WO2020224161A1

WO2020224161A1 - Vertebral-body bone filling and support apparatus

Info

Publication number: WO2020224161A1
Application number: PCT/CN2019/106791
Authority: WO
Inventors: 郝定均
Original assignee: 郝定均
Priority date: 2019-05-09
Filing date: 2019-09-19
Publication date: 2020-11-12
Also published as: CN110025371A

Abstract

Provided is a vertebral-body bone filling and support apparatus, comprising: an implant member (100), comprising a central tube part (102) and a plurality of surrounding protruding parts (101); one end of the central tube part (102) is a blind end (105), and the other end is an injection port (104); the surrounding protruding parts (101) are arranged on the main body of the central tube (102), and the plurality of surrounding protruding parts (101) are distributed in a divergent shape along the circumference of the outer wall of the central tube (102); the inner cavity of the surrounding protrusion (101) is in communication with the inner cavity of the central tube (102); the center line of the central tube is a straight line or an arc; the materials of the main body of the central tube (102) and the surrounding protruding parts (101) are soft flexible materials; when pressure is applied to the inner cavity of the central tube (102), the surrounding protruding parts (101) can expand and extend to form a support structure. Therefore the disadvantage of existing products of the difficulty of evenly supporting the bone fracture site in all directions for position reset is resolved.

Description

Vertebral body bone filling and supporting device

【Technical Field】

The invention relates to the technical field of bone cement devices, in particular to a vertebral body bone filling and supporting device.

【Background technique】

At present, with the aging of the population and people's emphasis on quality of life, osteoporosis has attracted much attention and has become a global public health problem. Osteoporotic vertebral compression fractures (OVCF) are one of the most common complications of osteoporosis, and they are also an important cause of disability and death in the elderly. For vertebral compression fractures, traditional treatments are still conservative, including bed rest, pain relief, wearing thoracolumbar braces, etc. 84% of patients will have acute and chronic thoracolumbar pain, spinal deformities, etc., which restrict daily life and affect spinal function , Reduce the quality of life. However, surgical treatment is chosen. In the past, pedicle screw fixation caused insufficient holding force due to osteoporosis in patients, and it was extremely prone to screw loosening and internal fixation failure. Although in recent years, most scholars have developed bone cement screws to treat osteoporotic spine Fractures have brought new hope to patients, but most patients are forced to abandon surgical treatment of internal fixation because they cannot tolerate anesthesia due to combined medical diseases.

For such patients, percutaneous vertebroplasty (PVP) and kyphoplasty (PKP) under local anesthesia are currently the most recognized minimally invasive methods for the treatment of OVCF. However, these two procedures have high According to literature reports, the leakage rate of bone cement is 11%-76%, and the latter is about 4.8%-39.0%. In order to further reduce the leakage rate of bone cement and improve the safety of the operation, the shaper is often expanded before the bone cement is inserted to form a cyst, and the bone cement is injected at low pressure. The earliest Kyphon balloon kyphoplasty (Balloon- Kyphoplasty, BKP) was invented by Mark Reiley in 1994. In 1998, the FDA approved its clinical application to expand indirectly through the hydraulic system, resetting and compressing the collapsed vertebral body, creating a cavity, which is soft expansion, and the expansion is not easy to be oriented. In 2004, Israel Disc-O-Tech company invented the Sky-bone expander kyphoplasty (EKP) made of polymer materials. The anterior part of the cylindrical expander was folded and folded during the operation for expansion. , It is rigid expansion and can be oriented. The disadvantages are: the expansion height is limited, the position after expansion cannot be changed, the height cannot be adjusted, and the shape after expansion is "mulberry", so the height of the middle part of the vertebral body is restored slightly higher, and the kyphotic Cobb angle is not improved well. . In 2007, A-Spine company invented a new type of bone capsule-filled vertebral body forming (Vesselplasty) technology, which was officially certified by the my country Food and Drug Administration in 2013 and introduced it to my country. The Vessel-X capsular bag filler used in this technology is made of polymer materials interlaced and woven into a mesh bag-like structure. The purpose of expansion can be achieved by directly pouring viscous bone cement. Its dense polymer mesh structure can wrap Most bone cements only allow a small amount of bone cement to penetrate outside the mesh layer, which can effectively control the occurrence of bone cement leakage. According to the literature, the leakage rate is still 1.7% to 54.5%, and due to the mesh bag It restricts the cement exudation and prevents the microscopic locking between the bone cement and the bone trabecula. After surgery and in the literature, the mesh bag of bone cement becomes loose and free from the vertebral body. Secondly, the mesh bag bone cement is inside the vertebral body. It still exists in the state of agglomerates, and the local strength and temperature during polymerization are too high. According to research, the exothermic reaction temperature of bone cement polymerization is as high as 47℃-100℃. High temperature leads to necrosis of vertebral bone cells, and bone cement polymerization exothermic heat and bone The thickness of the cement has a certain relationship, the thicker the bone cement, the more heat is released.

Bone cement leakage is one of the most common and most serious complications in the minimally invasive treatment of spinal compression fractures. Bone cement drawing stage and mass stage pushing reduce leakage, but the uneven dispersion of bone cement makes the operation The local formation of the post-perfusion segment has poor mechanical gradients, and it is prone to fractures of the non-perfused segment and adjacent segments of the vertebral body, and it is not uncommon for the bone cement to form a mass in the vertebral body and to relocate the bone cement again. Secondly, the toxicity of bone cement, allergies and shock.

So far, all the shaping systems currently on the market have caused leakage of the injected bone cement, uneven distribution of agglomerates, thermal damage, toxic reactions, and later bone cement displacement, which are the main urgent problems in the current spine vertebroplasty surgery. problem.

[Content of the invention]

The purpose of the present invention is to provide a vertebral bone filling and supporting device, which can completely solve the leakage and toxic reaction of bone cement, reduce its displacement, and make the pouring slurry evenly distributed, and reduce the problem of bone cement as agglomerates. Perfusion occurs due to the occurrence of osteonecrosis caused by heat injury, and can most effectively restore the height of the vertebral body where the upper endplate collapses, and the bone cement forms a good device system similar to trabecular columnar support with uniform force.

In order to achieve the above tasks, the present invention adopts the following technical solutions:

A vertebral body bone filling and supporting device includes:

The implant includes a central tube and a plurality of surrounding protrusions. One end of the central tube is a blind end and the other end is an injection port; the surrounding protrusions are arranged on the main body of the central tube, and there are more The surrounding protrusions are distributed along the periphery of the outer wall of the central tube in a divergent shape; the lumen of the surrounding protrusions is communicated with the lumen of the central tube;

The material of the main body of the central tube and the material of the surrounding protrusions are both soft elastic materials. When pressure is applied to the inner cavity of the central tube, the surrounding protrusions can expand and expand to form a supporting structure.

As a further improvement of the present invention, when the injection port is filled with the perfusion slurry into the central tube portion by injection, the perfusion slurry pushes the surrounding protrusions to expand and then extends and solidifies into the bone tissue.

As a further improvement of the present invention, the central tube part has a columnar structure, the surrounding protrusion part is a truncated cone structure, one end of the surrounding protrusion part is a blind end, the other end is an open end, and the open end is connected to the central tube part.

As a further improvement of the present invention, the peripheral protrusions are evenly arranged in a ring shape along the circumferential direction of the central tube, and the ring-shaped peripheral protrusions are evenly arranged along the axial direction of the central tube.

As a further improvement of the present invention, the adjacent annular protrusions are arranged in a staggered manner.

As a further improvement of the present invention, the center line of the central tube is a straight line; the wall thickness of the surrounding protrusion of the central tube placed on the side of the unfractured tissue is greater than that of the surrounding protrusion placed on the side of the fracture cavity The wall thickness.

As a further improvement of the present invention, the center line of the central tube portion is an arc; wherein the surrounding protrusions include an outer curved portion and an inner curved portion, and the wall thickness of the surrounding protrusions of the outer curved portion is smaller than that of the inner curved portion. Wall thickness.

As a further improvement of the present invention, it also includes:

Auxiliary positioning part, which includes a positioning core and a clamping part, the clamping part is arranged at the end of the positioning core; the inner wall of the blind end is provided with a clamping groove, after the auxiliary positioning part extends into the inner cavity of the central tube, the clamping part In contact with the inside of the blind end, the core part is rotated and positioned, and the clamping part can be locked and fixed with the clamping slot.

As a further improvement of the present invention, the implant further includes: a developing snap ring, which is arranged at the front, middle and rear end of the outer wall of the central tube.

As a further improvement of the present invention, the inner wall of the injection port is provided with internal threads.

Compared with the prior art, the present invention has the following beneficial effects:

In the vertebral bone filling and supporting device of the present invention, the surrounding protrusions of the implant are of hollow structure, and are connected to the inner surface of the central tube, and a plurality of peripheral protrusions are arranged around the central tube. The central tube main body and the surrounding protrusions The soft elastic material can expand and expand. When pressure is applied to the inner cavity of the central tube, the surrounding protrusions can expand and expand to form a support structure. When the vertebral body is inserted, the implant can be easily inserted into the diseased vertebral body through the channel, and the cement will enter through the surrounding protrusions of the side opening. As the perfusion pressure at the rear gradually increases, it gradually expands around the central tube. The columnar extension of the bone-like trabecula is formed in the bone tissue; then the bone cement is ossified to form a uniform trapezoidal columnar support. The divergent surrounding protrusions of the implant solve the leakage of bone cement during infusion, so that the leakage rate of bone cement is reduced to zero; at the same time, it solves the problem of uneven distribution of bone cement injected into the vertebral body in the existing shaping system The shortcomings of the bone-like trabeculae are formed to make the perfusion slurry evenly distributed. The thickening of the lower and posterior walls allows the perfusion slurry to flow to the front and upper ends of the surrounding protrusions, and gradually uniform columnar support for the collapse of the front and middle of the fractured vertebral body. Effective reduction and correction of kyphotic deformity; uniform distribution of bone cement reduces the existence of local mechanical gradients of the diseased vertebral body, which greatly reduces postoperative fractures of the diseased vertebral body and loss of height, and fractures of adjacent segments of the vertebral body risk. The existing mass-shaped bone cement will be replaced by divergent surrounding protrusions, which solves the thermal damage caused by the polymerization reaction when the bone cement mass is distributed, and reduces the thermal damage caused by the bone cement mass.

Furthermore, when three metal wires in the front, middle and back of the central pipe wall of the device are determined to be located at the front of the midline of the vertebral body through fluoroscopy, when the bone cement is directly poured through the central pipe, it is convenient for positioning and instrument tracking observation.

Furthermore, the thickness of the trapezoidal columnar wall of the trabecular bone forming part near the lower end and the back of the vertebral body of the device is twice the thickness of the front end and the upper end. The significance of this design is that when the bone cement is injected, the surrounding protrusions located at the front end and the upper end It is easy to expand, and the pressure is higher than the lower end and the rear. Because the compression fracture of the vertebral body often occurs in the collapse of the anterior middle and upper endplate, the density of the cortical bone above and in front of the fractured vertebral body is higher than that of the unfractured part of the residual vertebral body. According to the internal pressure distribution of the vertebral body, the expansion of the surrounding protrusion forming part has a tendency to expand to the lower area. The thickening of the lower and rear end walls forces the bone cement to flow to the easy expansion of the upper end and the protruding parts around the front end, thus solving the current problem. All products on the market have the disadvantage that it is difficult to evenly spread the fracture site in all directions for directional reduction.

Furthermore, the surrounding protrusions are staggered to form a gap, which is conducive to the settlement of the remaining bone trabecula in the vertebral body. After the fracture is healed, the vertebral body filling and supporting device is stabilized in the vertebral body, reducing the bone caused by the patient's movement in the later period. Loosening of cement and occurrence of displacement.

【Explanation of drawings】

Figure 1 is a schematic cross-sectional view of the vertebral bone filling and supporting device of the present invention;

Figure 2 is a schematic diagram of the vertebral body bone filling and supporting device of the present invention after expansion and expansion (linear type);

Figure 3 is a schematic diagram of the vertebral body bone filling and supporting device after expansion and expansion (curved type);

Figure 4 is a partial cross-sectional view (curved type) of the vertebral body bone filling support device of the present invention after expansion and expansion;

Figure 5 is a schematic diagram of the expanded and extended rear end of the vertebral bone filling and supporting device of the present invention (blind end);

Figure 6 is a partial cross-sectional view (dimensions) of the vertebral bone filling support device of the present invention after expansion and expansion;

Figure 7 is a diagram of the vertebral body bone filling and supporting device implanted into the vertebral body of the present invention;

Figure 8 is a schematic diagram of the implantation of the vertebral body bone filling support device into the vertebral body (single linear type);

Figure 9 is a schematic diagram of the implantation of the vertebral body bone filling support device into the vertebral body (two straight lines);

Figure 10 is a schematic diagram of the implantation of the vertebral body bone filling support device into the vertebral body (single curved type);

Among them, 100-implant; 101-peripheral protrusion; 102-central tube; 103-visualization snap ring; 104-injection port; 105-blind end; 106-slot; 1011-outer bend; 1012-inner Curved part; 200-auxiliary positioning part; 201-positioning core; 202-clamping part; 300-infusion slurry; 400-vertebral body; 401-fracture cavity; 402 unfractured tissue; 500-bone cement push Note the device.

【Detailed ways】

In order to enable those skilled in the art to better understand the solutions of the present invention, the technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only The embodiments are a part of the present invention, not all embodiments, and are not intended to limit the scope of the present invention. In addition, in the following description, descriptions of well-known structures and technologies are omitted to avoid unnecessary confusion of the concepts disclosed in the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.

The drawings show various structural schematic diagrams according to the disclosed embodiments of the present invention. The figures are not drawn to scale, some details are enlarged and some details may be omitted for clarity of presentation. The shapes of the various regions and layers shown in the figure and the relative size and positional relationship between them are only exemplary. In practice, there may be deviations due to manufacturing tolerances or technical limitations. Areas/layers with different shapes, sizes, and relative positions can be designed as needed.

In the context of the present disclosure, when a layer/element is referred to as being "on" another layer/element, the layer/element may be directly on the other layer/element, or there may be an intermediate layer/element between them. element. In addition, if a layer/element is located “on” another layer/element in one orientation, the layer/element may be located “under” the other layer/element when the orientation is reversed.

It should be noted that the terms "first" and "second" in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects, and not necessarily used to describe a specific sequence or sequence. It should be understood that the data used in this way can be interchanged under appropriate circumstances so that the embodiments of the present invention described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "including" and "having" and any variations of them are intended to cover non-exclusive inclusions. For example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to the clearly listed Those steps or units may include other steps or units that are not clearly listed or are inherent to these processes, methods, products, or equipment.

The present invention will be described in further detail below in conjunction with the accompanying drawings:

As shown in Figures 1 to 6, a vertebral bone filling and supporting device of the present invention includes:

The implant 100 includes a central tube 102 and a plurality of peripheral protrusions 101. One end of the central tube 102 is a blind end 105, and the other end is an injection port 104; the peripheral protrusion 101 is set in the center On the main body of the tube portion 102, a plurality of surrounding protrusions 101 are distributed in a divergent shape along the outer wall of the central tube portion 102; the lumen of the surrounding protrusions 101 communicates with the inner cavity of the central tube portion 102; the center line of the central tube portion 102 Be a straight line or an arc;

The main body of the central tube 102 and the surrounding protrusions 101 are made of soft elastic materials. When pressure is applied to the inner cavity of the central tube 102, the surrounding protrusions 101 can expand and expand to form a supporting structure. When the injection port 104 is injected and filled with the perfusion slurry 300 into the central tube portion 102, the perfusion slurry 300 pushes the peripheral protrusion 101 to expand and then extends into and solidifies into the bone tissue. The divergent surrounding protrusions of the implant solve the leakage of bone cement during infusion, so that the leakage rate of bone cement is reduced to zero; at the same time, it solves the problem of uneven distribution of bone cement injected into the vertebral body in the existing shaping system The disadvantage of the surrounding protrusion 101 is a trabecular bone-like structure so that the pouring slurry is evenly distributed.

Preferably, the central tube 102 has a columnar structure, the peripheral protrusion 101 is a truncated cone structure, one end of the peripheral protrusion 101 is a blind end, and the other end is an open end, and the open end is connected to the central tube 102. The cement spreads from the bottom to the top of the round table structure to facilitate flow and expansion.

Preferably, the peripheral protrusions 101 are uniformly arranged in a ring shape along the circumferential direction of the central pipe portion 102, and the annular peripheral protrusions are uniformly arranged along the axial direction of the central pipe portion 102.

Preferably, the adjacent annular protrusions are arranged in a staggered manner.

Preferably, the wall thickness of the surrounding protrusion of the central tube portion 102 on the side of the unfractured tissue 402 is greater than the wall thickness of the surrounding protrusion on the side of the cavity 401 of the fracture fissure. When the bone cement is injected, the surrounding protrusions 101 at the front end and the upper end are easy to expand, and the pressure is higher than the lower end and the rear. The expansion of the surrounding protrusion 101 has a tendency to expand to the lower area according to the internal pressure distribution of the vertebral body. The thickening of the lower and posterior walls forces the bone cement to flow to the easy-expandable upper and front-end forming parts for expansion and reduction, thereby solving The existing products have the disadvantage that it is difficult to evenly spread the fracture site in all directions for reduction.

Preferably, it also includes:

The auxiliary positioning member 200 includes a positioning core 201 and a clamping part 202. The clamping part 202 is arranged at the end of the positioning core 201; the inner wall of the blind end 105 is provided with a clamping groove 106, and the auxiliary positioning member 200 extends into the center After the inner cavity of the tube portion 102, the clamping portion 202 is in contact with the inside of the blind end 105, the core portion 201 is rotated and positioned, and the clamping portion 202 can be locked and fixed with the clamping slot 106. After being sent to the preset position, the positioning core 201 is rotated, the clamping part 202 can be unlocked from the card slot 106, and the auxiliary positioning member 20 is withdrawn.

Preferably, the implant 100 further includes a developing snap ring 103, which is arranged at the front, middle and rear end of the outer wall of the central tube 102. To ensure the best position for implanting the device.

Preferably, the inner wall of the injection port 104 is provided with an internal thread. It is convenient for screw connection with bone cement injection device.

Example 1

As shown in Figure 1, Figure 2 and Figure 5, a vertebral bone filling and supporting device includes an elastic implant 100 and an auxiliary positioning member 200; the overall external structure of the central tube 102 is a cylindrical hollow structure with a diameter of about 5.0mm The surrounding protrusion 101 is a trapezoidal columnar hollow structure (cone structure), one end of which is a blind end, and the other end opening is connected to the inner surface of the central tube 102, and 10 surrounding protrusions 101 are provided in a circumferential circle around the central tube 102, a total of There are 7 circles with a total length of about 25cm. The vertebral body bone filling support device is hollow and folded at the inner mouth when it is inserted. The open channel can be easily inserted into the diseased vertebral body; the outer wall of the central tube 102 of the device There are developing snap rings 103 made of three metal wires in the front, middle and rear. When the imaging snap ring 103 is determined to be located at the anterior position of the midline of the vertebral body through fluoroscopy, when the slurry 300 (such as bone cement) is directly injected through the injection port 104 of the central tube portion 102, its distal end is the blind end 105, and the slurry 300 is injected Will enter the peripheral protrusions 101 of the side opening. As the perfusion pressure at the rear gradually increases, the 70 peripheral protrusions 101 surrounding the central tube 102 gradually expand and expand to form bone-like trabeculae that penetrate into the bone tissue; then bone cement After curing, a uniform truncated cone-shaped support is formed.

The auxiliary positioning member 200 includes a positioning core 201 and a clamping part 202. The clamping part 202 is arranged at the end of the positioning core 201. The side wall of the blind end 105 is provided with a clamping groove 106. The auxiliary positioning member 200 extends into the central tube 102 After the cavity, the clamping portion 202 is in contact with the blind end 105 of the central tube portion 102, and the core portion 201 is rotated and positioned, and the clamping portion 202 can be locked and fixed with the clamping slot 106. Through the auxiliary positioning member 200, the implant 100 can be accurately delivered into the diseased vertebra 400. The main body of the clamping portion 202 is a disc structure, and the disc is provided with a buckle that cooperates with the clamping groove 106.

Because compression fractures of the vertebral body often occur in the anterior middle and upper endplates of the vertebral body, the density of the cortical bone above and in front of the fractured vertebral body is higher than the unfractured part of the residual vertebral body. Therefore, the device is close to the lower end of the vertebral body and The wall thickness of the rear peripheral protrusion 101 is twice that of the front end and the upper end. The feature of this structure is that when the bone cement is injected, the peripheral protrusion 101 at the front end and the upper end is easy to expand, and the pressure is higher than the lower end and the rear. The expansion of the peripheral protrusion 101 designed by the present invention tends to expand to the lower area according to the internal pressure distribution of the vertebral body. The thickening of the lower and rear end walls forces the bone cement to flow to the easy-expandable upper and front end forming parts for expansion and reduction. Therefore, the disadvantage of the existing products that it is difficult to evenly spread the fracture site in all directions for reduction is solved.

The truncated cone-shaped design makes the surrounding protrusion 101 formed similar to the principle of a "jack", with a large diameter of 3.5mm at the bottom and a small diameter of 1.5mm at the top, which will exert the maximum supporting force for resetting. Around the central tube portion 1021, there are 10 surrounding protrusions 101 diverging and extending around, and there are 7 circles with a total length of about 27 mm.

In order to prevent the distance between the surrounding protrusions 101 on adjacent loops from being too large and causing uneven supporting force, the surrounding protrusions 101 of the second loop designed by the present invention rotate the whole 15° clockwise relative to the previous loop. The gap between the protrusions 101 around the first circle is filled, so that the structural interval span between the trabecula and the trabecula is reduced and distributed evenly.

Example 2

As shown in Figure 1, Figure 3, Figure 4 and Figure 5, a vertebral body bone filling and supporting device of the present invention has the same overall structure as that of Embodiment 1, except that the central tube 102 is slightly curved after being fully expanded. In the structure, 70 surrounding protrusions 101 are arranged in an arc along the axial direction of the central tube 102, and the axis of the central tube 102 is parallel to the outer coronal surface of the surrounding protrusions 101.

The wall thickness of the surrounding protrusions on the outer curved portion 1011 of the arc-shaped structure is half of the wall thickness of the surrounding protrusions of the inner curved portion 1012. The outer curved portion 1011 is correspondingly arranged at the cavity 401 of the fracture fissure, and the inner curved portion 1012 is arranged at the unfractured tissue 402.

The infusion slurry 300 can be bone cement, PMMA, CPC, etc.

As shown in Figure 6, the vertebral body bone filling and supporting device of the present invention can be set in three models: large, medium and small, to meet the surgical needs of different subjects. Taking the medium as an example, the size is as follows:

A: total height 20mm; B: total length 27mm; C: central tube diameter 4.0mm; D: central hollow tube diameter 2.4mm; E: peripheral protrusion 101 base diameter 3.5mm; F: peripheral protrusion 101 blind end 1.5mm ; H: Convex side type first circle trabecular bone spacing 4.8mm from the second circle trabecular bone spacing; G: concave side bone trabecular spacing 3.0mm; J: coaxial trabecular bone spacing is 4.9mm.

As shown in Figures 7-10, a vertebral bone filling and supporting device of the present invention is used as follows:

1. The channel tube used in the current clinical use of vertebroplasty can be easily inserted into the diseased vertebral body 400. The device has a development ring 103 of titanium alloy in the front, middle and back to ensure the implantation of the device. In the best position, when the projection of the central snap ring on the orthographic film overlaps or is close to the projection position of the spinous process, the nut behind the rotating channel exits the inner core 200 of the central tube 102.

2. In conjunction with the bone cement injection device 500, inject the prepared bone cement through the central tube 102. When the bone cement passes through the surrounding protrusions 101 of the opening on the central tube 102, gradually open its folds and slowly expand The principle of first expansion is a soft material, and the infusion of bone cement is liquid. When the surrounding protrusion 101 encounters hard unfractured tissue 402, it will bypass and extend to other soft tissues or gaps, that is, fracture cavity 401 Spread, cut the surrounding unfractured bone trabecula to a small extent, and can expand to form a frustum-like structure;

Figures 8 and 9 show the linear structure of Example 1. One vertebral bone filling support device (Figure 8) or two vertebral bone filling support devices (Figure 9) are placed according to the surgical requirements.

Fig. 10 shows the curved structure of Embodiment 2, and the curved profile of the implant 100 is consistent with the curved structure of the vertebra 400.

3. With the bolus injection of the posterior bone cement, the pressure in the surrounding protrusion 101 gradually increases. Due to the thickening of the trabecular bone structure below and behind the capsule wall, the pressure is concentrated to the upper and front forming part, which will fracture The endplate and the collapsed vertebral cortex are supported and reset, and the trapezoidal cylindrical structure of the embedded vertebral bone tissue is gradually formed and solidified. The gap between the bone-like trabecular columns will be filled with the remaining fractured cancellous bone. The movement of the device is completely restricted after the fracture has healed.

4. The infusion slurry 300 is used, such as bone cement, which can be polymethylmethacrylate (PMMA), hydroxyapatite (HA), or bone substitute (bone cement). substitute), such as gypsum, calcium phosphate, calcium sulfate series, etc., not limited here;

The present invention solves several clinical problems, adopting the above technical scheme, compared with the prior art, has the following advantages and positive effects:

1. Completely solve the leakage of bone cement during pouring, so that the leakage rate of bone cement is reduced to zero;

2. It solves the shortcoming that the bone cement injected into the vertebral body in all the shaping systems in the market is unevenly distributed. The formation of the bone-like trabecula makes the pouring slurry evenly distributed, and the thickening of the lower and rear walls makes the pouring slurry move towards The anterior and upper forming parts of the forming part flow, and the anterior and middle part of the fractured vertebral body collapses gradually and uniformly columnar support is effectively reduced to correct the kyphotic deformity;

3. The uniform distribution of bone cement reduces the existence of local mechanical gradients of the diseased vertebral body, and the risk of fractures and height loss of the diseased vertebral body after surgery, and the risk of fractures of adjacent segments of the vertebral body.

4. The mass of bone cement will be replaced by 70 protrusions 101 around 3.5mm thick, which will solve the thermal damage caused by the polymerization reaction when the bone cement mass is distributed. Some studies have found that the thickness of the bone cement affects the polymerization heat release Temperature, and the bone cement has no thermal damage when it is 5mm thick, and it will cause thermal damage if it exceeds 5mm;

5. There are gaps in the staggered distribution of the surrounding protrusions 101, which is conducive to the settlement of the residual bone trabecula in the vertebral body. After the fracture is healed, the vertebral body bone filling and supporting device is stabilized in the vertebral body, reducing the squeeze caused by patient activities in the later period Cause the loosening and displacement of bone cement;

6. The closed device of bone-like trabecula completely solves the adverse reactions of bone cement monomer contact with human body such as toxicity, allergy, inflammation, embolism, etc.;

7. The device has the characteristics of non-leakage, which breaks the taboo of all vertebroplasty systems in the market due to damage to the posterior wall of the vertebral body and incomplete use. The appearance of this product expands its indications.

The above content is only to illustrate the technical ideas of the present invention, and cannot be used to limit the scope of protection of the present invention. Any changes made on the basis of the technical solutions according to the technical ideas proposed by the present invention fall into the claims of the present invention. Within the scope of protection.

Claims

A vertebral body bone filling and supporting device is characterized in that it comprises:

The implant (100) includes a central tube (102) and a plurality of surrounding protrusions (101). One end of the central tube (102) is a blind end (105), and the other end is an injection port (104) ); The peripheral protrusions (101) are arranged on the main body of the central tube (102), and a plurality of peripheral protrusions (101) are distributed in a divergent shape along the outer wall of the central tube (102); the peripheral protrusions ( 101) The inner cavity is communicated with the inner cavity of the central tube portion (102);

The material of the main body of the central tube (102) and the material of the surrounding protrusions (101) are both soft elastic materials. When pressure is applied to the inner cavity of the central tube (102), the surrounding protrusions (101) can be expanded and formed supporting structure.
The vertebral bone filling and supporting device according to claim 1, characterized in that, when the injection port (104) is filled with a slurry (300) into the central tube portion (102) by injection, the slurry ( 300) Push the surrounding protrusions (101) to expand and then extend and solidify into the bone tissue.
The vertebral bone filling and supporting device according to claim 1, wherein the central tube portion (102) is a columnar structure, the surrounding protrusion (101) is a truncated cone structure, and one end of the surrounding protrusion (101) is The blind end, the other end is an open end, and the open end is connected with the central pipe part (102).
The vertebral body bone filling and supporting device according to claim 1, wherein the peripheral protrusions (101) are evenly arranged in a ring shape along the circumferential direction of the central tube portion (102), and the ring-shaped peripheral protrusions It is evenly arranged along the axial direction of the central tube portion (102).
The vertebral bone filling and supporting device according to claim 4, wherein the surrounding protrusions of adjacent rings are arranged in a staggered manner.
The vertebral body bone filling and supporting device according to claim 1, wherein the center line of the central tube portion (102) is a straight line; the central tube portion (102) is placed on one side of the unfractured tissue (402) The wall thickness of the surrounding protrusions is greater than the wall thickness of the surrounding protrusions on the side of the cavity (401) of the fracture fissure.
The vertebral body bone filling and supporting device according to claim 1, wherein the center line of the central tube portion (102) is an arc; wherein the surrounding protrusions (101) include an outer curved portion (1011) and an inner curved portion (1011). The wall thickness of the surrounding protrusion of the curved portion (1012) and the outer curved portion (1011) is smaller than the wall thickness of the surrounding protrusion of the inner curved portion (1012).
The vertebral bone filling and supporting device according to any one of claims 1 to 7, characterized in that it further comprises:

Auxiliary positioning member (200), which includes a positioning core (201) and a clamping part (202), the clamping part (202) is arranged at the end of the positioning core (201); the inner wall of the blind end (105) is arranged There is a slot (106). After the auxiliary positioning member (200) extends into the inner cavity of the central tube (102), the clamping portion (202) contacts the blind end (105), rotates the positioning core (201), and clamps The part (202) can be locked and fixed with the card slot (106).
The vertebral bone filling and supporting device according to any one of claims 1 to 7, wherein the implant (100) further comprises: a visualization snap ring (103), and the visualization snap ring (103) is arranged in the The front, middle and rear ends of the outer wall of the central pipe part (102) are described.
The vertebral bone filling and supporting device according to any one of claims 1 to 7, wherein the inner wall of the injection port (104) is provided with an internal thread.