CN219354310U - Customized medical external fixation support - Google Patents

Abstract

A customized medical external fixation support, which belongs to the field of medical appliances. Comprises an external fixing support main body and at least three groups or three buckles; the outer fixing support body is of a single-piece type structure, a tile type structure or an L-shaped tile type structure; the external fixing support main body is matched with the three-dimensional shape of the affected part of the patient; the buckle comprises a magic tape, a bandage or an elastic rope; the buckle is fixedly connected with the outer fixing support body into a whole through a rivet or a hook arranged on the outer fixing support body; a plurality of hollow structures are arranged on the outer fixing support main body; the edge of the hollow structure is provided with a flanging structure. The three-dimensional external shape data of the patient is customized and designed based on the three-dimensional external shape data of the patient, so that the three-dimensional external shape data has good matching degree with an affected part, and the safety and the effectiveness are guaranteed; the large-area hollow structure that sets up has guaranteed good gas permeability, waterproof and easy washing, wears the travelling comfort high, and support structure is through finite element analysis and topology optimization, light in weight, structural efficiency is high.

Description

Customized medical external fixation support

Technical Field

The utility model belongs to the field of medical instruments, and particularly relates to an orthopedic appliance for non-surgical treatment of bones or joints.

Background

External fixation is the maintenance of the affected limb in a therapeutically desired position by means of an external device, such as after a fracture, dislocation reduction or after certain limb orthotics, in order to facilitate the repair of fractures and other soft tissues.

External fixation brace refers to an external fixation device or product that assists with surgical treatment by limiting certain movements of the body, or is used directly in non-surgical treatment, for preventing disability, improving, compensating, replacing human functions, and assisting in treatment.

The traditional external fixation support made of gypsum, a low-temperature thermoplastic plate and a high-temperature thermoplastic plate is a conventional conservative treatment means for limb fracture after the reduction.

The utility model patent with the authority of publication number CN 102068060B, the authority of publication number 2013, 8 and 21, discloses a dynamic wrist brace which is composed of a hard protector with the function of shunt stress and a soft inner cushion with the function of buffering stress; wherein the hard protective tool comprises a palm protective tool fixed on the hand and a forearm protective tool fixed on the forearm; the palm protector and the forearm protector are adjacent at the wrist joint, and the palm protector and the forearm protector are connected by a soft inner pad but are not contacted with each other when the wrist joint is in a neutral position; the soft inner pad is adhered or sewed on the inner surface of the hard protective clothing.

The utility model patent with the authorized bulletin number of CN 204169966U and 25 days 2 month in 2015 discloses an orthopedic brace for elbows, which comprises ventilation holes, a fracture, a sheath, springs, knobs and a brace body, wherein the brace body is divided into two parts at the tip of the elbow, the middle is provided with a spring, the two sides are respectively provided with a fracture, the brace can freely move through the springs, the tail ends of the springs are provided with the knobs, the two parts of the brace body are respectively provided with the sheaths, the brace body is full of the ventilation holes, the orthopedic brace is simple in structure, can freely move through the springs in the orthopedic process, is convenient to use, is convenient to adjust, can carry out mass standardized production, and reduces production cost.

The utility model patent with the publication number of CN 206792536U discloses a knee fixing support, which comprises an elastic coating part for coating the knee from the back side of the knee, wherein the elastic coating part is provided with a fixing plate for propping against the back side of the knee along the longitudinal direction, and an air permeable layer arranged on the inner surface of the elastic coating part, which is convenient for self-disassembly and fixation, a patient can massage the knee after self-disassembly, the fixing plate can prevent the unintentional bending action of the knee, and the elastic coating part can not squeeze the knee due to the elastic characteristic of the elastic coating part when coating the knee, so that the stiffness of the knee joint and the blood circulation of the knee are not blocked; the breathable layer is detachably adhered and fixed on the inner surface of the elastic coating part through the magic tape, so that the breathable and dry coating part can be guaranteed on one hand, the breathable layer is convenient to replace and clean, and the cleanness and the sanitation of the breathable layer are guaranteed.

The utility model patent with the grant bulletin number of CN 211797109U, which is 10 months and 30 days in 2020, discloses a foot ankle brace which comprises a shell, a lining and a plurality of adhesive tapes; the shell is made of plastic, surrounds the lower leg part of the rear side of the lower leg of the patient and surrounds the plantar part of the patient, and the lower leg part is vertically connected with the plantar part; the lining is arranged on the inner side of the shell and is made of loose fabric materials; at the junction of the shank and the foot bottom, there is a cushion, the cushion is formed into a curved shape, its inner side corresponds to the physiological curved surface of the heel of the human body, its outer side is connected with a sticky hook, fix to the surface of the lining by the sticky hook hooking on the surface of the loose fabric material of the lining; the inner surface of the cushion is formed as a wavy undulating surface from top to bottom. Through setting up the cushion in the heel department of ankle brace, alleviate the pressure that patient's heel received in the right angle department of brace, effectively avoid the emergence of bubble.

However, in the above-mentioned technical solutions, the difference in the individual body shape or the specific size of the user is not taken into consideration, and the customized external fixation brace with individual parameter characteristics cannot be provided for a specific patient individual, and the customized external fixation brace is only suitable for the design or the manufacture of the universal external fixation brace with uniform specification, mass production and conventional size.

Meanwhile, the design and manufacture of the traditional external fixing support are very dependent on low-efficiency manual operation, and have inherent defects in the aspects of matching degree and comfort.

From the perspective of a patient, the traditional support is difficult to keep the affected part clean and dry when being worn; the support has poor air permeability, and the problems of itching, sweating, stink and rash often occur; traditional braces (particularly plaster braces) are quite heavy and seriously affect the daily life of patients; poor matching degree, pressure points and friction positions exist, and redness, swelling and numbness are easy to cause; difficult to put on and take off.

From the medical care perspective, the traditional support needs a great deal of manual operation during manufacturing, and the risk of scalding, chemical burn, dust inhalation and other labor injuries exists; the producer needs a certain experience, especially the deformation and time of the thermoplastic brace are short, and reworking and repeated fine tuning are often needed.

Computer aided design (CAE, computer Aided Engineering) and additive manufacturing (AM, additive Manufacturing) combined rehabilitation brace represent future development directions of trauma medicine and rehabilitation medicine, and have been gradually popularized.

However, these techniques have exposed some of the problems in practical use that have prevented large-scale clinical use of custom-made external fixation braces. The design process of the brace needs a great deal of experienced designers to participate, has large design difficulty, low efficiency and long time consumption, and is difficult to realize personalized design aiming at the self situation of a patient and simultaneously has production efficiency. Patients often need to wait days or even weeks for custom-made additive manufacturing external fixation braces, and the lack of early stability can directly affect the success rate of treatment of limb fractures, creating a number of unnecessary complications.

Accordingly, further improvements in the art are needed to address the inherent shortcomings of conventional braces and the problems of existing custom external fixation braces exposed during design and use.

Disclosure of Invention

The utility model aims to provide a customized medical external fixing support. The support is custom designed based on the three-dimensional shape data of the patient, can provide a mechanical environment suitable for healing for the fracture parts of the limbs, has good matching degree with the affected parts, and has guarantee in the aspects of safety and effectiveness; the large-area hollow structure arranged on the support body ensures good air permeability, is waterproof, is easy to clean and high in wearing comfort, and the support structure is subjected to finite element analysis and topological optimization, so that the support is light in weight and high in structural efficiency.

The technical scheme of the utility model is as follows: the utility model provides a medical external fixation brace of customization, characterized by:

the external fixation support is a fracture external fixation support and comprises an external fixation support main body and at least three groups or three buckles;

the outer fixing support body is of a single-piece structure, a tile-type structure or an L-shaped tile-type structure;

the external fixing support body is matched with the three-dimensional shape of the affected part of the patient, and has good fit degree with the skin of the affected part;

the buckle comprises a magic tape, a bandage or an elastic rope;

the buckle is fixedly connected with the outer fixing support body into a whole through a rivet or a hook arranged on the outer fixing support body;

a plurality of hollow structures are arranged on the outer fixing support main body;

and a flanging structure is arranged at the edge of at least one hollow structure.

Specifically, the external fixation brace consists of a wrist brace main body, a forearm buckle, a first radius buckle, a second radius buckle and a palm buckle;

the wrist support main body is of a single-piece structure and is fixed at the fracture part of the wrist of a patient through a forearm fastener, a first radius fastener, a second radius fastener and a palm fastener;

the appearance of the wrist support main body is matched with the three-dimensional appearance of the affected part of the wrist of a patient, and good fit degree is achieved between the wrist support main body and the skin of the affected part;

the forearm buckle, the first radius buckle, the second radius buckle and the palm buckle are magic tapes, bandages or elastic ropes;

the forearm buckle, the first radius buckle, the second radius buckle and the palm buckle are fixedly connected with the wrist support main body into a whole through rivets or hooks;

wherein, the first radius buckle and the second radius buckle are arranged close to the fracture line;

a plurality of hollow structures are arranged on the wrist support main body;

and the edges of each hollow structure are provided with flanging structures.

Further, the main body of the wrist brace is made of nylon materials through material addition;

alternatively, the body of the wrist brace is made from thermoplastic polymers including ABS engineering plastics by injection molding.

Specifically, the customized medical external fixation brace comprises a knee brace main body, a thigh buckle, a first knee buckle, a second knee buckle and a shank buckle;

the knee brace main body is of a tile-shaped structure and is fixed on the knee of a patient through a thigh buckle, a first knee buckle, a second knee buckle and a shank buckle;

the shape of the knee brace main body is matched with the three-dimensional shape of the skin of an affected part of a patient, and good fit degree is achieved between the knee brace main body and the skin of the affected part;

the thigh buckle, the first knee buckle, the second knee buckle and the shank buckle are magic tapes, bandages or elastic ropes;

the thigh buckle, the first knee buckle, the second knee buckle or the shank buckle are fixedly connected with the knee brace main body into a whole through rivets or hooks;

wherein, the thigh buckle is positioned at one half of the femur of the patient;

the shank buckle is positioned at one half of the tibia of the patient;

the first knee buckle and the second knee buckle are respectively close to the upper edge and the lower edge of the knee joint;

a plurality of hollowed-out structures are arranged on the knee brace main body;

and the edges of each hollow structure are provided with flanging structures.

Further, a wear-resistant layer made of thermoplastic polyurethane TPU is arranged above the edge part or the joint surface of the knee brace main body;

the knee brace main body is made of nylon materials through material addition;

alternatively, the knee brace body is made from thermoplastic polymers including ABS engineering plastics by injection molding.

Specifically, the external fixation brace comprises an ankle brace main body, a first shank buckle, a second shank buckle, a first foot buckle and a second foot buckle;

the ankle brace body is of an L-shaped tile-shaped structure and is fixed at the ankle part of a patient through a first shank buckle, a second shank buckle, a first foot buckle and a second foot buckle;

the shape of the ankle brace main body is matched with the three-dimensional shape of the ankle part of a patient, and the ankle brace main body has good fit degree with the skin at the ankle part;

the first shank buckle, the second shank buckle, the first foot buckle or the second foot buckle are magic tapes, bandages or elastic ropes;

the first shank buckle, the second shank buckle, the first foot buckle or the second foot buckle are fixedly connected with the ankle support main body into a whole through rivets or hooks;

wherein the first calf fastener is positioned at one half of the tibiofibula of the patient;

the second foot fastener is positioned at the base of the toes of the patient;

the second shank buckle and the first foot buckle are respectively close to the upper edge and the lower edge of the ankle joint;

a plurality of hollowed structures are arranged on the ankle brace main body;

the edge of the ankle brace main body or the edge of each hollowed-out structure is provided with a flanging structure.

Further, the ankle brace main body is provided with a particle anti-slip structure on the inner bottom surface contacted with the sole of the patient; or, an anti-skid groove is arranged;

the ankle brace main body is provided with a rubber wear-resistant anti-slip layer on the outer bottom surface contacted with the ground and positioned at the toe and heel parts;

the ankle brace main body is made of nylon materials through material addition;

alternatively, the ankle brace body is made from thermoplastic polymers including ABS engineering plastics by injection molding.

Specifically, the external fixation brace comprises an elbow brace main body, an upper arm buckle, a forearm buckle and a palm buckle;

the elbow support main body is of an L-shaped tile-shaped structure and is fixed at the elbow of a patient through an upper arm buckle, a forearm buckle and a palm buckle;

the shape of the elbow support main body is matched with the three-dimensional shape of the upper arm of a patient, and good fit degree is achieved between the elbow support main body and the skin of an affected part;

the upper arm buckle, the forearm buckle or the palm buckle is a magic tape, a bandage or an elastic rope;

the upper arm buckle, the forearm buckle or the palm buckle is fixedly connected with the elbow support main body into a whole through rivets or hooks;

wherein, the upper arm buckle is positioned at one half of the humerus of the patient;

the forearm fastener is positioned at one half of the radius of the patient's ulna;

the palm buckle is positioned at the palm center of the patient;

a plurality of hollow structures are arranged on the elbow support main body;

and the edges of each hollow structure are provided with flanging structures.

Further, a wear-resistant layer made of thermoplastic polyurethane TPU is arranged on the edge part of the elbow support main body or above the elbow joint surface;

the elbow brace main body is made of nylon materials through material addition;

alternatively, the elbow rest body is made of thermoplastic polymers including ABS engineering plastics through an injection molding method.

Furthermore, a plurality of hollow structures are arranged on the outer fixing support main body;

the position and the shape of the hollowed-out structure are simulated according to finite elements of the wrist stress condition of a patient and are generated through a topological optimization result, the topological optimization result is subjected to secondary design, sharp angles are removed, excessive arcs are added, so that stress concentration is reduced, and the capacity of the brace for resisting accidental impact of daily activities of the patient on the brace is improved.

Compared with the prior art, the utility model has the advantages that:

(1) According to the external fixing support, the design is customized based on the three-dimensional shape data of a patient, the support has good matching degree with an affected part, the support is tightly attached to the skin of the affected part, the support is prevented from loosening due to overlarge gaps, and the situation that the contact area is too small and limb numbness, unsmooth blood supply and pain are caused due to pressure concentration can be avoided;

(2) The external fixing support adopting the technical scheme has the advantages that the structure is analyzed and topologically optimized through finite elements, the whole weight is light, and huge burden on the daily life of a patient is prevented due to the weight of the support when the support is worn; the topological-optimized support has high structural efficiency and good rigidity, and can provide sufficient stability for fracture parts with lighter structural weight;

(3) By adopting the external fixation support, through mechanical test and try-on inspection, a mechanical environment suitable for healing can be provided for the fracture part, and the safety and effectiveness of the support are ensured;

(4) The support body structure is subjected to arc treatment, has no sharp angle and no stress concentration point, and can bear various accidental impacts without breaking when a patient wears the support;

(5) The flanging and reinforcing rib structures arranged on the support body structure can conveniently adjust the mechanical properties of the support so as to adapt to the requirements of different fracture parts of patients on the mechanical properties of the support;

(6) The brace body structure is provided with a large-area hollowed-out structure, so that good air permeability is ensured, ventilation is facilitated, patients cannot feel stuffy and itching, and good thermal comfort is achieved;

(7) The support body is made of waterproof polymer materials, is waterproof and easy to clean, can be normally bathed after being worn by a patient, and can be cleaned by using neutral detergent;

(8) The brace body can be manufactured and molded by using the additive, can be molded by using injection molding, and simultaneously meets two requirements of urgent custom products and prefabricated products produced in batches, and meets the requirements of the two aspects of demand response speed and production cost.

Drawings

Figure 1 is a schematic view of a front view of an embodiment of a wrist brace of the utility model;

FIG. 2a is a schematic front view of a knee brace embodiment of the utility model;

FIG. 2b is a schematic side view of an embodiment of the knee brace of the present utility model;

FIG. 3a is a schematic front view of an ankle brace embodiment of the utility model;

FIG. 3b is a schematic side view of an ankle brace embodiment of the utility model;

FIG. 4a is a schematic front view of an elbow brace according to an embodiment of the utility model;

FIG. 4b is a right side view of an elbow brace according to an embodiment of the utility model;

fig. 4c is a schematic top view of an elbow brace according to an embodiment of the utility model.

In the figure, 101 is a wrist brace main body, 102 is a forearm buckle, 103 is a first radius buckle, 104 is a second radius buckle, 105 is a palm buckle, 106 is a hollowed-out structure, 107 is a flanging structure, and 108 is a wrist affected part of a patient;

201 is a knee brace main body, 202 is a knee affected part of a patient, 203 is a thigh buckle, 204 is a first knee buckle, 205 is a second knee buckle, 206 is a shank buckle, 207 is a rivet, 208 is a hollowed-out structure, 209 is a flanging structure;

301 is an ankle brace body, 302 is an affected part of a patient's ankle, 303 is a first shank fastener, 304 is a second shank fastener, 305 is a first foot fastener, 306 is a second foot fastener, 307 is a rivet, 308 is a flanging structure, 309 is a hollowed-out structure;

401 is an elbow brace main body, 402 is an upper arm buckle, 403 is a rivet, 404 is a forearm buckle, 405 is a palm buckle, 406 is a hollowed-out structure, and 407 is a flanging structure.

Detailed Description

The utility model will be further described with reference to the drawings and examples.

The technical scheme provides a customized medical external fixation support, which has the following utility model points:

the external fixation support is a fracture external fixation support and comprises an external fixation support main body and at least three groups or three buckles;

the outer fixing support body is of a single-piece structure, a tile-type structure or an L-shaped tile-type structure;

the external fixing support body is matched with the three-dimensional shape of the affected part of the patient, and has good fit degree with the skin of the affected part;

the buckle comprises a magic tape, a bandage or an elastic rope;

the buckle is fixedly connected with the outer fixing support body into a whole through a rivet or a hook arranged on the outer fixing support body;

a plurality of hollow structures are arranged on the outer fixing support main body;

and a flanging structure is arranged at the edge of at least one hollow structure.

The present technical scheme will be further described below with reference to specific fracture or affected parts to be fixed.

Examples:

1. wrist brace:

fig. 1 is a front view of an embodiment of the wrist brace of the present utility model, which is an external fixation brace for fracture, and is divided into a wrist brace body 101, a forearm buckle 102, a first radius buckle 103, a second radius buckle 104, and a palm buckle 105.

The wrist brace main body 101 adopts a single-piece structure, and is fixed at the fracture position of the wrist of a patient by four buckles, namely a forearm buckle 102, a first radius buckle 103, a second radius buckle 104 and a palm buckle 105.

The first radius buckle and the second radius buckle are close to the fracture line to provide additional stability for the fracture part, and the four buckles are made of materials such as magic tape, bandage or elastic rope to help patients resist the gravity of the wrist and the accidental traction of the fracture part in daily activities.

A plurality of hollow structures 106 are arranged on the wrist support main body, so that the weight of the support is reduced, the structural efficiency of the support is improved, and the support cannot bring great burden to the daily life of a patient because of the weight of the support when the wrist support is worn.

The position and the shape of the hollowed-out structure on the wrist support main body are simulated according to finite elements of the wrist stress condition of a patient by a computer and are generated through a topological optimization result, and the topological optimization result is subjected to secondary design to remove sharp angles and add excessive arcs so as to reduce stress concentration and improve the capacity of the support for resisting accidental impact of daily activities of the patient on the support.

The flanging structures 107 are arranged at the edges of each hollow structure, so that the mechanical properties such as rigidity and torsion resistance of the wrist brace can be improved on the premise of not increasing the contact area between the brace and the skin of a patient, and the stability of the fracture part of the patient can be enhanced.

The design of the hollow structure is adopted, so that ventilation on the skin surface of a patient is facilitated, perspiration and heat dissipation are facilitated, the feeling of stuffiness and itching of the patient is avoided, and good thermal comfort is achieved.

The appearance of this wrist brace main part generates according to the three-dimensional appearance of patient's wrist affected part 108, has good laminating degree/laminating nature with the affected part skin between, can effectively avoid the too big support that leads to in space not hard up, also can avoid because contact area is too little to lead to the pressure to concentrate and then lead to limbs numbness, blood supply unsmooth and painful.

The main body of the wrist brace is made of nylon materials through additive manufacturing, is waterproof and easy to clean, and can be normally bathed by a patient and washed by neutral detergent.

The main body of the wrist brace can also be made of ABS engineering plastics or other thermoplastic polymers through an injection molding method, and can be produced in large scale in order to reduce production cost.

After the production, the main body of the wrist brace can provide a mechanical environment suitable for healing for the fracture part through mechanical test and try-on inspection, so that the safety and effectiveness of the brace are ensured.

2. Knee brace:

fig. 2a and 2b are main and side views of an embodiment of the knee brace of the present utility model, which is a fracture external fixation brace, divided into a knee brace main body 201, a thigh brace 203, a first knee brace 204, a second knee brace 205, and a shank brace 206.

The knee brace body 201 is of a tile-type structure, and the shape of the knee brace body is generated according to the three-dimensional shape of the skin of the patient affected area 202. The knee brace body is fixed to the knee of the patient by four fasteners, namely, thigh fastener 203, first knee fastener 204, second knee fastener 205, and shank fastener 206.

Wherein thigh clip 203 is located at one half of the patient's femur and shank clip 206 is located at one half of the patient's tibia, both of which together maintain the stability of the knee brace. The first knee fastener 204 and the second knee fastener 205 are respectively proximate the upper and lower edges of the knee joint, providing additional stability to the knee.

The four buckles are made of materials such as velcro or bandages or elastic ropes and are combined with the knee brace body by means of rivets 207. The four buckles together help the patient to counter gravity and accidental traction on the knee during daily activities.

A plurality of hollowed structures 208 are arranged on the knee brace main body, so that the weight of the brace is reduced, the structural efficiency of the knee brace is improved, and the knee brace is not burdened with impeding the daily life of a patient due to the weight of the brace when worn.

The position and the shape of the hollowed-out structure on the knee brace main body are simulated according to finite elements of the wrist stress condition of a patient by a computer and are generated through a topological optimization result, the closed angle of the topological optimization result is removed through secondary design, and excessive circular arcs are added, so that stress concentration is reduced, and the capacity of the brace for resisting accidental impact of daily activities of the patient on the brace is improved.

The flanging structure 209 is arranged at the edge of the hollowed-out structure and the edge of the knee brace main body, so that the rigidity, the torsion resistance and other mechanical properties of the brace can be improved on the premise of not increasing the contact area between the brace and the skin of a patient, and the stability of the fracture part of the patient is enhanced.

The hollow structure is arranged, so that ventilation on the skin surface of a patient is facilitated, perspiration and heat dissipation are facilitated, the feeling of stuffiness and itching of the patient is avoided, and good thermal comfort is achieved.

The appearance of knee brace main part generates according to the three-dimensional appearance of patient's knee affected part 202 skin, has good laminating degree/laminating nature with the affected part skin, can effectively avoid the too big support that leads to in space not hard up, also can avoid because contact area is too little leads to the pressure to concentrate and then leads to limbs numbness, blood supply unsmooth and painful.

The body of the knee brace is made of nylon material or other materials that can be used for additive manufacturing that is waterproof and easy to clean, and the patient can normally bath and rinse with neutral detergent.

The main body of the knee brace can also be made of acrylonitrile-butadiene-styrene (ABS) engineering plastics or other thermoplastic polymers by injection molding, and can be mass-produced in large scale to reduce production cost.

A wear-resistant layer of Thermoplastic Polyurethane (TPU) is applied to the knee brace body above the edge portion and the joint surface to reduce the pressure and friction of the patient during long-term wear. Avoid the skin of the patient from being red and swelling, itching and even ulceration.

After the knee brace main body is produced, mechanical tests and try-on tests can provide a mechanical environment suitable for healing for the ankle of a patient, and the safety and effectiveness of the brace are ensured.

3. Ankle brace:

fig. 3a and 3b are main and side views of an ankle brace according to an embodiment of the utility model, which is a fracture external fixation brace, and is divided into an ankle brace body 301, a first calf buckle 303, a second calf buckle 304, a first foot buckle 305, and a second foot buckle 306.

The main body of the ankle brace adopts an L-shaped tile-shaped structure, and four buckles, namely a first shank buckle 303, a second shank buckle 304, a first foot buckle 305 and a second foot buckle 306, are used for fixing the ankle part of a patient.

The first shank buckle is positioned at one half of the tibiofibula of the patient, the second foot buckle is positioned at the base of the toes of the patient, and the first shank buckle and the second foot buckle both maintain the stability of the ankle brace.

Further, the second calf buckle and the first foot buckle are respectively arranged close to the upper edge and the lower edge of the ankle joint, and provide additional stability for the ankle joint.

The four buckles are made of materials such as velcro or bandages or elastic ropes and are combined with the ankle brace body by means of rivets 307. The four buckles help the patient to resist gravity and accidentally pull the ankle during daily walking.

A plurality of hollow structures 309 are arranged on the ankle support main body, so that the weight of the support is reduced, the structural efficiency of the support is improved, and the support cannot bring great burden to the daily life of a patient due to the weight of the support when the support is worn.

The position and the shape of the hollowed-out structure are simulated according to finite elements of stress conditions of the ankle of a patient by a computer and are generated through a topological optimization result, and the topological optimization result is subjected to secondary design to remove sharp angles and add excessive arcs so as to reduce stress concentration and improve the capability of the brace for resisting accidental impact of daily activities of the patient on the brace.

The flange structure 308 is arranged at the edge of the hollowed-out structure and the edge of the ankle brace main body, so that the rigidity, the torsion resistance and other mechanical properties of the brace can be improved on the premise of not increasing the contact area between the brace and the skin of a patient, and the stability of the fracture part of the patient is enhanced.

The hollow structure is beneficial to ventilation of the skin surface of a patient, helps perspiration and heat dissipation, avoids the feeling of stuffiness and itching of the patient, and has good thermal comfort.

The appearance of ankle brace main part generates according to the three-dimensional appearance of patient's ankle affected part 302, has good laminating degree/laminating nature with the affected part skin between, can effectively avoid the too big support that leads to in space not hard up, also can avoid because contact area is too little to lead to the pressure to concentrate and then lead to limbs numbness, blood supply unsmooth and painful.

The main body of the ankle brace is made of nylon materials through additive manufacturing, is waterproof and easy to clean, and can be used for normal bath and washing with neutral detergent.

The main body of the ankle brace can also be made of ABS engineering plastics or other thermoplastic polymers through an injection molding method, and can be produced in large scale and in batch, so that the production cost is reduced.

The ankle brace main body is rough and carved with anti-skidding grooves on the surface contacted with the bottom of the sole of the patient compared with other parts, so that the foot of the patient is prevented from sliding due to movement when the patient wears the ankle brace to walk.

The contact surface of the ankle brace main body and the ground is adhered with a wear-resistant anti-slip layer (not shown in the figure) made of rubber at the toe and heel parts, and the anti-slip layer protects the brace main body from being worn and prevents a patient from slipping due to insufficient friction force when wearing the ankle brace for walking.

After the ankle brace main body is produced, mechanical tests and test wear tests are carried out, so that a mechanical environment suitable for healing can be provided for fracture parts, and the safety and effectiveness of the brace are ensured.

4. Elbow brace:

fig. 4a, 4b and 4c are schematic diagrams of a front view structure, a right view structure and a top view structure of an elbow support according to an embodiment of the present utility model, which is an external fracture fixation support, and is divided into an elbow support body 401, an upper arm fastener 402, a forearm fastener 404 and a palm fastener 405.

The elbow support body 401 adopts an L-shaped tile structure, and is fixed at the elbow of a patient by three buckles, namely an upper arm buckle 402, a forearm buckle 404 and a palm buckle 405.

Wherein, the upper arm buckle 402 is located at one half of the humerus of the patient, the forearm buckle 404 is located at one half of the ulna and radius of the patient, and the palm buckle 405 is located at the palm center of the patient, and the three parts together maintain the stability of the patient when wearing the elbow brace.

The three buckles of the upper arm buckle, the forearm buckle and the palm buckle are made of materials such as magic tape, bandage or elastic rope, and are combined with the elbow support main body 401 by means of rivets 403. The three buckles together help the patient to resist the unexpected traction of gravity and daily activities on the elbow.

The elbow brace main body 401 is provided with a plurality of hollow structures 406 for lightening the weight of the brace, increasing the structural efficiency of the brace, and avoiding huge burden on the daily life of a patient because of the weight of the brace when the brace is worn.

The position and the shape of the hollowed-out structure are simulated according to finite elements of the wrist stress condition of the patient by a computer and are generated through a topological optimization result, and the closed angle is removed and an excessive arc is added through secondary design of the topological optimization result, so that stress concentration is reduced, and the capability of the brace for resisting accidental impact of daily activities of the patient on the brace is improved.

The edge of the hollowed-out structure is provided with the flanging structure 407, so that the mechanical properties such as rigidity and torsion resistance of the brace can be improved on the premise of not increasing the contact area of the brace and the skin of a patient, and the stability of the fracture part of the patient is enhanced.

The hollow structure is favorable for ventilation of the skin surface of a patient, helps perspiration and heat dissipation, avoids the feeling of stuffiness and itching of the patient, and has good thermal comfort.

The shape of the elbow support main body 401 is generated according to the three-dimensional shape of the upper arm of a patient, and good fitting degree/fitting performance is achieved between the elbow support main body and the skin of an affected part, so that the support is effectively prevented from loosening caused by overlarge gaps, and limb numbness, unsmooth blood supply and pain caused by concentrated pressure due to overlarge contact area can be avoided.

The body of the elbow rest body 401 is made of nylon material by additive manufacturing, is waterproof and easy to clean, and can be normally bathed by a patient and flushed with neutral detergent.

The body of the elbow rest body 401 can also be made of ABS engineering plastics or other thermoplastic polymers by injection molding, and can be mass-produced in order to reduce production cost.

An anti-wear layer (not shown) of Thermoplastic Polyurethane (TPU) is applied to the elbow brace body 401 over the rim portion and elbow joint surface to reduce pressure and friction during long term patient wear. Avoid pressing armpit, medial and lateral humerus condyle, olecranon and other parts, so as to avoid skin redness, itching and even ulceration of patients.

After the elbow brace main body 401 is produced, mechanical tests and test wear tests can provide a mechanical environment suitable for healing of fracture parts, and the safety and effectiveness of the brace are ensured.

According to the technical scheme, the design of the customized external fixation support main body for a specific patient is carried out by adopting the following steps:

(a) Collecting CT data of a patient and point cloud data of an affected part, establishing a three-dimensional model of the skin of the affected part, and generating an original design scheme of the brace according to the three-dimensional model;

(b) Performing finite element analysis on the original design scheme, and simulating stress distribution when a patient wears the brace;

(c) Performing topology optimization on the original design scheme;

(d) Adding a hollowed-out structure for the original design scheme according to the topology optimization result;

(e) Performing secondary finite element analysis on the scheme after topology optimization, and simulating stress distribution of the patient when the patient wears the brace again;

(f) The flanging is added for the scheme after topology optimization, and the mechanical properties such as rigidity and torsion resistance of the support are improved on the premise of not increasing the contact area between the external fixing support and the skin of a patient.

According to the technical scheme, the customized external fixing support is provided, the shape or structure of the main body of the external fixing support is designed based on three-dimensional shape data of a patient, and the main body of the external fixing support has good matching degree with an affected part; after mechanical test and try-on inspection, the brace can provide a mechanical environment suitable for healing for the fracture parts of the limbs, and has the advantages of ensuring safety and effectiveness; the structure of the external fixing support is subjected to finite element analysis and topological optimization, so that the structure is light in weight, high in structural efficiency, good in air permeability, waterproof, easy to clean and high in wearing comfort, and the large-area hollow structure is good.

The utility model can be widely used in the field of custom design and manufacture of medical external fixation braces.

Claims (10)

1. A customized medical external fixation brace, which is characterized in that:

the external fixation support is a fracture external fixation support and comprises an external fixation support main body and at least three groups or three buckles;

the outer fixing support body is of a single-piece structure, a tile-type structure or an L-shaped tile-type structure;

the external fixing support body is matched with the three-dimensional shape of the affected part of the patient in appearance;

the buckle comprises a magic tape, a bandage or an elastic rope;

the buckle is fixedly connected with the outer fixing support body into a whole through a rivet or a hook arranged on the outer fixing support body;

a plurality of hollow structures are arranged on the outer fixing support main body;

and a flanging structure is arranged at the edge of at least one hollow structure.

2. The customized medical external fixation brace of claim 1, wherein the external fixation brace comprises a wrist brace body, a forearm buckle, a first radius buckle, a second radius buckle, and a palm buckle;

the wrist support main body is of a single-piece structure and is fixed at the fracture part of the wrist of a patient through a forearm fastener, a first radius fastener, a second radius fastener and a palm fastener;

the appearance of the wrist support main body is matched with the three-dimensional appearance of the affected part of the wrist of the patient;

the forearm buckle, the first radius buckle, the second radius buckle and the palm buckle are magic tapes, bandages or elastic ropes;

the forearm buckle, the first radius buckle, the second radius buckle and the palm buckle are fixedly connected with the wrist support main body into a whole through rivets or hooks;

wherein, the first radius buckle and the second radius buckle are arranged close to the fracture line;

a plurality of hollow structures are arranged on the wrist support main body;

and the edges of each hollow structure are provided with flanging structures.

3. The customized medical grade external fixation brace of claim 2, wherein the body of the wrist brace is made of nylon material by additive material;

alternatively, the body of the wrist brace is made from thermoplastic polymers including ABS engineering plastics by injection molding.

4. The customized medical grade external fixation brace of claim 1, wherein the customized medical grade external fixation brace comprises a knee brace body, a thigh brace, a first knee brace, a second knee brace, and a shank brace;

the knee brace main body is of a tile-shaped structure and is fixed on the knee of a patient through a thigh buckle, a first knee buckle, a second knee buckle and a shank buckle;

the shape of the knee brace main body is matched with the three-dimensional shape of the skin of the affected part of the patient;

the thigh buckle, the first knee buckle, the second knee buckle and the shank buckle are magic tapes, bandages or elastic ropes;

the thigh buckle, the first knee buckle, the second knee buckle or the shank buckle are fixedly connected with the knee brace main body into a whole through rivets or hooks;

wherein, the thigh buckle is positioned at one half of the femur of the patient;

the shank buckle is positioned at one half of the tibia of the patient;

the first knee buckle and the second knee buckle are respectively close to the upper edge and the lower edge of the knee joint;

a plurality of hollowed-out structures are arranged on the knee brace main body;

and the edges of each hollow structure are provided with flanging structures.

5. The customized medical grade external fixation brace of claim 4, wherein a wear layer made of thermoplastic polyurethane TPU is provided over the edge portion or the joint surface of the knee brace body;

the knee brace main body is made of nylon materials through material addition;

alternatively, the knee brace body is made from thermoplastic polymers including ABS engineering plastics by injection molding.

6. The customized medical grade external fixation brace of claim 1, wherein the external fixation brace comprises an ankle brace body, a first calf buckle, a second calf buckle, a first foot buckle, and a second foot buckle;

the ankle brace body is of an L-shaped tile-shaped structure and is fixed at the ankle part of a patient through a first shank buckle, a second shank buckle, a first foot buckle and a second foot buckle;

the shape of the ankle support main body is matched with the three-dimensional shape of the ankle part of a patient;

the first shank buckle, the second shank buckle, the first foot buckle or the second foot buckle are magic tapes, bandages or elastic ropes;

the first shank buckle, the second shank buckle, the first foot buckle or the second foot buckle are fixedly connected with the ankle support main body into a whole through rivets or hooks;

wherein the first calf fastener is positioned at one half of the tibiofibula of the patient;

the second foot fastener is positioned at the base of the toes of the patient;

the second shank buckle and the first foot buckle are respectively close to the upper edge and the lower edge of the ankle joint;

a plurality of hollowed structures are arranged on the ankle brace main body;

the edge of the ankle brace main body or the edge of each hollowed-out structure is provided with a flanging structure.

7. The customized medical grade external fixation brace of claim 6, wherein the ankle brace body has a granular anti-slip structure disposed on an inner bottom surface in contact with the plantar portion of the patient; or, an anti-skid groove is arranged;

the ankle brace main body is provided with a rubber wear-resistant anti-slip layer on the outer bottom surface contacted with the ground and positioned at the toe and heel parts;

the ankle brace main body is made of nylon materials through material addition;

alternatively, the ankle brace body is made from thermoplastic polymers including ABS engineering plastics by injection molding.

8. The customized medical grade external fixation brace of claim 1, wherein the external fixation brace comprises an elbow brace body, an upper arm brace, a forearm brace, and a palm brace;

the elbow support main body is of an L-shaped tile-shaped structure and is fixed at the elbow of a patient through an upper arm buckle, a forearm buckle and a palm buckle;

the shape of the elbow support main body is matched with the three-dimensional shape of the upper arm of the patient;

the upper arm buckle, the forearm buckle or the palm buckle is a magic tape, a bandage or an elastic rope;

the upper arm buckle, the forearm buckle or the palm buckle is fixedly connected with the elbow support main body into a whole through rivets or hooks;

wherein, the upper arm buckle is positioned at one half of the humerus of the patient;

the forearm fastener is positioned at one half of the radius of the patient's ulna;

the palm buckle is positioned at the palm center of the patient;

a plurality of hollow structures are arranged on the elbow support main body;

and the edges of each hollow structure are provided with flanging structures.

9. The customized medical grade external fixation brace of claim 8, wherein a wear layer of thermoplastic polyurethane TPU is provided over the rim portion or elbow joint surface of the elbow brace body;

the elbow brace main body is made of nylon materials through material addition;

alternatively, the elbow rest body is made of thermoplastic polymers including ABS engineering plastics through an injection molding method.

10. The customized medical external fixation brace according to claim 1, wherein a plurality of hollow structures are arranged on the external fixation brace body;

the position and the shape of the hollowed-out structure are simulated according to finite elements of the wrist stress condition of a patient and are generated through a topological optimization result, the topological optimization result is subjected to secondary design, sharp angles are removed, excessive arcs are added, so that stress concentration is reduced, and the capacity of the brace for resisting accidental impact of daily activities of the patient on the brace is improved.