CN111150545A - Phase-change cooling support, preparation method thereof and phase-change cooling combined support - Google Patents
Phase-change cooling support, preparation method thereof and phase-change cooling combined support Download PDFInfo
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- CN111150545A CN111150545A CN202010001436.8A CN202010001436A CN111150545A CN 111150545 A CN111150545 A CN 111150545A CN 202010001436 A CN202010001436 A CN 202010001436A CN 111150545 A CN111150545 A CN 111150545A
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- Prior art keywords
- phase
- change cooling
- change
- spiral shell
- bracket
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y80/00—Products made by additive manufacturing
-
- C—CHEMISTRY; METALLURGY
- C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
- C09K—MATERIALS FOR MISCELLANEOUS APPLICATIONS, NOT PROVIDED FOR ELSEWHERE
- C09K5/00—Heat-transfer, heat-exchange or heat-storage materials, e.g. refrigerants; Materials for the production of heat or cold by chemical reactions other than by combustion
- C09K5/02—Materials undergoing a change of physical state when used
- C09K5/06—Materials undergoing a change of physical state when used the change of state being from liquid to solid or vice versa
- C09K5/066—Cooling mixtures; De-icing compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/008—Methods or devices for eye surgery using laser
- A61F2009/00885—Methods or devices for eye surgery using laser for treating a particular disease
- A61F2009/00891—Glaucoma
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
Abstract
The invention relates to the technical field of ophthalmic stents, in particular to a phase-change cooling stent and a preparation method and application thereof. The phase-change cooling support comprises a spiral shell with a hollow structure and a core material filled in the spiral shell, wherein the core material is a phase-change cooling material, and the spiral shell is a medical high polymer material; the outer diameter of the phase-change cooling bracket is adapted to the inner diameter of the Schlemm's tube. The invention takes the phase-change cooling material as a core layer component, and the phase-change cooling material can automatically absorb or release heat energy to the environment by utilizing the phase state or the structural change of the phase-change cooling material, thereby achieving the purpose of regulating and controlling the environment temperature.
Description
Technical Field
The invention relates to the technical field of ophthalmic supports, in particular to a phase-change cooling support, a preparation method thereof and a phase-change cooling combined support.
Background
Glaucoma is the first irreversible blinding eye disease in the world and is mainly classified into Primary closed angle Glaucoma (PACG) and Primary Open Angle Glaucoma (POAG). With the development of socioeconomic in China and the change of life style of people, POAG has become the most common irreversible high-blindness eye disease in China at present, and accounts for 70.4 percent of the total number of glaucoma patients. Increased intraocular pressure is considered to be an important factor in the onset of glaucoma and is the only factor that can be intervened at present, and increased resistance to drainage of aqueous humor is considered to be the main cause of increased intraocular pressure. While the anterior chamber angle of POAG is open, its increased intraocular pressure is primarily due to lesions of the trabecular meshwork cells, resulting in increased resistance of the aqueous humor drainage system.
Clinically current treatment regimens for glaucoma are primarily targeted at lowering intraocular pressure, including drugs and surgery. Drug therapy is usually the first choice, but currently available drug therapies almost require at least once daily use to be effective, which can have a number of serious side effects, including: congestive heart disease, tachypnea, hypertension, depression, kidney stones, aplastic anemia, and sexual dysfunction; drug compliance is also a major problem, and it is estimated that more than half of glaucoma patients do not follow their correct time dose, causing fluctuations in intraocular pressure, resulting in optic nerve damage and visual field defects. When the administration of the drug is insufficient to reduce the intraocular pressure, laser trabeculoplasty or trabeculectomy is usually performed, and such intervention may cause scarring of the scleral flap, closing the outflow tract of the artificially-made aqueous humor, thereby causing the intraocular pressure to rise again; at the same time, a pathway for bacteria on the surface of the eye and eyelids to enter the interior of the eye is also created, and an internal eye infection known as endophthalmitis, which often results in permanent and more severe loss of vision, can occur. Therefore, there is an urgent need for novel and effective therapeutic means for continuously lowering intraocular pressure.
Disclosure of Invention
The phase-change cooling bracket provided by the invention can absorb heat by utilizing the phase-change process of the phase-change cooling material, reduce the environmental temperature of trabecular meshwork tissues, prevent and relieve protein error folding of trabecular meshwork cells, can repeatedly act, continuously reduce intraocular pressure and slow down or block the pathological process of glaucoma.
In order to achieve the above object, the present invention provides the following technical solutions:
the invention provides a phase-change cooling support which comprises a spiral shell with a hollow structure and a core material filled in the spiral shell, wherein the core material is a phase-change cooling material, and the spiral shell is a medical high polymer material; the outer diameter of the phase-change cooling bracket is adapted to the inner diameter of the Schlemm's tube.
Preferably, the length of the phase-change cooling support is 1-6 mm.
Preferably, the mass ratio of the spiral shell to the core material is (40-80): (20-60).
Preferably, the raw materials for preparing the phase-change cooling material comprise hydrogel, an organic phase-change material and a gelling agent.
Preferably, the mass ratio of the hydrogel to the organic phase change material to the gelling agent is (20-60): (30-80): (1-10).
Preferably, the organic phase change material comprises one or more of polyvinyl alcohol, isopropanol, glycerol and propylene glycol.
The invention also provides a preparation method of the phase change cooling bracket in the technical scheme, which comprises the following steps:
and (3) printing the phase-change cooling material serving as a core material and the medical high polymer material serving as a spiral shell by adopting a 3D printing technology to obtain the phase-change cooling support.
The invention also provides a phase-change cooling combined bracket, which is formed by combining a plurality of phase-change cooling brackets in the technical scheme or the phase-change cooling brackets prepared by the preparation method in the technical scheme; the combination mode is to connect the port of the phase change cooling bracket to the port.
Preferably, the spiral pitch between each phase change cooling support is 0.2-0.5 mm.
The invention provides a phase-change cooling support which comprises a spiral shell with a hollow structure and a core material filled in the spiral shell, wherein the core material is a phase-change cooling material, and the spiral shell is a medical high polymer material; the outer diameter of the phase-change cooling bracket is adapted to the inner diameter of the Schlemm's tube. The phase-change cooling material is used as a core material, and can automatically absorb heat energy to the environment by utilizing the phase-change cooling material according to the self phase state or structure change, so that the aim of regulating and controlling the environment temperature is fulfilled; the phase-change cooling material is coated and fixed in a bracket shape by using a medical high polymer material, is implanted into Schlemm's canal (Schlemm), can ensure the cooling effect of the phase-change cooling material, and is suitable for treating glaucoma. The phase change cooling support provided by the invention is simple in structure, low in manufacturing cost and suitable for popularization and application.
Drawings
Fig. 1 is a schematic view of a phase change cooling stent prepared in embodiment 1 of the present invention;
FIG. 2 is a schematic diagram of a phase change process of the phase change temperature reducing material.
Detailed Description
The invention provides a phase-change cooling support which comprises a spiral shell with a hollow structure and a core material filled in the spiral shell, wherein the core material is a phase-change cooling material, and the spiral shell is a medical high polymer material; the outer diameter of the phase-change cooling bracket is adapted to the inner diameter of the Schlemm's tube.
The phase change cooling support provided by the invention comprises a spiral shell with a hollow structure, wherein the spiral shell is made of a medical high polymer material, and hydrogel is preferable. In the present invention, the thickness of the hydrogel is preferably 200 to 500. mu.m.
The phase-change cooling support provided by the invention comprises a core material filled in the spiral shell, wherein the core material is a phase-change cooling material, the preparation raw materials of the phase-change cooling material preferably comprise hydrogel, an organic phase-change material and a gelling agent, and the mass ratio of the hydrogel to the organic phase-change material to the gelling agent is preferably (20-60): (30-80): (1-10). In the present invention, the thickness of the hydrogel is preferably 200 to 500. mu.m. In the invention, the hydrogel is used as a matrix of the phase-change cooling material to coat the phase-change material.
In the invention, the phase change temperature of the organic phase change material is preferably 30-34 ℃, and more preferably 31-33 ℃; the organic phase change material preferably comprises one or more of polyvinyl alcohol, isopropanol, glycerol and propylene glycol. In the invention, the organic phase-change material takes away local micro-environment heat through a phase-change process, reduces the local temperature of trabecular meshwork tissues (reaching 32 +/-2 ℃), reverses or blocks protein misfolding and accumulation of trabecular meshwork cells by utilizing a low-temperature environment, improves the blocked state of outflow of aqueous humor, can act repeatedly, and realizes continuous intraocular pressure reduction through one-time intervention.
In the invention, the specific composition of the gelling agent is preferably sodium alginate or borax. The invention enhances the adhesion between the organic phase-change material and the hydrogel through the gelling agent, and improves the stability and the durability of the phase-change cooling effect.
In the present invention, the preparation method of the phase-change cooling material preferably includes: and mechanically blending the hydrogel, the phase-change material and the gelling agent to obtain the phase-change cooling material. In the invention, the mechanical blending mode is preferably stirring, the stirring temperature is 30-80 ℃, and the stirring time is preferably 1-5 h.
In the invention, the phase-change cooling bracket is in the shape of a spiral bracket, as shown in figure 1. In the invention, the outer diameter of the phase-change cooling bracket is consistent with the inner diameter of the Schlemm's tube, particularly preferably 150-250 μm, and the length of the phase-change cooling bracket is preferably 1-6 mm.
The invention provides a preparation method of the phase change cooling bracket in the technical scheme, which comprises the following steps: and (3) printing the phase-change cooling material serving as a core material and the medical high polymer material serving as a spiral shell skin material by adopting a 3D printing technology to obtain the phase-change cooling support. The preparation method provided by the invention is simple and convenient, has high precision and can meet medical requirements.
The invention also provides a phase-change cooling combined bracket, which is formed by combining a plurality of phase-change cooling brackets in the technical scheme or the phase-change cooling brackets prepared by the preparation method in the technical scheme; the combination mode is that the ports of the phase-change cooling support are connected with the ports, and preferably the phase-change cooling support is connected in series. In the present invention, the joining is preferably performed by using a suture. In the invention, the pitch between each phase change cooling bracket is 0.2-0.5 mm. In a specific embodiment of the invention, the phase-change cooling combined bracket is formed by connecting 4-6 phase-change cooling brackets in series.
In the specific use process of the invention, the conventional eye surgery disinfection is preferably carried out firstly, the scleral flap is manufactured, and the phase-change cooling stent or the phase-change cooling combined stent is implanted into Schlemm's canal of a patient.
The invention adopts low-temperature physical therapy, has no side effect of drugs, avoids infection risk caused by an aqueous humor outflow channel manufactured by trabecular surgery, and more importantly, the stent therapy provided by the invention only needs one intervention, can achieve the aims of continuously reducing intraocular pressure, preventing and relieving abnormal protein accumulation of primary open-angle glaucoma trabecular meshwork tissue, and slowing down the damage loss of pathological trabecular cells and the pathological process of glaucoma.
The technical solution of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. 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 invention.
Example 1
Mixing 1g of hydrogel, 0.5g of polyvinyl alcohol and 0.1g of sodium alginate, heating to 50 ℃ under uniform stirring, and stirring for 2 hours to obtain a phase-change cooling material;
and (3) placing the phase-change cooling material serving as a core material and 2g of medical pure water gel serving as a spiral shell material in a 3D printer, and obtaining the phase-change cooling support by adopting a 3D printing technology.
The schematic diagram of the obtained phase-change cooling stent is shown in fig. 1, the phase-change cooling stent is in the shape of a spiral stent, the length of the phase-change cooling stent is 3mm, the outer diameter of the phase-change cooling stent is 200 mu m, and when the phase-change cooling stent is used, a single stent can be implanted for use or a plurality of stents can be implanted for use in a combined manner according to the disease progression stage or the lesion degree in a grading. When a plurality of stents are used in a combined way, a plurality of phase-change cooling stents are connected in series through sutures to obtain a phase-change cooling combined stent, the pitch between the single phase-change cooling stents is 0.3mm, and then the combined stent is implanted into Schlemm's canal of a patient; the phase change process (as shown in figure 2) of the phase change composite material brings away local microenvironment heat, reduces local temperature of trabecular meshwork tissues, reverses or blocks protein misfolding and accumulation of trabecular meshwork cells by utilizing a low-temperature environment, improves the blocked state of outflow of aqueous humor, can repeatedly act, can continuously reduce intraocular pressure through one-time intervention, prevents and relieves abnormal protein accumulation of primary open-angle glaucoma trabecular meshwork tissues, and slows down damage loss of pathological changes of the trabecular meshwork cells and pathological processes of glaucoma.
Example 2
Mixing 1.2g of hydrogel, 0.6g of isopropanol and 0.2g of sodium alginate, heating to 60 ℃ under uniform stirring, and stirring for 1h to obtain a phase-change cooling material;
and (3) placing the phase-change cooling material serving as a core material and 3g of medical pure water gel serving as a spiral shell material in a 3D printer, and obtaining the phase-change cooling support by adopting a 3D printing technology.
Example 3
Mixing 1.5g of hydrogel, 0.8g of glycerol and 0.1g of borax, heating to 40 ℃ under uniform stirring, and stirring for 3 hours to obtain a phase-change cooling material;
and (3) placing the phase-change cooling material serving as a core material and 2.5g of medical pure water gel serving as a spiral shell material in a 3D printer, and obtaining the phase-change cooling support by adopting a 3D printing technology.
Example 4
Mixing 1g of hydrogel, 0.8g of propylene glycol and 0.2g of sodium alginate, heating to 70 ℃ under uniform stirring, and stirring for 0.5h to obtain a phase-change cooling material;
and (3) placing the phase-change cooling material serving as a core material and 4g of medical pure water gel serving as a spiral shell material in a 3D printer, and obtaining the phase-change cooling support by adopting a 3D printing technology.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (9)
1. The phase-change cooling support is characterized by comprising a spiral shell with a hollow structure and a core material filled in the spiral shell, wherein the core material is a phase-change cooling material, and the spiral shell is a medical high polymer material; the outer diameter of the phase-change cooling bracket is adapted to the inner diameter of the Schlemm's tube.
2. The phase-change cooling bracket according to claim 1, wherein the length of the phase-change cooling bracket is 1-6 mm.
3. The phase change cooling support according to claim 1, wherein the mass ratio of the spiral shell to the core material is (40-80): (20-60).
4. The phase-change cooling bracket according to claim 1, wherein the phase-change cooling material is prepared from raw materials including hydrogel, organic phase-change material and gelling agent.
5. The phase-change cooling bracket according to claim 4, wherein the mass ratio of the hydrogel to the organic phase-change material to the gelling agent is (20-60): (30-80): (1-10).
6. The phase-change cooling bracket according to claim 4 or 5, wherein the organic phase-change material comprises one or more of polyvinyl alcohol, isopropanol, glycerol and propylene glycol.
7. The preparation method of the phase-change cooling bracket according to any one of claims 1 to 6, which is characterized by comprising the following steps:
and (3) printing the phase-change cooling material serving as a core material and the medical high polymer material serving as a spiral shell by adopting a 3D printing technology to obtain the phase-change cooling support.
8. A phase-change cooling combined bracket is characterized by being formed by combining a plurality of phase-change cooling brackets according to any one of claims 1 to 6 or prepared by the preparation method according to claim 7; the combination mode is to connect the port of the phase change cooling bracket to the port.
9. The phase-change cooling combined bracket according to claim 8, wherein the spiral pitch between each phase-change cooling bracket is 0.2-0.5 mm.
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Application publication date: 20200515 |