An osteogenic cyclic pressurized shell for treating large bone defects

Abstract

The present invention discloses an osteogenic cyclic pressurized shell for treating large bone defects. The shell comprises an annular structure and a strip structure disposed between a pair of annular structures. The annular structure and the strip structure form a relatively closed cavity, in which the ectopic osteogenic material is disposed. The strip structure is flexible and retractable to pressurize the ectopic osteogenic material within the cavity. The present invention provides an osteogenic cyclic pressurized shell for treating large bone defects. The shell is suitable for ectopic osteogenesis treatment of large bone defects. The shell has a rational structure and an ingenious design. The strip structure disposed between the annular structures is retractable, allowing the ectopic osteogenic material disposed between the annular structures to be pressurized, thereby promoting the speed and quality of osteogenesis.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an osteogenic cyclic pressurized shell for treating large bone defects. Background Art

[0002] With the rapid development of bone tissue engineering in recent years, the application of bone tissue engineering techniques to treat bone defects has become a current development trend. Heterotopic osteogenesis models can reduce the variables that affect osteogenesis compared to in situ osteogenesis and can evaluate the effects of osteogenic stem cells and osteoinductive materials. Heterotopic ossification (HO) refers to the abnormal osteogenesis that occurs in the normal soft tissue outside of bone tissue. It is a dynamic process and is a type of ectopic osteogenesis.

[0003] Cyclic pressure plays an important role in bone regeneration and remodeling, especially in the treatment of large bone defects using heterotopic osteogenesis. Effectively improving the quality and rate of heterotopic osteogenesis in vivo is crucial. Currently, there is no mature osteogenic cyclic pressure shell for the treatment of large bone defects.

[0004] Patent CN100571662C discloses a prosthesis for repairing maxillary defects and its preparation method. The prosthesis comprises an outer silicone rubber layer adapted to the maxillary defect area, within which is located an inner cylindrical skin and soft tissue expander layer. This inner cylindrical skin and soft tissue expander layer is connected to an inflatable device extending beyond the outer silicone rubber layer. Magnetic retainers are provided on the outer silicone rubber layer, the inner cylindrical skin and soft tissue expander layer, or the inflatable device. This invention is applicable only to the repair of maxillary defects.

[0005] Patent CN103992947A discloses a loading device and loading method for compressive stress of bone cells in porous titanium alloy. The loading device includes a servo motor, an action chamber, an action piston, a pressurized chamber, a movable wall plate, a transmission rod, a pressure and temperature sensor, etc. The servo motor is controlled by a motion control card through a PC and is connected to the transmission rod, which is connected to the action piston. The servo motor drives the piston up and down through the transmission rod. The front side wall of the pressurized chamber is provided with an openable and closable movable wall plate. After disinfection and sterilization, the device is placed in a cell culture box, and the bone cell suspension is implanted in the porous titanium alloy. The pressurized system stimulates the cells in the porous titanium alloy with a compressive load. This invention discloses a test device that cannot be used for clinical bone defect treatment.

[0006] Therefore, there is an urgent need to design an osteogenic cyclic pressurized shell for the treatment of large bone defects to effectively improve the quality and speed of ectopic osteogenesis in vivo. Summary of the Invention

[0007] The purpose of the present invention is to address the above-mentioned technical problems. The present invention provides an osteogenic cyclic pressurized shell for the treatment of large bone defects, which is suitable for ectopic osteogenesis to treat large bone defects. It has a reasonable structure and ingenious design. The strip structures arranged between the annular structures are elastic, so that the ectopic osteogenesis material between the annular structures is pressurized, thereby promoting the speed and quality of osteogenesis.

[0008] In order to solve the above technical problems, the present invention provides an osteogenic cyclic pressurized shell for the treatment of large bone defects, including an annular structure and a strip structure arranged between a pair of annular structures. The annular structure and the strip structure form a relatively closed cavity, and the ectopic bone-forming material is arranged in the cavity; the strip structure can be freely extended and retracted to pressurize the ectopic bone-forming material in the cavity.

[0009] In some embodiments, the strip structure is formed by bonding and fixing multiple layers of strips.

[0010] In some embodiments, the strips are hydrogels or polymers, and biological glue is provided between adjacent strips.

[0011] In some embodiments, the strip is retractable.

[0012] In some embodiments, the strip structure includes a plurality of strips of different lengths, and the strips are stretched to equal lengths along the length direction and then fixed together by bioadhesive.

[0013] In some embodiments, the strip structure includes a plurality of strips of different widths, and the strips are stretched to equal lengths along the width direction and then fixed together by bioadhesive.

[0014] In some embodiments, the strip structures are evenly distributed along the axis of the ring structure.

[0015] In some embodiments, the gap between adjacent strip structures is adjustable.

[0016] In some embodiments, the cross-section of the strip structure is any one of rectangular, triangular, elliptical, and circular.

[0017] In some embodiments, the strips of different lengths are bonded and fixed together in descending or increasing order of length.

[0018] In some embodiments, the strips of different widths are bonded and fixed together in descending or increasing order of width.

[0019] Beneficial effects of the present invention:

[0020] The osteogenic cyclic pressurized shell for treating large bone defects provided by the present invention is suitable for ectopic osteogenesis to treat large bone defects. It has a reasonable structure and ingenious design. The strip structures arranged between the annular structures are elastic, so that the ectopic osteogenesis material arranged between the annular structures is pressurized. When the muscles contract and are compressed by the muscles, the distance between the annular structures is increased, the axial pressure is reduced, and the radial pressure is increased. Intermittent pressure changes are generated by the expansion and contraction of the muscles themselves. The gaps between the strip structures are adjustable, which facilitates the entry of nutrients, the growth of blood vessels, and the discharge of metabolic products, thereby promoting the speed and quality of osteogenesis. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The above advantages of the present invention will become clearer and easier to understand through the detailed description made in conjunction with the following drawings, which are only exemplary and do not limit the present invention, wherein:

[0022] Figure 1 This is a schematic structural diagram of the osteogenic cyclic pressurized shell for treating large bone defects according to the present invention;

[0023] Figures 2 to 3 is a cross-sectional view of the strip structure of the present invention along the length direction;

[0024] Figure 4 is a cross-sectional view of the strip structure of the present invention along the width direction;

[0025] Figure 5 This is a schematic diagram of the application of the osteogenic cyclic pressurized shell for treating large bone defects according to the present invention;

[0026] Figure 6a and Figure 6b This is a comparison chart of the results of the Alizarin Red staining test;

[0027] Figure 7a and Figure 7b This is a comparison chart of the ectopic osteogenesis results of the osteogenic cyclic pressurized shell for treating large bone defects described in the present invention.

[0028] In the picture:

[0029] 10. Ring structure; 20. Strip structure; 21. Strip; F1, axial pressure; F2, longitudinal pressure. DETAILED DESCRIPTION

[0030] The following describes in detail the osteogenic cyclic pressurized shell for treating large bone defects described in the present application in conjunction with specific embodiments and drawings.

[0031] The embodiments described herein are specific embodiments of the present invention and are used to illustrate the concept of the present invention. They are illustrative and exemplary and should not be construed as limiting the embodiments and scope of the present invention. In addition to the embodiments described herein, those skilled in the art can also adopt other obvious technical solutions based on the claims and the disclosure of the specification, including technical solutions that adopt any obvious substitutions and modifications to the embodiments described herein.

[0032] The accompanying drawings of this specification are schematic diagrams to assist in explaining the concept of the present invention and schematically show the shapes of various parts and their mutual relationships. Please note that in order to clearly show the structure of various components of the embodiments of the present invention, the same reference numerals are used to represent the same parts.

[0033] A schematic diagram of the structure of the osteogenic cyclic pressurized shell for treating large bone defects according to the present invention is shown in FIG. Figures 1 to 4 As shown, it includes an annular structure 10 and a strip structure 20 arranged between a pair of annular structures 10, the annular structure 10 and the strip structure 20 form a relatively closed cavity, and the ectopic bone forming material is arranged in the cavity; the strip structure 20 can freely expand and contract to pressurize the ectopic bone forming material in the cavity.

[0034] As an embodiment of the present invention, the strip structure 20 is formed by bonding and fixing multiple layers of strips 21. Figures 2 to 4 In the embodiment shown, the number of the strips 21 is three layers. The number of the strips 21 may also be three layers, four layers, five layers, etc.

[0035] As one aspect of this embodiment, the strips 21 are made of hydrogels or polymers, which cannot undergo an elimination reaction with the human body, thus hindering the integration of the ectopic osteogenic material with human tissue. As another aspect of this embodiment, bioglue is provided between adjacent strips 21 to ensure rapid integration of the ectopic osteogenic material with human tissue.

[0036] As an embodiment of the present invention, the strip 21 is stretchable. During the bonding process of the multi-layer strip 21, the strip 21 is stretched along the length direction and / or width direction and then bonded to other strips 21. In this way, the strip structure 20 formed by bonding the multi-layer strips 21 is stretchable and can be stretched along the length direction and / or width direction to pressurize the osteogenic material in the relatively closed cavity formed by the annular structure 10 and the strip structure 20.

[0037] As one aspect of this embodiment, the strip structure 20 includes a plurality of strips 21 of different lengths, and the strips 21 are stretched to equal lengths along the length direction and then fixed together by bio-glue; Figure 2As shown in the figure, the dotted line represents the state of the strip 21 after being stretched in the length direction, and the solid line represents the state of the strip 21 without being stretched. The shorter strip 21 is stretched in the length direction to be equal to the corresponding length of the longer strip 21, and then fixed together with biological glue. The strip structure 20 formed by bonding multiple layers of strips 21 is stretchable and can be stretched in the length direction to pressurize the osteogenic material in the relatively closed cavity formed by the annular structure 10 and the strip structure 20.

[0038] The strip structure 20 includes a plurality of strips 21 of different widths, which are stretched to equal lengths along the width direction and then fixed together by bio-glue. Figure 4 As shown in the figure, the dotted line represents the state of the strip 21 after being stretched in the width direction, and the solid line represents the state of the strip 21 without being stretched. The shorter strip 21 is stretched in the width direction to be equal to the corresponding width of the longer strip 21, and then fixed together with biological glue. The strip structure 20 formed by bonding multiple layers of strips 21 is stretchable and can be stretched in the width direction to pressurize the osteogenic material in the relatively closed cavity formed by the annular structure 10 and the strip structure 20.

[0039] exist Figure 1 In the embodiment shown, the strip structures 20 are evenly distributed along the axis of the annular structure 10, and the strip structures 20 can freely expand and contract to pressurize the ectopic bone forming material in the cavity. As a variation of this embodiment, the strip structures 20 can also be unevenly distributed along the axis of the annular structure 10, as long as the gap between adjacent strip structures 20 is ensured to be 1mm-5mm, the strip structures 20 can freely expand and contract to pressurize the ectopic bone forming material in the cavity.

[0040] In the present invention, the gaps between adjacent strip structures 20 are adjustable. Figure 4 In the illustrated embodiment, the strip structures 20 are extendable along the width direction, so that the gap between adjacent strip structures 20 can be adjusted by extending and retracting the strip structures 20 along the width direction.

[0041] As an embodiment of the present invention, the cross-section of the strip structure 20 is any one of a rectangle, a triangle, an ellipse, and a circle. It is understood that the cross-section of the strip structure 20 can also be other closed shapes, such as a trapezoid, a combination of a rectangle and a semicircle, etc., as long as the strip structure 20 is easy to bond and fix and the bonded strip structure 20 has good elasticity.

[0042] As an embodiment of the present invention, the strips 21 of different lengths are bonded and fixed together in descending or increasing order of length, such as Figure 2As a variation of this embodiment, the strips 21 may also be bonded and fixed in other arrangements, such as symmetrically distributed in descending or ascending order, such as Figure 3 As shown, the strips 21 on both sides are shorter, and the shorter strips 21 on both sides are stretched and fixed to the longer strip 21 in the middle using biological glue, which can also ensure good elasticity.

[0043] The strips 21 of different widths are bonded and fixed together in the order of decreasing or increasing widths, such as Figure 4 As shown; as a variation of this embodiment, the strips 21 can also be glued and fixed in other arrangements, such as symmetrically distributed in descending or ascending order, so that the widths of the strips 21 on both sides are shorter, and the strips 21 with shorter widths on both sides are stretched and fixed to the strip 21 with longer width in the middle using biological glue, which can also ensure good stretchability.

[0044] The osteogenic cyclic pressurized shell for treating large bone defects of the present invention is arranged along the direction of the muscle. When the muscle contracts, the strip structure 20 is lengthened under the action of the muscle squeezing force, and the axial pressure F1 along the ectopic bone-forming material is reduced, while the radial pressure F2 is increased. In this way, with the intermittent contraction of the muscle, intermittent cyclic pressure can be formed in the radial and axial directions of the ectopic bone-forming material, which accelerates the comprehensive exchange of substances and promotes the speed and quality of bone formation. Figure 5 As shown, the double arrow direction in the figure is the direction of muscle contraction. Figure 1 An embodiment of a pair of annular structures 10 is shown, which may also include multiple annular structures 10, with multiple strip structures 20 arranged between adjacent annular structures 10, so as to form a longer cyclic pressurizing device suitable for treating different forms of bone defects.

[0045] The steps and process for using the osteogenic cyclic pressurized shell for treating large bone defects of the present invention are as follows:

[0046] Heterotopic osteogenesis surgery was performed in a special operating room for experimental animals that had been irradiated with ultraviolet light. After anesthesia took effect, the skin of the surgical area was prepared using a special animal shaver.

[0047] Place the New Zealand white rabbit prone on the operating table, disinfect the skin within the area with medical iodine, and lay a drape in a conventional manner to expose the back of the experimental animal.

[0048] Make two incisions about 2 cm long on both sides of the spine in the back. After lifting the skin, use vascular forceps and tissue scissors to separate the subcutaneous tissue and superficial fascia, reaching deep into the fat layer until the superficial muscle fascia is exposed.

[0049] Use a blunt separator to separate the pocket-shaped muscle bag, load the tissue engineering scaffold into the device, soak it with saline, and then place it flat into the muscle bag. Set the circulating pressure device along the direction of the muscle, and then suture the wound layer by layer and mark it.

[0050] Figure 6a This is the result of Alizarin red staining of simple ectopic bone culture. Figure 6b This is the Alizarin Red staining result of placing a 3D printed bone tissue engineering scaffold in the device of the present invention, compared with the simple ectopic bone culture ( Figure 6a ); After 2 weeks, the alizarin red staining results of the 3D-printed bone tissue engineering scaffold placed in the device of the present invention were good, and a good osteogenesis effect was achieved ( Figure 6b ).

[0051] Figure 7a and Figure 7b The results of the ectopic osteogenic scaffold obtained by the device were compared in vivo. In a rabbit radius defect model, the cyclic pressurization device of the present invention was used to first ectopically ossify the tissue engineering scaffold for 2 weeks before implanting it into the bone defect site (such as Figure 7a Compared with directly implanting tissue engineering scaffolds into bone defects ( Figure 7a showed better osteogenesis at 16 weeks.

[0052] The present invention provides an osteogenic cyclic pressurized shell for treating large bone defects, which is suitable for ectopic osteogenesis to treat large bone defects. It has a reasonable structure and ingenious design. The strip structures arranged between the annular structures are elastic, so that the ectopic osteogenesis material arranged between the annular structures is pressurized, thereby promoting the speed and quality of osteogenesis, and has good promotion value.

[0053] The present invention is not limited to the above-mentioned embodiments. Anyone can derive other forms of products under the inspiration of the present invention. However, no matter what changes are made in the shape or structure, any product with the same or similar technical solutions as the present application falls within the scope of protection of the present invention.

Claims

1. An osteogenic cyclic pressurized shell for treating large bone defects, comprising an annular structure and a strip structure disposed between a pair of annular structures, wherein the annular structure and the strip structure form a relatively closed cavity, and an ectopic bone-forming material is disposed in the cavity; The strip structure comprises a plurality of strips of different lengths, which are stretched along the length direction to the same length and then fixed together by bioadhesive; The strip-shaped structure can freely expand and contract to pressurize the ectopic bone-forming material in the cavity, so as to form intermittent cyclic pressure in the radial and axial directions of the ectopic bone-forming material.

2. The osteogenic cyclic pressurized shell for treating large bone defects according to claim 1, characterized in that: The strip structure is formed by bonding and fixing multiple layers of strips.

3. The osteogenic cyclic pressurized shell for treating large bone defects according to claim 2, characterized in that: The strips are made of hydrogel or polymer, and biological glue is arranged between adjacent strips.

4. The osteogenic cyclic pressurized shell for treating large bone defects according to claim 1, characterized in that: The strip is retractable.

5. The osteogenic cyclic pressurized shell for treating large bone defects according to claim 1, characterized in that: The strip structure comprises a plurality of strips with different widths, and the strips are stretched to equal lengths along the width direction and then fixed into one piece by means of biological glue.

6. The osteogenic cyclic pressurized shell for treating large bone defects according to claim 1, characterized in that: The strip structures are evenly distributed along the axis of the ring structure.

7. The osteogenic cyclic pressurized shell for treating large bone defects according to claim 1, characterized in that: The gaps between adjacent strip structures are adjustable.

8. The osteogenic cyclic pressurized shell for treating large bone defects according to claim 1, characterized in that: The cross section of the strip structure is any one of rectangular, triangular, elliptical and circular.

9. The osteogenic cyclic pressurized shell for treating large bone defects according to claim 1, characterized in that: The strips of different lengths are bonded and fixed together in descending or increasing order of length.

10. The osteogenic cyclic pressurized shell for treating large bone defects according to claim 5, characterized in that: The strips with different widths are bonded and fixed together in a decreasing or increasing order of width.

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