CN110974500B - Urethral stent for noninvasive surgery and preparation method thereof - Google Patents

Urethral stent for noninvasive surgery and preparation method thereof Download PDF

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Publication number
CN110974500B
CN110974500B CN201911335439.9A CN201911335439A CN110974500B CN 110974500 B CN110974500 B CN 110974500B CN 201911335439 A CN201911335439 A CN 201911335439A CN 110974500 B CN110974500 B CN 110974500B
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spiral
main body
stent
cavity
urethral stent
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CN110974500A (en
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王丽珍
候博成
林承延
靳凯翔
杜鑫
樊瑜波
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Beihang University
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Beihang University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A61F2/885Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
    • 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
    • A61L31/14Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067Means for introducing or releasing pharmaceutical products into the body

Abstract

The invention provides a urethral stent for non-invasive surgery, comprising: the main body structure is made of a Poly Glyceryl Dodecanoate (PGD) material, is in a slender strip shape at normal temperature, and is changed into a spiral structure after being implanted into a human body; and the degradable alloy wire is coiled on the outer surface of the main body structure. The main structure of the stent is made of the polyglycerol dodecanoate, the polyglycerol dodecanoate is in a long and thin strip shape at normal temperature, the polyglycerol dodecanoate can be conveniently placed into a urethra in an operation, has a memory effect at body temperature, can deform after being implanted into a human body and becomes a spiral structure, and the effect of dilating the urethra is achieved, so that the operation difficulty is obviously reduced, and the comfort of the stent after being implanted is improved. According to the invention, the degradable alloy wire is coiled on the main body structure, so that the support is provided for the stent structure, and simultaneously the stent structure can deform along with PGD materials, thereby playing a role in dilating urethra.

Description

Urethral stent for noninvasive surgery and preparation method thereof
Technical Field
The invention belongs to the technical field of urethral stents, and particularly relates to a urethral stent which is controllable in degradation, has good mechanical properties, can be customized in a personalized manner, is comfortable and is used for a noninvasive implantation operation, and a preparation method thereof.
Background
The prostatic hyperplasia is a common disease and frequently encountered disease of middle-aged and old men, which easily causes the stenosis of the urethral orifice to cause the problem of urine retention. The existing clinical treatment measures are mainly open peeling operations or cavity surgery, but the operation is relatively traumatic and dangerous, so that some patients cannot accept the operation due to the factors such as age, low wound healing capacity and the like, and only auxiliary drug treatment or intervention of a permanently indwelling catheter can be adopted for treatment. However, both methods still have significant problems: the drug therapy needs to be taken for life and is difficult to effectively and timely solve the urethral obstruction symptom; the suprapubic cystostomy or catheter indwelling mode brings great inconvenience to the life of patients and is easy to cause urethral irritability expansion to generate traumatic infection, thereby not only influencing the life time of the patients, but also reducing the life quality of the patients.
Except the treatment technology, the prostatic hyperplasia can be treated in a mode of intervening a urethral stent by a minimally invasive means at present, the early urethral stent is mostly made of non-degradable metal materials, the stent needs to be taken out by a secondary operation, pain is brought to a patient, meanwhile, certain risk exists, and because all metal is selected as the stent material, the hardness is high, and urethral endothelium is easy to be damaged. Under the circumstances, a urethral stent made of a degradable material has become a research focus in the field, for example, chinese patent document CN103170007A in the prior art discloses a urethral stent which is a tissue engineering stent having a tubular appearance shape, is made of a completely biodegradable polymer material, is soft and flexible, has a porous three-dimensional scaffold microstructure, has an average pore size of 20 to 200 μm, and is completely degradable, so that the problem of secondary surgical extraction can be avoided. However, the existing degradable scaffold still has the following problems: on the one hand, the stent needs to be manually expanded by a doctor when being implanted, so that good fitting performance cannot be guaranteed, the operation is complex, and foreign body sensation of a patient after the stent is implanted is increased. Meanwhile, after the stent is implanted, the stent and the urethral canal wall move mutually when the stent is washed by urine, and the endothelium is easily damaged. In addition, the urethral stent with a general structure can open a narrow urethra to prevent urinary retention, but the patients have different disease positions and complicated physiological structures, and the urethral stent can cause urinary incontinence due to incomplete closing of the internal orifice of the urethra caused by improper implantation, fuzzy positioning marks and other factors.
Disclosure of Invention
The utility model provides a laminating nature that current degradable support exists is poor, the operation is more complicated, the urine easily removes when scouring, and lack individualized customized technical problem, and then provides a degradation controllable, have good mechanical properties, can individualize customized, comfortable urethral support that is used for not having invasive implantation operation, this application still provides urethral support's preparation method.
The technical scheme adopted by the application for solving the technical problems is as follows:
a urethral stent for non-invasive surgery, comprising: the main body structure is made of a polydodecanoic acid glyceride material, is in a slender strip shape at the temperature lower than 30 ℃, and is converted into a spiral structure at the temperature of a human body; and the degradable alloy wire is coiled on the outer surface of the main body structure.
The front end of the main body structure is a cone structure, and the tip of the cone structure is of an arc structure.
The main body structure is in a slender strip shape with the diameter of 3-5mm under the temperature condition of being lower than 30 ℃; after being implanted into human body, the spiral structure is changed into a spiral structure with the axial length of 30-50 mm.
The spiral structure is including the front end spiral body, crane span structure body, the rear end spiral body that connect gradually the setting, the spiral structure that front end spiral body and rear end spiral body reduce to middle direction along the tip for the diameter gradually, the crane span structure body is tubulose spiral structure.
The maximum diameter of the front end spiral body is 15-20mm, the minimum diameter is 8-12mm, and the thread pitch is 3-5 mm; the maximum diameter of the rear end spiral body is larger than 12mm and smaller than or equal to 15mm, the minimum diameter is 8-12mm, and the thread pitch is 3-5 mm; the inner diameter of the bridge frame body is 8-10mm, and the thread pitch is 3-5 mm.
The ratio of the axial length of the front end spiral body to the axial length of the bridge frame body is (3-4): (6-10); the ratio of the axial length of the rear end spiral body to the axial length of the bridge body is (2-3): (6-10).
The degradable alloy wire is in a cylindrical wire shape with the diameter of 0.1-1mm, and the winding density of the degradable alloy wire on the unit length of the main body structure is 2-50 turns/cm.
The preparation method of the urethral stent for non-invasive surgery comprises the following steps: (1) preparing a mould, wherein the shape of a cavity of the mould is matched with the outer contour of the urethral stent in a spiral structure; (2) keeping the shape of the cavity of the mold unchanged, injecting a molten polyglycerol dodecanoate material into the cavity, and curing and molding at 90-150 ℃ to prepare the main body structure; (3) and taking the solidified and molded main body structure out of the mold, straightening at the temperature lower than 30 ℃, and winding the degradable alloy wire on the surface of the main body structure.
The preparation method of the urethral stent for non-invasive surgery comprises the following steps: (1) preparing a tubular elastic mould by using a 3D printing technology, wherein the shape of a cavity of the tubular elastic mould is matched with the outer contour of the urethral stent in a spiral structure; (2) keeping the shape of the cavity of the tubular elastic mold unchanged, injecting a molten polyglycerol dodecanoate material into the cavity, and performing curing molding at 90-150 ℃ to prepare the main body structure; (3) and (3) straightening the cavity of the elastic mold and the main body structure positioned in the cavity under the temperature condition of lower than 30 ℃, drawing out the main body structure from the cavity, and winding the degradable alloy wire on the surface of the main body structure.
The preparation method of the polyglycerol dodecanoate material comprises the following steps: (1) mixing glycerol and dodecanedioic acid according to a molar ratio of 1:1 to obtain a mixture; (2) heating the mixture to 90-150 ℃ under the nitrogen atmosphere, and reacting for 24-36h under the stirring condition to obtain a reactant; (3) placing the reactant in a vacuum environment, continuously stirring for 24-36h, and eliminating bubbles to obtain a prepolymer; (4) and (3) placing the prepolymer in a vacuum drying oven, and curing for 70-210h at the temperature of 90-150 ℃ to prepare the polyglycerol dodecanoate material.
The urethral stent for non-invasive surgery has the advantages that:
(1) the urethral stent for non-invasive surgery is characterized in that the main structure of the urethral stent is made of poly (glycerol do decanoate) and PGD (poly (glycerol do decanoate)), the main structure is in a long and thin strip shape at normal temperature, the urethral stent is convenient to place in surgery, the poly (glycerol dodecanoate) has a memory effect at body temperature, and can deform at the body temperature after being implanted into a human body to form a spiral structure, so that the urethral stent plays a role in dilating the urethra, the surgical difficulty is remarkably reduced, and the comfort of the implanted stent is improved.
In addition, the polydodecanoic acid glyceride is soft in texture in a temperature range of about 37 ℃ and has a swelling characteristic, so that the symptom of incomplete urinary tract closure caused by the traditional urethra is effectively solved, and the structural stability is improved.
According to the invention, the degradable alloy wire is coiled on the main body structure, the degradable alloy wire has excellent mechanical property and high compliance, can deform along with PGD materials while providing support for the support structure, and plays a role in dilating urethra.
(2) The urethra support for the non-invasive surgery, provided by the invention, preferably comprises a front end spiral body, a bridge frame body and a rear end spiral body which are sequentially connected, wherein the diameters of the front end spiral body and the rear end spiral body are gradually reduced from the end parts to the middle direction, the two ends of the support are provided with large spiral structures, one end of the support can be fixed at a bladder orifice in a fixing mode, and the other end of the support can be fixed at the front urethra in the surgery, so that the possibility of displacement of the support during urine scouring is obviously reduced.
The invention preferably selects the maximum diameter of the front end spiral body to be 15-20mm, the minimum diameter to be 8-12mm and the thread pitch to be 3-5 mm; the maximum diameter of the rear end spiral body is larger than 12mm and smaller than or equal to 15mm, the minimum diameter is 8-12mm, and the thread pitch is 3-5 mm; the inner diameter of the bridge frame body is 8-10mm, and the thread pitch is 3-5 mm. Meanwhile, the ratio of the axial length of the front end spiral body to the axial length of the bridge frame body is preferably (3-4): (6-10); the ratio of the axial length of the rear end spiral body to the axial length of the bridge body is (2-3): (6-10). The advantage lies in that such structure setting is convenient for be fixed in the urethra with the support is stable, prevents unexpected slippage.
The structure of the stent can set different 3D printing models according to different disease positions and physiological parameters of patients, and the encrypted spiral structure can be adopted at the affected swollen tissue to keep good urinary tract circulation and prevent the dislocation of the spiral structure generated by extrusion, so that the personalized customization is performed, the fitting degree of each part of the stent and the urethra is improved, the complications of urinary incontinence, granulation hyperplasia, urinary tract infection and the like caused by the traditional stent are reduced, and the curative effect is effectively improved.
In order to make the technical solution of the urethral stent for non-invasive surgery according to the present invention more clearly understood, the present invention will be further described in detail with reference to the accompanying drawings and the detailed description.
Drawings
Fig. 1 is a schematic structural diagram of the urethral stent implanted at room temperature lower than 30 ℃ according to the invention;
fig. 2 is a schematic structural view of the urethral stent of the present invention in a spiral state after being implanted into a human body;
figure 3 is a top view of the urethral stent of the present invention in a helical state;
wherein the reference numerals are:
1-a front end helix; 11-the front end of the front end helix; 12-the end of the front end helix;
2-a bridge body; 21-the front end of the bridge body; 22-ends of said bridge body;
3-a rear end helix; 31-the front end of the rear end helix; 32-the end of the rear end helix;
4-a first transition section; 5-a second transition section; 51. 52-straight line segment; 6-degradable alloy wire; 10-main body structure.
Detailed Description
In the following embodiments, the directions "front", "rear", "end" and the like in the directions are referred to the usage state of the urethral stent, and the end inserted into the urethra first in the usage is referred to as "front end", and the other is referred to as "rear end" and "end".
Example 1
The present embodiments provide a urethral stent for non-invasive surgery, comprising: the main body structure 10 made of the polyglyceryl dodecanoate material is in a shape of a long and thin strip with a diameter of 3mm as shown in fig. 1 at a normal temperature lower than 30 ℃, wherein the normal temperature is lower than 30 ℃, specifically, between 15 ℃ and lower than 30 ℃. A degradable alloy wire is coiled on the outer surface of the main body structure, in this embodiment, the degradable alloy wire is a cylindrical wire-shaped magnesium alloy wire with a diameter of 0.1mm, and the winding density of the magnesium alloy wire per unit length of the main body structure is 50 turns/cm.
The surfaces of the main body structure 10 and the degradable alloy wire 6 are coated with medicines with lubricating and antibacterial effects. In order to facilitate the implantation of the urethra in the operation, the front end of the main body structure in this embodiment is a cone structure, and the tip of the cone structure is set to be a circular arc structure.
The average internal diameter of the normal urethra part of a patient using the urethral stent in the embodiment is 8mm, the length of the narrow part is 35mm, the average diameter of the narrow part is 2mm, the distance from the narrow starting part to the bladder outlet is 30mm, the main structure 10 of the urethral stent is transformed into a spiral structure shown in fig. 2 and 3 under the condition of the body temperature after being implanted into the urethra of a human body, the spiral structure comprises a front end spiral body 1, a bridge frame body 2 and a rear end spiral body 3 which are sequentially connected, and the front end spiral body 1 and the rear end spiral body are spiral structures of which the diameters are gradually reduced from the end part to the middle direction. In order to realize the supporting and fixing effects, in this embodiment, the maximum diameter of the front end spiral body 1 of the spiral structure is 20mm, the minimum diameter is 12mm, the thread pitch is 3mm, the axial length between the front end 11 and the tail end 12 of the front end spiral body 1 is 15mm, the axial distance (i.e., the distance in the axial direction of the spiral structure) between the tail end 12 of the front end spiral body 1 and the front end 21 of the bridge body 2 is 10mm, and the tail end of the front end spiral body 1 is connected with the front end 21 of the bridge body 2 through the first transition section 4; the crane span structure body is the helical structure of 8 coils of winding, the diameter of crane span structure body is 8mm, the front end 21 of crane span structure body is 35mm to the axial length between the end 22, the end 22 of crane span structure body with the axial interval between the front end 31 of rear end spiral body 3 is 15mm, the end 22 of crane span structure body 2 with the front end 31 of rear end spiral body 3 passes through second changeover portion 5 and connects, the axial length between the front end 31 of rear end spiral body 3 to the end 32 is 10mm, the maximum diameter of rear end spiral body 3 is 15mm, and the minimum diameter is 8mm, and the pitch is 3 mm. In this embodiment, the first transition section 4 is configured as a curved section, and the second transition section 5 is configured as a bent section composed of two straight sections 51 and 52, and as an alternative embodiment, the first transition section 4 and the second transition section 5 may adopt any one of a straight structure and a curved structure.
For the urethral structure of the patient in this embodiment, the urethral stent is prepared by using a 3D printing technique in this embodiment, and the preparation method includes the following steps:
(1) preparing a tubular elastic mold by using a 3D printing technology, wherein the tubular elastic mold is a silicone tube with openings at two ends, and the hollow cavity shape of the silicone tube is matched with the outer contour of the urethral stent in a spiral structure;
(2) keeping the spiral structure of the silicone tube, injecting a molten polyglycerol dodecanoate material into the cavity until the silicone tube is filled with the polyglycerol dodecanoate material, and curing and molding the silicone tube at 90 ℃ to obtain the main body structure;
(3) and (3) placing the silicone tube at a normal temperature lower than 30 ℃, straightening the silicone tube and the main body structure positioned in the silicone tube by virtue of external force, extracting the main body structure from the silicone tube, and winding the degradable alloy wire on the surface of the silicone tube to obtain the urethral stent.
The polyglycerol dodecanoate material in the embodiment is prepared by the following method: (1) mixing glycerol and dodecanedioic acid according to a molar ratio of 1:1 to obtain a mixture; (2) heating the mixture to 90 ℃ under the nitrogen atmosphere, and reacting for 36 hours under the stirring condition to obtain a reactant; (3) placing the reactant in a vacuum environment, continuously stirring for 24 hours, and eliminating bubbles to obtain a prepolymer; (4) and (3) placing the prepolymer in a vacuum drying oven, and curing for 210 hours at the temperature of 90 ℃ to prepare the poly glyceryl dodecanoate material.
Example 2
The present embodiments provide a urethral stent for non-invasive surgery, comprising: the main body structure 10 made of the polyglyceryl dodecanoate material is in a shape of a long and thin strip with a diameter of 5mm as shown in fig. 1 at a normal temperature lower than 30 ℃, wherein the normal temperature is lower than 30 ℃, specifically, between 15 ℃ and lower than 30 ℃. A degradable alloy wire is coiled on the outer surface of the main body structure, in this embodiment, the degradable alloy wire is a cylindrical filamentous magnesium alloy wire with the diameter of 1mm, and the winding density of the magnesium alloy wire per unit length of the main body structure is 2 turns/cm. The surfaces of the main body structure 10 and the degradable alloy wire 6 are coated with medicines with lubricating and antibacterial effects. In order to facilitate the implantation of the urethra in the operation, the front end of the main body structure in this embodiment is a cone structure, and the tip of the cone structure is set to be a circular arc structure.
In addition to the personalized customized preparation method in example 1, the urethral stent can be prefabricated according to the average data of patients, and the appropriate size is selected according to the conditions of different patients when in use. Urethra support in this embodiment after putting into human urethra, under human body temperature condition transition become as the heliciform structure as shown in fig. 2 and fig. 3, the heliciform structure is including connecting gradually the front end spiral body 1, crane span structure body, the rear end spiral body that sets up, front end spiral body 1 and rear end spiral body are the diameter along the spiral structure that the tip reduces to middle direction gradually. In this embodiment, the maximum diameter of the front end spiral body 1 of the spiral structure is 15mm, the minimum diameter is 8mm, the thread pitch is 4mm, the axial length from the front end 11 to the tail end 12 of the front end spiral body 1 is 20mm, and in order to achieve a good fixing effect, the preferred range of the axial length is 15-20 mm; the axial distance between the tail end 12 of the front end spiral body 1 and the front end 21 of the bridge body 2 is 15mm, and the preferable range is 10-15 mm; the tail end of the front end spiral body 1 is connected with the front end 21 of the bridge body 2 through a first transition section 4; the bridge frame body is of a spiral structure wound by 8 turns, the diameter of the bridge frame body in the embodiment is 8mm, and the preferable range is 8-12 mm; the axial length between the front end 21 and the tail end 22 of the bridge body is 40mm, and the preferable range is 30-50 mm; the axial distance between the tail end 22 of the bridge body and the front end 31 of the rear end spiral body 3 is 15mm, and the preferable range is 15-25 mm; in this embodiment, the tail end 22 of the bridge body 2 is connected to the front end 31 of the rear end spiral body 3 through the second transition section 5, the axial length between the front end 31 and the tail end 32 of the rear end spiral body 3 is 10mm, the preferable range is 10-15mm, the maximum diameter of the rear end spiral body is 15mm, the minimum diameter of the rear end spiral body is 8mm, and the thread pitch of the rear end spiral body is 4 mm. In this embodiment, the first transition section is a curved section, and the second transition section 5 is a bent section formed by two straight sections 51 and 52.
The preparation method of the urethral stent in the embodiment comprises the following steps:
(1) preparing a mold, wherein the shape of a cavity of the mold is matched with the outline of the urethral stent in a spiral structure, and the mold in the embodiment is a glass mold, in particular a glass tube in a spiral structure;
(2) keeping the shape of the cavity of the mold unchanged, injecting a molten polyglycerol dodecanoate material into the cavity of the glass tube, and curing and molding at 150 ℃ to prepare the main body structure;
(3) taking out the cured and molded main body structure from the glass tube, straightening at a temperature lower than 30 ℃, specifically, straightening at a temperature of 15 ℃ to lower than 30 ℃ in the embodiment, and winding the degradable alloy wire on the surface of the straightened main body structure.
The polyglycerol dodecanoate material in the embodiment is prepared by the following method: (1) mixing glycerol and dodecanedioic acid according to a molar ratio of 1:1 to obtain a mixture; (2) heating the mixture to 150 ℃ under the nitrogen atmosphere, and reacting for 24 hours under the stirring condition to obtain a reactant; (3) placing the reactant in a vacuum environment, continuously stirring for 24 hours, and eliminating bubbles to obtain a prepolymer; (4) and (3) placing the prepolymer in a vacuum drying oven, and curing for 70 hours at the temperature of 150 ℃ to prepare the poly glyceryl dodecanoate material.
The urethral stent prepared in the above embodiments 1 and 2 has a main structure in a shape of a thin strip at normal temperature, so that the urethral stent can be conveniently placed in an operation, the operation difficulty is remarkably reduced, and the comfort of the implanted stent is improved. The support can take place to warp under human temperature condition and form helical structure, helical structure support stable in structure to through adopt degradable alloy wire rod coil in major structure can make the support have good mechanical properties, can provide effectual support for the urethra after implanting the urethra.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the claims.

Claims (8)

1. A urethral stent for non-invasive surgery, comprising:
the main body structure is made of a polydodecanoic acid glyceride material, is in a slender strip shape at the temperature lower than 30 ℃, and is converted into a spiral structure at the temperature of a human body; the spiral structure comprises a front end spiral body, a bridge frame body and a rear end spiral body which are sequentially connected, wherein the diameter of the rear end spiral body is gradually reduced along the rear end part to the middle direction, the diameter of the front end spiral body is also gradually reduced in the same direction, and the bridge frame body is of a tubular spiral structure; the maximum diameter of the front end spiral body is 15-20mm, the minimum diameter is 8-12mm, and the thread pitch is 3-5 mm; the maximum diameter of the rear end spiral body is larger than 12mm and smaller than or equal to 15mm, the minimum diameter is 8-12mm, and the thread pitch is 3-5 mm; the inner diameter of the bridge frame body is 8-10mm, and the thread pitch is 3-5 mm; the tail end of the front end spiral body is connected with the front end of the bridge frame body through a first transition section; the first transition section adopts any one of a straight line structure or a curve structure;
and the degradable alloy wire is coiled on the outer surface of the main body structure.
2. A urethral support for non-invasive surgery according to claim 1, characterised in that the front end of the main body structure is a cone structure, the tip of which is arranged in a circular arc configuration.
3. A urethral support for non-invasive surgery according to claim 1 or 2, characterized in that the main structure is in the form of an elongated strip with a diameter of 3-5mm at a temperature below 30 ℃; after being implanted into human body, the spiral structure is changed into a spiral structure with the axial length of 30-50 mm.
4. A urethral stent for non-invasive surgery according to claim 3, characterized in that the ratio of the axial length of the front spiral body to the bridge body is (3-4): (6-10); the ratio of the axial length of the rear end spiral body to the axial length of the bridge body is (2-3): (6-10).
5. A urethral stent for non-invasive surgery according to claim 1, 2 or 4, characterized in that the degradable alloy wires are in the shape of a cylindrical wire with a diameter of 0.1-1mm and the winding density of the degradable alloy wires per unit length of the body structure is 2-50 turns/cm.
6. A method of preparing a urethral stent for non-invasive surgery according to any one of claims 1 to 5, characterized by comprising the steps of: (1) preparing a mould, wherein the shape of a cavity of the mould is matched with the outer contour of the urethral stent in a spiral structure; (2) keeping the shape of the cavity of the mold unchanged, injecting a molten polyglycerol dodecanoate material into the cavity, and curing and molding at 90-150 ℃ to prepare the main body structure; (3) and taking the solidified and molded main body structure out of the mold, straightening at the temperature lower than 30 ℃, and winding the degradable alloy wire on the surface of the main body structure.
7. The method of preparing a urethral stent for non-invasive surgery according to claim 6, characterized by comprising the steps of: (1) preparing a tubular elastic mould by using a 3D printing technology, wherein the shape of a cavity of the tubular elastic mould is matched with the outer contour of the urethral stent in a spiral structure; (2) keeping the shape of the cavity of the tubular elastic mold unchanged, injecting a molten polyglycerol dodecanoate material into the cavity, and performing curing molding at 90-150 ℃ to prepare the main body structure; (3) and (3) straightening the cavity of the elastic mold and the main body structure positioned in the cavity under the temperature condition of lower than 30 ℃, drawing out the main body structure from the cavity, and winding the degradable alloy wire on the surface of the main body structure.
8. The method for preparing a urethral stent for non-invasive surgery according to claim 6 or 7, characterized in that the polyglyceryl dodecanoate material is prepared as follows: (1) mixing glycerol and dodecanedioic acid according to a molar ratio of 1:1 to obtain a mixture; (2) heating the mixture to 90-150 ℃ under the nitrogen atmosphere, and reacting for 24-36h under the stirring condition to obtain a reactant; (3) placing the reactant in a vacuum environment, continuously stirring for 24-36h, and eliminating bubbles to obtain a prepolymer; (4) and (3) placing the prepolymer in a vacuum drying oven, and curing for 70-210h at the temperature of 90-150 ℃ to prepare the polyglycerol dodecanoate material.
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