阅读说明：本技术 一种串并联型形状记忆合金椎体支架 (Series-parallel connection type shape memory alloy vertebral body support ) 是由 王荣 杨波 左宏 李群 韩旭 于 2020-12-16 设计创作，主要内容包括：本发明提供了一种串并联型形状记忆合金椎体支架,属于医疗器械技术领域,包括多个串联连接的并联单体,所述并联单体包括多个支架单体,所述支架单体交叉并联形成一个所述并联单体,所述并联单体由符合生物相容性要求的形状记忆合金材料制成,使得所述并联单体在不同温度时能够呈现收缩状态或扩张状态。本发明结构简单,操作使用方便,能够与现有的通用外套管椎体成形器械搭配使用,明显降低了经济成本,本发明仅使用支架就能达到支撑椎体的作用,不需要填充骨水泥,从而避免了骨水泥的渗漏问题,有效防止了骨水泥对神经等组织的灼伤破坏,能够有效减轻病人手术痛苦,减少患者术后并发症。(The invention provides a series-parallel connection type shape memory alloy vertebral body support, which belongs to the technical field of medical instruments and comprises a plurality of series-connected parallel-connection monomers, wherein each parallel-connection monomer comprises a plurality of support monomers, the support monomers are connected in a cross-parallel mode to form one parallel-connection monomer, and the parallel-connection monomer is made of a shape memory alloy material meeting the biocompatibility requirement, so that the parallel-connection monomers can be in a contraction state or an expansion state at different temperatures. The invention has simple structure and convenient operation and use, can be matched with the existing universal outer sleeve centrum forming instrument for use, and obviously reduces the economic cost.)

1. A series-parallel connection type shape memory alloy vertebral body support is characterized in that: the single stent comprises a plurality of serially connected parallel monomers (1), wherein each parallel monomer (1) comprises a plurality of stent monomers (3), each stent monomer (3) is connected in parallel in a crossed mode to form one parallel monomer (1), and each parallel monomer (1) is made of a shape memory alloy material meeting the biocompatibility requirement, so that the parallel monomers (1) can be in a contraction state or an expansion state at different temperatures.

2. The series-parallel type shape memory alloy vertebral body scaffold according to claim 1, wherein: the plurality of parallel monomers (1) are connected in series through connecting ribs (2).

3. The series-parallel type shape memory alloy vertebral body scaffold according to claim 1, wherein: the support single body (3) is of a symmetrical closed circular ring structure, the circular ring structure is provided with a convex part and a concave part, and the circular ring structure is of an M-shaped structure after being unfolded.

4. The series-parallel type shape memory alloy vertebral body scaffold according to claim 1, wherein: the shape memory alloy material is nickel-titanium memory alloy which meets the biocompatibility requirement.

5. The series-parallel type shape memory alloy vertebral body scaffold according to claim 4, wherein: when the parallel single bodies (1) are in a contraction state, the parallel single bodies (1) extend and contract along the axial direction of the parallel single bodies (1), and the final contraction state is a thin tubular structure; the upper and lower ports of the parallel monomer (1) are both in an open shape in an expansion state, and the circumferential side surface of the parallel monomer is in a net structure.

6. The series-parallel type shape memory alloy vertebral body scaffold according to claim 1, wherein: the parallel monomers (1) are bilaterally symmetrical along the central axis thereof.

7. The series-parallel type shape memory alloy vertebral body scaffold according to claim 6, wherein: the cross section of the parallel monomer (1) is circular, and meanwhile, the circumferential side surface of the parallel monomer (1) is of a net-shaped hole structure.

8. The series-parallel type shape memory alloy vertebral body scaffold according to claim 7, wherein: the diameters of different cross sections of the parallel monomers (1) are equal when the parallel monomers are expanded into a net shape; the diameters of different cross sections of the parallel monomers (1) are equal when the parallel monomers are contracted into a tubular shape.

9. The series-parallel type shape memory alloy vertebral body scaffold according to claim 7, wherein: the surfaces of the parallel monomers (1) are subjected to treatment for reducing the surface roughness.

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a series-parallel connection type shape memory alloy vertebral body support.

Background

With the advent of aging society, the incidence of osteoporotic fracture increases year by year, and the vertebral body is the part where osteoporosis is most likely to occur. Approximately 150 million osteoporotic fractures are reported in the United states annually, with 70 thousand vertebral compression fractures, and with a continuing trend to increase, with 1/3 patients having chronic pain and the majority being elderly women. According to the population proportion, about 400 million people in China have osteoporosis compression fracture every year, wherein more than 170 million people are accompanied by pain, and 70 million people need hospitalization. For a long time, the traditional treatment principle of the compression fracture of the vertebral body of the elderly patients caused by osteoporosis is bed rest, oral medication pain relief, external support and the like, but only partial pain symptoms of the patients can be temporarily relieved, the osteoporosis degree is aggravated after the patients lie in bed for a long time, the further compression of the vertebral body, the further aggravation of pain and kyphosis are further aggravated, the reduction of the volume of the thoracic cavity, the ventilation obstacle, the oxygen deficiency and the heart-lung dysfunction are caused, the life quality of the patients is rapidly reduced, and the death rate is increased in severe cases. Surgery is further complicated by the presence of osteoporosis and can present dangerous secondary conditions, and is rarely used unless decompression is required in conjunction with the symptoms of nerve compression. In 1987, Galibert et al, first reported Percutaneous Vertebroplasty (PVP) with cement injected into the vertebral body, and in 1990 this technique was applied to the treatment of osteoporotic vertebral fractures (OVCF). Reiley et al, 1998, in the United states, designed Percutaneous Kyphoplasty (PKP). Vertebroplasty is developed in China since 1999, and has become an effective treatment method for senile osteoporotic vertebral compression fracture for more than 20 years so far, the trauma is small, the pain relieving effect is reliable, and the vertebroplasty is accepted by most orthopedic doctors and patients. However, the currently most commonly used filler, namely, the bone cement, namely, polymethyl methacrylate (PMMA), has the inherent disadvantages of monomer toxicity, heat generation and leakage, and cannot be applied to young people. The search or the optimized design of a substitute material with low damage and better tissue compatibility is a research hotspot of interdisciplinary subjects of mechanics, materials science, medicine and the like in recent years.

Disclosure of Invention

In view of the above, the invention aims to provide a series-parallel connection type shape memory alloy vertebral body support, which is simple in structure and convenient to operate and use, can achieve the effect of supporting a vertebral body only by using the support, does not need to be filled with bone cement, thereby avoiding the leakage problem of the bone cement, effectively preventing the bone cement from burning and damaging tissues such as nerves and the like, effectively relieving the operation pain of a patient and reducing the postoperative complications of the patient.

In order to achieve the purpose, the technical scheme of the invention is realized as follows: a series-parallel connection type shape memory alloy vertebral body support comprises a plurality of series-connected parallel-connection single bodies, each parallel-connection single body comprises a plurality of support single bodies, the support single bodies are connected in a cross-parallel mode to form one parallel-connection single body, the parallel-connection single bodies are made of shape memory alloy materials meeting biocompatibility requirements, and therefore the parallel-connection single bodies can be in a contraction state or an expansion state at different temperatures.

Furthermore, a plurality of the parallel monomers are connected in series through connecting ribs.

Furthermore, the support monomer is a symmetrical closed ring structure, the ring structure is provided with a convex part and a concave part, and the ring structure is of an M-shaped structure after being unfolded.

Further, the shape memory alloy material is a nickel titanium memory alloy meeting the biocompatibility requirement.

Furthermore, when the parallel single bodies are in a contraction state, the parallel single bodies stretch and contract along the axial direction of the parallel single bodies, and the final contraction state is a thin tubular structure; the upper and lower ports of the parallel monomer are both in an open shape in an expansion state, and the circumferential side surface of the parallel monomer is in a net structure.

Further, the parallel single bodies are symmetrical left and right along the central axis thereof.

Furthermore, the cross section of the parallel monomer is circular, and the circumferential side surface of the parallel monomer is of a net-shaped hole structure.

Further, the diameters of different cross sections of the parallel monomers are equal when the parallel monomers are expanded into a net shape; the diameters of different cross sections of the parallel monomers are equal when the parallel monomers are contracted into a tubular shape.

Further, the surfaces of the parallel monomers are subjected to treatment for reducing the surface roughness.

Compared with the prior art, the series-parallel shape memory alloy vertebral body support has the following advantages:

(1) the vertebral body supporting function can be achieved by using the bracket only, and bone cement does not need to be filled, so that the leakage problem of the bone cement is avoided, and the burning damage of the bone cement to tissues such as nerves and the like is effectively prevented;

(2) after the bone fracture centrum is implanted into a human body, the bone fracture centrum can be expanded to obtain larger supporting force by using smaller expansion radius, so that the bone fracture centrum can be supported, the structure is simple, and the operation is easy;

(3) the reticular hole structure on the circumference of the vertebral body support creates good conditions for the subsequent regrowth of bone tissues, and can ensure that the vertebral body support is connected with the peripheral bone tissues to well fix the vertebral body support and the vertebral body;

(4) the nickel-titanium shape memory alloy has the advantages of good biocompatibility, high strength, fatigue resistance, no magnetism, no toxic or side effect and the like, and is suitable for long-term centrum stent implantation;

(5) the vertebral body supports arranged in a series-parallel connection mode can provide larger supporting force, and the size of the supporting force is close to the strength of the compression damage of the vertebral sections;

(6) the surface of the vertebral body support is smooth, so that damage to surrounding bone tissues caused by implantation of the vertebral body support is effectively avoided;

(7) the minimally invasive channel is implanted into the compressed vertebral body, so that the operation pain of a patient is effectively relieved, postoperative complications are reduced, the survival quality of the patient is obviously improved, the minimally invasive operation is simple and convenient to operate, and the controllability is strong;

(8) the invention can be matched with the existing universal outer sleeve vertebroplasty instrument for use, and can obviously reduce the economic cost.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate an embodiment of the invention and, together with the description, serve to explain the invention and not to limit the invention. In the drawings:

FIG. 1 is a schematic structural view of a series-parallel type shape memory alloy vertebral body scaffold according to an embodiment of the present invention;

FIG. 2 is a front view of a series-parallel type shape memory alloy vertebral body scaffold according to an embodiment of the present invention;

FIG. 3 is a left side view of a series-parallel type shape memory alloy vertebral body stent according to an embodiment of the present invention;

FIG. 4 is a schematic view of FIG. 3 after 45 counterclockwise or clockwise rotation about the central axis of the vertebral body support;

FIG. 5 is a schematic view of FIG. 4 in a contracted state;

FIG. 6 is a schematic structural diagram of a parallel monomer according to an embodiment of the present invention;

FIG. 7 is a front view of a parallel cell according to an embodiment of the present invention;

FIG. 8 is a top view of a parallel cell according to an embodiment of the present invention;

FIG. 9 is a schematic structural diagram of a single stent according to an embodiment of the present invention;

fig. 10 is a schematic deployment view of a stent unit according to an embodiment of the present invention.

Description of reference numerals:

1. monomers are connected in parallel; 2. connecting ribs; 3. and (3) a bracket monomer.

Detailed Description

It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict.

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention. Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.

The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings.

As shown in fig. 1 to 10, the invention relates to a series-parallel type shape memory alloy vertebral body stent, which comprises a plurality of series-connected parallel monomers 1, wherein different numbers of the parallel monomers 1 are selected to be connected in series according to actual needs of different patients, so that the practicability is improved, the parallel monomers 1 comprise a plurality of stent monomers 3, the stent monomers 3 are connected in parallel in a crossing manner to form one parallel monomer 1, and the parallel monomer 1 is made of a shape memory alloy material meeting the biocompatibility requirement, so that the parallel monomer 1 can be in a contraction state or an expansion state at different temperatures, specifically, in a contraction state at a low temperature (0-5 ℃) and can be restored to a memorized expansion state at a human body temperature (30-37 ℃). Based on the material characteristics of memory alloy, the vertebral body support is in a contracted tubular shape at low temperature (0-5 ℃), can be placed in an outer sleeve matched with a general vertebral body forming instrument for use, and is restored to a memorized expanded net shape at the temperature of a human body (30-37 ℃), the vertebral body supports arranged in a series-parallel connection mode can provide larger supporting force, when the compression displacement of the vertebral body is 5mm, the supporting force provided by the vertebral body support is about 1000N and is close to the strength of the compression damage of the vertebral segment, so that the vertebral body support can obtain larger supporting force by using smaller expansion radius after being expanded into the human body, plays a role in supporting the fractured vertebral body, has a simple structure, is easy to operate and meets the clinical requirements. The vertebral body support can support the vertebral body only by using the vertebral body support, and does not need to be filled with bone cement, so that the leakage problem of the bone cement is avoided, the burn damage of the bone cement to tissues such as nerves and the like is effectively prevented, and the vertebral body support is implanted into a compressed vertebral body through a minimally invasive channel under the condition of controllable temperature, so that the minimally invasive surgery is simple and convenient to operate and has strong controllability.

A plurality of the parallel monomers 1 are connected in series through connecting ribs 2.

The support monomer 3 is a symmetrical closed circular ring structure, the circular ring structure is provided with a convex part and a concave part, and the circular ring structure is of an M-shaped structure after being unfolded.

The shape memory alloy material is nickel-titanium memory alloy which meets the biocompatibility requirement, and the nickel-titanium shape memory alloy has the advantages of good biocompatibility, high strength, fatigue resistance, no magnetism, no toxic or side effect and the like, and is suitable for long-term centrum stent implantation.

When the parallel single bodies 1 are in a contraction state, the parallel single bodies 1 extend and contract along the axial direction of the parallel single bodies 1, and the final contraction state is a thin tubular structure; the upper and lower ports of the parallel monomer 1 are both open when in an expanded state, and the circumferential side surface of the parallel monomer is of a net structure.

The parallel single bodies 1 are symmetrical left and right along the central axis thereof.

The cross section of the parallel monomer 1 is circular, meanwhile, the circumferential side surface of the parallel monomer 1 is of a net-shaped hole structure, the net-shaped hole structure creates a good condition for subsequent bone tissue regrowth, and the vertebral body support can be connected with the peripheral bone tissue, so that the vertebral body support and the vertebral body can be well fixed.

The diameters of different cross sections of the parallel monomers 1 are equal when the parallel monomers are expanded into a net shape; the diameters of different cross sections of the parallel single bodies 1 are equal when the parallel single bodies contract in a tubular shape, so that the supporting force of the vertebral body support in the vertebral body cavity can be uniformly distributed, the supporting requirement after the reduction of the compression fracture is ensured, and the normal vertebral body height is further reached.

The surface of the parallel monomer 1 is subjected to surface roughness reduction treatment, so that damage to surrounding bone tissues caused by implantation of a vertebral body support is effectively avoided.

In vertebroplasty, a vertebral body support is matched with a general existing vertebroplasty instrument for use, the vertebral body support in a contraction state is placed into one end of an outer sleeve, an inner sleeve is placed at the other end of the outer sleeve far away from the vertebral body support, the inner sleeve is pushed to convey the vertebral body support to a diseased vertebra needing to be propped open through a micro wound, then the inner sleeve and the outer sleeve of the vertebral body support are withdrawn in sequence, along with the rise of temperature, when the vertebral body support reaches the temperature of a human body (30-37 ℃), the vertebral body support is slowly propped open to be in a net shape, supporting force is provided to prop open the fractured vertebral body, and therefore the purpose of treating the compression fracture of the vertebral body is achieved, and the outer sleeve.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.