Novel self-expanding laser engraving nickel-titanium alloy stent system

Abstract

The invention provides a novel self-expanding laser engraving nickel-titanium alloy stent system, which belongs to the field of medical equipment, and comprises a metal bare stent, a lead-in assembly and a catheter assembly, the metal bare support is composed of an upper support and a lower support. According to the stent, the first carving holes are formed in the surface of the upper stent body, the second carving holes are formed in the surface of the lower stent body, the diameter of the first carving holes is generally designed to range from 2 mm to 3 mm so that enough blood flow can pass through, and the first carving holes are irregularly arranged so that the flexibility of the stent can be improved; the size of the second engraved holes is relatively small and generally ranges from 1 mm to 2 mm, by means of the design, stimulation to the blood vessel wall can be reduced while the strength of the stent is guaranteed, the arrangement density of the second engraved holes is high, and therefore the overall supporting performance of the stent is enhanced. Compared with an existing support, the support has good structural strength, deformation can be avoided in the using process, and the using requirement is met.

Description

Technical Field

[0001] The present invention relates to the field of medical device equipment, and specifically to a novel self-expanding laser-engraved nitinol stent system. Background Art

[0002] Distal residue after aortic dissection is a common clinical problem, which may lead to the dilation of the distal blood vessel into a giant dissecting aneurysm, or even the rupture of the blood vessel again, endangering the life of the patient. Existing laser-engraved stent technologies have limitations. For example, standard laser-engraved nitinol stents tend to break and cannot fully adapt to complex blood vessel morphologies; the blank balloon technology has unsatisfactory treatment effects alone and a high probability of restenosis; although drug-eluting metal stents reduce the probability of restenosis, anticoagulant or antiplatelet drugs need to be taken for a long time or even for life, and once restenosis occurs, re-treatment is difficult or the probability of adverse events increases. Currently used aortic stents, multiple bare stents, etc. all have problems such as insufficient supporting force, too small or too large openings, and the implanted stents are prone to deformation, unable to meet clinical needs. Summary of the Invention

[0003] The purpose of the present invention is to provide a novel self-expanding laser-engraved nitinol stent system to solve the problems in the above background art that currently used aortic stents, multiple bare stents, etc. all have problems such as insufficient supporting force, too small or too large openings, and the implanted stents are prone to deformation, unable to meet clinical needs.

[0004] To achieve the above purpose, the present invention provides the following technical solution: A novel self-expanding laser-engraved nitinol stent system, including a metal bare stent, an introduction assembly, and a catheterization assembly;

[0005] Among them, the metal bare stent is composed of an upper stent and a lower stent. The surface of the upper stent is provided with first engraved holes, the surface of the lower stent is provided with second engraved holes, and the first engraved holes are arranged irregularly;

[0006] The introduction assembly includes a sheath, a catheter, and a guide wire. A conical interface is installed at the front end of the sheath, a fixing member is installed at the front end of the conical interface, an insertion hole is opened in the middle of the fixing member, the catheter is inserted into the insertion hole and fixed by the fixing member, a grip is fixedly installed at one end of the catheter, an adjustment knob is rotatably installed on the surface of the grip, one end of the guide wire is fixedly connected to the middle of the adjustment knob, and the guide wire is inserted into the catheter and one end extends through to the outside of the sheath;

[0007] The catheter assembly includes a catheter. One end of the catheter is equipped with an airbag, and the bare metal stent is sleeved on the surface of the airbag. The other end of the catheter is installed with a connector. An air cylinder is provided outside the catheter. The internal piston of the air cylinder is connected to a push rod. One end of the air cylinder is connected to a connecting pipe, and the connecting pipe is inserted into the connector. An air inlet pipe is connected to the surface of one end of the air cylinder, and a filter sleeve is installed on the surface of the air inlet pipe. A pressure gauge is also installed at one end of the air cylinder.

[0008] As a preferred embodiment of the present invention: The fixing member includes two connecting seats correspondingly installed at the front end of the conical interface. The bottom of the connecting seat is connected with an insertion piece. A fixing screw is inserted through the middle of the connecting seat. Fixing clamp blocks are symmetrically connected to both ends of the fixing screw. Slots are opened at both inner ends of the fixing clamp blocks, and the insertion piece is inserted into the slots.

[0009] As a preferred embodiment of the present invention: The connector includes a connecting sleeve. One end of the connecting sleeve is installed with a mounting ring. A number of steel balls are circumferentially embedded in the mounting ring. A pushing cap is slidably installed on the surface of the connecting sleeve. A spring is provided between the connecting sleeve and the pushing cap. Anti-detachment grooves corresponding to the steel balls are circumferentially opened at one end of the connecting pipe, and the steel balls are inserted into the anti-detachment grooves.

[0010] As a preferred embodiment of the present invention: A fixing seat is fixedly connected to the surface of the conical interface, and a sampling pipe is connected to the surface of the fixing seat.

[0011] As a preferred embodiment of the present invention: A hemostatic valve is installed on the surface of the sheath.

[0012] As a preferred embodiment of the present invention: Anti-slip grooves are opened on the surfaces of the grip and the adjustment knob.

[0013] As a preferred embodiment of the present invention: An external connecting pipe is fixedly connected to one side of the conical interface, and an infusion connector is installed at one end of the external connecting pipe.

[0014] As a preferred embodiment of the present invention: A one-way valve is installed inside the infusion connector.

[0015] As a preferred embodiment of the present invention: Scale lines may be provided on the surface of the air cylinder, and the air cylinder has a structure of an ordinary syringe.

[0016] As a preferred embodiment of the present invention: The bare metal stent is made of nitinol alloy.

[0017] Compared with the prior art, the beneficial effects of the present invention are:

[0018] (1) The bare metal stent consists of two parts: an upper stent and a lower stent. The surface of the upper stent is provided with first engraved holes, and the surface of the lower stent is provided with second engraved holes. The aperture of the first engraved holes is generally designed to be between 2 and 3 millimeters to ensure sufficient blood flow while maintaining the structural strength of the stent. The arrangement of the first engraved holes is irregular to increase the flexibility of the stent and enable it to better adapt to the bending and twisting of blood vessels. The size of the second engraved holes is relatively small, generally between 1 and 2 millimeters. This design can reduce the irritation to the blood vessel wall while ensuring the strength of the stent. The arrangement density of the second engraved holes is relatively high to enhance the overall support performance of the stent. Compared with existing stents, it has better structural strength. In blood vessels with a diameter of 16 - 32 millimeters, the radial support force of this stent can reach 0.5 - 1.2 Newtons / mm, meeting the basic requirements of clinical stent support force, and it can avoid deformation during use and meet the usage requirements;

[0019] (2) Through the provided introduction component, the introduction component includes a sheath, a catheter, and a guide wire. A conical interface is installed at the front end of the sheath, and a fixing piece is installed at the front end of the conical interface. An insertion hole is opened in the middle of the fixing piece to facilitate the entry of the catheter into the sheath. After the catheter is inserted into the insertion hole, the catheter is fixed to the sheath through the fixing piece. A grip is installed at one end of the catheter, and an adjustment knob is rotatably installed on the surface of the grip. The adjustment knob is connected to one end of the guide wire. The guide wire is inserted into the catheter and extends into the sheath. By controlling the adjustment knob, the guide wire is driven into the blood vessel at the arterial dissection, and the sheath is inserted into the blood vessel according to the guide wire to provide guiding support for the installation of the bare metal stent.

[0020] (3) Through the provided catheter placement component, the catheter placement component includes an intubation tube. An airbag is installed at one end of the intubation tube. The bare metal stent is sleeved on the surface of the airbag. A connector is installed at the other end of the intubation tube. An air cylinder is arranged outside the intubation tube. The air cylinder is inserted and connected to the connector through a connecting tube at one end. The intubation tube is sent into the sheath, and the intubation tube enters the arterial dissection position through the sheath. By pressing the push rod connected to the piston inside the air cylinder, external air enters the airbag through the air inlet tube. The inflation of the airbag drives the expansion of the bare metal stent and supports it at the arterial dissection position. A filter sleeve is installed on the surface of the air inlet tube to filter the air. At the same time, a pressure gauge is installed at one end of the air cylinder to observe the amount of air injected into the airbag;

[0021] (4) The bare metal stent selects nitinol as the manufacturing material. Nitinol has superelasticity and shape memory characteristics, can adapt to the complex morphology and dynamic changes of blood vessels, has good biocompatibility and high tissue compatibility, and can promote vascular endothelialization. By optimizing the design and processing technology of the stent, the radial support force and flexibility of the nitinol stent can be further improved to meet clinical requirements. Description of the Drawings

[0022] Figure 1 Schematic diagram of the overall structure of the present invention;

[0023] Figure 2 Schematic diagram of the structure of the introduction component of the present invention;

[0024] Figure 3 Schematic diagram of the structure of the catheter placement component of the present invention;

[0025] Figure 4 Schematic diagram of the composition structure of the fixing member of the present invention;

[0026] Figure 5 Schematic diagram of the composition structure of the connector head of the present invention;

[0027] Figure 6 Schematic diagram of the structure of the bare metal stent of the present invention.

[0028] In the figure: 1, bare metal stent; 101, upper stent; 102, lower stent; 103, first engraved hole; 104, second engraved hole; 2, introduction component; 21, sheath tube; 201, conical interface; 202, fixing member; 203, insertion hole; 213, connection seat; 214, insertion piece; 215, fixing screw; 216, fixing clamp block; 217, slot; 22, catheter; 23, guide wire; 24, grip; 25, adjustment knob; 3, catheter placement component; 31, cannula; 32, balloon; 33, connector head; 331, connection sleeve; 332, mounting ring; 333, steel ball; 334, push cap; 335, spring; 34, air cylinder; 35, push rod; 36, connecting pipe; 361, anti - detachment groove; 37, intake pipe; 38, filter sleeve; 39, pressure gauge; 4, fixing seat; 5, sampling tube; 6, hemostatic valve; 7, anti - slip groove; 8, external connecting pipe; 9, infusion connector; 10, one - way valve; 11, scale line. Specific embodiments

[0029] To make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0030] Please refer to Figures 1-6 , a novel self - expanding laser - engraved nitinol stent system, comprising:

[0031] A bare metal stent 1, an introduction component 2 and a catheter placement component 3;

[0032] Please refer to Figure 1 ,Figure 6 , the bare metal stent 1 is composed of two parts: an upper stent 101 and a lower stent 102. The surface of the upper stent 101 is provided with first engraved holes 103, and the surface of the lower stent 102 is provided with second engraved holes 104. The first engraved holes 103 are arranged irregularly;

[0033] During specific use: The bare metal stent 1 is composed of an upper stent 101 and a lower stent 102. The surface of the upper stent 101 is provided with first engraved holes 103, and the surface of the lower stent 102 is provided with second engraved holes 104. The aperture of the first engraved holes 103 is generally designed to be between 2 and 3 millimeters to ensure sufficient blood flow while maintaining the structural strength of the bare metal stent 1. The arrangement of the first engraved holes 103 is irregular to increase the flexibility of the bare metal stent 1 and enable it to better adapt to the bending and twisting of blood vessels. The size of the second engraved holes 104 is relatively small, generally between 1 and 2 millimeters. This design can reduce the irritation to the blood vessel wall while ensuring the strength of the stent. The arrangement density of the second engraved holes 104 is relatively high to enhance the overall support performance of the bare metal stent 1. Compared with existing stents, it has better structural strength. In blood vessels with a diameter of 16 - 32 millimeters, the radial support force of this stent can reach 0.5 - 1.2 Newtons per millimeter, meeting the basic requirements of clinical support force for stents and avoiding deformation during use to meet the usage requirements.

[0034] Please refer to Figure 2 , the introduction component 2 includes a sheath 21, a catheter 22, and a guide wire 23. A tapered interface 201 is installed at the front end of the sheath 21, a fixing member 202 is installed at the front end of the tapered interface 201, an insertion hole 203 is provided in the middle of the fixing member 202, the catheter 22 is inserted inside the insertion hole 203 and fixed by the fixing member 202. One end of the catheter 22 is fixedly installed with a grip 24, an adjustment knob 25 is rotatably installed on the surface of the grip 24, one end of the guide wire 23 is fixedly connected to the middle of the adjustment knob 25, and the guide wire 23 is inserted inside the catheter 22 and one end extends through and outside the sheath 21.

[0035] During specific use: The introduction component 2 includes a sheath 21, a catheter 22, and a guide wire 23. A conical interface 201 is installed at the front end of the sheath 21, and a fixing member 202 is installed at the front end of the conical interface 201. An insertion hole 203 is formed in the middle of the fixing member 202 to facilitate the entry of the catheter 22 into the sheath 21. After the catheter 22 is inserted into the insertion hole 203, the catheter 22 is fixed to the sheath 21 through the fixing member 202. A grip 24 is installed at one end of the catheter 22, and an adjustment knob 25 is rotatably installed on the surface of the grip 24. The adjustment knob 25 is connected to one end of the guide wire 23. The guide wire 23 is inserted into the catheter 22 and extends into the sheath 21. By controlling the adjustment knob 25, the guide wire 23 is driven into the blood vessel at the arterial dissection, and the sheath 21 is inserted into the blood vessel according to the guide wire 23, facilitating the guiding and supporting for the installation of the bare metal stent 1.

[0036] Please refer to Figure 3 , the catheterization component 3 includes an intubation tube 31. An airbag 32 is installed at one end of the intubation tube 31. The bare metal stent 1 is sleeved on the surface of the airbag 32. A connector 33 is installed at the other end of the intubation tube 31. An air cylinder 34 is arranged outside the intubation tube 31. A push rod 35 is connected to the piston inside the air cylinder 34. One end of the air cylinder 34 is connected to a connecting pipe 36, and the connecting pipe 36 is inserted into the connector 33. An air inlet pipe 37 is connected to the surface of one end of the air cylinder 34, a filter sleeve 38 is installed on the surface of the air inlet pipe 37, and a pressure gauge 39 is also installed at one end of the air cylinder 34.

[0037] During specific use: The catheterization component 3 includes an intubation tube 31. An airbag 32 is installed at one end of the intubation tube 31. The bare metal stent 1 is sleeved on the surface of the airbag 32. A connector 33 is installed at the other end of the intubation tube 31. The air cylinder 34 is connected to the connector 33 through a connecting pipe 36 at one end. The intubation tube 31 is sent into the sheath 21. The intubation tube 31 enters the arterial dissection position through the sheath 21. By pressing the push rod 35 connected to the piston inside the air cylinder 34, external air enters the airbag 32 through the air inlet pipe 37. The airbag 32 expands to drive the bare metal stent 1 to expand and support at the arterial dissection position. The filter sleeve 38 is installed on the surface of the air inlet pipe 37 to facilitate air filtration. At the same time, a pressure gauge 39 is installed at one end of the air cylinder 34 to observe the amount of air injected into the airbag 32.

[0038] Please refer to Figure 4 , the fixing member 202 includes two connecting seats 213 correspondingly installed at the front end of the conical interface 201. A inserting piece 214 is connected to the bottom of the connecting seat 213. A fixing screw 215 is inserted through the middle of the connecting seat 213. Fixing clamp blocks 216 are symmetrically connected to both ends of the fixing screw 215. Slots 217 are formed at both inner ends of the fixing clamp blocks 216, and the inserting piece 214 is inserted into the slots 217.

[0039] During specific use: the fixing member 202 includes two connecting seats 213 correspondingly arranged at the front end of the conical interface 201, the bottom of the connecting seat 213 is connected with an insert 214, and the middle of the connecting seat 213 is inserted with a fixing screw 215, and two symmetrically designed fixing clamps 216 are connected to the two ends of the fixing screw 215. When the catheter 22 is inserted into the conical interface 201, the two fixing clamps 216 are clamped on the outer wall of the catheter 22, and the fixing screw 215 is rotated to fix and tighten the two fixing clamps 216, so that the catheter 22 is fixedly connected to the conical interface 201 to prevent the catheter 22 from sliding during operation. When the fixing clamps 216 approach or move away from each other, the insert 214 at the bottom of the connecting seat 213 is inserted into the slots 217 at the two ends of the inner side of the fixing clamps 216, so that the fixing clamps 216 remain stable.

[0040] See also Figure 5 The connector 33 includes a connecting sleeve 331, one end of which is provided with a mounting ring 332, a plurality of steel balls 333 are embedded around the inside of the mounting ring 332, a push cap 334 is slidably mounted on the surface of the connecting sleeve 331, a spring 335 is provided between the connecting sleeve 331 and the push cap 334, and an anti-slip groove 361 corresponding to the steel ball 333 is provided around one end of the connecting tube 36, and the steel ball 333 is inserted into the anti-slip groove 361.

[0041] During specific use: the connecting head 33 includes a connecting sleeve 331, one end of which is equipped with a mounting ring 332, a plurality of steel balls 333 are arranged around the mounting ring 332, a push cap 334 is slidably installed on the surface of the connecting sleeve 331, a spring 335 drives the push cap 334 to move toward the connecting tube 36, an anti-slip groove 361 is arranged around one end of the connecting tube 36, the push cap 334 drives the steel balls 333 to penetrate into the anti-slip groove 361, and the push cap 334 is prevented from retreating under the push of the spring 335, thereby ensuring a stable connection between the connecting head 33 and the connecting tube 36; when it is necessary to disassemble the connection between the gas cylinder 34 and the cannula 31, the push cap 334 is pulled back to make it out of contact with the steel balls 333, at which time the steel balls 333 move from the anti-slip groove 361, and the disassembly can be completed, which is convenient for operation.

[0042] See also Figure 1 A fixing seat 4 is fixedly connected to the surface of the conical interface 201 , a sampling tube 5 is connected to the surface of the fixing seat 4 , and a hemostatic valve 6 is installed on the surface of the sheath tube 21 .

[0043] During specific use: a fixing seat 4 is fixedly connected to the surface of the conical interface 201, and a sampling tube 5 is connected to the surface of the fixing seat 4. Before installing the bare metal stent 1, when the sheath 21 is inserted into the blood vessel, a blood sample is extracted through the sampling tube 5 by opening the hemostatic valve 6.

[0044] See also Figure 2, anti-slip grooves 7 are provided on the surfaces of the grip 24 and the adjusting knob 25.

[0045] During specific use: anti-slip grooves 7 are provided on the surfaces of the grip 24 and the adjusting knob 25, which facilitate increasing the friction of the hand during operation and facilitate operation.

[0046] Please refer to Figure 1 , an external connecting tube 8 is fixedly connected to one side of the conical interface 201, an infusion connector 9 is installed at one end of the external connecting tube 8, and a one-way valve 10 is installed inside the infusion connector 9.

[0047] During specific use: an external connecting tube 8 is fixedly connected to one side of the conical interface 201, an infusion connector 9 is installed at one end of the external connecting tube 8. The contrast agent can be input into the blood vessel through the infusion connector 9, which is convenient for guiding during the subsequent installation of the bare metal stent 1. A one-way valve 10 installed inside the infusion connector 9 can prevent the contrast agent from leaking during injection.

[0048] Please refer to Figure 3 , scale lines 11 may be provided on the surface of the air cylinder 34, and the air cylinder 34 has a structure of an ordinary syringe.

[0049] During specific use: scale lines 11 are engraved on the surface of the air cylinder 34. The air cylinder 34 uses an ordinary transparent syringe structure. The amount of gas inflated into the airbag 32 can be known through the scale lines 11, which is convenient for injecting an appropriate amount of gas into the airbag 32 according to the expansion amount of the bare metal stent 1.

[0050] Please refer to Figure 6 , the bare metal stent 1 is made of nitinol alloy.

[0051] The bare metal stent 1 selects nitinol alloy as the manufacturing material. Nitinol alloy has superelasticity and shape memory characteristics, can adapt to the complex morphology and dynamic changes of blood vessels, has good biocompatibility and high tissue compatibility, and can promote vascular endothelialization. By optimizing the design and processing technology of the bare metal stent 1, the radial support force and flexibility of the nitinol alloy stent can be further improved to meet clinical needs.

[0052] During specific use: When designing this kind of bare metal stent, it is necessary to fully consider the anatomical structure and physiological functions of the descending aorta and abdominal vascular regions. The descending aorta and abdominal vascular regions are important components of the human circulatory system. Their blood vessel walls are relatively thin and the blood flow velocity is relatively fast, requiring higher support force and stability for the stent. According to clinical needs, the upper part of the bare metal stent 1 is designed with larger first engraved holes 103, approximately 5×5 mm, with a length of 5 - 8 cm, which can provide sufficient space for the placement of branch stents to meet the treatment requirements for complex lesions. For example, during the treatment of aortic dissection, branch stents can be used to reconstruct important branch blood vessels such as the affected celiac trunk artery, superior mesenteric artery, and renal artery to ensure unobstructed blood flow. In addition, the material selection and structural design of the stent also need to take into account biocompatibility and antithrombotic properties to reduce the occurrence of postoperative complications.

[0053] The first engraved hole 103 is designed with a large hole of 5×5 mm in the upper part and a length of 5 - 8 cm, mainly considering meeting the treatment requirements for complex lesions in the descending aorta and abdominal vascular regions. This design can provide sufficient space for the placement of branch stents to ensure that during the treatment of diseases such as aortic dissection, important branch blood vessels such as the celiac trunk artery, superior mesenteric artery, and renal artery can be effectively reconstructed to ensure unobstructed blood flow. In addition, the large hole design helps to reduce excessive compression on the blood vessel wall and reduce the risk of postoperative complications. In terms of material selection, considering biocompatibility and antithrombotic properties, high-performance materials such as nitinol are preferentially selected to ensure the stability and effectiveness of the stent in a complex hemodynamic environment. At the same time, by optimizing the structural design of the stent, such as using laser engraving technology, the pore size and shape can be precisely controlled to further improve the mechanical properties and conformability of the stent.

[0054] The lower part of the bare metal stent 1 is designed with smaller engraved holes. The first engraved hole 103 is approximately 2 mm, with a length of approximately 8 - 10 cm, aiming to provide sufficient support force for the abdominal aorta segment to promote the apposition of the true and false lumens of the dissection. In the pathological state of aortic dissection, the existence of the false lumen will lead to abnormal blood flow and further damage to the blood vessel wall, increasing the risks of aortic rupture and organ ischemia. By optimizing the engraved pore size and length of the stent, it can better adapt to the shape of the blood vessel wall, increase the contact area between the stent and the blood vessel wall, thereby improving the support force and conformability of the stent to the blood vessel wall. Research shows that a reasonable stent design can significantly improve the apposition effect of the true and false lumens of the dissection, reduce the blood flow velocity in the false lumen, promote thrombosis in the false lumen, and further reduce the risks of aortic dilation and rupture. At the same time, the design of the stent also needs to consider its mechanical properties in different blood vessel segments to ensure stability and effectiveness in a complex hemodynamic environment.

[0055] The lower part of the bare metal stent 1 is designed with small holes of 2 mm and a length of about 8 - 10 cm. The main purpose is to provide sufficient support for the abdominal aorta segment and promote the apposition of the true and false lumens of the dissection. Under the pathological condition of aortic dissection, the presence of the false lumen will lead to abnormal blood flow and further damage to the vascular wall, increasing the risks of aortic rupture and organ ischemia. By optimizing the carving aperture and length of the stent, it can better adapt to the morphology of the vascular wall, increase the contact area between the stent and the vascular wall, thereby improving the support force and apposition degree of the stent to the vascular wall. Research shows that a reasonable stent design can significantly improve the apposition effect of the true and false lumens of the dissection, reduce the blood flow velocity in the false lumen, promote false lumen thrombosis, and further reduce the risks of aortic dilation and rupture. In addition, the small hole design helps to improve the flexibility of the stent, enabling it to better conform to the natural curvature of the blood vessel in complex vascular morphologies, reducing damage to the vascular wall. In terms of material and process selection, high-performance materials such as nitinol are also used and combined with laser engraving technology to ensure the mechanical properties and biocompatibility of the stent.

[0056] The bare metal stent 1 is composed of an upper stent 101 and a lower stent 102. The surface of the upper stent 101 is provided with first carving holes 103, and the surface of the lower stent 102 is provided with second carving holes 104. Specifically, the aperture of the first carving holes 103 is generally designed between 2 - 3 mm to ensure sufficient blood flow while maintaining the structural strength of the bare metal stent 1. The arrangement of the first carving holes 103 adopts an irregular arrangement to increase the flexibility of the bare metal stent 1 and make it better adapt to the bending and twisting of the blood vessel. The size of the second carving holes 104 is relatively small, generally between 1 - 2 mm. This design can reduce the irritation to the vascular wall while ensuring the strength of the stent. The arrangement density of the second carving holes 104 is relatively high to enhance the overall support performance of the bare metal stent 1. The bare metal stent 1 selects nitinol as the manufacturing material. Nitinol has superelasticity and shape memory characteristics, can adapt to the complex morphology and dynamic changes of the blood vessel, has good biocompatibility and high tissue compatibility, and can promote vascular endothelialization. By optimizing the design and processing technology of the bare metal stent 1, the radial support force and flexibility of the nitinol stent can be further improved to meet clinical needs. Compared with existing stents, it has better structural strength. The radial support force of this stent can reach 0.5 - 1.2 N / mm in blood vessels with a diameter of 16 - 32 mm, meeting the basic requirements of clinical support force for stents. In vitro experimental results show that when the stent is subjected to the maximum design pressure, the deformation amount is only 0.5 mm, far lower than the safety threshold, and deformation can be avoided during use, meeting the usage requirements.

[0057] The content not described in detail in this specification belongs to the prior art well-known to those skilled in the art. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent replacements for some of the technical features. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A novel self-expanding laser-engraved nitinol stent system, characterized in that, Comprising: A bare metal stent (1), the bare metal stent (1) being composed of two parts, an upper stent (101) and a lower stent (102). The surface of the upper stent (101) is provided with first engraved holes (103), and the surface of the lower stent (102) is provided with second engraved holes (104). The first engraved holes (103) are arranged irregularly; An introduction assembly (2), the introduction assembly (2) including a sheath (21), a catheter (22), and a guide wire (23). A tapered interface (201) is installed at the front end of the sheath (21), a fixing member (202) is installed at the front end of the tapered interface (201), an insertion hole (203) is provided in the middle of the fixing member (202), the catheter (22) is inserted inside the insertion hole (203) and fixed by the fixing member (202). One end of the catheter (22) is fixedly installed with a grip (24), an adjustment knob (25) is rotatably installed on the surface of the grip (24), one end of the guide wire (23) is fixedly connected to the middle of the adjustment knob (25), and the guide wire (23) is inserted inside the catheter (22) and one end extends through to the outside of the sheath (21); A catheter placement assembly (3), the catheter placement assembly (3) including an intubation tube (31). An airbag (32) is installed at one end of the intubation tube (31), the bare metal stent (1) is sleeved on the surface of the airbag (32), a connector (33) is installed at the other end of the intubation tube (31), an air cylinder (34) is provided outside the intubation tube (31), a push rod (35) is piston-connected inside the air cylinder (34), one end of the air cylinder (34) is connected with a connecting pipe (36), the connecting pipe (36) is inserted inside the connector (33), an air inlet pipe (37) is connected to the surface of one end of the air cylinder (34), a filter sleeve (38) is installed on the surface of the air inlet pipe (37), and a pressure gauge (39) is also installed at one end of the air cylinder (34).

2. A novel self-expanding laser-engraved nitinol stent system according to claim 1, characterized in that: The fixing member (202) includes two connecting seats (213) correspondingly installed at the front end of the tapered interface (201). A inserting piece (214) is connected to the bottom of the connecting seat (213), a fixing screw (215) is inserted through the middle of the connecting seat (213), fixing clamp blocks (216) are symmetrically connected to both ends of the fixing screw (215), slots (217) are provided at both inner ends of the fixing clamp blocks (216), and the inserting piece (214) is inserted inside the slots (217).

3. A novel self-expanding laser-engraved nitinol stent system according to claim 1, characterized in that: The connector (33) includes a connecting sleeve (331). An installation ring (332) is installed at one end of the connecting sleeve (331), a number of steel balls (333) are annularly embedded inside the installation ring (332), a pushing cap (334) is slidably installed on the surface of the connecting sleeve (331), a spring (335) is provided between the connecting sleeve (331) and the pushing cap (334), an anti-disengagement groove (361) corresponding to the steel balls (333) is annularly provided at one end of the connecting pipe (36), and the steel balls (333) are inserted inside the anti-disengagement groove (361).

4. A novel self-expanding laser-engraved nitinol stent system according to claim 1, characterized in that: A fixing base (4) is fixedly connected to the surface of the conical interface (201), and a sampling tube (5) is connected to the surface of the fixing base (4).

5. A novel self-expanding laser-engraved nitinol stent system according to claim 1, characterized in that: A hemostatic valve (6) is installed on the surface of the sheath tube (21).

6. A novel self-expanding laser-engraved nitinol stent system according to claim 1, characterized in that: Anti-slip grooves (7) are formed on the surfaces of the grip (24) and the adjusting knob (25).

7. A novel self-expanding laser-engraved nitinol stent system according to claim 1, characterized in that: An external connecting tube (8) is fixedly connected to one side of the conical interface (201), and an infusion connector (9) is installed at one end of the external connecting tube (8).

8. A novel self-expanding laser-engraved nitinol stent system according to claim 7, characterized in that: A one-way valve (10) is installed inside the infusion connector (9).

9. A novel self-expanding laser-engraved nitinol stent system according to claim 1, characterized in that: Scale lines (11) may be provided on the surface of the syringe barrel (34), and the syringe barrel (34) has a structure of a common syringe.

10. A novel self-expanding laser-engraved nitinol stent system according to claim 1, characterized in that: The bare metal stent (1) is made of nitinol.

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