阅读说明：本技术 囊体骨架、可膨胀装置及其应用 (Balloon cage, inflatable device and applications thereof ) 是由 王筱凡 秦勇 袁征 郭东杰 于 2020-06-04 设计创作，主要内容包括：本发明公开了一种囊体骨架,包括骨架本体,骨架本体具有若干孔洞,使骨架本体形成一网络状孔隙结构,骨填充物质在网络状孔隙结构之间弥散并最终弥散至骨架本体外,以抬升骨组织。还公开了一种可膨胀装置及其应用。本发明的骨填充物质被网络状孔隙结构分散,骨填充物质与骨架本体之间会形成一定的间隙,极大的降低了骨填充物质的弹性模量,降低了骨填充物质的硬度,从而降低了团块状的结构对骨组织造成的压力；并且,形成的间隙允许血液、骨细胞在骨填充物质内流通,因此能够提高骨填充物质在骨组织内的稳定性；另外,骨架本体与骨填充物质之间的间隙,形成了供骨生长的空间,具有一定促骨长入的功效。(The invention discloses a capsule skeleton which comprises a skeleton body, wherein the skeleton body is provided with a plurality of holes, so that the skeleton body forms a network-shaped pore structure, and bone filling materials are dispersed among the network-shaped pore structure and finally dispersed outside the skeleton body so as to lift bone tissues. An inflatable device and its use are also disclosed. The bone filler is dispersed by the network pore structure, a certain gap is formed between the bone filler and the skeleton body, the elastic modulus of the bone filler is greatly reduced, and the hardness of the bone filler is reduced, so that the pressure of the lumpy structure on bone tissues is reduced; in addition, the formed gap allows blood and bone cells to flow in the bone filler, so that the stability of the bone filler in bone tissues can be improved; in addition, a space for bone growth is formed by a gap between the skeleton body and the bone filling material, and the bone growth promoting device has the effect of promoting bone growth.)

1. The capsule skeleton is characterized by comprising a skeleton body, wherein the skeleton body is provided with a plurality of holes and is formed by mutually connecting a plurality of primary structures, so that the skeleton body forms a network-shaped pore structure; the primary structure comprises at least one of a linear, tubular or sheet structure, and the capsule skeleton is used for receiving bone filler after being implanted into a target position, and the bone filler is dispersed among the network pore structures.

2. The capsule skeleton of claim 1, wherein the skeleton body is made of a degradable material, and the skeleton body is degraded to form pore channels in the molded bone filler.

3. The capsule skeleton of claim 2, wherein the primary structures are the same size from the inside of the skeleton body outwards, or gradually increase in size from the inside of the skeleton body outwards; or, from the inside of the framework body to the outside, the size of the primary structure is gradually reduced.

4. The capsule skeleton according to claim 1, 2 or 3, wherein the size of the primary structure is 1nm to 999mm, preferably 50nm to 10mm, further preferably 200nm to 1mm, more preferably 200nm to 300 nm.

5. The capsule skeleton of claim 1, wherein the skeleton body carries at least one of a bone growth promoting composition, an anti-inflammatory pharmaceutical composition, and a visualization composition.

6. The capsule skeleton of claim 5, wherein the skeleton body has a channel disposed therein, the composition filling the channel; or the component is a coating coated on the surface of the skeleton body.

7. The bladder carcass according to claim 1, wherein the carcass body comprises at least one layer of bladders, said bladders having connecting structures disposed therein; or the skeleton body comprises a plurality of layers of sleeved sac bodies.

8. The bladder carcass according to claim 7, wherein a connecting structure is provided between adjacent bladders.

9. The balloon scaffold according to claim 7 or 8, wherein the connection structure is at least one of a linear connection structure, a criss-cross network connection structure or a spiral connection structure, the connection structure being connected to the balloon.

10. The capsule body scaffold according to claim 7 or 8, wherein the material of the connection structure is a degradable material.

11. The capsule body skeleton according to claim 7 or 8, wherein the capsule body is at least one of a spherical, strip, gourd, sub gourd, peanut, olive, mace, dumbbell, kidney, cylinder, bullet, cube, cuboid structure.

12. The capsule skeleton of claim 1, wherein the skeleton body comprises at least one small pore region having a pore size smaller than pore sizes at remaining locations, the small pore region extending outwardly from within the skeleton body to the skeleton body surface.

13. The capsule skeleton of claim 12, wherein the skeleton body comprises a plurality of the small pore regions, the small pore regions being circumferentially spaced around the skeleton body.

14. The capsule skeleton of claim 1, wherein the network pores gradually increase in size from an inner center of the skeleton body outward; or, from the inner center of the skeleton body outwards, the size of the network pores is gradually reduced.

15. The bladder carcass according to any one of claims 1-3, 5-8, 12, 13, 14, wherein said carcass body is shaped in at least one of knitting, ligation or 3D printing; and, the primary structure is a helical structure.

16. The balloon scaffold of claim 1, wherein the scaffold body further comprises a rigid guidewire disposed within the primary structure or wrapped around a surface of the rigid guidewire.

17. The bladder carcass according to claim 1, wherein a reinforcement is further provided at the cross-connection position of the carcass body.

18. The bladder carcass of claim 17, wherein the reinforcement is an adhesive and/or melt bonded connection.

19. An inflatable device comprising a plurality of bladder armatures according to any one of claims 1-18 and further comprising a connector by which a plurality of said bladder armatures are connected.

20. The inflatable apparatus of claim 19, wherein each of said bladder armatures fits over said connector or each of said bladder armatures is attached to a surface of said connector.

21. The inflatable apparatus of claim 19, wherein said connector is a tubular structure for delivering bone filler, each of said bladder armatures being attached to a surface of said tubular structure, said tubular structure further having a plurality of bone filler delivery ports.

22. An inflatable device according to claim 19, 20 or 21, wherein said connecting element is made of a degradable material.

23. Use of a balloon scaffold according to any of claims 1-18 or an inflatable device according to any of claims 19-22 in vertebroplasty, kyphoplasty, discoplasty or intervertebral fusion.

Technical Field

The invention relates to a medical instrument for guiding bone filling materials, in particular to a bone guide device in vertebroplasty, kyphoplasty and intervertebral fusion.

Background

In the prior art, bone cement is dispersed in a vertebral body or a vertebral space in the processes of vertebroplasty, kyphoplasty, intervertebral fusion and intervertebral disc arthroplasty, and most of the bone cement is in a block shape. In particular, in PKP surgery, after the balloon is inflated to create a cavity, the filling of the cavity with bone cement often forms a compact cement sphere. Due to the progressive aggravation of osteoporosis, the independent bone cement blocks can gradually generate certain mobility along with the osteoporosis of peripheral bone, and finally generate certain looseness in a cancellous bone cavity of a vertebral body, so that secondary fracture of the vertebral body is induced, even the bone cement can damage cortical bone and fall out of the vertebral body, and a series of complications risks are caused.

It is therefore a core object of the present invention how to maintain the implanted bone cement to exhibit a better stability.

Disclosure of Invention

The invention provides a capsule framework, which can solve the defects in the prior art.

The technical scheme of the invention is as follows:

a capsule skeleton comprises a skeleton body, wherein the skeleton body is provided with a plurality of holes and is formed by at least one of a plurality of primary structure linear structures, tubular structures and sheet structures which are connected with one another, so that the skeleton body forms a network-shaped pore structure; the capsule body framework is implanted into a target position and is used for receiving bone filling materials, and the bone filling materials are dispersed among the network-shaped pore structures to lift bone tissues.

Whole skeleton body presents for a network form pore structure for the bone cement of packing can disperse between network form pore structure, and the bone filler material can not concentrate on a point outflow, has slowed down the speed that the bone filler material outflows, and the bone filler material can be followed and dispersed to the skeleton originally extrasomatic between network form pore structure simultaneously, and the bone filler material solidifies the back, forms the clearance between skeleton body and bone filler material.

Compared with the compact and lumpy bone cement in the prior art, the bone filler is dispersed by the skeleton body with the network-shaped pore structure, the formed gap greatly reduces the elastic modulus of the bone filler, and the pressure of the lumpy structure on bone tissues is reduced, so that the risk of inducing secondary fracture is reduced; moreover, the gap between the bone filler and the skeleton body can allow blood and bone cells to flow in the bone filler, but does not prevent blood from flowing like a compact block; in addition, the gap between the skeleton body and the bone filling material forms a space for bone growth, and has the effect of promoting bone growth to a certain extent, so that the stability of connection with bone tissues can be further improved.

Preferably, the skeleton body is made of a degradable material, and the skeleton body with the network-shaped pore structure is degraded to form a network-shaped pore channel on the bone filler, so that the skeleton body has a certain bone growth promoting effect, the bone filler and the bone are mutually occluded to form a connection relation of ' I, I ' in your middle '; meanwhile, the network-shaped pore channels formed in the bone filler are beneficial to the circulation of blood and bone cells in bone tissues, maintain the normal body fluid circulation in pathological bone tissues, improve the stability of the bone filler, really solve the relevance between bone cement and bones and reduce the risk caused by the movement of the bone cement.

The sizes of the primary structures distributed at different positions of the framework body can be the same or different. When the primary structure is a linear or tubular structure, the size of the primary structure refers to the diameter of the linear or tubular structure; when the primary structure is a sheet structure, the size of the primary structure refers to the thickness of the sheet structure.

In one embodiment, the primary structures gradually decrease in size from the outer layer to the inner layer of the skeletal body. In this way, the part with large external dimension is degraded first, and bone preferentially grows in, which is suitable for patients with strong bone growth ability, good bone quality and relatively stable vertebral body.

In one embodiment, the primary structure gradually increases in size from the outer layer to the inner layer of the skeleton body, i.e., the primary structure is from thin to thick from the surface of the skeleton body to the inside thereof. The capsule body designed in the way is not degraded in the initial stage, maintains the support strength in a short period, is accelerated in the later stage, and is suitable for the situations that the bone is weak, the vertebral body is unstable and needs to be supported stably at once.

Preferably, the porosity of the skeletal body is from 10% to 90%, preferably from 40% to 80%, more preferably from 60% to 80%;

the diameter of the linear and tubular structure is in the range of nanometer to millimeter, several nanometers or several tens millimeters, preferably 50nm to 10mm, more preferably 200nm to 1mm, and even more preferably 200nm to 300nm

The thickness of the sheet structure is in a range from nanometer to millimeter, and can be several nanometers or several tens of millimeters, preferably, 50nm to 10mm, further preferably 200nm to 1mm, and more preferably 200nm to 300 nm.

In order to better promote the bone growth and further strengthen the connection between the bone filling material and the bone, the skeleton body is loaded with bone growth promoting components, including bone growth promoting factors, BMP, beta calcium phosphate and the like. Furthermore, the skeleton body can also carry anti-inflammatory medicinal components, such as antibiotics: gentamicin, vancomycin and the like, and reduce inflammatory reaction after bone cement implantation.

The skeleton body can also be loaded with developing components, and the addition proportion of the developing components is 0.01-50%.

In one embodiment, the framework body is provided with a channel, and the components are filled in the channel; or the component is a coating coated on the surface of the skeleton body.

In one embodiment, the skeleton body comprises at least one layer of capsule body, a connecting structure is arranged in the capsule body, and a plurality of holes are formed in the capsule body. The holes on the surface of the capsule body can be regular in shape and uniformly distributed on the surface of the capsule body, or irregular in shape, so that bone filling materials can freely flow into and embed the open pore structure better. The capsule body can be one of spherical, strip, calabash, sub-calabash, peanut, olive, spike, dumbbell, kidney, cylinder, bullet, cube, and cuboid.

In one embodiment, the skeleton body comprises a plurality of layers of sleeved capsules, the capsules sleeved in the skeleton body can be in a spiral coiled shape and have certain elasticity, the skeleton can be unfolded after being implanted into a vertebral body, and the whole skeleton of the capsule is in a three-dimensional network structure. Preferably, a connecting structure is further provided between adjacent capsules for forming pores with different sizes. Preferably, the connection structure is at least one of a linear connection structure, a criss-cross network connection structure, or a spiral connection structure. Linear connection structure has the simple advantage of shaping, and further shaping is vertically and horizontally staggered's network connection structure between the linear connection structure, perhaps linear connection structure further shaping is spiral connection structure, connection structure can play certain supporting role to outside utricule to make the utricule skeleton present the network structure for three-dimensional, such three-dimensional network structure can slow down bone filler material flow rate, avoids bone filler material seepage. The connecting structure can be connected with the bag body in a weaving mode or in an adhesion mode.

In one embodiment, the material of the connecting structure is degradable, so that the whole body of the capsule skeleton can be degraded to form network-shaped pore channels.

In one embodiment, the skeletal body comprises at least one small pore region having a pore size that is smaller than the pore size at the remaining locations, the small pore region extending outwardly from within the skeletal body to the surface of the skeletal body. In the small pore region, less bone filler material is packed, while in the rest of the positions where the pore size is large, more bone filler material is packed.

In one embodiment, the skeletal body comprises a plurality of the small pore regions, the small pore regions being circumferentially spaced around the skeletal body. Therefore, when the bone filling material is dispersed from the inside, the bone filling material can present irregular characters, such as the shape like a wolf tooth rod, the structure effect can lead to special functions, more bone filling material exists in the area with large network pore size, the supporting effect is achieved, and the function that the bone filling material can be degraded, absorbed and can promote bone growth can be achieved if the bone filling material exists in the small pore area, so that after long-term implantation, the bone grows into the inside of the bone filling material, the mutual occlusion is achieved, and the effect of anchoring in bone tissues is achieved.

In one embodiment, the network pores gradually increase in size from the interior center of the skeletal body outward. The bone filler is filled in the middle part, and the flow rate is more uniform after the bone filler is dispersed to the area with large network pore size.

In one embodiment, the network pores gradually decrease in size from the interior center of the skeletal body outward. The bone filler is filled in the middle part and is further dispersed after being dispersed to the small pore area, so that the condition that the bone filler flows out in a concentrated manner is not presented. Meanwhile, the function of preventing the bone filler from dispersing to the periphery is achieved.

In one embodiment, the skeletal body is shaped in at least one of a weave, a ligation, or a 3D print. Specifically, the threadlike structure may be woven into a certain thick threadlike structure, and then formed into the skeleton body. In one embodiment, the tubular or sheet structure is a helical structure having a certain elasticity, such that the balloon framework can be expanded after being implanted into a vertebral body. The sheet structure can be a woven structure processed by a linear structure, or the sheet structure is a sheet material, and holes are arranged on the sheet material.

Preferably, the skeleton body further comprises a hard guide wire, the hard guide wire is arranged in the primary structure, for example, the hard guide wire is arranged in the linear, tubular or sheet structure in a penetrating manner, or the linear, tubular or sheet structure is wound on the surface of the hard guide wire. The primary structure is wound on the surface of the hard guide wire in a winding mode, or the primary structure is woven into a tubular structure, and the hard guide wire is arranged in the woven tubular structure in a penetrating mode. This stereoplasm seal wire can be degradable polymer material seal wire, or metal seal wire, or elasticity seal wire or the seal wire of memory metal material etc. for the whole structure that presents for predetermineeing that presents of utricule skeleton, after implanting the centrum, the utricule skeleton is spread out so that receive bone filler material.

In one embodiment, the framework body is further provided with a reinforcing part at the position of the cross connection, so as to improve the stability of the weaving structure.

In one embodiment, the reinforcing part can be connected at the cross-connecting position of the framework body through an adhesive or connected in a melting mode, so that the stability of the connection of the woven structure is enhanced.

The invention also provides an inflatable device which comprises a plurality of capsule skeletons and a connecting piece, wherein the plurality of capsule skeletons are connected through the connecting piece to form a combined structure formed by connecting the plurality of capsule skeletons in series or in parallel.

In one embodiment, each of the capsule skeletons is sleeved on the connecting piece, or each of the capsule skeletons is connected to the surface of the connecting piece. The connecting piece can be a tubular structure, a linear structure or a hard guide wire, and after the whole device is implanted into a vertebral body, bone filling materials are conveyed to the gap between the capsule frameworks through a filling tool.

In one embodiment, the connector is a tubular structure for delivering bone filler, each balloon skeleton is connected to the surface of the tubular structure, and the tubular structure is further provided with a plurality of bone filler delivery ports. Bone filler material is delivered into the vertebral body through the tubular structure, the bone filler material filling the gaps between the balloon cages. In one embodiment, the connector is made of a degradable material. The connecting piece can form the pore passageway in bone filler material after degrading, when the utricule skeleton also can degrade, as long as there is one end and bone tissue contact just can realize inflatable device's degradation absorption for whole integrated configuration can degrade fast.

The combined structure among a plurality of capsule skeletons further improves the porosity, the formed bone filler is mutually connected but in an irregular branch shape, and after the whole device is degraded, the bone filler forms a structure like veins and vegetable sponge, so that the elastic modulus of the bone filler is reduced, the bone is promoted to grow in, and the mutual crosslinking between the bone filler and the bone filler is realized.

The degradable material is not limited to polylactic acid material, and the degradation speed is controllable. The degradable material has certain high temperature resistance, can realize the heat-resistant effect, and the heat-resistant effect can reach more than 40 ℃ at least.

The balloon skeleton and the inflatable device provided by the invention can be used in vertebroplasty (PVP), kyphoplasty (PKP), intervertebral disc plasty or intervertebral fusion operation.

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

firstly, the whole framework body is in a network-shaped pore structure, and bone filling materials can be dispersed out of the framework body from the network-shaped pore structure to form gaps between the framework body and the bone filling materials; compared with the compact and lumpy bone cement in the prior art, the bone filler is dispersed by the skeleton body with the network-shaped pore structure, and the formed gap greatly reduces the elastic modulus of the bone filler and the hardness of the bone filler, so that the pressure of the lumpy structure on bone tissues is reduced, and the risk of inducing secondary fracture is reduced; moreover, the gap between the bone filler and the skeleton body can allow blood and bone cells to flow in the bone filler, but does not prevent blood from flowing like a compact block; because the blood and the bone cells can flow in the gap of the bone filler, the impact force of the blood on the bone filler is reduced, and the stability of the bone filler in bone tissues can be improved; in addition, the gap between the skeleton body and the bone filling material forms a space for bone growth, has the effect of promoting bone growth to a certain extent, and can further improve the stability of connection with bone tissues.

Secondly, the skeleton body is made of degradable materials, and after the skeleton body is gradually degraded and absorbed, a network-shaped pore channel is formed in the bone filler, and has the effect of promoting bone growth to a certain extent, so that the bone filler and the bone are mutually occluded to form a connection relation of 'you in your and you in my'; meanwhile, the formed network-shaped pore channels are beneficial to the circulation of blood and bone cells in bone tissues, maintain the normal body fluid circulation in pathological bone tissues, further improve the stability of the bone filling material, really solve the relevance between the bone filling material and bones and reduce the risk caused by the movement of the bone filling material.

Thirdly, when the skeleton body is loaded with components for promoting bone growth, the bone growth can be further promoted, the relation between bone cement and bone is enhanced, the stability of the bone filling material is further improved, and the risk caused by the movement of the bone cement is reduced; when loaded with anti-inflammatory drugs, it can reduce the inflammatory reaction of the body.

Fourth, when setting up connection structure in the utricule, connection structure plays certain supporting role to outside utricule to make whole skeleton body present network form pore structure, the network form pore structure of formation has slowed down the speed that bone filler material flows, prevents the seepage.

Fifthly, the inflatable device formed by connecting a plurality of capsule skeletons has larger specific surface area, and after the inflatable device is implanted into a target position, more gaps are formed between the whole device and the bone filler, so that the stability of the bone filler in bone tissues is improved; when the balloon skeleton and the connecting piece are made of degradable materials, the whole inflatable device can be rapidly degraded and absorbed as long as one end of the balloon skeleton is in contact with bone tissues, and a high-porosity channel can be formed in the bone filling material after the whole device is degraded; the formed bone filling materials are mutually connected, when the whole device is degraded, the bone filling materials form a structure like veins and luffa sacs, so that the elastic modulus of the bone filling materials is greatly reduced, the bone growth is promoted, the mutual cross-linking with the bone filling materials is realized, and the stability of the bone filling materials in bone tissues is improved.

Of course, it is not necessary for any product in which the invention is practiced to achieve all of the above-described advantages at the same time.

Drawings

Fig. 1 is a schematic perspective view of a capsule skeleton according to embodiment 1 of the present invention;

fig. 2 is a front view of a bladder skeleton of example 1 of the present invention;

fig. 3 is a schematic perspective view of another capsule skeleton according to embodiment 1 of the present invention;

fig. 4 is a cross-sectional view of a bladder skeleton of embodiment 1 of the present invention;

FIG. 5 is a schematic perspective view of a spiral tubular structure according to example 1 of the present invention;

FIG. 6 is a schematic perspective view of a spiral sheet structure in example 1 of the present invention;

FIG. 7 is another perspective view of the spiral sheet structure of example 1 of the present invention;

fig. 8 is a cross-sectional view of another bladder skeleton of embodiment 1 of the present invention;

fig. 9 is a schematic perspective view of a capsule skeleton according to embodiment 2 of the present invention;

figure 10 is a side view of a bladder carcass of example 2 of the present invention;

figure 11 is a cross-sectional view of a bladder carcass of example 3 of the present invention;

fig. 12 is a cross-sectional view of a bladder skeleton of example 4 of the present invention;

figure 13 is a cross-sectional view of a bladder skeleton of example 5 of the present invention;

figure 14 is a cross-sectional view of a bladder carcass of example 6 of the present invention;

fig. 15 is a cross-sectional view of another bladder carcass of embodiment 6 of the present invention;

FIG. 16 is a schematic view showing the construction of an inflatable device according to example 7 of the present invention;

FIG. 17 is a schematic view showing the construction of an inflatable device in which the connecting member of example 7 of the present invention is a wire;

FIG. 18 is a schematic structural view showing a structure in which the linking member of embodiment 7 of the present invention is a rigid guidewire;

FIG. 19 is a schematic representation of the delivery of the inflatable device of example 7 of the present invention through a delivery tube;

FIG. 20 is a schematic view of another inflatable device of example 7 of the present invention being delivered through a delivery tube;

FIG. 21 is a schematic view of the construction of an inflatable device according to example 8 of the present invention.

Detailed Description

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

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 meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are only for illustrating the present invention and are not intended to limit the scope of the present invention. In practice, the invention will be understood to cover all modifications and variations of this invention provided they come within the scope of the appended claims.

Example 1

The present embodiment provides a capsule body skeleton, referring to fig. 1-8, the capsule body skeleton includes a skeleton body 100, the skeleton body 100 has a plurality of holes 110, the skeleton body is formed by connecting a plurality of primary structures 102, so that the skeleton body 100 forms a network-shaped pore structure; the primary structure 102 comprises at least one of a linear, tubular, and sheet-like structure, and is configured to receive a bone filler material, such as bone cement, dispersed between the network-like pore structures after the balloon framework is implanted at the target site.

The bone cement used in the prior art is in a foreign body state in bone tissues, and has no capability of promoting bone growth and promoting bone growth into the bone cement. In addition, the lump bone cement structure in the prior art has large elastic modulus and high hardness, and particularly in the environment of osteoporosis, the hardness of surrounding cancellous bone is lower, so that the bone cement in an independent state is easy to loosen, move over time and threaten fragile bone tissues, and the secondary fracture of a vertebral body and even the falling of cortical bone out of the vertebral body are easily caused.

On the other hand, the existing bag structure or mesh bag structure used in the vertebroplasty or kyphoplasty process is a hollow structure, bone cement is filled into the hollow structure, and the bag structure or mesh bag structure wraps the bone cement to form a compact sphere for lifting collapsed bone tissues. The bag or mesh bag structure aims to limit the leakage of bone cement or limit the flow of bone cement in a certain direction so as to avoid the problem of paralysis and even death caused by the leakage of bone cement.

The whole framework body 100 of the embodiment is of a network-shaped pore structure, so that filled bone cement can be dispersed among the network-shaped pore structures, bone filling materials cannot flow out at one point in a centralized mode, the outflow speed of the bone filling materials is reduced, meanwhile, the bone filling materials can be dispersed to the outside of the framework body from among the network-shaped pore structures, and gaps are formed between the framework body and the bone filling materials after the bone filling materials are solidified. The gap between the skeleton body 100 and the bone filler forms a space for bone growth, so that the stability of connection with the bone tissue can be improved.

Referring to fig. 1 to 3, the skeleton body 100 includes a capsule 120, the capsule 120 is a structure with full open pores, and the holes 110 on the surface of the capsule 120 may be regular shapes, such as square, circle, ellipsoid, polygon, etc.; alternatively, the holes 110 in the surface of balloon 120 may be irregular in shape, and the holes 110 in the surface of balloon 120 allow the bone filler material to flow more freely into and embed the open cell structure.

Fig. 1 is a schematic perspective view of a bladder 120, and fig. 2 is a front view thereof, in which regular square holes and irregular holes are uniformly distributed on the surface of the bladder 120. As shown in fig. 3, the balloon 120 may also be a spiral-wound structure, forming the surface holes 110, and the spiral-wound shape provides the balloon with a certain deformation recovery capability, and can be quickly unfolded after being implanted into a vertebral body. Fig. 8 shows that the surface of the bladder 120 is formed with holes having different sizes and shapes and arranged in a staggered manner, so as to form the cross-grid-shaped bladder 120.

The shape of the bag body 120 may be one or a combination of a plurality of structures selected from a sphere, a bar, a gourd, a sub-gourd, a peanut, an olive, a mace, a dumbbell, a kidney, a cylinder, a bullet, a cube, and a rectangular parallelepiped, and the shape of the bag body 120, the size, the shape, and the distribution of the holes 110 are determined according to specific requirements.

In another embodiment, a connection structure 130 is further disposed in the capsule body 120, and the connection structure 130 is a criss-cross network connection structure, see fig. 4. The connecting structure 130 can support the outer first capsule 121 to a certain extent, and the capsule skeleton is in a three-dimensional network structure, so that the dispersion speed of the bone filler in the capsule skeleton is reduced, and a bone channel for bone growth is formed after degradation.

In this embodiment, the skeleton body 100 is formed in a braided or tied manner. Specifically, the bag body 120 may be formed by a thread structure, a tubular structure or a sheet structure, or the thread structure may be woven into a certain thicker thread structure, and the thicker thread structure is further woven into the frame body 100; or the linear structure, the tubular structure and the sheet structure are combined in pairs or three structures are combined and then molded into the framework body 100, and the combination sequence or mode can be selected according to actual conditions. In another embodiment, the skeleton body 100 may be formed by 3D printing, and the forming manner of the skeleton body 100 should be selected according to the actual therapeutic effect.

In one embodiment, the tubular structure is a helical tubular structure and the sheet structure is a helical sheet structure. Referring to fig. 5 and 6, the spiral tubular structure or the spiral sheet structure has certain elasticity, so that the balloon framework can be unfolded after being implanted into a vertebral body. The sheet structure may be a woven structure formed by processing a linear structure, or the sheet structure may be a sheet, and the sheet may further have holes, as shown in fig. 7.

Attachment structure 130 may be formed from primary structure 102 and attached to bladder 120 by weaving or by adhesive bonding, which may be by adhesive. Alternatively, the connection structure 130 and the capsule body 120 are integrally formed, and the integrally forming includes a knitting and ligating manner, and a 3D printing manner. The forming method of the connecting structure 130 and the framework body 100 should be selected according to actual needs.

The frame body 100 is loose due to the knitting manner, and the cross-connecting position of the bladder frame is further provided with a reinforcing part 140, referring to fig. 4, the reinforcing part 140 is used for improving the stability of the knitting structure, so that the frame body 100 takes on a preset shape. The reinforcement 140 may be bonded by an adhesive to enhance the strength of the cross-connect or fused to enhance the stability of the woven structure connection.

Preferably, the framework body 100 further comprises a hard guide wire 103, which is disposed inside the primary structure 102, as shown in fig. 6; or the primary structure 102 is wound on the surface of the hard guide wire 103. The winding mode can be that the linear structure is wound on the surface of the hard guide wire 103 in a winding mode, or the linear structure is woven into a tubular structure, and the hard guide wire 103 is arranged in the woven tubular structure in a penetrating mode. The hard guide wire can be a degradable high polymer guide wire, or a metal guide wire, or an elastic guide wire or a guide wire made of a memory metal material, and the like, so that the whole capsule framework is of a predesigned structure, and the structure can be made into an irregular shape such as a peanut shape, an olive shape, a wolf tooth bar shape, a dumbbell shape and the like or a strip shape according to different people. After implantation in a vertebral body, the skeletal body 100 is spread apart to facilitate receiving bone filler material.

The sizes d of the primary structures distributed at different positions of the skeleton body 100 may be the same or different. Referring to fig. 5-7, when the primary structure 102 is a wire-like or tubular structure, the dimension d of the primary structure refers to the diameter of the wire-like or tubular structure; when the primary structure is a sheet structure, the dimension d of the primary structure refers to the thickness of the sheet structure.

In one embodiment, the primary structure decreases in size d from the outer layer to the inner layer of the skeletal body 100, as shown in fig. 8, the primary structure of the outer layer has a size d2 that is greater than the primary structure of the inner layer of size d 1. In this way, the part with large external dimension is degraded first, and bone preferentially grows in, which is suitable for patients with strong bone growth ability, good bone quality and relatively stable vertebral body.

In one embodiment, the primary structure increases in size d from the outer layer to the inner layer of the carcass body 100, i.e., the primary structure increases from thin to thick from the surface of the carcass body to the interior thereof. The capsule body designed in the way is not degraded in the initial stage, maintains the support strength in a short period, is accelerated in the later stage, and is suitable for the situations that the bone is weak, the vertebral body is unstable and needs to be supported stably at once.

Preferably, the matrix body has a porosity of 10% to 90%, preferably 40% to 80%, more preferably 60% to 80%.

When the primary structure 102 is a linear or tubular structure, the diameter (d) of the linear or tubular structure is in the range of nanometer to millimeter, and may be several nanometers, or several tens of millimeters, preferably 50nm to 10mm, further preferably 200nm to 1mm, and more preferably 200nm to 300 nm; when used for the interstagon fusion cage, the diameter is 200nm-300 nm; when used in vertebral body, the diameter is 0.3-0.5 mm. When the primary structure 102 is a sheet structure, the thickness (d) of the sheet structure is in the range of nanometers to millimeters, and may be several nanometers or several tens of millimeters, preferably, 50nm to 10mm, further preferably 200nm to 1mm, and further preferably 200nm to 300 nm.

In this embodiment, the capsule body frame may be provided with an opening for delivering the bone filler, the opening is provided on the capsule body 120, and the bone filler is filled into the frame body 100 by inserting a filling tool into the opening of the capsule body 120 during filling. Of course, the filling tool may be directly inserted into the balloon skeleton from the network-shaped pores of the skeleton body 100 without the preset opening structure, and then the balloon skeleton is conveyed to a predetermined position, so as to complete the filling.

In one embodiment, the material forming the skeleton body 100 is degradable material, which is not limited to polylactic acid material, and the degradation speed is controllable. The degradable material has certain high temperature resistance, can realize the heat-resistant effect, and the heat-resistant effect can reach more than 40 ℃ at least. The material of the connecting structure 130 is also degradable.

After the skeleton body 100 and the connecting structure 130 are completely degraded, a network-shaped pore channel is formed in the bone filling material to form a space for bone growth, and the network-shaped pore channel has a certain effect of promoting bone growth, so that the bone filling material and the bone are mutually occluded to form a connection relation of 'you in me and you in me', the stability of the bone filling material is improved, and the bone filling material is not existed in the middle of bone tissues as an independent entity. Meanwhile, the formed network-shaped pore channels are beneficial to the circulation of blood and bone cells in bone tissues, maintain the normal body fluid circulation in pathological bone tissues, really solve the relevance between bone filling materials and bones and reduce the risk caused by the movement of the bone filling materials.

In other embodiments, the material of one of the skeleton body 100 and the connection structure 130 is degradable, the skeleton body 100 is degradable and the connection structure 130 is not degradable, or the skeleton body 100 is not degradable and the connection structure 130 is degradable, so as to form a certain pore channel in the bone filler, thereby promoting bone ingrowth. Or, the materials of the skeleton body 100 and the connecting structure are not degradable, so the capsule skeleton can disperse the bone filler, and reduce the elastic modulus of the bone filler, and the material can be supported by a high molecular polymer material or a metal material, so that the capsule skeleton can be unfolded to form a network-shaped pore structure for receiving bone cement after being implanted into a target position, such as a vertebral body. Wherein, the degradation refers to complete degradation or partial degradation, and in the specific implementation, the material can be ensured to be completely degraded as much as possible.

The skeleton body 100 may be loaded with some nutritional or pharmaceutical ingredients, such as bone growth promoting ingredients, bone growth promoting factors, BMP, beta calcium phosphate, etc., which can promote bone growth and bone growth into bone cement, thereby further enhancing the connection between the bone cement and bone tissue. The medicinal component can be anti-inflammatory medicine, such as gentamicin, vancomycin, etc., and can be used for treating inflammatory reaction caused in bone cement formation process. The framework body 100 can also carry developing components, and the adding proportion of the developing components is 0.01-50%.

The nutrient component, the drug component or the developing component can be a coating layer coated on the surface of the skeleton body 100, when the skeleton body 100 is formed by a tubular structure, a channel is formed in the skeleton body 100, the components can be filled in the channel formed by the tubular structure, and the components carried by the skeleton body 100 can be absorbed along with the degradation of the skeleton body 100.

Example 2

This example provides a capsule skeleton, which is adjusted based on example 1. The frame body 100 of the present embodiment includes a plurality of sleeved bladders 120.

Referring to fig. 9, which is a schematic perspective view of a bladder skeleton, fig. 10 is a side view of the bladder skeleton, and the skeleton body 100 includes three layers of sleeved bladders, including a first bladder 121, a second bladder 122, and a third bladder 123 in sequence from outside to inside. Of course, the number of the capsules 120 may be 2, 4 or more, and the larger the number, the more dense the network structure of the capsule skeleton is formed. The number of capsules 120 should be set according to the specific case requirements and the therapeutic objectives to be achieved.

In this embodiment, the first capsule 121 is a cross grid structure, the second capsule 122 and the third capsule 123 are spiral coiled structures, and the spiral coiled capsule sleeved therein has a better supporting effect. In other embodiments, the first capsule 121 may also be a spiral-wound structure, the second capsule 122 and the third capsule 123 are cross-grid structures, and the structure of the capsule 120 may be selected according to actual needs.

In this embodiment, the balloon framework may be formed by knitting a thread-like structure or a tubular structure from inside to outside, or the first balloon 121, the second balloon 122, the third balloon 123 and the connecting structure 130 are respectively formed and then connected in sequence from inside to outside, where the connection mode may be a knitting mode or an adhesion mode, and the adhesion mode refers to adhesion by a cross-linking agent.

Further, a connecting structure 130 may be disposed between adjacent bladders. The connecting structure 130 may be a linear connecting structure, which is a wire, a tubular structure or a rigid guide wire, and has an advantage of easy molding.

Of course, in other embodiments, the linear connection structures may be further connected by weaving to form a criss-cross network connection structure, or the linear connection structures may be further formed to be spiral connection structures, the criss-cross network connection structure may further form a dense region in the balloon, and the spiral connection structure may enable the balloon to be rapidly unfolded. The specific representation of the connecting structure 130 can be selected according to specific use requirements, and is not limited herein.

Example 3

Referring to fig. 11, a cross-sectional view of the capsule skeleton of the present embodiment is shown, and the present embodiment is an adjustment made on the basis of embodiment 1 or 2.

The skeleton body 100 includes a small pore region 101, the pore size of the small pore region 101 is smaller than that of the rest positions, and the small pore region 101 extends outwards from the inside of the skeleton body 100 to the surface of the skeleton body 100. In the small pore region 101, less bone filler material is packed, while in the remaining locations the pore size is larger, more bone filler material is packed.

The small pore regions 101 may be distributed on the left or right side of the skeletal body 100, or the small pore regions 101 may be distributed on the upper or lower side of the skeletal body 100, or the small pore regions 101 may be distributed on the front or rear side of the skeletal body 100.

During the use, the small pore region 101 is kept away from the bone tissue that collapses and the region that the pore size is big sets up towards the bone tissue that collapses, and in bone filler carried to the utricule skeleton, the regional bone filler matter that the pore size is big is more, can demonstrate the supporting role to the bone that collapses. Of course, in other embodiments, the small-aperture region 101 may also be disposed toward collapsed bone tissue.

Specifically, the skeleton body 100 includes a balloon 120, and a connection structure 130 is disposed in the balloon 120, and the connection structure 130 is a criss-cross network connection structure and is formed by weaving a linear connection structure. The connecting structure 130 may be integrally formed with the bladder body 120, and integrally formed means that it is woven from a thread-like structure or a tubular structure; alternatively, the connection structure 130 and the capsule body 120 are separately molded and then connected. When the capsule body framework is formed, the small pore area 101 is formed when the linear connecting structures are densely distributed, and the area with large pore size is formed when the linear connecting structures are sparsely distributed. The distribution position and distribution range of the small pore region 101, the specific pore size of the small pore region 101 and the pore sizes at the rest positions are set according to the actual case requirements. The small aperture region 101 of the present embodiment is also suitable for the case where a plurality of capsules are sleeved.

Example 4

Referring to fig. 12, a cross-sectional view of the capsule skeleton of the present embodiment is shown, and the present embodiment is an adjustment made on the basis of embodiment 1 or 2. The carcass body 100 of this embodiment includes a plurality of small-pore regions 101, the plurality of small-pore regions 101 being circumferentially distributed around the carcass body 100.

The present embodiment includes a plurality of sleeved capsules 120, the adjacent capsules are connected by a connecting structure 130, the number of the small-aperture regions 101 is 4, and the small-aperture regions are uniformly distributed on the circumference of the skeleton body 100. When the bone filling materials are dispersed from the framework body 100, the bone filling materials can present irregular characters, such as the shapes of wolf tooth rods, the structural effect can achieve a special function, more bone filling materials exist in the area with large network pore sizes, the supporting effect is achieved, and the function that the bone filling materials are degradable, absorbable and capable of promoting bone growth can be achieved when the bone filling materials in the small pore area 101 are less, so that after long-term implantation, the bone grows into the bone filling material blocks, the mutual occlusion is achieved, and the effect of anchoring in bone tissues is achieved.

The number of the small pore regions 101 of this embodiment may also be 2, 3, 5 or more, and may be uniformly distributed around the skeleton body 100, or may be randomly distributed around the skeleton body 100. The number of capsules 120 may also be 2, 3, 4 or more, the connecting structures 130 are mainly linear connecting structures, and are distributed along the radial direction and the circumferential direction, and the areas where the connecting structures 130 are densely distributed form the small pore areas 101. The number of capsules 120, the number of small-aperture regions 101, and the distribution thereof are not intended to limit the scope of the present invention, and can be set by those skilled in the art according to specific requirements, and are not limited herein.

This embodiment is also applicable to the case of the one-layer capsule 120 in embodiment 1, in which criss-cross network connection structures or spiral connection structures are disposed in the capsule 120 to form the plurality of small-aperture regions 101.

Example 5

Referring to fig. 13, a cross-sectional view of the balloon skeleton of the present embodiment is shown, and the present embodiment is an adjustment made on the basis of embodiment 1 or 2. The skeleton body 100 includes a plurality of sleeved capsules, and adjacent capsules are connected by a connecting structure 130, which is mainly a linear connecting structure. From the inside center of skeleton body 100 outwards, the size of network hole increases gradually, and bone filler fills in the middle part, and after the bone filler dispersed to the region that network hole size is big, the velocity of flow is more even.

This embodiment is also applicable to the case of the one-layer capsule 120 in embodiment 1, and the criss-cross network connection structure or spiral connection structure is disposed in the capsule 120 to form the variation of the network pore size.

Example 6

Referring to fig. 14, a cross-sectional view of the capsule skeleton of the present embodiment is shown, and the present embodiment is an adjustment made on the basis of embodiment 1 or 2. The skeleton body 100 includes a plurality of layers of sleeved capsules, and adjacent capsules are connected by a connecting structure 130, which is mainly a linear connecting structure. The network pores gradually decrease in size from the inner center of the skeleton body 100 outward. The reduction of the size of the network pores is mainly reflected in the reduction of the distance between two adjacent layers of capsules. The bone filler is filled in the middle part and is further dispersed after being dispersed to the small pore area, so that the condition that the bone filler flows out in a concentrated manner is not presented. Meanwhile, the function of preventing the bone filler from dispersing to the periphery is achieved.

In another alternative embodiment, the frame body 100 includes a plurality of layers of sleeved balloons, and the adjacent balloons are connected by a connecting structure 130, and the connecting structure 130 is mainly a linear connecting structure. Referring to fig. 15, which is a cross-sectional view of the balloon skeleton, the network pore sizes are randomly distributed from the inner center of the skeleton body 100 to the outside, and the network pore size is large at a predetermined position near the center of the skeleton body 100, small at another predetermined position from the center to the outside, and large at a predetermined position near the surface of the skeleton body 100.

This embodiment is also applicable to the case of the one-layer capsule 120 in embodiment 1, in which criss-cross network connection structures or spiral connection structures are arranged in the capsule 120 to form the variation of the network pore size.

Example 7

This embodiment provides an inflatable device, comprising a plurality of capsule skeletons 1 as described in any of embodiments 1 to 6, and a connecting member 150, wherein the plurality of capsule skeletons 1 are connected by the connecting member 150 to form a combined structure connected among the plurality of capsule skeletons 1.

Compared with the single capsule skeleton in the above embodiments, in the case of using the capsule skeleton in combination in the present embodiment, the capsule skeleton 1 has a smaller individual size, thus having a high specific surface area, forming more gaps in the bone filler, having the effect of promoting bone ingrowth, and allowing blood and bone cells to flow therethrough, thereby maintaining normal body fluid circulation in the bone tissue to some extent.

Referring to fig. 16, a schematic diagram of a combined use structure of the capsule skeletons of the present embodiment, a plurality of capsule skeletons 1 are connected by a connecting member 150 to form a serial structure, and the connecting member 150 in the middle is a tubular structure. Referring to fig. 17, a plurality of capsule bodies frames 1 are connected in series through a connecting member 150, and the connecting member 150 is mainly a wire. In another embodiment, in a combined structure in which a plurality of balloon skeletons 1 are connected in series through a connecting member 150, referring to fig. 18, the connecting member 150 is a hard guide wire, the balloon skeletons 1 connected in series can be pushed into a bone tissue cavity by means of a tube at the rear part of the hard guide wire, and the hard guide wire is a guide wire with certain elasticity or made of memory alloy, so that the hard guide wire can be in a linear shape or a bent shape. After the device is integrally implanted into a vertebral body, bone filler is conveyed into the gaps between the capsule frameworks 1 through a filling tool.

Referring to fig. 19, which is a schematic view of the connection of the plurality of capsule bodies 1 in series according to the present embodiment, the capsule bodies 1 may be in the shape of a bead, and the plurality of capsule bodies 1 are connected in series through a connecting member 150, and mixed with the bone filler and loaded into the bone filler pusher, for example: may be a delivery tube 300. The bone filler and the capsule skeleton 1 are pushed into the bone tissue cavity at the same time.

Referring to fig. 20, which is a schematic view of the multiple capsule bodies 1 connected in series in this embodiment, the capsule bodies 1 may be in an ellipsoid shape, and are connected in series through a connecting member 150, and mixed with the bone filling material, and then filled into the conveying tool, and the rear push rod pushes the capsule bodies, so that the bone filling material and the moniliform capsule bodies in the mixed state can be simultaneously filled into the bone tissue cavity. Of course, in other embodiments, a plurality of capsule skeletons 1 may be connected to the surface of the connecting member 150 in parallel.

In this embodiment, the number of the capsule skeleton 1 may be 2, 3, 4 or more, and the larger the number is, the larger the specific surface area of the whole composite structure is, the better the dispersion effect on the bone filler is, the more gaps are formed after the bone filler is solidified, which has the effect of promoting bone ingrowth and the effect of reducing the elastic modulus of the bone filler.

Preferably, the balloon frameworks 1 and the connecting piece 150 are made of degradable materials, and as long as one balloon framework 1 is in contact with bone tissue, the degradable material can be degraded, the whole combined structure can be rapidly degraded and absorbed, so that a high-porosity channel is formed on the bone filler, the elastic modulus of the bone filler is further reduced, the bone growth promoting effect is achieved, and the body fluid circulation in the bone tissue can be maintained.

The combination of multiple bladder frames, which may be connected in series or in parallel, may be connected to the connecting member 150 by weaving, or may be connected to the connecting member 150 by bonding. The method of use may be to fill cavities in pre-expanded bone tissue, all of the balloon skeleton may be crenellated to fill the entire cavity, the remaining pores may be refilled with a filling tool into the bone filler material. All the bone fillers are connected, but are irregularly branched like veins and loofah capsules, and the capsule skeleton is gradually degraded and absorbed along with implantation, promotes bone growth, and realizes mutual crosslinking with the bone filler network structure.

Of course, in other embodiments, one of the capsule body skeleton 1 and the connecting element 150 is made of degradable material, the capsule body skeleton 1 can be degraded while the connecting element 150 can not be degraded, or the capsule body skeleton 1 can not be degraded while the connecting element 150 can be degraded, so that a certain pore channel is formed after degradation and absorption; alternatively, the balloon skeleton 1 and the connecting member 150 are made of non-degradable materials, and the detailed description is omitted here.

Example 8

This example provides an inflatable device, which is modified based on example 7, and is shown in fig. 21, which is a schematic structural view of the inflatable device of this example,

wherein, a plurality of utricule skeletons 1 are attached to on the perisporium of injection pipe 200, and utricule skeleton 1 can be woven on injection pipe 200, also can be the adhesion on injection pipe 200, is provided with delivery port 201 between two adjacent utricule skeletons 1. When the bone filler is conveyed, the bone filler flows out of the gaps of the balloon frameworks 1 along with the conveying openings 201, and the multilayer and multi-surface contact between the balloon frameworks 1 and the bone filler is achieved. Of course, in other embodiments, the delivery port 201 may not be provided, and delivery of the bone filler material may be accomplished by a filling tool.

It is noted that the balloon skeleton and inflatable device of examples 1-8 are used in vertebroplasty (PVP) or kyphoplasty (PKP) to lift collapsed bone to physiological height. Of course the balloon cage and inflatable device described may also be used in disc arthroplasty or intervertebral fusion procedures.

The foregoing disclosure discloses only the preferred embodiments of the invention. The preferred embodiments are not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Obviously, many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and the practical application, to thereby enable others skilled in the art to best utilize the invention. The invention is limited only by the claims and their full scope and equivalents.