WO2019109981A1

WO2019109981A1 - Self-expanding woven stent and conveying device thereof

Info

Publication number: WO2019109981A1
Application number: PCT/CN2018/119590
Authority: WO
Inventors: 陈树国; 党军; 程增兵; 李峰
Original assignee: 苏州恒瑞宏远医疗科技有限公司
Priority date: 2017-12-07
Filing date: 2018-12-06
Publication date: 2019-06-13
Also published as: CN107837135B; CN109602522B; CN109602522A; CN107837135A

Abstract

A stent conveying device comprising a self-expanding woven stent and a conveying component. The length of the stent prior to release is 1.82-2.22 times the length of the stent after release. An axial shortening ratio of the stent is 45-55%, and a stent weave angle is 90-140°. The conveying component includes an inner tube (1), a stent pushing tube (2), a stent binding tube (3), a handle housing (4), a driving device connector (5), a Luer connector (6), a stent binding tube connector (7), a stent pushing tube driving device (8), and a gearing device. The self-expanding woven stent is designed to prevent the stent from elongating upon release. During release of the stent, the stent pushing tube moves to the distal end, thereby compensating the amount of axial shortening after the stent is released and boosting vascular patency rates after stent implantation.

Description

Self-expanding braided bracket and conveying device thereof

Technical field

The invention belongs to the field of medical instruments, and in particular relates to a self-expanding braided stent and a conveying device thereof.

Background technique

Vascular disease, known as vascular disease in Chinese medicine, has increased significantly in recent years, such as arterial stenosis, arteriovenous thrombosis, and aneurysm. Peripheral arterial stenosis and occlusive disease, common in atherosclerosis, diabetes, arteritis, etc., mainly manifested as decreased skin temperature, muscle atrophy, impaired pulse or pulse, intermittent claudication, severe limb necrosis in severe cases. It even needs amputation, which is life-threatening in severe cases; venous thrombotic disease can cause blood flow stagnation and swelling of the affected limb, and at the same time there is a risk of fatal pulmonary embolism; aneurysmal disease has the risk of rupture and death of the tumor at any time. Vascular disease has a high disability rate and a certain mortality rate. The effect of medical treatment is very small. Surgical treatment is an invasive treatment method with limited effect.

According to the 2014 American Society of Cardiovascular Angiography and Interventions (SCAI) published a consensus statement on endovascular intervention for peripheral arterial disease, almost all of the main-iliac artery peripheral arterial disease (PAD) can be treated with endovascular intervention, but there is no evidence One type of bracket is superior to other types of brackets. For TASC (TransAtlantic Inter-Society Consensus) graded A, B, and C primary-radial PAD, endovascular intervention is superior to endarterectomy, and evidence suggests that the former is more likely to reduce patient mortality. Advantages (intra-arterial incision hospital mortality rate 2.7%). Due to the risk of surgery, open surgical treatment is the last choice for this type of disease; the success rate of endovascular interventions is more than 90%, and the mortality rate is low, which is a suitable treatment strategy for patients with lifestyle changes and exercise can not effectively control symptoms.

There are many classification criteria for vascular stents. The stent can be divided into balloon-expandable and self-expanding stents. The stent function is divided into bare stents, drug-coated stents and stent grafts. The stent structure is divided into a tubular stent, a circular stent, a wound stent and a braided stent. Bracket materials include stainless steel, nickel titanium and cobalt chrome brackets.

The balloon-expanding stent itself is inelastic, and the design is that the stent is pre-installed on the balloon, and the stent is delivered to the vascular lesion through the balloon catheter. After the balloon is expanded to a certain diameter, the balloon is attached to the blood vessel wall by the retracting force of the blood vessel wall. No sustained expansion tension is created on the vessel wall. The biggest advantage is accurate release positioning, suitable for open lesions, such as vertebral artery opening, renal artery opening lesions. In addition, the axial shortening phenomenon is not obvious after release, and the radial support force is stronger than the self-expanding bracket. However, the balloon-expanded stent itself lacks elasticity, is prone to collapse and occlusion after compression, and has poor flexibility. It is not suitable for vulnerable or active joints such as extracranial carotid artery and femoral artery. Peripheral blood vessels are used for localized short-segment stenosis lesions (<4 cm) in the straight, inactive joint region.

The self-expanding stent is attached to the vessel wall by compressing the stent into the delivery sheath and delivering it to the vascular lesion. The sheath is withdrawn and released from the stent, and the vessel wall is attached according to a balance between the stent's own expansion tension and the elastic limitation of the vessel wall. However, the disadvantages of the self-expanding stent include: forward jump and axial shortening when the stent is released, and the precise positioning and release is difficult; the axial length of the stent after being released from the sheath tube is significantly decreased, and the stent length is obviously axially shortened, and the stent is shortened. During the release process, the proximal end is displaced as the release progresses, requiring the operator to manually adjust the position of the delivery system during the procedure, resulting in the operator not being able to accurately control the positioning of the stent during the procedure. The stent has distal and proximal ends. The positioning is difficult, and the release position is not ideal; the flexibility and bending and kink resistance of the stent cannot fully adapt to the complex force generated by the long-term continuous mechanical movement of the blood vessel, and the stress fatigue occurs after long-term implantation. The fracture causes symptoms of restenosis in the blood vessels. The long-term patency rate of blood vessels decreased. Therefore, such stents have been unsatisfactory for the treatment of vascular lesions.

To this end, there is a need in the art to develop an intravascular stent and a delivery device thereof, the stent should have good performance, and the delivery device can enable the stent to be accurately and rapidly released into the target diseased blood vessel.

Summary of the invention

The object of the present invention is to provide a self-expanding braided stent capable of achieving accurate intravascular delivery, avoiding excessive elongation/compression release, improving vascular patency, accurate positioning, and convenient operation, and a delivery device thereof.

According to a first aspect of the present invention, a self-expanding braided stent is provided, wherein the length of the stent before release is 1.82-2.22 times the length of the stent after release; the axial shortening ratio of the stent is 45-55%; The braiding angle of the stent is 90-140°.

In another preferred embodiment, the length of the stent before release is from 1.85 to 2.1 times, preferably from 1.9% to 1.95 times the length after stent release.

In another preferred embodiment, the stent has an axial shortening ratio of 46-52%, preferably 47-49%.

In another preferred embodiment, the stent has a weave angle of 110-135°, preferably 115-125°.

In another preferred embodiment, the outer diameter of the stent after loading is 1.6-2.13 mm.

In another preferred embodiment, the stent has a compressed outer diameter of from 1.7 to 2.0 mm, preferably from 1.75 to 1.9 mm.

In another preferred embodiment, the stent has a wire diameter of 0.1 to 0.2 mm.

In another preferred embodiment, the stent has a diameter of 4-8 mm.

In another preferred embodiment, the stent has a diameter of 4.5 to 7.0 mm.

In another preferred embodiment, the number of braided heads of the stent is 4-8 heads.

A second aspect of the invention provides a stent delivery device comprising: (a) a self-expanding braided stent provided by the first aspect of the invention; (b) a delivery member.

In another preferred embodiment, the conveying member comprises an inner tube, a bracket pushing tube, a bracket binding tube, a handle housing, a driving device joint, a luer connector, a bracket binding tube joint, a bracket pushing tube driving device, and a transmission device.

In another preferred embodiment, the stent-binding tube has an outer diameter of 2.0 to 2.33 mm.

In another preferred embodiment, the stent-binding tube has an inner diameter of 1.6-2.13 mm.

In another preferred embodiment, the bracket push tube driving device includes a rigid push tube connected to the bracket push tube, and a drive handle connected to the rigid push tube, the distal end of the rigid push tube and the The bracket push tube is connected at a proximal end, and the driving device joint is fixed on an outer surface of the rigid push tube.

In another preferred embodiment, the distal end of the rigid push tube is placed in the stent tether tube.

In another preferred embodiment, the drive handle coupled to the rigid push tube is provided with a scale display for indicating the distance the rigid push tube is moved distally.

In another preferred embodiment, the distance between the proximal end of the rigid push tube and the proximal end of the stent tether tube is 2-2.5 times the nominal length of the self-expanding braided stent.

In another preferred embodiment, the inner tube is provided with a development ring mark for indicating the proximal and distal positions after the stent is released.

In another preferred embodiment, the drive unit joint and the bracket-binding tube joint move in opposite directions along the rigid slide bar.

In another preferred embodiment, the transmission consists of a conveyor belt and a fixed pulley.

In another preferred embodiment, the stent tether tube is used to bind a loaded stent, the transmission is composed of a conveyor belt and the fixed pulley, the conveyor belt passes through the fixed pulley, and one end of the conveyor belt and the bracket are bound The outer surface of the tube is connected by the bracket binding tube joint, the bracket binding tube joint is fixed on the proximal outer surface of the bracket binding tube, and the proximal end of the bracket pushing tube is connected to the bracket pushing tube driving device, The other end of the conveyor belt and the bracket push tube drive are connected by the drive unit joint.

In another preferred embodiment, the transmission consists of a gear and a rack.

In another preferred embodiment, the stent tether tube is used to bind the loaded stent, the transmission consists of two gears S1, S2 and a gear S3 moving toward each other, the rack S2 being bound by a conveyor belt and the bracket The pipe joint is connected to the bracket binding tube, and the rack S1 is connected by the rigid pushing tube and the bracket pushing tube. The gear S3 moves clockwise to drive the racks S1 and S2 to move in opposite directions, and the bracket binding tube joint is fixed at The bracket binds the proximal outer surface of the tube, and the proximal end of the bracket push tube connects the bracket push tube driving device.

In another preferred embodiment, a bracket push tube driving device for use with a transmission composed of the gear and the rack is driven by a gun handle, the gun handle and the gear and the rack Form a separate handle.

In another preferred embodiment, the bracket binding tube is coupled to the rigid connector of the gun handle by a buckle, and when the rigid connector moves to the distal end, the bracket binding tube is moved to the distal end; The bracket pushing tube is also coupled to the rigid connector of the gun handle by the buckle, and when the rigid connector moves to the proximal end, the bracket pushing tube is moved to the proximal end, and the The rigid connector is moved toward each other by the gun handle to drive the bracket tether tube and the bracket push tube (2) to maintain the opposing movement.

In another preferred embodiment, the buckle is composed of a positioning chuck fixed to the surface of the bracket binding tube, and a positioning card fixed to the rigid connecting member.

In another preferred embodiment, the buckle is composed of a positioning chuck fixed to the surface of the bracket pushing tube and a positioning card fixed to the rigid connecting member.

In another preferred embodiment, the rigid connector is coupled to the rack S2 and the rigid connector is coupled to the rack S1. The handle drive gear S3 moves clockwise.

It is to be understood that within the scope of the present invention, the various technical features of the present invention and the various technical features specifically described hereinafter (as in the embodiments) may be combined with each other to constitute a new or preferred technical solution. Due to space limitations, we will not repeat them here.

DRAWINGS

1 is a schematic view of a knitting angle in one embodiment of the present invention.

2 is a front elevational view of the braided stent nominal length and the loaded stent in accordance with one embodiment of the present invention.

Figure 3 is a schematic view of a fixed pulley transfer device in accordance with one embodiment of the present invention.

4 is a schematic view of a rack and pinion conveying device in accordance with an embodiment of the present invention.

Figure 5 is a cross-sectional view of a gun handle in accordance with one embodiment of the present invention.

Figure 6 is a schematic view of a buckle in an embodiment of the present invention.

Figure 7 is a one-year vascular patency rate of different release effects of a woven stent in a comparative example of the present invention.

Wherein, the number A1 represents the weaving angle, L represents the nominal length of the stent, D represents the nominal diameter of the stent, D1 represents the diameter after loading of the stent, and L1 represents the length after loading of the stent. 1 represents the inner tube, 2 represents the bracket push tube, 3 represents the bracket binding tube, 4 represents the handle housing, 5 represents the drive connector, 6 represents the luer connector, 7 represents the bracket binding tube connector, and 8 represents the bracket push tube driving device, 9 On behalf of the conveyor belt, 10 represents fixed pulleys, 11 and 12 represent rigid connectors, 13 and 14 represent gun-type handles, 15 represents buckles, 151 represents positioning cards, and 152 represents positioning chucks.

Detailed ways

Through extensive and in-depth research, the present invention has for the first time developed a self-expanding braided stent and a delivery device thereof, wherein the length of the stent before release is 1.82-2.22 times the length of the stent after release; the axial direction of the stent The shortening ratio is 45-55%; the knitting angle of the bracket is 90-140°. The self-expanding braided stent and the conveying device thereof can realize the accurate release of the stent, avoid the elongated release of the stent, obviously improve the patency rate of the blood vessel after the stent is implanted, and have accurate positioning and convenient operation. Based on the above findings, the inventors completed the present invention.

the term

As used herein, the term "nominal length" refers to the length after stent release, ie the axial length after the stent has been detached from the stent-binding tube.

As used herein, the term "diameter of the stent" refers to the outer diameter of the stent.

As used herein, the term "wire diameter of the stent" refers to the diameter of the stent filament.

As used herein, the term "outer diameter after stent loading compression" refers to the outer diameter of the stent that the stent is loaded to compress within the delivery system.

As used herein, the term "length before stent release" refers to the axial length of the stent loaded within the stent-binding tube.

As used herein, the term "length after stent release" refers to the axial length of the stent after it has been released from the interior of the delivery system.

As used herein, the term "axial shortening" refers to the percentage change in length before stent release and length after stent release.

Self-expanding braided bracket

The invention provides a self-expanding braided stent, wherein the length of the stent before release is 1.82-2.22 times the length of the stent after release; the axial shortening ratio of the stent is 45-55%; the braiding angle of the stent For 90-140.

The axial shortening refers to the percentage change in length before stent release and length after stent release.

The knitting angle A1 is defined as an angle A1 formed by the stent wires crossing in the axial direction when the stent is at the nominal diameter D, as shown in FIG. 1, the nominal diameter is the diameter of the stent at the nominal length, that is, the stent is released. After the diameter.

After repeated experiments and research by the inventors, it is found that the self-expanding braided woven bracket has a weaving angle A1 of 90-140°, the bracket has good radial support and flexibility, and a low axial shortening ratio, weaving angle. The larger the A1, the better the support force and flexibility, but the larger the axial shortening rate of the stent, the less likely it is to be transported. Further, after several experiments, the inventors found that when the braiding angle A1 of the stent is at 110-135°, the support force, flexibility and axial shortening of the stent reach an ideal balance. Further, when the knitting angle A1 of the bracket is at 115-125 ° C, the bracket has good supporting force and flexibility, and a suitable axial shortening ratio. At this time, the axial shortening ratio of the bracket is between 47% and 49%. At this time, the length before the stent is released is between 1.90 and 1.95 times the length of the stent after release. as shown in picture 2.

In the present invention, the length of the stent before release is 1.82-2.22 times, preferably 1.85-2.1 times, more preferably 1.9-1.95 times, the length after stent release, and the stent can be prevented from being axially elongated and released. The self-expanding woven stent of the present invention is released by a slight axial compression, overcoming the problem that the operator may slightly move the delivery system to the proximal end during the surgical release of the stent, causing the stent to be axially elongated and elongated. However, the existing clinical trials have found that after the stent is axially elongated, the patency rate of the diseased blood vessels is significantly reduced. Thus, the self-expanding braided stent of the present invention is capable of compensating for the stent to be slightly elongated during surgery.

In a preferred embodiment of the present invention, the inventors separately design features such as the compressed outer diameter of the stent of the self-expanding braided stent, the diameter of the stent, the diameter of the stent, and the number of braided heads, as follows:

In a preferred embodiment, the compressed outer diameter of the vascular stent has a greater impact on the passage of the stent and the delivery device. The smaller the outer diameter of the stent after compression, the smaller the diameter of the stent-binding tube for loading the stent, and the better the permeability of the stent and delivery system within the blood vessel. However, the smaller outer diameter of the vascular stent after loading and compressing also increases the difficulty of releasing the stent from the stent-binding tube, and the release force of the stent from the stent-binding tube is significantly increased, and the outer diameter of the stent after the stent is loaded and compressed For screening optimization, the outer diameter after compression of the stent is selected to be 1.6-2.13 mm, preferably 1.7-2.0 mm, more preferably 1.75-1.9 mm.

In a preferred embodiment, the wire diameter of the stent has a significant influence on the support force of the stent. The larger the wire diameter of the stent, the support force of the stent increases almost squarely, but the diameter of the larger stent also affects the blood vessel pair. The effect of the stent on the endothelium-enveloping stent. In the present invention, through experimental design and preferred research, the wire diameter of the stent is 0.1-0.2 mm, which can ensure the stent has good support performance and the stent can complete endothelialization in a short time.

In a preferred embodiment, the stent has a diameter of 4-8 mm. In the embodiment of the present invention for treating peripheral lower limb stenosis, the self-expanding braided stent with a diameter of 4-8 mm for the stent has good support properties for the blood vessel, can maintain effective support for the narrow plaque, and the stent has a better support. The low radial outward force prevents the stent from stimulating the vascular tissue and causes excessive proliferation of the vascular endothelium. At the same time, the stent also has good flexibility and bending resistance in the blood vessel, and can adapt to the twisted shape of the blood vessel and the complicated stress environment. Ensure that the support force can be quickly delivered and released with a low axial shortening. In another preferred embodiment of the invention, the stent has a diameter of 4.5 to 7.0 mm.

In another preferred embodiment, the number of braided heads of the bracket is defined as the number of meshes in the circumferential direction of the bracket. When the diameter of the bracket is determined, the number of braided heads of the braided bracket determines the size of the mesh area of the bracket, and thus affects The metal coverage area of the stent in the blood vessel. The more the number of braided heads, the smaller the mesh area of the stent, and the metal coverage area of the stent in the blood vessel will increase significantly, which will seriously affect the endothelialization process of the stent covered by the endothelial cells. In the present invention, after our experiment Designed and preferred, the number of braided heads of the stent is 4-8 heads. At this time, the bracket has a suitable mesh area, and the metal coverage area of the bracket is between 16-27%.

Self-expanding braided stent delivery device

The invention provides a conveying device, the conveying device comprising:

(a) self-expanding braided stent;

(b) conveying parts.

In a preferred embodiment of the present invention, the conveying member comprises an inner tube 1, a bracket pushing tube 2, a bracket binding tube 3, a handle housing 4, a driving device joint 5, a luer connector 6, a bracket binding tube joint 7, and a bracket. Pushing tube drive device 8, transmission device;

It has been experimentally studied that the stent-binding tube 3 preferably used for loading the compression stent has an outer diameter of 6-7F, that is, the outer diameter of the stent-binding tube is between 2.0-2.33 mm.

In another preferred embodiment, the stent-binding tube 3 has an inner diameter of 1.6-2.13 mm. The inventors have found through research that within a certain range, the outer diameter of the stent after loading and compressing has little effect on the axial shortening rate of the stent. Since the braiding angle of the stent loading compression in the stent binding tube is small, the knitting angle occurs at this time. A slight change has a greater effect on the outer diameter of the stent after compression, but has less effect on the axial shortening of the stent. Therefore, the stent is loaded with a similar axial shortening in the stent tether tube having an inner diameter of 1.6-2.13 mm.

In another preferred embodiment, the bracket push tube driving device 8 includes a rigid push tube connected to the bracket push tube 2, and a drive handle connected to the rigid push tube, the distal end of the rigid push tube The bracket pushing tube 2 is connected at a proximal end, and the driving device joint 5 is fixed on an outer surface of the rigid pushing tube. Preferably, the distal end of the rigid push tube is placed in the stent tether tube 3. In another preferred embodiment, the distance between the proximal end of the rigid push tube and the proximal end of the stent tether tube 3 is 2-2.5 times the nominal length of the self-expanding braided stent. When the stent is released, the distal end of the rigid push tube moves distally into the stent-binding tube 3, and the proximal end of the stent-binding tube 3 moves proximally, so that the stent is compensated in situ for release at the target lesion vessel position.

In another preferred embodiment, the drive handle coupled to the rigid push tube is provided with a scale display for indicating the distance the rigid push tube is moved distally. It is convenient for the operator to observe the length of the stent release.

In another preferred embodiment, the inner tube 1 is provided with a development ring mark for indicating the proximal and distal positions after the stent is released.

In another preferred embodiment, the drive unit joint 5 and the bracket-binding tube joint 7 move toward each other along a rigid slide bar.

In another preferred embodiment, the transmission consists of a conveyor belt 9 and a fixed pulley 10.

In another preferred embodiment, the stent tether tube 3 is used to bind a loaded stent, the transmission consists of a conveyor belt 9 and the fixed pulley 10, the conveyor belt 9 passes through the fixed pulley 10, the conveyor belt One end of the 9 and the outer surface of the stent binding tube 3 are connected by the bracket binding tube joint 7, and the bracket binding tube joint 7 is fixed to the proximal outer surface of the stent binding tube 3, the bracket pushing tube 2 The proximal end is connected to the bracket push tube drive device 8, and the other end of the conveyor belt 9 and the bracket push tube drive unit 8 are connected by the drive unit joint 5. As shown in Figure 3. In a preferred embodiment of the present invention, the conveyor belt 9 passes through the fixed pulley 10 in a tension state, and the bracket pushing tube driving device 8 drives the bracket pushing tube 2 to move distally, since the bracket binding tube 3 passes The transmission belt 9 and the fixed pulley are connected to the bracket pushing tube 2, and at this time, the bracket pushing tube driving device 8 also synchronously drives the bracket binding tube 3 to move toward the proximal end, that is, the bracket binding tube 3 and the bracket push tube 2 maintain the same moving speed to make a relative movement.

In another preferred embodiment, the transmission consists of a gear and a rack, in addition to the relative movement of the transmission combined with the fixed pulley and the fixed pulley. As shown in Figure 4.

In another preferred embodiment, the bracket binding tube 3 is used to bind the loaded bracket, the transmission consists of two gears S1, S2 and a gear S3 moving toward each other, the rack S2 passing through the conveyor belt and the said The bracket binding tube joint 7 is connected with the bracket binding tube 3, and the rack S1 is connected by the rigid pushing tube and the bracket pushing tube 2, and the gears S3 are moved clockwise to drive the racks S1 and S2 to move toward each other, the bracket A tethered joint 7 is secured to the proximal outer surface of the stent tether 3, and a proximal end of the stent pusher 2 is coupled to the stent pusher drive 8.

In another preferred embodiment, a bracket push tube drive 8 for use with a transmission of the gear and the rack is driven by a gun handle, the gun handle and the gear and the tooth The strips form a separate handle. The separate handle can be assembled with the stent delivery device during the surgical procedure without the need for pre-operative packaging.

In another preferred embodiment, the bracket binding tube 3 is coupled to the rigid connecting member 11 of the gun handle by a buckle 15, and when the rigid connecting member 11 is moved distally, the bracket binding tube 3 is driven. Moving to the distal end; and the bracket pushing tube 2 is also coupled to the rigid connecting member 12 of the gun handle by the buckle 15, and the rigid connecting member 12 drives the bracket to push when moving to the proximal end The tube 2 is moved proximally, and the

rigid links

11, 12 are moved toward each other by the gun handles 13, 14, thereby driving the stent tether 3 and the stent push tube 2 to maintain relative movement. As shown in Figure 5.

Furthermore, the handle and the stent binding tube and the stent push tube can be assembled before surgery. As shown in FIG. 6, in another preferred embodiment, the buckle 15 is composed of a positioning chuck 152 and a positioning card 151, and the positioning chuck 152 is fixed on the surface of the bracket binding tube 3, and the positioning card 151 It is fixed to the rigid connector 11. The positioning card 151 is caught in the inter-ring gap of the positioning chuck 152 before the operation, so that the rigid connecting member 11 is driven by the handle to drive the bracket binding tube 3 to move.

In another preferred embodiment, the buckle 15 is composed of a positioning chuck 152 and a positioning card 151. The positioning chuck 152 is fixed on the surface of the bracket pushing tube 2, and the positioning card 151 is fixed on the rigid connecting member 12. . The positioning card 151 is stuck in the inter-ring gap of the positioning chuck 152 before the operation, so that the rigid connecting member 12 is driven by the handle to drive the bracket pushing tube 2 to move.

In another preferred embodiment, the rigid connector 11 is coupled to the rack S2, and the rigid connector 12 is coupled to the rack S1. The

handles

13, 14 drive the gear S3 for clockwise movement.

Main technical advantages of the present invention

(1) The invention realizes the accurate release of the stent, avoids excessive elongation/compression release of the stent during the surgical implantation, and significantly improves the patency rate of the blood vessel after the stent is implanted.

(2) In addition, the technical solution effectively solves the problem that the proximal end positioning of the stent is not clear by the current vascular surgery clinician. In the reciprocating design of the prior art, the stent is pushed out one by one, and the elongation or compression of the stent depends on Immediately at the doctor's site, the doctor was unable to determine the release position of the proximal end of the stent during surgery. If the proximal end of the stent is closer to the bifurcation of the blood vessel, it may block the bifurcated blood vessel. It is common practice for doctors to release the stent from the proximal end of the stent after the controlled stent is released. buffer. But the amount of buffer distance cannot be controlled. If the distance from the bifurcation vessel is too large after the stent is released and the lesion cannot be completely covered, a short stent needs to be placed at the proximal end. This leads to an increase in the cost of treatment for patients. The present invention effectively solves this problem. In the present invention, the length of the stent after release is close to half of that before the stent is released, and the release position of the proximal end of the stent can be observed and judged before the stent is released, and the release position of the proximal end of the stent is usually marked by setting a development mark on the inner tube surface. In the present invention, the inner tube is kept in a fixed position during the release of the stent, which helps the doctor to judge the proximal position after the stent is released. In the reciprocating release process in the prior art, the development of the proximal end of the stent is indicated. The marker reciprocates during the release of the stent. The surgeon can only judge the expected proximal position of the stent before the stent is released. During the stent release process, the inner tube/outer tube may reciprocate and cannot be referenced during the operation. The proximal end is released.

(3) The push release bracket is used to avoid the cumbersome operation of the reciprocating release. In the surgical operation, the stent release process is consistent with the existing ordinary nickel-titanium cutting stent release process, and the surgeon does not need to relearn the release operation; The reciprocating release requires the surgeon to control the amount of stent release compensation, which requires a very high release technique and thus a long learning curve.

The invention is further illustrated below in conjunction with specific embodiments. It is to be understood that the examples are not intended to limit the scope of the invention. The experimental methods in the following examples which do not specify the specific conditions are usually in accordance with conventional conditions or according to the conditions recommended by the manufacturer.

Example 1

In this embodiment, the bracket is woven with 0.15 mm nickel-titanium wire, the diameter is 4.5 mm, the number of braided heads is 4, and the knitting angle A1 is 120°. The bracket is loaded and compressed in the bracket-binding tube, and the bracket is released from the stent-binding tube. The axial shortening rate is 47.6%, and the inner diameter of the stent-binding tube is about 1.75 mm. In this embodiment, the fixed pulley conveyor controls the bracket binding tube 3 and the bracket pushing tube 2 to perform the relative movement. The transmission device is composed of a conveyor belt 9 and a fixed pulley 10. One end of the conveyor belt and the outer surface of the bracket binding tube 3 are connected by a bracket binding tube joint 7, and the bracket binding tube joint 7 is fixed on the outer surface of the proximal end of the bracket binding tube 3, and the bracket pushing tube The proximal end of 2 is connected to a drive unit 8, and the other end of the conveyor belt 9 is coupled to the carriage push tube drive unit 8 via a drive unit joint 5. The conveyor belt 9 passes through the fixed pulley 10 and is in tension tension. The driving device 8 drives the bracket pushing tube 2 to move to the distal end. Since the bracket binding tube 3 is connected to the bracket pushing tube 2 through the driving belt 9 and the fixed pulley, the driving device 8 also synchronously drives the bracket binding tube 3 to move toward the proximal end. That is, the stent tether tube 3 and the stent push tube 2 maintain the same moving speed for the relative movement. At the same time, the drive unit 8 includes a rigid push tube connected to the bracket push tube and a drive handle connected to the rigid push tube. The distal end of the rigid push tube is connected to the proximal end of the stent push tube 2, and the driver connector 5 is fixed to the outer surface of the rigid push tube. Preferably, the distal end of the rigid push tube is placed in the stent tether tube 3. The distance between the proximal end of the rigid push tube and the proximal end of the stented tube 3 should be more than twice the nominal length of the loaded stent. When the stent is released, the distal end of the rigid push tube moves distally into the stent-binding tube 3, and the proximal end of the stent-binding tube 3 moves to the proximal end, so that the stent is compensated in situ at the position of the target lesion vessel.

Example 2

In this embodiment, the bracket is woven with 0.18 mm nickel-titanium wire, the diameter is 7.0 mm, the number of braided heads is 6 and the knitting angle A1 is 118.5°. The bracket is loaded and compressed in the stent-binding tube, and the stent is released from the stent-binding tube. The axial shortening rate is 46.6%, and the inner diameter of the stent-binding tube is about 1.9 mm. In this embodiment, the rack and pinion tube 3 and the bracket push tube 2 are controlled to move in opposite directions by a rack and pinion conveying device. The transmission device is composed of two oppositely moving racks S1, S2 and a gear S3, wherein the rack S2 is connected to the bracket binding tube through a conveyor belt and a bracket binding pipe joint, and the rack S1 is connected by a rigid pushing tube and a bracket pushing tube. By loading the rotary handle on the gear S3, the drive gear S3 is rotated clockwise, thereby driving the racks S1 and S2 to move in opposite directions.

Example 3

In this embodiment, the bracket is woven with 0.15 mm nickel-titanium wire, the diameter is 6.0 mm, the number of the braided head of the bracket is six, and the knitting angle A1 is 119°. The bracket is loaded and compressed in the stent-binding tube, and the stent is released from the stent-binding tube. The axial shortening rate is 46.9%, and the inner diameter of the stent-binding tube is about 1.65 mm. In the present embodiment, the same rack and pinion conveying device as in Embodiment 2 is used to control the bracket restraining tube 3 and the bracket pushing tube 2 to perform the relative movement. The difference is that the pre-operative separable gun handle drive gear S3 is rotated clockwise.

The specific process is as follows: the bracket binding tube 3 is coupled to the rigid connecting member 11 of the handle through the buckle 15, and when the rigid connecting member 11 moves to the distal end (right end), the bracket binding tube 3 is moved to the distal end; and the bracket pushing tube 2 is moved. Also, the buckle is coupled to the rigid connector 12 of the handle, and when the rigid connector 12 is moved toward the proximal end (left end), the bracket push tube 2 is moved to the proximal end. The

rigid connectors

11 and 12 are moved toward each other by the gun handles 13 and 14, so that the carriage restraining tube 3 and the bracket pushing tube 2 are kept in opposite directions.

Further, the handle and the bracket binding tube bracket push tube can be assembled before surgery. The buckle 15 is composed of 152 and 151. As shown in Fig. 6, 152 is fixed to the surface of the

bracket binding tube

3, and 151 is fixed to the rigid connecting member 11. Before the operation, 151 is stuck in the inter-ring gap of 152, so that the rigid connecting member 11 is driven by the handle, and the bracket binding tube 3 is driven to move.

Similarly, 152 is fixed to the surface of the

bracket push tube

2, and 151 is fixed to the rigid connecting member 12. Before the operation, 151 is stuck in the inter-ring gap of 152, so that the rigid connecting member 12 can be driven by the handle to drive the bracket pushing tube 2 to move.

The rigid connector 11 is connected to S2, and the rigid connector 12 is connected to S1. The

handles

13 and 14 drive the S3 for clockwise movement. The driving process is the same as the conventional gun movement mechanism.

One-year patency rate of different release effects of woven stents

The existing clinical results show that (as shown in Figure 7), the 1-year vascular patency rate of the different release effects of the braided stent is reciprocating, only 36% of the stents achieve the stent release according to the nominal length, while 50% of the stents are Extended release, 14% of the stent is compressed and released. The stent vascular patency rate of the elongated release was reduced by at least 15%. Seriously affected the therapeutic effect of the braided stent. The self-expanding braided stent of the invention avoids the stent from being excessively elongated or compressed and released from the design angle, and the stent push-pull tube moves to the distal end during the release process, thereby compensating for the axial shortening after the stent is released, and improving The braided stent has a vascular patency rate, thereby improving the therapeutic effect of the stent.

All documents mentioned in the present application are hereby incorporated by reference in their entirety in their entireties in the the the the the the the the In addition, it should be understood that various modifications and changes may be made by those skilled in the art in the form of the appended claims.

Claims

A stent delivery device, characterized in that the delivery device comprises:

(a) self-expanding braided stent;

(b) conveying parts;

The length of the stent before release is 1.82-2.22 times the length of the stent after release; the axial shortening ratio of the stent is 45-55%; the braiding angle of the stent is 90-140°;

The outer diameter of the bracket after loading and compressing is 1.6-2.13 mm, and the wire diameter of the bracket is 0.1-0.2 mm;

The conveying member comprises an inner tube (1), a bracket pushing tube (2), a bracket binding tube (3), a handle housing (4), a driving device joint (5), a luer connector (6), and a bracket binding tube joint. (7), bracket push tube drive device (8), transmission device;

The bracket pushing tube driving device (8) comprises a rigid pushing tube connected to the bracket pushing tube (2), and a driving handle connected with the rigid pushing tube, the distal end of the rigid pushing tube and the bracket a push tube (2) is connected at a proximal end, and the drive connector (5) is fixed to an outer surface of the rigid push tube;

The distal end of the rigid push tube is placed in the bracket binding tube;

The inner tube is provided with a developing ring mark for indicating the proximal and distal positions after the stent is released;

The drive handle connected to the rigid push tube has a scale display for displaying the distance that the rigid push tube moves to the distal end;

The transmission consists of a conveyor belt and a fixed pulley for binding the loaded carriage, the transmission consisting of a conveyor belt and the fixed pulley, the conveyor belt passing through the fixed pulley, the conveyor belt end and An outer surface of the stent tether tube is connected by the bracket binding tube joint, the bracket binding tube joint is fixed on a proximal outer surface of the bracket binding tube, and the proximal end of the bracket pushing tube is connected to the bracket pushing The tube driving device, the other end of the conveyor belt and the bracket push tube driving device are connected by the driving device joint.
A stent delivery device, characterized in that the delivery device comprises:

(a) self-expanding braided stent;

(b) conveying parts;

The length of the stent before release is 1.82-2.22 times the length of the stent after release; the axial shortening ratio of the stent is 45-55%; the braiding angle of the stent is 90-140°;

The outer diameter of the bracket after loading and compressing is 1.6-2.13 mm, and the wire diameter of the bracket is 0.1-0.2 mm;

The conveying member comprises an inner tube (1), a bracket pushing tube (2), a bracket binding tube (3), a handle housing (4), a driving device joint (5), a luer connector (6), and a bracket binding tube joint. (7), bracket push tube drive device (8), transmission device;

The bracket pushing tube driving device (8) comprises a rigid pushing tube connected to the bracket pushing tube (2), and a driving handle connected with the rigid pushing tube, the distal end of the rigid pushing tube and the bracket a push tube (2) is connected at a proximal end, and the drive connector (5) is fixed to an outer surface of the rigid push tube;

The distal end of the rigid push tube is placed in the bracket binding tube;

The inner tube is provided with a developing ring mark for indicating the proximal and distal positions after the stent is released;

The drive handle connected to the rigid push tube has a scale display for displaying the distance that the rigid push tube moves to the distal end;

The transmission consists of a gear and a rack for binding the loaded carrier, the transmission consisting of two racks S1, S2 and a gear S3 moving towards each other, the rack S2 passing the conveyor belt and The bracket binding tube joint is connected to the bracket binding tube, the rack S1 is connected by a rigid pushing tube and a bracket pushing tube, and the gears S3 move clockwise to drive the racks S1 and S2 to move in opposite directions, the bracket binding A pipe joint is fixed to a proximal outer surface of the bracket binding tube, and a proximal end of the bracket pushing tube is coupled to the bracket pushing tube driving device.
The stent delivery device according to claim 1 or 2, wherein the length of the stent before release is 1.9 to 1.95 times the length of the self-expanding braided stent.
A stent delivery device according to claim 1 or 2, wherein the stent has a diameter of 4-8 mm.
A stent delivery device according to claim 1 or 2, wherein the number of braided heads of the stent is 4-8.
The delivery device according to claim 1 or 2, characterized in that the outer diameter of the stent-binding tube (3) is 2.0-2.33 mm.
The delivery device according to claim 1 or 2, wherein the stent-binding tube has an inner diameter of 1.6-2.13 mm.
A delivery device according to claim 1 or 2, wherein the distance between the proximal end of the rigid push tube and the proximal end of the stent tether tube is 2-2.5 times the nominal length of the self-expanding braided stent .
A conveyor according to claim 1 or 2, wherein said drive joint and said bracket tie tube joint move in opposite directions along the rigid slide.
A conveyor apparatus according to claim 2, wherein a bracket push tube driving device for use with a transmission of said gear and said rack is driven by a gun handle, said gun handle and said The gear and the rack form a separate handle;

The bracket binding tube is coupled to the rigid connector of the gun handle by a buckle, and when the rigid connector moves to the distal end, the bracket binding tube is moved to the distal end; and the bracket pushing tube is the same Coupling with the rigid connector of the gun handle, the rigid connector moves the proximal end to move the bracket, and the rigid connector passes the gun handle The opposing movement is achieved to drive the stent tether tube and the stent push tube (2) to maintain the relative movement.