CN110604639A - Intravascular current limiter for treating esophageal and gastric varices and rupture hemorrhage thereof and manufacturing method thereof - Google Patents
Intravascular current limiter for treating esophageal and gastric varices and rupture hemorrhage thereof and manufacturing method thereof Download PDFInfo
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- CN110604639A CN110604639A CN201910765784.XA CN201910765784A CN110604639A CN 110604639 A CN110604639 A CN 110604639A CN 201910765784 A CN201910765784 A CN 201910765784A CN 110604639 A CN110604639 A CN 110604639A
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- 206010052211 Oesophageal rupture Diseases 0.000 title claims abstract description 13
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 10
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- 239000008280 blood Substances 0.000 claims abstract description 41
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- 238000004804 winding Methods 0.000 claims description 39
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical group [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 claims description 35
- 241001424392 Lucia limbaria Species 0.000 claims description 18
- 229910052751 metal Inorganic materials 0.000 claims description 11
- 239000002184 metal Substances 0.000 claims description 11
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- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 claims description 8
- 210000004204 blood vessel Anatomy 0.000 claims description 8
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 8
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 6
- 238000002844 melting Methods 0.000 claims description 6
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Classifications
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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
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- 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
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
-
- 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
- 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
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
-
- 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
- A61F2240/002—Designing or making customized prostheses
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Prostheses (AREA)
Abstract
The invention relates to an intravascular current limiter for treating esophageal and gastric varices and rupture bleeding thereof and a manufacturing method thereof. After the front-end stent is attached to the vascular wall, the flow guide pipe tightly connected with the stent can directly guide blood to the far end of the thin film tube, so that the blood is limited to the far end of the flow guide pipe after passing through the stent while being shunted; the arrangement of the flow guide pipe is equivalent to that a layer of fluorine material film is added in the tortuous vein, so that the tissue support degree around the varicose vein is greatly increased, the rupture bleeding of the varicose vein is reduced, the vein shunt passage naturally established by the human body is kept, and the dual functions of reducing the portal vein pressure and increasing the support of the varicose vein wall are achieved.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an intravascular current limiter for treating esophageal and gastric varices and rupture bleeding thereof and a manufacturing method thereof.
Background
Esophageal fundal varices are one of the main clinical manifestations of portal hypertension, and the most common cause of portal hypertension is cirrhosis. The liver cirrhosis patients have 40 percent of esophageal and gastric varices, and about 50 to 60 percent of patients with the esophageal and gastric varices have concurrent massive hemorrhage, and the liver cirrhosis patients are characterized by large amount of bleeding, rapid coming, serious illness and high death rate of more than 40 percent, and if the liver cirrhosis patients are not treated in time, the patients can have serious consequences due to hemorrhagic shock caused by acute massive hemorrhage. The pressure of varicose veins and the supporting force of surrounding tissues are two of the most important factors affecting bleeding, and blood vessels are varicose to a certain extent and cannot be ruptured if strong tissue support is arranged around the varicose veins. However, the mucosal surface of the supporting tissue may be damaged by local factors such as inflammation and erosion, so that the supporting force of the tissue is weakened and the supporting tissue is easy to rupture. Any factor that increases portal vein pressure, or any defect in the surrounding supporting tissue, may contribute to bleeding by rupture of the varicose veins when they increase in tension to a highly dangerous level. Previous treatments include rest, diet, immunity enhancement, liver protection, etiological treatment, hemostats, blood transfusions, balloon compression hemostasis, sclerotherapy, surgical treatments, liver transplantation, and radiological intervention.
In the current non-surgical treatment (percutaneous transhepatic gastrocoronary vein embolization (PTVE) and percutaneous transhepatic portal vein embolization (PTO)), the recent hemostasis rate and the re-bleeding rate are superior to vasopressin, air sac compression and sclerotherapy, particularly to fundus varicosis, the sclerotherapy cannot be carried out, and the PTO can effectively stop bleeding. However, PTO requires certain technical conditions, and can also cause complications such as portal thrombosis, pulmonary or cerebral infarction, peritonitis, hematuria, right-side pleural effusion, septicemia, and the like, the incidence rate of PTO can reach 25% -40%, and PTO cannot reduce portal pressure. Therefore, severe bleeding tendency, severe liver function injury, high fever, large amount of ascites and vascular diseases such as cancer embolus or thrombosis in puncture route are contraindications. Transjugular Intrahepatic Portosystemic Shunt (TIPS) is mainly used for treating portal hypertension varicose vein hemorrhage, and also can be used for treating intractable ascites and portal hypertension caused by various reasons, and the like. The clinical application effect is obvious, and the wide attention is paid, and the number of the domestic and foreign users is increasing. However, the rebleeding rate of acute hemorrhage is higher, and the death rate in 30 days is 3.6-19.6%.
Disclosure of Invention
Therefore, the invention provides an intravascular current limiter for treating esophageal and gastric varices and rupture bleeding thereof and a manufacturing method thereof.
In order to solve the technical problems, the invention adopts the following technical scheme:
the intravascular current limiter for treating esophageal and gastric varices and rupture hemorrhage thereof comprises a blood inflow bracket and a flow guide tube, wherein the blood inflow bracket is formed by spirally winding metal wires, the flow guide tube is a film tube, the inner diameter of the blood inflow bracket is consistent with that of the flow guide tube, and the blood inflow bracket is fixedly connected with the flow guide tube by hot melting.
The metal wire is a nickel-titanium wire with the outer diameter of 0.10-0.15 mm.
The blood inflow support is formed by spirally winding nickel-titanium wires in a bidirectional crossed manner.
The honeycomb duct is made of a thin film tube which has good softness and can be attached to the wall of the blood vessel along the blood flow direction.
Preferably, the flow guide pipe is an ETFE thin film pipe.
The inner side of the blood inflow stent can be coated with a layer of covering film.
The tectorial membrane is medical silica gel or membranous material of coating and extends to the honeycomb duct.
The membranous material is one of polytetrafluoroethylene, terylene, polyester and polyurethane.
A method for manufacturing an intravascular current limiter for treating esophageal and gastric varices and rupture bleeding thereof comprises the following steps:
s1, taking copper core rods with equal diameters, arranging two groups of small holes on the copper core rods at intervals along the circumferential direction of the copper core rods, and inserting small copper core rods matched with the diameters of the small holes into each small hole to form two groups of small copper core rods;
s2, winding a metal wire on the two groups of small copper core rods in a diagonal direction according to a preset first winding angle to complete winding of all the two groups of small copper core rods to form a first layer of winding net;
s3, winding the two groups of small copper core rods alternately in a diagonal direction according to a preset second winding angle to complete winding of the two groups of small copper core rods, forming a second layer of winding net interwoven with the first layer of winding net, and forming a woven wire mesh by the wound second layer of winding net and the first layer of winding net;
s4, placing the woven metal wire mesh woven in the step S3 and the copper core rod together into a pre-formed support for heat treatment for 15-30min at the temperature of 330-370 ℃ to obtain a pre-formed support;
s5, taking one thin film tube, and connecting one end of the thin film tube with the end of the preformed bracket prepared in the step S4 by a hot melting method to obtain the required current limiter.
S6, the blood flowing into the stent through the flow restrictor prepared in step S4 is coated with medical silica gel or membrane material and extends to the flow guide tube.
In the step S1, the outer diameter of the copper core rod is 6-10mm, and the outer diameter of the copper core rod is 0.3-0.7 mm every 45 degrees along the circumferential direction of the copper core rod.
The technical scheme of the invention has the following advantages:
the invention relates to an intravascular current limiter for treating esophageal and gastric varices and rupture hemorrhage thereof, which consists of a flow guide pipe consisting of a front blood inflow bracket and a rear fluorine material film pipe. After the front-end bracket is attached to the vascular wall, the guide pipe tightly connected with the bracket can directly guide blood to the far end of the thin film tube, thereby realizing the purpose of limiting the flow of the blood to the far end of the guide pipe through the guide pipe behind the bracket while shunting. Therefore, when blood flows through the area, the blood is limited to flow in the cavity of the flow guide pipe, so that the blood does not have the effect of increasing load on the blood vessel wall in the area, and the shunting venous bed does not have the difficulty in tortuous blood backflow and secondary expansion. The flow restrictor is characterized in that the rear part of the stent is connected with a long-section fluorine material film tube, namely, a layer of fluorine material film is added in a tortuous vein, so that the tissue support degree around the varicose vein is greatly increased, the blood is limited to enter a body vein through a reinforced channel, so that the varicose vein rupture bleeding is reduced, a vein shunt channel naturally established by a human body is maintained, the dual functions of reducing portal vein pressure and increasing the support of the wall of the varicose vein are achieved, and when the film tube of the flow guide tube is not well stretched, the flow restrictor can be used as an embolism material to block the blood flow of the tortuous vein embolism.
Drawings
In order to more clearly illustrate the embodiments of the present invention, the drawings which are needed to be used in the embodiments will be briefly described below, and it is apparent that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained from the drawings without inventive labor to those skilled in the art.
FIG. 1 is a schematic diagram of the overall structure of a current limiter according to the present invention;
FIG. 2 is a cross-sectional view of a blood flow into a stent in the configuration of the covered flow restrictor of the present invention;
fig. 3 is a schematic diagram of the nickel-titanium wire mesh weaving of the current limiter of the present invention.
Description of reference numerals:
1-blood flow into the stent; 2-a flow guide pipe; and 3, coating a film.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
As shown in figure 1, the invention provides an intravascular current limiter for treating esophageal and gastric varices and rupture hemorrhage thereof, which comprises a blood inflow support 1 and a flow guide tube 2, wherein the blood inflow support 1 is formed by spirally winding metal wires, the flow guide tube 2 is a thin film tube, the inner diameter of the blood inflow support 1 is consistent with that of the flow guide tube 2, and the blood inflow support 1 is fixedly connected with the flow guide tube 2 through hot melting. The invention relates to an intravascular current limiter for treating esophageal and gastric varices and rupture hemorrhage thereof, which consists of a flow guide pipe consisting of a front blood inflow bracket and a rear fluorine material film pipe. After the front-end bracket is attached to the vascular wall, the guide pipe tightly connected with the bracket can directly guide blood to the far end of the thin film tube, thereby realizing the purpose of limiting the flow of the blood to the far end of the guide pipe through the guide pipe behind the bracket while shunting. Therefore, when the blood flows through the area, the blood flow is limited to flow in the cavity of the flow guide pipe, the influence of load increase on the vascular wall in the area is avoided, and the difficulty of tortuous blood backflow and secondary expansion of the shunt venous bed are avoided. The flow restrictor is characterized in that the rear part of the stent is connected with a long-section fluorine material film tube, namely, a layer of fluorine material film is added in a tortuous vein, so that the tissue support degree around the varicose vein is greatly increased, the blood is limited to enter a body vein through a reinforced channel, so that the rupture bleeding of the varicose vein is reduced, the vein shunt channel naturally established by a human body is maintained, the dual functions of reducing portal vein pressure and increasing the support of the wall of the varicose vein are achieved, and when the film tube of the flow guide tube is not well stretched, the flow restrictor can be used as an embolism material to block the blood flow of the tortuous vein embolism.
Furthermore, the metal wire is a nickel-titanium wire with the outer diameter of 0.10-0.15 mm; the blood inflow stent 1 is formed by spirally winding a nickel titanium wire in a bidirectional crossing manner, and the winding angle is not particularly limited, but cannot be parallel and perpendicular to the radial direction of the blood inflow stent 1. The flow guide tube 2 is made of a film tube which has good flexibility and can be attached to the blood vessel wall along the blood flow direction, and is preferably an ETFE film tube.
Still can wrap up one deck tectorial membrane 3 in blood inflow support 1 inboard, as shown in fig. 2, tectorial membrane 3 is coated medical silica gel or membranous material and extends to the honeycomb duct, one of polytetrafluoroethylene, dacron, polyester, polyurethane can be selected to membranous material, forms the one deck film after the coating, avoids blood to spill from the gap, leads to the fact the impact to the honeycomb duct vascular wall for blood flows into and produces the clearance between support and honeycomb duct and vascular wall, weakens the holding power of honeycomb duct to the vascular wall.
The inner diameter of the outlet of the draft tube can be slightly narrower than the inner diameter of the inlet, namely, the draft tube is made into a shape from thick to thin.
The invention also provides a method for manufacturing the intravascular current limiter for treating esophageal and gastric varices and rupture bleeding thereof, which comprises the following steps:
s1, taking a copper core rod with the outer diameter of 8mm, arranging two groups of 8 small holes with the outer diameter of 0.5mm on the copper core rod at intervals along the circumferential direction of the copper core rod at intervals of 45 degrees, and inserting small copper core rods matched with the hole diameters of the small holes into each small hole to form two groups of small copper core rods;
s2, winding a nickel-titanium wire with the outer diameter of 0.12mm on the two groups of small copper core rods in a diagonal and alternate mode according to a preset first winding angle to complete winding of the two groups of small copper core rods and form a first layer of winding net;
s3, winding the two groups of small copper core rods alternately in a diagonal direction according to a preset second winding angle to complete winding of the two groups of small copper core rods, forming a second layer of winding net interwoven with the first layer of winding net, and forming a woven wire mesh by the wound second layer of winding net and the first layer of winding net;
s4, placing the woven metal wire mesh woven in the step S3 and the copper core rod together into a heat treatment chamber at the temperature of 350 ℃ for 20min to obtain a preformed support, as shown in FIG. 3;
s5, taking one ETFE fluorine material film tube, and connecting one end of the ETFE fluorine material film tube with the end part of the preformed bracket prepared in the step S4 by a hot melting method to obtain the required current limiter.
S6, the inner side of the blood flowing into the stent of the flow restrictor prepared in the step S4 is coated with medical silica gel or membranous materials to form a coated layer, so that the blood is prevented from leaking out of the gap of the stent and impacting the wall of the blood vessel of the flow guide tube, gaps are generated among the blood flowing out of the stent, the outside of the flow guide tube and the wall of the blood vessel, and the supporting force of the flow guide tube to the wall of the blood vessel is weakened.
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are intended to be within the scope of the invention.
Claims (10)
1. The intravascular current limiter for treating esophageal and gastric varices and rupture hemorrhage of the esophageal and gastric varices is characterized by comprising a blood inflow bracket (1) and a flow guide pipe (2), wherein the blood inflow bracket (1) is formed by spirally winding metal wires, the flow guide pipe (2) is a thin film pipe, the inner diameter of the blood inflow bracket (1) is consistent with that of the flow guide pipe (2), and the blood inflow bracket (1) is fixedly connected with the flow guide pipe (2) through hot melting.
2. The intravascular flow restrictor of claim 1, wherein the metal wire is a nickel-titanium wire with an outer diameter of 0.10-0.15 mm.
3. Intravascular flow restrictor for treatment of esophageal fundic varices and its rupture bleeding according to claim 2, characterized in that the blood inflow stent (1) is made of nickel titanium wire wound in a bidirectional crosswise spiral.
4. The intravascular flow restrictor of claim 3, wherein the flow guiding tube (2) is made of a thin film tube with good flexibility and capable of adhering to the wall of the blood vessel along the direction of blood flow.
5. The intravascular flow restrictor of claim 4, wherein the flow guide tube (2) is an ETFE thin film tube.
6. The intravascular flow restrictor of claim 5, wherein the blood inflow stent (1) is further covered with a covering membrane (3) on the inner side.
7. The intravascular flow restrictor of claim 6, wherein the covering membrane (3) is a coated medical silica gel or membrane material and extends to the flow guide tube (2).
8. A method for manufacturing an intravascular current limiter for treating esophageal and gastric varices and rupture bleeding thereof is characterized by comprising the following steps:
s1, taking copper core rods with equal diameters, arranging two groups of small holes on the copper core rods at intervals along the circumferential direction of the copper core rods, and inserting small copper core rods matched with the diameters of the small holes into each small hole to form two groups of small copper core rods;
s2, winding a metal wire on the two groups of small copper core rods in a diagonal direction according to a preset first winding angle to complete winding of all the two groups of small copper core rods to form a first layer of winding net;
s3, winding the two groups of small copper core rods alternately in a diagonal direction according to a preset second winding angle to complete winding of the two groups of small copper core rods, forming a second layer of winding net interwoven with the first layer of winding net, and forming a woven wire mesh by the wound second layer of winding net and the first layer of winding net;
s4, placing the woven metal wire mesh woven in the step S3 and the copper core rod together into a pre-formed support for heat treatment for 15-30min at the temperature of 330-370 ℃ to obtain a pre-formed support;
s5, taking one thin film tube, and connecting one end of the thin film tube with the end of the preformed bracket prepared in the step S4 by a hot melting method to obtain the required current limiter.
9. A method of making a flow restrictor as claimed in claim 8 further comprising the steps of:
s6, the blood of the flow restrictor prepared in the step S4 flows into the inner side of the stent and is coated by medical silica gel or membrane material and extends to the flow guide pipe.
10. The method of manufacturing a flow restrictor of claim 9 wherein the copper core rod of step S1 has an outer diameter of 6-10mm, and the outer diameter of 0.3-0.7 mm is provided on the copper core rod at 45 ° intervals along the circumferential direction thereof.
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