Medicine carrying support and conveying system
By designing temporary drug-loading stents and balloon dilated catheters, the barbs carry therapeutic drugs, which helps the drug directly contact the blood vessel wall, solving the problem of poor treatment effect of existing drug-loading stents, achieving stable and long-lasting therapeutic effects and high Reprint rate.
Patent Information
- Application Number
- CN202323199150.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2023-11-27
- Publication Date
- 2024-12-17
- Estimated Expiration
- 2033-11-27
AI Technical Summary
The existing drug-loading stents cannot provide stable and long-lasting therapeutic effects, and there are problems such as inflammation, endothelial disorders, and advanced thrombosis caused by implantation. The drug reprint rate is low, the drug content is high, and the long-term treatment effect is not good.
A temporary drug-loading stent was designed, including a stent body and a recycling part. The surface of the stent body has multiple action parts and tip parts, and a coating part. The stent is expanded through a balloon dilation catheter. The barb is loaded with therapeutic drugs to help the drug. Direct contact with the blood vessel walls to improve drug reprint rate.
It solves the problems of inflammation, endothelial disorders and advanced thrombosis caused by drug-loading stent implantation, improves the drug reprint and diffusion effect, provides stable and long-lasting therapeutic effects, avoids traditional drug elution and thrombosis, and improves the Reproduction rate of drug at the target lesion location.
Smart Images

Figure CN222172385U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to a temporary drug-carrying stent, in particular to a temporary drug-carrying stent and a conveying system, belonging to the technical field of interventional medical equipment. Background Art
[0002] Since the 1970s, percutaneous balloon dilatation catheter angioplasty has been used to treat patients with
[0003] In the early days of percutaneous balloon angioplasty,
[0004] It has an immediate therapeutic effect, but due to its postoperative complications, especially the occurrence of vascular stenosis
[0005] The rate is high, and the long-term treatment effect is not satisfactory. The subsequent intravascular stent angioplasty is to implant a bare metal stent or a drug-loaded stent while the balloon is dilating the narrow part of the blood vessel. It can effectively prevent the elastic retraction of the blood vessel from causing the problem of re-stenosis, but the implantation of the stent also leads to many new problems, such as endothelialization disorder, poor iron wall in the late stage of the stent, and thrombosis in the stent. In addition, if the stenosis occurs again after intravascular stent angioplasty, the difficulty of treatment will be greatly increased. Drug balloon is a treatment method that has emerged in recent years. While the balloon is dilating the narrow blood vessel, the drug coating attached to the outer surface of the balloon contacts the lesion. The drug inhibits the proliferation of the intima, thereby preventing the occurrence of re-stenosis. Because of the concept of no implantation of the drug balloon, the rejection phenomenon and thrombosis caused by the implant in the body are avoided. However, the drug balloon has also been questioned because of the large amount of drug loss during its delivery process, the poor drug transfer rate and long-term treatment effect. Moreover, since it is difficult for the drug to penetrate into the smooth muscle cells through the intima, only a small amount of drug is transferred to the middle membrane. Therefore, drug-coated balloons generally require a larger drug loading to achieve their effect. However, the drug loading of drug-coated balloons is large, but the actual drug transfer rate is small. A large amount of drug entering the blood can cause great harm to the human body.
[0006] At present, the existing technologies have some defects in drug balloon technology and drug-eluting stent technology, including but not limited to
[0007] Limited to CN108144131A, CN107865983B, US10231854, US7919108B2, US8425459B2,
[0008] In the disclosure of relevant information such as US8414526B2 and US8241249B2, the technical solutions recorded have one or more
[0009] There are some defects, such as large drug loss, blockage of distal blood vessels, and difficulty in drug penetration.
[0010] Problems such as poor long-term treatment effects cannot provide stable and lasting results. Utility Model Content
[0011] The technical problem to be solved by the utility model is to provide a drug-carrying stent and a delivery system to solve
[0012] The existing drug-eluting stents cannot provide stable and lasting effects.
[0013] The technical problem to be solved by the utility model is achieved by adopting the following technical solutions:
[0014] The drug-loaded stent comprises a stent body and a recovery part, wherein:
[0015] The support body has a plurality of action parts on its surface, and a tip part located at the end of the action parts;
[0016] At least one of the stent body, the action portion, and the tip portion has a coating portion.
[0017] As a preferred technical solution of the utility model, one end of the bracket body has the recovery part, wherein the recovery part has a marking part, and the marking part is embedded in the recovery part or installed on the recovery part.
[0018] As a preferred technical solution of the utility model, the bracket body includes several bracket components.
[0019] And connecting rods located at the ends of several bracket components, wherein the bracket components include one of rhombus, quadrilateral, W-shape and V-shape.
[0020] As a preferred technical solution of the utility model, the bracket body is made of cobalt-based alloy, stainless steel,
[0021] The stent body is made of one of titanium alloy, nickel-titanium alloy, magnesium alloy, PLA or PLGA, wherein the stent body is formed by one of laser cutting, wire weaving and 3D printing.
[0022] As a preferred technical solution of the utility model, the length of the bracket body is 10mm-200mm,
[0023] The diameter is 1mm-12mm, wherein the action portion on the bracket body includes a barb integral therewith.
[0024] As a preferred technical solution of the utility model, the recovery part includes a rope type, a buckle type, a spring type,
[0025] The reed tube or inner tube is integrally formed.
[0026] As a preferred technical solution of the utility model, the barb angle is 10°-120°, and the length
[0027] 0.2mm-5mm.
[0028] The utility model also provides a delivery system, comprising the aforementioned drug-carrying stent, and also comprising a balloon part,
[0029] A delivery device and an outer tube, wherein the balloon portion passes through a stent body, and the stent body and the balloon portion are both arranged in the outer tube of the delivery device.
[0030] As a preferred technical solution of the utility model, the conveying device includes an inner tube, the inner tube and the
[0031] The conveying device further comprises a holding portion, wherein the holding portion comprises a first impeller and a second impeller, and one end of the holding portion is connected to a tailstock.
[0032] As a preferred technical solution of the utility model, the moving distance of the outer tube is 10mm-200mm.
[0033] The beneficial effects of the utility model are: solving inflammation, endothelialization disorder, late
[0034] While preventing and treating problems such as thrombosis, the utility model can increase the drug transfer volume and increase the diffusion of drugs in the target lesion location; compared with traditional treatment methods such as drug balloons, the utility model can provide stable and lasting treatment effects for the treatment of atherosclerosis, vascular obstruction, stenosis and other diseases; the temporary drug-eluting stent has a recovery device, which can remove the temporary drug-eluting stent after the treatment, avoiding the problems of twisting and breaking of traditional drug-eluting stents in the human body, forming thrombi, and patients taking medicine for life; it can better deliver drugs to the blood vessel wall and the middle membrane of the blood vessel, solving the problems of low drug transfer rate, high drug content, and poor long-term treatment effect in traditional treatment methods; it can expand the diseased and narrow blood vessels by self-expansion or balloon expansion, and the thorns can expand outward when the stent is expanded, passing through lipid substances or calcified lesions that are difficult for the stent to pass through. The barbs carry therapeutic drugs, which help the drugs directly contact the blood vessel wall or the middle layer of the blood vessel, thereby improving the drug transfer rate and treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS
[0035] FIG1 is a schematic diagram of the structure of the utility model;
[0036] FIG2 is a second schematic diagram of the structure of the utility model;
[0037] FIG3 is a third schematic diagram of the structure of the utility model;
[0038] FIG4 is a fourth schematic diagram of the structure of the utility model;
[0039] FIG5 is a fifth schematic diagram of the structure of the utility model;
[0040] FIG6 is a sixth schematic diagram of the structure of the present utility model;
[0041] FIG7 is a seventh schematic diagram of the structure of the utility model;
[0042] FIG8 is an eighth structural diagram of the utility model;
[0043] FIG9 is a ninth structural diagram of the present utility model;
[0044] FIG10 is a tenth schematic diagram of the structure of the utility model;
[0045] FIG11 is a schematic diagram of the structure of the utility model eleven;
[0046] FIG12 is a twelfth schematic diagram of the structure of the present utility model;
[0047] In the figure: 100, support body; 1001, support component; 1002, connecting rod; 101, action part;
[0048] 1011, tip portion; 200, recovery portion; 201, marking portion; 300, balloon portion; 400, conveying device; 401, holding portion; 4011, first impeller; 4012, second impeller; 402, tail stock; 500, outer tube. DETAILED DESCRIPTION
[0049] In order to make the technical means, creative features, objectives and effects of the utility model easier to understand,
[0050] The present invention is further described below in conjunction with specific embodiments.
[0051] Example 1
[0052] As shown in Figures 1-8, the utility model provides a drug-loaded stent, including a stent body 100 and a recovery part 200, wherein the stent body 100 has a plurality of action parts 101 on its surface, and a tip part 1011 located at the end of the action part 101; at least one of the stent body 100, the action part 101, and the tip part 1011 has a coating part, and multiple parts can also be provided as needed, or all of them are provided with coating parts, the coating part is a drug coating, including but not limited to one or more active drugs for treating vascular stenosis, vascular atherosclerosis and other diseases, antiplatelet drugs, anticoagulant drugs, anti-inflammatory drugs, hormones, and anticancer drugs. It can be a pure drug coating or a composite drug coating composed of a drug and a drug substrate, selected from active fat-soluble drugs that are effective against vascular stenosis.
[0053] Preferably, the drugs include but are not limited to paclitaxel, rapamycin and its derivatives, and the drug base is selected to be a hydrophilic substance that combines well with the active drug and can effectively help the active drug to be transferred to the blood vessels. The drug base includes but is not limited to: triethyl citrate, trihexyl citrate, ethyl lactate, benzyl alcohol, citric acid, polysorbate, sorbitol, magnesium stearate, phospholipids, polylactic acid, polyvinyl alcohol, iopromide, iohexol, etc. or their derivatives.
[0054] In this embodiment, preferably, the drug coating is coated on the temporary drug-loaded stent, including but not limited to,
[0055] Coated on the outer surface of the stent, coated on the barbs, coated on the outer surface of the barbs and balloon, coated on the entire
[0056] On the bracket, etc.
[0057] In this embodiment, preferably, the coating method includes but is not limited to ultrasonic spraying, dipping, manual brushing, etc.;
[0058] One end of the stent body 100 has a recovery portion 200, wherein the recovery portion 200 has a marking portion 201.
[0059] The marking part 201 is embedded in the recovery part 200 or installed on the recovery part 200. The recovery structure is fixedly connected to the balloon catheter or the inner tube of the conveyor. The recovery structure can remove the temporary drug-loaded stent from the patient's body after the expansion and drug transfer are completed. Specifically, the recovery part 200 includes a rope type, a buckle type, a spring tube or an inner tube integrated form. The connection method of the recovery structure includes but is not limited to glue bonding, laser welding, hot melt welding, etc. Regarding the marking part 201, it includes but is not limited to being fixed in the card slot in the form of a round block, fixed on the stent rod in the form of a sleeve, etc. The material of the non-radiopaque marking includes but is not limited to gold, platinum iridium, tantalum and its alloys. The stent body 100 includes a plurality of stent components 1001 and a connecting rod 1002 located at the end of the plurality of stent components 1001, wherein the stent component 1001 includes one of a rhombus, a quadrilateral, a W shape, and a V shape. Specifically, the stent component 1001 can be in the form of an open loop or a closed loop.
[0060] The stent body 100 is made of cobalt-based alloy, stainless steel, titanium alloy, nickel-titanium alloy, magnesium alloy, PLA or PLGA.
[0061] The stent body 100 is made of one of the following methods: laser cutting, wire weaving, and 3D printing. The stent body 100 has a length of 10 mm to 200 mm and a diameter of 1 mm to 12 mm. The action portion 101 on the stent body 100 includes a barb integral therewith, the barb angle is 10° to 120°, and the length is 0.2 mm to 5 mm.
[0062] In this embodiment, it is preferably arranged on the side of the bracket, and the tip head can also be bent to the side by heat treatment.
[0063] Example 2
[0064] As shown in Figures 9-12, the utility model provides a delivery system, which has a temporary drug-loaded stent in Example 1, and specifically, also includes a balloon part 300, a delivery device 400 and an outer tube 500, wherein the balloon part 300 passes through the stent body 100, and the stent body 100 and the balloon part 300 are both arranged in the outer tube 500 of the delivery device 400. Specifically, the balloon part 300 is a part of a balloon dilatation catheter, which is composed of a dilatation balloon (balloon part 300), a multi-lumen catheter, a stress diffusion tube and a Y-shaped tail seat. The balloon dilatation catheter can assist the stent in dilation, effectively help the stent to dilate the narrow blood vessels, and help the barbs pass through the lesion site or the inner membrane to improve the drug transfer rate. More specifically, the balloon dilatation catheter can use a marked balloon catheter. The balloon of the balloon dilatation catheter can use a high-pressure balloon, and the rated burst pressure (RBP) of the balloon can be 6-40Mpa. The balloon may be a semi-compliant balloon, a compliant balloon, or the like, with a compliance between 11% and 100%. The balloon diameter D of the balloon dilatation catheter is selected to be 1 to 14 mm. The balloon material is selected to be a polymer material, including but not limited to silicone, TPU, PA, Pebax, or a blend thereof. The surface of the balloon may be loaded with drugs, and therapeutic drugs include but are not limited to paclitaxel, rapamycin, and its derivatives. The balloon dilatation catheter may be used as a stent dilatation component, enter the lesion site together with the stent, and achieve radial support of the stent through balloon expansion.
[0065] Preferably, the balloon dilatation catheter can be used as a post-stent dilatation component, after the stent has completed self-expansion,
[0066] Entering the lesion site to perform post-expansion on the stent can more effectively pass the thorns on the stent through the calcification or lipid accumulation at the lesion site. The outer tube is a hollow structure installed on the outside of the balloon dilatation catheter and the temporary drug-loaded stent. When the temporary drug-loaded stent system is transported from the entrance of the blood vessel to the lesion site, the outer tube of the conveyor is always wrapped around the outside of the balloon dilatation catheter and the temporary drug-loaded stent to prevent the stent or balloon from damaging the blood vessel during the transportation of the temporary drug-loaded stent system. The outer tube of the conveyor is fixedly connected to the conveying connector, and the conveying connector can control the forward and backward movement of the conveying outer tube. After the conveying outer tube reaches the distal end of the vascular lesion, the conveying outer tube is controlled to move backward through the conveying connector to release the balloon dilatation catheter and the temporary drug-loaded stent in the vascular lesion area. After the balloon and stent dilatation treatment is completed, the conveying outer tube is controlled to move forward through the conveyor connector to recycle the balloon and stent into the conveying outer tube, and then the entire temporary drug-loaded stent system is withdrawn from the patient's body to complete the operation.
[0067] The conveying device 400 includes an inner tube connected to the recovery part 200 at one end of the support body 100; the conveying device 400 also includes a gripping part 401, wherein the gripping part 401 includes a first impeller 4011 and a second impeller 4022, and one end of the gripping part 401 is connected to a tailstock 402. The moving distance of the outer tube 500 is 10mm-200mm.
[0068] Example 3
[0069] The utility model provides a drug-loaded stent and a delivery system, which differs from embodiments 1 and 2 in that
[0070] In this embodiment, the drug-loaded stent has a diamond-shaped stent component 1001, and a barb surface is provided with
[0071] The groove can be used to carry drugs; specifically, the stent is a closed-loop diamond structure, so that the stent has the property of circumferential deformation.
[0072] The barbs are distributed at the ends of the individual rhombus units of the stent. The ends of the rhombus units of the stent have a transition from wide to narrow.
[0073] The wider part is connected to the barb tail as a whole, making the barb connection section have higher strength and less prone to
[0074] The barbs are broken or fall off, and the narrower part is connected to the next diamond unit, so that the bracket still has good
[0075] The barb part is connected to the end of the stent with two arc transitions, which makes the stent have better circumferential deformation performance.
[0076] While improving the deformation performance, the barbs are allowed to remain on the central axis without displacement after the stent is expanded.
[0077] The tail of the stent has a recovery structure, which is fixedly connected to the conveyor together with the radiopaque marker. In this embodiment, the stent body 100 is preferably a metal tube made of NiTi shape memory alloy. The NiTi metal tube is laser engraved into a vascular stent according to the above figure, and then the vascular stent is inserted into a heat treatment mold, the vascular stent is expanded and the thorns on the stent are tied with copper wire to turn it inside out, and the stent is placed in a heat treatment furnace for shaping heat treatment, and then taken out and water quenched. Preferably, the heat treatment temperature is in the range of 400°C-550°C, and the heat treatment time is
[0078] The temporary drug-loaded stent that has been heat-treated and shaped is then coated with drugs. Preferably, the drugs coated on the temporary drug-loaded stent can be a pure drug coating or a composite drug coating composed of drugs and drug substrates.
[0079] Preferably, the drug may be, but not limited to, paclitaxel, rapamycin and its derivatives. Preferably, the drug substrate may be, but not limited to, triethyl citrate, trihexyl citrate, ethyl lactate, benzyl alcohol, citric acid, polysorbate, sorbitol, magnesium stearate, phospholipids, polylactic acid, polyvinyl alcohol, iopromide, iohexol, etc. or their derivatives. Preferably, the drug coating is coated on the temporary drug-loaded stent, and may be, but not limited to, coated on the outer surface of the stent, coated on the barbs, coated on the outer surface of the barbs and the balloon, coated on the entire stent, etc. Preferably, the coating method may be, but not limited to, ultrasonic spraying, dipping, manual brushing, etc.
[0080] In this embodiment, rapamycin is selected as the therapeutic drug, phospholipids are used as the drug base, and ultrasonic spraying is used to spray the phospholipids.
[0081] The drug-eluting stent is coated on the outer surface of the temporary drug-eluting stent.
[0082] The conveyor in this embodiment is composed of a conveyor handle, a stress diffusion tube, a conveying inner tube and a conveying outer tube.
[0083] The front end of the conveyor handle is connected to the stress diffusion tube, and the handle is equipped with a knob to control the forward and backward movement of the outer conveyor tube.
[0084] The stent retrieval knob controls the forward and backward movement of the delivery inner tube and the catheter channel through which the balloon dilatation catheter can pass.
[0085] The recovery structure of the drug-loaded stent is fixedly connected to the inner tube of the conveyor, and the recovery of the stent is controlled by the stent recovery knob.
[0086] The conveying tube is fixedly connected to the conveyor handle, and the forward and backward movement of the conveying tube is controlled by the conveying tube telescopic knob.
[0087] The tail catheter channel can pass through the balloon dilatation catheter to assist the expansion of the stent.
[0088] Preferably, the delivery tube can be selected from but not limited to metal braided wire catheter, high-strength polymer braided catheter,
[0089] A spring-wound catheter, etc., is used to prevent the stent from expanding during delivery. The delivery tube is a multi-cavity structure with 2 to 5 cavities, including one or more catheter channels that can pass through a balloon dilatation catheter, a guidewire channel that can pass through a guidewire, and a recovery channel of a stent recovery device.
[0090] In this embodiment, the distal end of the conveyor is provided with a radiopaque marker.
[0091] Fixedly connected to the delivery tube. The radiopaque marker can be developed under X-ray irradiation, which can help the doctor determine the position of the front end of the delivery device in the blood vessel during surgery.
[0092] In this embodiment, the conveyor head has a pointed conical head, which has a smaller volume and better
[0093] Its compliance and moderate hardness enable it to pass through tortuous blood vessels without causing damage.
[0094] In this embodiment, the pointed conical head is radiopaque and can be developed in the blood vessel under X-ray irradiation, assisting the doctor in delivering the temporary drug-carrying device. More specifically, the processed temporary drug-carrying stent is pressed and gripped in the conveyor, and the head end of the stent is aligned with the developing point at the far end of the conveyor, which is convenient for the doctor to confirm the release position of the stent during the operation. The tail of the stent has a wave design, which can effectively improve the cornering performance of the stent tail recovery device. The stent tail recovery device is connected to the conveying inner tube, and the stent recovery knob on the conveyor controls the forward and backward movement of the stent. The conveying outer tube is connected to the conveyor handle, and the conveyor handle can control the forward and backward movement of the conveying outer tube.
[0095] The balloon dilatation catheter in this embodiment uses a high-pressure balloon loaded with rapamycin and has a small
[0096] The outer diameter of the contour can pass through the inner cavity of the conveyor and reach the stent position to perform post-expansion of the stent.
[0097] The temporary drug-loaded stent recovery device is fixedly connected to the conveyor and is controlled by the stent recovery knob.
[0098] The overpressure grip is placed in the delivery tube for protection, and the delivery tube can be controlled by the delivery tube telescopic knob to release the stent.
[0099] The balloon dilatation catheter uses a high-pressure balloon to post-expand the stent. During the operation, the doctor inserts a vascular sheath and a medical guidewire into the patient's blood vessels, passes the guidewire through the narrow position of the vascular lesion, and then inserts the front end of the conveyor loaded with a temporary drug-loaded stent into the patient's body along the guidewire. After pushing the delivery tube to the narrow position of the vascular lesion, the delivery tube telescopic knob on the conveyor handle is rotated to withdraw the delivery tube. The temporary drug-loaded stent in the delivery tube is released due to its self-expansion characteristics, and the narrow blood vessels with lesions are opened. Then the high-pressure balloon dilatation catheter is pushed from the inner cavity catheter passage at the tail of the conveyor handle to the position of the temporary drug-loaded stent, and then the balloon body is filled to assist the stent in post-expansion. The thorns on the temporary drug-loaded stent will pass through the narrow position of the lesion and reach the vascular media. The drug coating on the stent is directly released in the vascular media layer, which has a good therapeutic effect of precise drug administration. After waiting for the drug to diffuse, the stent recovery knob on the conveyor handle is rotated to recover the temporary drug-loaded stent into the delivery tube, and then the delivery tube and the stent are withdrawn from the patient's body together.
[0100] Example 4
[0101] The utility model provides a drug-loaded stent, which is different from Example 1 or 2 in that the drug-loaded stent or delivery system of this embodiment has a transition feature from wide to narrow at the end of the stent rhombus unit, and the wider part is connected to the tail of the barb as a whole, so that the barb connection section has a higher strength and is not prone to barb breakage, falling off, etc. The narrower part is connected to the next rhombus unit, so that the stent still has good circumferential deformation performance. The barb part is connected to the end of the stent with two arc transitions, which not only makes the stent have good circumferential deformation performance, but also allows the barbs to remain on the central axis after the stent is expanded without displacement changes. The tail of the stent has a recovery structure, which is fixedly connected to the conveyor or balloon catheter together with the radiopaque marker. The marking portion 201 can also be a polygonal marker, preferably welded to the stent rod.
[0102] Example 5
[0103] The utility model provides a drug-loaded stent, which is different from embodiment 1 or 2 in that the drug-loaded stent or delivery system of this embodiment has stent circumferential connection sections interlaced with each other, and is composed of a plurality of open-loop structures combined with a closed-loop structure, which reduces the connection units of the stent, so that the stent has higher compliance performance, and is not prone to stent bending or breaking. The stent axial connection units are arranged in an interlaced manner, and are not prone to stent anisotropy. The stent axial unit column tails all have a recovery structure, and when connected to a balloon or a conveyor, they have a high connection strength and are not prone to breaking; in this embodiment, the stent is fixedly connected to the balloon dilatation catheter, and the connection method is a three-layer overlapping connection, the innermost layer is the straight section of the balloon body, the middle layer is the recovery structure of the stent, and the outermost layer is an outer sleeve, and the preferred outer sleeve can be a polymer material tube with heat shrinkage performance, a polymer material tube with light transmission performance, a balloon outer tube, etc. The stent tail recovery structure is fixedly connected to the balloon by glue bonding, laser welding, hot melt welding, etc.
[0104] Example 6
[0105] The utility model provides a drug-loaded stent, which is different from Example 1 or 2 in that, in the drug-loaded stent or delivery system of the present embodiment, different stent units have different edge heights, the stent unit with thorns has a smaller edge height, preferably 1-5mm, and the ordinary stent unit has a larger edge height, preferably 2-8mm. The stent unit with a smaller edge height can provide a stronger supporting force, and can effectively improve the ability of the thorns to penetrate the diseased area, thereby improving the treatment effect. The stent unit with a larger edge height provides normal supporting force for the stent, meets the supporting force required for expanding narrow blood vessels, and has better flexibility; the preferred connection method of the stent unit with a larger edge height can be an arc transition form, and the connection method of the stent unit with a smaller edge height can be a connecting rod form.
[0106] Example 7
[0107] The utility model provides a drug-loaded stent, which is different from the embodiment 1 or 2 in that the drug-loaded stent or delivery system of the present embodiment is made of cobalt-based alloy MP35N, with straight spikes formed by non-heat treatment on the side, a rope recovery device with a developing ring at the bottom fixedly connected to the delivery device, and a drug coating is coated on the outer surface of the stent, which is a combination of rapamycin and sorbitol. The stent is made of non-self-expanding material, and the stent is pressed and gripped on the balloon dilatation catheter before delivery. When the stent reaches the location of the vascular lesion, the radial force of the stent to expand outward is completely provided by the expansion of the balloon catheter.
[0108] Example 8
[0109] The utility model provides a drug-loaded stent, which is different from the embodiment 1 or 2 in that the drug-loaded stent or delivery system of the embodiment, the balloon part in the balloon dilatation catheter uses a compliant balloon, preferably,
[0110] The compliance of the balloon is between 11% and 100%. During the operation, the stent is expanded by filling the balloon.
[0111] During the process, the compliance balloon does not reach its elastic limit, which is not likely to cause damage or destruction of the balloon.
[0112] During the contraction process, the balloon releases pressure and produces elastic retraction. Due to its good compliance, it can retract into a smaller outer shape.
[0113] After the diameter is reached, it is withdrawn together with the bracket.
[0114] Example 9
[0115] The utility model provides a drug-loaded stent, which is different from the embodiment 1 or 2 in that, in the drug-loaded stent or delivery system of the embodiment, after the temporary drug-loaded stent is expanded, the stent is recovered, and the delivery device and the catheter are left at the vascular lesion, and then a drug balloon catheter is introduced to perform post-expansion on the lesion site and drug diffusion. After the drug diffusion is completed, the drug balloon and the delivery device are withdrawn from the patient's body together.
[0116] Example 10
[0117] The utility model provides a drug-loaded stent, which is different from embodiment 1 or 2 in that the drug-loaded stent or delivery system of this embodiment, the delivery device is composed of a delivery device outer tube, a push handle, a reinforcement tube and a fixed handle, the delivery device outer tube is fixedly connected to the push handle, the reinforcement tube is fixedly connected to the fixed handle, the fixed handle is fixedly connected to the outer tube of the balloon dilatation catheter, and the rear of the push handle has a circular base, which is convenient for doctors to hold the push handle and move it forward and backward during the operation to achieve the forward and backward movement of the delivery outer tube, so as to achieve the release of the temporary drug-loaded stent and the balloon at the vascular lesion. There are two side wings on both sides of the fixed handle, which is convenient for doctors to hold the fixed handle during the operation so that the fixed handle does not rotate. The reinforcement tube can effectively guarantee the pushing effect, prevent the pushing outer tube from bending, and maintain a good pushing force. The combination of the push handle, the pushing outer tube, the fixed handle and the reinforcement tube can effectively assist doctors in achieving the release and recovery of the temporary drug-loaded stent and the balloon during the operation.
[0118] The utility model solves the problems of inflammation, endothelialization disorder, late thrombosis, etc. caused by implantation of drug-loaded stent.
[0119] At the same time, the drug transfer amount is increased, and the drug diffusion in the target lesion position is increased; compared with traditional treatment methods such as drug balloons, the utility model can provide stable and lasting treatment effects; the temporary drug-loaded stent has a recovery device, which can remove the temporary drug-loaded stent after the treatment is completed, avoiding the problems of twisting and breaking of traditional drug-eluting stents in the human body, forming thrombi, and patients taking medicine for life; it can better deliver drugs to the blood vessel wall and the vascular membrane, solving the problems of low drug transfer rate, high drug content, and poor long-term treatment effect in traditional treatment methods; it can expand the stenotic blood vessels by self-expansion or balloon expansion, and the thorns can expand outward when the stent is expanded, passing through lipid substances or calcified lesions that are difficult for the stent to pass through. The barbs carry therapeutic drugs, which help the drugs to directly contact the blood vessel wall or the middle layer of the blood vessel, thereby improving the drug transfer rate and treatment effect; the barbs carry anti-stenosis drugs that can treat atherosclerosis, and the thorns can easily pass through the lipid substances or calcified lesions of the stenotic blood vessels during the expansion process, effectively helping the drugs to pass through the obstacles and diffuse to the vascular membrane, achieving a higher drug transfer rate and good treatment effect. It solves the dilemma of poor therapeutic effect of drug balloon in the case of severe vascular stenosis and severe calcification; due to its special drug delivery method, the overall drug content is low, which does not affect the therapeutic effect while reducing the damage to the patient's body caused by excessive drug concentration;
[0120] It can prevent the drug from entering the blood and causing drug loss during the delivery process before reaching the lesion. When the temporary drug-loaded stent reaches the lesion, the delivery tube telescopic knob on the conveyor can be used to control the forward and backward movement of the delivery tube, so as to realize the function of releasing and self-expanding the temporary drug-loaded stent at the lesion site; after the temporary drug-loaded stent self-expands, it enters through the catheter passage at the proximal end of the conveyor to assist in re-expanding the temporary drug-loaded stent, helping the thorns on the temporary drug-loaded stent to smoothly pass through the vascular lesions and calcification sites. It ensures the delivery and transfer of drugs and provides good drug treatment effects; it moves forward and backward under the control of the stent recovery knob on the conveyor. After the drug diffuses to the lesion site, the temporary drug-loaded stent can be recovered through the conveyor recovery knob, leaving no foreign matter in the patient's body. It solves the adverse problems of endothelialization disorders, inflammation, late thrombosis, etc. caused by traditional implantable stents in the patient's body.
[0121] The above shows and describes the basic principles, main features and advantages of the utility model.
[0122] Personnel should understand that the present invention is not limited to the above-mentioned embodiments, and the present invention is not limited to the above-mentioned embodiments.
[0123] The present invention may also have various changes and improvements within the scope of the present invention, and these changes and improvements are within the scope of the present invention.
[0124] The scope of protection required by the utility model is determined by the attached claims and their equivalents.
[0125] Definition of effect.
Claims
1. A drug-eluting stent, characterized in that: The invention comprises a stent body (100) and a recovery part (200), wherein the stent body (100) has a plurality of action parts (101) and a tip part (1011) located at the end of the action part (101) on its surface; at least one of the stent body (100), the action part (101) and the tip part (1011) has a coating part; One end of the stent body (100) has the recovery portion (200), wherein the recovery portion (200) has a marking portion (201), and the marking portion (201) is embedded in the recovery portion (200) or installed on the recovery portion (200); The support body (100) comprises a plurality of support components (1001) and connecting rods (1002) located at the ends of the plurality of support components (1001), wherein the support components (1001) comprise one of a rhombus, a quadrilateral, a W shape, and a V shape.
2. The drug-loaded stent according to claim 1, characterized in that: The support body (100) The stent body (100) is made of one of cobalt-based alloy, stainless steel, titanium alloy, nickel-titanium alloy, magnesium alloy, PLA or PLGA, wherein the stent body (100) is formed by one of laser cutting, wire weaving and 3D printing.
3. The drug-loaded stent according to claim 1, characterized in that: The length of the stent body (100) is 10 mm to 200 mm, and the diameter is 1 mm to 12 mm, wherein the action portion (101) on the stent body (100) includes barbs integral therewith.
4. A drug-loaded stent according to claim 1 or 2, characterized in that: The recovery part (200) includes a rope type, a snap-on type, a spring tube or an inner tube integrated form.
5. The drug-loaded stent according to claim 3, characterized in that: The barb has an angle of 10°-120° and a length of 0.2mm-5mm.
6. A delivery system comprising a drug-loaded stent according to any one of claims 1 to 5, characterized in that: It also includes a balloon portion (300), a conveying device (400) and an outer tube (500), wherein the balloon portion (300) passes through the stent body (100), and the stent body (100) and the balloon portion (300) are both arranged in the outer tube (500) of the conveying device (400).
7. A conveying system according to claim 6, characterized in that: The conveying device (400) comprises an inner tube, which is connected to the recovery part (200) at one end of the support body (100); the conveying device (400) also comprises a holding part (401), wherein the holding part (401) comprises a first impeller (4011) and a second impeller (4022), and one end of the holding part (401) is connected to the tailstock (402).
8. A conveying system according to claim 7, characterized in that: The moving distance of the outer tube (500) is 10 mm-200 mm.
