CN216148180U - Bone filling bag - Google Patents
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- CN216148180U CN216148180U CN202122100023.8U CN202122100023U CN216148180U CN 216148180 U CN216148180 U CN 216148180U CN 202122100023 U CN202122100023 U CN 202122100023U CN 216148180 U CN216148180 U CN 216148180U
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Abstract
The utility model provides a bone filling bag which is provided with a plurality of layers of net structures from inside to outside, wherein each layer of net structure comprises a first balloon, a second balloon and a waist structure for connecting the first balloon and the second balloon; each layer of the net-shaped structure is provided with a plurality of holes, and the hole diameters of the holes on the net-shaped structure are gradually decreased from the inner layer to the outer layer. The bone filling bag is of a multilayer waist-contracting type structure, so that the problem of stress concentration of a circular structure is effectively relieved, the mechanical property of the bag is improved, the leakage of a bone filling material caused by the rupture of the bag is prevented, the compression of excessive stress on peripheral non-treatment tissues is not caused, the bone filling material is easy to take out, and the problem of difficulty in taking out the bag after operation is solved.
Description
Technical Field
The utility model relates to the field of medical equipment, in particular to a bone filling capsular bag.
Background
The bone cement filling has the advantages of fast fixation, permanent existence and good biocompatibility in the aspect of treating bone defects and fractures, the bag is a bone cement carrier, plays a role in transporting the bone cement in the bone cement filling, generally, the bone cement is directly poured into the bag, the bag filled with the bone cement is transported to a specified position in a body, the bone cement is released, the bone cement is rapidly solidified, and the bag is taken out of the body after operation. The capsular bag is usually folded and contracted to enter the body due to the fact that the capsular bag is entered into the body through a minimally invasive surgery, but the problem that the capsular bag is not sufficiently opened when bone cement is released by the capsular bag is caused, so that the difficulty of the surgery is increased, even the failure of the surgery is caused, and therefore the structural design and preparation of the capsular bag are of great significance to the bone cement filling surgery.
At present, a common bag is divided into a single-layer spherical structure and a double-layer spherical structure, the double-layer bag is formed by folding the single-layer bag, namely, the apertures of two layers of nets of the double-layer bag are completely the same, so that the dispersion force and the injection force of bone cement cannot be well controlled, the bone cement cannot be uniformly dispersed at a specified position, the leakage of the bone cement is easy to occur, the bone cement is easy to be detained in the bag, the stress of the bag of the single-layer spherical structure is concentrated, after the bone cement is filled into the bag, the middle part of the bag can be excessively expanded to cause the compression that peripheral non-treatment tissues bear the excessive stress, the bag is difficult to take out, and the problem of the leakage of the bone cement due to the rupture of the bag can also be caused.
Chinese patent application No. 200820033098.0 discloses a knitted fabric pocket, which is difficult to be taken out because bone cement oozes out of the pocket in a permeating manner and the bone cement is solidified when the pocket is withdrawn, and which is easy to leak out of the vertebral body because the pores of the pocket are regular pores; chinese patent application No. 201610859543.8, which addresses the problem of extraction of the pouch by adding an auxiliary item based on a fabric pouch, has resulted in the addition of auxiliary devices, increasing the complexity and size of the bone filler device.
In view of the above, the present invention is particularly proposed.
SUMMERY OF THE UTILITY MODEL
The utility model aims to provide a bone filling bag which is of a multilayer waist-contracting type structure, effectively relieves the problem of stress concentration of a circular structure, improves the mechanical property of the bag, prevents the leakage of a bone filling material caused by the rupture of the bag, does not cause the compression of the peripheral non-treatment tissues by overlarge stress, is easy to take out, and solves the problem of difficulty in taking out the bag after operation.
The utility model is realized by the following steps:
a bone filling bag is provided with a plurality of layers of net structures from inside to outside, wherein each layer of net structure comprises a first balloon, a second balloon and a waist-contracting structure for connecting the first balloon and the second balloon;
each layer of the net-shaped structure is provided with a plurality of holes, and the hole diameters of the holes on the net-shaped structure are gradually decreased from the inner layer to the outer layer.
The bone filling bag is of a multilayer waist-contracting type structure, so that the problem of stress concentration of a circular structure is effectively relieved, the mechanical property of the bag is improved, the leakage of a bone filling material caused by the rupture of the bag is prevented, the compression of excessive stress on peripheral non-treatment tissues is not caused, the bone filling material is easy to take out, and the problem of difficulty in taking out the bag after operation is solved.
Further, the number of layers of the net-shaped structure is 2-4; not only can effectively solve the problem of bone cement leakage, but also improves the mechanical property of the bag.
Furthermore, the thickness of each layer of the net-shaped structure is 0.06-0.15 mm.
Furthermore, the aperture of the holes on the net-shaped structure of the inner layer is 0.1-10 mm; the aperture of the holes on the outer layer of the net-shaped structure is 0.01-1 mm; the aperture size of the holes on the middle layer net structure is between the numerical values; the aperture gradually decreases from the inner layer to the outer layer, the bone cement can be filtered layer by layer, the diffusion of the bone cement into the sac bag layer by layer is facilitated, and the bone cement is uniformly distributed in the sac bag.
Furthermore, the hole density of the holes on the net-shaped structure is 1-10/cm2The bone cement can be prevented from leaking out of the vertebral body.
Further, a radius of the waisted structure cross-section is less than a cross-sectional radius of the first balloon and the second balloon.
Further, the volume of the first balloon or the second balloon is 48-87 cm3。
Further, a hollow convex structure is arranged at one end, far away from the waist-contracting structure, of the first balloon.
Further, an introducer connecting port is arranged at one end, far away from the waist-tightening structure, of the second balloon, and the introducer connecting port is connected to an introducer pushing rod.
Furthermore, a supporting structure is arranged in the protruding structure, and one end of the supporting structure extends from the inside of the protruding structure to the inserter connecting port. The bulge structure is used for fixing the support structure, and the support structure is arranged from the bulge structure to the inserter connecting port, so that the support effect can be effectively provided for the bone filling capsular bag, the capsular bag is better connected with the inserter, and the capsular bag can be effectively placed and retracted.
Furthermore, the material of the support structure is hard metal.
The preparation method of the bone filling capsular bag comprises the following steps:
(1) pretreatment of the yarn: sequentially cleaning the yarns by acid solution and ultrasonic wave, coating the cleaned yarns in the coating slurry, and drying the yarns;
(2) weaving of the waisted multilayer fabric: warping the yarn dried in the step (1), using the yarn after the whole warp treatment as a warp yarn, and drafting by adopting a partition drafting method, wherein the warp yarn of the reticular structure of the outer layer penetrates in a front area, the warp yarn of the reticular structure of the middle layer penetrates in a middle area, and the warp yarn of the reticular structure of the inner layer penetrates in a rear area; the warps after drafting pass through a profiled reed plate respectively, and wefts are introduced into the warps penetrating through the profiled reed plate to be woven to obtain a waisted multilayer fabric;
(3) preparing a bone filling pouch: and (3) padding the waisted multilayer fabric woven in the step (2) by using a coating solution, and drying to obtain the bone filling bag.
In the step (1), the acid solution includes any one of an oxalic acid solution, a hydrochloric acid solution or a sulfuric acid solution; the acid solution cleaning has the function of removing dust, rust, impurities and the like on the surface of the yarn, and is beneficial to disinfection and sterilization of subsequent products;
preferably, the mass concentration of the acid solution is 1-10%;
preferably, the cleaning temperature of the acid solution cleaning is 60-100 ℃, and the cleaning time is 10-30 min;
preferably, the ultrasonic power of the ultrasonic cleaning is 30-100W; the ultrasonic cleaning fully removes dust, rust, impurities and residual oxalic acid on the surface of the yarn.
Preferably, the yarn is a natural fiber or a synthetic fiber; the adoption of natural fibers or synthetic fibers is beneficial to ensuring good biocompatibility and providing proper mechanical properties.
More preferably, the natural fiber is one or more of silk, chitosan yarn, chitin yarn or collagen yarn;
more preferably, the synthetic fiber is any one or combination of more of polyamide, polyester, polypropylene, polylactic acid, polycaprolactone, polyglycolide, polydioxanone or polyglycolide;
preferably, the fineness of the yarn is 30-300D, and the complex number is 1-200F;
preferably, the yarns are monofilament or multifilament;
preferably, the sizing rate of the yarn is 1-20%, and the moisture regain after sizing is 1-10%.
The coating slurry is polyvinyl alcohol solution;
preferably, the polyvinyl alcohol solution contains 1 to 10 mass% of glycerol;
preferably, the temperature of the coating is 30-80 ℃, and the speed of the coating is 10-50 m/s; the coating enhances the weaving performance, the coating condition provides proper sizing rate for the yarn, the viscosity of coating slurry is reduced due to overhigh coating temperature, the sizing rate is reduced, the coating temperature is too low, and the coating slurry cannot completely permeate the interior of the yarn; if the coating speed is too fast, the grouting time is short, and vice versa;
preferably, the coating adopts one or more of a single-dipping single-pressing method, a double-dipping double-pressing method or a three-dipping three-pressing method;
preferably, the drying temperature is 30-80 ℃.
In the step (2), in the warping treatment, the warping density is 10-300 pieces/cm; the warping speed is 5-100 rpm/min;
if the warping density is too high, the elastic loss of the yarns is more, and the broken ends are more easily generated in the weaving process; if the warping density is too low, the yarns are easy to loosen in the winding process; if the warping speed is too high, the yarn tension is higher, and the ends are easy to break in the warping process; if the warping speed is too low, the yarn tension is too low, the yarn is easy to loosen in the winding process, and the forming is poor.
Preferably, the drafting adopts 2-20 pages of palm frames;
preferably, the profiled reed plate is a rhombic reed plate; the profiled reed plate is a reed plate of 30-350 reed/10 cm; the fabric with a waist-contracting structure can be obtained by reeding the special-shaped reed plate; the reed number of the reed plate is too small, and the warp density is too small; and vice versa. The adoption of a profiled reed plate of 30-350 reed/10 cm is beneficial to controlling proper warp density and ensuring that a double-balloon bone filling fabric mesh bag is woven;
preferably, the arrangement mode of the warp yarns of the reticular structure on the outer layer, the warp yarns of the reticular structure on the middle layer and the warp yarns of the reticular structure on the inner layer is (1-5): 1-5);
preferably, the arrangement modes of the weft yarns of the net-shaped structure at the outer layer, the weft yarns of the net-shaped structure at the middle layer and the weft yarns of the net-shaped structure at the inner layer are (1-5): (1-5): 1-5);
preferably, the warp density of the waisted multilayer fabric is 10-200 pieces/cm, and the weft density of the waisted multilayer fabric is 10-200 pieces/cm; the width of the waist-shrinking type multilayer fabric is 1-10 cm.
Preferably, in the step (2), drafting of the front region, the middle region and the back region adopts a forward drawing-through method or a drawing-through method;
in the step (3), the coating solution is a solution containing any one or a mixture of silk fibroin, collagen, chitosan or polylactic acid;
preferably, the mass concentration of the coating solution is 6-8%;
preferably, the number of padding treatment is 2-10; the padding treatment enhances the biocompatibility of the capsular bag;
preferably, the drying temperature is 80-200 ℃;
before padding treatment, washing is carried out, wherein the washing process is deionized water rinsing combined with ultrasonic cleaning;
preferably, the rinsing temperature is 20-100 ℃, and the time is 10-300 min;
preferably, the power of the ultrasonic wave is 20-80W, and the time for dispersing the ultrasonic wave is 1-20 min;
the working principle of the bone filling bag is as follows: the bone filling bag is contracted and folded to enter the body through minimally invasive surgery, plays the role of bearing and transporting bone cement, is fully unfolded after reaching the designated position, releases and solidifies the bone cement, and is taken out after the surgery.
A preparation method of a bone filling capsular bag comprises the following specific steps:
(1) pretreatment of the yarn: drawing the yarn into a cleaning tank filled with an acid solution with the mass concentration of 1-10%, cleaning for 10-30 min at the temperature of 60-100 ℃, drawing into an ultrasonic cleaner with the power of 30-100W for cleaning, and repeating the operation for 2-10 times to fully remove dust, rust, impurities and residual oxalic acid on the surface of the yarn; drawing the cleaned yarn into a size box filled with coating size, coating at the temperature of 30-80 ℃ at the speed of 10-50 m/s, enabling the size to permeate into the yarn by adopting one or more of single-dipping single-pressing, double-dipping double-pressing or triple-dipping triple-pressing methods, drawing the yarn into a drying oven, and drying at the temperature of 30-80 ℃;
wherein the coating slurry is a polyvinyl alcohol solution containing 1-10% by mass of glycerol;
(2) weaving of the waisted multilayer fabric: warping the yarn dried in the step (1) with the warping density of 10-300 pieces/cm; warping at a warping speed of 5-100 rpm/min, using the yarns subjected to warping processing as warp yarns, and drafting by adopting a 2-20-page palm frame according to a partition drafting method, wherein the warp yarns of the reticular structure on the outer layer penetrate in the front region, the warp yarns of the reticular structure on the middle layer penetrate in the middle region, and the warp yarns of the reticular structure on the inner layer penetrate in the rear region; the warps after drafting pass through a profiled reed plate with reed per 10cm of 30-350 respectively, and a multi-shuttle box operating system is adopted, and wefts are sequentially introduced into the warps penetrating through the profiled reed plate by using a plurality of shuttles, wherein the warps of the reticular structures of the outer layer, the middle layer and the inner layer are arranged according to the ratio of (1-5) to (1-5), and the wefts of the reticular structures of the outer layer, the middle layer and the inner layer are arranged according to the ratio of (1-5) to (1-5), so that the waisted multilayer fabric is woven; the warp density of the waisted multilayer fabric is 10-200 pieces/cm, and the weft density is 10-200 pieces/cm; the width of the waist-shrinking type multilayer fabric is 1-10 cm;
(3) preparing a bone filling pouch: rinsing the waist-shrunk multilayer fabric woven in the step (2) in deionized water at the temperature of 20-100 ℃ for 10-300 min, ultrasonically dispersing for 1-20 min by adopting an ultrasonic cleaner with the power of 20-80W, and repeating for 2-8 times to remove the slurry on the surface of the waist-shrunk multilayer fabric; soaking the waist-shrinking type multilayer fabric in a coating solution with the mass concentration of 6-8%, padding the coated fabric for 2-10 times, and finally drying and shaping at the temperature of 80-200 ℃ to obtain the bone filling bag;
wherein, the coating solution is a solution containing any one or a mixture of more of silk fibroin, collagen, chitosan or polylactic acid.
The utility model has the following beneficial effects:
the bone filling bag is of a multilayer waist-contracting type structure, so that the problem of stress concentration of a circular structure is effectively relieved, the mechanical property of the bag is improved, the leakage of a bone filling material caused by the rupture of the bag is prevented, the compression of excessive stress on peripheral non-treatment tissues is not caused, the bag is easy to take out, and the problem of difficulty in taking out the bag after operation is solved.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.
Fig. 1 is a structural view of a bone filling pouch according to example 1 of the present invention.
In the figure: 1. the first balloon 2, the waist-tightening structure 3, the second balloon 4, the eyelet 5, the bulge structure 6, the inserter connecting port 7 and the inserter pushing rod.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products commercially available.
Example 1
As shown in fig. 1, a bone-filling pouch is provided with a double-layer net structure from inside to outside, wherein each layer of net structure comprises a first balloon 1, a second balloon 3 and a waist structure 2 connecting the first balloon 1 and the second balloon 3; each layer of the net-shaped structure is provided with a plurality of holes 4, and the aperture of each hole 4 on the net-shaped structure is gradually reduced from the inner layer to the outer layer.
The aperture of the holes 4 on the net-shaped structure of the inner layer is 0.8 mm; the aperture of the eyelet 4 on the outer layer of the reticular structure is 0.05 mm; the density of the holes 4 on the net-shaped structure is 6/cm2(ii) a The radius of the cross section of the waist-tightening structure 2 is smaller than the radius of the cross sections of the first balloon 1 and the second balloon 3; the first balloon 1 or the second balloon 3 has a volume of 48cm3(ii) a The thickness of each layer of the reticular structure is 0.15 mm.
A hollow convex structure 5 is arranged at one end of the first balloon 1 far away from the waist-contracting structure 2; an introducer connecting port 6 is arranged at one end of the second balloon 3 far away from the waist-contracting structure 2, and the introducer connecting port 6 is connected to an introducer pushing rod 7; the support structure is arranged in the protruding structure 5, one end of the support structure extends from the inside of the protruding structure 5 to the insert connecting port 6, and the support structure is made of hard metal.
The preparation method of the bone filling capsular bag with the double-layer reticular structure comprises the following specific steps:
pretreatment of the yarn: drawing 30D/12F chitosan yarn into a cleaning tank filled with 10% oxalic acid solution, cleaning for 30min at 60 ℃, drawing into an ultrasonic cleaner with power of 80W, cleaning, and repeating the operation for 5 times to fully remove dust, rust, impurities and residual oxalic acid on the surface of the yarn; drawing the cleaned yarn into a size box filled with coating size, coating at the temperature of 30 ℃ at the speed of 50m/s, infiltrating the size into the yarn by adopting a three-dipping three-pressing method, drawing the yarn into a drying oven, and drying at the temperature of 30 ℃;
wherein the coating slurry is a polyvinyl alcohol solution containing glycerol with the mass concentration of 3%; the preparation method of the coating slurry comprises the following steps: dissolving 100g of polyvinyl alcohol powder in 1000mL of water to obtain a polyvinyl alcohol solution, adding 25mL of glycerol into the polyvinyl alcohol solution to ensure that the mass concentration of the glycerol in the solution is 3%, and stirring and dissolving the mixture for 3 hours to obtain coating slurry;
(2) weaving of the waisted multilayer fabric: warping the yarn dried in the step (1) with the warping density of 100 threads/cm; warping at 30rpm/min, using the processed yarn as warp, and drafting with 12-page frame in a sectional drafting method, wherein the outer layer of the mesh structure is threaded in the front region, and the inner layer of the mesh structure is threaded in the rear region; the warps after drafting pass through a profiled reed plate of 200 reed/10 cm respectively, a multi-shuttle box operating system is adopted, two shuttles are used for sequentially introducing wefts into the warps passing through the profiled reed plate, and the outer layer and the inner layer of the mesh-shaped warps are arranged according to the ratio of 1:1, arranging the weft yarns of the net structures of the outer layer and the inner layer according to a ratio of 1:1, and weaving to obtain a waist-contracting type double-layer fabric; the warp density of the waist-shrinking double-layer fabric is 100 pieces/cm, and the weft density is 80 pieces/cm; the width of the waist-shrinking type double-layer fabric is 5 cm;
(3) preparing a bone filling pouch: rinsing the waist-shrinking type double-layer fabric woven in the step (2) in deionized water at the temperature of 60 ℃ for 100min, ultrasonically dispersing for 10min by adopting an ultrasonic cleaner with the power of 60W, and repeatedly removing the serous fluid on the surface of the waist-shrinking type double-layer fabric for 5 times; soaking the waist-shrinking type double-layer fabric in a coating solution with the mass concentration of 6%, padding the coating solution for 5 times, and finally drying and shaping at the temperature of 80 ℃ to obtain a bone filling bag;
wherein the coating solution is a solution of silk fibroin, and the preparation method of the coating solution comprises the following steps: dissolving 25g of degummed silkworm fibroin fiber in 100mL of LiBr solution with the concentration of 9.3M, sealing with tinfoil paper, putting into a 60 ℃ oven for dissolving for 4 hours, taking out, putting into a dialysis bag, dialyzing for 36 hours in a water solvent, and centrifuging to obtain a supernatant, namely the fibroin protein solution.
Example 2
A bone filling bag is provided with three layers of net structures from inside to outside, wherein each layer of net structure comprises a first balloon 1, a second balloon 3 and a waist structure 2 connecting the first balloon 1 and the second balloon 3; each layer of the net-shaped structure is provided with a plurality of holes 4, and the aperture of each hole 4 on the net-shaped structure is gradually reduced from the inner layer to the outer layer.
The aperture of the hole 4 on the net-shaped structure of the inner layer is 0.1 mm; the aperture of the eyelet 4 on the outer layer of the reticular structure is 0.01mm, and the aperture of the eyelet 4 on the middle layer of the reticular structure is 0.05; the hole density of the holes 4 on the reticular structure is 10/cm2(ii) a The radius of the cross section of the waist-tightening structure 2 is smaller than the radius of the cross sections of the first balloon 1 and the second balloon 3; the first balloon 1 or the second balloon 3 has a volume of 87cm3(ii) a The thickness of each layer of the reticular structure is 0.13 mm.
A hollow convex structure 5 is arranged at one end of the first balloon 1 far away from the waist-contracting structure 2; an introducer connecting port 6 is arranged at one end of the second balloon 3 far away from the waist-contracting structure 2, and the introducer connecting port 6 is connected to an introducer pushing rod 7; the support structure is arranged in the protruding structure 5, one end of the support structure extends from the inside of the protruding structure 5 to the insert connecting port 6, and the support structure is made of hard metal.
The preparation method of the bone filling capsular bag with the three-layer reticular structure comprises the following specific steps:
(1) pretreatment of the yarn: drawing 50D/24F polyamide yarn into a cleaning tank filled with 1% sulfuric acid solution, cleaning at 60 ℃ for 10min, drawing into an ultrasonic cleaner with power of 100W, cleaning, and repeating the above operation for 2 times to fully remove dust, rust, impurities and residual oxalic acid on the surface of the yarn; drawing the cleaned yarn into a size box filled with coating size, coating at the temperature of 80 ℃ at the speed of 10m/s, penetrating the size into the yarn by adopting a double-dipping double-pressure method, drawing the yarn into a drying oven, and drying at the temperature of 80 ℃;
wherein the coating slurry is a polyvinyl alcohol solution containing 1% by mass of glycerol; the preparation method of the coating slurry comprises the following steps: dissolving 110g g polyvinyl alcohol powder in 1000mL of water to obtain a polyvinyl alcohol solution, adding 34mL of glycerol into the polyvinyl alcohol solution to ensure that the mass concentration of the glycerol in the solution is 1%, and stirring and dissolving for 3 hours to obtain coating slurry;
(2) weaving of the waisted multilayer fabric: warping the yarn dried in the step (1) with the warping density of 300 yarns/cm; warping at a warping speed of 100rpm/min, taking the finished yarns as warps, and drafting by a sectional drafting method by using a 20-page palm frame, wherein the warps of the reticular structure on the outer layer penetrate in the front region, the warps of the reticular structure on the middle layer penetrate in the middle region, and the warps of the reticular structure on the inner layer penetrate in the rear region; the warps after drafting pass through a profiled reed plate of 350 reed/10 cm respectively, and a multi-shuttle box operating system is adopted, three shuttles are used for sequentially introducing wefts into the warps penetrating through the profiled reed plate, the warps of the net-shaped structures of the outer layer, the middle layer and the inner layer are arranged according to 5:5:5, and the wefts of the net-shaped structures of the outer layer, the middle layer and the inner layer are arranged according to 5:5:5, so that a waisted three-layer fabric is obtained by weaving; the warp density of the waisted three-layer fabric is 200 pieces/cm, and the weft density is 200 pieces/cm; the width of the waist-shrinking type three-layer fabric is 10 cm;
(3) preparing a bone filling pouch: rinsing the waisted three-layer fabric woven in the step (2) in deionized water at the temperature of 20 ℃ for 300min, ultrasonically dispersing for 20min by adopting an ultrasonic cleaner with the power of 20W, and repeatedly removing the serous fluid on the surface of the waisted three-layer fabric for 8 times; soaking the waist-shrinking type three-layer fabric in a coating solution with the mass concentration of 7%, padding the coating solution for 2 times, and finally drying and shaping at the temperature of 200 ℃ to obtain a bone filling bag;
wherein the coating solution is a mixture solution containing collagen and chitosan; preparing the resulting solution; the preparation method of the coating solution comprises the following steps: weighing 4g of chitosan powder, adding the chitosan powder into 100mL of 2% acetic acid solution by volume fraction, fully stirring until the chitosan is completely dissolved, adding 3g of gelatin, and fully stirring until the gelatin is completely dissolved to obtain a coating solution with the mass concentration of 7%.
Example 3
A bone filling bag is provided with four layers of net structures from inside to outside, wherein each layer of net structure comprises a first balloon 1, a second balloon 3 and a waist structure 2 connecting the first balloon 1 and the second balloon 3; each layer of the net-shaped structure is provided with a plurality of holes 4, and the aperture of each hole 4 on the net-shaped structure is gradually reduced from the inner layer to the outer layer.
The aperture of the eyelet 4 on the reticular structure of the inner layer is 10 mm; the aperture of the eyelet 4 on the outer layer of the mesh structure is 1mm, and the aperture of the eyelet 4 on the middle layer of the mesh structure is 7mm and 4mm from inside to outside respectively; the hole density of the holes 4 on the reticular structure is 1/cm2(ii) a The radius of the cross section of the waist-tightening structure 2 is smaller than the radius of the cross sections of the first balloon 1 and the second balloon 3; the first balloon 1 or the second balloon 3 has a volume of 65cm3(ii) a The thickness of each layer of the reticular structure is 0.06 mm.
A hollow convex structure 5 is arranged at one end of the first balloon 1 far away from the waist-contracting structure 2; an introducer connecting port 6 is arranged at one end of the second balloon 3 far away from the waist-contracting structure 2, and the introducer connecting port 6 is connected to an introducer pushing rod 7; the support structure is arranged in the protruding structure 5, one end of the support structure extends from the inside of the protruding structure 5 to the insert connecting port 6, and the support structure is made of hard metal.
The preparation method of the bone filling capsular bag with the four-layer mesh structure comprises the following specific steps:
(1) pretreatment of the yarn: drawing 75D/48F polylactic acid yarn into a cleaning tank filled with a hydrochloric acid solution with the mass concentration of 5%, cleaning for 20min at the temperature of 100 ℃, drawing into an ultrasonic cleaner with the power of 30W, cleaning, and repeating the operation for 10 times to fully remove dust, rust, impurities and residual oxalic acid on the surface of the yarn; drawing the cleaned yarn into a size tank filled with coating size, coating at the temperature of 50 ℃ at the speed of 30m/s, penetrating the size into the yarn by adopting a double-dipping double-pressing and three-dipping three-pressing method, and drawing the yarn into a drying oven to be dried at the temperature of 50 ℃;
wherein the coating slurry is a polyvinyl alcohol solution containing 10% by mass of glycerol; the preparation method of the coating slurry comprises the following steps: dissolving 120g of polyvinyl alcohol powder in 1000mL of water to obtain a polyvinyl alcohol solution, adding 43mL of glycerol into the polyvinyl alcohol solution to ensure that the mass concentration of the glycerol in the solution is 10%, and stirring and dissolving for 3 hours to obtain coating slurry;
(2) weaving of the waisted multilayer fabric: warping the yarn dried in the step (1) with the warping density of 10 yarns/cm; warping at a warping speed of 5rpm/min, taking the finished yarns as warps, and drafting by adopting a 2-page palm frame according to a partition drafting method, wherein the warps of the outer-layer reticular structure penetrate in the front area, the warps of the two layers of the reticular structures in the middle layer penetrate in the middle area, and the warps of the inner-layer reticular structure penetrate in the rear area; the warps after drafting pass through a profiled reed plate with the reed/10 cm respectively, and four shuttles are adopted to introduce wefts into the warps passing through the profiled reed plate in sequence by adopting a multi-shuttle box operating system, the warps of the net-shaped structures of the outer layer, the middle layer and the inner layer are arranged according to the ratio of 5:5:5, and the wefts of the net-shaped structures of the outer layer, the middle layer and the inner layer are arranged according to the ratio of 5:5:5, so that a waisted four-layer fabric is woven; the warp density of the waist-tightening type four-layer fabric is 10 pieces/cm, and the weft density is 10 pieces/cm; the width of the waist-shrinking four-layer fabric is 1 cm;
(3) preparing a bone filling pouch: putting the waist-shrinking type four-layer fabric woven in the step (2) into deionized water, rinsing for 10min at the temperature of 100 ℃, ultrasonically dispersing for 1min by adopting an ultrasonic cleaner with the power of 80W, and repeatedly removing the serous fluid on the surface of the waist-shrinking type four-layer fabric for 2 times; soaking the waist-shrinking type four-layer fabric in a coating solution with the mass concentration of 8%, padding the coating solution for 10 times, and finally drying and shaping at the temperature of 160 ℃ to obtain a bone filling bag;
wherein the coating solution is polylactic acid solution; the preparation method of the coating solution comprises the following steps: 8g of PLLA were placed in a beaker, 1000mL of dichloromethane were added and stirring was carried out on a magnetic stirrer until complete dissolution, giving a coating solution with a mass concentration of 8%.
Test example 1 mechanical Property test
The bone filling capsules of examples 1 to 3 of the present invention and commercially available double-layered bone filling mesh bags were subjected to a performance test according to ISO 7198: 2016 using a materials testing machine (INSTRON-3365); the test results are shown in table 1:
table 1 mechanical properties test results table
Wherein, the double-layer bone filling mesh bag is a mesh bag with a circular structure obtained in common market.
As shown in the above table, the bone-filling pouch of the present invention has a radial rupture strength and a longitudinal rupture strength that are both significantly superior to those of commercially available double-layered bone-filling mesh pouches. The radial tensile breaking strength of the double-layer bone filling mesh bag in the embodiment 1 of the utility model is about 1.5 times of that of a common commercial round mesh bag, the longitudinal tensile breaking strength of the double-layer bone filling mesh bag is about 1.1 times of that of a commercial mesh bag, and the mechanical property of the mesh bag is increased along with the increase of the layer number of the mesh bag. The bone filling capsular bag effectively relieves the problem of stress concentration of a circular structure, improves the mechanical property of the capsular bag, prevents the leakage of bone filling materials caused by the rupture of the capsular bag, does not cause the compression of excessive stress on peripheral non-treatment tissues, is easy to take out, and solves the problem of difficult extraction of the postoperative capsular bag.
In conclusion, the bone filling bag is of a multilayer waist-contracting type structure, the problem of stress concentration of a circular structure is effectively relieved, the mechanical property of the bag is improved, the leakage of a bone filling material caused by the rupture of the bag is prevented, the compression of excessive stress on peripheral non-treatment tissues is avoided, the bag is easy to take out, the problem that the bag is difficult to take out after operation is solved, the pore diameter on the multilayer net structure of the bag is gradually reduced from the inner layer to the outer layer, the bone cement can be filtered layer by layer, the dispersing force and the injection force of the bone cement are improved, and the bone cement is uniformly dispersed at a designated position.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. A bone filling pocket is characterized in that the pocket is provided with a plurality of layers of net structures from inside to outside, each layer of net structure comprises a first balloon (1), a second balloon (3) and a waist structure (2) connecting the first balloon (1) and the second balloon (3);
each layer of the net-shaped structure is provided with a plurality of holes (4), and the aperture of each hole (4) on the net-shaped structure is gradually reduced from the inner layer to the outer layer.
2. The bone filling pouch of claim 1, wherein the mesh structure has 2-4 layers.
3. The bone filling pouch of claim 1, wherein each layer of the mesh structure has a thickness of 0.06-0.15 mm.
4. The bone-filling pouch according to claim 1, wherein the perforations (4) on the mesh structure of the inner layer have a pore size of 0.1-10 mm; the outer layer is on the network structure the aperture of the eyelet (4) is 0.01-1 mm.
5. The bone-filling pouch according to claim 1, wherein the mesh-like structure has perforations (4) with a hole density of 1-10/cm2。
6. The bone filling pouch according to claim 1, wherein the radius of the cross section of the waisted structure (2) is smaller than the cross section radius of the first balloon (1) and the second balloon (3).
7. A bone filling pouch according to claim 6, wherein the volume of the first balloon (1) or the second balloon (3) is 48-87 cm3。
8. A bone filling pouch according to claim 1, wherein the second balloon (3) is provided with an inserter connection port (6) at an end remote from the waisted structure (2), the inserter connection port (6) being connected to an inserter push rod (7).
9. A bone filling pouch according to claim 8, wherein the first balloon (1) is provided with a hollow convex structure (5) at an end remote from the waisted structure (2); and a supporting structure is arranged in the protruding structure (5), and one end of the supporting structure extends from the inside of the protruding structure (5) to the inserter connecting port (6).
10. The bone filling bladder according to claim 9, wherein the support structure is metal.
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| CN202122100023.8U CN216148180U (en) | 2021-09-01 | 2021-09-01 | Bone filling bag |
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| CN202122100023.8U CN216148180U (en) | 2021-09-01 | 2021-09-01 | Bone filling bag |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115068689A (en) * | 2022-06-17 | 2022-09-20 | 北京邦塞科技有限公司 | Bone filling capsular bag and preparation method and application thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115068689A (en) * | 2022-06-17 | 2022-09-20 | 北京邦塞科技有限公司 | Bone filling capsular bag and preparation method and application thereof |
| CN115068689B (en) * | 2022-06-17 | 2024-01-19 | 北京邦塞科技有限公司 | Bone filling bag, and preparation method and application thereof |
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