WO2023001302A1 - 输尿管支架 - Google Patents

输尿管支架 Download PDF

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Publication number
WO2023001302A1
WO2023001302A1 PCT/CN2022/107485 CN2022107485W WO2023001302A1 WO 2023001302 A1 WO2023001302 A1 WO 2023001302A1 CN 2022107485 W CN2022107485 W CN 2022107485W WO 2023001302 A1 WO2023001302 A1 WO 2023001302A1
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Prior art keywords
stent
expandable coating
ureteral
expandable
coating
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PCT/CN2022/107485
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English (en)
French (fr)
Inventor
罗万川
王强
Original Assignee
上海火点医疗器械有限公司
黎艾蔻先进材料私人有限公司
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Publication of WO2023001302A1 publication Critical patent/WO2023001302A1/zh

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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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • 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
    • A61F2/00—Filters 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
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L31/00—Materials 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
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L31/00—Materials 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L31/00—Materials 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/145—Hydrogels or hydrocolloids
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/048—Ureters
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0061—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable

Definitions

  • the invention relates to the field of medical stents, in particular to a ureteral stent.
  • Ureteral stenosis is not uncommon in clinical practice.
  • secondary ureteral stenosis mainly includes iatrogenic stenosis, stone incarceration, infection, endometriosis, retroperitoneal fibrosis, malignant tumor, radiation therapy, etc. cause.
  • the traditional treatment method is open surgery, but open surgery for ureteral reconstruction has the disadvantages of large trauma, complicated operation, many complications, slow postoperative recovery and easy recurrence.
  • endoscopic surgery for ureteral stenosis is becoming more and more popular.
  • Endoscopic ureteral balloon dilatation or internal ureterotomy for ureteral stenosis is the first choice.
  • ureteral stents need to be placed to prevent recurrence of stenosis.
  • the commonly used double J tubes in clinic have disadvantages such as discomfort after tube insertion, formation of stent shell and even induced stone formation, and need for regular replacement.
  • metal stents have begun to be used clinically. They have the advantages of biocompatibility, flexibility, and corrosion resistance, but they still cannot be permanently placed in the body.
  • Metal stents are mainly Resonance TM produced by American COOK Company and Silhouette TM produced by APPLIED Medical Company.
  • the spiral coil design increases the tensile strength and stability at the same time, greatly prolonging the indwelling time of metal stents, and the complications are more than double J tubes.
  • the treatment effect on ureteral stricture caused by malignant tumor is better, but there are still problems such as stent obstruction, patient discomfort and urinary tract infection.
  • some new metal stents have been developed. They do not cover the entire length of the ureter, but only for narrow ureters. They are also called expandable metal ureteral stents. According to the expansion mechanism, they can be divided into self-expansion and balloon expansion.
  • clinically expandable metal ureteral stents usually refer to self-expandable metal stents.
  • the first expandable metal ureteral stent was Boston Scientific's Wallstent, a wire mesh made of stainless steel that could be placed antegradely or retrogradely. Although it is unavoidable for tumor growth to compress the stent or even block it, the patency rate of the stent can be as high as 54%.
  • the downside is that it was not originally designed for use in the ureter, so stent removal is difficult.
  • expandable metal ureteral stents have many advantages over traditional double J tubes, too many complications limit their wide application in clinic.
  • Early stent-related adverse events include iatrogenic injury, stent migration, and patient discomfort, and late stent-related complications include infection and difficulty with stent replacement, hardware failure, and stent fouling.
  • Rarely, prolonged stent placement has resulted in ureteroarterial fistula and iliac vessel erosion.
  • U.S. Patent US2012/0123527A1 discloses a ureteral stent, which includes a mesh-shaped metal-based expandable stent-graft body and a hydrogel coating on the outer surface of the stent-graft body. Slightly inflated afterward, but the part that stretches the stenosis is mainly the expandable stent graft body.
  • the main role of the hydrogel coating is to increase the biocompatibility of the stent surface and to increase the conformity with the implant wall, rather than against ureteral strictures.
  • this solution still has the following technical problems:
  • the expandable covered stent Since the expandable covered stent is in the shape of a cylinder as a whole, it cannot be stably positioned in the ureter, and the stent will be displaced to varying degrees after operation, and it is very difficult to adjust the position once the displacement occurs.
  • the thickness of the expandable stent-graft body is uniform, and the thickness of the hydrogel coating is also uniform, while the inner diameter of the narrow part of the ureter is usually gradual.
  • the hydrogel coating expands, due to The compressive force on the gel coat at the ureteral stricture is greater than that at other parts, which will cause a large depression in the gel coat here. After the new ureteral wall grows and the stent is removed, The inner diameter corresponding to the original ureteral stricture will still be smaller than the rest, affecting the therapeutic effect.
  • the technical problem to be solved by the present invention is to overcome the defect in the prior art that the inner diameter corresponding to the original ureteral stenosis is still smaller than the rest after the ureteral stent is used, and to provide a new type of ureteral stent.
  • a ureteral stent comprising a stent body and an expandable coating on the outer surface of the stent body, the thickness of the expandable coating corresponding to the ureteral stenosis is greater than that of the rest of the ureter.
  • the expandable coating can better resist the compressive force of the ureteral stenosis, so that the treated ureter has a more uniform inner diameter, and the treatment effect is better.
  • the thickness of the expandable coating gradually increases from both ends to the middle, and this structure is suitable for ureters with tapered inner diameter stenosis, or the expandable coating includes a shaft A uniform section and tapered sections located at both ends of the uniform section in the axial direction. This structure is suitable for ureters with axially uniform internal diameter stenosis.
  • the stent body is provided with multiple sections of the expandable coating continuously or discontinuously along the axial direction. This structure can be applied to ureters with multiple strictures.
  • flow-guiding lines are provided on the outer surface of the expandable coating, and/or anti-slip lines are provided on the inner surface of the expandable coating.
  • the drainage lines can drain urine and stones, and the anti-slip lines can enhance the friction with the stent body to avoid peeling off of the expandable coating.
  • the stent body is a non-expandable hollow tube, and drainage holes and openings larger than the drainage holes are provided on the outer surface of the stent body.
  • the non-expandability means that the outer diameter of the stent body does not change after implantation.
  • the function of the drainage hole is to drain urine and stones, and the function of the opening is to discharge the stones with larger diameters out of the body to avoid blockage in the ureter.
  • the diameter of the drainage hole is 0.1mm-1.7mm, and the diameter of the opening is 0.3mm-2.5mm.
  • the stent body has a limiting portion at a position corresponding to the end of the expandable coating for limiting the axial movement of the expandable coating.
  • the limiting portion is a protrusion disposed around the outer surface of the stent body, and the circumferential outer diameter of the protrusion is less than or equal to that after the expandable coating is expanded. maximum outer diameter.
  • the protrusion is funnel-shaped, and the end of the expandable coating is arranged facing the funnel surface of the protrusion. Adopting such a structure can better prevent the expandable coating from peeling off the stent body.
  • the protrusion is a boss or a sheet.
  • the axial end of the stent body has a locking portion for limiting the movement of the stent body.
  • the locking parts are respectively placed in the renal pelvis and/or the bladder to limit the position of the stent body.
  • the anti-peeling force between the expandable coating and the stent body is 0.5N-15N.
  • the expandable coating is a material that expands when exposed to liquid, the initial thickness of the expandable coating is 0.01mm-2mm, and the expanded thickness is 0.03mm-8mm.
  • the positive progressive effect of the present invention is:
  • the superimposed structure of the stent body and the expandable coating is adopted, and the thickness of the expandable coating corresponding to the ureteral stenosis is thicker than other parts.
  • the expandable coating The layer can better resist the compressive force of the ureteral stenosis, so that the treated ureter has a more uniform inner diameter and the treatment effect is better.
  • the self-expandable expandable coating is adopted, which is convenient for implantation. After expansion, the expandable coating can fit the inner wall of the ureter well, and can maintain sufficient supporting force before the ureteral stricture is repaired, and is not easy to shift. The expandable coating is soft and does not damage the ureter and reduces discomfort.
  • the thickness of the expandable coating corresponding to the stenosis of the ureter When the thickness of the expandable coating corresponding to the stenosis of the ureter is located in the middle of the expandable coating, the thickness of the expandable coating gradually increases from both ends to the middle or the thickness gradually increases from both ends to the middle to a certain value.
  • the uniform thickness extends to the middle, so that the treated ureter has a more uniform inner diameter, and the treatment effect is better.
  • the body of the stent is continuously or discontinuously provided with multiple segments of the expandable coating along the axial direction, which can be applied to ureters with multiple strictures.
  • the outer surface of the expandable coating is provided with diversion lines, and/or the inner surface of the expandable coating is provided with anti-skid lines.
  • the drainage lines can drain urine and stones, and the anti-slip lines can enhance the friction with the stent body, preventing the expandable coating from peeling off from the stent body.
  • the expandable coating is mostly made of materials with good biocompatibility such as gel, which can realize the endothelialization of the ureter at the ureteral stent within a reasonable period and reduce the occurrence of complications.
  • the stent body is hollow tubular, and the outer surface of the stent body is provided with drainage holes and larger openings than the drainage holes.
  • the drainage hole can be used to drain urine and stones, and the function of the opening is to discharge stones with larger diameters out of the body to avoid blockage in the ureter.
  • the body of the stent is provided with a limiting portion adjacent to the end of the expandable coating, which restricts the expandable coating from moving toward the limiting portion.
  • the limiting part can prevent the expandable coating from peeling off from the stent body.
  • At least one end of the stent body in the axial direction has a locking portion to restrict the movement of the stent body towards the locking portion.
  • the locking part can be placed in the renal pelvis or the bladder, and plays a role of limiting the stent body and preventing the stent body from moving.
  • Fig. 1 is a ureteral stent diagram when the expandable coating is in the lower segment
  • Figure 2 is a diagram of the ureteral stent when the expandable coating is in the middle section
  • Fig. 3 is a ureteral stent diagram when the expandable coating is in the upper segment
  • Fig. 4 is a kind of embodiment that adopts non-uniform thickness expandable coating
  • Fig. 5 is another embodiment that adopts non-uniform thickness expandable coating
  • Fig. 6 is a perspective view of drainage holes and openings
  • Fig. 7 is the setting scheme of a kind of boss
  • Fig. 8 is the setting scheme of another kind of boss
  • Fig. 9 is another setting scheme of the boss
  • Fig. 10 is the schematic diagram of experimental example 1;
  • Fig. 11 is the schematic diagram of experimental example 2.
  • Bracket body 100 drainage hole 110, opening 120, clamping part 140, expandable coating 200, protrusion 210, placing tool 300, ring placing part 310, pull plate 320, tooling device 400, internal space 410, through hole 420.
  • Computerized tensile testing machine 500 Computerized tensile testing machine 500.
  • a ureteral stent includes a stent body 100 and an expandable coating 200.
  • the stent body 100 is a non-expandable stent, and the non-expandability here refers to that the stent body 100 will remain stable after implantation.
  • the outer diameter does not change, and the expandable coating 200 is arranged on at least a part of the outer surface of the stent body 100.
  • the expandable coating 200 can expand after absorbing body fluids and expand the ureter, thereby treating the ureter. Narrow effect.
  • the expandable coating 200 is located at any one or several places on the outer surface of the stent body 100, which may be the upper part, the middle part or the lower part of the stent body 100, and the position depends on the position of the patient's ureteral stenosis.
  • the thickness of the expandable coating 200 can be uniform or non-uniform.
  • the thickness of the expandable coating 200 corresponding to the stricture of the ureter is greater than the thickness of the expandable coating 200 corresponding to the rest of the ureter.
  • the expandable coating 200 corresponding to the ureteral stenosis can better resist the compressive force of the ureteral stenosis, so that the ureter after treatment has a more uniform inner diameter, and the treatment effect is better.
  • the thickness of the expandable coating 200 gradually increases from both ends to the middle, and this structure is suitable for ureters with narrowing portions with tapered inner diameters.
  • the expandable coating 200 includes a uniform axial segment in the middle and tapered segments at both ends of the uniform axial segment.
  • the axial uniform section corresponds to the stenosis of the ureter, and this structure is suitable for the ureter with the stenosis of the axial uniform inner diameter.
  • the stent body 100 is provided with multiple sections of expandable coating 200 along the axial direction, which can be arranged continuously or discontinuously. This structure can be applied to ureters with multiple strictures.
  • the thickness above refers to the thickness in the radial direction of the stent.
  • ureters with non-uniform thickness in the radial direction can also be used according to the actual shape of the patient's ureter.
  • the expandable coating 200 is a liquid-expandable material.
  • Materials that can swell when encountering liquids are materials that can swell when encountering human body fluids or water, such as hydrogel materials, polyvinyl alcohol, polyethylene glycol, polyethylene glycol dimethacrylate, poly(ethylene glycol) can be selected.
  • Diol diacrylate hydroxyethyl methacrylate, polyethylene oxide-polyoxypropylene-polyethylene oxide, polyurethane, polyvinylpyrrolidone, vinylpyrrolidone-acrylic acid copolymer, polyacrylamide, polyvinylcaprolactam, poly Acrylate, polyamino acid, carboxymethyl cellulose, polymethyl acrylate, alginate, polyhydroxyethyl acrylate, acrylamide, polyacrylic acid, hydrolyzed polyacrylonitrile, polyethyleneimine, ethoxylated poly One or more of ethyleneimine polyallylamine, hyaluronic acid, methacrylated hyaluronic acid, chitosan, collagen, gelatin, fibrin, dextran, agarose.
  • the gel material has good elasticity and can fit the inner wall of the ureter well, so that the expandable coating 200 can be stably supported on the narrow section of the ureter, and is not easy to shift; and the gel material is soft and can gently touch the inner wall of the ureter , it is not easy to cause damage to the inner wall of the ureter, and can reduce the discomfort of the patient.
  • the expandable coating 200 has a thickness of 0.01mm-2mm in the initial state (ie dry state), and a thickness of 0.03mm-8mm after absorbing liquid and swelling.
  • the ureteral stent with the expandable coating 200 in a dry state is implanted into the ureter. Since the outer diameter of the stent is small at this time, it can be easily moved to a designated position in the ureter without causing damage to the patient's ureter. . After being implanted at a designated location, the expandable coating 200 absorbs body fluid and expands to a predetermined diameter, thereby dilating the narrow section of the ureter to prevent or treat ureteral stricture.
  • the expandable coating of the present application can effectively dilate the ureter and resist ureteral stricture.
  • the maximum thickness of the expandable coating after expansion can reach 8mm, which is equivalent to the inner diameter of the ureter, so it can effectively treat ureteral stricture patients with severe ureteral stricture.
  • the stent body 100 is hollow tubular, and a plurality of drainage holes 110 are uniformly arranged on the outer surface of the stent body 100, after the expandable coating 200 is expanded and the ureter is blocked, urine can pass through the drainage holes 110 enters the stent body 100 and exits the body, thereby realizing the drainage of urine.
  • the urine in the ureter will stay at the end of the expandable coating 200, where stones are likely to be formed. Due to the large diameter of the stones, it is difficult to enter the stent body through the drainage hole 110 100 and excreted from the body, so after the stent is implanted for a period of time, the stones will continue to accumulate, resulting in the problem of urinary tract blockage.
  • the larger opening 120 allows stones to enter the stent body 100 through the opening 120 and be discharged from the body, thereby overcoming the problem of urinary tract blockage.
  • the opening 120 at the outer end is not limited to being set at the end of the expandable coating 200, but can also be set at any place on the outer surface of the stent body 100 , as long as the calculus entering the stent body 100 can be discharged.
  • the diameter of the drainage hole 110 of the stent body 100 is 0.1 mm-1.7 mm, and the diameter of the opening 120 is 0.3 mm-2.5 mm. Adopting such a structure can not only ensure the drainage effect of the stent body 100 on urine and calculi, but also ensure the strength of the stent body 100 and prevent the stent body 100 from breaking during use.
  • the inner wall of the ureter will be scratched during the operation, causing iatrogenic damage to the ureter, thereby causing ureteral stenosis, which accounts for a large part of ureteral stenosis.
  • ureteral stricture not only the treatment of ureteral stricture, but also the smooth excretion of stones should be considered.
  • Currently available ureteral stents on the market are generally thinner.
  • the inner diameter of the ureteral stent from Boston Scientific Corporation is 2.31mm (7Fr).
  • the ureter is a slender muscular tube, which is flat and cylindrical, with an average diameter of about 5 to 7 mm.
  • the diameter of the non-expandable ureteral stent is much smaller than the diameter of the ureter.
  • the ureteral stent of the present application can effectively treat ureteral stenosis because it has an expandable coating. Protruded so that urine in the ureter can only pass through the inside of the ureteral stent. In order to avoid the accumulation of stones in the ureter, it is especially clinically valuable to design larger openings on the exposed outer surface of the stent at both ends of the expandable coating. The opening at the lower end of the ureteral stent allows the stones to be discharged from the ureter, one in and one out so that the stones can be smoothly discharged from the body.
  • the ureteral stent of the present application simultaneously realizes the treatment of ureteral stenosis, and avoids the problems of urinary tract blockage and hydronephrosis caused by the accumulation of stones, and has predictable use value for patients.
  • the opening size of this application has been designed through theoretical analysis and laboratory demonstration, which is not only conducive to the discharge of stones, but also will not cause the ureteral stent to break due to the large diameter of the opening, which realizes the effectiveness of the ureteral stent while ensuring , ensuring more security.
  • the stent body 100 has a limiting portion at a position close to the end of the expandable coating 200 for limiting the axial movement of the expandable coating, It is used to maintain the integrity of the ureteral stent and prevent the peeled expandable coating 200 from remaining in the ureter, causing urinary tract infection, blockage or calculus.
  • the expandable coating 200 Since the outer diameter of the ureteral stent is small when implanted, the expandable coating 200 does not directly abut against the inner wall of the ureter, and the problem of peeling off of the expandable coating 200 is not easy to occur.
  • the expandable coating 200 after expansion is against the inner wall of the ureter, and the friction force between the expandable coating 200 and the inner wall of the ureter needs to be overcome before the ureteral stent can be taken out. Problem with layer 200 delamination.
  • a limiting part can also be provided only at the lower end of the expandable coating 200 (that is, the end close to the bladder), only for limiting the expandable coating 200 when the stent is taken out.
  • the peeling problem of the expandable coating 200 is basically overcome, and the production cost can be reduced.
  • the present invention preferably adopts a structural form in which limiting portions are provided at both ends of the expandable coating 200 to avoid peeling of the expandable coating 200 to the greatest extent.
  • the limiting portion is a protruding portion 210 disposed around the outer surface of the bracket body 100 .
  • the circumferential outer diameter of the protrusion 210 is smaller than or equal to the maximum outer diameter of the expandable coating 200 after expansion, so as to avoid hindering the implantation and removal of the ureteral stent.
  • the protruding portion 210 may be a boss or a sheet or the like.
  • the protruding portion 210 may also be funnel-shaped, and the end of the expandable coating 200 is disposed facing the funnel surface of the protruding portion 210 .
  • Adopting such a structure can make the end of the expandable coating 200 and the inner surface of the protrusion 210 (the inner surface is the concave funnel surface) adhere to each other, and better prevent the expandable coating 200 from peeling off. .
  • the axial end of the stent body 100 has a locking portion for limiting the movement of the stent body.
  • the retaining portion can be in the shape of a coiled disc, a coiled ball, etc., which can play a position-limiting role in the renal pelvis and bladder.
  • the locking part is provided with a locking part 140 with the opposite winding direction, and the locking part 140 can be in the shape of a coiled disc, a coiled ball, etc., which can play a limiting role in the renal pelvis and bladder.
  • the locking parts 140 at both ends are respectively placed in the renal pelvis and the bladder, thereby realizing the limitation of the stent.
  • the locking portion 140 is also a hollow tubular structure and integrally connected with the bracket body 100 , and the locking portion 140 is also provided with a drainage hole 110 to improve drainage of urine.
  • the stent body 100 is made of polymer material, which may be polyurethane or silicone rubber, and its radial support force is 0.5N-20N.
  • the length of the bracket body 100 is 5cm-40cm. The length of the stent body 100 in actual use depends on the length of the patient's ureter.
  • the expandable coating 200 is coated on the surface of the stent body 100 by one or more methods of spray coating, brush coating, mold filling coating, dip coating, roll coating, spin coating, molding, electrodeposition, and vacuum vapor deposition. , and fixed on the stent body by one or more methods of air oxidation curing, solvent volatilization curing, thermal reaction or chemical reaction curing, radiation curing (including ultraviolet light curing and electron beam curing), melt curing and infrared catalytic thermal reaction curing
  • the surface of 100 is preferably fixed by a photocuring method with high bonding strength.
  • the peeling resistance of the expandable coating 200 is 0.5N-15N.
  • Flow guide lines are provided on the outer surface of the expandable coating 200 , and/or anti-slip lines are provided on the inner surface of the expandable coating 200 .
  • the drainage lines can drain urine and stones, and the anti-slip lines can enhance the friction with the stent body 100 to prevent the expandable coating from peeling off.
  • the mode of use of the ureteral stent of the present invention is as follows:
  • the expandable coating 200 expands to a specified thickness after absorbing body fluids, thereby dilating the stricture of the ureter;
  • the ureteral stent is removed. At this time, the patient's narrow ureter has been healed and the diameter of the ureter has reached normal.
  • the superimposed structure of the stent body and the expandable coating is adopted, and the thickness of the expandable coating corresponding to the ureteral stenosis is thicker than other parts.
  • the expandable coating The layer can better resist the compressive force of the ureteral stenosis, so that the treated ureter has a more uniform inner diameter and the treatment effect is better.
  • the self-expandable expandable coating is adopted, which is convenient for implantation. After expansion, the expandable coating can fit the inner wall of the ureter well, and can maintain sufficient supporting force before the ureteral stricture is repaired, and is not easy to shift. The expandable coating is soft and does not damage the ureter and reduces discomfort.
  • the thickness of the expandable coating corresponding to the stenosis of the ureter When the thickness of the expandable coating corresponding to the stenosis of the ureter is located in the middle of the expandable coating, the thickness of the expandable coating gradually increases from both ends to the middle or the thickness gradually increases from both ends to the middle to a certain value.
  • the uniform thickness extends to the middle, so that the treated ureter has a more uniform inner diameter, and the treatment effect is better.
  • the body of the stent is continuously or discontinuously provided with multiple segments of the expandable coating along the axial direction, which can be applied to ureters with multiple strictures.
  • the outer surface of the expandable coating is provided with diversion lines, and/or the inner surface of the expandable coating is provided with anti-skid lines.
  • the drainage lines can drain urine and stones, and the anti-slip lines can enhance the friction with the stent body, preventing the expandable coating from peeling off from the stent body.
  • the expandable coating is mostly made of materials with good biocompatibility such as gel, which can realize the endothelialization of the ureter at the ureteral stent within a reasonable period and reduce the occurrence of complications.
  • the stent body is hollow tubular, and the outer surface of the stent body is provided with drainage holes and larger openings than the drainage holes.
  • the drainage hole can be used to drain urine and stones, and the function of the opening is to discharge stones with larger diameters out of the body to avoid blockage in the ureter.
  • the stent body has a limiting part adjacent to the end of the expandable coating, which restricts the expandable coating from moving toward the limiting part.
  • the limiting part can prevent the expandable coating from peeling off from the stent body.
  • At least one end of the bracket body in the axial direction has a locking part to limit the movement of the bracket body towards the locking part.
  • the locking part can be placed in the renal pelvis or the bladder, and plays a role of limiting the stent body and preventing the stent body from moving.
  • the expandable coating swells when it encounters liquid (such as water or urine), and its outer diameter will be larger than that of the ureteral lesion, thus playing an anti-stenosis effect.
  • the ureteral stent must ensure that its expandable coating will not be broken due to radial extrusion, or that the ureteral stent body will not be deformed due to extrusion. Therefore, the purpose of this experiment is to test the radial support force of the ureteral stent.
  • the placement tool 300 includes a pull plate 320, and an annular placement member 310 arranged at the edge of the pull plate 320 at intervals for the bracket body 100 to penetrate.
  • Sample preparation fully soak the ureteral stent in liquid (such as water or urine), until the diameter of the expandable coating expands to 100% (that is, the diameter of the expandable coating does not change), and the soaking time is ⁇ 29 days ;
  • the two pull plates 320 on which the tooling 300 is placed are connected to the computerized tensile testing machine 500; the ring-shaped placement parts 310 of the two pull plates 320 on which the tooling 300 is placed are arranged in a staggered manner, thereby forming a tubular place where the bracket body 100 can penetrate. area;
  • the computerized tensile testing machine 500 drives the two pull plates 320 on which the tooling 300 is placed to move in opposite directions, and the tooling 300 to be placed After the two pull plates 320 move 0.5mm, the computerized tensile testing machine 500 stops automatically. During this process, it should be observed whether the expandable coating is intact, whether the bracket body is intact and not deformed, and the maximum force value during the process should be recorded;
  • the radial pressure on the ureteral stent during use should not exceed this radial support force, so as to ensure that the expandable coating and the stent body are not damaged or deformed.
  • the ureteral stent with the expandable coating After the ureteral stent with the expandable coating is soaked in liquid (such as water or urine), the expandable coating will expand, and after being inserted into the ureter, the expandable coating will play an anti-stenosis effect due to the expansion. However, after the use of the ureteral stent is over, the ureteral stent with the expandable coating needs to be removed from the ureter of the human body.
  • liquid such as water or urine
  • this test is used to detect the anti-peeling force required for the swellable coating to fall off or break due to the narrow channel during the passage of the ureteral stent through the simulated human ureter.
  • This experiment adopts the tooling device 400 as shown in Figure 11, has a hollow interior space 410 in this tooling device 400, and the top of this tooling device 400 has the through-hole 420 that communicates with the outside, and the through-hole 420 that establishs should be able to ensure the test sample
  • the bracket body just passes freely.
  • the tooling device 400 is placed under the computerized tensile testing machine 500 and can be fixed on the computerized tensile testing machine 500 to ensure that the tooling device 400 will not move during the testing process and affect the accuracy of the testing results.
  • Sample preparation put the ureteral stent into a liquid (such as water or urine) and soak it until the diameter of the expandable coating expands to 100%, the soaking time is ⁇ 29 days, and then take it out;
  • a liquid such as water or urine
  • the stent body 100 through the through hole 420 from bottom to top, make the part of the stent body 100 that does not have an expandable coating pass through the upper end of the through hole 420, connect the stent body 100 with a computerized tensile testing machine 500 and fix it, and fine-tune the position of the sample , ensuring that the expandable coating is partially located in the hollow interior space 410 of the tooling appliance 400;
  • the maximum force of the tensile testing machine 500 in this process is the anti-peeling force of the expandable coating.
  • the expanded expandable coating When the expanded expandable coating is partly peeled off, it is completely peeled off as a whole, and no residual expandable coating is left on the stent body.
  • the pulling force suffered by the ureteral stent during use should not exceed this anti-peeling force, so as to ensure that the expandable coating does not peel off from the stent.
  • the tooling device 400 in this experiment is a rigid material, and the friction force between the through hole 420 and the ureteral stent is relatively small, and the ureteral stent can easily pass through the through hole 420 , so the peeling resistance measured in the experiment is relatively small. If the through hole 420 is replaced with a flexible channel that simulates the ureter, the friction between the channel and the ureteral stent will increase, and it will become difficult for the ureteral stent to pass through the channel, so the anti-peeling force measured in the experiment will increase. Big. After several experiments, the experimental results show that the anti-peeling force between the expandable coating and the stent body is in the range of 0.5N-15N.

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Abstract

本发明公开了一种输尿管支架，包括支架本体和设于所述支架本体外表面的可膨胀涂层，对应所述输尿管狭窄部分的可膨胀涂层厚度较其余部分的可膨胀涂层厚度更大。采用这样的结构，该可膨胀涂层能够更好地抵抗输尿管狭窄部分的压迫力，使治疗后的输尿管具有更均匀的内径，治疗效果更佳。

Description

输尿管支架
本申请要求申请日为2021/7/23的中国专利申请2021108382095的优先权。本申请引用上述中国专利申请的全文。
技术领域
本发明涉及医用支架领域，特别涉及一种输尿管支架。
背景技术
输尿管狭窄在临床上并不少见，除了先天性狭窄，继发性输尿管狭窄主要为医源性狭窄、结石嵌顿、感染、子宫内膜异位症、腹膜后纤维化、恶性肿瘤、放射治疗等引起。
传统治疗方式为开放手术，但输尿管重建的开放手术具有创伤大，手术复杂，并发症多，术后恢复较慢以及容易复发等缺点。随着内镜技术的发展，输尿管狭窄腔内手术治疗逐渐普及，首选内镜下输尿管球囊扩张或者输尿管狭窄内切开术，术后需要置入输尿管支架防止狭窄复发。目前，临床常用的双J管存在置管后不适感、支架皮壳形成甚至诱发结石生成以及需要定期更换等缺点。近年来金属支架开始应用于临床，具有生物相容性、柔软性和耐腐蚀性的优点，但仍然不能永久性留置体内，另外并发症很多，特别是容易移位，大大降低了输尿管狭窄治愈率。
金属支架主要是美国COOK公司生产的Resonance TM和APPLIED医疗公司生产的Silhouette TM，螺旋式的线圈设计同时增加了拉伸强度和稳定性，极大地延长金属支架留置时间，同时并发症比双J管少，而且对恶性肿瘤造成的输尿管狭窄的治疗效果更好，但仍然存在支架梗阻、患者不适以及***等问题。近年来有些新的金属支架被研发，它们并不覆盖输尿管全长，仅仅针对狭窄的输尿管，又被称为可膨胀金属输尿管支架，根据膨胀机制可以分为自身膨胀和球囊膨胀。球囊膨胀因为存在梗阻性尿路上皮增生反应而在临床上应用受限，因此临床上可膨胀金属输尿管支架通常指的是自身膨胀性金属支架。第一款可膨胀金属输尿管支架是波士顿科学公司生产的Wallstent,是不锈钢制成的钢丝网,既可顺行也可逆行置入。虽然不能避免肿瘤生长压迫支架甚至发生堵塞，但支架通畅率可高达54％。缺点是它最初设计并不是用于输尿管的，因此支架移除存在困难。
虽然可膨胀金属输尿管支架比传统的双J管有很多优点，但是太多的并发症限制了它们在临床的广泛应用。早期支架相关的不良反应包括医源性损伤，支架移位和患者不适感，晚期支架相关并发症包括感染和支架更换困难，硬件故障以及支架结垢。极少数情况下，延长支架放置会导致输尿管动脉瘘和髂血管糜烂。另外，关于可膨胀金属输尿管 支架的治疗效果缺乏大宗病例的随机临床试验和长期随访观察，也没有临床数据比较各种支架的治疗效果。同时，发现术后支架发生不同程度的移位，而一旦发生移位后调整位置非常困难。另外，一旦支架输出后，如果放置不当不能回收，增加了手术医生的心理负担和患者的经济负担。
美国专利US2012/0123527A1公开了一种输尿管支架，包括网状的金属基可膨胀覆膜支架本体和设于覆膜支架本体外表面的水凝胶涂层，该水凝胶涂层可在浸润液体后略微膨胀，但将狭窄部撑开的部件主要是可膨胀的覆膜支架本体。水凝胶涂层的主要作用是增加支架表面的生物相容性，增加与植入管壁的贴合性，而非对抗输尿管狭窄。但是，本方案依旧存在以下的技术问题：
该可膨胀的覆膜支架由于整体呈圆柱体的形状，在输尿管中无法很稳定地定位，术后支架会发生不同程度的移位，而且一旦发生移位后调整位置非常困难。同时，可膨胀的覆膜支架本体的厚度是均一的，其水凝胶涂层的厚度也是均一的，而输尿管的狭窄部内径则通常是渐变的，当水凝胶涂层膨胀开后，由于输尿管狭窄处对凝胶涂层的压迫力要大于其他部位对凝胶涂层的压迫力，会使此处凝胶涂层产生较大的凹陷，在新的输尿管内壁长成、取出支架后，对应原输尿管狭窄处的内径仍会较其余部分小，影响治疗效果。
发明内容
本发明所要解决的技术问题，是克服现有技术在输尿管支架使用完毕后，对应原输尿管狭窄处的内径仍会较其余部分小的缺陷，提供了一种新型的输尿管支架。
本发明通过如下方式解决该技术问题：
一种输尿管支架，包括支架本体和设于所述支架本体外表面的可膨胀涂层，对应所述输尿管狭窄部分的可膨胀涂层厚度较其余部分的可膨胀涂层厚度更大。采用这样的结构，该可膨胀涂层能够更好的抵抗输尿管狭窄部分的压迫力，使治疗后的输尿管具有更均匀的内径，治疗效果更佳。
作为本发明的一种优选实施方式，所述可膨胀涂层的厚度从两端向中间逐渐变大，此种结构适用于具有内径渐缩狭窄部的输尿管，或者所述可膨胀涂层包括轴向均一段和位于所述轴向均一段两端的渐小段。此种结构适用于具有轴向均一内径狭窄部的输尿管。
作为本发明的一种优选实施方式，所述支架本体沿轴向连续或非连续地设有多段所述可膨胀涂层。此种结构能够适用于具有多处狭窄部的输尿管。
作为本发明的一种优选实施方式，所述可膨胀涂层的外表面上设有导流纹路，和/或，所述可膨胀涂层的内表面上设有防滑纹路。该导流纹路能够对尿液和结石进行引流，该 防滑纹路能够增强与支架本体之间的摩擦力，避免可膨胀涂层剥离。
作为本发明的一种优选实施方式，所述支架本体为非膨胀性的中空管状，所述支架本体的外表面上设有引流孔以及较所述引流孔更大的开孔。在本发明中，所述非膨胀性是指支架本体在植入后其外径不发生变化。该引流孔的作用是对尿液和结石进行引流，该开孔的作用是将直径较大的结石排出至体外，避免输尿管内出现堵塞。
作为本发明的一种优选实施方式，所述引流孔的直径为0.1mm-1.7mm，所述开孔的直径为0.3mm-2.5mm。
作为本发明的一种优选实施方式，所述支架本体在对应所述可膨胀涂层端部的位置处具有用于限制所述可膨胀涂层发生轴向移动的限位部。
作为本发明的一种优选实施方式，所述限位部为周设于所述支架本体外表面上的突起部，所述突起部的周向外径小于或等于所述可膨胀涂层膨胀后的最大外径。
作为本发明的一种优选实施方式，所述突起部呈漏斗形，所述可膨胀涂层的端部面朝所述突起部的漏斗面设置。采用这样的结构能够更好地避免可膨胀涂层剥离支架本体。
作为本发明的一种优选实施方式，所述突起部为凸台或薄片。
作为本发明的一种优选实施方式，所述支架本体的轴向端具有用于限制所述支架本体移动的卡位部。卡位部分别置于肾盂和/或膀胱中，以起到对支架本体的限位作用。
作为本发明的一种优选实施方式，所述可膨胀涂层与所述支架本体间的抗剥离力为0.5N-15N。
作为本发明的一种优选实施方式，所述可膨胀涂层为遇液体可膨胀的材料，所述可膨胀涂层的初始厚度为0.01mm-2mm，膨胀后的厚度为0.03mm-8mm。
综合以上，本发明的积极进步效果在于：
1.本发明提供的输尿管支架中，采用了支架本体和可膨胀涂层叠加的结构，并且可膨胀涂层对应输尿管狭窄部分的厚度相对于其他部分更厚，采用这样的结构，该可膨胀涂层能够更好地抵抗输尿管狭窄部分的压迫力，使治疗后的输尿管具有更均匀的内径，治疗效果更佳。
2.采用自膨胀的可膨胀涂层，植入方便，可膨胀涂层膨胀后能够很好的贴合输尿管内壁，在输尿管狭窄修复前能够保持足够的支撑力，不易发生移位。可膨胀涂层质地柔软，不会损伤输尿管，并能够减少不适感。
3.当对应输尿管狭窄部分的可膨胀涂层厚度位于可膨胀涂层中部时，可膨胀涂层 的厚度从两端向中间逐渐变大或厚度从两端向中间逐渐变大到一定数值后以均一厚度向中间延伸，使治疗后的输尿管具有更均匀的内径，治疗效果更佳。
4.支架本体沿轴向连续或非连续地设有多段所述可膨胀涂层，能够适用于具有多处狭窄部的输尿管。
5.所述可膨胀涂层的外表面上设有导流纹路，和/或，所述可膨胀涂层的内表面上设有防滑纹路。该导流纹路能够对尿液和结石进行引流，该防滑纹路能够增强与支架本体之间的摩擦力，避免可膨胀涂层从支架本体上剥离。可膨胀涂层多采用凝胶等生物相容性好的材料，能够在合理周期内实现输尿管支架处的输尿管的内皮化，减少并发症的发生。
6.所述支架本体为中空管状，所述支架本体的外表面上设有引流孔以及较所述引流孔更大的开孔。该引流孔可用于对尿液和结石进行引流，该开孔是作用是将直径较大的结石排出至体外，避免输尿管内出现堵塞。
7.所述支架本体上与可膨胀涂层端部毗邻处具有限位部，限制可膨胀涂层向限位部方向移动。该限位部能够避免可膨胀涂层从支架本体上剥离。
8.所述支架本体的轴向至少一端具有卡位部，以限制支架本体向卡位部方向移动。卡位部可置于肾盂或膀胱中，起到对支架本体的限位作用，防止支架本体移动。
附图说明
下面结合附图来对本发明进行进一步的说明：
图1为可膨胀涂层处于下段时的输尿管支架图；
图2为可膨胀涂层处于中段时的输尿管支架图；
图3为可膨胀涂层处于上段时的输尿管支架图；
图4为采用非均一厚度可膨胀涂层的一种实施例；
图5为采用非均一厚度可膨胀涂层的另一种实施例；
图6为引流孔和开孔的立体视图；
图7为一种凸台的设置方案；
图8为另一种凸台的设置方案；
图9为又一种凸台的设置方案；
图10为实验例1的示意图；
图11为实验例2的示意图；
附图标记及说明：
支架本体100、引流孔110、开孔120、卡位部140、可膨胀涂层200、突起部210、放置工装300、环形放置件310、拉板320、工装器具400、内部空间410、通孔420、电脑式拉力试验机500。
具体实施方式
以下通过具体实施例来对本发明进行进一步阐述：
如图1至图3所示，一种输尿管支架，包括支架本体100与可膨胀涂层200，该支架本体100为非膨胀性支架，这里的非膨胀性是指支架本体100在植入后其外径不发生变化，该可膨胀涂层200环设于支架本体100外表面的至少一部分上，该可膨胀涂层200能够在吸收人体体液后膨胀，将输尿管扩张开，由此起到治疗输尿管狭窄的作用。
该可膨胀涂层200位于支架本体100外表面的任何一处或几处，可以是支架本体100的上部、中部或下部，位置取决于患者输尿管狭窄的位置。
该可膨胀涂层200的厚度既可以是均一的，也可以是非均一的。
如图4和图5所示，在可膨胀涂层200厚度是非均一的实施例中，对应输尿管狭窄处的可膨胀涂层200厚度大于对应输尿管其余部分的可膨胀涂层200厚度。采用这样的结构，对应输尿管狭窄处的可膨胀涂层200能够更好的抵抗输尿管狭窄部的压迫力，使治疗后的输尿管具有更均匀的内径，治疗效果更佳。
如图4所示，在一些实施例中，该可膨胀涂层200的厚度从两端到中间逐渐增大，此种结构适用于具有内径渐缩狭窄部的输尿管。在可替代的实施例中，可膨胀涂层200包括位于中间的轴向均一段和设于轴向均一段两端的渐小段。该轴向均一段对应输尿管的狭窄部，此种结构适用于具有轴向均一内径狭窄部的输尿管。
如图5所示，在另一些实施例中，该支架本体100沿轴向设有多段可膨胀涂层200，可以连续设置或非连续设置。此种结构能够适用于具有多处狭窄部的输尿管。
需要说明的是，上文的厚度指支架径向方向上的厚度。当然，也可以根据病人输尿管的实际形状采用径向方向上厚度不均一的输尿管。
该可膨胀涂层200为遇液体可膨胀的材料。遇液体可膨胀的材料即为遇到人体体液或水便可以膨胀的材料，比如水凝胶材质，可选用聚乙烯醇、聚乙二醇、聚乙二醇二甲基丙烯酸酯、聚(乙二醇)二丙烯酸酯、甲基丙烯酸羟乙酯、聚氧化乙烯-聚氧化丙烯-聚氧化乙烯、聚氨酯、聚乙烯吡咯烷酮、乙烯基吡咯烷酮-丙烯酸共聚物、聚丙烯酰胺、聚乙烯基己内酰胺、聚丙烯酸酯、聚氨基酸、羧甲基纤维素、聚丙烯酸甲酯、海藻酸盐、聚羟乙基丙烯酸甲酯、丙烯酰胺、聚丙烯酸、水解聚丙烯腈、聚乙烯亚胺、乙氧基化聚乙 烯亚胺聚烯丙基胺、透明质酸、甲基丙烯酸化的透明质酸、壳聚糖、胶原、明胶、纤维蛋白、葡聚糖、琼脂糖中的一种或多种。
凝胶材质具有良好的弹性力度，能够良好的贴合输尿管内壁，使可膨胀涂层200能够稳定地支撑在输尿管的狭窄段，不易发生移位；且凝胶材质柔软，能够轻柔地接触输尿管内壁，不易造成输尿管内壁损伤，并能够降低病人的不适感。
该可膨胀涂层200在初始状态(即干态)下的厚度为0.01mm-2mm，吸收液体膨胀后的厚度0.03mm-8mm。
使用时，将可膨胀涂层200处于干态的输尿管支架植入输尿管中，由于此时支架的外径较小，因此可以方便的将其移至输尿管内的指定位置而不易对病人输尿管造成损伤。在植入至指定位置后，可膨胀涂层200吸收体液扩张至预定直径，从而扩张输尿管的狭窄段，达到预防或治疗输尿管狭窄的作用。
本申请可膨胀涂层可有效扩张输尿管和对抗输尿管狭窄。可膨胀涂层膨胀后的最大厚度可达8mm，与输尿管内径相当，因此对于较严重的输尿管狭窄患者可以有效地治疗输尿管狭窄。
如图6所示，该支架本体100为中空管状，支架本体100的外表面上均匀布置有多个引流孔110，在可膨胀涂层200膨胀并将输尿管封堵后，尿液可经引流孔110进入支架本体100并排出体外，由此实现对尿液的引流。
当可膨胀涂层200封堵输尿管后，输尿管内的尿液会滞留在可膨胀涂层200的端部位置，容易在此处产生结石，由于结石直径较大，不易经引流孔110进入支架本体100并排出体外，因此在植入支架一段时间后，结石会不断累积，导致出现尿路堵塞的问题，为解决该问题，优选在可膨胀涂层200两端的支架裸露外表面上设置较引流孔更大的开孔120，使结石能够经开孔120进入支架本体100并排出体外，从而克服尿路堵塞的问题。
需要说明的是，靠外一端的开孔120(即靠近尿道一端的开孔)并不局限于设置在可膨胀涂层200的端部，也可以设置在支架本体100外表面上的任意一处，只要能够使进入支架本体100的结石排出即可。
具体的，该支架本体100的引流孔110的直径为0.1mm-1.7mm，该开孔120的直径为0.3mm-2.5mm。采用这样的结构，既能保证支架本体100对尿液和结石的引流效果，又可以保证支架本体100的强度，避免支架本体100在使用中断裂。
由于在治疗肾结石时，手术过程中会划伤输尿管内壁，对输尿管造成医源性损伤，从而引发输尿管狭窄，这种病例占输尿管狭窄很大的一部分。对于这种患者的输尿管治疗，不仅要考虑治疗输尿管狭窄，同时要考虑结石能顺利排出体外。目前市面上已有的 输尿管支架一般较细，例如波士顿科学公司的输尿管支架最大通过鞘管的内径为2.31mm(7Fr)。而输尿管为细长的肌性管道，呈扁圆柱状，管径平均约为5～7mm。可见该不可膨胀输尿管支架的管径要远远小于输尿管的直径，在植入输尿管后，尿液和结石除了通过输尿管支架的内部排出外，还可以从输尿管支架和输尿管之间的缝隙排出体外的，因此也就无须考虑在输尿管支架上设置便于结石排出的较大的开孔。
本申请的输尿管支架由于带有可膨胀涂层，可有效治疗输尿管狭窄，在可膨胀涂层膨胀后会与输尿管紧密贴合，两者间没有一点间隙，可膨胀涂层可把输尿管狭窄处充分撑开，因此输尿管中的尿液只能通过输尿管支架的内部通过。为避免结石在输尿管中累积，设计更大的开孔于所述可膨胀涂层两端的支架裸露外表面上就尤其具有临床价值，位于输尿管支架上端的开口用于使结石进入输尿管支架的内部向下排出，而在输尿管支架下端的开口是使结石从输尿管中排出体外，一进一出使结石可以顺利排出体外。作为医疗器械产品，即使输尿管支架为短期植入也需要考虑相应的风险，且输尿管支架不宜重复更换，以免给患者造成损伤和痛苦，且会极大地增加患者的医疗支出。本申请的输尿管支架同时实现了治疗输尿管狭窄，并避免结石累积而导致出现尿路堵塞和肾积水的问题，对患者有可预期的使用价值。本申请的开孔尺寸在设计时已经经过理论分析和实验室论证，既有利于结石排出，又不会因为开孔的孔径过大而使输尿管支架破裂，实现了在保证输尿管支架有效性的同时，更多地确保了其安全性。
如图7、图8与图9所示，优选的，支架本体100的在靠近可膨胀涂层200端部的位置处具有用于限制所述可膨胀涂层发生轴向移动的限位部，用于保持输尿管支架的完整，避免剥离的可膨胀涂层200留在输尿管中，导致***、堵塞或出现结石。
由于输尿管支架在植入时的外径较小，可膨胀涂层200不直接抵顶于输尿管内壁，不易发生可膨胀涂层200剥离的问题。而在取出输尿管支架时，膨胀后的该可膨胀涂层200抵顶于输尿管的内壁，需克服可膨胀涂层200与输尿管内壁间的摩擦力方能取出输尿管支架，此时容易发生可膨胀涂层200剥离的问题。
因此在一些实施例中，也可以仅在可膨胀涂层200的下端(即靠近膀胱的一端)处设置限位部，仅用于在取出支架时对可膨胀涂层200进行限位，既能够基本克服可膨胀涂层200的剥离问题，又能减少生产成本。当然，本发明优选采用的是在可膨胀涂层200的两端均设置有限位部的结构形式，以最大限度地避免可膨胀涂层200剥离的情况发生。
该限位部为周设于支架本体100外表面上的突起部210。该突起部210的周向外径小于或等于可膨胀涂层200膨胀后的最大外径，以避免阻碍输尿管支架的植入和取出。该突起部210可以是凸台或薄片等。
优选的，如图7所示，该突起部210还可以呈漏斗形，该可膨胀涂层200端部面朝突起部210的漏斗面设置。采用这样的结构能够使可膨胀涂层200的端部与突起部210的内表面(该内表面即内凹的漏斗面)相互贴合，更好的起到防止可膨胀涂层200剥离的作用。
该支架本体100的轴向端端具有用于限制所述支架本体移动的卡位部。卡位部可以是卷绕盘状，卷绕球状等可以在肾盂和膀胱中能够起到限位作用的任何形状。在本实施例中卡位部是设有卷绕方向相反的卡位部140，卡位部140可以是卷绕盘状、卷绕球状等能够在肾盂和膀胱中起到限位作用的形状，在支架安装完毕后，两端的卡位部140分别置于肾盂和膀胱中，由此实现对支架的限位。优选的，该卡位部140同为中空管状结构并与支架本体100一体化相连，该卡位部140上同样设有引流孔110，以提高对尿液的引流作用。
该支架本体100由高分子材料制作，该高分子材料可以是聚氨酯或硅橡胶，其径向支撑力为0.5N-20N。该支架本体100的长度为5cm-40cm。实际使用时的支架本体100的长度取决于病人的输尿管长度。
该可膨胀涂层200通过喷涂、刷涂、模具填充涂覆、浸涂、辊涂、旋转涂、模塑、电沉积、真空气相沉积中的一种或多种方式涂覆于支架本体100表面，并通过空气氧化固化、溶剂挥发固化、热反应或化学反应固化、辐射固化(含紫外光固化和电子束固化)、熔融固化及红外催化热反应固化的一种或多种方法固定于支架本体100的表面，优选采用结合强度高的光固化法进行固定。在本发明中，可膨胀涂层200的抗剥离力为0.5N-15N。
可膨胀涂层200的外表面上设有导流纹路，和/或，可膨胀涂层200的内表面上设有防滑纹路。该导流纹路能够对尿液和结石进行引流，该防滑纹路能够增强与支架本体100之间的摩擦力，避免可膨胀涂层剥离。
本发明的输尿管支架的使用方式如下：
将可膨胀涂层200处于干态时的输尿管支架植入病人的输尿管中的对应位置；
可膨胀涂层200吸收人体体液后膨胀至指定厚度，从而扩张输尿管的狭窄部；
经过28天，新的输尿管内壁形成后，将输尿管支架取出，这时患者狭窄的输尿管已经痊愈，并达到正常的输尿管直径。
本输尿管支架的优点在于：
1.本发明提供的输尿管支架中，采用了支架本体和可膨胀涂层叠加的结构，并且可膨胀涂层对应输尿管狭窄部分的厚度相对于其他部分更厚，采用这样的结构，该可膨胀 涂层能够更好地抵抗输尿管狭窄部分的压迫力，使治疗后的输尿管具有更均匀的内径，治疗效果更佳。
2.采用自膨胀的可膨胀涂层，植入方便，可膨胀涂层膨胀后能够很好的贴合输尿管内壁，在输尿管狭窄修复前能够保持足够的支撑力，不易发生移位。可膨胀涂层质地柔软，不会损伤输尿管，并能够减少不适感。
3.当对应输尿管狭窄部分的可膨胀涂层厚度位于可膨胀涂层中部时，可膨胀涂层的厚度从两端向中间逐渐变大或厚度从两端向中间逐渐变大到一定数值后以均一厚度向中间延伸，使治疗后的输尿管具有更均匀的内径，治疗效果更佳。
4.支架本体沿轴向连续或非连续地设有多段所述可膨胀涂层，能够适用于具有多处狭窄部的输尿管。
5.可膨胀涂层的外表面上设有导流纹路，和/或，可膨胀涂层的内表面上设有防滑纹路。该导流纹路能够对尿液和结石进行引流，该防滑纹路能够增强与支架本体之间的摩擦力，避免可膨胀涂层从支架本体上剥离。可膨胀涂层多采用凝胶等生物相容性好的材料，能够在合理周期内实现输尿管支架处的输尿管的内皮化，减少并发症的发生。
6.支架本体为中空管状，支架本体的外表面上设有引流孔以及较引流孔更大的开孔。该引流孔可用于对尿液和结石进行引流，该开孔是作用是将直径较大的结石排出至体外，避免输尿管内出现堵塞。
7.支架本体上与可膨胀涂层端部毗邻处具有限位部，限制可膨胀涂层向限位部方向移动。该限位部能够避免可膨胀涂层从支架本体上剥离。
8.支架本体的轴向至少一端具有卡位部，以限制支架本体向卡位部方向移动。卡位部可置于肾盂或膀胱中，起到对支架本体的限位作用，防止支架本体移动。
以下通过实验例来进一步说明本发明的效果：
实验例1(径向支撑力实验)：
实验目的：
本输尿管支架在使用过程中，可膨胀涂层遇液体(例如水或尿液)后膨胀，其外径会比输尿管病灶部位要大，从而起到抗狭窄的作用。在这个支架使用过程中，输尿管支架要保证其可膨胀涂层不会因为径向挤压而破碎，或者输尿管支架本体不会因为挤压而变形。因此，本试验的目的是测试输尿管支架的径向支撑力。
实验器具：
本实验例采用如图10所示的放置工装300，该放置工装300包括拉板320，以及间 隔布置于拉板320边缘处的供支架本体100穿入的环形放置件310。
实验步骤：
样品制备：使输尿管支架充分浸泡在液体中(例如水或尿液)，到可膨胀涂层的直径膨胀到100％程度(即可膨胀涂层的直径不再发生变化)，浸泡时间≤29天；
将放置工装300的两个拉板320连接电脑式拉力试验机500；使放置工装300的两个拉板320的环形放置件310交错布置，由此构成一个可供支架本体100穿入的管状放置区域；
将浸入液体(例如水或尿液)后膨胀的支架本体100置于该放置区域中；
开启电脑式拉力试验机500，以调整环形放置件310与样品的相对位置，应确保环形放置件310与可膨胀涂层部分相接触，但不会对其造成挤压；
设定两个拉板320的移动位移为0.5mm(等同于压缩形变量为0.5mm)，电脑式拉力试验机500驱动放置工装300的两个拉板320朝相反的方向移动，待放置工装300的两个拉板320移动0.5mm后，电脑式拉力试验机500自动停止，该过程中应观察可膨胀涂层是否完好，支架本体是否完好未变形，并记录过程中的最大力值；
将移动位移依次设置为1mm、1.5mm、2mm、2.5mm、3mm和4mm，重复上述步骤，并记录过程中的最大力值，即输尿管支架的径向支撑力。
实验结果：
压缩形变量与径向支撑力的关系，所得的实验数据如表1所示：
表1
压缩形变量 径向支撑力 可膨胀涂层是否完好 支架本体是否完好
0.5mm 0.552N 是 是
1mm 4.138N 是 是
1.5mm 7.726N 是 是
2mm 10.804N 是 是
2.5mm 13.942N 是 是
3mm 16.402N 是 是
4mm 19.942N 是 是
由表1可知，在各个压缩形变量下，膨胀后的可膨胀涂层均未破碎无破损，支架本体也未发生形变，保持完好。具有可膨胀涂层的输尿管的径向支撑力的范围是0.5N-20N。
输尿管支架在使用过程中所受的径向压力应该不超过这个径向支撑力，从而保证可 膨胀涂层和支架本体无破损和未发生形变。
实验例2(抗剥离力实验)：
实验目的：
具有可膨胀涂层的输尿管支架浸泡到液体(例如水或尿液)里后，可膨胀涂层会膨胀，在***输尿管后，可膨胀涂层由于膨胀，起到抗狭窄的作用。但在输尿管支架使用结束后，需要将具有可膨胀涂层的输尿管支架从人体输尿管中取出。
在整个取出的过程中，可膨胀涂层不能破碎且不能从输尿管支架本体脱落，以确保输尿管支架的安全性和有效性。因此本次试验，用来检测输尿管支架在通过模拟人体输尿管的过程中，较窄的通道造成可膨胀涂层脱落或者破碎所需的抗剥离力。
实验器具：
本实验采用如图11所示的工装器具400，该工装器具400中具有中空的内部空间410，该工装器具400的顶部具有连通外部的通孔420，所设通孔420应能确保测试样品的支架本体刚好自由通过。工装器具400置于电脑式拉力试验机500的下面，并能固定在电脑式拉力试验机500上，确保不会在检测过程中出现工装器具400移动等影响检测结果准确度的情况发生。
实验步骤：
样品制备：将输尿管支架放入到液体(例如水或尿液)中浸泡到可膨胀涂层的直径膨胀到100％程度，浸泡时间≤29天，然后取出；
将支架本体100从下至上穿过通孔420，使支架本体100未具有可膨胀涂层的部分穿过通孔420的上端部位，电脑式拉力试验机500连接支架本体100并固定，微调样品位置，确保可膨胀涂层部分位于工装器具400的中空的内部空间410内；
开启电脑式拉力试验机500，电脑式拉力试验机500开始以300mm/min将支架本体100从通孔420中拉出，当可膨胀涂层部分完全被拉出工装器具400，试验结束，记录电脑式拉力试验机500在此过程中的最大力即为可膨胀涂层的抗剥离力。
实验结果：
所得的实验结果如表2所示：
表2
实验序号 1 2 3
抗剥离力 1.442N 1.255N 1.412N
膨胀后的可膨胀涂层部分被剥离时均为整体完全剥离，无残留可膨胀涂层遗留在支 架本体上。输尿管支架在使用过程中所受的拉力应该不超过这个抗剥离力，从而保证可膨胀涂层不从支架上剥离。
本实验的工装器具400是刚性材料，通孔420与输尿管支架的摩擦力相对较小，输尿管支架很容易从通孔420中穿过，因此实验所测的抗剥离力相对较小。如果把通孔420换成一个模拟输尿管的柔性通道，该通道与输尿管支架的摩擦力就会增大，输尿管支架从该通道中穿过会变困难，因此实验所测的抗剥离力就会增大。经过多次实验，实验结果显示可膨胀涂层与所述支架本体间的抗剥离力的范围为0.5N-15N。
虽然以上描述了本发明的具体实施方式，但是本领域的技术人员应当理解，这些仅是举例说明，在不背离本发明的原理和实质的前提下，可以对这些实施方式做出多种变更或修改。因此，本发明的保护范围由所附权利要求书限定。

Claims (13)

  1. 一种输尿管支架，包括支架本体和设于所述支架本体外表面的可膨胀涂层，其特征在于：对应所述输尿管狭窄部分的可膨胀涂层厚度较其余部分的可膨胀涂层厚度更大。
  2. 按照权利要求1所述的输尿管支架，其特征在于：所述可膨胀涂层的厚度从两端向中间逐渐变大，或者，所述可膨胀涂层包括轴向均一段和位于所述轴向均一段两端的渐小段。
  3. 按照权利要求1或2所述的输尿管支架，其特征在于：所述支架本体沿轴向连续或非连续地设有多段所述可膨胀涂层。
  4. 按照权利要求1-3中至少一项所述的输尿管支架，其特征在于：所述可膨胀涂层的外表面上设有导流纹路，和/或，所述可膨胀涂层的内表面上设有防滑纹路。
  5. 按照权利要求1-4中至少一项所述的输尿管支架，其特征在于：所述支架本体为非膨胀性的中空管状，所述支架本体的外表面上设有引流孔以及较所述引流孔更大的开孔。
  6. 按照权利要求5所述的输尿管支架，其特征在于：所述引流孔的直径为0.1mm-1.7mm，所述开孔的直径为0.3mm-2.5mm。
  7. 按照权利要求1-6中至少一项所述的输尿管支架，其特征在于：所述支架本体在对应所述可膨胀涂层端部的位置处具有用于限制所述可膨胀涂层发生轴向移动的限位部。
  8. 根据权利要求7所述的输尿管支架，其特征在于：所述限位部为周设于所述支架本体外表面上的突起部，所述突起部的周向外径小于或等于所述可膨胀涂层膨胀后的最大外径。
  9. 按照权利要求8所述的输尿管支架，其特征在于：所述突起部呈漏斗形，所述可膨胀涂层的端部面朝所述突起部的漏斗面设置。
  10. 按照权利要求8所述的输尿管支架，其特征在于：所述突起部为凸台或薄片。
  11. 如权利要求1-10中至少一项所述的输尿管支架，其特征在于：所述支架本体的轴向端具有用于限制所述支架本体移动的卡位部。
  12. 如权利要求1-11中至少一项所述的输尿管支架，其特征在于：所述可膨胀涂层与所述支架本体间的抗剥离力为0.5N-15N。
  13. 如权利要求1-12中至少一项所述的输尿管支架，其特征在于：所述可膨胀涂层为遇液体可膨胀的材料，所述可膨胀涂层的初始厚度为0.01mm-2mm，膨胀后的厚 度为0.03mm-8mm。
PCT/CN2022/107485 2021-07-23 2022-07-22 输尿管支架 WO2023001302A1 (zh)

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