the lower fixing component are respectively provided with connecting flanges, and the connecting flanges are provided with force application plates; the connecting flanges on the lower fixing component are respectively fixed with pins and studs; one end face of the pin and the stud fits with the end face of the connecting flange on the upper fixing component, and the connecting screws pass through the connecting flanges and are respectively assembled with the pin and the stud by screw thread. The present invention can make surgical plans before surgery, ensure accurate planning, personalized design, and convenient use. It also integrates the functions and advantages of stress stimulation, external fixation brackets, and plaster fixation, and is an integrated innovation. The present invention adopts 3D printing technology to realize the personalized design and rapid production of innovative rehabilitation braces for fractures of affected limbs, and can flexibly define the components of the brace.

Description

Technical Field

[0001] The invention relates to medical equipment, in particular to a fracture external fixation brace capable of applying stress stimulation. Background Art

[0002] In traditional fracture surgery, an external fixator is required to correct the fracture. The defects of the current external fixator are mainly:

[0003] 1. The installation process depends entirely on the operator's experience and temporary installation on site after resetting, lacking preoperative planning;

[0004] 2. During the installation process, the C-arm machine is needed to determine the appropriate reduction angle and reduction condition to ensure the installation of the external fixator;

[0005] 3. The traditional plaster fracture fixation treatment mode is bulky, inconvenient to carry, and has poor air permeability.

[0006] 4. Under natural conditions, the healing time of the patient's fracture is long and the healing speed is slow. A large number of studies have shown that mechanical stress can cause small movements of the fracture ends to promote bone healing, but the current external fixation brackets do not have this function. Summary of the invention

[0007] In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is to provide a fracture external fixation brace that can apply stress stimulation, which is easy to install and can apply mechanical stress to promote healing.

[0008] To achieve the above-mentioned object, the present invention provides a fracture external fixation brace capable of applying stress stimulation, comprising an upper fixing component and a lower fixing component, wherein the upper fixing component and the lower fixing component are respectively used to be sleeved on the outside of the fracture, and the upper fixing component and the lower fixing component are respectively provided with a connecting flange, and the connecting flange is provided with a force application plate;

[0009] A pin shaft and a stud are fixed to the connecting flange on the lower fixing component respectively; one end face of the pin shaft and the stud fits with the end face of the connecting flange on the upper fixing component, and the connecting screw passes through the connecting flange and is screwed together with the pin shaft and the stud by threads.

[0010] Preferably, the force application plate is provided with a matching groove.

[0011] Preferably, a connecting spring is mounted on the pin shaft, and both ends of the connecting spring are respectively tightly attached to the connecting flanges on the upper fixing component and the lower fixing component; a limiting nut is mounted on the part of the stud located between the connecting flanges on the upper fixing component and the lower fixing component.

[0012] Preferably, the upper fixing assembly and the lower fixing assembly have the same structure.

[0013] Preferably, the upper fixing assembly comprises a first bracket, a second bracket, and a steel pin, and the first bracket and the second bracket are assembled as one body;

[0014] At least one of the second bracket and the first bracket is provided with a base, the base is provided with a fixing hole, a slot, and a base through hole, and the fixing hole is connected with the base through hole;

[0015] A fixing plug is installed in the through hole of the base, and a limiting ring, a locking hole, and a steel needle through hole are respectively provided on the fixing plug, and the limiting ring cannot pass through the through hole of the base;

[0016] The portion of the fixing plug provided with the locking hole is inserted into the through hole of the base, and the locking hole is connected with the fixing hole. One end of the steel needle passes through the steel needle through hole, pierces the skin and muscle, and is assembled and fixed with the bone, while the other end of the steel needle is provided with an external thread.

[0017] The external thread can be assembled with the threaded hole arranged on the adjusting nut through threaded screwing, and the clamping groove can be assembled with the clamping half-shaft. The clamping half-shaft is arranged on the pressure plate, and a force-bearing part is also arranged on the pressure plate.

[0018] Preferably, a first fixing protrusion is arranged near the end surface where the first bracket and the second bracket are in contact; a second fixing protrusion is arranged at a position where the second bracket corresponds to the first fixing protrusion, the end surfaces of the first fixing protrusion and the second fixing protrusion are in contact with each other, and the hexagon socket bolt passes through the first fixing protrusion and the second fixing protrusion and is assembled and fixed with the first fixing protrusion and / or the second fixing protrusion by threaded engagement, so that the first bracket and the second bracket are assembled as a whole.

[0019] Preferably, the base has a notch on the side of the base through hole close to the skin, and the notch separates a gap between the steel needle and the skin puncture site and the base;

[0020] The first bracket is provided with a plurality of penetrating first hollows, and the second bracket is provided with a plurality of penetrating second hollows at least around the base.

[0021] Preferably, the engaging half-axis of the pressure plate is inserted into the engaging groove on the base, and the force-bearing part at the other end is in contact with the end surface of the adjusting nut.

[0022] Preferably, transverse and / or longitudinal reinforcing ribs are provided on the first bracket and the second bracket, and the thickness of the reinforcing ribs is 3 mm.

[0023] Preferably, the first bracket and the second bracket are made of nylon material through 3D printing.

[0024] The beneficial effects of the present invention are:

[0025] 1. The present invention can make surgical plans before surgery, ensuring accurate planning, personalized design, and easy use. It also integrates the functions and advantages of stress stimulation, external fixation, and plaster fixation, and is an integrated innovation. Compared with external fixation, the present invention has a better cost-effectiveness.

[0026] 2. The present invention adopts 3D printing technology to realize the personalized design and rapid production of innovative rehabilitation braces for fractured limbs. The product is lightweight and the components of the brace can be flexibly defined.

[0027] 3. The present invention is made of nylon powder, and its elastic modulus is close to that of real bone tissue, and it is well compatible with the installation and use environment.

[0028] 4. The present invention already includes a reset operation technology (adjusting the nut and adjusting the steel needle), which eliminates the need to use a C-arm machine (C-arm) for repeated confirmation during installation, thereby reducing the harm caused by radiation to the user. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1-Figure 6 It is a structural schematic diagram of the present invention.

[0030] Figure 7 It is a schematic diagram of the structure of the lower fixing component of the present invention.

[0031] Figure 8-Figure 13 It is a schematic diagram of the structure of the upper fixing assembly of the present invention.

[0032] Figure 14-16 It is a schematic diagram of the structure of the lower fixing component of the present invention.

[0033] Fig.17 It is a schematic diagram of the structure of the pressing plate and the fixing plug of the present invention. DETAILED DESCRIPTION

[0034] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0035] In the description of the present invention, it is necessary to understand that the terms "upper", "lower", "front", "back", "left", "right", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship are based on the orientation or position relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0036] See also Figure 1-Figure 17A fracture external fixation brace capable of applying stress stimulation comprises an upper fixing component A and a lower fixing component B, wherein the upper fixing component and the lower fixing component are respectively used to be mounted on the outside of the fracture, and the upper fixing component and the lower fixing component are respectively provided with a connecting flange 810, and a force applying plate 820 is provided on the connecting flange 810, and a matching notch 821 is provided on the force applying plate 820;

[0037] A pin shaft 320 and a stud 350 are fixed to the connecting flange 810 on the lower fixing component respectively; one end face of the pin shaft 320 and the stud 350 are fitted with the end face of the connecting flange 810 on the upper fixing component, and the connecting screw 310 passes through the connecting flange 810 and is respectively assembled with the pin shaft 320 and the stud 350 by threading, thereby connecting the upper fixing component A and the lower fixing component B as a whole.

[0038] The pin shaft 320 is provided with a connecting spring 340, and the two ends of the connecting spring 340 are respectively tightly attached to the connecting flanges 810 on the upper fixing component A and the lower fixing component B; the part of the stud 350 located between the connecting flanges 810 on the upper fixing component A and the lower fixing component B is provided with a limiting nut 330.

[0039] When mechanical stress needs to be applied, first loosen the connecting screw 310 so that the upper fixing component A and the lower fixing component B can move back and forth in the axial direction of the pin shaft, that is, mechanical stress can be applied, and then adjust the position of the limit nut 330 on the stud 350 to limit the displacement of the upper fixing component A on the stud 350. Finally, install the loading head at the force plate 820 to apply mechanical stress to the fixing component A and the lower fixing component B, thereby accelerating the healing of the fracture. In this process, the connecting spring 340 stores elastic force when the fixing component A and the lower fixing component B are close to each other, and the connecting spring 340 provides a reset elastic force after the force applied to the fixing component A and the lower fixing component B to bring them close to each other disappears, thereby forming the effect of reciprocating mechanical stress on the fixing component A and the lower fixing component B.

[0040] The structures of the upper fixing component A and the lower fixing component B can be the same, but their sizes may be different. In this embodiment, the upper fixing component A and the lower fixing component B are respectively fixed to different positions of the tibia with an external sleeve, and the size difference lies in the need to fit the skin and muscles of different parts.

[0041] The upper fixing assembly A includes a first bracket 100, a second bracket 200, and a steel needle 410. The first bracket 100 is provided with a plurality of first hollows 101 passing through, and a first fixing protrusion 110 is provided near the end surface where the first bracket 100 and the second bracket 200 are in contact.

[0042] The second bracket 200 is provided with a second fixing protrusion 220 at a position corresponding to the first fixing protrusion 110, the end surfaces of the first fixing protrusion 110 and the second fixing protrusion 220 are in contact with each other, and the hexagon socket bolt passes through the first fixing protrusion 110 and the second fixing protrusion 220 and is screwed together and fixed with the first fixing protrusion 110 and / or the second fixing protrusion 220 by screwing, so that the first bracket 100 and the second bracket 200 are assembled as one body;

[0043] The second bracket 200 is also provided with a base 210, and the base 210 is provided with a fixing hole 211, a slot 212, and a base through hole 213. The fixing hole 211 is connected with the base through hole 213. The second bracket 200 is provided with a second hollow 201 penetrating at least around the base 210. The second hollow 201 and the notch 202 are conducive to the disinfection and maintenance of the steel needle and the skin puncture site.

[0044] The first hollowing 101 and the second hollowing 201 of this embodiment also have the effect of reducing the overall weight and having little effect on the overall strength.

[0045] A fixing plug 420 is installed in the base through hole 213, and a limiting ring 421, a locking hole 422, and a steel needle through hole 423 are respectively provided on the fixing plug 420. The diameter of the limiting ring 421 is larger than the inner diameter of the base through hole 213, so that the limiting ring 421 is tightly attached to the end surface of the base 210 and cannot be installed in the base through hole 213;

[0046] The portion of the fixing plug 420 provided with the locking hole 422 is inserted into the base through hole 213, and the locking hole 422 is connected to the fixing hole 211. One end of the steel needle 410 passes through the steel needle through hole 423, pierces the skin and muscle, and is assembled and fixed to the bone at the fracture site that needs to be corrected, and the other end of the steel needle is provided with an external thread.

[0047] The external thread can be assembled with the threaded hole set on the adjusting nut 430 through threaded screwing, and the slot 212 can be assembled with the engaging half shaft 441. The engaging half shaft 441 is set on one side of the pressure plate 440, and a force-bearing part 442 is also set on the other side of the pressure plate 440.

[0048] In actual use, the upper fixing assembly A of this embodiment undergoes the following steps:

[0049] 1. Obtain medical imaging data and collect bone tissue and skin information of the case area;

[0050] 2. Perform simulated resetting on the computer through professional medical software to confirm the resetting path and the position of the needle after resetting;

[0051] 3. According to the planned bone tissue and skin information, reduction path, steel needle position, etc., design the size of the first and second brackets (inner side, length, thickness, height of the base protruding from the second bracket or the first bracket surface, etc.), the position and number of the base on the second bracket or the first bracket (the base can be set on the first bracket), etc.; here, it can be customized according to the actual situation of different patients, and preoperative planning is carried out in advance before the operation, which can greatly improve the success rate and efficiency;

[0052] 4. In the design, the basic thickness of the brace structure (first bracket, second bracket) is 3-5mm; transverse and / or longitudinal reinforcing ribs 510 are arranged on the brace to ensure the overall rigidity and strength, and the thickness of the reinforcing ribs 510 is 3mm; a reinforced base is designed at the contact part between the brace and the steel needle, and a notch 202 is provided on the side of the base close to the skin, which is used to insert a cotton swab into the contact part between the steel needle and the skin through the notch 202 after surgery to disinfect and prevent infection; the steel needle can easily enter the base hole through the base through the base through hole and the notch;

[0053] 5. After the design is completed, the first bracket and the second bracket are printed using nylon powder material using SLS 3D printing technology. Locking screws, hexagon socket bolts, adjusting nuts, steel needles, pressure plates, etc. are standard parts and can be prefabricated in advance; the use of 3D printing technology has high preparation efficiency, short time, and high dimensional accuracy, which can meet the material preparation requirements before surgery.

[0054] 6. The tail of the steel needle is processed with M6 standard external threads, which are screwed together with the threaded hole of the adjusting nut, and the axial adjustment of the steel needle can be performed through the adjusting nut and the pressing plate 440. The engaging half shaft 441 of the pressing plate 440 is inserted into the slot on the base, and the inner side surface of the force-bearing part 442 at the other end is in contact with the outer end surface of the adjusting nut 430. When the adjusting nut is rotated, the adjusting nut is in close contact with the force-bearing part 442, so that the steel needle 410 is pulled away from the skin in the axial direction, so that the function of axial adjustment of the steel needle is achieved by rotating the nut. When the end surface of the steel needle 410 is in close contact with the inner side surface of the force-bearing part 442, it is determined that the axial position of the steel needle is adjusted in place, and then the locking pin or locking screw is passed through the fixing hole 212 and the locking hole 422 and then pressed against the steel needle 410 to lock the steel needle and the base. In this embodiment, the locking screw is fixed to the fixing hole 212 by screwing together.

[0055] The lower fixing assembly B includes a first sub-bracket 610, a second sub-bracket 620, and a steel needle 410. The first sub-bracket 610 is provided with a plurality of first sub-hollows 611 penetrating therethrough, and a first sub-fixing protrusion 612 is provided near the end surface where the first sub-bracket 610 and the second sub-bracket 620 are attached.

[0056] The second sub-bracket 620 is provided with a second sub-fixing protrusion 622 at a position corresponding to the first sub-fixing protrusion 612, the end surfaces of the first sub-fixing protrusion 612 and the second sub-fixing protrusion 622 are fitted to each other, and the hexagon socket bolt passes through the first sub-fixing protrusion 612 and the second sub-fixing protrusion 622 and is screwed together and fixed with the first sub-fixing protrusion 612 and / or the second sub-fixing protrusion 622 by screwing, so that the first sub-bracket 610 and the second sub-bracket 620 are assembled as one body;

[0057] The second sub-bracket 620 is also provided with a sub-base 622. The sub-base 622 has the same structure as the base 210, and is provided with a sub-fixing hole 211, a slot 212, and a base through hole 213. The fixing hole 211 is communicated with the base through hole 213. The second sub-bracket 620 is provided with a second sub-hollow 621 penetrating at least around the sub-base 622. The second sub-hollow 621 and the notch 202 are useful for disinfecting and maintaining the steel needle and the skin puncture site.

[0058] The first hollowing 621 and the second hollowing 611 of this embodiment also have the effect of reducing the overall weight and having little effect on the overall strength.

[0059] A fixing plug 420 is installed in the base through hole 213, and a limiting ring 421, a locking hole 422, and a steel needle through hole 423 are respectively provided on the fixing plug 420. The diameter of the limiting ring 421 is larger than the inner diameter of the base through hole 213, so that the limiting ring 421 is tightly attached to the end surface of the base 210 and cannot be installed in the base through hole 213;

[0060] The portion of the fixing plug 420 provided with the locking hole 422 is inserted into the base through hole 213, and the locking hole 422 is connected to the fixing hole 211. One end of the steel needle 410 passes through the steel needle through hole 423, pierces the skin and muscle, and is assembled and fixed to the bone at the fracture site that needs to be corrected, and the other end of the steel needle is provided with an external thread.

[0061] The external thread can be assembled with the threaded hole set on the adjusting nut 430 through threaded screwing, and the slot 212 can be assembled with the engaging half shaft 441. The engaging half shaft 441 is set on one side of the pressure plate 440, and a force-bearing part 442 is also set on the other side of the pressure plate 440.

[0062] The manufacturing and installation methods of the lower fixing component B are the same as those of the upper fixing component A.

[0063] The installation process of the upper fixing component A and the lower fixing component B:

[0064] 1. Install the first bracket and the second bracket of the upper fixing assembly A to the corresponding positions of the limbs, and install the hexagon socket bolts to form a complete brace;

[0065] Install the first and second sub-brackets of the lower fixing assembly B to the corresponding positions of the limbs, and insert the hexagon socket bolts to form a complete brace;

[0066] 3. Adjust the position of the brace so that the steel needle enters the corresponding through hole of the base, and insert the fixing plug (the steel needle through hole 423 is sleeved outside the steel needle) so that the relative position of the steel needle and the base in the circumferential direction is in place;

[0067] 4. Adjust and lock each steel needle in turn. The specific steps are: screw the external thread at the tail of the steel needle into the threaded hole of the adjusting nut, insert the pressure plate, rotate the adjusting nut to make the end plane of the tail of the steel needle flush with the end surface of the adjusting nut away from the pressure plate, screw in the locking screw, lock the steel needle with the base or sub-base, remove the pressure plate, and screw out the adjusting nut;

[0068] 5. Use C-arm fluoroscopy to ensure that the fracture reduction is normal; if there is any deviation, fine-tune it appropriately (by adjusting the nut);

[0069] 6. Check the tightness of all screws and locking screws.

[0070] 7. When mechanical stress needs to be applied, loosen the connecting screw 310 and adjust the limit nut 330 into place, so that the upper fixing component A and the lower fixing component B are in a relaxed state in the axial direction, and then install the loading head into the matching groove 821, and perform stress stimulation and adjustment treatment on the patient through an external motor. After the treatment, remove the loading head, tighten the connecting screw 310 and the limit nut 330 to return to the normal recovery state.

[0071] The loading head of this embodiment mainly presses the two connecting flanges towards each other and then releases them to obtain the effect of reciprocating movement of the two connecting flanges. In this embodiment, the existing loading head is directly used to drive the motor to achieve the above function.

[0072] The matters not described in detail in the present invention are all known technologies to those skilled in the art.

[0073] The preferred specific embodiments of the present invention are described in detail above. It should be understood that a person skilled in the art can make many modifications and changes based on the concept of the present invention without creative work. Therefore, any technical solution that can be obtained by a person skilled in the art through logical analysis, reasoning or limited experiments based on the concept of the present invention on the basis of the prior art should be within the scope of protection determined by the claims.

Claims

1. A fracture external fixation brace capable of applying stress stimulation, characterized in that: It comprises an upper fixing assembly and a lower fixing assembly, wherein the upper fixing assembly and the lower fixing assembly are respectively used to be sleeved on the outside of the fracture, and the upper fixing assembly and the lower fixing assembly are respectively provided with a connecting flange, the connecting flange is provided with a force application plate, the force application plate is installed with a loading head, and the loading head is used to apply mechanical stress to the upper fixing assembly and the lower fixing assembly; A pin shaft and a stud are fixed to the connection flange on the lower fixing assembly respectively; one end face of the pin shaft and the stud fits with the end face of the connection flange on the upper fixing assembly, and the connection screw passes through the connection flange and is screwed and assembled with the pin shaft and the stud respectively through threads; The force application plate is provided with a matching notch; A connecting spring is sleeved on the pin shaft, and two ends of the connecting spring are respectively tightly attached to the connecting flanges on the upper fixing component and the lower fixing component; a limiting nut is sleeved on the part of the stud located between the connecting flanges on the upper fixing component and the lower fixing component.

2. The fracture external fixation brace according to claim 1, characterized in that: The upper fixing component and the lower fixing component have the same structure.

3. The fracture external fixation brace according to claim 2, characterized in that: The upper fixing assembly includes a first bracket, a second bracket, and a steel pin, and the first bracket and the second bracket are assembled into one body; At least one of the second bracket and the first bracket is provided with a base, the base is provided with a fixing hole, a slot, and a base through hole, and the fixing hole is connected with the base through hole; A fixing plug is installed in the through hole of the base, and a limiting ring, a locking hole, and a steel needle through hole are respectively provided on the fixing plug, and the limiting ring cannot pass through the through hole of the base; The portion of the fixing plug provided with the locking hole is inserted into the through hole of the base, and the locking hole is connected with the fixing hole. One end of the steel needle passes through the steel needle through hole, pierces the skin and muscle, and is assembled and fixed with the bone, while the other end of the steel needle is provided with an external thread. The external thread can be assembled with the threaded hole arranged on the adjusting nut through threaded screwing, and the clamping groove can be assembled with the clamping half-shaft. The clamping half-shaft is arranged on the pressure plate, and a force-bearing part is also arranged on the pressure plate.

4. The fracture external fixation brace according to claim 3, characterized in that: A first fixing protrusion is arranged near the end surface where the first bracket and the second bracket are in contact; a second fixing protrusion is arranged at the position where the second bracket corresponds to the first fixing protrusion, the end surfaces of the first fixing protrusion and the second fixing protrusion are in contact with each other, and the hexagon socket bolt passes through the first fixing protrusion and the second fixing protrusion and is assembled and fixed with the first fixing protrusion and / or the second fixing protrusion by threaded engagement, so that the first bracket and the second bracket are assembled as a whole.

5. The fracture external fixation brace according to claim 3, characterized in that: The base has a notch on the side of the base through hole close to the skin, and the notch separates a gap between the steel needle and the skin puncture site and the base; The first bracket is provided with a plurality of penetrating first hollows, and the second bracket is provided with a plurality of penetrating second hollows at least around the base.

6. The fracture external fixation brace according to claim 3, characterized in that: The engaging half-shaft of the pressing plate is inserted into the slot on the base, and the force-bearing part at the other end is fitted with the end face of the adjusting nut.

7. The fracture external fixation brace according to claim 3, characterized in that: Transverse and / or longitudinal reinforcing ribs are arranged on the first bracket and the second bracket, and the thickness of the reinforcing ribs is 3 mm.

8. The fracture external fixation brace according to claim 3, characterized in that: The first bracket and the second bracket are made of nylon material through 3D printing.

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