TECHNICAL FIELD

The present disclosure relates generally to technical field of medical device, particularly to a method and system for a medical device designing, and more particularly to a method and system for a brace designing.

BACKGROUND

When the human skeleton structure is locally deformed or damaged, a brace is often used outside the body in the process of intervention and treatment. Taking the scoliosis as an example, it has a high incidence in adolescents, if the diagnosis and treatment are not timely, the scoliotic curve will increase with the development of the adolescents and even lead to serious body deformity, which will not only affect the cardiopulmonary functions of the patients, but also cause serious damage to their mental health. For most patients with scoliosis, in order to avoid the deterioration of scoliosis, brace treatment is needed. The brace needs to produce orthopedic forces on the spine at different points so as to give the orthopedic treatment to the scoliosis. The scoliosis brace is generally worn for 23 hours every day. However, the long-term of continuous skin compression of the brace would cause skin pressure sores, while the reduced orthopedic force avoiding the skin compression would affect the orthopedic effect. Therefore, how to design a brace which can guarantee a good orthopedic effect and meanwhile avoid continuous skin compression for different patients has been a challenge for the professionals working in this area for a long time.

At present, there are many designing schemes for spinal brace in the world, but they are all similar. They usually include the following steps. Step 1, understand the adjustable degree of the scoliosis (detecting the adjustable degree of the scoliosis on the X-ray film after requesting the patient to bend their body left and right). Step 2, adjust the spine by a device and determine the adjustment degree from the appearance (the patient can be lying or standing, the device usually has several adjustable rods rest against both side of the torso). Step 3, obtain the three-dimensional shape of the human torso in the adjusted state (via a plaster mold casting method or a three-dimensional scanning method on the body surface). Step 4, manufacture and adjust the brace according to the obtained three-dimensional shape of the human torso combining with experience. Step 5, let the patient to wear the brace and make the corresponding fine adjustment (by changing the local shape of the brace, adding the pad to the local portion or changing the tightness) for obtaining the best effect. In order to achieve a good adjustment effect, an X-ray imaging is also used to obtain multiple X-ray images during the adjustment of the brace, but this method will give the patient a lot of harmful radiation. It can be seen that in the existing design methods, there are too many uncertain factors in the determination of the adjustment degree from the appearance, which makes it difficult to achieve the desired therapeutic effect of the obtained brace, to guarantee a good orthopedic effect and meanwhile to avoid continuous skin compression for different patients. Moreover, the fine adjustment process of the brace is very tedious. Accordingly, it is necessary to create a new method and system for the brace designing to overcome the above problems.

SUMMARY

The object of the present application is to provide a method and system for a brace designing, capable of designing a brace which can ensure a good orthopedic effect and meanwhile avoid continuous skin compression with a high efficiency, aiming at the technical problems in the prior art that there are too many uncertain factors in the determination of the adjustment degree from the appearance, which makes it difficult to achieve the desired therapeutic effect of the obtained brace, to guarantee a good orthopedic effect and meanwhile to avoid continuous skin compression for different patients and the fine adjustment process of the brace is very tedious.

In a first aspect, a method for a brace designing is provided, comprising following steps:

S1, fixing a subject requiring a brace via an adjustment device comprising one or more adjustment head provided with a force sensor;

S2, scanning the subject to obtain skeletal image information of the subject;

S3, determining an adjustment solution for implementing an adjustment with respect to the subject and a target state that is to be achieved ultimately according to the skeletal image information;

S4, adjusting the subject to change a skeletal structure of the subject by using the adjustment head according to the adjustment solution, and meanwhile detecting a magnitude, direction and distribution of a force applied to the subject by the adjustment head via the force sensor;

S5, scanning the subject to obtain adjusted skeletal image information of the subject;

S6, determining whether the skeletal structure of the subject has been adjusted to the target state according to the adjusted skeletal image information; if yes, terminating adjustment and proceeding to step S7, or else, returning to step S4;

S7), obtaining a body surface three-dimensional shape of the subject having achieved the target state, and recording information about the magnitude, direction and distribution of the force applied to the subject by the adjustment headland detected by the force sensor for manufacturing a corresponding brace.

The method for a brace designing according to the present application, further comprises a step SA implemented after the steps S4 but before the step S5: determining whether the magnitude of the force applied to the subject by the adjustment head and detected by the force sensor is larger than a targeted value; if yes, proceeding to step S7, or else, proceeding to step S5.

In the method for a brace designing according to the present application, the skeletal image information in step S2 is displayed in real time for giving reference to step S3.

In a first aspect, a system for a brace designing is provided, comprising:

an adjustment device for fixing a subject requiring a brace, comprising one or more adjustment head provided with a force sensor for detecting a magnitude, direction and distribution of a force applied to the subject by the adjustment head;

a scanning imaging device for scanning the subject to obtain adjusted skeletal image information of the subject;

a first calculation unit for reading, quantizing and calculating the skeletal image information for obtaining a corresponding current parameter and target parameter of the subject;

a second calculation unit for calculating an adjustment solution of the adjustment head for guiding an operator to adjust the subject by using the adjustment head, according to the current parameter, the target parameter, the magnitude, direction and distribution of the force applied to the subject by the adjustment head and detected by the force sensor;

a monitoring module for monitoring whether the current parameter is consistent with the target parameter; if yes, sending out a termination signal to prompt the operator to terminate the adjustment and obtain the body surface three-dimensional shape of the subject by using a body surface three-dimensional shape obtaining device, or else sending out an operation signal to prompt the operator to continue the adjustment.

The system for a brace designing according to the present application further comprises an alarm device for reading information about the magnitude of the force applied to the subject by the adjustment head and detected by the force sensor, and sending out an alarm signal to prompt the operator to terminate the adjustment when the magnitude of the force applied to the subject by the adjustment head and detected by the force sensor is larger than a targeted value.

In the system for a brace designing according to the present application, the adjustment head is controlled by a first mechanical device having a brake module for receiving the alarm signal, wherein the first mechanical device stops running when the brake module receives the alarm signal.

In the system for a brace designing according to the present application, the first mechanical device has a first numerical control module for receiving signals sent by the monitoring module, wherein when the first numerical control module receives the termination signal, the first mechanical device stops running, while when the first numerical control module receives the operation signal, the first mechanical device reads the adjustment solution calculated by the second calculation unit and controls the adjustment head to adjust the subject according to the adjustment solution.

In the system for a brace designing according to the present application, the scanning imaging device is controlled by a second mechanical device comprising a second numerical control module for receiving signals sent by the monitoring module; wherein when the second numerical control module receives the termination signal, the scanning imaging device stops running, while when the second numerical control module receives the operation signal, the second mechanical device controls the scanning imaging device to scan the subject for obtaining the skeletal image information of the subject.

In the system for a brace designing according to the present application, the body surface three-dimensional shape obtaining device obtains the body surface three-dimensional shape of the subject by obtaining a cross-sectional view of the subject and a spatial position of each cross-sectional view.

In the system for a brace designing according to the present application, the scanning imaging device comprises a flexible imaging probe attached to a body surface of the subject.

When implementing the method and system for a brace designing according to the present application, following beneficial effects can be obtained. The brace suitable for the corresponding subject can be designed efficiently and intelligently for the different subjects, and the designed brace can ensure a good orthopedic effect and meanwhile avoid continuous skin compression, thus seeking a valuable treatment time and ideal treatment effect for the patients.

