CN113749831B

CN113749831B - Balloon scaffold, inflatable device and application thereof

Info

Publication number: CN113749831B
Application number: CN202010500966.7A
Authority: CN
Inventors: 王筱凡; 秦勇; 袁征; 郭东杰
Original assignee: Shanghai Kinetic Medical Co Ltd
Current assignee: Shanghai Kinetic Medical Co Ltd
Priority date: 2020-06-04
Filing date: 2020-06-04
Publication date: 2024-04-26
Anticipated expiration: 2040-06-04
Also published as: CN113749831A

Abstract

The invention discloses a capsule body framework, which comprises a framework body, wherein the framework body is provided with a plurality of holes, so that the framework body forms a network-shaped pore structure, and bone filling substances are dispersed among the network-shaped pore structures and finally dispersed outside the framework body so as to lift bone tissues. An inflatable device and its use are also disclosed. According to the invention, the bone filling material is dispersed by the network-shaped pore structure, a certain gap is formed between the bone filling material and the skeleton body, so that the elastic modulus of the bone filling material is greatly reduced, the hardness of the bone filling material is reduced, and the pressure of the block-shaped structure on bone tissues is reduced; the formed gap allows blood and bone cells to circulate in the bone filler, so that the stability of the bone filler in bone tissue can be improved; 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 in-growth to a certain extent.

Description

Balloon scaffold, inflatable device and application thereof

Technical Field

The invention relates to a medical appliance guided by bone filling substances, in particular to a bone guider in vertebroplasty, kyphoplasty and interbody fusion operation.

Background

In the prior art, bone cement is mostly in the form of agglomerates in the vertebral body or the intervertebral space during vertebroplasty, kyphoplasty, interbody fusion, and discoplasty. In particular, in PKP surgery, after balloon inflation creates a cavity, the filling of cement therein tends to form a compact cement sphere. The patient is further aggravated by osteoporosis, and the independent bone cement blocks gradually generate certain activity along with the osteoporosis of surrounding bones, and finally generate certain looseness in the cancellous bone cavity of the vertebral body, so that secondary fracture of the vertebral body is induced, even the bone cement can destroy cortical bone to fall outside the vertebral body, and a series of complications are caused.

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

Disclosure of Invention

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

The technical scheme of the invention is as follows:

The bag body framework comprises a framework body, wherein the framework body is provided with a plurality of holes, and the framework body is formed by mutually connecting at least one of a plurality of primary structure linear structures, tubular structures and sheet structures, so that the framework body forms a network-shaped pore structure; the primary structure comprises at least one of a linear, tubular, and sheet structure, and the capsule body skeleton is configured to receive a bone filler material after implantation at a target site, the bone filler material being dispersed between the network-like pore structures to elevate bone tissue.

The whole skeleton body presents a network-shaped pore structure, so that the filled bone cement can be dispersed among the network-shaped pore structures, bone filling substances can not be concentrated in one point to outflow, the outflow speed of the bone filling substances is slowed down, meanwhile, the bone filling substances can be dispersed outside the skeleton body from among the network-shaped pore structures, and after the bone filling substances are solidified, gaps are formed between the skeleton body and the bone filling substances.

Compared with the dense and agglomerated bone cement in the prior art, the bone filling material is dispersed by the skeleton body of the network-shaped pore structure, the formed gaps greatly reduce the elastic modulus of the bone filling material, and the pressure of the agglomerated structure on bone tissues is reduced, so that the risk of inducing secondary fracture is reduced; moreover, the gap between the bone filling material and the skeleton body can allow blood and bone cells to circulate in the bone filling material without preventing blood circulation 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 a certain effect of promoting bone growth, so that the stability of connection with bone tissues can be further improved.

Preferably, the skeleton body is made of degradable material, and after being degraded, the skeleton body with a network-shaped pore structure forms network-shaped pore channels on the bone filling substances, so that the bone filling substances and bones are mutually meshed to form a connection relationship of 'you have me in you and you have me in me'; meanwhile, the network-shaped pore channels formed in the bone filling material are beneficial to the circulation of blood and bone cells in bone tissues, so that the normal body fluid circulation in diseased bone tissues is maintained, the stability of the bone filling material is improved, the correlation between bone cement and bone is truly solved, and the risk brought by the movement of the bone cement is reduced.

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

In one embodiment, the primary structure decreases 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, bone grows in preferentially, and the method is suitable for patients with strong bone growth capacity, good bone quality and relatively stable vertebral bodies.

In one embodiment, the primary structure increases in size from the outer layer to the inner layer of the skeletal body, i.e., from the surface of the skeletal body to the interior thereof, from thin to thick. The capsule body designed in this way is not degraded in the initial stage, keeps the supporting strength in a short period, accelerates the degradation speed in the later stage, and is suitable for the situations that the bone is weaker, the vertebral body is unstable and the supporting is needed to be stabilized immediately.

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, can be several nanometers, can be several tens millimeters, is preferably 50nm to 10mm, is more preferably 200nm to 1mm, and is more preferably 200nm to 300nm

The thickness of the sheet-like structure is in the order of nanometers to millimeters, may be several nanometers, may be several tens of millimeters, and is preferably 50nm to 10mm, further preferably 200nm to 1mm, and further preferably 200nm to 300nm.

In order to better promote bone ingrowth, the connection between the bone filling material and the bone is further enhanced, and the skeleton body is loaded with components for promoting bone growth, 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, etc., reduce inflammatory response after bone cement implantation.

The skeleton body can also be loaded with developing components, and the developing components are added in an adding ratio of 0.01% to 50%.

In one embodiment, a channel is arranged in the skeleton body, 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 bag body, a connecting structure is arranged in the bag body, and a plurality of holes are formed in the bag body. The holes on the surface of the capsule body can be in a regular shape and uniformly distributed on the surface of the capsule body or in an irregular shape, so that bone filling substances can flow into and embed the open pore structure better. The capsule body can be one of spherical, strip-shaped, calabash-shaped, sub-calabash-shaped, peanut-shaped, olive-shaped, wolf tooth stick-shaped, dumbbell-shaped, kidney-shaped, cylindrical, bullet-shaped, square and cuboid structures.

In one embodiment, the skeleton body comprises a plurality of layers of sleeved bag bodies, the sleeved bag bodies can be spirally coiled, certain elasticity is provided, the bag body skeleton can be unfolded after being implanted into the vertebral body, and the whole bag body skeleton is in a three-dimensional network structure. Preferably, a connecting structure is further arranged between the adjacent bag bodies and used 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. The linear connecting structure has the advantage of simple forming, the linear connecting structure is further formed into a criss-cross network connecting structure, or the linear connecting structure is further formed into a spiral connecting structure, the connecting structure can play a certain supporting role on an external bag body, the bag body framework is enabled to be a three-dimensional network structure, and the three-dimensional network structure can slow down the flow rate of bone filling materials and avoid the leakage of the bone filling materials. The connecting structure can be connected with the bag body in a braiding mode or connected with the bag body in an adhesive mode.

In one embodiment, the material of the connecting structure is a degradable material, and the entire capsule skeleton is degradable to form network-like pore channels.

In one embodiment, the skeletal body includes at least one small pore region having a pore size smaller than the pore size at the remaining locations, the small pore region extending from within the skeletal body outward to the skeletal body surface. In the small pore region, the bone filler material is less filled, while the pore size in the remaining locations is large, so that the bone filler material is more filled.

In one embodiment, the skeletal body includes a plurality of the small pore regions circumferentially spaced around the skeletal body. When the bone filling material is dispersed from inside to outside, the bone filling material can take on irregular shapes like a wolf tooth stick, the special function can be caused by the structural effect, the bone filling material in the area with large network pore size is more, the supporting effect is achieved, the bone filling material in the small pore area is less, the functions of degrading, absorbing and promoting bone growth can be reflected, and therefore, after long-term implantation, the bone growth enters the inside of the bone filling material, and the effects of mutual occlusion and anchoring in bone tissues are achieved.

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

In one embodiment, the network pores decrease in size from the interior center of the skeletal body outward. The bone filler is filled in the middle part, and after the bone filler is dispersed into the small pore area, the bone filler is further dispersed, and the condition of concentrated outflow is not shown. At the same time, the function of blocking the dispersion of the bone filler to the periphery is also achieved.

In one embodiment, the skeletal body is formed in at least one of braiding, ligating, or 3D printing. Specifically, the linear structure may be woven into a thicker linear structure, and then formed into the skeleton body. In one embodiment, the tubular or sheet-like structure is a spiral structure having a certain elasticity, so that the capsule skeleton can be spread out after being implanted into the vertebral body. The sheet structure may be a woven structure formed by processing a linear structure, or the sheet structure may be a sheet material, and holes are formed in the sheet material.

Preferably, the skeleton body further comprises a hard guide wire, wherein the hard guide wire is arranged in the primary structure, for example, the hard guide wire is arranged in the linear, tubular or sheet-shaped structure in a penetrating manner, or the linear, tubular or sheet-shaped 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 is woven into a tubular structure, and the hard guide wire is arranged in the tubular structure after weaving 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 memory metal guide wire, etc., so that the whole capsule body framework is in a presettable structure, and after being implanted into the vertebral body, the capsule body framework is spread out so as to receive bone filling substances.

In one embodiment, the cross-connection position of the skeleton body is further provided with a reinforcing part for improving the stability of the knitting structure.

In one embodiment, the reinforcement part can be connected with the cross connection position of the skeleton body through an adhesive or connected through a melting mode, so that the stability of the connection of the knitting structure is enhanced.

The invention also provides an inflatable device, which comprises a plurality of balloon skeletons as described above, and further comprises a connecting piece, wherein the plurality of balloon skeletons are connected through the connecting piece to form a combined structure of serial connection or parallel connection among the plurality of balloon skeletons.

In one embodiment, each of the capsule body frameworks is sleeved on the connecting piece, or each of the capsule body frameworks is connected to the surface of the connecting piece. The connecting member may be a tubular structure, a wire-like structure, or a stiff guidewire, and the bone filler material is delivered to the space between the capsular frame by the filling tool after the entire device is implanted into the vertebral body.

In one embodiment, the connecting piece is a tubular structure for conveying bone filling substances, each capsule body framework is connected to the surface of the tubular structure, and the tubular structure is further provided with a plurality of bone filling substance conveying ports. The bone filler material is delivered into the vertebral body through the tubular structure, and the bone filler material fills the gaps between the capsular skeletons. In one embodiment, the connector is made of a degradable material. The connecting piece can form pore channel in bone filling material after degrading, and when the capsule skeleton also can degrade, only one end contacts with bone tissue just can realize the degradation absorption of inflatable device for whole integrated configuration can quick degradation.

The combined structure among the plurality of capsule body skeletons further improves the porosity, and the formed bone filling materials are mutually connected but irregularly branched, so that after the whole device is degraded, the bone filling materials form a vein-like structure and a vegetable sponge-like structure, the elastic modulus of the bone filling materials is reduced, the bone growth is promoted, and the mutual crosslinking with the bone filling materials 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, and can realize heat resistance effect which reaches more than 40 ℃ at the lowest.

The balloon scaffold and inflatable device provided by the invention can be used in vertebroplasty (PVP), kyphoplasty (PKP), discoplasty or interbody fusion.

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

Firstly, the whole skeleton body of the invention presents a network-shaped pore structure, bone filler materials can be dispersed outside the skeleton body from the network-shaped pore structure, and gaps are formed between the skeleton body and the bone filler materials; compared with the dense and lumpy bone cement in the prior art, the bone filling material is dispersed by the skeleton body of the network-shaped pore structure, the formed gaps greatly reduce the elastic modulus of the bone filling material, and the hardness of the bone filling material, 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 filling material and the skeleton body can allow blood and bone cells to circulate in the bone filling material without preventing blood circulation like a compact block; because blood and bone cells can circulate in the gaps of the bone filling substances, the impact force of the blood on the bone filling substances is reduced, and therefore the stability of the bone filling substances 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 a certain effect of promoting bone growth, and can further improve the stability of connection with bone tissues.

Secondly, the skeleton body is made of degradable materials, after the skeleton body is gradually degraded and absorbed, a network-shaped pore channel is formed in the bone filling material, and the network-shaped pore channel has the effect of promoting bone ingrowth to a certain extent, so that the bone filling material and bones are mutually meshed to form a connection relationship of 'you have me in you and you have me in me'; 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 diseased bone tissues, further improve the stability of bone filling substances, truly solve the correlation between the bone filling substances and bones and reduce the risk caused by the movement of the bone filling substances.

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

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

Fifth, the inflatable device formed by connecting a plurality of capsule skeletons has larger specific surface area, and after being implanted into a target position, the whole device forms more gaps with the bone filling substances, so that the stability of the bone filling substances in bone tissues is improved; when the capsule body framework and the connecting piece are both degradable materials, the rapid degradation and absorption of the whole inflatable device can be realized only if one end of the capsule body framework is contacted with bone tissue, and a high-pore channel can be formed in bone filling materials 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 a loofah bag, so that the elastic modulus of the bone filling materials is greatly reduced, the bone growth is promoted, the mutual crosslinking 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 one product to practice the invention to achieve all of the advantages set forth above 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 balloon skeleton of embodiment 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 capsule skeleton according to example 1 of the present invention;

Fig. 5 is a schematic perspective view of a helical tubular structure of embodiment 1 of the present invention;

fig. 6 is a schematic perspective view of a spiral sheet structure of embodiment 1 of the present invention;

FIG. 7 is another perspective view of the spiral sheet structure of embodiment 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;

FIG. 10 is a side view of the balloon skeleton of example 2 of the present invention;

FIG. 11 is a cross-sectional view of a balloon skeleton of example 3 of the present invention;

FIG. 12 is a cross-sectional view of the capsule shell skeleton of example 4 of the present invention;

FIG. 13 is a cross-sectional view of the capsule shell skeleton of example 5 of the present invention;

FIG. 14 is a cross-sectional view of the capsule shell skeleton of example 6 of the present invention;

FIG. 15 is a cross-sectional view of another bladder skeleton of example 6 of the present invention;

FIG. 16 is a schematic view showing the structure of an expandable device in accordance with embodiment 7 of the present invention;

FIG. 17 is a schematic view showing the structure of an expandable device with a connecting member in line according to embodiment 7 of the present invention;

FIG. 18 is a schematic view showing the structure of a hard guide wire as the connecting member according to embodiment 7 of the present invention;

FIG. 19 is a schematic view showing the structure of the expandable device of example 7 of the present invention transported through a delivery tube;

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

Fig. 21 is a schematic structural view of an expandable device of embodiment 8 of the present invention.

Detailed Description

In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific 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 explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

The invention will be further illustrated with reference to specific examples. It should be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. Modifications and adaptations of the invention will occur to those skilled in the art and are intended to be within the scope of the invention in practice.

Example 1

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

The bone cement used in the prior art is a foreign body state in bone tissue and does not have the ability to promote bone growth or promote bone ingrowth into bone cement. In addition, the bone cement structure of the prior art is large in elastic modulus and high in hardness, and particularly in the osteoporosis environment, the hardness of surrounding cancellous bone is lower, so that the bone cement in an independent state is easy to loosen, move over time, threaten fragile bone tissues, easily cause secondary fracture of vertebral bodies and even destroy cortical bone to drop out of the vertebral bodies.

On the other hand, the existing bag structure or mesh bag structure used in vertebroplasty or kyphoplasty 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 tissue. The bag or mesh bag structure aims to limit the leakage of bone cement or limit the flowing of the bone cement in a certain direction so as to avoid the problems of paralysis and even death caused by the leakage of the bone cement.

The whole skeleton body 100 of the present embodiment presents a network-shaped pore structure, so that the filled bone cement can be dispersed between the network-shaped pore structures, the bone filling material can not concentrate at one point outflow, the outflow speed of the bone filling material is slowed down, meanwhile, the bone filling material can be dispersed outside the skeleton body from between the network-shaped pore structures, and after the bone filling material is solidified, a gap is formed between the skeleton body and the bone filling material. The gap between the bone filling material and the bone body 100 forms a space for bone growth, so that the stability of connection with bone tissue can be improved.

Referring to fig. 1 to 3, the skeleton body 100 includes a bag body 120, the bag body 120 has a fully open structure, and the holes 110 on the surface of the bag body 120 may have a regular shape, such as a square shape, a round shape, an ellipsoid shape, a polygon shape, etc.; alternatively, the holes 110 on the surface of the capsule 120 may be irregularly shaped, and the holes 110 on the surface of the capsule 120 allow the bone filler to freely flow into and embed in the open-cell structure.

Fig. 1 is a schematic perspective view of a capsule 120, and fig. 2 is a front view thereof, wherein regular square holes and irregularly shaped hole structures are uniformly distributed on the surface of the capsule 120. As shown in fig. 3, the balloon 120 may also be in a spiral coiled configuration, forming a surface aperture 110, the spiral coiled configuration imparting a certain ability to recover deformation to the balloon structure, and allow for rapid deployment after implantation into the vertebral body. Fig. 8 shows that the surface of bladder 120 is of varying size, shape, and staggered holes, thereby forming a cross-grid bladder 120.

The overall shape of the capsule 120 may be one or more of sphere, bar, gourd, sub-gourd, peanut, olive, wolf tooth stick, dumbbell, kidney, cylinder, bullet, cube, and cuboid, and the shape of the capsule 120, the size, shape and distribution of the holes 110 should be set according to specific requirements.

In another embodiment, the connecting structure 130 is further disposed in the bladder 120, and the connecting structure 130 is a crisscross network connecting structure, see fig. 4. The connecting structure 130 can play a certain supporting role on the first capsule 121 of the outer layer, and make the capsule skeleton present a three-dimensional network structure so as to slow down the dispersion speed of the bone filling material therein, and form a bone canal for bone ingrowth after degradation.

In this embodiment, the skeleton body 100 is formed by braiding or ligating. Specifically, the balloon 120 may be formed by a linear structure, a tubular structure or a sheet structure, or the linear structure may be woven into a thicker linear structure, and further woven into the skeleton body 100 by the thicker linear structure; or the wire-shaped structure, the tubular structure, the sheet-shaped structure are combined two by two or are combined and then are formed into the skeleton body 100, and the combination sequence or mode can be selected according to actual situations. In another embodiment, the skeleton body 100 may be formed in a 3D printing manner, 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 capsule skeleton can be unfolded after being implanted into the 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 holes may be formed in the sheet, see fig. 7.

The attachment structure 130 may be formed from the primary structure 102 and attached to the bladder 120 by braiding or bonding, which refers to bonding by an adhesive. Or, the connecting structure 130 and the bag body 120 are integrally formed, wherein the integrally formed structure comprises a braiding and ligation mode from inside to outside and a 3D printing mode integrally formed structure. The molding modes of the connecting structure 130 and the skeleton body 100 should be selected according to actual needs.

Since the structure of the skeleton body 100 is loosened due to the knitting manner, the cross connection position of the bag skeleton is further provided with the reinforcing portion 140, and referring to fig. 4, the reinforcing portion 140 is used for improving the stability of the knitting structure, so that the skeleton body 100 presents a preset shape. The reinforcement 140 may be bonded by an adhesive to strengthen the connection strength at the cross-connection or by fusing to strengthen the stability of the connection of the woven structure.

Preferably, the skeleton body 100 further includes a hard guide wire 103, which is disposed in the primary structure 102, as shown in fig. 6; or the primary structure 102 is wound around the surface of the stiff guidewire 103. The winding mode may be that the wire-like structure is wound on the surface of the hard guide wire 103 in a winding mode, or the wire-like structure is woven into a tubular structure, and the hard guide wire 103 is arranged in the tubular structure after weaving 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 memory metal guide wire, etc., so that the whole body of the capsule body framework is in a presettable structure, the structure can be made into irregular shapes such as peanut type, olive type, wolf tooth stick type, dumbbell type, etc., or long strip shape according to the difference of people. After implantation into the vertebral body, the cage body 100 is spread apart to receive bone filler material.

The primary structures distributed at different positions of the skeleton body 100 may have the same or different sizes d. 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 has a dimension d that gradually decreases from the outer layer to the inner layer of the skeletal body 100, as shown in fig. 8, with the primary structure of the outer layer having a dimension d2 that is greater than the dimension d1 of the primary structure of the inner layer. In this way, the part with large external dimension is degraded first, bone grows in preferentially, and the method is suitable for patients with strong bone growth capacity, good bone quality and relatively stable vertebral bodies.

In one embodiment, the primary structure increases in size d from the outer layer to the inner layer of the skeletal body 100, i.e., from the surface of the skeletal body to the interior thereof, from thin to thick. The capsule body designed in this way is not degraded in the initial stage, keeps the supporting strength in a short period, accelerates the degradation speed in the later stage, and is suitable for the situations that the bone is weaker, the vertebral body is unstable and the supporting is needed to be stabilized immediately.

Preferably, the porosity of the skeletal body is from 10% to 90%, preferably from 40% to 80%, more preferably from 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 order of nanometers to millimeters, may be several nanometers, may be several tens of millimeters, and is preferably 50nm to 10mm, further preferably 200nm to 1mm, and more preferably 200nm to 300nm; when the fusion cage is used for an intersyramid fusion cage, the diameter is 200nm-300nm; when used in the vertebral body, the diameter is 0.3-0.5mm. When the primary structure 102 is a sheet structure, the thickness (d) of the sheet structure is in the order of nanometers to millimeters, may be several nanometers, or may be several tens of millimeters, preferably, 50nm to 10mm, further preferably, 200nm to 1mm, and still more preferably, 200nm to 300nm.

In this embodiment, the capsule body skeleton may be provided with an opening for delivering the bone filler material, the opening is provided on the capsule body 120, and the bone filler material is filled into the skeleton body 100 by inserting a filling tool into the opening of the capsule body 120 during filling. Of course, the opening structure may not be preset, and the filling tool may be directly inserted into the balloon skeleton from the network-shaped pores of the skeleton body 100 and conveyed to a predetermined position, thereby completing the filling.

In one embodiment, the material forming the skeletal body 100 is a degradable material, which is, and is not limited to, polylactic acid material, and the rate of this degradation is controllable. The degradable material has certain high temperature resistance, can realize heat resistance effect, and the minimum heat resistance effect reaches more than 40 ℃. The material of the connection structure 130 is also a degradable material.

After the skeleton body 100 and the connection structure 130 are all degraded, network-shaped pore channels are formed in the bone filling material to form a space for bone growth, and the network-shaped pore channels have a certain effect of promoting bone growth, so that the bone filling material and the bone are mutually meshed to form a connection relationship of 'you have me in you and you have me in me', and the stability of the bone filling material is improved, but not exists 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 diseased bone tissues, truly solve the correlation between bone filling substances and bones and reduce the risk caused by the movement of the bone filling substances.

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, and a certain pore channel can be formed in the bone filling material, so that the bone ingrowth promoting effect is achieved. Or the materials of the skeleton body 100 and the connecting structure are non-degradable, so that the capsule skeleton can disperse the bone filling material and reduce the elastic modulus of the bone filling material, and the material can be supported by using a high 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, degradation refers to complete degradation or partial degradation, and in specific implementation, the material should be ensured to be capable of complete degradation as much as possible.

The skeleton body 100 may be loaded with some nutritional components or pharmaceutical components, such as components for promoting bone growth, bone growth promoting factors, BMP, beta calcium phosphate, etc., which can promote bone growth and promote bone ingrowth into bone cement, thereby further enhancing the connection between 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 skeleton body 100 may further carry a developing component in an addition ratio of 0.01% to 50%.

The nutritional ingredient, the pharmaceutical ingredient or the developing ingredient may be a coating 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, and the above ingredient may be filled in the channel formed by the tubular structure, and the ingredient carried by the skeleton body 100 may be absorbed along with degradation of the skeleton body 100.

Example 2

The present example provides a capsule body skeleton, which is adjusted based on example 1. The skeleton body 100 of the present embodiment includes a multi-layered sleeved bladder 120.

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

In this embodiment, the first bladder 121 has a cross grid structure, the second bladder 122 and the third bladder 123 have spiral coiled structures, and the spiral coiled bladders sleeved inside have good supporting effect. In other embodiments, the first bladder 121 may be a spiral coiled structure, the second bladder 122 and the third bladder 123 may be cross-grid structures, and the structure of the bladder 120 may be selected according to actual needs.

In this embodiment, the balloon skeleton may be formed by braiding a wire-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 connection structure 130 are formed separately and then connected sequentially from inside to outside, and the connection manner may be a braiding manner or a bonding manner, and the bonding manner refers to bonding by a crosslinking agent.

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

Of course, in other embodiments, the linear connection structure may be further woven to form a crisscross network connection structure, or the linear connection structure may be further formed into a spiral connection structure, where the crisscross network connection structure may further form a dense area in the balloon body, and the spiral connection structure may enable the balloon body to be rapidly unfolded. The particular form of the connection structure 130 may be selected according to particular needs of use and is not limited herein.

Example 3

Referring to fig. 11, a cross-sectional view of a capsule skeleton according to this embodiment is shown, which 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. The small pore region 101 has less packing of bone filler material, while the remaining sites have larger pore sizes, and more packing of bone filler material.

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.

In use, the small pore region 101 is disposed away from collapsed bone tissue, while the large pore region is disposed toward collapsed bone tissue, with the bone filler material being delivered into the capsule skeleton, and the large pore region having a greater pore size being capable of exhibiting a supportive effect on collapsed bone. Of course, in other embodiments, the small pore region 101 may also be disposed toward collapsed bone tissue.

Specifically, the skeleton body 100 includes a bag body 120, a connection structure 130 is disposed in the bag body 120, and the connection structure 130 is a crisscross network connection structure, and is formed by weaving linear connection structures. The connection structure 130 may be integrally formed with the bladder 120, which means that it is woven from a linear or tubular structure; or the connection structure 130 and the bladder 120 are formed separately and then connected. When the capsule body skeleton is formed, the small pore area 101 is formed when the linear connection structure is densely distributed, and when the linear connection structure is sparsely distributed, the area with large pore size is formed. The location of the distribution of the small pore region 101, the extent of the distribution, the specific pore size of the small pore region 101, and the pore size at the remaining locations should be set according to actual case needs. The small pore region 101 of the present embodiment is also applicable to the case where a plurality of capsules are sleeved.

Example 4

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

The present embodiment includes a plurality of sleeved capsules 120, adjacent capsules are connected by a connection structure 130, and the number of small pore areas 101 is 4, and the small pore areas are uniformly distributed in the circumferential direction of the skeleton body 100. When the bone filling material is dispersed from the inside of the skeleton body 100, the bone filling material can take on irregular shapes like a wolf's tooth stick, the special function can be achieved by the structural effect, the bone filling material in the area with large network pore size is more, the supporting effect is achieved, the bone filling material in the small pore area 101 is less, the functions of degrading, absorbing and promoting bone growth can be reflected, and therefore, after long-term implantation, the bone is grown into the bone filling material block, and the effects of mutual occlusion and anchoring in bone tissues are achieved.

The number of the small pore regions 101 in this embodiment may be 2, 3, 5 or more, may be uniformly distributed around the skeleton body 100, or may be randomly distributed around the skeleton body 100. The number of the capsules 120 may be 2, 3, 4 or more, the connection structures 130 are mainly linear connection structures, the connection structures 130 are distributed along the radial direction and the circumferential direction, and the densely distributed areas of the connection structures 130 form the small pore areas 101. The number of the capsules 120, the number of the small pore regions 101 and the distribution are not intended to limit the scope of the present invention, and may 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 balloon 120 in embodiment 1, and the criss-cross network connection structure or the spiral connection structure disposed in the balloon 120 is used to form a plurality of small pore areas 101.

Example 5

Referring to fig. 13, a cross-sectional view of a capsule skeleton according to this embodiment is shown, which is an adjustment made on the basis of embodiment 1 or 2. The skeleton body 100 includes multiple sleeved bags, and adjacent bags are connected by a connecting structure 130, wherein the connecting structure is mainly a linear connecting structure. The size of the network pores gradually increases from the inner center of the skeleton body 100 to the outside, and the bone filler is filled in the middle part, so that the flow rate is more uniform after the bone filler is dispersed to the region with large network pore size.

This embodiment is also applicable to the case of the one-layer balloon 120 in embodiment 1, and the crisscrossed network connection structure or spiral connection structure provided in the balloon 120 is used to form the change of the network pore size.

Example 6

Referring to fig. 14, a cross-sectional view of the capsule body skeleton of the present embodiment is a modification of embodiment 1 or 2. The skeleton body 100 includes several layers of sleeved bags, and adjacent bags are connected by a connecting structure 130, where the connecting structure is mainly a linear connecting structure. The size of the network pores gradually decreases from the inner center of the skeleton body 100 to the outside. The reduction of the network pore size is mainly reflected in the reduction of the spacing between two adjacent layers of capsules. The bone filler is filled in the middle part, and after the bone filler is dispersed into the small pore area, the bone filler is further dispersed, and the condition of concentrated outflow is not shown. At the same time, the function of blocking the dispersion of the bone filler to the periphery is also achieved.

In another alternative embodiment, the skeleton body 100 includes several layers of sleeved bags, and adjacent bags are connected by a connecting structure 130, where the connecting structure 130 is mainly a linear connecting structure. Referring to fig. 15, in a cross-sectional view of the bladder skeleton, the network pore sizes are randomly distributed from the inner center of the skeleton body 100, the network pore size is large at a predetermined position near the center of the skeleton body 100, the network pore size is small at another predetermined position from the center outward, and the pore size is 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 balloon 120 in embodiment 1, in which criss-cross network connection structures or spiral connection structures are disposed in the balloon 120 to form a change in the network pore size.

Example 7

The present embodiment provides an inflatable device, which includes a plurality of balloon skeletons 1 according to any one of embodiments 1 to 6, and further includes a connecting member 150, wherein a plurality of the balloon skeletons 1 are connected by the connecting member 150, so as to form a combined structure of connection between a plurality of balloon skeletons 1.

In comparison with the individual capsule body skeletons in the above-described embodiments, in the case of the combined use of the present embodiment, the individual size of the capsule body skeleton 1 is small, and thus has a high specific surface area, forms many gaps in the bone filler, has the effect of promoting bone ingrowth, and allows blood and bone cells to circulate therein, maintaining normal body fluid circulation in bone tissue to some extent.

Referring to fig. 16, a combined structure of the capsule body frames of the present embodiment is shown, a plurality of capsule body frames 1 are connected by a connecting member 150 to form a serial structure, and the connecting member 150 is a tubular structure. Referring to fig. 17, a plurality of capsule body frames 1 are connected in series by a connecting member 150, and the connecting member 150 is mainly a wire. In another embodiment, in the combined structure of a plurality of capsule skeletons 1 connected in series through the connecting piece 150, referring to fig. 18, the connecting piece 150 is a hard guide wire, the capsule skeletons 1 connected in series can be pushed into the bone tissue cavity by means of a pipe fitting at the rear part of the hard guide wire, and the hard guide wire is a guide wire with a certain elasticity or a material of a memory alloy, so that the hard guide wire can be in a straight line shape or a bent shape. After the device is integrally implanted into the vertebral body, bone filler material is delivered into the interstices between the capsular frame 1 by a filling tool.

Referring to fig. 19, in this embodiment, a plurality of capsule frames 1 are connected in series, the capsule frames 1 may be in a shape of a candid, and the plurality of capsule frames 1 are connected in series by a connecting piece 150, and mixed with a bone filling material, and then placed into a bone filling material pusher, for example: may be a delivery tube 300. The bone filling material and the capsule skeleton 1 are pushed into the bone tissue cavity at the same time.

Referring to fig. 20, in this embodiment, the plurality of capsule frames 1 are serially connected, and the capsule frames 1 may be in an elliptical shape, and are serially connected through a connecting piece 150, and then are mixed with the bone filling material, and then are filled into the conveying tool, and the rear push rod is pushed to enable the mixed bone filling material and the candid capsule to be filled into the bone tissue cavity at the same time. Of course, in other embodiments, multiple bladder frames 1 may be connected in parallel to the surface of the connector 150.

In this embodiment, the number of the capsule body frameworks 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 filling material is, and the more gaps are formed after the bone filling material is solidified, so that the effect of promoting bone ingrowth and the effect of reducing the elastic modulus of the bone filling material are achieved.

Preferably, the materials of the capsule body skeleton 1 and the connecting piece 150 are degradable materials, so long as one of the capsule body skeletons 1 is in contact with bone tissue, the whole combined structure can be rapidly degraded and desorbed, so that high-pore channels are formed on the bone filling material, the elastic modulus of the bone filling material is further reduced, the effect of promoting bone ingrowth is achieved, and the body fluid circulation in the bone tissue can be maintained.

The multiple bag body frameworks can be used in series or in parallel, and can be connected to the connecting piece 150 in a braiding manner or connected to the connecting piece 150 in an adhesive manner. The use mode can be to fill the cavity in the bone tissue formed by pre-expansion, all the capsule skeletons can be crenel to fill the whole cavity, the rest of the pores can be refilled with bone filling materials by using a filling tool. All the bone filling materials are connected, but are irregularly branched, like veins, like towel gourd sacs, and the cyst skeletons are gradually degraded and absorbed along with implantation, promote bone growth and realize cross-linking with the network structure of the bone filling materials.

Of course, in other embodiments, one of the balloon skeleton 1 and the connecting member 150 is a degradable material, and the balloon skeleton 1 is degradable and the connecting member 150 is not degradable, or the balloon skeleton 1 is not degradable and the connecting member 150 is degradable, so that a certain pore channel is formed after degradation and absorption; or the balloon skeleton 1 and the connecting piece 150 are made of non-degradable materials, and are not described herein.

Example 8

This embodiment provides an inflatable device, which is an adjustment made on the basis of embodiment 7, see fig. 21, which is a schematic structural view of the inflatable device of this embodiment,

Wherein, a plurality of capsule body frameworks 1 are attached to the peripheral wall of the injection tube 200, the capsule body frameworks 1 can be woven on the injection tube 200 or adhered to the injection tube 200, and a conveying port 201 is arranged between two adjacent capsule body frameworks 1. When the bone filling material is conveyed, the bone filling material flows out along the conveying port 201 between the gaps of the capsule body frameworks 1, so that the contact between the capsule body frameworks 1 and the multi-layer multi-surface of the bone filling material is achieved. Of course, in other embodiments, delivery of bone filler material may be accomplished by a filling tool without delivery port 201.

It should be noted that the balloon scaffold of examples 1-8 and the inflatable device were used in vertebroplasty (PVP) or kyphoplasty (PKP) to elevate collapsed bone to physiological height. Of course the balloon scaffold and inflatable device may also be used in vertebroplasty or interbody fusion procedures.

The foregoing disclosure is only of the preferred embodiments of the invention. The preferred embodiments are not exhaustive or to limit the invention to the precise form 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 the full scope and equivalents thereof.

Claims

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

the framework body is made of degradable materials, pore channels are formed on the formed bone filling substances after the framework body is degraded, a space for bone growth is formed, and the bone growth is promoted, so that the bone filling substances are mutually meshed with the bone;

The size of the primary structure is gradually increased from the inside of the skeleton body to the outside; or the size of the primary structure gradually decreases from the inside of the skeleton body to the outside.

2. The capsule body scaffold of claim 1, wherein the primary structure has a size of 1nm to 999mm.

3. The capsule body scaffold of claim 2, wherein the primary structure has a size of 50nm to 10mm.

4. A capsule body scaffold as in claim 3, wherein the primary structure has a size of 200nm-1mm.

5. The capsule body scaffold of claim 4, wherein the primary structure has a size of 200nm-300nm.

6. The capsule body scaffold of claim 1, wherein the scaffold body carries thereon at least one of a component for promoting bone growth, an anti-inflammatory drug component, and a visualization component.

7. The capsule body skeleton of claim 6, wherein a channel is provided within the skeleton body, the composition filling the channel; or the component is a coating coated on the surface of the skeleton body.

8. The capsule body framework of claim 1, wherein the framework body comprises at least one layer of capsule body, and a connecting structure is arranged in the capsule body; or the skeleton body comprises a plurality of layers of sleeved bag bodies.

9. The bladder skeleton according to claim 8 wherein a connecting structure is provided between adjacent bladders.

10. The capsule body framework of claim 8 or 9, wherein the connection structure is at least one of a linear connection structure, a criss-cross network connection structure or a spiral connection structure, and the connection structure is connected with the capsule body.

11. The capsule shell as in claim 8 or claim 9, wherein the material of the attachment structure is a degradable material.

12. The capsule body skeleton of claim 10, wherein the capsule body is at least one of a sphere, a bar, a gourd, a sub-gourd, a peanut, an olive, a wolf tooth bar, a dumbbell, a kidney, a cylinder, a bullet, a cube, a cuboid.

13. The capsule body scaffold of claim 1, wherein the scaffold body comprises at least one small pore region having a pore size that is smaller than a pore size at the remaining locations, the small pore region extending from within the scaffold body outward to the scaffold body surface.

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

15. The capsule body scaffold of claim 1, wherein the network pores progressively increase in size from an interior center of the scaffold body outward; or from the inner center of the skeleton body outwards, the size of the network pores gradually decreases.

16. The bladder skeleton according to any one of claims 1, 6-9, 13, 15 wherein the skeleton body is formed by at least one of braiding, ligating, or 3D printing; and the primary structure is a spiral structure.

17. The capsule body scaffold of claim 1, wherein the scaffold body further comprises a stiff guidewire disposed within the primary structure or the primary structure is wrapped around the stiff guidewire surface.

18. The bladder skeleton according to claim 1 wherein the skeleton body cross-connect locations are further provided with reinforcements.

19. The capsule body scaffold of claim 18, wherein the reinforcement is an adhesive and/or a fused connection.

20. An inflatable device comprising a plurality of balloon armatures according to any of claims 1-19, said inflatable device further comprising a connector, a plurality of said balloon armatures being connected by said connector.

21. The inflatable device of claim 20, wherein each of said balloon armatures is sleeved over said connector or each of said balloon armatures is connected to a surface of said connector.

22. The inflatable device of claim 20, wherein said connector is a tubular structure for delivering bone filler material, each of said balloon backbones being attached to a surface of said tubular structure, said tubular structure further having a plurality of bone filler material delivery ports.

23. The inflatable device according to any one of claims 20-22, wherein the connector is made of a degradable material.