WO2022041654A1

WO2022041654A1 - Diabetic foot treatment device

Info

Publication number: WO2022041654A1
Application number: PCT/CN2021/074270
Authority: WO
Inventors: 徐淑芬; 张茜垚; 王凌; 邢羽杰; 辜阿林; 方明
Original assignee: 浙江科惠医疗器械股份有限公司
Priority date: 2020-08-28
Filing date: 2021-01-29
Publication date: 2022-03-03
Also published as: CN111973288B; CN111973288A

Abstract

Disclosed is a diabetic foot treatment device, comprising at least two first elastic support rods, at least one supporting rod and at least two magnetic-control telescopic rods. At least two deformable frame bodies are formed in the device, and the supporting rod has the function of supporting the deformable frame bodies. In the device, by means of a magnetic field, the magnetic-control telescopic rod is adjusted and controlled to extend and retract, such that the deformable frame body deforms, and therefore, periosteal distraction is achieved and blood vessel repairing is promoted. The device has a simple structure, and when in use, the whole device is implanted into a human body and in-vitro adjustment and control are used, such that infections can be effectively prevented, and an accurate regulation function can also be achieved. Furthermore, a bone spicule can be further provided in the device, such that bone marrow can further participate in repairing and rebuilding blood vessels, thereby facilitating the treatment and recovery of diabetic feet.

Description

A device for treating diabetic foot

technical field

The invention belongs to the medical technical field, and relates to a diabetic foot treatment device and a use method thereof.

Background technique

Diabetic foot and other diseases can easily cause limb ischemia, pain and necrosis. Many patients have to amputate their limbs, and even after amputation, the wound will still not heal. , vascular stent and other treatment methods to reconstruct the microcirculation of limb tissue.

In recent years, the widely used transverse bone transfer technique is an effective method for the treatment of diabetic foot. This technique promotes the regeneration and recanalization of local bone, soft tissue and blood vessels through slow and continuous tension stimulation. However, the lateral bone transfer technique is complicated to operate during the operation, and requires delicate operation to separate a section of bone fragments. Regenerates and recanalizes blood vessels by stimulating the conditioning of the isolated bone mass.

In addition, there is also a periosteal distraction technique, which inserts a plate under the periosteum, installs a screw on the plate, the flat head of the screw bears against the cortical bone, and rotates the screw to elevate the plate and the periosteum along the way, thereby stimulating the subperiosteal. Angiogenesis and recanalization.

The above two technologies usually involve device products with large defects and high risks; first, the product needs to use Kirschner wire for positioning on the cortical bone and a retractor-type bone needle for bone transport, and one side enters the bone. The other side is exposed to the air, which is easy to cause bone infection; secondly, the driving part of the adjustment screw is often exposed outside the skin, and the overlapping part of the thread and the skin has been in contact with the outside air, which is also likely to cause infection; and usually the screw is Full thread, there is no effective limit on the lifting distance, and there is the possibility of misoperation. Excessive lifting will not only cause treatment failure, but even increase complications. Therefore, the adjustment accuracy and quality depend on the doctor's work experience.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a diabetic foot treatment device and a method of using the same in view of the deficiencies of the prior art. The device has a simple structure, and can be implanted into the human body using in vitro regulation, which can effectively prevent infection and simultaneously realize Accurate adjustment function, in addition, the device of the present invention can also be provided with bone needles to further realize the repair and reconstruction of bone marrow involved in blood vessels, which is beneficial to the treatment and recovery of diabetic foot.

The technical scheme adopted in the present invention is:

A diabetic foot treatment device, comprising at least two first elastic support rods, at least two second elastic support rods, and at least one support rod; the length of the first elastic support rod is greater than that of the second elastic support rod, and the first elastic support rod The two ends of the support rod and the two ends of the second elastic support rod are respectively fixedly connected to form a deformable frame body, and each of the two ends of the support rod is fixedly connected with one of the deformable frame bodies, and the two deformable frame bodies are distributed symmetrically; the deformable frame also includes at least one magnetron telescopic rod, and the two ends of the magnetron telescopic rod are respectively fixed with the first elastic support rod and the second elastic support rod, or the magnetron telescopic rod The two ends of the telescopic rod are respectively fixed with the two ends of the first elastic support rod and the two ends of the second elastic support rod.

Further, the two ends of the support rod are respectively fixed with the midpoint of the first elastic support rod in the deformable frame body, and the support rod is also provided with a bone pin without threads, and the upper end of the bone pin is Being fixed with the support rod, the cutting edge end faces downward toward the second elastic support rod, and the length of the bone needle exceeds the plane formed by the second elastic support rods in the two deformable frame bodies.

In addition, the present invention also provides a diabetic foot treatment device, which includes at least two first elastic support rods, at least one support rod, and at least two magnetron telescopic rods; two ends of each first elastic support rod are connected to a magnetic Two ends of the telescopic control rod are fixedly connected to form a deformable frame body, and two deformable frame bodies are fixedly connected to each end of the support rod, and the two deformable frame bodies are symmetrically distributed.

Further, both ends of a support rod are respectively fixed with the midpoint of the first elastic support rod in the deformable frame body, and an unthreaded bone pin is also provided on the support rod, and the upper end of the bone pin is It is fixed with the support rod, and the cutting edge end faces downwards in the direction of the magnetron telescopic rod, and the length of the bone pin exceeds the plane formed by the magnetron telescopic rod in the two deformable frames.

In the above technical solution, further, there are three support rods in total, and they are parallel to each other, and the two ends of one support rod are respectively fixed with the midpoint of the first elastic support rod in the deformable frame body, and the other two Both ends of each support rod are fixed with both ends of the two first elastic support rods.

Further, the magnetron telescopic rod can be made of magnetostrictive material.

Further, the first elastic support rod and the support rod are made of non-magnetic materials. When the device has a second elastic support rod and a bone pin, the second elastic support rod and bone pin are made of non-magnetic materials

Further, each component of the device is provided with an antibacterial coating.

The beneficial effects of the present invention are:

1. When the device of the present invention is used, the whole is implanted under the periosteum of the human body, and no related parts are exposed in vitro, so there is no problem of in vitro infection caused by external parts infection;

2. The device of the present invention realizes the stretch of the periosteum by constructing a deformable frame structure and deforming the frame body by using a magnetic field change in vitro, which is beneficial to the repair and reconstruction of blood vessels. Furthermore, it can also deform the frame body. Drive the bone needle up and down to move the bone block.

3. The device of the present invention utilizes the magnetic field to regulate and retract the telescopic rod to drive the deformable frame structure to deform. The regulation of the magnetic field can be controlled by a computer, and the present invention can realize automatic regulation and precise regulation without relying on the experience of doctors;

4. In addition, the device of the present invention also conforms to the technical principle of transverse bone transport, and can drive the bone needle into the medullary cavity, so that the bone marrow can flow out along the position hole, which is beneficial to the repair and reconstruction of blood vessels.

5. The device of the present invention regulates the expansion and contraction of the telescopic rod through the magnetic field, and drives the deformable frame to deform to increase or decrease the height of the deformable frame. When the support rod in the middle is lifted, the periosteum of the corresponding part is also lifted, causing the periosteum to be distracted. The expansion area increases, and the vascular repair and reconstruction area increases; when the support rod located in the middle moves down, the periosteal distraction is reduced.

The above description is only an overview of the technical solution of the present invention, in order to be able to understand the technical means of the present invention more clearly, it can be implemented according to the content of the description, and in order to make the above and other objects, features and advantages of the present invention more obvious and easy to understand , the preferred embodiments are given below and described in detail in conjunction with the accompanying drawings.

Description of drawings

1 is a schematic structural diagram of an embodiment of the device of the present invention;

2 is a schematic structural diagram of another embodiment of the device of the present invention;

Fig. 3 is another perspective schematic diagram of the device of Fig. 2;

Fig. 4 is a kind of deformation result schematic diagram of the deformable frame in the present invention;

5 is a schematic diagram of another deformation result of the deformable frame in the present invention;

6 is a schematic diagram of a deformation of the deformable frame body according to another embodiment of the present invention;

Fig. 7 is another deformation schematic diagram of the variable frame body in another embodiment of the present invention;

FIG. 8 is a schematic structural diagram of another embodiment of the apparatus of the present invention.

detailed description

In order to further illustrate the technical means and effects adopted by the present invention to achieve the predetermined purpose of the invention, the following describes the specific implementation, structure, features and effects of the display control method and system proposed according to the present invention with reference to the accompanying drawings and preferred embodiments. , as detailed below.

The foregoing and other technical contents, features and effects of the present invention will be clearly presented in the following detailed description of the preferred embodiments with reference to the drawings. Through the description of the specific embodiments, the technical means and effects adopted by the present invention to achieve the predetermined purpose can be more deeply and specifically understood. However, the accompanying drawings are only used for reference and description, and are not used for the present invention. limit.

As shown in FIG. 1, in a specific embodiment of the present invention, the diabetic foot treatment device includes two first elastic support rods 1, two second elastic support rods 2, and three support rods 3; the first elastic support rods The length of the support rod 1 is greater than that of the second elastic support rod 2, and the two ends of the first elastic support rod 1 are fixedly connected with the two ends of the second elastic support rod 2 to form a deformable frame. Due to the length of the first elastic support rod 1 Longer, so under the action of no external force, the two elastic struts are in a state of bending;

One of the deformable frame bodies is fixedly connected to each end of the support rod 3 , and the two deformable frame bodies are symmetrically distributed; among the three support rods 3 , one end is connected to the midpoint of the first elastic support rod 1 fixed, the other two ends are connected with the first

The fixed ends of an elastic support rod 1 and a second elastic support rod 2 are fixed to each other, and the three support rods 3 are parallel to each other; it provides support for the entire device and increases the area of periosteal peeling;

The deformable frame also includes a magnetron telescopic rod 5, and the two ends of the magnetron telescopic rod 5 are respectively fixed to the rod bodies of the first elastic support rod 1 and the second elastic support rod 2 (as shown in Figures 1 and 2). , 4, 5), or the two ends of the magnetron telescopic rod 5 are respectively fixed with the two ends of the first elastic support rod 1 and the two ends of the second elastic support rod 2 (as shown in Figures 6 and 7). The deformable frame body can be deformed by the expansion and contraction of the magnetron telescopic rod 5. Generally, the magnetron telescopic rod 5 can be made of magnetostrictive material. The first elastic rod 1, the second elastic rod 2, The support rods 3 are made of non-magnetic materials, such as medical plastic, pure titanium and medical stainless steel. In addition, the surface of the magnetron telescopic rod 5 can also be coated with a biocompatible material. Alternatively, various components of the device of the present invention may be further provided with an antimicrobial coating.

When in use, the entire device of the present invention is implanted under the periosteum of the human body, and the magnetic field is regulated outside the implantation site, so that the magnetron telescopic rod 5 is telescopically deformed, thereby driving the deformable frame to deform, as shown in Figure 4 when The shape of the deformable frame body when the magnetron telescopic rod 5 is controlled to be shortened, Figure 5 is the shape of the deformable frame body when the control magnetron telescopic rod 5 is extended, the deformation of the device of the present invention can achieve the distraction effect on the periosteum .

As shown in FIG. 2, in another specific embodiment of the present invention, in addition to the structure shown in FIG. 1, the device is also provided with two unthreaded bone pins 4. The upper end of the bone pins 4 is connected to a central one The root support rod 3 is fixed, and the cutting edge end faces downwards in the direction of the second elastic support rod 2. The length of the bone pin 4 exceeds the plane formed by the second elastic support rod 2 in the two described deformable frames, as shown in the figure. 3 shown. The bone needle 4 can be made of non-magnetic materials such as pure titanium or medical stainless steel.

When the device of this embodiment is adopted, when the external magnetic field changes so that the magnetron telescopic rod 5 is telescopically deformed, the deformable frame body can be deformed. When deformed, it moves down or up accordingly, which drives the bone pieces inserted with the spicules to also rise up to complete the bone transfer.

Since the device of the present invention adopts external magnetic field regulation, the change of the magnetic field can be controlled by the computer, the deformation amount of the magnetron telescopic rod 5 can be designed in advance, and the whole treatment process is controlled by the computer, which can realize automatic and precise regulation.

The principle and function of periosteal distraction of the device of the present invention: the change of the external magnetic field causes the magnetron telescopic rod 5 to undergo telescopic deformation, which can drive the deformation of the deformable frame to increase or decrease the height of the deformable frame. When the support rod in the middle is lifted When the periosteum is lifted, the periosteum of the corresponding part is also lifted, resulting in an increase in the stretched area of the periosteum; when the support rod in the middle moves down, the stretch of the periosteum is reduced.

In addition, with the same principle as above, in another embodiment of the present invention, as shown in FIG. 8 , the diabetic foot treatment device includes at least two first elastic support rods 1 , at least one support rod 3 , and at least two magnetron telescopic rods 5 The two ends of each first elastic support rod 1 are fixedly connected with the two ends of a magnetron telescopic rod 5 to form a deformable frame body, and each of the two ends of the support rod 3 is fixedly connected with a described deformable frame body , and the two deformable frames are symmetrically distributed. same,

On the basis of this embodiment, two ends of one of the support rods 3 can be respectively fixed with the midpoint of the first elastic support rod 1 in the deformable frame body, and the support rod 3 is also provided with a Threaded bone needle 4, the upper end of the bone needle 4 is fixed with the support rod 3, the cutting edge end faces the direction of the magnetron telescopic rod 5 downward, and the length of the bone needle 4 exceeds the magnetron in the two deformable frames. The plane formed by the telescopic rod 5.

The above are only preferred embodiments of the present invention, and do not limit the present invention in any form. Although the present invention has been disclosed above with preferred embodiments, it is not intended to limit the present invention. The technical personnel, within the scope of the technical solution of the present invention, can make some changes or modifications by using the technical content disclosed above to be equivalent embodiments of equivalent changes, provided that they do not depart from the technical solution content of the present invention, according to the technical solution of the present invention. Any simple modifications, equivalent changes and modifications made to the above embodiments still fall within the scope of the technical solutions of the present invention.

Claims

A device for treating diabetic foot, characterized in that it comprises at least two first elastic support rods (1), at least two second elastic support rods (2), and at least one support rod (3); the first elastic support rods (3) The length of the rod (1) is greater than that of the second elastic support rod (2), and the two ends of the first elastic support rod (1) are fixedly connected to the two ends of the second elastic support rod (2) respectively to form a deformable frame body. Both ends of the support rod (3) are fixedly connected to one of the deformable frame bodies, and the two deformable frame bodies are symmetrically distributed; at least one magnetron telescopic rod (5) is also included in the deformable frame body. The two ends of the magnetron telescopic rod (5) are respectively fixed with the rod bodies of the first elastic support rod (1) and the second elastic support rod (2).
The diabetic foot treatment device according to claim 1, characterized in that both ends of a support rod (3) are respectively fixed with the midpoint of the first elastic support rod (1) in the deformable frame body.
A device for treating diabetic foot, characterized in that it comprises at least two first elastic support rods (1), at least two second elastic support rods (2), and at least one support rod (3); the first elastic support rods (3) The length of the rod (1) is greater than that of the second elastic support rod (2), and the two ends of the first elastic support rod (1) are fixedly connected to the two ends of the second elastic support rod (2) respectively to form a deformable frame body. The two ends of the support rod (3) are fixedly connected with one of the deformable frame bodies, and the two deformable frame bodies are symmetrically distributed; the deformable frame body also includes a magnetically controlled telescopic rod (5), The two ends of the magnetron telescopic rod (5) are respectively fixed with the two ends of the first elastic support rod (1) and the two ends of the second elastic support rod (2).
The diabetic foot treatment device according to claim 3, characterized in that both ends of a support rod (3) are respectively fixed to the midpoint of the first elastic support rod (1) in the deformable frame body.
A device for treating diabetic foot, characterized in that it comprises at least two first elastic support rods (1), at least one support rod (3), and at least two magnetron telescopic rods (5); each first elastic support rod Both ends of (1) are fixedly connected to two ends of a magnetron telescopic rod (5) to form a deformable frame body, and one of the two ends of the support rod (3) is fixedly connected to a deformable frame body, and The two deformable frames are distributed symmetrically.
The diabetic foot treatment device according to claim 5, characterized in that both ends of a support rod (3) are respectively fixed with the midpoint of the first elastic support rod (1) in the deformable frame body.
The diabetic foot treatment device according to any one of claims 1-6, characterized in that, there are three supporting rods (3) in total, and they are parallel to each other, and two ends of one supporting rod (3) are respectively connected with the other supporting rods (3). The middle points of the first elastic support rods (1) in the deformable frame body are fixed, and both ends of the other two support rods (3) are fixed with both ends of the two first elastic support rods (1).
The diabetic foot treatment device according to any one of claims 1-6, characterized in that, the support rod (3) is further provided with a bone pin (4) without thread, and the bone pin (4) The upper end is fixed with the support rod (3), the cutting edge end faces downwards in the direction of the second elastic support rod (2), and the length of the bone pin (4) exceeds the second elastic support rod ( 2) The formed plane.
The diabetic foot treatment device according to any one of claims 1-6, characterized in that, the magnetron telescopic rod (5) is made of magnetostrictive material.
The diabetic foot treatment device according to any one of claims 1-6, wherein the first elastic support rod (1) and the support rod (3) are made of non-magnetic materials, and when the device has a first elastic support rod (1) and a support rod (3), non-magnetic materials are used. When there are two elastic support rods (2) and bone pins (4), the second elastic support rods (2) and bone pins (4) are made of non-magnetic materials.
The diabetic foot treatment device according to any one of claims 1-6, wherein each component in the device has an antibacterial coating.