CN112972779A - Implanted flexible magnetic response artificial bladder matrix and manufacturing method thereof - Google Patents

Implanted flexible magnetic response artificial bladder matrix and manufacturing method thereof Download PDF

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CN112972779A
CN112972779A CN202110164842.0A CN202110164842A CN112972779A CN 112972779 A CN112972779 A CN 112972779A CN 202110164842 A CN202110164842 A CN 202110164842A CN 112972779 A CN112972779 A CN 112972779A
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ferromagnetic
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silica gel
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CN112972779B (en
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臧剑锋
吴清扬
凌青
羊佑舟
王佳鑫
凌乐
杨甲申
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Wuhan Ciji Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02Inorganic materials
    • A61L31/028Other inorganic materials not covered by A61L31/022 - A61L31/026
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
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    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09DCOATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D183/00Coating compositions based on macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing silicon, with or without sulfur, nitrogen, oxygen, or carbon only; Coating compositions based on derivatives of such polymers
    • C09D183/04Polysiloxanes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/04Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases

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Abstract

The invention relates to an implanted flexible magnetic response artificial bladder matrix, 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): the ferromagnetic composite body 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 matrix is 20-40%. The implanted flexible magnetic response artificial bladder matrix can be manufactured into the implanted flexible magnetic response artificial bladder matrix, ferromagnetic materials can show reliable actuation by virtue of the high coercive force and the distributed actuation source of the permanent magnetic particles in the ferromagnetic composite, and simultaneously a large amount of magnetic force is output, so that the artificial detrusor can be used for squeezing and emptying the bladder.

Description

Implanted flexible magnetic response artificial bladder matrix and manufacturing method thereof
Technical Field
The invention relates to the technical field of biomedicine, in particular to an implanted flexible magnetic response artificial bladder matrix and a manufacturing method thereof.
Background
The rapid development of soft robots for biomedical applications aims to improve medical conditions and provide novel therapeutic tools such as surgical instruments, body simulation and drug delivery. As an active system with high compliance and biocompatibility, the soft robot has wide prospect in assisting the movement of organs and even reconstructing the organs. Efforts have been made to use soft-body robots in prosthetic aids to cope with various diseased muscles, such as the myocardium, hand muscles and sphincters.
The low functional bladder (UAB) is characterized by prolonged urination time due to weakness of muscles, leading to serious complications and even death, and the incidence of UAB is high, with 9-98% in men and 12-45% in women, affected by aging, neurological diseases, trauma, diabetes, etc. Neuro-based therapies represented by neuromodulation (SNM) have shown potential to overcome OAB (overactive bladder)/DU (detrusor hypoactivity). However, a complete micturition reflex arc neural circuit is essential to achieve the clinical efficacy of SNM, suggesting that the device is not suitable for patients with sacral or pudendal nerve injury or with pathological detrusor muscle.
Unlike current solutions, increasing the force of detrusor contraction is a direct and fundamental solution to voiding the bladder. Attempts have been made to restore detrusor contractile capacity through regenerative medical strategies (e.g., muscle transplantation and stem cell injection). However, these methods only partially restore the urine storage function of the bladder, and the risk-to-benefit ratio remains to be further evaluated in a wider range of OAB/DU patients.
Several solutions for directly pressing the bladder based on a contact type hydraulic system directly implanted by a soft robot are proposed in the prior art, and are named as Endoskeleton/artificial detrusor muscle. These intravesical pressure maintenance system driving forces are mainly derived from thermally responsive gels or shape memory alloys, intended to encapsulate the bladder and physically contract in response to stimuli. Previous research results have shown that these mechanical strategies effectively increase intravesical pressure, ameliorate the problem of hypodynamic bladder, and that, while encouraging results have been achieved, existing artificial detrusor muscles provide limited hydraulic pressure, far from human muscle levels, due to the relatively inefficient operation of the stimulation source. In addition, current soft bladder assisted robotic systems do not enable reliable long-term functionality due to lack of realistic medical design and optimization of biological safety.
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, and can benefit from an actuation source of high coercive force and distribution of permanent magnetic particles in a ferromagnetic complex, ferromagnetic shows reliable actuation, 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 solidification 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 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 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.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
Fig. 1 is a schematic flow chart of a manufacturing method of an implantable flexible magnetic response artificial bladder substrate according to an embodiment of the present application.
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 body, includes: 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 thermally melted and then is solidified and bonded with the ferromagnetic complex to form a whole; 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 compound to obtain a ferromagnetic compound;
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 centrifuge, and controlling the rotation 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 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 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 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; 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) were first mixed with a PDMS resin (Sylgard 184, Dow Corning) 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 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 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% platinum-containing curing agent into the uncured ferromagnetic composite, stirring uniformly, 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.
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 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.

Claims (10)

1. An implantable flexible magnetically responsive artificial bladder matrix comprising: 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 body comprising 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%.
2. The implantable flexible magnetically-responsive artificial bladder matrix according to claim 1, wherein said magnetic particles are any one or combination of NdFeB, Fe, FeC; the magnetic particles are uniformly magnetized.
3. The implantable flexible magnetically-responsive artificial bladder matrix according to claim 2, wherein said magnetic particles are NdFeB and have an average particle size of 5 μm.
4. The implantable flexible magnetically-responsive artificial bladder matrix according to claim 1, wherein said flexible nonmagnetic matrix is thermally fused and bonded to said ferromagnetic composite by curing; the magnetic particles of the ferromagnetic composite body are uniformly magnetized in a pulsed magnetic field with a magnetic induction intensity of 3.0T.
5. A manufacturing method of the implanted flexible magnetic response artificial bladder matrix according to any one of claims 1 to 4, comprising 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.
6. The method for manufacturing the implanted flexible magnetic response artificial bladder matrix according to claim 5, wherein the organic silica gel and the polydimethylsiloxane resin are mixed by a planetary mixer during the formation of the uncured matrix composite rubber material, the rotation speed is controlled to be 800-1500 rpm, and the mixing time is controlled to be 2-5 min.
7. The method for manufacturing the implanted flexible magnetic response artificial bladder matrix according to claim 5, wherein the magnetic particles and the uncured matrix composite rubber compound are mixed by a vibration mixer, and the mixing time is controlled to be 2-10 min.
8. The method for manufacturing the implantable flexible magnetically-responsive artificial bladder matrix according to claim 5, wherein the platinum-containing curing agent is 5.0-10.3% by 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.
9. The method for manufacturing the implantable flexible magnetic-response artificial bladder matrix according to claim 5, wherein the solution of the flexible non-magnetic matrix is mixed with the ferromagnetic composite by injection molding and then solidified, and the injection molding process is performed 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.
10. The method for manufacturing an implantable flexible magnetically-responsive artificial bladder matrix according to claim 5, wherein the step of manufacturing the ferromagnetic composite further comprises:
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.
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