CN113558813A - Blood vessel external protection support for internal arteriovenous fistula - Google Patents

Blood vessel external protection support for internal arteriovenous fistula Download PDF

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CN113558813A
CN113558813A CN202110704159.1A CN202110704159A CN113558813A CN 113558813 A CN113558813 A CN 113558813A CN 202110704159 A CN202110704159 A CN 202110704159A CN 113558813 A CN113558813 A CN 113558813A
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diameter
woven
section
anastomotic stoma
titanium alloy
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郭旭英
胡金鹏
许贤春
杨卫杰
刘灿
王卿馨
陈娟
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Shanghai Shape Memory Alloy Material Co Ltd
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Shanghai Shape Memory Alloy Material Co Ltd
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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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • 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

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The invention relates to an arteriovenous internal fistula extravascular protective stent, belonging to the technical field of medical instruments. Comprises a cylindrical venous segment, an anastomotic stoma and a cylindrical arterial segment; an anastomotic stoma is arranged between the venous segment and the arterial segment; the diameter of the venous segment is set to be 4-8mm, the diameter of the anastomotic stoma is set to be 6-8mm, the diameter of the arterial segment is set to be 4-6mm, and the angle of the anastomotic stoma is set to be 35-55 degrees. The arteriovenous internal fistula external vascular protection stent can keep the optimal anastomosis state of the postoperative anastomosis. Structurally, the mechanical support is improved, the protection of an anastomosis area is enhanced, the anastomosis can be guaranteed to keep the best anastomosis state within a few weeks which is the key period of postoperative maturation, and the success rate of the operation is improved. Meanwhile, the unblocked rate of the venous segment is improved, the stenosis of the postoperative arteriovenous internal fistula is reduced, and the service life of the arteriovenous internal fistula is prolonged.

Description

Blood vessel external protection support for internal arteriovenous fistula
Technical Field
The invention relates to an arteriovenous internal fistula extravascular protective stent, belonging to the technical field of medical instruments.
Background
End-stage renal disease (ESRD) is the end stage of various chronic kidney diseases, and is the most severe stage of renal failure, and uremia is the manifestation of end stage renal failure. The main treatment methods for end stage renal disease are: hemodialysis, peritoneal dialysis and kidney transplantation, by which the life cycle of a patient can be prolonged and the quality of life of the patient can be improved. The first treatment option for these treatments is kidney transplantation, but it is often difficult for economic reasons and problems of scarcity of the kidney source and matching, and therefore the most common methods are hemodialysis and peritoneal dialysis.
Hemodialysis utilizes the principle of a semipermeable membrane to remove harmful and redundant metabolic wastes and electrolytes out of a body in modes of diffusion, convection and the like so as to achieve the purposes of purifying blood and correcting acid-base and water electrolyte balance. The circulatory pathway in hemodialysis that draws the patient's blood out of the body, through a dialyzer or other purification device in a steady flow of blood, and finally transports the blood back into the body is called the vascular pathway. Establishing a reliable and stable vascular access is a basic guarantee for smooth hemodialysis and is an important guarantee for prolonging the life of hemodialysis patients and improving the quality of life of the hemodialysis patients. Thus, the vascular access is self-evident as the "lifeline" on which a hemodialysis patient lives. Hemodialysis access is mainly autologous arteriovenous fistulas (AVF), intravascular graft fistulas (AVG), and Central Venous Catheters (CVC).
Autologous arteriovenous internal fistulae (AVF) are the clinically preferred permanent vascular access, mature internal fistulae have long service life, few complications, low hospitalization and cost, and can reduce the mortality and morbidity of patients relative to other access, which is internationally agreed. Autologous arteriovenous internal fistula (AVF) angioplasty is a surgical procedure that anastomoses the peripheral artery and superficial vein of a patient, allowing arterial blood to flow to the superficial vein, achieving the blood flow requirements required for hemodialysis, and facilitating vascular puncture, thereby establishing hemodialysis extracorporeal circulation.
The invention provides an arteriovenous internal fistula external vascular protection stent which can keep the optimal anastomosis state of a postoperative anastomosis opening. The arteriovenous internal fistula protective stent is implanted in the operation process, the mechanical support is structurally improved, the protection of an anastomotic region is enhanced, the anastomotic stoma can be guaranteed to keep the best anastomotic state within the key weeks of postoperative maturation, and the success rate of the operation is improved. It also promotes remodeling of downstream blood vessels and is ultimately suitable for hemodialysis. The arteriovenous internal fistula protective stent provides external support for the AVF, controls remodeling of an anastomotic site, improves the hemodynamics of the AVF, reduces the area of a region with disturbed flow (or turbulent flow), enables the arterial blood flow to be smoothly transited to a downstream venous blood vessel, promotes the downstream blood vessel to thicken towards the outer wall, and is finally used for hemodialysis.
Disclosure of Invention
The invention aims to solve the technical problem of how to maintain the optimal anastomosis state of the postoperative anastomotic stoma.
In order to solve the problems, the technical scheme adopted by the invention is to provide an arteriovenous internal fistula external protective stent; comprises a cylindrical venous segment, an anastomotic stoma and a cylindrical arterial segment; an anastomotic stoma is arranged between the venous segment and the arterial segment; the diameter of the venous segment is set to be 4-8mm, the diameter of the anastomotic stoma is set to be 6-8mm, the diameter of the arterial segment is set to be 4-6mm, and the angle of the anastomotic stoma is set to be 35-55 degrees.
Preferably, the periphery of the venous segment is provided with a wavy bulge with the protruding height of 1-2 mm.
The invention provides a method for manufacturing an arteriovenous internal fistula external blood vessel protective stent, which comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same and are 10-20 mm; the length of the woven net is set to be 4cm-8 cm;
step 2: determining a vein section by heat treatment and shaping of the woven mesh in the step 1, wherein the diameter of the vein section is set to be 4-8 mm;
and step 3: and determining an anastomotic stoma and an artery section by heat treatment and sizing of the woven mesh in the step 2, wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
The invention provides a method for manufacturing an arteriovenous internal fistula external blood vessel protective stent, which comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a horn-mouth-shaped nickel-titanium alloy woven mesh through a horn-mouth-shaped mesh weaving mold, the diameter of the woven mesh at the venous section of the woven mesh is set to be 10-20mm, and the length of the woven mesh is set to be 10-20 mm; the arterial segment woven mesh is in a horn mouth shape, the diameter of the bottom of the horn mouth is 10-20mm, the diameter of the opening of the horn mouth is 16-26mm, and the length of the horn mouth is 13-19 mm;
step 2: determining a vein section by heat treatment and shaping of the woven mesh in the step 1, wherein the diameter of the vein section is set to be 4-8 mm;
and step 3: and determining an anastomotic stoma and an artery section by heat treatment and sizing of the woven mesh in the step 2, wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
The invention provides a method for manufacturing an arteriovenous internal fistula external blood vessel protective stent, which comprises the following steps:
step 1: the venous section and the arterial section of the stent are separately woven, wherein the venous section firstly passes nickel-titanium alloy wires through needle holes of suture needles, is fixed by knotting, and is woven into a straight barrel type nickel-titanium alloy woven mesh through a straight barrel type mesh weaving mold, and the upper diameter and the lower diameter of the woven mesh are the same and are 10-20 mm; the length is 2cm-4 cm; for the artery section, firstly, the nickel-titanium alloy wires penetrate through needle holes of suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same and are 10-20 mm; the length is 2cm-4 cm;
step 2: heat-treating and shaping the mesh grid vein segment in the step 1 to determine the vein segment, wherein the diameter of the vein segment is set to be 4-8 mm;
and step 3: and (2) determining an anastomotic stoma and an artery section by performing heat treatment and shaping on the woven mesh artery section in the step (1), wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
And 4, step 4: and (3) connecting the venous segment stent shaped in the step (2) with the arterial segment stent shaped in the step (3) by using a suture, wherein the length of a connecting part is 5 mm.
The invention provides a method for manufacturing an arteriovenous internal fistula external blood vessel protective stent, which comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the vertical diameters of the woven net at the vein section are the same and are 10-20 mm; the length of the woven net is set to be 4cm-8 cm;
step 2: the artery section is made of a nickel-titanium alloy plate with the thickness of 2-4mm and cut by a laser cutting machine;
and step 3: heat-treating and shaping the vein section knitted net in the step 1 to determine a vein section, wherein the diameter of the vein section is set to be 4-8 mm;
and 4, step 4: and (3) determining an anastomotic stoma and an artery section by performing heat treatment and shaping on the nickel-titanium alloy cutting plate at the artery section in the step (2), wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
And 5: and (4) connecting the venous section braided stent in the step (3) and the arterial section cut stent in the step (4) in a laser welding mode.
The invention provides a method for manufacturing an arteriovenous internal fistula external blood vessel protective stent, which comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same and are 10-20 mm; the length of the woven net is set to be 4cm-8 cm;
step 2: determining a vein section by heat treatment and shaping of the woven mesh in the step 1, wherein the diameter of the vein section is set to be 4-8 mm; the periphery of the vein segment is provided with a wavy bulge with the protruding height of 1-2 mm;
and step 3: and determining an anastomotic stoma and an artery section by heat treatment and sizing of the woven mesh in the step 2, wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
Compared with the prior art, the invention has the following beneficial effects:
the external protecting support for arteriovenous internal fistula has the working principle that an anastomotic stoma is in the optimal anastomotic state after the formation of autologous arteriovenous internal fistula (AVF). The arteriovenous internal fistula protective stent is implanted in the operation process, the mechanical support is structurally improved, the protection of an anastomotic region is enhanced, the optimal anastomotic and hemodynamic states of an anastomotic stoma can be kept within a few weeks of key postoperative maturation, and the success rate of the operation is improved. ② the blood vessel remodeling at the downstream is promoted, and the blood vessel remodeling is finally suitable for hemodialysis.
The arteriovenous internal fistula external vascular protection stent can keep the optimal anastomosis state of the postoperative anastomosis. Structurally, the mechanical support is improved, the protection of an anastomosis area is enhanced, the anastomosis can be guaranteed to keep the best anastomosis state within a few weeks which is the key period of postoperative maturation, and the success rate of the operation is improved. Meanwhile, the unblocked rate of the venous segment is improved, the stenosis of the postoperative arteriovenous internal fistula is reduced, and the service life of the arteriovenous internal fistula is prolonged.
Drawings
Fig. 1 is a schematic structural diagram of embodiment 1 of the present invention.
Fig. 2 is a schematic structural diagram of embodiment 2 of the present invention.
Fig. 3 is a schematic structural diagram of embodiment 3 of the present invention.
Fig. 4 is a schematic structural diagram of embodiment 4 of the present invention.
Fig. 5 is a schematic structural diagram of embodiment 5 of the present invention.
Reference numerals: 1. a venous segment; 2. anastomotic stoma; 3. an arterial segment; 4. a connecting portion; 5. the wave is convex.
Detailed Description
In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings:
as shown in fig. 1-5, an arteriovenous internal fistula extravascular protective stent is provided for the present invention; comprises a cylindrical venous segment, an anastomotic stoma and a cylindrical arterial segment; an anastomotic stoma is arranged between the venous segment and the arterial segment; the diameter of the venous segment is set to be 4-8mm, the diameter of the anastomotic stoma is set to be 6-8mm, the diameter of the arterial segment is set to be 4-6mm, and the angle of the anastomotic stoma is set to be 35-55 degrees. The periphery of the vein segment can be provided with a wavy bulge with the protruding height of 1-2 mm.
The invention provides a method for manufacturing an arteriovenous internal fistula external blood vessel protective stent, which comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same and are 10-20 mm; the length of the woven net is set to be 4cm-8 cm;
step 2: determining a vein section by heat treatment and shaping of the woven mesh in the step 1, wherein the diameter of the vein section is set to be 4-8 mm;
and step 3: and determining an anastomotic stoma and an artery section by heat treatment and sizing of the woven mesh in the step 2, wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
The invention provides a method for manufacturing an arteriovenous internal fistula external blood vessel protective stent, which comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a horn-mouth-shaped nickel-titanium alloy woven mesh through a horn-mouth-shaped mesh weaving mold, the diameter of the woven mesh at the venous section of the woven mesh is set to be 10-20mm, and the length of the woven mesh is set to be 10-20 mm; the arterial segment woven mesh is in a horn mouth shape, the diameter of the bottom of the horn mouth is 10-20mm, the diameter of the opening of the horn mouth is 16-26mm, and the length of the horn mouth is 13-19 mm;
step 2: determining a vein section by heat treatment and shaping of the woven mesh in the step 1, wherein the diameter of the vein section is set to be 4-8 mm;
and step 3: and determining an anastomotic stoma and an artery section by heat treatment and sizing of the woven mesh in the step 2, wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
The invention provides a method for manufacturing an arteriovenous internal fistula external blood vessel protective stent, which comprises the following steps:
step 1: the venous section and the arterial section of the stent are separately woven, wherein the venous section firstly passes nickel-titanium alloy wires through needle holes of suture needles, is fixed by knotting, and is woven into a straight barrel type nickel-titanium alloy woven mesh through a straight barrel type mesh weaving mold, and the upper diameter and the lower diameter of the woven mesh are the same and are 10-20 mm; the length is 2cm-4 cm; for the artery section, firstly, the nickel-titanium alloy wires penetrate through needle holes of suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same and are 10-20 mm; the length is 2cm-4 cm;
step 2: heat-treating and shaping the mesh grid vein segment in the step 1 to determine the vein segment, wherein the diameter of the vein segment is set to be 4-8 mm;
and step 3: and (2) determining an anastomotic stoma and an artery section by performing heat treatment and shaping on the woven mesh artery section in the step (1), wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
And 4, step 4: and (3) connecting the venous segment stent shaped in the step (2) with the arterial segment stent shaped in the step (3) by using a suture, wherein the length of a connecting part is 5 mm.
The invention provides a method for manufacturing an arteriovenous internal fistula external blood vessel protective stent, which comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the vertical diameters of the woven net at the vein section are the same and are 10-20 mm; the length of the woven net is set to be 4cm-8 cm;
step 2: the artery section is made of a nickel-titanium alloy plate with the thickness of 2-4mm and cut by a laser cutting machine;
and step 3: heat-treating and shaping the vein section knitted net in the step 1 to determine a vein section, wherein the diameter of the vein section is set to be 4-8 mm;
and 4, step 4: and (3) determining an anastomotic stoma and an artery section by performing heat treatment and shaping on the nickel-titanium alloy cutting plate at the artery section in the step (2), wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
And 5: and (4) connecting the venous section braided stent in the step (3) and the arterial section cut stent in the step (4) in a laser welding mode.
The invention provides a method for manufacturing an arteriovenous internal fistula external blood vessel protective stent, which comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same and are 10-20 mm; the length of the woven net is set to be 4cm-8 cm;
step 2: determining a vein section by heat treatment and shaping of the woven mesh in the step 1, wherein the diameter of the vein section is set to be 4-8 mm; the periphery of the vein segment is provided with a wavy bulge with the protruding height of 1-2mm
And step 3: and determining an anastomotic stoma and an artery section by heat treatment and sizing of the woven mesh in the step 2, wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
Autologous arteriovenous internal fistula (AVF) angioplasty is a surgical procedure that anastomoses the peripheral artery and superficial vein of a patient, allowing arterial blood to flow to the superficial vein, achieving the blood flow requirements required for hemodialysis, and facilitating vascular puncture, thereby establishing hemodialysis extracorporeal circulation.
The operating principle of the external protecting bracket of the arteriovenous internal fistula is to enable an anastomotic stoma to reach an optimal anastomotic state after an autologous arteriovenous internal fistula (AVF) forming operation. The arteriovenous internal fistula protective stent is implanted in the operation process, the mechanical support is structurally improved, the protection of an anastomotic region is enhanced, the optimal anastomotic and hemodynamic states of an anastomotic stoma can be kept within a few weeks of key postoperative maturation, and the success rate of the operation is improved. ② the blood vessel remodeling at the downstream is promoted, and the blood vessel remodeling is finally suitable for hemodialysis. The arteriovenous internal fistula protective stent provides external support for AVF (automatic volvulus and venous fistula) to control remodeling of an anastomotic site, and simultaneously after the stent is implanted, the peak flow rate in the arterial systole is kept to be 0.71-1.59m/s, the arterial resistance index is 0.3-0.6, the arterial blood flow rate is 372-1438ml/min, and the venous blood flow rate is 402-2060ml/min after 3 months of the autologous arteriovenous internal fistula (AVF) forming operation. Improving the hemodynamics of autologous arteriovenous internal fistula (AVF), reducing the area of a disturbed flow area, enabling the arterial blood flow to be stably transited to a downstream venous blood vessel, promoting the downstream blood vessel to thicken towards the outer wall, and finally being used for hemodialysis.
The implantation process of the external protecting bracket of the arteriovenous fistula comprises the following steps:
1. lying down, extending the forearm of the patient, disinfecting and paving the forearm by a conventional method, and locally anaesthetizing 2% lidocaine;
2. taking 2 fingers on the wrist joint, and making a radial longitudinal incision with the length of about 4 cm;
3. separating subcutaneous tissues, fully dissociating cephalic veins, and ligating branches;
4. cutting the deep fascia, exposing the radial artery, and ligating branches;
5. the cephalic vein is penetrated from the upper section of the device, and then the cephalic vein hemostatic clamp is blocked at the proximal end;
6. dilating the lumen with heparin water, and performing a radial artery longitudinal incision of about 6-9 mm;
7. the broken end of the cephalic vein is anastomosed with the end side of the radial artery incision line by 7-0 suture lines, the needle pitch is 0.3-0.5mm, the edge pitch is 0.3mm, the lower section of the instrument is wrapped on the radial artery blood vessel after anastomosis, and the instrument is fixed on the radial artery by 7-0 suture lines.
8. After the suture is finished, the anastomotic stoma is observed, the vein is obviously expanded, continuous trembling can be performed, the anastomotic stoma has no blood leakage, the bleeding is carefully stopped, the incision is sutured, the incision is covered by dressing, and the part is lightly bandaged.
The external protecting stent for the internal arteriovenous fistula is formed by weaving nickel-titanium alloy wires into a net and then carrying out heat treatment and shaping on the stent in a mold.
The external protecting support for the arteriovenous internal fistula comprises three parts, namely a venous section, an anastomotic stoma and an arterial section, and the specific manufacturing process is as follows:
the first step is as follows: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a nickel-titanium alloy woven mesh through a mesh weaving mold;
the second step is that: heat-treating and shaping the mesh grid subjected to the first step to determine the diameter (4-8mm) of a venous segment;
the third step: determining the angle of an anastomotic stoma (35-55 degrees), the diameter of the anastomotic stoma (6-8mm) and the diameter of the arterial segment (4-6mm) by heat treatment and sizing of the woven mesh subjected to the second step; the external protecting stent of the internal arteriovenous fistula can be manufactured through the three steps.
In a word, the arteriovenous internal fistula external vascular protection stent can keep the optimal anastomosis state of the postoperative anastomosis. Structurally, the mechanical support is improved, the protection of an anastomosis area is enhanced, the anastomosis can be guaranteed to keep the best anastomosis state within a few weeks which is the key period of postoperative maturation, and the success rate of the operation is improved. Meanwhile, the unblocked rate of the venous segment is improved, the stenosis of the postoperative arteriovenous internal fistula is reduced, and the service life of the arteriovenous internal fistula is prolonged.
The operation principle and the manufacturing method of the arteriovenous internal fistula external protection stent are described above, and specific examples are described below.
Example 1:
the external protecting support for the arteriovenous internal fistula is composed of three parts, namely a venous section 1, an anastomotic stoma 2 and an arterial section 3, and the specific manufacturing process is as follows:
the first step is as follows: the nickel-titanium alloy wires penetrate through needle holes of suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same, and are 10-20mm, and the length of the woven net is 4-8 cm;
the second step is that: determining the diameter (4-8mm) of a venous segment 1 through heat treatment and shaping of a woven mesh in the first step;
the third step: determining the angle of an anastomotic stoma 2 to be (35-55 degrees), the diameter of the anastomotic stoma to be (6-8mm) and the diameter of an artery section 3 to be (4-6mm) through the heat treatment and shaping of the woven mesh in the second step;
the arteriovenous internal fistula external vascular protective stent can be manufactured through the three steps, and the stent structure is shown in figure 1.
Example 2:
the external protecting support for the arteriovenous internal fistula is composed of three parts, namely a venous section 1, an anastomotic stoma 2 and an arterial section 3, and the specific manufacturing process is as follows:
the first step is as follows: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a horn-mouth-shaped nickel-titanium alloy woven mesh through a horn-mouth-shaped mesh weaving mold, and the diameter of the woven mesh at the venous section of the woven mesh is 10-20mm, and the length of the woven mesh is 10-20 mm; the artery section woven mesh is a horn mouth, the diameter of the short side of the horn mouth is 10-20mm, the diameter of the long side of the horn mouth is 16-26mm, and the length of the horn mouth is 13-19 mm.
The second step is that: determining the diameter (4-8mm) of a venous segment 1 through heat treatment and shaping of a woven mesh in the first step;
the third step: determining the angle of an anastomotic stoma 2 to be (35-55 degrees), the diameter of the anastomotic stoma to be (6-8mm) and the diameter of an artery section 3 to be (4-6mm) through the heat treatment and shaping of the woven mesh in the second step;
the arteriovenous internal fistula external vascular protective stent can be manufactured through the three steps, and the stent structure is shown in figure 2.
Example 3:
the external protecting support for the arteriovenous internal fistula is composed of three parts, namely a venous section 1, an anastomotic stoma 2 and an arterial section 3, and the specific manufacturing process is as follows:
the first step is as follows: the venous segment and the arterial segment of the stent are separately woven, and the venous segment: firstly, nickel-titanium alloy wires pass through a suture needle hole, are knotted and fixed, and are woven into a straight-tube nickel-titanium alloy woven net through a straight-tube woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same and are 10-20 mm; the length is 2cm-4 cm; ② arterial segment: firstly, nickel-titanium alloy wires penetrate through needle holes of suture needles, are knotted and fixed, and are woven into a straight-cylinder nickel-titanium alloy woven net through a straight-cylinder woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same and are 10-20 mm; the length is 2cm-4 cm;
the second step is that: determining the diameter (4-8mm) of the vein section 1 through heat treatment and shaping of the vein section woven mesh in the first step;
the third step: performing heat treatment on the woven arterial segment net through the first step of heat treatment and shaping of the woven arterial segment net, and determining that the angle of an anastomotic stoma 2 is (35-55 degrees), the diameter of the anastomotic stoma 2 is (6-8mm) and the diameter of the arterial segment 3 is (4-6 mm);
the fourth step: and connecting the venous segment stent shaped in the second step and the arterial segment stent shaped in the third step by using a suture, wherein the length of the connecting part 4 is 5 mm.
The external vascular protection stent for internal arteriovenous fistula can be manufactured through the four steps, and the stent structure is shown in figure 3.
Example 4:
arteriovenous internal fistula extravascular protective cradle comprises vein section 1, anastomotic stoma 2 and artery section 3 triplex, and this embodiment uses nickel titanium alloy silk weaving process with vein section 1, and artery section 3 uses nickel titanium alloy sheet material to cut through laser cutting, connects through laser welding's mode after carrying out the heat setting respectively, and concrete manufacture process is as follows:
the first step is as follows: the nickel-titanium alloy wires penetrate through needle holes of suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net at the vein section are the same, and are 10-20mm, and the length of the woven net is 4-8 cm;
the second step is that: the artery section 3 is made of a nickel-titanium alloy plate with the thickness of 2-4mm and is cut by a laser cutting machine.
The third step: fixing the vein section knitted net on a one-step shaping die, and determining the diameter (4-8mm) of the vein section 1 through heat treatment shaping;
the fourth step: the nickel-titanium alloy cutting plate of the artery section is subjected to heat treatment and shaping to determine that the angle of an anastomotic stoma 2 is (35-55 degrees), the diameter of the anastomotic stoma 2 is (6-8mm) and the diameter of the artery section 3 is (4-6 mm);
the fifth step: and connecting the vein section braided stent and the artery section cutting stent in a laser welding mode.
The external vascular protection stent for internal arteriovenous fistula can be manufactured through the five steps, and the stent structure is shown in figure 4.
Example 5:
the external protecting support for the arteriovenous internal fistula is composed of three parts, namely a venous section 1, an anastomotic stoma 2 and an arterial section 3, and the specific manufacturing process is as follows:
the first step is as follows: the nickel-titanium alloy wires penetrate through needle holes of suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same, and are 10-20mm, and the length of the woven net is 4-8 cm;
the second step is that: determining the diameter (4-8mm) of a vein section 1 through heat treatment and shaping of a woven mesh in the first step, wherein the periphery of the vein section is provided with a wave bulge with the protruding height of 1-2 mm;
the third step: determining the angle of an anastomotic stoma 2 to be (35-55 degrees), the diameter of the anastomotic stoma 2 to be (6-8mm) and the diameter of an artery section 3 to be (4-6mm) through the heat treatment and shaping of the woven mesh in the second step;
the arteriovenous internal fistula external vascular protective stent can be manufactured through the three steps, and the stent structure is shown in figure 5.
While the invention has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.

Claims (7)

1. An arteriovenous internal fistula extravascular protective stent; the method is characterized in that: comprises a cylindrical venous segment, an anastomotic stoma and a cylindrical arterial segment; an anastomotic stoma is arranged between the venous segment and the arterial segment; the diameter of the venous segment is set to be 4-8mm, the diameter of the anastomotic stoma is set to be 6-8mm, the diameter of the arterial segment is set to be 4-6mm, and the angle of the anastomotic stoma is set to be 35-55 degrees.
2. The arteriovenous internal fistula extravascular protective stent of claim 1 wherein: the periphery of the vein section is provided with a wavy bulge with the protruding height of 1-2 mm.
3. The method for manufacturing an arteriovenous internal fistula external vascular protective stent of claim 1, which comprises the following steps: the method comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same and are 10-20 mm; the length of the woven net is set to be 4cm-8 cm;
step 2: determining a vein section by heat treatment and shaping of the woven mesh in the step 1, wherein the diameter of the vein section is set to be 4-8 mm;
and step 3: and determining an anastomotic stoma and an artery section by heat treatment and sizing of the woven mesh in the step 2, wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
4. The method for manufacturing an arteriovenous internal fistula external vascular protective stent of claim 1, which comprises the following steps: the method comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a horn-mouth-shaped nickel-titanium alloy woven mesh through a horn-mouth-shaped mesh weaving mold, the diameter of the woven mesh at the venous section of the woven mesh is set to be 10-20mm, and the length of the woven mesh is set to be 10-20 mm; the arterial segment woven mesh is in a horn mouth shape, the diameter of the bottom of the horn mouth is 10-20mm, the diameter of the opening of the horn mouth is 16-26mm, and the length of the horn mouth is 13-19 mm;
step 2: determining a vein section by heat treatment and shaping of the woven mesh in the step 1, wherein the diameter of the vein section is set to be 4-8 mm;
and step 3: and determining an anastomotic stoma and an artery section by heat treatment and sizing of the woven mesh in the step 2, wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
5. The method for manufacturing an arteriovenous internal fistula external vascular protective stent of claim 1, which comprises the following steps: the method comprises the following steps:
step 1: the venous section and the arterial section of the stent are separately woven, wherein the venous section firstly passes nickel-titanium alloy wires through needle holes of suture needles, is fixed by knotting, and is woven into a straight barrel type nickel-titanium alloy woven mesh through a straight barrel type mesh weaving mold, and the upper diameter and the lower diameter of the woven mesh are the same and are 10-20 mm; the length is 2cm-4 cm; for the artery section, firstly, the nickel-titanium alloy wires penetrate through needle holes of suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same and are 10-20 mm; the length is 2cm-4 cm;
step 2: heat-treating and shaping the mesh grid vein segment in the step 1 to determine the vein segment, wherein the diameter of the vein segment is set to be 4-8 mm;
and step 3: and (2) determining an anastomotic stoma and an artery section by performing heat treatment and shaping on the woven mesh artery section in the step (1), wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
And 4, step 4: and (3) connecting the venous segment stent shaped in the step (2) with the arterial segment stent shaped in the step (3) by using a suture, wherein the length of a connecting part is 5 mm.
6. The method for manufacturing an arteriovenous internal fistula external vascular protective stent of claim 1, which comprises the following steps: the method comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the vertical diameters of the woven net at the vein section are the same and are 10-20 mm; the length of the woven net is set to be 4cm-8 cm;
step 2: the artery section is made of a nickel-titanium alloy plate with the thickness of 2-4mm and cut by a laser cutting machine;
and step 3: heat-treating and shaping the vein section knitted net in the step 1 to determine a vein section, wherein the diameter of the vein section is set to be 4-8 mm;
and 4, step 4: and (3) determining an anastomotic stoma and an artery section by performing heat treatment and shaping on the nickel-titanium alloy cutting plate at the artery section in the step (2), wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
And 5: and (4) connecting the venous section braided stent in the step (3) and the arterial section cut stent in the step (4) in a laser welding mode.
7. The method for manufacturing an arteriovenous internal fistula external vascular protective stent of claim 2, which comprises the following steps: the method comprises the following steps:
step 1: the nickel-titanium alloy wires penetrate through needle holes of the suture needles, are knotted and fixed, and are woven into a straight barrel type nickel-titanium alloy woven net through a straight barrel type woven net mould, wherein the upper diameter and the lower diameter of the woven net are the same and are 10-20 mm; the length of the woven net is set to be 4cm-8 cm;
step 2: determining a vein section by heat treatment and shaping of the woven mesh in the step 1, wherein the diameter of the vein section is set to be 4-8 mm; the periphery of the vein segment is provided with a wavy bulge with the protruding height of 1-2mm
And step 3: and determining an anastomotic stoma and an artery section by heat treatment and sizing of the woven mesh in the step 2, wherein the angle of the anastomotic stoma is set to be 35-55 degrees, the diameter of the anastomotic stoma is set to be 6-8mm, and the diameter of the artery section is set to be 4-6 mm.
CN202110704159.1A 2021-06-24 2021-06-24 Blood vessel external protection support for internal arteriovenous fistula Pending CN113558813A (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104837514A (en) * 2012-08-01 2015-08-12 拉米内特医疗技术有限公司 Apparatus for configuring an arteriovenous fistula
CN104853695A (en) * 2013-03-15 2015-08-19 波士顿科学国际有限公司 Anti-migration micropatterned stent coating
CN110251285A (en) * 2019-05-21 2019-09-20 泰升医疗有限公司 Expandable stent
CN112168445A (en) * 2020-09-21 2021-01-05 东华大学 Y-shaped integrated corrugated netted braided tracheal stent and manufacturing method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104837514A (en) * 2012-08-01 2015-08-12 拉米内特医疗技术有限公司 Apparatus for configuring an arteriovenous fistula
CN104853695A (en) * 2013-03-15 2015-08-19 波士顿科学国际有限公司 Anti-migration micropatterned stent coating
CN110251285A (en) * 2019-05-21 2019-09-20 泰升医疗有限公司 Expandable stent
CN112168445A (en) * 2020-09-21 2021-01-05 东华大学 Y-shaped integrated corrugated netted braided tracheal stent and manufacturing method thereof

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