WO2013016984A1

WO2013016984A1 - Aortic aneurysm dissection stent system and preparation method thereof

Info

Publication number: WO2013016984A1
Application number: PCT/CN2012/077245
Authority: WO
Inventors: 刘刚; 曾筝; 成正辉; 黄连军
Original assignee: 北京华医圣杰科技有限公司
Priority date: 2011-08-03
Filing date: 2012-06-20
Publication date: 2013-02-07
Also published as: CN102379731B; CN102379731A

Abstract

An aortic aneurysm dissection stent system comprises a stent (1) and a plugging device (6) separated from each other, a stent conveying system, and a plugging device conveying system. By using the stent (1) and the plugging device (6) separated from each other in a cooperation way, the plugging device (6) is pushed to a lesion position through the plugging device conveying system, is released and unfolded to plug a cut on a blood vessel wall, to isolate a parent artery of an aorta (16) from a dissection (17) and to change the haemodynamics of the lesion part of an aortic aneurysm; and the stent (1) is pushed to the lesion part through the stent conveying system, is released and unfolded to support the inner wall of a blood vessel and the plugging device (6), so as to ensure that the plugging device (6) is firm and is not displaced under the impact of blood and a surgery is safer and more effective. In addition, since the conveying processes of the plugging device (6) and the stent (1) are separated, the size of a puncture point for a minimally invasive surgery and the diameter of a conveying sheath are greatly reduced, thereby preventing excessive damage to the artery.

Description

Aortic aneurysm sandwich scaffold system and preparation method thereof

Technical field

The invention relates to a novel medical device, in particular to a sandwich stent system for implanting aortic aneurysm and a preparation method thereof. Background information

Aortic dissection aneurysm is the most dangerous type of aortic aneurysm. Generally, the high blood flow of the artery enters the middle layer of the artery wall from the tear of the aortic intima, separating the inner and outer layers and expanding along the middle layer to form a "mezzanine. "A structure of an aneurysm. The high pressure blood flow inwardly compresses the intima to narrow the obstruction of the aorta, causing the weak aortic wall to bulge outwards, which can cause rupture. In addition to the intimal tearing injury, the degeneration of the middle layer and the decrease of tissue adhesion are also important causes of aortic dissection. According to different classification methods, aortic aneurysm can be divided into several types. Stanford classification can be divided into type A and type B; Debakey classification can be divided into type I, type II and type III. Stanford type A is equivalent to Debakey type I and type II, accounting for approximately 65-70% of dissecting aneurysms; Stanford type B is equivalent to Debakey type III, accounting for approximately 30-35%. Common aneurysm dissection is often due to rupture of blood loss, pericardial tamponade, arrhythmia or renal failure. The aortic dissection aneurysm is extremely dangerous. The 24-hour survival rate after dissection of the aneurysm is only 40%, the 1-week survival rate is 25%, and the 3-month survival rate is only 10%. The prognosis of patients with lesions involving the ascending aorta is worse, with a 1-month survival rate of only 8%, and a one-month survival rate of up to 75% in patients with lesions involving only the descending thoracic aorta.

To date, there is no effective drug for the treatment of dissection aneurysms, and surgery is the only effective way to prevent rupture of dissection aneurysms. Previously, dissection aneurysms were almost incurable because there were no suitable vascular substitutes. In the late 1950s, artificial blood vessels appeared, and an effective traditional surgical method, artificial blood vessel replacement, was gradually developed. The operation of artificial blood vessel replacement is quite complicated, with large trauma, more bleeding, slow recovery, and more complications. Long-term aortic blockade has a direct adverse effect on other important organs, resulting in multiple complications such as myocardial infarction, renal failure, and paraplegia. In the 1990s, Argentine vascular surgeon Parodi pioneered a minimally invasive treatment of aneurysms, endovascular exclusion. Endovascular exclusion is performed in the lumen of the artery. It does not require a thoracotomy. It only cuts a small opening in the groin. Under X-ray monitoring, a catheter containing a suitable size of artificial blood vessels is placed from the femoral artery. After introduction, after reaching the aortic lesion, the artificial blood vessel is released from the catheter, and the artificial blood vessel with the Nitinol stent is automatically opened, firmly fixed to the inner wall of the aorta, and the gap is completely closed. The residual resting blood will gradually become thrombotic and eventually become scarred.

Aortic stenting for the treatment of aortic dissection and dissection aneurysms is a recent advancement in interventions. The treatment goal of the aortic dissection is to isolate the proximal aortic rupture, thereby opening the true cavity, sealing the false lumen, and forming a thrombus in the false lumen. However, if it is not handled properly, it will cause the reverse tear of the interlayer, causing the dissection of the aortic arch or even the ascending aorta. Difficult complications. Placing the stent in the relatively fragile dissection of the aortic wall and placement on the atherosclerotic aneurysm vessel wall may result in completely different results. In the latter case, the stent-targeting zone requires only a small portion of the relatively normal vessel wall; however, the aortic dissection requires both a better orientation and no excessive damage to the vessel wall. In addition, the stent also requires a certain degree of compliance, which ensures that the true cavity can be gradually expanded, and the false lumen is continuously compressed, so as to ensure the success of the treatment. Some literature reports that the effect of endoluminal stenting on the treatment of thoracic aortic aneurysm caused by Marfan syndrome is not ideal. Clinical results showed that the sandwich vessel wall was torn into multiple true and false lumens, and the stent spanned the true and false lumens. Although the dissection was repaired, the stent vessels did not repair the fracture. Since 1991, intraluminal techniques have been used to treat thoracic aortic aneurysm lesions, but this technique is far from mature. How to reduce the incision to prevent arterial injury, make the stent system more compliant and the application of safety devices, so that the clinical results are worthy of further study. In addition, endovascular treatment is not recommended for patient specialists with aortic dissection due to connective tissue lesions. Summary of the invention

In order to solve the above problems, the present invention provides a system for providing an aortic aneurysm sandwich stent and a method for preparing the same.

The aortic aneurysm stent system includes a separate stent and an occlusion device, and further includes a stent delivery system and a occlusion device delivery system, the stent is woven from the stent braided wire, and the release state is the same as the main a cylindrical structure in which the inner wall of the aneurysm is fitted, the occlusion device comprises a occlusion device net body, and the net body of the occlusion device is woven by a tying device, and is sealed in a released state. The occlusion surface of the aortic aneurysm wall opening, the stent delivery system comprising a stent delivery catheter and a distal end thereof for assembling and delivering the stent, and a stent delivery guide for transporting the vessel through the stent delivery catheter to the aortic aneurysm The occlusion device delivery system includes a occlusion device delivery catheter having a locating marker at the distal end and a distal end thereof for fixing and releasing the occlusion device, and a delivery catheter from the occlusion device to the aortic aneurysm A occlusion device at the opening of the vessel wall delivers a guidewire.

The stent has contractility, and has a mesh-like cylindrical shape in a released state, and is contracted and fixed on the stent delivery guide wire in a delivery state and transported from the lumen of the stent delivery catheter to the aortic aneurysm.

a bracket indicator is disposed on the two ends of the length direction of the bracket, and the bracket is made of a platinum alloy, a nickel-titanium alloy or a gold alloy, and is fixedly connected to the bracket braided wire by welding, and the bracket conveys a guide wire. A stent delivery guidewire indicator corresponding to the stent indicator is fixed on the upper surface.

The stent delivery guide wire is made of a biopolymer material having an outer diameter of 2.37-2.41 mm, an inner diameter of 1.02-1.06 mm, a guide wire of 0.036"-0.040" in the middle, and a length of 900-1000 mm.

The stent delivery catheter is made of a biopolymer material having an outer diameter of 0.60 mm to 1.80 mm and an inner diameter of 0.35 mm to 1.20 mm.

The bracket is made of nickel-titanium gold wire, titanium wire, tungsten wire, NITI wire, silk wire, composite wire of stainless steel wire and platinum, one or several kinds of bracket braided wires of NITI and gold composite wire. , the stent braided wire has a diameter of 0.020 mm to 0.060mm, the number is one, the outer diameter of the bracket after full release is 6mm to 30mm, and the length is 10mm to 50mm. The occlusion device has a layered double-disc structure with a shape memory function in a state in which the occlusion device is in a released state, and the outer surface of the occlusion surface is sewn with a medical refractory film.

The occlusion device comprises a distal end indication of the occlusion device on the sealing surface of the occlusion device, a proximal end indication of the occlusion device on the opposite side of the double disc structure, and a connection member connected to the proximal end indication of the occlusion device, The guiding device conveying guide wire comprises a distal plug head, a middle shaft and a joint from the distal end, and an outer tube on the outer side, wherein the outer tube is made of biomedical polymer material, and the distal end of the distal plug is connected with the connecting piece. The tube is mated in the inner cavity, and the other end is connected to the central shaft by welding.

The central shaft is made of stainless steel or nickel-titanium alloy, the outer tube has an inner diameter of 1.0 mm to 2.0 mm, an outer diameter of 1.5 mm to 2.5 mm, a length of 1000 mm to 1500 mm, and a proximal end of the outer tube is bonded to a handle. The outer diameter of the shaft is 0.25 mm to 0.8 mm, the length is 1200 mm to 1800 mm, and the distal end of the central shaft has a tapered transition section.

The proximal indicator of the distal marking and blocking device of the occlusion device is made of platinum alloy, nickel-titanium alloy, stainless steel or gold alloy, and the distal end of the tying device and the occlusion device of the occlusion device and the occlusion device The proximal indicator is fixedly connected by soldering.

The occlusion device delivery catheter is made of a biopolymer material having an inner diameter of 2 mm to 5 mm and an outer diameter of 2.5 mm to 6 mm, and the distal end is provided with a distal end of the occlusion device delivery catheter.

The occlusion device net body adopts one or more kinds of nickel-titanium gold wire, titanium wire, tungsten wire, NiTi wire, filature wire, composite wire of stainless steel wire and bismuth, and composite wire of NiTi and gold. The woven wire of the device is woven by a diameter of 0.05 mm to 0.1 mm, and the number is 8 to 288. The diameter of the double disk after the net body of the occlusion device is completely released is 2 mm to 10 mm.

The method for preparing the aortic aneurysm sandwich stent system comprises the following steps: A. stent weaving and sizing, the stent braided wire is manually woven on the stent woven mold, and the stent is placed on both ends of the stent during the weaving process. The woven finished stent is heat treated and shaped together with the mold. After the thermoforming, the bracket is removed from the mold, and the bracket and the bracket indicator are welded by welding; B. The stent is conveyed by a guide wire, and the plastic tube is extruded on the tube extruder. After assembling the plastic pipe, the plastic pipe is fused on the rheometer, and the joint is injected on the injection molding machine after the pipe is completed; C. The mesh body of the woven plugging device is woven, and the braiding wire of the plugging device is woven on the knitting machine to seal The braided wire of the plugging device is evenly distributed; D. The plugging device is prepared, the net body of the plugging device is mounted on the forming device of the plugging device, and then the mesh body of the plugging device after the molding is heat-treated and shaped, and the mold is sealed after thermoforming. The plugging device is taken out from the net body, and the two ends of the netting device of the plugging device are equipped with a distal end marking device and a proximal end indicating device for the blocking device, and the closing device is shown at the proximal end. The connecting piece is installed inside, and the netting device of the plugging device and the distal end of the plugging device and the proximal end of the plugging device are welded by welding, and the meshing body of the plugging device after welding is sealed with a choke film; The shaft is made by the plugging device. The alloy wire is placed on the stainless steel ruler to measure the length. The alloy wire is cut with the diagonal pliers. One end of the middle shaft is ground on the cylindrical grinding machine, and the plug and the seal are sealed. The blocking device conveying guide wire is connected by welding.

The heat treatment is performed by a vacuum heat treatment furnace under the condition of 50 CTC for 30 minutes; the welding is performed by a laser welding machine or a TIG welding method. Technical effect:

Compared with the prior art, the aortic aneurysm stent system utilizes a separate stent and a occlusion device, and the guide wire is connected to the occlusion device through the occlusion device, and is pushed to the lesion through the occlusion device delivery catheter, and released. After opening, the opening of the vessel wall is blocked, the aortic artery and the dissection are isolated, and the hemodynamics of the aortic aneurysm is changed. The stent is pushed to the lesion by the stent delivery system, and the inner wall of the vessel is supported after being released. The blocking device ensures the firmness of the occlusion device and does not shift under the impact of blood flow, which makes the operation safer and more effective. In addition, due to the separation of the occlusion device and the stent, the minimally invasive surgical puncture point and delivery The diameter of the sheath is greatly reduced to prevent excessive arterial damage.

The stent delivery guide wire of the invention has good flexibility and pushing performance, is soft at the distal end, can be freely transported in complicated blood vessels and does not damage the inner wall of the blood vessel; the proximal end is hard and can provide good push performance; the flexibility of the stent delivery catheter is flexible Well, it can freely transport in complex blood vessels without damaging the inner wall of the blood vessel; the occlusion device delivers a flexible catheter and a good folding resistance, and can be freely transported in complex blood vessels.

During the preparation of the aortic aneurysm stent system, a vacuum heat treatment process is adopted during the molding process of the stent and the occlusion device to ensure the shape memory property and elasticity of the occlusion device, and the material is not oxidized and deformed by the internal stress of the material; The stent delivery catheter and the occlusion device The delivery catheter tube body is reinforced with a steel mesh and a spring to ensure the tensile strength of the tube body and has good bending resistance, and can ensure bending and damage of the endovascular membrane in the curved blood vessel. The plugging device network tube and plug head adopt laser welding or TIG welding process to ensure the welding strength is firm. DRAWINGS

Figure 1 is a schematic view of a stent of the present invention,

Figure 2 is a schematic view showing the guide wire of the stent and the stent of the present invention,

Figure 3 is a structural view of the conveying device of the patent holder of the present invention,

Figure 4 is a schematic view of the occlusion device of the present invention,

Figure 5 is a schematic view showing the assembly of the guide wire of the occlusion device of the present invention,

Figure 6 is a structural view of the conveying device of the patented occlusion device of the present invention,

Figure 7 is a schematic view of the aortic aneurysm sandwich device before placement,

Figure 8 Schematic diagram of the delivery process of the aortic aneurysm sandwich device

Figure 9 is a schematic view of the aortic aneurysm sandwich device after placement,

Figure 10 Schematic diagram of the aortic aneurysm stent graft delivery process,

Figure 11 Schematic diagram of the placement of the aortic aneurysm sandwich stent,

12 is a schematic view showing a braided mesh tube of an embodiment of the aortic aneurysm sandwich stent system;

Figure 13 is a structural view of a molding die of an occlusion device of the embodiment of the aortic aneurysm sandwich stent system, The numbers in the drawings are listed below:

1-bracket, 2a-bracket proximal end labeling, 2b-bracket distal labeling, 3a-bracket delivery guide wire distal marking, 3b-bracket conveying guide wire positioning indicator, 3c- stent delivery guide wire proximal end Standard, 4-bracket delivery guide wire, 5-bracket delivery catheter, 6-plugging device mesh, 7-blocking device distal marking, 8-blocking device proximal marking, 9-connector, 10- Distal plug, 11-axis, 12-outer tube, 13-plug device delivery guide wire connector, 14-plug device delivery catheter, 15-plug device delivery catheter distal indicator, 16-aorta, 17-Aortic aneurysm dissection, 18-occlusion device delivers guidewire. detailed description

The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

The aortic aneurysm stent system of the present embodiment comprises a stent and a occlusion device, and respectively comprises a stent delivery system and a delivery system of the occlusion device, and the specific structure is as follows:

As shown in Fig. 1, the bracket 1 is a mesh structure using a superelastic NITI alloy wire, and of course, other braided wires capable of forming a radial contraction may be used, including a bracket proximal end indicator 2a and a bracket distal end labeling. 2b. As shown in Fig. 2, the stent delivery guide wire 4 has three indicators, that is, the stent delivery guide wire distal indicator 3a, the stent delivery guide wire positioning indicator 3b, and the stent delivery guide wire proximal indicator 3c. As shown in Fig. 3, in the delivery state, the stent 1 is assembled on the stent delivery guide wire 4 and passed through the lumen of the stent delivery catheter 5. The distal end marker 2b of the stent coincides with the distal marker 3a of the stent delivery guidewire, and the proximal marker 2a of the stent coincides with the proximal marker 3c of the stent delivery guidewire. After reaching the predetermined position, the stent delivery catheter 5 is withdrawn, the stent 1 is released from the stent delivery catheter 5, and the superelastic NITI alloy wire is automatically expanded to open the original mesh structure.

As shown in FIG. 4, the occlusion device of the present embodiment is also made of a superelastic NITI alloy wire or other woven wire having a memory function, and includes a occlusion device net body 6 and a distal end indication plate 7 of the occlusion device. The closure device has a proximal indicator 8 and a connector 9. As shown in Fig. 5, the occlusion device delivery guide 18 includes a distal plug 10, a central shaft 11, an outer tube 12 and a joint 13. The delivery guide wire distal end plug 10 and the occlusion device connector 9 are cooperatively connected in the inner cavity of the delivery guide wire outer tube 12, and the delivery guide wire middle shaft 11 and the distal ferrule 10 are connected by welding. When the delivery guide wire outer tube 12 is withdrawn, the distal plug head 10 is loosened with the occlusion device connector 9, and the occlusion device mesh body 6 can be detached from the delivery guide wire. As shown in Fig. 6, in the delivery state, the occlusion device delivery guide wire 18 with the occlusion device mesh body 6 is passed along the lumen of the occlusion device delivery catheter 14, and the occlusion device is pushed to transport the guide wire 18 until it is observed under DSA development. The occlusion device distal indicator 7 coincides with the occlusion device delivery catheter distal indicator 15. The occlusion device delivery catheter 14 is withdrawn, and the occlusion device mesh body 6 is released from the delivery catheter, and the superelastic NITI alloy wire is automatically expanded and expanded into its original shape.

As shown in Fig. 7, Fig. 8 and Fig. 9, the delivery process of the occlusion device mesh body, using the occlusion device to deliver the visibility of the catheter distal end 15 under X-rays, the occlusion device delivery catheter 14 along the aorta 16 Pushed to the aortic aneurysm 17 at a predetermined location. The occlusion device delivery guide wire 18 with the occlusion device mesh body 6 is fed into the delivery catheter 14, and the relative position of the delivery guide wire guide shaft 13 and the delivery guide wire outer tube 12 is tightened by tightening the occlusion device delivery guide wire connector 13. . Feed the guide wire 18 forward until The occlusion device distal indicator 7 and the occlusion device delivery catheter distal indicator 15 coincide. At this point, the delivery catheter 14 is withdrawn, and the occlusion device mesh 6 begins to be released. Under DSA development, the visibility of the distal indication 7 of the occlusion device and the proximal indicator 8 of the occlusion device under X-rays , adjust the corresponding position, so that the two devices of the occlusion device net body 6 are located on both sides of the inner membrane of the vascular sandwich. After the net body 6 of the occlusion device is completely released, the occlusion device is released to transport the guide wire connector 13, the outer guide tube 12 of the guide wire is retracted, the mesh body 6 of the occlusion device is released, and the guide wire 18 is withdrawn from the occlusion device. The occlusion device delivers the catheter 14. At this time, the occlusion device net body 6 is attached to the inner membrane of the vascular sandwich, and the mesh body blocks the opening of the vascular sandwich layer.

As shown in Fig. 10 and Fig. 11, the stent is transported, and the stent 1 is loaded into the stent delivery catheter 5, and the distal guide 3a of the guide wire is transported through the stent, the positioning indicator 3b, the proximal indicator 3c and the distal end of the stent are provided. The visibility of the indicator 2b and the stent proximal indicator 2a under X-rays conveys the stent 1 to a predetermined position. Keeping the position of the stent delivery guide wire 4 unchanged, the stent delivery catheter 5 is withdrawn, and the stent 1 is then released. After the stent 1 is completely released, the stent delivery guide wire 4 and the stent delivery catheter 5 are withdrawn. 1 Attached to the inner wall of the blood vessel as shown in Fig. 11, supporting the blood vessel of the aorta 16 and the occlusion device.

The specific steps of the aortic dissection stent system of the present embodiment are as follows: 1. When the clinically diagnosed patient is an active tumor dissection patient, the patient is routinely observed before surgery; 2. The patient is subjected to femoral artery puncture, and the conventional aneurysm is found to be aortic aneurysm lesion. After the position, the occlusion device delivery catheter 14 is sent to the lesion portion of the aortic aneurysm 17 through the occlusion device delivery guide wire 18; 3. The occlusion device is used to transport the guide wire 18, and the occlusion device mesh body 6 is inserted into the occlusion device. In the device delivery catheter 14, under the X-ray monitoring, the occlusion device is pushed forward to convey the guide wire 18 until the distal indication Ί of the occlusion device coincides with the distal indication 15 of the occlusion device delivery catheter; 4. The delivery device is transported by the occlusion device The visibility of the distal end of the catheter 15 under X-ray confirms that the occlusion device delivery catheter 14 and the distal end of the occlusion device delivery guide wire 18 have passed through the active tumor sandwich opening and into the vascular sandwich; 5. Fixed occlusion device delivery The guide wire 18 retracts the occlusion device delivery catheter 14 at which time the occlusion device mesh body 6 begins to release and expand, and the visibility of the distal and distal ends of the occlusion device 8 and 7 under X-rays is Whether the two plates of the netting device 6 of the blocking device are located on both sides of the inner membrane of the aortic aneurysm 17 and block the opening of the sandwich; if the position is appropriate, the release process of the netting device 6 is completed, and if the position is not suitable, the plate is passed. The occlusion device transports the guide wire 18 to re-integrate the occlusion device net body 6 into the occlusion device delivery catheter 14 so that the distal end of the two components are coincident; the position of the occlusion device delivery catheter 14 is re-adjusted under X-ray monitoring, and the retracement is retracted. The occlusion device delivery catheter 14 releases the occlusion device mesh body 6, until the position of the occlusion device mesh body 6 is just reached the preset position under the DSA development; 6. releasing the occlusion device to transport the guide wire 13 connector, The traverse delivery guide wire outer tube 12 is such that the occlusion device net body 6 is disengaged from the delivery guide wire shaft 11 and the retort occlusion device transports the guide wire 18; 7. After observing the blood patency of the place by contrast imaging technology, The occlusion device delivery catheter 14 is withdrawn from the body; 8. The stent delivery catheter 5 containing the stent 1 is delivered to the lesion portion of the aortic aneurysm 17 via the stent delivery guide wire 4; IX. The distal and distal end marker 3a is guided through the stent delivery guide wire 3c and 3b illustrates a suitable bit in the position marked visibility under X-ray confirmed the stent delivery system; ten fixed guide wire stent delivery 4, 5 to a stent delivery catheter pullback this time begins to release the stent 1 expanded. The stent 1 is located at the opening of the aortic aneurysm 17 by the visibility of the distal end markers 2b, 2a under the X-ray; ^1, the stent is transported to the guidewire 4, and the blood patency of the site is observed by contrast technique. Thereafter, the stent delivery catheter 5 is withdrawn from the body. Preparation

The preparation method of this embodiment includes the following steps:

1. Bracket weaving and heat treatment shaping;

Second, the stent delivery guide wire is made;

Third, the mesh body weaving and blocking device production;

4. The production of the guide shaft of the guiding device for the occlusion device;

Bracket weaving and sizing: Hand-knit the bracket on the bracket woven mold with a diameter of 0.14mm NITI alloy wire. During the weaving process, a platinum-iridium alloy wire-wound indicator is placed on both ends of the bracket; The mold was placed in a ZSK2-12-6 vacuum heat treatment furnace manufactured by Wuhan Industrial Electric Furnace Plant for heat treatment and set at 500 °C for 30 minutes. After thermoforming, the bracket was removed from the mold, and the bracket and the indicator were placed. It is welded by LCT-W1 laser welding machine or TIG welding method manufactured by Beijing Ze Optoelectronic Technology Co., Ltd.

Bracket transport guide wire production: After drying the Pebax material pellets, the corresponding specifications of plastic tubes were extruded on a 25-machine extrusion equipment group manufactured by America Kuhne. Inc., and the plastic tubes were assembled after the Granada technology ( Several plastic pipes were fused on the rheometer produced by Shenzhen Co., Ltd. After the pipe was completed, the joints were injection molded on a vertical injection molding machine manufactured by Boy Machines Inc.

Braided mesh body: The mesh body shown in Figure 12 was woven on the HTBZ-40 braiding machine manufactured by Shenzhen Huitai Medical Instrument Co., Ltd. with 72 pieces of 0.05mm NITI alloy wire. The NITI wire was evenly distributed on the mesh body.

Production of occlusion device: According to the design requirements of the drawings, the mesh body is mounted with the clogging device forming mold as shown in Fig. 13; then the woven mesh body after the molding is placed in ZSK1-12-6 manufactured by Wuhan Industrial Electric Furnace General Factory In the vacuum heat treatment furnace, the heat treatment is set, and the temperature is kept for 30 minutes under the condition of 50CTC; after the thermoforming, the mold is taken out from the net body, the ends of the net body are marked with a mark, and the proximal end of the display is equipped with a connecting piece, and the net body is attached. The indicator can be welded by LCT-W1 laser welding machine or TIG welding method manufactured by Beijing Ze Optoelectronic Technology Co., Ltd., and the sealing device after welding can be used to make a complete blocking device.

The occlusion device conveys the guide wire to the middle shaft: After cutting the NITI alloy wire with a diameter of 0.65mm according to the design requirements of the drawings, one end of the middle shaft is ground into a TG12X4 cylindrical grinding machine manufactured by ROYAL MASTER GEINDERS.INC in the United States. In accordance with the shape of the design requirements, the stainless steel bolt head and the guide wire purchased according to the design requirements of the drawings are connected by TIG welding method, that is, the shaft of the guide wire for guiding the conveying device is completed. Application examples:

In vivo test: A dog with a dissected aortic aneurysm, a set of aortic aneurysm stent system and its accessory accessories of the present invention, the stent has a diameter of 10 mm and a length of 30 mm; the stent delivery catheter has an inner diameter of 2.48 mm, and an outer diameter. 2.97mm; The inner diameter of the stent delivery guide wire is 1.63mm, the outer diameter is 2.39mm, and the middle can pass the guide wire of 0.038"; the diameter of the disk surface of the sealing device is 6mm, the axis of the delivery guide wire is 0.65mm, and the inner diameter of the delivery catheter is 1.8mm. , outer diameter of 2.3mm; transfemoral artery After puncture, after confirming the aortic aneurysm dissection lesion under angiography, under the X-ray monitoring, the guide wire is first fed, and the occlusion device delivery catheter is pushed to the preset position by the guiding action of the guide wire; The distal indicator determines whether the position of the catheter is correct, withdraws the guide wire, loads the occlusion device into the delivery catheter through the loader, and transports the delivery guide wire forward until the distal end of the occlusion device is observed under DSA development technology. The indicator is coincident with the distal indicator of the delivery catheter; the fixed occlusion device delivers the guide wire, and the delivery catheter is withdrawn. At this time, the occlusion device begins to release the expansion, and the indications at the ends of the occlusion device are visible under X-rays. To determine whether the two plates of the occlusion device are located on both sides of the intima of the aneurysm; if the position is appropriate, the release process of the occlusion device is completed, and if the position is not suitable, the occlusion device is re-received into the delivery catheter by the delivery guide wire Inside, the two parts are displayed at the distal end of the indicator, the position of the delivery catheter is re-adjusted under X-ray monitoring, and the delivery catheter is released to release the occlusion device until Under DSA development, it is observed that the position of the occlusion device just reaches the preset position; the occlusion device is used to transport the guide wire handle, the position of the shaft of the delivery guide wire is fixed, and the detachment of the guide wire outer tube is released and blocked. Guide wire, traverse delivery guide wire; after observing the blood patency of the place by contrast imaging technique, the occlusion device delivery catheter is evacuated, that is, the delivery and release process of the occlusion device is completed; The guide wire is sent to the aortic aneurysm lesion site, and the position of the stent is conveyed by the far and near end of the guide wire and the visibility of the positioning indicator under X-ray confirms that the position of the stent delivery system is appropriate; the fixed stent transports the guide wire, and the delivery catheter is At the time of withdrawal, the stent begins to release and expand; the visibility of the stent at the distal end of the stent is confirmed to be located at the opening of the aortic aneurysm; the stent is transported to the stent, and the blood patency of the stent is observed by contrast technique. After good, the stent delivery catheter is withdrawn from the body. The size of the specific bracket and blocking device can be adjusted according to actual needs. The operation is small in trauma to the patient. After the occlusion device is released, the two plates are located on both sides of the intima of the aortic aneurysm, blocking the opening of the dissection, cutting off the branch blood flow, preventing the aortic aneurysm from continuing to tear; The function of the fixed occlusion device ensures the strength of the vascular segment of the aneurysm and the normal flow of blood in the blood vessel. The combination of the two can achieve the purpose of curing the aortic aneurysm, and the success rate of the operation is high.

The design study of the aortic aneurysm stent system of the present invention and the preparation method thereof are not limited by the above embodiments, and the structures and methods and preparation methods of the present invention are used, and the size and substitution components are formed according to specific cases. The technical solutions are all within the scope of the present invention.

Claims

Claim

1. Aortic aneurysm stent system, characterized in that it comprises a separate stent and a occlusion device, and further comprises a stent delivery system and a occlusion device delivery system, the stent is woven from a stent braided wire, and is released under the state of release. a cylindrical structure adapted to the inner wall of the vessel at the aortic aneurysm, the occlusion device comprising a occlusion device mesh body, the occlusion device mesh body being woven by the occlusion device braided wire, having a release state A sealing surface sealing the opening of the aortic aneurysm wall, the stent delivery system comprising a stent delivery catheter and a distal end thereof for assembling and delivering the stent, and a stent for delivery to the vessel of the aortic aneurysm through the stent delivery catheter Transmitting a guide wire, the occlusion device delivery system includes a occlusion device delivery catheter having a positioning mark at a distal end and a distal end thereof for fixing and releasing the occlusion device, and passing through the delivery device from the occlusion device to the main delivery state A occlusion device at the opening of the vascular wall of the aneurysm delivers a guidewire.

2. The aortic aneurysm stent system according to claim 1, wherein the stent has contractility, and has a mesh-like cylindrical shape in a released state, and is contracted and fixed on the stent delivery guide wire in a delivery state. The stent delivery catheter lumen is delivered to the aortic aneurysm.

The aortic aneurysm stent system according to claim 1, wherein the stent has a stent on both ends of the longitudinal direction of the stent, and the stent is made of a platinum alloy, a nickel-titanium alloy or a gold alloy. The stent braided wire is fixedly connected by means of welding, and the stent delivery guide wire corresponding to the stent indicator is fixed on the stent delivery guide wire.

The aortic aneurysm stent system according to claim 1, wherein the stent delivery guide wire is made of a biopolymer material, and has an outer diameter of 2.37-2.41 mm and an inner diameter of 1.02-1.06 mm. There is a guide wire of 0.036"-0.040", and the length is 900-1000mm.

The aortic aneurysm stent system according to claim 1, wherein the stent delivery catheter is made of a biopolymer material having an outer diameter of 0.60 mm to 1.80 mm and an inner diameter of 0.35 mm to 1.20 mm. The pipe body is reinforced with a wire mesh and a spring.

The aortic aneurysm stent system according to any one of claims 1 to 5, characterized in that the stent is a composite of nickel-titanium gold wire, titanium wire, tungsten wire, NITI wire, silk wire, stainless steel wire and platinum. One or more kinds of stent braided wires of material filament, NITI and gold composite wire, the stent braided wire diameter is 0.020mm to 0.060mm, the number is one, and the outer diameter of the stent after complete release It is 6mm to 30mm and has a length of 10mm to 50mm.

The aortic aneurysm stent system according to claim 1, wherein the occlusion device has a layered double-disc structure having a shape memory function in a released state, and an outer layer of the sealing surface Medical choke.

The aortic aneurysm stent system according to claim 7, wherein the occlusion device comprises a distal end indication of the occlusion device on the sealing surface of the occlusion device, and a occlusion device on the opposite side of the double disc structure. a proximal indicator and a connector connected to the proximal end of the occlusion device, the occlusion device conveying the guide wire from the distal end including the distal ferrule, the central shaft and the joint, the outer side The outer tube is made of a biomedical polymer material, and one end of the distal plug is cooperatively connected with the connecting member in the inner tube inner cavity, and the other end is connected to the central shaft by welding.

The aortic aneurysm stent system according to claim 8, wherein the central shaft is made of stainless steel or nickel-titanium alloy, and the outer tube has an inner diameter of 1.0 mm to 2.0 mm and an outer diameter of 1.5 mm. 2.5mm, length from 1000mm to 1500mm, a handle attached to the proximal end of the outer tube, the outer diameter of the central shaft is 0.25mm to 0.8mm, the length is 1200mm to 1800mm, and the distal end of the central shaft has a tapered transition section.

10. The aortic aneurysm stent system according to claim 8, wherein the distal indicator of the distal end of the occlusion device and the occlusion device are made of platinum alloy, nickel titanium alloy, stainless steel or gold alloy. The occlusion device braiding wire and the distal end of the occlusion device and the proximal indicator of the occlusion device are fixedly connected by welding.

11. The aortic aneurysm stent system according to claim 8, wherein the occlusion device delivery catheter is made of a biopolymer material having an inner diameter of 2 mm to 5 mm and an outer diameter of 2.5 mm to 6 mm. The occlusion device has a distal end of the delivery catheter, and the tube body is reinforced with a steel mesh and a spring.

The aortic aneurysm stent system according to any one of claims 1 to 7, wherein the occlusion device mesh body is made of titanium wire, tungsten wire, NiTi wire, filature wire, stainless steel wire and enamel. One or more kinds of plugging devices of composite wire, NiTi and gold composite wire are woven by braiding wire, the wire diameter of the blocking device is 0.05 mm to 0.1 mm, and the number is 8 to 288. The diameter of the double disc after the net body of the plugging device is completely released is 2 mm to 10 mm.

13. The method for preparing an aortic aneurysm stent system according to any of claims 1-12, comprising the steps of: A. stent weaving and shaping, the stent braiding wire is hand-woven on the stent knitting mold, during the weaving process. The brackets are placed on both ends of the bracket; the braided bracket is heat-treated and shaped together with the mold, and the bracket is removed from the mold after thermoforming, and the bracket and the bracket indicator are welded together; B. the stent is conveyed by a guide wire, Extruding the plastic pipe on the pipe extruder, fusing the plastic pipe after the plastic pipe is assembled, and injecting the joint on the injection molding machine after the pipe is completed; C. Weaving the net body of the plugging device, weaving the plugging device The wire is woven on the knitting machine to evenly distribute the braiding wire of the plugging device; D. The plugging device is fabricated, the net body of the plugging device is mounted on the forming device of the plugging device, and then the mesh body of the plugging device after the molding is heat-treated and shaped After thermoforming, the mold is taken out from the net body of the plugging device, and the distal end of the netting body of the plugging device is equipped with a distal indicator of the blocking device and a proximal end of the blocking device. The connecting device is installed in the proximal end of the blocking device, and the netting device of the blocking device and the distal end of the blocking device and the proximal end of the blocking device are welded by welding, and the meshing device of the sealing device after welding is blocked. Flow film; E. Closing device conveying guide wire shaft manufacturing: The alloy wire is placed on a stainless steel ruler for a good length, the alloy wire is cut with a diagonal pliers, and one end of the middle shaft is ground on a cylindrical grinding machine. , the plug head and the blocking device conveying guide wire are connected by welding.

The method for preparing an aortic aneurysm stent system according to claim 13, wherein the heat treatment is performed by a vacuum heat treatment furnace under the condition of 50 CTC for 30 minutes; and the welding is performed by a laser welding machine or a TIG welding method. welding.