Disclosure of Invention
The application provides an implanted flexible magnetic response artificial bladder matrix and a manufacturing method thereof, and solves or partially solves the technical problems that in the prior art, the hydraulic pressure provided by an artificial detrusor is limited, is far from the level of human muscles, is lack of practical medical design and optimization of biological safety, and cannot realize reliable long-term functions; the matrix can be made into an implanted flexible magnetic response artificial bladder, benefits from an actuation source of high coercive force and distribution of permanent magnetic particles in a ferromagnetic complex, shows reliable actuation by ferromagnetism, and simultaneously outputs a large amount of magnetic force to play a role of an artificial detrusor to squeeze and empty the bladder.
The application provides an implanted flexible magnetic response artificial bladder base, which comprises: the flexible non-magnetic substrate comprises a flexible non-magnetic substrate and a ferromagnetic complex bonded with the flexible non-magnetic substrate; the flexible non-magnetic substrate comprises the following components: the silicone rubber and the polydimethylsiloxane resin are mixed according to a volume ratio of (4-10): 1; the ferromagnetic composite comprises the following components: the magnetic particle comprises organic silica gel, polydimethylsiloxane resin and magnetic particles, wherein the volume ratio of the organic silica gel to the polydimethylsiloxane resin is (4-10): 1, the volume fraction of the magnetic particles in the ferromagnetic composite body is 20-40%.
Preferably, the magnetic particles are any one or combination of more of NdFeB, Fe and FeC; the magnetic particles are uniformly magnetized.
Preferably, the magnetic particles are NdFeB and have an average particle size of 5 μm.
Preferably, the flexible non-magnetic matrix is integrated with the ferromagnetic composite body through curing and bonding after being subjected to hot melting; the magnetic particles of the ferromagnetic composite body are uniformly magnetized in a pulsed magnetic field with a magnetic induction intensity of 3.0T.
Based on the same invention creation, the application also provides a manufacturing method of the implanted flexible magnetic response artificial bladder matrix, which comprises the following steps:
uniformly mixing the organic silica gel and the polydimethylsiloxane resin according to a set volume ratio to form an uncured matrix composite sizing material;
adding the magnetic particles with a set volume fraction into the uncured matrix composite sizing material, and uniformly mixing to form an uncured ferromagnetic composite;
adding a platinum-containing curing agent into the uncured ferromagnetic composite, uniformly stirring, and curing to obtain a ferromagnetic composite;
uniformly magnetizing the magnetic particles in the ferromagnetic composite to obtain the ferromagnetic composite;
uniformly mixing the organic silica gel and the polydimethylsiloxane resin according to a set volume ratio to obtain a flexible non-magnetic matrix solution;
and mixing the flexible non-magnetic matrix solution with the ferromagnetic complex, and then curing to obtain the implanted flexible magnetic response artificial bladder matrix.
Preferably, when the uncured matrix composite sizing material is formed, the organic silica gel and the polydimethylsiloxane resin are mixed through a planetary mixer, the rotating speed is controlled to be 800-1500 rpm, and the mixing time is controlled to be 2-5 min.
Preferably, the magnetic particles and the uncured matrix composite sizing material are mixed through a vibration mixer, and the mixing time is controlled to be 2-10 min.
Preferably, the platinum-containing curing agent accounts for 5.0-10.3% of the weight of the uncured ferromagnetic composite; the platinum-containing curing agent is added into the uncured ferromagnetic compound and then stirred for 5-20 min; the temperature in the curing process is controlled to be 35-50 ℃, and the time is controlled to be 2-24 hours.
Preferably, the flexible non-magnetic matrix solution is mixed with the ferromagnetic complex in an injection molding mode and then is solidified, and the time of the injection molding process is controlled within 30 min; and when the flexible non-magnetic matrix solution and the ferromagnetic complex are solidified, controlling the temperature to be 35-50 ℃ and the time to be 2-24 h.
Preferably, after the ferromagnetic composite body is prepared, the method further comprises the following steps:
washing the ferromagnetic composite body by ethanol and isopropanol, and drying in a nitrogen flow environment;
mixing organic silica gel with a set volume ratio with a brightening agent to obtain an organic silica gel solution;
and uniformly spraying the organic silica gel solution on the surface of the ferromagnetic complex, and gelling to form a silica gel skin layer.
One or more technical solutions provided in the embodiments of the present application have at least the following technical effects or advantages:
the implantable flexible magnetic response artificial bladder substrate is used for manufacturing a flexible magnetic response bladder pump, and can play a role of an artificial detrusor through a ferromagnetic complex consisting of organic silica gel, polydimethylsiloxane resin and magnetic particles, so that the flexible magnetic response bladder pump can perform contact extrusion to empty a bladder; the ferromagnetic complexes are arranged in a flexible non-magnetic matrix frame conformal to the filled bladder to form a flexible magnetically responsive bladder pump, each magnetic particle is uniformly magnetized to press the filled bladder under a gradient magnetic field generated by a permanent magnet to resist the resistance of the sphincter and thereby reestablish the voiding function of the disabled bladder, and the ferromagnetic complexes have a higher modulus and a higher density than natural human organs. The flexible non-magnetic matrix bonded with the ferromagnetic complex consists of organic silica gel, polydimethylsiloxane resin and a brightening agent, so that the flexible non-magnetic matrix has good biocompatibility.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
The application provides an implanted flexible magnetic response artificial bladder base, which comprises: a flexible non-magnetic base body and a ferromagnetic complex bonded with the flexible non-magnetic base body; the flexible non-magnetic matrix comprises the following components: the silicone rubber and the polydimethylsiloxane resin are mixed according to a volume ratio of (4-10): 1; the ferromagnetic composite comprises the following components: the magnetic particle comprises organic silica gel, polydimethylsiloxane resin and magnetic particles, wherein the volume ratio of the organic silica gel to the polydimethylsiloxane resin is (4-10): 1, the volume fraction of the magnetic particles in the ferromagnetic composite body is 20-40%.
Furthermore, the organic silica gel of the flexible non-magnetic matrix and the organic silica gel of the ferromagnetic complex are platinum-based cured silica gel Ecoflex 00-30 which is a two-component material, and the volume ratio of the component A to the component B of the platinum-based cured silica gel Ecoflex 00-30 is 1: 1. The polydimethylsiloxane resin (PDMS resin) was model number Sylgard 184.
The magnetic particles are any one or combination of more of NdFeB, Fe and FeC; the magnetic particles are uniformly magnetized. As a preferred embodiment, the magnetic particles are NdFeB with an average particle size of 5 μm.
Furthermore, the flexible non-magnetic matrix is integrated with the ferromagnetic complex through solidification and bonding after being melted; the magnetic particles of the ferromagnetic composite bodies are uniformly magnetized in a pulsed magnetic field having a magnetic induction of 3.0T.
Based on the same invention creation, referring to the attached figure 1, the application also provides a manufacturing method of the implanted flexible magnetic response artificial bladder matrix, which comprises the following steps:
s1: uniformly mixing organic silica gel and polydimethylsiloxane resin according to a set volume ratio to form an uncured matrix composite sizing material;
s2: adding the magnetic particles with the set volume fraction into the uncured matrix composite sizing material, and uniformly mixing to form an uncured ferromagnetic composite;
s3: adding a platinum-containing curing agent into the uncured ferromagnetic composite, uniformly stirring, and curing to obtain a ferromagnetic composite;
s4: uniformly magnetizing the magnetic particles in the ferromagnetic composite to obtain a ferromagnetic composite;
s5: uniformly mixing organic silica gel and polydimethylsiloxane resin according to a set volume ratio to obtain a flexible non-magnetic matrix solution;
s6: and mixing the flexible non-magnetic matrix solution and the ferromagnetic complex, and then curing to prepare the implanted flexible magnetic response artificial bladder matrix.
Further, when the uncured matrix composite sizing material is formed, the organic silica gel and the polydimethylsiloxane resin are mixed through a planetary mixer, the rotating speed is controlled to be 800-1500 rpm, and the mixing time is controlled to be 2-5 min. And mixing the magnetic particles and the uncured matrix composite sizing material through a vibration mixer, wherein the mixing time is controlled to be 2-10 min.
The platinum-containing curing agent accounts for 5.0 to 10.3 percent of the weight of the uncured ferromagnetic composite; the time for stirring after adding the platinum-containing curing agent into the uncured ferromagnetic compound is controlled to be 5-20 min; the temperature in the curing process is controlled to be 35-50 ℃, and the time is controlled to be 2-24 hours.
Further, the flexible non-magnetic matrix solution is mixed with the ferromagnetic complex in an injection molding mode and then is solidified, and the time of the injection molding process is controlled within 30min so as to avoid local solidification of the flexible non-magnetic matrix. When the flexible non-magnetic matrix solution and the ferromagnetic complex are solidified, the temperature is controlled to be 35-50 ℃, and the time is controlled to be 2-24 hours.
Further, after the ferromagnetic composite body is prepared, the method further comprises the following steps: washing the ferromagnetic complex by ethanol and isopropanol, and drying in a nitrogen flow environment; mixing organic silica gel (specifically, Ecoflex 00-30 (part A: part B: 1)) and a brightening agent by a centrifugal machine, and controlling the rotating speed to be 800-1500 rpm; the volume ratio of the organic silica gel to the brightening agent is 1.5: 1; and uniformly spraying the organic silica gel solution on the surface of the ferromagnetic complex by a spray gun with an air pump, and then gelling to form a silica gel layer, wherein in the gelling process of the silica gel layer, the temperature is controlled to be 35-50 ℃, and the time is controlled to be 1-3 hours. The design of silica gel cortex is on the one hand in order to prevent the leakage of magnetic particle, and on the other hand is the convenience and the bonding of flexible no magnetism base member.
The preparation method of the implanted flexible magnetic response artificial bladder matrix is described in detail by the following specific embodiments:
example 1
Two silicone based materials Ecoflex 00-30(Smooth-on Inc) were first mixed with a PDMS resin (Sylgard 184, Dow Corning) by using a planetary mixer at a ratio of 5:1, preparing an uncured matrix composite sizing material, and continuously rotating at 800rpm for 2min and removing bubbles for 1 min. For the Ecoflex 00-30 component, the volume ratio of part a and part B is 1: 1.
the uncured ferromagnetic composite was prepared by uniformly mixing 25 volume percent NdFeB particles having an average particle size of 5 μm with the uncured matrix composite gum material on a 10-speed gear for 2min with a vibratory mixer, and defoaming for 1 min.
5.5 wt% of platinum-containing curing agent is added into the uncured ferromagnetic composite, and the mixture is uniformly stirred and cured, wherein the operations are completed within 30 min. And curing for 4 hours at the temperature of 40 ℃ to obtain the ferromagnetic composite. The magnetic particles in the ferromagnetic compound are uniformly magnetized in a pulse magnetic field (about 3.0T) generated by a pulse excitation coil with the diameter of 180mm and powered by a high-power supply (above 7000V) to prepare the ferromagnetic compound.
Washing the ferromagnetic complex by ethanol and isopropanol, and drying in a nitrogen flow environment; mixing Ecoflex 00-30 (part A: part B: 1) and a brightener by a centrifuge at 800 rpm; the volume ratio of Ecoflex 00-30 to the brightener is 1.5: 1; uniformly spraying the organic silica gel solution on the surface of the ferromagnetic complex by a spray gun with an air pump, and gelling to form a silica gel skin layer; and in the gelling process of the silica gel skin layer, the temperature is controlled to be 38 ℃, and the time is controlled to be 1.5 h.
A flexible non-magnetic matrix solution was then prepared by uniformly mixing Ecoflex 00-30(Smooth-on Inc) and PDMS resin (Sylgard 184, Dow Corning) using a planetary mixer, the volume ratio of Ecoflex 00-30 to PDMS resin being 4.5: 1, planetary mixer at 800rpm for 2min, debubbling for 1 min. For the Ecoflex 00-30 component, the volume ratio of part a and part B is 1: 1.
finally, mixing the flexible non-magnetic matrix solution with the ferromagnetic complex in an injection molding mode and then curing to prepare the implanted flexible magnetic response artificial bladder matrix; the time of the injection molding process is controlled to be 30min, and the temperature is controlled to be 38 ℃ and the time is controlled to be 5h when the curing is carried out.
Example 2
Two silicone based materials Ecoflex 00-30(Smooth-on Inc) were first mixed with a PDMS resin (Sylgard 184, Dow Corning) by using a planetary mixer at a ratio of 6: 1, preparing an uncured matrix composite sizing material, and continuously rotating at 800rpm for 3min to remove bubbles for 1 min. For the Ecoflex 00-30 component, the volume ratio of part a and part B is 1: 1.
the uncured ferromagnetic composite was prepared by uniformly mixing 30 volume percent NdFeB fine particles having an average particle size of 5 μm with an uncured matrix composite gum material on a 10-speed gear for 4min by a vibratory mixer, and defoaming for 1 min.
7.85 wt% of platinum-containing curing agent is added into the uncured ferromagnetic composite, and the mixture is uniformly stirred and cured, wherein the operations are completed within 30 min. And curing for 10 hours at 40 ℃ to obtain the ferromagnetic composite. The magnetic particles in the ferromagnetic compound are uniformly magnetized in a pulse magnetic field (about 3.0T) generated by a pulse excitation coil with the diameter of 180mm and powered by a high-power supply (above 7000V) to prepare the ferromagnetic compound.
Washing the ferromagnetic matrix by ethanol and isopropanol, and drying in a nitrogen flow environment; mixing Ecoflex 00-30 (part A: part B: 1) and a brightener by a centrifuge at 800 rpm; the volume ratio of Ecoflex 00-30 to the brightener is 1.5: 1; uniformly spraying the organic silica gel solution on the surface of the ferromagnetic complex by a spray gun with an air pump, and gelling to form a silica gel skin layer; in the gelling process of the silica gel skin layer, the temperature is controlled to be 40 ℃, and the time is controlled to be 2 hours.
Then a flexible non-magnetic matrix solution was prepared by uniformly mixing Ecoflex 00-30(Smooth-on Inc) and PDMS resin (Sylgard 184, Dow Corning) using a planetary mixer, the volume ratio of Ecoflex 00-30 to PDMS resin being 5.5: 1, planetary mixer at 800rpm for 2min, debubbling for 1 min. For the Ecoflex 00-30 component, the volume ratio of part a and part B is 1: 1.
finally, mixing the flexible non-magnetic matrix solution with the ferromagnetic complex in an injection molding mode and then curing to prepare the implanted flexible magnetic response artificial bladder matrix; the time of the injection molding process is controlled to be 20min, and the temperature is controlled to be 40 ℃ and the time is controlled to be 12h when the curing is carried out.
Example 3
Two silicone-based materials Ecoflex 00-30(Smooth-on Inc) and PDMS resin (Sylgard 184, Dow Corning) were first mixed by using a planetary mixer at 9: 1, preparing an uncured matrix composite sizing material, and continuously rotating at 1200rpm for 3min to remove bubbles for 1 min. For the Ecoflex 00-30 component, the volume ratio of part a and part B is 1: 1.
the uncured ferromagnetic composite was prepared by uniformly mixing 40 volume percent NdFeB fine particles having an average particle size of 5 μm with the uncured matrix composite gum material on a 10-speed gear for 6min by a vibratory mixer, and defoaming for 1 min.
9.09 wt% of platinum-containing curing agent is added into the uncured ferromagnetic composite, and the mixture is uniformly stirred and cured within 30 min. And curing for 20h at 42 ℃ to obtain the ferromagnetic composite. The magnetic particles in the ferromagnetic compound are uniformly magnetized in a pulse magnetic field (about 3.0T) generated by a pulse excitation coil with the diameter of 180mm and powered by a high-power supply (above 7000V) to prepare the ferromagnetic compound.
Washing the ferromagnetic matrix by ethanol and isopropanol, and drying in a nitrogen flow environment; mixing Ecoflex 00-30 (part A: part B: 1) and a brightener by a centrifuge at 1200 rpm; the volume ratio of Ecoflex 00-30 to the brightener is 1.5: 1; uniformly spraying the organic silica gel solution on the surface of the ferromagnetic complex by a spray gun with an air pump, and gelling to form a silica gel skin layer; in the gelling process of the silica gel skin layer, the temperature is controlled to be 42 ℃, and the time is controlled to be 2 hours.
Then a flexible non-magnetic matrix solution was prepared by uniformly mixing Ecoflex 00-30(Smooth-on Inc) and PDMS resin (Sylgard 184, Dow Corning) using a planetary mixer, the volume ratio of Ecoflex 00-30 to PDMS resin being 1.5:1, planetary mixer at 1200rpm for 2min, debubbling for 1 min. For the Ecoflex 00-30 component, the volume ratio of part a and part B is 1: 1.
finally, mixing the flexible non-magnetic matrix solution with the ferromagnetic complex in an injection molding mode and then curing to prepare the implanted flexible magnetic response artificial bladder matrix; the time of the injection molding process is controlled to be 22min, and the temperature is controlled to be 40 ℃ and the time is controlled to be 20h when the curing is carried out.
Example 4
Two silicone based materials Ecoflex 00-30(Smooth-on Inc) were first mixed with a PDMS resin (Sylgard 184, Dow Corning) by using a planetary mixer at a ratio of 9.5: 1, preparing an uncured matrix composite sizing material, and continuously rotating at 1500rpm for 4.5min and removing bubbles for 1 min. For the Ecoflex 00-30 component, the volume ratio of part a and part B is 1: 1.
the uncured ferromagnetic composite was prepared by uniformly mixing 40 volume percent NdFeB fine particles having an average particle size of 5 μm with an uncured matrix composite gum material on a 10-speed gear for 5min by a vibratory mixer, and defoaming for 1 min.
Adding 10.1 wt% of platinum-containing curing agent into the uncured ferromagnetic composite, uniformly stirring, and curing within 30 min. And curing for 20 hours at the temperature of 45 ℃ to obtain the ferromagnetic composite. The magnetic particles in the ferromagnetic compound are uniformly magnetized in a pulse magnetic field (about 3.0T) generated by a pulse excitation coil with the diameter of 180mm and powered by a high-power supply (above 7000V) to prepare the ferromagnetic compound.
Washing the ferromagnetic matrix by ethanol and isopropanol, and drying in a nitrogen flow environment; mixing Ecoflex 00-30 (part A: part B: 1) and a brightener by a centrifuge at 1500 rpm; the volume ratio of Ecoflex 00-30 to the brightener is 1.5: 1; uniformly spraying the organic silica gel solution on the surface of the ferromagnetic complex by a spray gun with an air pump, and gelling to form a silica gel skin layer; in the gelling process of the silica gel skin layer, the temperature is controlled to be 45 ℃ and the time is controlled to be 2.5 h.
A flexible non-magnetic matrix solution was then prepared by uniformly mixing Ecoflex 00-30(Smooth-on Inc) and PDMS resin (Sylgard 184, Dow Corning) using a planetary mixer, the volume ratio of Ecoflex 00-30 to PDMS resin being 9: 1, planetary mixer at 1500rpm for 2min, defoaming for 1 min. For the Ecoflex 00-30 component, the volume ratio of part a and part B is 1: 1.
finally, mixing the flexible non-magnetic matrix solution with the ferromagnetic complex in an injection molding mode and then curing to prepare the implanted flexible magnetic response artificial bladder matrix; the time of the injection molding process is controlled to be 25min, and the temperature is controlled to be 42 ℃ and the time is controlled to be 24h when the curing is carried out.
The implanted flexible magnetic response artificial bladder matrix is used for manufacturing a flexible magnetic response bladder pump, and can play a role of an artificial detrusor through a ferromagnetic complex consisting of organic silica gel, polydimethylsiloxane resin and magnetic particles, so that the flexible magnetic response bladder pump can perform contact extrusion to empty the bladder; the ferromagnetic complex is arranged in a flexible non-magnetic matrix frame conformal to the filled bladder to form a flexible magnetic response bladder pump, the flexible magnetic response bladder pump is integrally sleeved on the disabled bladder, each magnetic particle is uniformly magnetized, and the filled bladder is pressed under a gradient magnetic field generated by a permanent magnet to resist the resistance of a sphincter, so that the urination function of the disabled bladder is reconstructed, and compared with natural human organs, the ferromagnetic complex has higher modulus and higher density. The flexible non-magnetic matrix bonded with the ferromagnetic complex consists of organic silica gel, polydimethylsiloxane resin and a brightening agent, so that the flexible non-magnetic matrix has good biocompatibility.
The above-mentioned embodiments, objects, technical solutions and advantages of the present invention are further described in detail, it should be understood that the above-mentioned embodiments are only illustrative of the present invention and are not intended to limit the present invention, and any modifications, equivalents, improvements and the like made within the spirit and principle of the present invention should be included in the protection scope of the present invention.