CN215937824U - Multilayer composite construction medicine carrying air flue support - Google Patents
Multilayer composite construction medicine carrying air flue support Download PDFInfo
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- CN215937824U CN215937824U CN202120207916.XU CN202120207916U CN215937824U CN 215937824 U CN215937824 U CN 215937824U CN 202120207916 U CN202120207916 U CN 202120207916U CN 215937824 U CN215937824 U CN 215937824U
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Abstract
The utility model relates to a multilayer composite structure drug-loaded airway stent. The multilayer composite structure drug-loaded airway stent comprises an inner layer and an outer layer, wherein the inner layer is hollow inside, the outer layer is matched with an airway, the inner layer and the outer layer are nested, the inner layer and the outer layer are attached through an embedded part, a cavity with two closed ends is formed between the inner layer and the outer layer, and a drug-loaded layer is arranged in the cavity; the outer wall of the outer layer is provided with a plurality of bulges. The drug-loaded airway stent with the multilayer composite structure provided by the utility model comprises an inner layer, an outer layer and a drug-loaded layer, has a better matching effect with an airway, and can effectively prevent the airway stent from shifting, prevent tissue infection and inhibit restenosis.
Description
Technical Field
The utility model belongs to the technical field of medical instruments, and particularly relates to a multilayer composite structure drug-loaded airway stent.
Background
Airway stenosis is a respiratory disease with over 50% of airway lumen stenosis, the clinical symptoms of the airway stenosis are usually manifested as dyspnea symptoms such as irritable cough, expectoration weakness, chest blockage and chest distress, and severe dyspnea, respiratory failure and even death can be caused when the stenosis is serious, and the life safety of patients is seriously threatened. The trachea incision, intubation or stent implantation and other methods are commonly adopted clinically to relieve the airway stenosis and save the life of a patient. The stent implantation is a minimally invasive therapy for relieving dyspnea of patients with airway stenosis, and has gradually become a preferred method for treating benign airway stenosis in recent years due to the characteristics of low requirements on cardiopulmonary functions of the patients, rapidness and effectiveness of clinical operations and the like.
The existing airway stent is of a metal stent, a film-coated metal stent, a high polymer material stent and the like. The naked metal bracket has large stimulation to the air passage, and has the defects of blood coagulation complication, unmatched flexibility, permanent retention of metal foreign bodies in the body, high incidence rate of restenosis and the like. The film-covered metal stent retains the compressible function of the metal stent, has the characteristics of film materials and can overcome the problem of restenosis of a metal bare stent. However, after the airway is covered, ciliary movement of the mucosa is inhibited, which easily causes difficulty in sputum excretion. The airway stent prepared by adopting high polymer materials such as polylactic acid, polycaprolactone, silicone and the like has the advantages of good biocompatibility, convenience in molding and processing, easiness in taking out and the like. However, the airway stent made of the above-mentioned polymer base material by the existing extrusion and molding methods has basically fixed shape and tube diameter ((e.g. CN208464356U, CN204547751U)), which cannot meet the individual requirements of different airway shapes of different patients, is easy to shift clinically, and has not ideal curative effect.
Therefore, the development of the novel airway stent which is matched with the shape of the airway of a patient, is not easy to shift and has better treatment effect has important research significance and clinical application value.
Disclosure of Invention
The utility model aims to overcome the defects or shortcomings of stent displacement, tissue infection and restenosis caused by tissue proliferation caused by mismatching of an airway stent and an airway anatomical structure in the prior art, and provides a multilayer composite structure drug-loaded airway stent. The drug-loaded airway stent with the multilayer composite structure provided by the utility model comprises an inner layer, an outer layer and a drug-loaded layer, has a better matching effect with an airway, and can effectively prevent the airway stent from shifting, prevent tissue infection and inhibit restenosis.
In order to realize the purpose of the utility model, the utility model adopts the following technical scheme:
a multilayer composite structure drug-loaded airway stent comprises an inner layer and an outer layer, wherein the inner layer is hollow inside, the outer layer is matched with an airway, the inner layer and the outer layer are nested, the inner layer and the outer layer are attached through an embedded part, a cavity with two closed ends is formed between the inner layer and the outer layer, and a drug-loaded layer is arranged in the cavity; the outer wall of the outer layer is provided with a plurality of bulges.
The outer layer is made of hydrophilic modified polyurethane.
The utility model provides a multilayer composite structure drug-loaded airway stent which comprises an inner layer, an outer layer and a drug-loaded layer; the inner layer plays a supporting role, and the inner layer is hollow, so that airway secretions can be conveniently discharged; the outer layer is matched with the air passage, and the outer wall of the outer layer is provided with a bulge, so that the displacement of the air passage support can be effectively prevented, the tissue infection can be prevented, and the restenosis can be inhibited; in addition, the bulge can construct a gap between the bracket and the airway wall, and can effectively prevent secretion retention; the drug-loaded layer is loaded with drugs to play a therapeutic role. When arranging multilayer composite construction medicine carrying air flue support in the air flue, the outer dissolves formation hole under the air flue environment and can realize the release of medicine in the medicine carrying layer, and then reaches better treatment.
The multilayer composite structure drug-loaded airway stent provided by the utility model can be obtained by printing through the following method, so that the personalized matching of the outer layer and the airway of a patient can be realized.
(1) Scanning an airway of a patient to obtain an airway image, and performing three-dimensional reconstruction to obtain an airway three-dimensional image;
(2) determining the size and the shape of the airway stent according to the airway three-dimensional image in the step (1);
(3) designing an inner layer and an outer layer respectively:
the inner layer is hollow;
the outer wall of the outer layer is provided with a bulge, and the inner wall of the outer layer is hollow; forming an internal cavity at the hollow part when the inner layer and the outer layer are nested and combined;
s4: printing an outer layer and an inner layer by using a 3D printing technology, sleeving the inner layer into the outer layer for assembly, placing a medicine serving as a medicine-carrying layer in a cavity between the inner layer and the outer layer, and then sealing two ends (for example, forming an annular part) of the outer layer and the inner layer by using hot melting to obtain the multilayer composite structure medicine-carrying air passage support; the inner wall of the outer layer is not hollowed out, and the part for sealing the end forms an embedded part.
The thickness of the inner layer can be adjusted according to the requirement of the supporting effect.
Preferably, the thickness of the inner layer is 0.6-1.0 mm.
Preferably, the inner layer is cylindrical.
Preferably, the inner wall of the inner layer is a smooth surface to facilitate discharge of airway secretions.
Preferably, the thickness of the outer layer is 0.8-1.2 mm.
Preferably, the protrusions are spike-shaped with smooth apexes.
The nail-shaped bulge can play a better role in fixing; in addition, the smooth design of the vertex can prevent the puncture of airway tissues.
More preferably, the protrusion comprises a circular truncated cone at the bottom and a hemisphere arranged on the circular truncated cone.
Further preferably, the diameter of the bottom surface of the circular truncated cone is 1.6-2.2 mm, the diameter of the top surface of the circular truncated cone is 0.6-1.2 mm, and the height of the circular truncated cone is 1.5-2.0 mm; the diameter of the hemisphere is 0.6-1.2 mm.
Preferably, the protrusion is provided on an outer wall of the outer layer corresponding to the fitting member.
The drug-loaded layer is a cavity part between the embedded piece and the inner layer and the outer layer, and the protrusion is arranged on the outer wall of the outer layer corresponding to the embedded piece, so that the outer layer is preferentially degraded in the region except the protrusion, and the release of the drug is promoted.
Preferably, the mosaic member comprises annular parts which are mosaic with two ends of the outer layer and the inner layer and a plurality of cross-shaped grids arranged at the middle sections of the outer layer and the inner layer.
More preferably, the cruciform mesh is symmetrically distributed.
More preferably, the cross-shaped meshes do not contact each other.
The design can make the cavities of the inner layer and the outer layer communicated with each other.
Preferably, the thickness of the embedded part is 0.6-1.0 mm.
Preferably, the drug of the drug-carrying layer is an anti-tumor drug, such as paclitaxel, mitomycin, and the like.
Preferably, the drug-loaded layer is a solution formulation.
The drug-loaded layer is prepared into a solution preparation, so that the problems of high temperature resistance requirement of hot-pressing film drug loading on drugs and good drug solubility requirement of dip-coating drug loading are solved.
The drugs with different dissolution characteristics can be dissolved in solvents with different attributes to achieve better dissolution and control of the release rate. For example:
the solvent selected for the fat-soluble medicine is a polymer of alpha-hydrogen-omega-hydroxyl (oxygen-1, 2-ethanediyl) with the number average molecular weight of 200-600.
The solvent used for the water-soluble drug is a polymer of alpha-hydrogen-omega-hydroxyl (oxygen-1, 2-ethanediyl) with the number average molecular weight of 400-800.
Preferably, the hydrophilic modified polyurethane comprises the following components in parts by weight:
75-98 parts of TPU (thermoplastic polyurethane),
2-25 parts of hydrophilic modifier.
A certain amount of hydrophilic modifier is added to modify polyurethane (TPU), and the hydrophilic modifier is gradually dissolved in an airway environment, so that pores are formed on the outer layer, the release of the medicine in the medicine carrying layer is realized, and a better treatment effect is achieved.
More preferably, the hydrophilic modified polyurethane comprises the following components in parts by weight:
86-92 parts of TPU (thermoplastic polyurethane),
8-14 parts of hydrophilic modifier.
The number and size of the pores can be adjusted according to the dosage of the hydrophilic modifier so as to realize the drug release rate under different requirements.
For the outer layer printing the selected material:
preferably, the TPU has a melt flow index of 5-10 g/10min (test condition: 210 ℃/2.16KG) and a hardness of 30-40D. Further preferably medical grade.
Preferably, the hydrophilic modifier is one or both, preferably both, of an alpha-hydro-omega-hydroxy (oxy-1, 2-ethanediyl) polymer or a (propylene oxide-ethylene oxide) copolymer.
More preferably, the polymer of the α -hydro- ω -hydroxy (oxy-1, 2-ethanediyl) group has a molecular weight of 1000 to 10000.
More preferably, the molecular weight of the (propylene oxide-ethylene oxide) copolymer is 500 to 5000, and the HLB is 15 to 30.
More preferably, the hydrophilic modified polyurethane comprises the following components in parts by weight:
75-98 parts of TPU (thermoplastic polyurethane),
0 to 2 parts of an alpha-hydro-omega-hydroxy (oxy-1, 2-ethanediyl) polymer,
2-13 parts of (propylene oxide-ethylene oxide) copolymer.
The hydrophilic modified polyurethane is prepared by the following method: and mixing the TPU and the hydrophilic modifier, melting, extruding and granulating to obtain the hydrophilic modified polyurethane.
Specifically, TPU and a hydrophilic modifier are mixed uniformly in advance to obtain a premix; melting the mixture and extruding for granulation, wherein the conditions are as follows: melting, mixing and granulating (for example, granulating into 3D printing standard wire rod with the diameter of 1.75 +/-5 mm) at the temperature of 190-220 ℃ and the rotating speed of 200-500 rpm by a double-screw extruder.
The material selected for the middle layer and the inner layer can be the existing conventional 3D printing material.
Compared with the prior art, the utility model has the following beneficial effects:
the multilayer composite structure drug-loaded airway stent provided by the utility model comprises an inner layer and an outer layer, wherein the inner layer is a three-layer composite structure of a drug-loaded layer, and the multilayer composite structure drug-loaded airway stent has a better matching effect with an airway, and can effectively prevent the displacement of the airway stent, prevent tissue infection and inhibit restenosis.
Drawings
Fig. 1 is a schematic structural diagram of a multilayer composite structure drug-loaded airway stent provided in example 1;
fig. 2 is a schematic structural diagram of a cross-shaped grid in a mosaic in a multilayer composite structure drug-loaded airway stent provided in example 1;
fig. 3 is a schematic structural diagram of a bulge in a multilayer composite structure drug-loaded airway stent provided in example 1;
fig. 4 is a flowchart of the preparation of the multilayer composite structure drug-loaded airway stent provided in example 1;
fig. 5 is a design drawing of the inner layer of the multilayer composite structure drug-loaded airway stent provided in example 1;
fig. 6 is a design drawing of a cross-shaped grid of a multilayer composite structure drug-loaded airway stent provided by an embodiment;
fig. 7 is a design drawing of an outer layer and protrusions of a multilayer composite structure drug-loaded airway stent provided by an embodiment;
wherein, 1 is a bulge, 101 is a hemisphere, and 102 is a circular truncated cone; 2 is an outer layer; 3 is a medicine carrying layer, 4 is an inner layer, 5 is an embedded part, 501 is an annular part, and 502 is a cross-shaped grid.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the utility model and are not intended to limit the utility model. In addition, the technical features involved in the embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.
It will be understood that when an element is referred to as being "on" or "mounted on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The use of the terms "upper", "lower", "left", "right" and the like in the present invention is for illustrative purposes only and does not mean that the embodiments are unique.
Example 1
As shown in fig. 1, the present embodiment provides a drug-loaded airway stent with a multilayer composite structure, which includes an inner layer 4, an outer layer 2, a drug-loaded layer 3, a protrusion 1 and a fitting part 5.
The inner layer 4 is a cylinder with a hollow inner part, and the inner wall is a smooth surface, the thickness of the inner layer 4 can be 0.6-1.0 mm, in this embodiment, the thickness of the inner layer is 0.8 mm.
The outer wall and the air flue phase-match of outer 2, its thickness can be 0.8 ~ 1.2mm, and in this embodiment, the thickness of outer 2 is 1.0 mm.
The outer layer 2 is nested outside the inner layer 4 and is jointed by the embedded piece 5. The thickness of the fitting 5 may be 0.6 to 1.0mm, and in the present embodiment, 0.8 mm. Specifically, as shown in fig. 2, the fitting member 5 includes annular portions 501 at both ends and a plurality of cross-shaped grids 502 which are symmetrically distributed and do not contact each other at the middle section; the inner wall and the outer wall of the annular part 501 are respectively attached to the inner layer 4 and the inner layer 2, so that a cavity with two closed ends and communicated with the inner layer 4 and the outer layer 2 is formed between the inner layer 4 and the outer layer 2, and the drug-loaded layer 3 is arranged in the cavity.
The outer wall of the outer layer 2 corresponding to the center of the cross-shaped grid is provided with a nail-shaped bulge (as shown in fig. 3) with a smooth peak, specifically, the bulge comprises a round table 102 at the bottom and a hemisphere 101 arranged on the round table, the diameter of the bottom surface of the round table 102 can be 1.6-2.2 mm, the diameter of the top surface can be 0.6-1.2 mm, and the height can be 1.5-2.0 mm; the diameter of the hemisphere 101 can be 0.6-1.2 mm; in the embodiment, the diameter of the bottom surface of the circular truncated cone 102 is 2mm, the diameter of the top surface is 1.0mm, and the height is 2 mm; the diameter of the hemisphere 101 is 1.0 mm.
This multilayer composite construction medicine carrying air flue support can realize better individualized matching with patient's air flue through 3D printing technique, and the specific process is as follows (as figure 4):
(1) scanning an airway of a patient to obtain an airway image, and performing three-dimensional reconstruction to obtain an airway three-dimensional image;
(2) determining the size and the shape of the airway stent according to the airway three-dimensional image in the step (1);
(3) designing an inner layer and an outer layer respectively:
the inner layer is hollow (as shown in figure 5);
the outer wall of the outer layer is provided with bulges (as shown in figure 7), and the inner wall is hollowed out to obtain a cross-shaped grid (as shown in figure 6); forming an internal cavity at the hollow part when the inner layer and the outer layer are nested and combined;
(4) printing an outer layer and an inner layer by using a 3D printing technology, sleeving the inner layer into the outer layer for assembly, placing a medicine serving as a medicine-carrying layer in a cavity between the inner layer and the outer layer, and then sealing two ends of the outer layer and the inner layer by using hot melting to form annular parts to obtain the multilayer composite structure medicine-carrying air passage support; the inner wall of the outer layer is not hollowed out, and the part for sealing the end forms an embedded part.
Specifically, the formula of the hydrophilic modified polyurethane material selected for 3D printing is as follows: TPU 40D (MI ═ 10) 86 parts, and (propylene oxide-ethylene oxide) copolymer (Mn ═ 5000, HLB ═ 25)6 parts.
The hydrophilic modified polyurethane is prepared by the following method: the medical TPU and the (epoxypropane-epoxyethane) copolymer are uniformly mixed in advance to obtain a premix, and the premix is melted, mixed and granulated by a double-screw extruder at the temperature of 210 ℃ and the rotating speed of 300rpm to prepare the hydrophilic modified polyurethane.
According to the multilayer composite structure drug-loaded airway stent provided by the embodiment, the inner layer 4 plays a supporting role, so that stent collapse caused by insufficient structural strength of the drug-loaded layer 3 is prevented; and the smooth inner surface of the inner layer is convenient for discharging airway secretion, and the problems of inflammation and the like caused by secretion retention are avoided.
The drug-loaded layer 3 can be loaded with various drugs, and the clinical treatment requirements are met through the controllable release of the drugs.
The shape and the size of outer 2 and air flue have better matching degree, and outer 2 gradually dissolves under the air flue environment and forms tiny hole and then realizes the controllable release of the medicine in medicine-carrying layer 3.
The bulge 1 and the outer layer 2 are combined to realize better fixation of the airway stent, effectively prevent the displacement of the airway stent, prevent tissue infection and inhibit restenosis; in addition, the bulge 1 can construct a gap between the airway stent and the airway wall, and can effectively prevent secretion retention.
Taking a loaded paclitaxel solution as an example, the performance of the loaded paclitaxel solution is tested, and specifically, the drug solution is prepared by the following method: the drug paclitaxel 10mg was weighed out accurately and dissolved in a solvent α -hydro- ω -hydroxy (oxy-1, 2-ethanediyl) polymer (Mn ═ 200) (mL).
The following performance tests were performed on the airway stent: radial compressive force, compressive strength, drug sustained release time, and average rate of drug release, etc.
The radial compression force and the compressive strength are tested by an electronic universal testing machine according to the method described in GB/T1041-2008 standard. The diameter was laid flat in the middle of a compression die, pressure was applied in the diameter direction, and the maximum force and compressive strength at a diameter compressive strain of 30% were tested.
The drug release rate was determined using a High Performance Liquid Chromatography (HPLC) system consisting of a binary pump, 1290 sample injector, temperature control module, and 1290DAD detector. The chromatographic column is an Agilent ODS C18 column (particle size 5mm, 4.6 mm. times.250 mm), the detection wavelength is 227nm, the data processing software is chemstation for LC 3D system, the mobile phase is acetonitrile: the flow rate was 1mL/min and the amount of water was 20. mu.l at 60: 40. All samples were filtered using a 0.45 μm PTFE filter head before injection.
Establishment of a standard curve: PTX 2.5mg is precisely weighed and placed in a 25mL volumetric flask, and the volume is determined after 60 percent acetonitrile is dissolved, so as to obtain paclitaxel solution with the concentration of 100 mu g/mL as mother solution. And then diluted to 0.1, 0.2, 0.5, 1,2, 5, 10, 20 and 50. mu.g/mL, respectively, as standard solutions. And (3) injecting the standard solution and the mother solution according to the HPLC method, measuring peak areas of the standard solution and the mother solution, and drawing a regression curve of the concentration C by using the peak area A to obtain a regression equation.
In vitro drug release testing of drug-loaded scaffolds: the scaffolds were placed in 50mL centrifuge tubes with caps and 40mL of 1% SDS-containing PBS (pH 7.4) solution was added to simulate an in vivo liquid environment. The tube was placed in a constant temperature shaking bath and shaken continuously at a constant temperature of 37 ℃ and a speed of 70 r/min. And when a certain time point is reached, taking out the centrifugal tube, taking out the bracket, sucking the surface residual solution by using filter paper, placing the filter paper into a fresh 40ml PBS solution, and then returning to the shaking pool for continuous release.
The concentration of PTX in the released solution taken out was determined by the HPLC method described above: 1mL of the released solution is diluted by one time by adding 1mL of acetonitrile, shaken uniformly, filtered by a 0.45 mu m filter membrane and injected.
The daily release amount of the drug was continuously measured, and the number of days (D) for which continuous maintenance was 0.5% or more was calculated, and the cumulative release amount of the drug was divided by the number of days to obtain the average release amount.
The radial compressive force of the airway stent is 160.4N, the compressive strength is 1.36MPa, the compressive modulus is 5.92MPa, the sustained release days of the drug are 83 days, and the daily average release rate is 0.92%.
The above embodiments are preferred embodiments of the present invention, but the present invention is not limited to the above embodiments, and any other changes, modifications, substitutions, combinations, and simplifications which do not depart from the spirit and principle of the present invention should be construed as equivalents thereof, and all such changes, modifications, substitutions, combinations, and simplifications are intended to be included in the scope of the present invention.
Claims (10)
1. The multilayer composite structure medicine-carrying airway stent is characterized by comprising an inner layer (4) and an outer layer (2), wherein the inner layer (4) is hollow inside, the outer layer (2) is matched with an airway, the inner layer (4) and the outer layer (2) are nested, the inner layer (4) and the outer layer (2) are attached through an embedded part (5), a cavity with two closed ends is formed between the inner layer (4) and the outer layer (2), and a medicine-carrying layer (3) is arranged in the cavity; the outer wall of the outer layer (2) is provided with a plurality of bulges (1).
2. The multilayer composite structure drug-loaded airway stent of claim 1, characterized in that the thickness of the inner layer (4) is 0.6-1.0 mm; the inner layer (4) is cylindrical; the inner wall of the inner layer (4) is a smooth surface.
3. The multilayer composite structure drug-loaded airway stent according to claim 1, characterized in that the outer layer (2) is obtained by 3D printing; the thickness of the outer layer (2) is 0.8-1.2 mm; the outer layer (2) is made of hydrophilic modified polyurethane.
4. The multilayer composite structure drug-loaded airway stent according to claim 1, characterized in that the protrusions (1) are in the shape of smooth-topped spikes.
5. The multilayer composite structure drug-loaded airway stent of claim 4, characterized in that the bulge (1) comprises a truncated cone (102) at the bottom and a hemisphere (101) arranged on the truncated cone.
6. The multilayer composite structure medicine-carrying airway stent of claim 5, characterized in that the diameter of the bottom surface of the circular truncated cone (102) is 1.6-2.2 mm, the diameter of the top surface is 0.6-1.2 mm, and the height is 1.5-2.0 mm; the diameter of the hemisphere (101) is 0.6-1.2 mm.
7. The multilayer composite structure drug-loaded airway stent as in claim 1, wherein the protrusions (1) are arranged on the outer wall of the outer layer (2) corresponding to the embedded part (5).
8. The multilayer composite structure drug-loaded airway stent of claim 1, wherein the embedded piece (5) comprises an annular part (501) embedded with the two ends of the outer layer (2) and the inner layer (4) and a plurality of cross-shaped grids (502) arranged in the middle section of the outer layer (2) and the inner layer (4).
9. The multilayer composite structure drug-loaded airway stent of claim 8, wherein the cross-shaped grid (502) is symmetrically distributed.
10. The multilayer composite structure drug-loaded airway stent of claim 1, wherein the thickness of the embedded part (5) is 0.6-1.0 mm.
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Effective date of registration: 20220727 Address after: 510000 unit 202-39, 2nd floor, No. 6, helix Third Road, Guangzhou International Biological Island, Huangpu District, Guangzhou, Guangdong Province (office only) Patentee after: Guangzhou Ruikang Medical Technology Co.,Ltd. Address before: 511436 Xinzao Road, Xinzao Town, Panyu District, Guangzhou City, Guangdong Province Patentee before: GUANGZHOU MEDICAL University Patentee before: Guangzhou Ruikang Medical Technology Co.,Ltd. |
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