CN111820963A - Novel double-layer plugging device - Google Patents
Novel double-layer plugging device Download PDFInfo
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- CN111820963A CN111820963A CN202010826503.XA CN202010826503A CN111820963A CN 111820963 A CN111820963 A CN 111820963A CN 202010826503 A CN202010826503 A CN 202010826503A CN 111820963 A CN111820963 A CN 111820963A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12031—Type of occlusion complete occlusion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
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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
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00588—Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00623—Introducing or retrieving devices therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00628—T-shaped occluders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
Abstract
The invention discloses a novel double-layer plugging device which comprises a plugging device body part, wherein a fixer is arranged at the upper end of the plugging device body part, a connector is arranged at the lower end of the plugging device body part, the plugging device body part is connected with an external conveying steel cable through the connector, the plugging device body part comprises an outer layer and an inner layer which are formed by metal wires, one end of each of the metal wires of the inner layer and the end of each of the metal wires of the outer layer are respectively fixed on the fixer, and the other end of each of the metal wires of the inner. The invention has the advantages of good stability, strong anatomical adaptability, difficult hemolysis and small valve influence, and completes the plugging of paravalvular leakage, unclosed arterial duct and ventricular septal defect in a duct intervention mode; the self radial supporting force is strong; the structure of the device is compact, red blood cells are not easy to pass through, and the related hemolysis of the occluder is not easy to cause; the upper and lower residual parts of the device after deformation and fixation are less and not close to the artificial valve, so that the opening and closing of the artificial valve are not easily influenced; the injury to the approach blood vessel is small, and the complication of the blood vessel is less.
Description
Technical Field
The invention belongs to the technical field of medical equipment, and particularly relates to a novel double-layer occluder for plugging perivalvular leaks, unclosed arterial ducts and ventricular septal defects through ducts.
Background
Perivalvular leakage refers to the concurrent leakage around the artificial valve after the heart valve replacement, which causes the regurgitation of the valve, and is clinically manifested as hemolytic anemia, cardiac insufficiency, infectious endocarditis and the like related to the leakage orifice and the regurgitation degree. According to the data statistics of the United states, about 2% -17% of patients after heart valve replacement have statistically different degrees of perivalvular leakage. Among them, mitral valve paravalvular leakage (7% -17%) is most common, aortic valve paravalvular leakage (2% -10%) is less frequent, and tricuspid and pulmonary valve paravalvular leakage occurs less frequently. The previous observational study shows that the peripheral leakage of the mitral valve is more likely to generate clinical symptoms than the peripheral leakage of the aortic valve, and the large-scale leakage with the diameter of 6mm-15mm is more likely to generate cardiac insufficiency and has higher probability of multiple leakage and hemolysis.
The treatment of perivalvular leakage comprises drug conservation treatment, surgical operation and catheter occlusion. The hemolysis and anemia caused by paravalvular hemorrhage are not serious, the hemodynamics is not obviously influenced, and the cardiac function is good, so that the medicine can be used for treating cardiotonic, diuresis, cardiac remodeling inhibition and the like, and regular follow-up visits are performed. In addition, perivalvular leaks require re-operative treatment, which is statistically symptomatic and requires surgical intervention with a perivalvular leak incidence of 1% -3%. The prior treatment of perivalvular leaks is mainly performed by surgical operations, but the surgical reoperation risk is high, complications are easy to occur, the death rate is correspondingly increased, and the death rate is 13% for 1 time of surgical operators, 15% for 2 times of surgical operators and 37% for 3 times of surgical operators. Therefore, after the first report by Hourihan et al in 1992, a plurality of reports of ductal paravalvular leak blocking appear in succession, and ductal paravalvular leak blocking gradually becomes the first strategy for clinical treatment of paravalvular leak.
However, no special occluder exists for perivalvular leak occlusion at present, and atrial defect occluders, ventricular defect occluders, patent ductus arteriosus occluders, vascular occlusion occluders and the like are commonly used in clinic (as shown in figure 1, A: vascular occlusion occluder I, B: vascular occlusion occluder II, C: patent ductus arteriosus occluder, D: atrial defect occluder, E: muscular ventricular defect occluder). Because the perivalvular leakage orifices have various shapes and sizes, are different from each other, are different from the position of the artificial valve, and have inconsistent hemodynamics of the perivalvular leakage of different valves, a plurality of types of occluders clinically applied at present have defects, and the occluders have the characteristics of strong stability, weak hemolysis, small influence on the artificial valve and the like. An ideal paravalvular leak occluder should have four features: 1. the self radial supporting force is strong, the stability is strong at the leakage position around the valve after the release, and the valve is not easy to fall off; 2. the apparatus has strong deformation capability and is suitable for perivalvular leakage of different forms; 3. the structure of the device is compact, red blood cells are not easy to pass through, and the related hemolysis of the occluder is not easy to cause; 4. the upper and lower residual parts of the device after deformation and fixation do not approach the artificial valve, so that the opening and closing of the artificial valve are not easily influenced. The atrial defect occluder has a large umbrella disc, has strong stability, has less residual leakage after occlusion, is easy to influence the opening and closing of the artificial valve, is designed for atrial septal defect with low pressure difference, and is easy to cause mechanical hemolysis due to the incompact internal structure when used for the occlusion of the valve periphery leakage with high pressure difference. Although the ventricular defect occluder and the patent ductus arteriosus occluder are compact compared with the ventricular defect occluder and reduce hemolysis, the mechanical hemolysis risk still exists after the peripheral leakage occlusion of the mitral valve with higher pressure difference, moreover, the umbrella disc is small, the stability is reduced, the fixation is not easy, the deformability is insufficient, the residual leakage after the occlusion is easy to occur, and the umbrella disc after the deformation easily influences the artificial valve. The vascular plug occluder I has good deformability, is suitable for perivalvular leakage with more forms, does not have an umbrella disc, is not easy to influence the artificial valve, but reduces the umbrella disc to reduce the compactness and has high hemolysis incidence. Due to the special weaving technology, the blood vessel plug occluder II has the advantages that the umbrella body compactness is high, the hemolysis is greatly reduced, the umbrella body deformability is good, the adaptability is strong, but the umbrella body radial supporting force is poor, the stability is insufficient, the umbrella discs on two sides are large, the artificial valve is easily influenced, and the specific characteristics are shown in the table 1 in the figure 2.
Both patent ductus arteriosus and ventricular septal defect are common congenital heart diseases, and the first strategy for the treatment of patent ductus arteriosus and ventricular septal defect is minimally invasive transcatheter occlusion. Because the pressure step difference between the two ends of the shunt passing through the unclosed arterial duct and the ventricular septal defect is large, the hemolysis risk exists after the occlusion of the unclosed arterial duct and the ventricular septal defect occluder in the past, and meanwhile, because the shapes of the arterial ducts are different, the occluder is very difficult to fix in some special shape cases (such as long-tube arterial ducts), and a proper occluder aiming at the unclosed long-tube arterial duct does not exist.
Disclosure of Invention
In view of the above, the present invention provides a novel double-layer occluder to solve the deficiencies in the prior art.
In order to achieve the purpose, the invention is realized by the following technical scheme:
the utility model provides a novel double-deck plugging device, wherein, including the plugging device somatic part, the upper end of plugging device somatic part is equipped with the fixer, the lower extreme of plugging device somatic part is equipped with the connector, the plugging device somatic part passes through the outside steel cable of carrying is connected to the connector, the plugging device somatic part includes the skin and the inlayer that constitute by the wire, the inlayer wire with one end of the tip of outer wire is fixed in respectively the fixer, another is fixed in respectively the connector.
The novel double-layer occluder is characterized in that the diameter of the metal wires of the inner layer is larger than that of the metal wires of the outer layer, and the weaving density of the metal wires of the inner layer is smaller than that of the metal wires of the outer layer
The novel double-layer occluder comprises an inner layer and an outer layer, wherein the diameter of the metal wires of the inner layer is 0.08mm, the weaving density is 72 wires, the diameter of the metal wires of the outer layer is 0.04mm, and the weaving density is 144-288 wires.
Above-mentioned novel double-deck plugging device, wherein, the wire is nickel titanium alloy wire.
Above-mentioned novel double-deck plugging device, wherein, the plugging device somatic part is used for treating the perivalvular leakage and is the cylinder type of rectangle for longitudinal section, the height of plugging device somatic part is 15mm, the diameter of plugging device somatic part is 6mm, 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, 26mm, 28mm, 30 mm.
Above-mentioned novel double-deck occluder, wherein, the occluder somatic part is used for treating the patent ductus arteriosus and for the cylinder type of longitudinal section "T" font, the occluder somatic part includes upper portion and lower part, the height of occluder somatic part is 7mm, 9mm, 11mm, 13mm, 15mm, 17mm, 19mm, the diameter of the lower part of occluder somatic part is 6mm, 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, 26mm, 28 mm.
Above-mentioned novel double-deck occluder, wherein, the occluder somatic part is used for treating ventricular septal defect and is the cylinder type of "worker" font for longitudinal section, the occluder somatic part includes upper portion, middle part and lower part, the height of occluder somatic part is 3mm, 5mm, 7mm, 9mm, the diameter at the middle part of occluder somatic part is 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, the diameter difference of the upper portion of occluder somatic part and middle part is 4mm, 6mm, 8mm, 10mm, the diameter of the lower part of occluder somatic part with the diameter on the upper portion of occluder somatic part is the same.
Above-mentioned novel double-deck plugging device, wherein, the fixer is fixation nut, the connector is connecting nut, there is the screw thread bayonet socket inside the connecting nut.
The technical scheme of the invention has the beneficial effects that:
the plugging agent has the advantages of good stability, strong anatomical adaptability, difficult hemolysis and small valve influence, and can complete the plugging of paravalvular leakage, unclosed arterial duct and ventricular septal defect in a catheter intervention mode;
the self radial supporting force is strong, the position stability is strong after releasing, and the displacement and the falling are not easy to happen;
the paravalvular leak apparatus has strong deformability and is suitable for paravalvular leaks of different forms;
the structure of the device is compact, red blood cells are not easy to pass through, and the related hemolysis of the occluder is not easy to cause;
after the device is deformed and fixed, the upper and lower residual parts of the device leaking around the valve are less and are not close to the artificial valve, so that the opening and closing of the artificial valve are not easily influenced;
the body of the occluder is of a pure nickel-titanium alloy wire structure, and a flow-resistant film and a suture made of polyester non-woven fabrics (PET) are not required to be added in the body, so that the diameter of the occluder is smaller after compression, the diameter of a delivery sheath is smaller, the occluder has less damage to an access blood vessel, and the vascular complications are fewer;
the body of the patent ductus arteriosus occluder has different length designs, so that the patent ductus arteriosus occluder is suitable for long-tube ductus arteriosus dissection, and the occlusion is more complete and has strong stability.
Drawings
FIG. 1 is a schematic view of a current clinical application of an occluder for transcatheter paravalvular leak occlusion;
FIG. 2 is a table showing the specific characteristics of the occluder applied to the transcatheter paravalvular leak plugging in the prior art;
FIG. 3 is a schematic structural diagram of an embodiment of the present invention;
FIG. 4 is a schematic structural diagram of a second embodiment of the present invention;
FIG. 5 is a schematic diagram of a third embodiment of the present invention;
wherein: 1. an occluder body portion; 2. a holder; 3. a connector; 4. a threaded bayonet; 5. an upper portion; 6. a lower portion; 7. a middle part; 11. an outer layer; 12. an inner layer.
Detailed Description
The invention is further described with reference to the following drawings and specific examples, which are not intended to be limiting.
Referring to fig. 3, 4 and 5, the novel double-layer occluder of the present invention comprises an occluder body 1, a fixer 2 is arranged at the upper end of the occluder body 1, a connector 3 is arranged at the lower end of the occluder body 1, the occluder body 1 is connected with an external conveying steel cable through the connector 3, the occluder body 1 comprises an outer layer 11 and an inner layer 12 which are composed of metal wires, one end of the metal wire of the inner layer 12 and one end of the metal wire of the outer layer 11 are respectively fixed on the fixer 2, and the other end of the metal wire of the inner layer 12 and the other end of the metal wire of the.
In the specific embodiment, the outer layer 11 and the inner layer 12 formed by the metal wires of the occluder body 1 are both made of nickel-titanium alloy metal wires, the nickel-titanium metal wires of the inner layer 12 are thicker and have the diameter of 0.08mm, the weaving density is sparser and is 72 wires, the nickel-titanium metal wires of the outer layer 11 are thinner and have the diameter of 0.04mm, the weaving density is denser and is 144-288 wires.
In a further preferred scheme, the fixer 2 is a fixing nut, the connector 3 is a connecting nut, the fixing nut and the connecting nut are both made of stainless steel, and a threaded bayonet 4 is arranged in the connecting nut and used for connecting a conveying steel cable.
During the use, be connected this plugging device through coupling nut and transport the steel cable, carry the steel cable and load in the external transportation connecting sheath of income, carry the connecting sheath and be connected the back with carrying the sheath, come the control plugging device in carrying sheath and internal position through propelling movement steel cable.
With continued reference to the paravalvular leakage double-layer occluder shown in figure 3, the occluder body 1 is cylindrical with a rectangular longitudinal section, the height of the occluder body 1 is 15mm, and the diameter of the occluder body 1 is 6mm, 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, 26mm, 28mm and 30 mm.
The simple operation steps of the plugging of the perivalvular leakage of the artificial aortic valve are as follows: firstly, puncturing a femoral artery, placing a 6F vascular sheath, and delivering a catheter and a super-smooth guide wire to an ascending aorta through the femoral artery; secondly, the catheter is delivered into the left ventricle through the perivalvular leakage of the artificial aortic valve under the assistance of the guide wire, and then the catheter is exchanged into the ultra-hard supporting guide wire to the left ventricle; thirdly, the conveying sheath is sent into the left chamber along the superhard supporting guide wire; fourthly, the plugging device is sent to the opening of the conveying sheath along the conveying sheath, the conveying steel cable is fixed, the conveying sheath is withdrawn, and the part of the plugging device is exposed out of the conveying sheath; continuously withdrawing the conveying sheath, wherein the conveying steel cable is not fixedly conveyed at the moment, and the conveying steel cable and the partially exposed plugging device are withdrawn to the perivalvular leakage position; sixthly, fixing the delivery steel cable, withdrawing the delivery sheath, and enabling the rest part of the stopper to be completely exposed out of the delivery sheath and fixed at the position of the paravalvular leakage; seventhly, slightly drawing and pushing the conveying steel cable, and observing the stability of the plugging device; eighthly, after confirming that the plugging device is stable, rotating the conveying steel cable anticlockwise to separate the conveying steel cable from the plugging device; ninthly, withdrawing the delivery steel cable back into the delivery sheath, and withdrawing the delivery steel cable and the delivery sheath out of the body; the vessel suture instrument is used for suturing the femoral artery puncture at the position in the R part. The simple operation steps of the artificial mitral valve perivalvular leak plugging are as follows: firstly, puncturing a femoral artery, placing a 6F vascular sheath, and delivering a catheter and a super-smooth guide wire to a left ventricle through the femoral artery; secondly, the catheter is delivered into the left atrium through the perivalvular leakage of the artificial mitral valve under the assistance of the guide wire, and then the catheter is exchanged into the ultra-hard supporting guide wire to the left atrium; thirdly, the conveying sheath is sent into the left room along the superhard supporting guide wire; fourthly, the plugging device is sent to the opening of the conveying sheath along the conveying sheath, the conveying steel cable is fixed, the conveying sheath is withdrawn, and the part of the plugging device is exposed out of the conveying sheath; continuously withdrawing the conveying sheath, wherein the conveying steel cable is not fixedly conveyed at the moment, and the conveying steel cable and the partially exposed plugging device are withdrawn to the perivalvular leakage position; sixthly, fixing the delivery steel cable, withdrawing the delivery sheath, and enabling the rest part of the stopper to be completely exposed out of the delivery sheath and fixed at the position of the paravalvular leakage; seventhly, slightly drawing and pushing the conveying steel cable, and observing the stability of the plugging device; eighthly, after confirming that the plugging device is stable, rotating the conveying steel cable anticlockwise to separate the conveying steel cable from the plugging device; ninthly, withdrawing the delivery steel cable back into the delivery sheath, and withdrawing the delivery steel cable and the delivery sheath out of the body; the vessel suture instrument is used for suturing the femoral artery puncture at the position in the R part.
With continued reference to the patent ductus arteriosus double-layer occluder shown in figure 4, the occluder body 1 is of a cylindrical shape with a T-shaped longitudinal section, the occluder body 1 comprises an upper part 5 and a lower part 6, the height of the occluder body 1 is 7mm, 9mm, 11mm, 13mm, 15mm, 17mm and 19mm, and the diameter of the lower part 6 of the occluder body 1 is 6mm, 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, 26mm and 28 mm.
Brief surgical procedure for patent closure of arterial ducts: firstly, puncturing a femoral artery and a femoral vein, and respectively placing a 6F vascular sheath; secondly, a catheter and an ultra-smooth guide wire are sent into the femoral artery, and the ultra-smooth guide wire passes through the arterial catheter to reach the pulmonary artery; feeding the femoral vein into a snare, sequentially entering pulmonary artery through the right atrium and the right ventricle, sleeving the ultra-smooth guide wire at the pulmonary artery, and pulling the ultra-smooth guide wire out of the femoral vein; fourthly, the conveying sheath is sent to the aorta along the femoral vein side of the ultra-smooth guide wire and is sent to the plugging device loaded on the conveying steel cable through the conveying sheath; fifthly, releasing the occluder at the arterial catheter by withdrawing the delivery sheath; sixthly, slightly drawing and pushing the conveying steel cable, and observing the stability of the plugging device; seventhly, after confirming that the position, the shape and the stability of the stopper are proper and stable through automatic pulse-side radiography, rotating the conveying steel cable anticlockwise to enable the conveying steel cable to be separated from the stopper; eighthly, withdrawing the conveying steel cable into the conveying sheath, and withdrawing the conveying steel cable out of the body together with the conveying sheath; ninthly, suturing the femoral artery puncture port by using the blood vessel suturing device, and performing compression hemostasis on the femoral vein puncture position.
With continued reference to the double-layer occluder for ventricular septal defect shown in figure 5, the occluder body 1 is in a cylinder shape with an I-shaped longitudinal section, the occluder body 1 comprises an upper part 5, a middle part 7 and a lower part 6, the height of the occluder body 1 is 3mm, 5mm, 7mm and 9mm, the diameter of the middle part 7 of the occluder body 1 is 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm and 18mm, the diameter difference between the upper part 5 and the middle part 7 of the occluder body 1 is 4mm, 6mm, 8mm and 10mm, and the diameter of the lower part 6 of the occluder body 1 is the same as that of the upper part 5 of the occluder body 1.
Brief surgical procedure for ventricular septal defect occlusion: firstly, puncturing a femoral artery and a femoral vein, and respectively placing a 6F vascular sheath; secondly, a catheter and the ultra-smooth guide wire are sent into the femoral artery, and the ultra-smooth guide wire passes through the ventricular septal defect to reach the right ventricle and then reaches the pulmonary artery; feeding the femoral vein into a snare, sequentially entering pulmonary artery through the right atrium and the right ventricle, sleeving the ultra-smooth guide wire at the pulmonary artery, and pulling the ultra-smooth guide wire out of the femoral vein; fourthly, the conveying sheath is sent to the aorta along the femoral vein side of the ultra-smooth guide wire and is sent to the plugging device loaded on the conveying steel cable through the conveying sheath; fifthly, releasing the occluder at the ventricular septal defect by withdrawing the delivery sheath; sixthly, slightly drawing and pushing the conveying steel cable, and observing the stability of the plugging device; seventhly, after confirming that the position, the shape and the stability of the occluder are proper and stable through radiography from the left ventricle side, rotating the conveying steel cable anticlockwise to separate the conveying steel cable from the occluder; eighthly, withdrawing the conveying steel cable into the conveying sheath, and withdrawing the conveying steel cable out of the body together with the conveying sheath; ninthly, suturing the femoral artery puncture port by using the blood vessel suturing device, and performing compression hemostasis on the femoral vein puncture position.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention.
Claims (8)
1. The utility model provides a novel double-deck plugging device, its characterized in that, includes the plugging device somatic part, the upper end of plugging device somatic part is equipped with the fixer, the lower extreme of plugging device somatic part is equipped with the connector, the plugging device somatic part passes through the outside steel cable of carrying is connected to the connector, the plugging device somatic part includes the skin and the inlayer that constitute by the wire, the inlayer the wire with the tip of outer wire is one end to be fixed in respectively the fixer, another is fixed in respectively the connector.
2. The novel double-layered occluder of claim 1, wherein the wires of said inner layer have a diameter greater than the diameter of the wires of said outer layer, and wherein the braid density of the wires of said inner layer is less than the braid density of the wires of said outer layer.
3. The novel double-layered occluder of claim 2, wherein the inner layer of wires has a diameter of 0.08mm and a braid density of 72 wires, and the outer layer of wires has a diameter of 0.04mm and a braid density of 144-288 wires.
4. The novel double-layered occluder of any one of claims 1 to 3, wherein said wires are nitinol wires.
5. The novel double-layer occluder of any one of claims 1 to 3, wherein said occluder body is for paravalvular leakage and is cylindrical with a rectangular longitudinal cross section, said occluder body has a height of 15mm, and said occluder body has a diameter of 6mm, 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, 26mm, 28mm, 30 mm.
6. The novel double-layer occluder of any one of claims 1 to 3, wherein said occluder body is used for patent ductus arteriosus and is of a cylindrical type with a T-shaped longitudinal section, said occluder body comprises an upper portion and a lower portion, said occluder body has a height of 7mm, 9mm, 11mm, 13mm, 15mm, 17mm, 19mm, and said occluder body has a diameter of 6mm, 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, 26mm, 28 mm.
7. A novel double-layer occluder according to any one of claims 1 to 3, wherein the occluder body is used for ventricular septal defect and has a cylindrical shape with an i-shaped longitudinal section, the occluder body comprises an upper part, a middle part and a lower part, the height of the occluder body is 3mm, 5mm, 7mm and 9mm, the diameter of the middle part of the occluder body is 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm and 18mm, the diameter difference between the upper part and the middle part of the occluder body is 4mm, 6mm, 8mm and 10mm, and the diameter of the lower part of the occluder body is the same as the diameter of the upper part of the occluder body.
8. The novel double-layer occluder of claim 1 wherein said retainer is a retaining nut and said connector is a connecting nut, said connecting nut having a threaded bayonet therein.
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| CN202010826503.XA CN111820963A (en) | 2020-08-17 | 2020-08-17 | Novel double-layer plugging device |
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| CN202010826503.XA CN111820963A (en) | 2020-08-17 | 2020-08-17 | Novel double-layer plugging device |
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| CN111820963A true CN111820963A (en) | 2020-10-27 |
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| CN202010826503.XA Pending CN111820963A (en) | 2020-08-17 | 2020-08-17 | Novel double-layer plugging device |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113017914A (en) * | 2021-03-17 | 2021-06-25 | 复旦大学附属中山医院 | Peripheral blood vessel composite stent for preventing intimal hyperplasia at access opening of covered stent |
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Application publication date: 20201027 |