WO2022222684A1 - 一种输尿管支架及制造方法 - Google Patents

一种输尿管支架及制造方法 Download PDF

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Publication number
WO2022222684A1
WO2022222684A1 PCT/CN2022/082939 CN2022082939W WO2022222684A1 WO 2022222684 A1 WO2022222684 A1 WO 2022222684A1 CN 2022082939 W CN2022082939 W CN 2022082939W WO 2022222684 A1 WO2022222684 A1 WO 2022222684A1
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WIPO (PCT)
Prior art keywords
layer structure
ureteral stent
outer layer
inner layer
wire
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PCT/CN2022/082939
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English (en)
French (fr)
Inventor
郭爱军
李志荣
王剑金
Original Assignee
珠海原妙医学科技股份有限公司
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Application filed by 珠海原妙医学科技股份有限公司 filed Critical 珠海原妙医学科技股份有限公司
Priority to EP22790793.8A priority Critical patent/EP4279112A1/en
Priority to KR1020237032111A priority patent/KR20230148218A/ko
Priority to US18/278,843 priority patent/US20240226513A9/en
Publication of WO2022222684A1 publication Critical patent/WO2022222684A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/008—Implant devices for drainage of body fluids from one part of the body to another pre-shaped, for use in the urethral or ureteral tract
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • 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
    • A61F2210/0014—Particular 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
    • 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
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/006—Catheters; Hollow probes characterised by structural features having a special surface topography or special surface properties, e.g. roughened or knurled surface
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0266—Shape memory materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A61M2207/10—Device therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1078—Urinary tract
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1078—Urinary tract
    • A61M2210/1089—Urethra
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter

Definitions

  • the invention relates to the field of medical devices, in particular to a ureteral stent and a manufacturing method.
  • the ureteral stent commonly used in hospitals commonly known as “pig tail tube”
  • pig tail tube is generally made of polyurethane, which has high radial strength and is not easily deformed. Good, but when used for a long time, the through hole is easily blocked by proliferative tissue, causing the "pig tail tube” to lose its guiding effect.
  • the present invention aims to solve at least one of the technical problems existing in the prior art. Therefore, the present invention proposes a ureteral stent, which can effectively reduce the situation that the ureteral stent loses its diversion effect.
  • the ureteral stent according to the first aspect of the present invention includes: an inner layer structure; an outer layer structure sleeved on the inner layer structure;
  • the first thread is an elastic thread.
  • the first wire is a memory alloy wire.
  • the first filaments are bent into coils and interlaced with each other to form the outer layer structure.
  • the first filaments are alternately formed along the first direction and the second direction to form the outer layer structure, and the first direction and the second direction are perpendicular to each other.
  • the inner layer structure is braided by at least one second wire, and a diversion gap for diversion is formed between the braided second wires.
  • both ends of the ureteral stent are bent, and the bending directions of the two ends of the ureteral stent are opposite.
  • the method for manufacturing a ureteral stent according to the second aspect of the present invention is used to manufacture the above-mentioned ureteral stent, comprising the following steps: using a first silk thread to weave an outer layer structure, and then sheathing the outer layer structure on the inner layer structure.
  • the first filaments are bent into loops and interlaced with each other to form an outer layer structure.
  • a weaving method is used to form an outer layer structure by interlacing the first threads in a first direction and a second direction, and the first direction and the second direction are perpendicular.
  • the tubular outer layer when in use, can be compressed in the radial direction, and then put into the urethra through the implantation device to form a support in the urethra, because the inner layer structure is supported by the inner layer structure.
  • the outer layer structure when the outer layer structure is deformed, the outer layer structure will not be deformed to be completely folded under the support of the inner layer structure, and the urine can also flow along the gap formed by the first silk thread of the outer layer, so that the outer layer structure is still Can play the role of catheterization; effectively reduce the occurrence of ureteral stent loss of drainage.
  • Fig. 1 is the assembled axonometric view of the inner layer structure and the outer layer structure in the ureteral stent assembly in the embodiment of the present invention
  • Fig. 2 is the assembled top view of the inner layer structure and the outer layer structure in the ureteral stent assembly in the embodiment of the present invention
  • FIG. 3 is an axonometric view of an outer layer structure in an embodiment of the present invention.
  • Fig. 4 is the enlarged view of A place in Fig. 3;
  • FIG. 5 is an axonometric view of another outer layer structure in an embodiment of the present invention.
  • Fig. 6 is the enlarged view at B place in Fig. 5;
  • FIG. 7 is a schematic diagram of a first inner layer structure in an embodiment of the present invention.
  • FIG. 8 is a schematic diagram of a second inner layer structure in an embodiment of the present invention.
  • Fig. 9 is an enlarged view at C in Fig. 8.
  • FIG. 10 is a schematic diagram of a third inner layer structure according to an embodiment of the present invention.
  • FIG. 11 is a schematic diagram of a fourth inner layer structure in an embodiment of the present invention.
  • the azimuth description such as the azimuth or position relationship indicated by up, down, front, rear, left, right, etc.
  • the azimuth description is based on the azimuth or position relationship shown in the drawings, only In order to facilitate the description of the present invention and simplify the description, it is not indicated or implied that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the present invention.
  • the meaning of several is one or more, the meaning of multiple is two or more, greater than, less than, exceeding, etc. are understood as not including this number, above, below, within, etc. are understood as including this number . If it is described that the first and the second are only for the purpose of distinguishing technical features, it cannot be understood as indicating or implying relative importance, or indicating the number of the indicated technical features or the order of the indicated technical features. relation.
  • the ureteral stent according to the first aspect of this embodiment includes: an inner layer structure 200; an outer layer structure 100 is sleeved on the inner layer structure 200; the outer layer structure 100 is a tubular structure, and the outer layer structure 100 is woven from a first thread 110 .
  • the tubular outer layer when in use, can be compressed radially, and then placed into the urethra through the implantation device to form a support in the urethra.
  • the support of the inner layer structure 200 when the outer layer structure 100 is deformed, the outer layer structure 100 will not be deformed to be completely folded under the support of the inner layer structure 200, and the urine can also be formed along the first silk thread 110 of the outer layer.
  • the flow between the gaps enables the outer layer structure 100 to still play the role of catheterization; effectively reducing the occurrence of the ureteral stent losing the role of drainage.
  • the outer layer structure 100 is a structure in which the first filaments 110 are tightly woven, a diversion gap can be formed between the first filaments 110 for diversion, and the tightly woven structure can prevent the growth of the proliferative tissue from entering In the duct, the ureteral duct is blocked.
  • an elastic thread can be used to make the first thread 110; It is made of shape memory alloy material, such as nickel-titanium alloy, etc. It can also be made of polymer material with high elasticity.
  • the outer layer structure 100 may be knitted by a knitting method, that is, the first filaments 110 are bent into loops and interlaced with each other to form the outer layer structure 100 .
  • the outer layer structure 100 can also be woven by the weaving method, that is, the first filaments 110 are staggered along the first direction and the second direction to form the outer layer structure 100, and the first direction and the second direction are mutually vertical.
  • the inner layer structure 200 is made of at least one second wire 210, and a diversion gap for diversion is formed between the braided second wires 210; wherein, urine can pass through the second wire 210.
  • the drainage gap between the two wires 210 gradually flows into the bladder from the renal pelvis, so that even when the outer layer structure 100 is compressed, a good catheterization effect can be achieved.
  • both ends of the ureteral stent are bent, and the two ends of the ureteral stent are bent in opposite directions; at this time, the shape of the ureteral stent can refer to the shape of the pigtail tube commonly used for urinary catheterization in the prior art. Prevents ureteral stent from migrating in the ureter.
  • the first aspect of this embodiment also relates to a method for manufacturing a ureteral stent, which is used to manufacture the above-mentioned ureteral stent, including the following steps: weaving a first silk thread 110 into an outer layer structure 100 , and then sheathing the outer layer structure 100 on the inner layer layer structure 200.
  • the outer layer structure 100 can adopt the knitting method, bend the first silk threads 110 into coils and interlock with each other to form the outer layer structure 100; or adopt the weaving method, and stagger the first silk threads 110 in the first direction and the second direction.
  • the outer layer structure 100 is formed, wherein the first direction and the second direction are perpendicular; in the weaving method, the first wire 110 woven in the first direction is the warp, and the second wire 210 woven in the second direction is the weft.
  • a ureteral stent including: an inner layer structure 200; an outer layer structure 100 sleeved on the inner layer structure 200; flow in the diversion gap.
  • the tubular outer layer when in use, can be compressed, and then placed into the urethra through the implantation device to form a catheterization channel in the urethra.
  • the outer layer structure 100 When the outer layer structure 100 is maximally compressed After being close to the inner layer, the urine can still be led out along the diversion gap opened on the inner layer structure 200 , which effectively reduces the occurrence of the ureteral stent losing its diversion effect.
  • the inner layer structure 200 is a rope-like structure woven by the second wires 210 , and a diversion gap is formed between the braided second wires 210 ; since the inner layer structure 200 is a rope-like structure, its It is incompressible in the radial direction, and can play an effective diversion role when the outer layer structure 100 is compressed; at the same time, a diversion gap can be formed between the second wires 210 after weaving, which is used for urine diversion, so that the ureteral stent is compressed It can still play a better diversion effect;
  • the second wire 210 can also be made of an elastic wire; the elastic wire can be made of a shape memory alloy material with superelasticity, such as nickel-titanium alloy, etc.; Polymer Materials.
  • the second wire 210 can be woven into the inner layer structure 200 in various ways, the details are as follows.
  • the inner layer structure 200 is formed by interlacing four second wires 210 with each other.
  • the inner layer structure 200 is formed by interlacing and interlacing four wire groups, and each wire group is formed by winding two second wires 210 .
  • the inner layer structure 200 may also be formed by winding four second wires 210 clockwise.
  • the inner layer structure 200 is formed by clockwise winding of four wire groups, and each wire group is formed by winding two second wires 210 .
  • the inner layer structure 200 is formed by winding eight second wires 210 along a first direction, and two adjacent second wires 210 are wound along a second direction, and the first direction and the second direction are opposite.
  • the inner wall of the outer layer structure 100 abuts the outer wall of the inner layer structure 200; at this time, the inner layer structure 200 can play a better supporting role for the outer layer structure 100, when both the inner and outer layers are braided with silk threads
  • urine can penetrate from the gap between the outer wall of the outer layer structure 100 and the inner wall of the inner layer structure 200, or from the gap between the inner and outer layers of silk.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Urology & Nephrology (AREA)
  • Epidemiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Otolaryngology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

一种输尿管支架及输尿管支架的制造方法，用于医疗器械领域，为有效减少输尿管支架失去导流作用的情况，包括：内层结构（200）；外层结构（100），套设在内层结构（200）上；外层结构（100）为管状结构，且外层结构（100）由第一丝线（110）编成；应用上述输尿管支架，能够有效减少输尿管支架失去导流作用的情况。

Description

一种输尿管支架及制造方法 技术领域
本发明涉及医疗器械领域，特别涉及一种输尿管支架及制造方法。
背景技术
在人体遇到肿瘤、腹膜后纤维化、输尿管狭窄等疾病导致输尿管梗阻、肾积水等问题时，通常需要进行侵入性手术，在输尿管内置入输尿管支架对输尿管进行支撑，以防止输尿管狭窄和黏连堵塞，并将尿液从肾盂引导至膀胱。
医院常用的输尿管支架，俗称“猪尾巴管”，一般由聚氨酯制成，其径向强度大，不易变形，而且“猪尾巴管”的侧壁设有多个通孔，使其导流性能更好，但是，长时间使用时，该通孔容易被增生组织堵塞，导致“猪尾巴管”失去导流作用。
发明内容
本发明旨在至少解决现有技术中存在的技术问题之一。为此，本发明提出一种输尿管支架，能够有效减少输尿管支架失去导流作用的情况。
本发明第一方面的输尿管支架，包括：内层结构；外层结构，套设在内层结构上；外层结构为管状结构，且外层结构由第一丝线编成。
根据本发明的一些实施例，第一丝线为弹性丝线。
根据本发明的一些实施例，第一丝线为记忆合金丝线。
根据本发明的一些实施例，第一丝线弯曲成线圈并相互串套形成外层结构。
根据本发明的一些实施例，第一丝线沿第一方向和第二方向交错形成外层结构，第一方向与第二方向相互垂直。
根据本发明的一些实施例，内层结构由至少一股第二丝线编成，被编织的第二丝线之间形成有用于导流的导流间隙。
根据本发明的一些实施例，输尿管支架的两端均弯曲，且输尿管支架的两端的弯曲方向相反。
本发明第二方面的输尿管支架的制造方法，用于制造上述输尿管支架，包括如下步骤：用第一丝线，编织成外层结构，然后将外层结构套设于内层结构上。
根据本发明的一些实施例，采用针织法，将第一丝线弯曲成线圈并相互串套形成外层结构。
根据本发明的一些实施例，采用梭织法，将第一丝线朝第一方向和第二方向交错形成外层结构，第一方向和第二方向垂直。
应用本发明的输尿管支架，在使用时，可以将管状的外层沿径向压缩后，通过植入装置放入到尿道当中，在尿道当中形成支撑，由于外层结构内部有内层结构的支撑，当外层结构变形时，在内层结构的支撑下外层结构不会变形至完全折叠，同时尿液还能够顺着外层的第一丝线形成的间隙之间流动，使得外层结构仍然能够起到导尿的作用；有效减少了输尿管支架失去导流作用的情况发生。
本发明的附加方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得明显，或通过本发明的实践了解到。
附图说明
本发明的上述和/或附加的方面和优点从结合下面附图对实施例的描述中将变得明显和容易理解，其中：
图1为本发明实施例中输尿管支架组件当中内层结构和外层结构的装配轴侧图；
图2为本发明实施例中输尿管支架组件当中内层结构和外层结构的装配俯视图；
图3为本发明实施例中一种外层结构的轴测图；
图4为图3中A处的放大图；
图5为本发明实施例中另一种外层结构的轴测图；
图6为图5中B处的放大图；
图7为本发明实施例中第一种内层结构的示意图；
图8为本发明实施例中第二种内层结构的示意图；
图9为图8中C处的放大图；
图10为本发明实施例在第三种内层结构的示意图；
图11为本发明实施例中第四种内层结构的示意图；
上述附图包含以下附图标记。
标号 名称
100 外层结构
110 第一丝线
200 内层结构
210 第二丝线
具体实施方式
下面详细描述本发明的实施例，实施例的示例在附图中示出，其中自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。下面通过参考附图描述的实施例是示例性的，仅用于解释本发明，而不能理解为对本发明的限制。
在本发明的描述中，需要理解的是，涉及到方位描述，例如上、下、前、后、左、右等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
在本发明的描述中，若干的含义是一个或者多个，多个的含义是两个及两个以上，大于、小于、超过等理解为不包括本数，以上、以下、以内等理解为包括本数。如果有描述到第一、第二只是用于区分技术特征为目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量或者隐含指明所指示的技术特征的先后关系。
本发明的描述中，除非另有明确的限定，设置、安装、连接等词语应做广义理解，所属技术领域技术人员可以结合技术方案的具体内容合理确定上述词语在本发明中的具体含义。
参照图1、图2，本实施例第一方面的输尿管支架，包括：内层结构200；外层结构100，套设在内层结构200上；外层结构100为管状结构，且外层结构100由第一丝线110编成。
应用本实施例第一方面的输尿管支架，在使用时，可以将管状的外层沿径向压缩后，通过植入装置放入到尿道当中，在尿道当中形成支撑，由于外层结构100内部有内层结构200的支撑，当外层结构100变形时，在内层结构200的支撑下外层结构100不会变形至完全折叠，同时尿液还能够顺着外层的第一丝线110形成的间隙之间流动，使得外层结构100仍然能够起到导尿的作用；有效减少了输尿管支架失去导流作用的情况发生。
另一方面，当外层结构100为第一丝线110紧密编成的结构时，第一丝线110之间能够形成导流间隙，用于导流，同时紧密编织的结构能够给阻止增生组织生长进入管道之中，堵塞输尿管道。
其中，为了增强输尿管支架的变形能力，使得外层结构100在被压缩后仍然能对尿道起到支撑作用，可以采用弹性丝线制作第一丝线110；其中弹性形丝线可以根据需要采用具有超弹性的形状记忆合金材料制成，例如镍钛合金等；也可以采用具有高弹性的高分子材料制成。
如图3、图4所示，可以采用针织法编织外层结构100，也即第一丝线110弯曲成线圈并相互串套形成外层结构100。
如图5、图6所示，也可以采用梭织法编织外层结构100，也即第一丝线110沿第一方向和第二方向交错形成外层结构100，第一方向与第二方向相互垂直。
如图7至图11所示，内层结构200由至少一股第二丝线210编成，被编织的第二丝线210之间形成有用于导流的导流间隙；其中，尿液能够通过第二丝线 210之间的导流间隙，从肾盂逐渐流道膀胱内；使得外层结构100被压缩时也能够起到良好的导尿效果。
在本实施例当中，输尿管支架的两端均弯曲，且输尿管支架的两端的弯曲方向相反；此时输尿管支架的外形可以参考现有技术当中常见的用于导尿的猪尾巴管的外形，有效防止输尿管支架在输尿管当中迁移。
本实施例第一方面还涉及一种输尿管支架的制造方法，用于制造上述输尿管支架，包括如下步骤：用第一丝线110，编织成外层结构100，然后将外层结构100套设于内层结构200上。
其中，外层结构100可以采用针织法，将第一丝线110弯曲成线圈并相互串套形成外层结构100；也可以采用梭织法，将第一丝线110朝第一方向和第二方向交错形成外层结构100，其中第一方向和第二方向垂直；在梭织法当中，第一方向编织的第一丝线110为经线，第二方向编织的第二丝线210为纬线。
本实施例第二方面，也给出一种输尿管支架，包括：内层结构200；外层结构100，套设在内层结构200上；内层结构200上开设有导流间隙，尿液能够在导流间隙当中流动。
应用本实施例第二方面的输尿管支架，在使用时，可以将管状的外层压缩后，通过植入装置放入到尿道当中，在尿道当中形成导尿通道，当外层结构100被最大压缩至紧贴内层后，尿液仍可以顺着内层结构200上开设的导流间隙导出；有效减少了输尿管支架失去导流作用的情况发生。
如图7至图11所示，内层结构200为第二丝线210编成的绳状结构，被编织的第二丝线210之间形成导流间隙；由于内层结构200为绳状结构，其径向不可压缩，当外层结构100被压缩时能够起到有效的导流作用；同时，编织后第二 丝线210之间能够形成导流间隙，用于尿液导流，使得输尿管支架被压缩后仍然能够起到较好的导流作用；
与第一丝线110类似，也可以采用弹性丝线制作第二丝线210；其中弹性形丝线可以根据需要采用具有超弹性的形状记忆合金材料制成，例如镍钛合金等；也可以采用具有高弹性的高分子材料。
如图8至图11所示，第二丝线210能够通过多种方式编织成内层结构200，具体如下。
如图7所示，内层结构200由四股第二丝线210相互交错穿插形成。
如图8、图9所示，内层结构200由四股丝线组相互交错穿插形成，每一股丝线组由两根第二丝线210缠绕形成。
当然，内层结构200也可以由四股第二丝线210顺时针缠绕形成。
如图10所示，内层结构200由四股丝线组顺时针缠绕形成，每股丝线组由两根第二丝线210缠绕形成。
如图11所示，内层结构200由八根第二丝线210沿第一方向缠绕形成，相邻两根第二丝线210沿第二方向缠绕，第一方向和第二方向相反。
为了增强输尿管支架的支撑作用，外层结构100的内壁抵接内层结构200的外壁；此时内层结构200能够对外层结构100起到更好的支撑作用，当内外两层均用丝线编成时，尿液可以从外层结构100的外壁与内层结构200的内壁间的间隙之间部分刘桐，也可以从内外层的丝线交织的夹缝之间渗透。
值得注意的是，本实施例各个方面的输尿管支架，均可以综合运用，成为一个性能优异的输尿管支架。
上面结合附图对本发明实施例作了详细说明，但是本发明不限于上述实施例，在所属技术领域普通技术人员所具备的知识范围内，还可以在不脱离本发明宗旨的前提下作出各种变化。

Claims (10)

  1. 一种输尿管支架，其特征在于，包括：
    内层结构(200)；
    外层结构(100)，套设在所述内层结构(200)上；
    所述外层结构(100)为管状结构，且所述外层结构(100)由第一丝线(110)编成。
  2. 根据权利要求1所述的输尿管支架，其特征在于，所述第一丝线(110)为弹性丝线。
  3. 根据权利要求2所述的输尿管支架，其特征在于，所述第一丝线(110)为记忆合金丝线。
  4. 根据权利要求1所述的输尿管支架，其特征在于，所述第一丝线(110)弯曲成线圈并相互串套形成所述外层结构(100)。
  5. 根据权利要求1所述的输尿管支架，其特征在于，所述第一丝线(110)沿第一方向和第二方向交错形成所述外层结构(100)，所述第一方向与所述第二方向相互垂直。
  6. 根据权利要求1所述的输尿管支架，其特征在于，所述内层结构(200)由至少一股第二丝线(210)编成，被编织的所述第二丝线(210)之间形成有用于导流的导流间隙。
  7. 根据权利要求1所述的输尿管支架，其特征在于，所述输尿管支架的两端均弯曲，且所述输尿管支架的两端的弯曲方向相反。
  8. 一种输尿管支架的制造方法，用于制造权利要求1所述的输尿管支架，其特征在于，包括如下步骤：
    用第一丝线(110)，编织成外层结构(100)，然后将外层结构(100)套设于内层结构(200)上。
  9. 根据权利要求8所述的输尿管支架的制造方法，其特征在于，采用针织法，将第一丝线(110)弯曲成线圈并相互串套形成外层结构(100)。
  10. 根据权利要求8所述的输尿管支架的制造方法，其特征在于，采用梭织法，将第一丝线(110)朝第一方向和第二方向交错形成外层结构(100)，第一方向和第二方向垂直。
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